{
  "schema_version": "chamgap-public-evidence-check-1.0",
  "public_id": "v2925-s1",
  "verdict_number": "2925",
  "title": "Darbepoetin alfa × Neurodevelopment in preterm infants — Evidence sheet with separate follow-up unverified",
  "view_version": "1.0",
  "view_created_date": "2026-10-10",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "review_date": null,
  "legacy_evidence_date": "2026-08-26",
  "review_scope": {
    "materials_read": "Existing review summaries and stored records of methodological application",
    "clinical_papers_directly_read": false,
    "new_clinical_search": false,
    "limitation": "The complete stored review summary was read for production and the original URLs and identifiers were linked. External abstracts, full texts, registrations, protocols, SAPs and linked verdicts were not newly read or checked.",
    "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature."
  },
  "claim_context": {
    "population": "Preterm infants with birth weight 500~1250 g, enrolled within 48 hours of birth; detailed baseline and eligibility information unread",
    "intervention": "Historical research exposure to darbepoetin alfa; no recommendation on transfusion or developmental treatment selection",
    "dose": "The original 10µg/kg once weekly and 35-week stopping condition are retained as history only; no individual administration, dose or suitability guidance",
    "comparator": "Placebo/sham and a standardized transfusion protocol; details of the other arm in the three-arm trial and concurrent exposures unread",
    "endpoint": "Original claim of improved neurodevelopment; subclaim '?', separate two-year secondary follow-up and direct instruments/values/denominators unverified",
    "duration": "The hospitalization/35-week research exposure and transfusion window are distinguished from separate two-year developmental follow-up; details of age definitions and actual duration unread",
    "excluded_extensions": [
      "Combining mean transfusions, transfusion-free status, donors and developmental assessment as the same effect",
      "Replacing '?' uniformly with D/B or inventing follow-up values, instruments or bibliography",
      "Counting follow-up, two questions or the same infants as new independent evidence",
      "Transferring effects from other ESAs or encephalopathy/cancer indications",
      "Recommendations on transfusion, dose, administration, suitability, product selection or treatment"
    ]
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Comparative efficacy",
      "question": "Were the selected claim and its subclaim grade distinguished from the parent verdict?",
      "needed": "Separate preservation of the existing claim, grade, note and parent values",
      "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 existing claim, grade, note and parent values",
      "basis": "Improved neurodevelopment",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Link additional material separately to each existing question and its parent context.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The selected claim is 'Improved neurodevelopment', with the subclaim grade retained as '?' from the stored summary. The note says this is a separate follow-up outcome rather than the primary endpoint of the main outcome paper. These are preserved separately from the parent B72 and Caution status.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Missing subclaim scores, status and axes are not filled with parent values. '?' is not uniformly replaced with D or confirmed B, and no new verdict is made.",
      "missingness": "Missing subclaim scores, status and axes are not filled with parent values. '?' is not uniformly replaced with D or confirmed B, and no new verdict is made.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Missing subclaim scores, status and axes are not filled with parent values. '?' is not uniformly replaced with D or confirmed B, and no new verdict is made."
    },
    {
      "item_id": "N02",
      "question_type": "Comparative efficacy",
      "question": "What were the actual birth weight, enrollment timing and preterm population?",
      "needed": "Original eligibility, baseline, birth weight, enrollment age 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 eligibility, baseline, birth weight, enrollment age and denominators",
      "basis": "Improved neurodevelopment",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original eligibility, baseline, weight, gestational age and enrollment/treatment timing material.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The existing review summary states that preterm infants with birth weight 500~1250 g were included within 48 hours of birth.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not extend this to all newborns, other weights/gestational ages or other anemia/encephalopathy indications. Detailed gestational age, eligibility exclusions and baseline risk are unread.",
      "missingness": "Do not extend this to all newborns, other weights/gestational ages or other anemia/encephalopathy indications. Detailed gestational age, eligibility exclusions and baseline risk are unread.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not extend this to all newborns, other weights/gestational ages or other anemia/encephalopathy indications. Detailed gestational age, eligibility exclusions and baseline risk are unread."
