{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Diabetic macular edema with already impaired vision × Anti-VEGF treatment",
  "language": "en",
  "translation_date": "2026-10-12",
  "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 method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "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 method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "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 method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "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 method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "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 method HTML copies; no current method-content re-review or official tool execution"
    }
  ],
  "status_dictionary": {
    "Met": "Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.",
    "Partly verified": "Some information in the stored summary is linked into the table. External comparison/content review is not complete.",
    "Unverified": "The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.",
    "Review incomplete": "Existing content review remains incomplete.",
    "Not reported": "Not reported within the stored material actually read; not extended to the entire primary paper.",
    "Inaccessible": "Means an actual access failure. Access not attempted here is not assigned this state.",
    "Not applicable": "Not used as a substitute for an evidence gap.",
    "Conflicting data": "Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.",
    "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "Selected treatment with impaired vision · Existing subclaim B",
      "needed": "Distinction between the selected existing question, grade/note and parent scope",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Distinction between the selected existing question, grade/note and parent scope to connect materials needed for the selected question with the materials currently available.",
      "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.",
      "criterion": "Original source materials and the relevant analysis scope for Distinction between the selected existing question, grade/note and parent scope must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "Question clarification principles in M03 §3.1 and §3.2.1–3.2.4; Detailed separation rules are internally designed; M04 §4.5, §4.6.3; Limitations of the current material conversion follow the review scope and internal design; M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are designed by CHAMGAP",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed update research connecting the original question with separate evidence; no new investigation, calculation or trial has been performed."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Already impaired vision · Mention of 20/50",
      "needed": "Visual acuity range, disease stage and actual recruitment criteria",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Visual acuity range, disease stage and actual recruitment criteria to connect materials needed for the selected question with the materials currently available.",
      "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.",
      "criterion": "Original source materials and the relevant analysis scope for Visual acuity range, disease stage and actual recruitment criteria must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M03 §3.2.1; Detailed population criteria are designed by CHAMGAP; M03 §3.2.1–3.2.4; Dose, duration and effect-modification details are designed by CHAMGAP; M03 §3.2.2–3.2.3; Reverse labels and test adaptations are designed by CHAMGAP",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on visual acuity and the scope of evidence applicability; no new investigation, calculation or trial has been performed."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Anti-VEGF · Formulation/strategy",
      "needed": "Drug, dose and initial/subsequent strategy in each separate trial",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Drug, dose and initial/subsequent strategy in each separate trial to connect materials needed for the selected question with the materials currently available.",
      "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.",
      "criterion": "Original source materials and the relevant analysis scope for Drug, dose and initial/subsequent strategy in each separate trial must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labels and checking adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing formulation/strategy and question scope; no new investigation, calculation or trial has been performed."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Separate trial comparators · Rescue treatment",
      "needed": "Actual comparator and subsequent treatment in each impaired vision trial",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Actual comparator and subsequent treatment in each impaired vision trial to connect materials needed for the selected question with the materials currently available.",
      "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.",
      "criterion": "Original source materials and the relevant analysis scope for Actual comparator and subsequent treatment in each impaired vision trial must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M03 §3.2.2–3.2.3; Reverse labels and test adaptations are designed by CHAMGAP; M03 §3.2.3, M08 §8.2.2–8.2.3; CHAMGAP adaptation; M08 §8.2.2, M15 §15.3.1; CHAMGAP adaptation; M04 §4.6.3, M15 §15.3.1–15.3.3; Status distinctions are designed by CHAMGAP",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing comparison strategies and subsequent treatment; no new investigation, calculation or trial has been performed."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Direct bibliography · VISTA/VIVID/T",
      "needed": "Trial/report identity, originals and correspondence to the selected question",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Trial/report identity, originals and correspondence to the selected question to connect materials needed for the selected question with the materials currently available.",
      "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.",
      "criterion": "Original source materials and the relevant analysis scope for Trial/report identity, originals and correspondence to the selected question must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research connecting textual mentions with actual trials/reports; no new investigation, calculation or trial has been performed."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Impaired vision benefit · Endpoint",
      "needed": "Selected outcome definition, units and direction in separate trials",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Selected outcome definition, units and direction in separate trials to connect materials needed for the selected question with the materials currently available.",
      "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.",
      "criterion": "Original source materials and the relevant analysis scope for Selected outcome definition, units and direction in separate trials must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M08 Table 8.2.a, M03 §3.2.4; custom application; M08 Table 8.2.a, M04 §4.6.3; custom application; M03 §3.2.4; custom extension boundary",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on population/endpoint specifications and effects; no new investigation, calculation or trial has been performed."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "Effect size · CI · Clinical meaning",