    },
    {
      "item_id": "N03",
      "question_type": "Comparative efficacy",
      "question": "Were darbepoetin and sham study identity distinguished from common care?",
      "needed": "Original drug, placebo/sham, concurrent treatment, baseline care 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 drug, placebo/sham, concurrent treatment, baseline care and actual exposure",
      "basis": "Improved neurodevelopment",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original drug, sham, common care, concurrent treatment and actual exposure material.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The existing review summary records darbepoetin, sham and standardized transfusion criteria.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not extend this to specific products, administration routes or other drugs, or fill in such details. Original details of concurrent exposures such as iron/nutrition are unread.",
      "missingness": "Do not extend this to specific products, administration routes or other drugs, or fill in such details. Original details of concurrent exposures such as iron/nutrition are unread.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not extend this to specific products, administration routes or other drugs, or fill in such details. Original details of concurrent exposures such as iron/nutrition are unread."
    },
    {
      "item_id": "N04",
      "question_type": "Comparative efficacy",
      "question": "Are 10µg/kg once weekly and the stopping time historical exposure conditions?",
      "needed": "Original study plan, dose, frequency, stopping time 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 study plan, dose, frequency, stopping time and actual exposure",
      "basis": "Improved neurodevelopment",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original exposure plan, age definitions and tables of actual completion, missed doses, dose reduction or discontinuation.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The existing Korean text retains 10µg/kg once weekly through 35 weeks of corrected gestational age, while the English text states through 35 weeks gestation as the research condition.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not turn this condition into individual instructions for administration, scheduling, stopping or suitability. Do not arbitrarily redefine the original gestational-age wording or certify that everyone actually completed treatment.",
      "missingness": "Do not turn this condition into individual instructions for administration, scheduling, stopping or suitability. Do not arbitrarily redefine the original gestational-age wording or certify that everyone actually completed treatment.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not turn this condition into individual instructions for administration, scheduling, stopping or suitability. Do not arbitrarily redefine the original gestational-age wording or certify that everyone actually completed treatment."
    },
    {
      "item_id": "N05",
      "question_type": "Comparative efficacy",
      "question": "Were 102 infants, 34 per arm and the three-arm design distinguished?",
      "needed": "Allocation, arm identity, arm-specific analyses, missing data 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": "Allocation, arm identity, arm-specific analyses, missing data and denominators",
      "basis": "Improved neurodevelopment",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original three-arm identities, allocation, analysis populations, missing data and participant flow.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The existing review summary and evidence list describe a multicenter masked placebo-controlled three-arm trial with 102 infants and 34 per arm.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not invent the remaining arm's drug, dose or effect from the numbers in the two displayed arms. Outcome-specific analysis, dropout and follow-up denominators are separately unread.",
      "missingness": "Do not invent the remaining arm's drug, dose or effect from the numbers in the two displayed arms. Outcome-specific analysis, dropout and follow-up denominators are separately unread.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not invent the remaining arm's drug, dose or effect from the numbers in the two displayed arms. Outcome-specific analysis, dropout and follow-up denominators are separately unread."
    },
    {
      "item_id": "N06",
      "question_type": "Comparative efficacy",
      "question": "Were other study arms, other ESAs and verdict 2798 combined as the same result?",
      "needed": "Original arm identities, ESAs, comparisons, indications and outcome 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 arm identities, ESAs, comparisons, indications and outcome relationships",
      "basis": "Improved neurodevelopment",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original material separately for each drug, arm, indication and direct comparison.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The existing review summary contains the three-arm trial and a cross-citation to high-dose epoetin alfa in verdict 2798 for a different encephalopathy indication.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not fill missing details of other arms with verdict 2798 values, or use that verdict to establish direct superiority/equivalence among ESAs or no effect on transfusion/development in preterm infants.",
      "missingness": "Do not fill missing details of other arms with verdict 2798 values, or use that verdict to establish direct superiority/equivalence among ESAs or no effect on transfusion/development in preterm infants.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not fill missing details of other arms with verdict 2798 values, or use that verdict to establish direct superiority/equivalence among ESAs or no effect on transfusion/development in preterm infants."
    },
    {
      "item_id": "N07",
      "question_type": "Comparative efficacy",
      "question": "What were the roles of standardized restrictive transfusion criteria and clinicians' decisions?",
      "needed": "Transfusion thresholds, Hb/Hct, respiratory support, symptoms, records and deviations",
      "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": "Transfusion thresholds, Hb/Hct, respiratory support, symptoms, records and deviations",
      "basis": "Improved neurodevelopment",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original protocol, implementation/deviations, records, arm-specific criteria and denominators.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The existing review summary records a standardized restrictive protocol based on Hb/Hct, respiratory support and symptoms, and actual blood administration records as the basis for treating transfusion as a hard endpoint.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not invent individual transfusion thresholds or procedures. Details of standardized implementation/deviations and other institutions' transfusion policies are unread.",
      "missingness": "Do not invent individual transfusion thresholds or procedures. Details of standardized implementation/deviations and other institutions' transfusion policies are unread.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not invent individual transfusion thresholds or procedures. Details of standardized implementation/deviations and other institutions' transfusion policies are unread."
    },
    {
      "item_id": "N08",
      "question_type": "Comparative efficacy",
      "question": "Were mean transfusions per infant and the ± notation preserved as recorded?",
      "needed": "Original counts, statistic, dispersion, arm order, duration 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 counts, statistic, dispersion, arm order, duration and denominators",
      "basis": "Improved neurodevelopment",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original dispersion type, denominators, duration, count distribution, model and test.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "Transfusions were 1.2±2.4 with darbepoetin versus 2.4±2.9 with placebo. The existing reader answer records a mean of 1.2 versus 2.4 transfusions per infant.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not newly identify ± as SD, SE or CI. Do not calculate event counts, transfused infant counts, total blood volume, donor counts, RR, P or CI.",
      "missingness": "Do not newly identify ± as SD, SE or CI. Do not calculate event counts, transfused infant counts, total blood volume, donor counts, RR, P or CI.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not newly identify ± as SD, SE or CI. Do not calculate event counts, transfused infant counts, total blood volume, donor counts, RR, P or CI."
    },
    {
      "item_id": "N09",
      "question_type": "Comparative efficacy",
      "question": "Was the original absolute reduction of 1.2 transfusions distinguished from preventing an infant from receiving a transfusion?",
      "needed": "Original mean difference, effect, observation duration, denominators and uncertainty",
      "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 mean difference, effect, observation duration, denominators and uncertainty",
      "basis": "Improved neurodevelopment",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original mean difference, model, interval, test, duration and denominators.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The existing reader answer describes an absolute reduction of 1.2 transfusions per infant.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not turn the mean difference into the same 1.2 reduction for every individual or a risk difference for receiving transfusion. There are no new mean differences, CIs, P values, total savings or event examples.",
      "missingness": "Do not turn the mean difference into the same 1.2 reduction for every individual or a risk difference for receiving transfusion. There are no new mean differences, CIs, P values, total savings or event examples.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not turn the mean difference into the same 1.2 reduction for every individual or a risk difference for receiving transfusion. There are no new mean differences, CIs, P values, total savings or event examples."
    },
    {
      "item_id": "N10",
      "question_type": "Comparative efficacy",
      "question": "Were the hospitalization transfusion-free proportions of 59% and 38% distinguished from the original 21%p difference?",
      "needed": "Transfusion-free definition, people, duration, denominators and original difference",
      "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": "Transfusion-free definition, people, duration, denominators and original difference",
      "basis": "Improved neurodevelopment",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original transfusion-free criteria, arm denominators, infant counts, duration, CI and test.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The original text records transfusion-free proportions of 59% versus 38%, an original absolute increase of 21%p.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not convert proportions into infant counts, RR, NNT or transfusion-free status for all periods. Details of original event counts, outcome denominators, CI and P are unread.",
      "missingness": "Do not convert proportions into infant counts, RR, NNT or transfusion-free status for all periods. Details of original event counts, outcome denominators, CI and P are unread.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not convert proportions into infant counts, RR, NNT or transfusion-free status for all periods. Details of original event counts, outcome denominators, CI and P are unread."
    },
    {
      "item_id": "N11",
      "question_type": "Comparative efficacy",
      "question": "Are transfusion counts, transfusion-free status and donor exposure the same measure?",
      "needed": "Counts, people, donors, blood volume and each denominator",
      "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": "Counts, people, donors, blood volume and each denominator",
      "basis": "Improved neurodevelopment",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original definitions for each measure, people/events, denominators and donor/blood-volume material.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The existing summary and citations describe reduced transfusion counts and donor exposure, and record the transfusion-free proportion separately.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not fill missing donor values or totals with transfusion values. Do not count multiple measures or repeated transfusions as new participants or independent trials.",
      "missingness": "Do not fill missing donor values or totals with transfusion values. Do not count multiple measures or repeated transfusions as new participants or independent trials.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not fill missing donor values or totals with transfusion values. Do not count multiple measures or repeated transfusions as new participants or independent trials."