      "needed": "Original estimate/CI and important difference for separate impaired vision comparisons",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Original estimate/CI and important difference for separate impaired vision comparisons to connect materials needed for the selected question with the materials currently available.",
      "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.",
      "criterion": "Original source materials and the relevant analysis scope for Original estimate/CI and important difference for separate impaired vision comparisons must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M15 §15.3.1–15.3.3; Chamgap application; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; design-specific adaptation is Chamgap’s own design; M04 §4.6.3 and M15 §15.3.1–15.3.3; separation of statuses is Chamgap’s own design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research examining precision and meaning for the same question; no new investigation, calculation or trial has been performed."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "People/eyes · Denominators/missingness",
      "needed": "Randomized, observed and analyzed denominators and missingness in separate trials",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Randomized, observed and analyzed denominators and missingness in separate trials to connect materials needed for the selected question with the materials currently available.",
      "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.",
      "criterion": "Original source materials and the relevant analysis scope for Randomized, observed and analyzed denominators and missingness in separate trials must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design; M08 §8.2.2, M15 §15.3.1; custom application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing populations/denominators and missingness assumptions; no new investigation, calculation or trial has been performed."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "Duration · Visits · Exposure",
      "needed": "Follow-up/exposure and measurement time points in separate trials",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Follow-up/exposure and measurement time points in separate trials to connect materials needed for the selected question with the materials currently available.",
      "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.",
      "criterion": "Original source materials and the relevant analysis scope for Follow-up/exposure and measurement time points in separate trials must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M03 §3.2.3 and M08 §§8.2.2–8.2.3; Chamgap adaptation; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing exposure/time points and selected outcomes; no new investigation, calculation or trial has been performed."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "Allocation · Concealment · Masking",
      "needed": "Design/allocation and measurement/analysis procedures in separate trials",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Design/allocation and measurement/analysis procedures in separate trials to connect materials needed for the selected question with the materials currently available.",
      "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.",
      "criterion": "Original source materials and the relevant analysis scope for Design/allocation and measurement/analysis procedures in separate trials must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M08 §§8.1–8.2.3; Chamgap adaptation; M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M04 §§4.5–4.6 material collection/selection principles; access/reading separation and hyperlink rules are Chamgap-designed",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on procedures and observed outcomes in each trial; no new investigation, calculation or trial has been performed."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Registration · Prespecified endpoints/SAP",
      "needed": "Registration, prespecified plans and changes in separate trials",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Registration, prespecified plans and changes in separate trials to connect materials needed for the selected question with the materials currently available.",
      "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.",
      "criterion": "Original source materials and the relevant analysis scope for Registration, prespecified plans and changes in separate trials must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; custom application; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research connecting prespecified plans and direct reports; no new investigation, calculation or trial has been performed."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Concurrent care · Treatment attribution",
      "needed": "Concurrent exposures, crossover and adherence in separate trials",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Concurrent exposures, crossover and adherence in separate trials to connect materials needed for the selected question with the materials currently available.",
      "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.",
      "criterion": "Original source materials and the relevant analysis scope for Concurrent exposures, crossover and adherence in separate trials must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; custom application; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are custom design; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on concurrent exposure and effect attribution; no new investigation, calculation or trial has been performed."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "Protocol V with good vision · Context",
      "needed": "Populations, comparisons and outcomes of the parent/sibling strategy question and the selected question",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Populations, comparisons and outcomes of the parent/sibling strategy question and the selected question to connect materials needed for the selected question with the materials currently available.",
      "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.",
      "criterion": "Original source materials and the relevant analysis scope for Populations, comparisons and outcomes of the parent/sibling strategy question and the selected question must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; Status distinctions are designed by CHAMGAP; M03 §3.2.1; Detailed population criteria are designed by CHAMGAP; M03 §3.2.2–3.2.3; Reverse labels and test adaptations are designed by CHAMGAP; Distinction between studies and reports in M04 §4.6.1–4.6.2; Cohort/outcome connections are CHAMGAP adaptations",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing baseline visual acuity and strategy differences; no new investigation, calculation or trial has been performed."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "Protocol W · Other outcomes",
      "needed": "Preventive strategies, anatomy/vision in another trial and the selected question",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Preventive strategies, anatomy/vision in another trial and the selected question to connect materials needed for the selected question with the materials currently available.",