    },
    {
      "item_id": "N12",
      "question_type": "Comparative efficacy",
      "question": "Were the hospitalization/35-week stopping window and two-year developmental follow-up distinguished?",
      "needed": "Intervention window, transfusion observation window, follow-up age, original duration 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": "Intervention window, transfusion observation window, follow-up age, original duration and denominators",
      "basis": "Improved neurodevelopment",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain each original duration, age definition, exposure, discharge, follow-up and denominator.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The parent record preserves the historical judgment that the period through 35 weeks matched the natural course of transfusion during hospitalization, and records separate two-year developmental follow-up.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not substitute long-term developmental assessment for the short intervention window or assume the same follow-up duration for all participants. Details of the exact end of transfusion observation, actual exposure and postnatal age are unread.",
      "missingness": "Do not substitute long-term developmental assessment for the short intervention window or assume the same follow-up duration for all participants. Details of the exact end of transfusion observation, actual exposure and postnatal age are unread.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not substitute long-term developmental assessment for the short intervention window or assume the same follow-up duration for all participants. Details of the exact end of transfusion observation, actual exposure and postnatal age are unread."
    },
    {
      "item_id": "N13",
      "question_type": "Comparative efficacy",
      "question": "What were the original computer block allocation, caregiver/investigator masking and sham procedures?",
      "needed": "Original allocation, concealment, masking, transfusion records and analysts",
      "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, masking, transfusion records and analysts",
      "basis": "Improved neurodevelopment",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original allocation, masking, recording, analysis and missing-data procedures.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The existing review summary records computer block randomization, caregiver/investigator masking, sham and standardized transfusion criteria as the historical basis for counting no additional defects.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not certify independent review of the original paper's procedures in this work or newly certify absence of bias. Detailed allocation concealment, analyst, missing-data and assessor procedures are unread.",
      "missingness": "Do not certify independent review of the original paper's procedures in this work or newly certify absence of bias. Detailed allocation concealment, analyst, missing-data and assessor procedures are unread.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not certify independent review of the original paper's procedures in this work or newly certify absence of bias. Detailed allocation concealment, analyst, missing-data and assessor procedures are unread."
    },
    {
      "item_id": "N14",
      "question_type": "Comparative efficacy",
      "question": "What is the actual access status for primary transfusion, secondary developmental follow-up and registration plans?",
      "needed": "Original endpoint hierarchy, registration, protocol, SAP, changes and multiplicity",
      "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 endpoint hierarchy, registration, protocol, SAP, changes and multiplicity",
      "basis": "Improved neurodevelopment",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original registration, plans, hierarchy, changes, multiplicity and analysis-population material.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The existing review summary states that transfusion count was prespecified primary, while neurodevelopment was a planned separate two-year secondary follow-up rather than primary in the main paper. The registration identifier is NCT00334737.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Registrations, full texts, plans and follow-up reports are not newly read. Do not invent test P values, α, ordering, multiplicity or changes to follow-up plans.",
      "missingness": "Registrations, full texts, plans and follow-up reports are not newly read. Do not invent test P values, α, ordering, multiplicity or changes to follow-up plans.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Registrations, full texts, plans and follow-up reports are not newly read. Do not invent test P values, α, ordering, multiplicity or changes to follow-up plans."
    },
    {
      "item_id": "N15",
      "question_type": "Comparative efficacy",
      "question": "Were the main paper, separate follow-up and relationships among the same participants distinguished?",
      "needed": "Original reports, follow-up bibliography, registration, assessment age and population mapping",
      "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 reports, follow-up bibliography, registration, assessment age and population mapping",
      "basis": "Improved neurodevelopment",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original follow-up bibliography, registration, arm-specific assessments and population/follow-up mapping.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The existing citation is the Ohls 2013 main paper, and the existing review summary describes planned/published separate two-year follow-up. It does not provide the specific bibliography, URL or result tables of that follow-up paper.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not count follow-up assessments of the same trial, two questions or other ESAs as independent trials or new participants. Final independent counts and total participants remain null.",
      "missingness": "Do not count follow-up assessments of the same trial, two questions or other ESAs as independent trials or new participants. Final independent counts and total participants remain null.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not count follow-up assessments of the same trial, two questions or other ESAs as independent trials or new participants. Final independent counts and total participants remain null."
    },
    {
      "item_id": "N16",
      "question_type": "Comparative efficacy",
      "question": "What are the gaps in direct neurodevelopmental effects, instruments and denominators?",
      "needed": "Original follow-up paper, assessment instruments, original scales, arm denominators, effects and intervals",
      "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 follow-up paper, assessment instruments, original scales, arm denominators, effects and intervals",
      "basis": "Improved neurodevelopment",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original follow-up paper, instruments, denominators, models, effects, intervals and tests.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The existing review summary describes separate two-year secondary follow-up but does not provide the developmental scores, between-arm effects, CIs, P values, original instruments or assessment denominators. The subclaim grade '?' remains unchanged.",
      "condition_status": "Unverified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not fill developmental effects with transfusion values or encephalopathy values for other ESAs. There are no new scale names, effects, scores, grades or clinical confirmations.",
      "missingness": "Do not fill developmental effects with transfusion values or encephalopathy values for other ESAs. There are no new scale names, effects, scores, grades or clinical confirmations.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not fill developmental effects with transfusion values or encephalopathy values for other ESAs. There are no new scale names, effects, scores, grades or clinical confirmations."
    },
    {
      "item_id": "N17",
      "question_type": "Comparative efficacy",
      "question": "Were two-year assessment age, survivors, dropout, missing data and repeated assessments distinguished?",
      "needed": "Corrected/chronological age, assessment population, survival, dropout, instruments and missing-data 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": "Corrected/chronological age, assessment population, survival, dropout, instruments and missing-data handling",
      "basis": "Improved neurodevelopment",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original assessment age, survival/follow-up flow, arm denominators, instruments and missing-data handling.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The stored summary records a two-year follow-up plan and separate outcomes.",
      "condition_status": "Unverified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not invent corrected-age definitions, survivor denominators, assessment completion, dropout, repeated assessments or institution-specific values. Do not use the initial 102 infants as the follow-up completer denominator.",
      "missingness": "Do not invent corrected-age definitions, survivor denominators, assessment completion, dropout, repeated assessments or institution-specific values. Do not use the initial 102 infants as the follow-up completer denominator.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not invent corrected-age definitions, survivor denominators, assessment completion, dropout, repeated assessments or institution-specific values. Do not use the initial 102 infants as the follow-up completer denominator."
    },
    {
      "item_id": "N18",
      "question_type": "Comparative efficacy",
      "question": "Were primary/secondary hierarchy, multiple developmental scales and clinical function established?",
      "needed": "Original secondary-outcome plan, scales, multiplicity, models, function and plan changes",
      "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 secondary-outcome plan, scales, multiplicity, models, function and plan changes",
      "basis": "Improved neurodevelopment",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original follow-up plan, scales, hierarchy, changes, multiplicity and clinical-function material.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The existing review summary states that development was separate secondary follow-up rather than primary in the main paper.",
      "condition_status": "Unverified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not newly decide which developmental scales, subscales, clinical disabilities or functions were prespecified key outcomes. Do not transfer transfusion success to success across multiple developmental outcomes.",
      "missingness": "Do not newly decide which developmental scales, subscales, clinical disabilities or functions were prespecified key outcomes. Do not transfer transfusion success to success across multiple developmental outcomes.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not newly decide which developmental scales, subscales, clinical disabilities or functions were prespecified key outcomes. Do not transfer transfusion success to success across multiple developmental outcomes."
    },
    {
      "item_id": "N19",
      "question_type": "Comparative efficacy",
      "question": "Was a separate follow-up report certified as an independent trial or individual neuroprotection?",
      "needed": "Original trial, same population, follow-up bibliography, drugs and direct long-term 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": "Original trial, same population, follow-up bibliography, drugs and direct long-term outcomes",
      "basis": "Improved neurodevelopment",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original registration, follow-up bibliography, same-population mapping and direct long-term outcomes.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "There is only a reference to separate follow-up of the same trial; the specified existing review summary contains no corresponding bibliography or effects.",
      "condition_status": "Unverified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. A reference to follow-up publication alone does not establish independent replication, neuroprotection, individual effects or confirmation for other ESAs/indications.",
      "missingness": "A reference to follow-up publication alone does not establish independent replication, neuroprotection, individual effects or confirmation for other ESAs/indications.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "A reference to follow-up publication alone does not establish independent replication, neuroprotection, individual effects or confirmation for other ESAs/indications."