      "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.",
      "criterion": "Original source materials and the relevant analysis scope for Preventive strategies, anatomy/vision in another trial and the selected question must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; Status distinctions are designed by CHAMGAP; M03 §3.2.4; CHAMGAP’s boundary for extensions; Distinction between studies and reports in M04 §4.6.1–4.6.2; Cohort/outcome connections are CHAMGAP adaptations; M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are designed by CHAMGAP",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on prevention/treatment and anatomical/vision outcome differences; no new investigation, calculation or trial has been performed."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Separate trial funding · Product support",
      "needed": "Funding/products and analysis/writing/publication support in separate trials",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Funding/products and analysis/writing/publication support in separate trials to connect materials needed for the selected question with the materials currently available.",
      "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.",
      "criterion": "Original source materials and the relevant analysis scope for Funding/products and analysis/writing/publication support in separate trials must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing individual support and report relationships; no new investigation, calculation or trial has been performed."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "Separate trial authors/company · COI",
      "needed": "Employee/affiliation, contributions, COI and data control in each trial",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Employee/affiliation, contributions, COI and data control in each trial to connect materials needed for the selected question with the materials currently available.",
      "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.",
      "criterion": "Original source materials and the relevant analysis scope for Employee/affiliation, contributions, COI and data control in each trial must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on author/company roles and report relationships; no new investigation, calculation or trial has been performed."
    },
    {
      "item_id": "N17",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Impaired vision harms · Follow-up",
      "needed": "Safety collection/denominators and observation scope in separate treatment trials",
      "role": "Supplementary",
      "role_reason": "Preparation item distinguishing Safety collection/denominators and observation scope in separate treatment trials to connect materials needed for the selected question with the materials currently available.",
      "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.",
      "criterion": "Original source materials and the relevant analysis scope for Safety collection/denominators and observation scope in separate treatment trials must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; detailed distinctions are custom design; M19 §19.1.2–19.2.4; custom application; M19 §19.1.2–19.2.4, M04 §4.6.3; custom application; M19 §19.1.2–19.2.4; custom application; M19 §19.1.2–19.2.4; custom application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on treatment outcomes and observed harms in each population; no new investigation, calculation or trial has been performed."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Independent trials · Bibliography · Population relationships",
      "needed": "Mentioned trials/reports, actual populations/endpoints and independent replication",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Mentioned trials/reports, actual populations/endpoints and independent replication to connect materials needed for the selected question with the materials currently available.",
      "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.",
      "criterion": "Original source materials and the relevant analysis scope for Mentioned trials/reports, actual populations/endpoints and independent replication must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort and outcome linkage is Chamgap's own application; M04 §4.6.1–4.6.2, M15 §15.3.1; Chamgap application; M04 §4.5–4.6 principles for collecting and selecting materials; separation of access and reading and hyperlink rules are Chamgap's own design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing identical reports/populations from separate evidence; no new investigation, calculation or trial has been performed."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Generalization to other vision, drugs/durations",
      "needed": "Application beyond the selected population, formulation and duration",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Application beyond the selected population, formulation and duration to connect materials needed for the selected question with the materials currently available.",
      "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.",
      "criterion": "Original source materials and the relevant analysis scope for Application beyond the selected population, formulation and duration must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M03 §3.2.1; detailed population conditions are custom design; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are custom design; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design; M03 §3.2.4; custom extension boundary",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on the selected question and other conditions; no new investigation, calculation or trial has been performed."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Original subclaim B · Parent D30/history",
      "needed": "Original subclaim values, parent axes/Korean-English text, dates/corrections and history",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Original subclaim values, parent axes/Korean-English text, dates/corrections and history to connect materials needed for the selected question with the materials currently available.",
      "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.",
      "criterion": "Original source materials and the relevant analysis scope for Original subclaim values, parent axes/Korean-English text, dates/corrections and history must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed update research distinguishing original material changes and production versions; no new investigation, calculation or trial has been performed."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Summary/links · Gap in direct materials",
      "needed": "Actual reading, URLs/identity and additional material scope for each material",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Actual reading, URLs/identity and additional material scope for each material to connect materials needed for the selected question with the materials currently available.",
      "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.",
      "criterion": "Original source materials and the relevant analysis scope for Actual reading, URLs/identity and additional material scope for each material must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.",
      "basis": "M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Propose scoped update research based on materials actually acquired; no new investigation, calculation or trial is performed now."
    }
  ]
}