    },
    {
      "item_id": "N20",
      "question_type": "Comparative efficacy",
      "question": "What are the small-study, original sample-size design and precision gaps?",
      "needed": "Original size, assumptions, plan, dropout, intervals and clinical importance",
      "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 size, assumptions, plan, dropout, intervals and clinical importance",
      "basis": "Improved neurodevelopment",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original size assumptions, power, dropout handling, intervals and clinical boundaries.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The existing review summary records 102 infants, 34 per arm, a sample-size plan adding dropout allowance to 27 per arm, and the historical judgment of one small-study item.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not convert this into new power, success probabilities, parent scores or subclaim scores. Original assumption, MCID and CI details are unread, and there is no new sample-size calculation.",
      "missingness": "Do not convert this into new power, success probabilities, parent scores or subclaim scores. Original assumption, MCID and CI details are unread, and there is no new sample-size calculation.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not convert this into new power, success probabilities, parent scores or subclaim scores. Original assumption, MCID and CI details are unread, and there is no new sample-size calculation."
    },
    {
      "item_id": "N21",
      "question_type": "Comparative efficacy",
      "question": "Were public/nonprofit research funding and Amgen antibody assays distinguished?",
      "needed": "Cash, products/in-kind support, assay provision, affiliations, analysis and 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, products/in-kind support, assay provision, affiliations, analysis and roles",
      "basis": "Improved neurodevelopment",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original disclosures of cash, drugs/in-kind support, assays, affiliations, design, analysis and writing.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "Support from Thrasher Research Fund, Colorado CTSI and NIH/NCRR/NCATS and Amgen's antibody assay work are retained. The existing review summary records that study-drug supply and trial funding were not disclosed.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not turn antibody assays into external efficacy analysis of the entire trial or certification of no study-drug/funding provision. Employee authors and other roles are separately unread.",
      "missingness": "Do not turn antibody assays into external efficacy analysis of the entire trial or certification of no study-drug/funding provision. Employee authors and other roles are separately unread.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not turn antibody assays into external efficacy analysis of the entire trial or certification of no study-drug/funding provision. Employee authors and other roles are separately unread."
    },
    {
      "item_id": "N22",
      "question_type": "Supplementary harm evidence",
      "question": "Were similar prematurity morbidity/ROP and the original safety denominators distinguished?",
      "needed": "Harm definitions, grades, events/people, exposure, denominators and relatedness",
      "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 definitions, grades, events/people, exposure, denominators and relatedness",
      "basis": "Improved neurodevelopment",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original harm definitions, arm-specific events/people, denominators, exposure, relatedness and tests.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The original safety text describes similar prematurity morbidity and retinopathy of prematurity across arms; the parent safety status is Caution.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not turn this into absence of all harms, equivalence or zero events for a specific harm. Details of each original event, denominator, CI, P, relatedness and collection are unread.",
      "missingness": "Do not turn this into absence of all harms, equivalence or zero events for a specific harm. Details of each original event, denominator, CI, P, relatedness and collection are unread.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not turn this into absence of all harms, equivalence or zero events for a specific harm. Details of each original event, denominator, CI, P, relatedness and collection are unread."
    },
    {
      "item_id": "N23",
      "question_type": "Supplementary harm evidence",
      "question": "Was a trial with 102 infants used to exclude rare/long-term harms or discontinuations?",
      "needed": "Rare harms, actual exposure, duration, discontinuations and safety population",
      "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": "Rare harms, actual exposure, duration, discontinuations and safety population",
      "basis": "Improved neurodevelopment",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original safety population, actual exposure, discontinuations, collection and rare/long-term harm material.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The existing review summary records that 102 infants are too few to exclude rare harms, and that long-term neurodevelopment and safety are separate questions.",
      "condition_status": "Unverified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Retain the original blood pressure, thrombosis and blood-count monitoring text as history only; do not create implementation instructions, new risk rates, P values, CIs or long-term safety claims.",
      "missingness": "Retain the original blood pressure, thrombosis and blood-count monitoring text as history only; do not create implementation instructions, new risk rates, P values, CIs or long-term safety claims.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Retain the original blood pressure, thrombosis and blood-count monitoring text as history only; do not create implementation instructions, new risk rates, P values, CIs or long-term safety claims."
    },
    {
      "item_id": "N24",
      "question_type": "Supplementary harm evidence",
      "question": "Were development and other ESAs/indications combined as the same harm or clinical effect?",
      "needed": "Developmental outcomes, other drugs, populations, indications and direct comparisons",
      "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": "Developmental outcomes, other drugs, populations, indications and direct comparisons",
      "basis": "Improved neurodevelopment",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain direct effects/harms and report relationships for each population, drug and indication.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The original verdict 2798 cross-citation concerns high-dose epoetin alfa for hypoxic-ischemic encephalopathy treatment: the same ESA class but a different indication.",
      "condition_status": "Unverified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not transfer cancer/encephalopathy judgments for other indications to transfusion or development in preterm infants. Do not create instructions on product/transfusion/drug/treatment selection, use or suitability.",
      "missingness": "Do not transfer cancer/encephalopathy judgments for other indications to transfusion or development in preterm infants. Do not create instructions on product/transfusion/drug/treatment selection, use or suitability.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not transfer cancer/encephalopathy judgments for other indications to transfusion or development in preterm infants. Do not create instructions on product/transfusion/drug/treatment selection, use or suitability."
    },
    {
      "item_id": "N25",
      "question_type": "Comparative efficacy",
      "question": "Were original bibliography, cross-citations, registration identifiers and access to follow-up material distinguished?",
      "needed": "Reports/related verdicts, original URLs, registration and material-specific access status",
      "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/related verdicts, original URLs, registration and material-specific access status",
      "basis": "Improved neurodevelopment",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Link user-provided original material by report type, assessment age and access status.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "Ohls 2013 PubMed PMID23776118, NCT00334737 and the original link to related verdict 2798 are retained. The existing review summary contains no separate follow-up bibliography.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. External abstracts, full texts, registrations, plans, follow-up reports and linked verdicts are unread, with no separate link testing. Do not invent DOIs, URLs or paper titles.",
      "missingness": "External abstracts, full texts, registrations, plans, follow-up reports and linked verdicts are unread, with no separate link testing. Do not invent DOIs, URLs or paper titles.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "External abstracts, full texts, registrations, plans, follow-up reports and linked verdicts are unread, with no separate link testing. Do not invent DOIs, URLs or paper titles."
    },
    {
      "item_id": "N26",
      "question_type": "Comparative efficacy",
      "question": "Were the Korean/English texts, axes, reference date, corrections, empty values, candidate history and production status retained?",
      "needed": "Distinguishing the selected verdict record, complete parent, languages and history from current production",
      "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": "Distinguishing the selected verdict record, complete parent, languages and history from current production",
      "basis": "Improved neurodevelopment",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Link only user material/decisions as separate events after preserving the complete original text.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The original 2026-08-26 date, empty correction/deliberation values, parent B72, Caution, axes, Korean/English texts, selected subclaim B/'?' and notes are preserved.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Original judgments of hard endpoints, independence and design defects are historical, not certification of review in this work. Missing subclaim values are not filled, and the original review-pending/production-eligibility labels are history.",
      "missingness": "Original judgments of hard endpoints, independence and design defects are historical, not certification of review in this work. Missing subclaim values are not filled, and the original review-pending/production-eligibility labels are history.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original judgments of hard endpoints, independence and design defects are historical, not certification of review in this work. Missing subclaim values are not filled, and the original review-pending/production-eligibility labels are history."
    }
  ],
  "reports": [
    {
      "report_id": "R01",
      "title": "Ohls RK, Christensen RD, Kamath-Rayne BD, et al. A Randomized, Masked, Placebo-Controlled Study of Darbepoetin Alfa in Preterm Infants. Pediatrics. 2013;132(1):e119-e127. PMID: 23776118.",
      "url": "https://pubmed.ncbi.nlm.nih.gov/23776118/",
      "report_type": "Original trial paper report",
      "existence": "Preserved information from the existing citation and evidence lists",
      "acquired_read": "Summary read; external or linked material unread",
      "study_family": "F01",
      "independent_replication": false,
      "observed_result": "Darbepoetin 1.2±2.4 versus placebo 2.4±2.9 transfusions; transfusion-free 59% versus 38%",
      "result_level": "Existing review summary; no comparison with the external original report",
      "source_evidence_date": "2026-08-26",
      "materials": [
        {
          "material_type": "local_summary",
          "public_status": "Original URL preserved",
          "access_status": "Summary read",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-08-26",
          "qualification": "Preserved parent verdict summary; report-specific links to the same stored summary copy"
        },
        {
          "material_type": "abstract",
          "public_status": "Original URL preserved",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External or linked verdict material unread; a URL does not mean reading or review is complete"
        },
        {
          "material_type": "fulltext",
          "public_status": "No separate URL in the original material",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External or linked verdict material unread; a URL does not mean reading or review is complete"
        },
        {
          "material_type": "registration",
          "public_status": "No separate URL in the original material",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External or linked verdict material unread; a URL does not mean reading or review is complete"
        },
        {
          "material_type": "protocol_sap",
          "public_status": "No separate URL in the original material",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External or linked verdict material unread; a URL does not mean reading or review is complete"
        }
      ],
      "links": [
        {
          "label": "PubMed",
          "url": "https://pubmed.ncbi.nlm.nih.gov/23776118/"
        }
      ]
    },
    {
      "report_id": "R02",
      "title": "High-dose epoetin alfa with no benefit × Neonatal hypoxic-ischemic encephalopathy: verdict 2798 has grade D and 34 points.",
      "url": "https://chamgap.com/verdicts/cognition/high-dose-epoetin-hypothermia-neonatal-hie-death-neurodevelopmental-disability/",
      "report_type": "Cross-citation to an existing verdict; original trial report/bibliography not acquired",
      "existence": "Only a cross-citation for a different indication in the parent review summary is present; linked material unread",
      "acquired_read": "Summary read; external or linked material unread",
      "study_family": "F02",
      "independent_replication": false,
      "observed_result": "The same ESA class, but a different indication: encephalopathy treatment.",
      "result_level": "Only the original cross-citation summary is preserved; no newly read clinical evidence for the other ESA/indication",
      "source_evidence_date": "2026-08-26",
      "materials": [
        {
          "material_type": "local_summary",
          "public_status": "Original URL preserved",
          "access_status": "Summary read",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-08-26",
          "qualification": "Preserved parent verdict summary; report-specific links to the same stored summary copy"
        },
        {
          "material_type": "source_link",
          "public_status": "Original URL preserved",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External or linked verdict material unread; a URL does not mean reading or review is complete"
        },
        {
          "material_type": "fulltext",
          "public_status": "No separate URL in the original material",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External or linked verdict material unread; a URL does not mean reading or review is complete"
        },
        {
          "material_type": "registration",
          "public_status": "No separate URL in the original material",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External or linked verdict material unread; a URL does not mean reading or review is complete"
        },
        {
          "material_type": "protocol_sap",
          "public_status": "No separate URL in the original material",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External or linked verdict material unread; a URL does not mean reading or review is complete"
        }
      ],
      "links": [
        {
          "label": "Official source",
          "url": "https://chamgap.com/verdicts/cognition/high-dose-epoetin-hypothermia-neonatal-hie-death-neurodevelopmental-disability/"
        }
      ]
    }
  ],
  "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": "Awaiting user review",
    "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"
  },
  "study_overlap": {
    "state": "Unverified",
    "unique_trial_count": null,
    "unique_participant_count": null,
    "reason": "The main transfusion paper of the same three-arm trial, a reference to separate two-year follow-up and two subclaim questions; follow-up bibliography/denominators not acquired. Verdict 2798 is a cross-citation to an existing verdict for another ESA and encephalopathy treatment; linked material unread and not independent replication of darbepoetin in preterm infants. Family IDs link relationships, not certified independent counts; events, composite components, institutions, cross-citations and the same participants are not newly counted as independent evidence."
  },
  "history": [
    {
      "date": "2026-10-10",
      "kind": "Separation of public-facing pages and materials",
      "view_version": "1.0",
      "change": "The reader view and materials were prepared from the existing 26 items. No new clinical search, verification-status changes or scoring were performed."
    }
  ],
  "language": "en",
  "translation_date": "2026-10-10"
}