{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "PSA-led active monitoring × Claim of equivalent metastasis and clinical progression",
  "language": "en",
  "translation_date": "2026-10-14",
  "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 equivalence claim and original grade",
      "needed": "Distinguish selected wording/grade/note from parent mortality verdict",
      "role": "Required",
      "role_reason": "An application item distinguishing Distinguish selected wording/grade/note from parent mortality verdict to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Relevant originals and analysis scope for Distinguish selected wording/grade/note from parent mortality verdict should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is 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 distinguishing each endpoint/comparison specification; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "PSA detection, localized cancer and population",
      "needed": "PSA-detected population, eligibility/risk and baseline characteristics",
      "role": "Required",
      "role_reason": "An application item distinguishing PSA-detected population, eligibility/risk and baseline characteristics to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Relevant originals and analysis scope for PSA-detected population, eligibility/risk and baseline characteristics should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.1; Detailed population conditions are Chamgap design; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details 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 comparative research specifying population conditions; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Identity of PSA-led monitoring",
      "needed": "Original monitoring approach, intervention/testing/switching criteria",
      "role": "Required",
      "role_reason": "An application item distinguishing Original monitoring approach, intervention/testing/switching criteria to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Relevant originals and analysis scope for Original monitoring approach, intervention/testing/switching criteria should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap 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 separating monitoring approach from applicability; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Three arms and comparison specifications",
      "needed": "Arm correspondence and actual monitoring/surgery/radiotherapy treatment",
      "role": "Required",
      "role_reason": "An application item distinguishing Arm correspondence and actual monitoring/surgery/radiotherapy treatment to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Relevant originals and analysis scope for Arm correspondence and actual monitoring/surgery/radiotherapy treatment should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations 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 three comparisons and actual treatment pathways; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Central randomization and concealment",
      "needed": "Historical allocation descriptions versus actual original-text access",
      "role": "Required",
      "role_reason": "An application item distinguishing Historical allocation descriptions versus actual original-text access to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Relevant originals and analysis scope for Historical allocation descriptions versus actual original-text access should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M08 §8.1–8.2.3; internal application; M04 §4.5–4.6 collection/selection principles; access/reading separation and hyperlink specifications 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 trial disclosing allocation procedures; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Masking and endpoint-specific adjudicators",
      "needed": "Separate cause-of-death committee from metastasis/progression assessment",
      "role": "Required",
      "role_reason": "An application item distinguishing Separate cause-of-death committee from metastasis/progression assessment to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Relevant originals and analysis scope for Separate cause-of-death committee from metastasis/progression assessment should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M03 §3.2.4; own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our 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 research distinguishing endpoint-specific adjudication and measurement differences; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "15 years and follow-up range",
      "needed": "15-year analysis, median/range and individual observation duration",
      "role": "Required",
      "role_reason": "An application item distinguishing 15-year analysis, median/range and individual observation duration to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Relevant originals and analysis scope for 15-year analysis, median/range and individual observation duration should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design; M08 §8.2.2, M15 §15.3.1; Chamgap adaptation",
      "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 research separately reporting time points and actual follow-up duration; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "Definition of metastasis events",
      "needed": "Metastasis definition, testing/adjudication, occurrence time and person units",
      "role": "Required",
      "role_reason": "An application item distinguishing Metastasis definition, testing/adjudication, occurrence time and person units to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Relevant originals and analysis scope for Metastasis definition, testing/adjudication, occurrence time and person units should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M08 §8.2.2, M15 §15.3.1; internal 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 specifying metastasis measurement; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "15-year metastasis percentages and cumulative counts",
      "needed": "Arm-specific metastasis percentages/counts, original time and denominators",
      "role": "Required",
      "role_reason": "An application item distinguishing Arm-specific metastasis percentages/counts, original time and denominators to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Relevant originals and analysis scope for Arm-specific metastasis percentages/counts, original time and denominators should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M15 §15.3.1–15.3.3; internal application; M08 §8.2.2, M15 §15.3.1; internal 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 research distinguishing metastasis counts/percentages from estimands; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "15-year clinical-progression percentages",
      "needed": "Progression definition, arm-specific percentages and distinction from metastasis",
      "role": "Required",
      "role_reason": "An application item distinguishing Progression definition, arm-specific percentages and distinction from metastasis to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Relevant originals and analysis scope for Progression definition, arm-specific percentages and distinction from metastasis should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is internally designed; M15 §15.3.1–15.3.3; internal 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 metastasis/progression overlap and definitions; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Metastasis/progression effects and precision",
      "needed": "Original percentages/interpretation versus exact between-arm effects/CI",
      "role": "Required",
      "role_reason": "An application item distinguishing Original percentages/interpretation versus exact between-arm effects/CI to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Relevant originals and analysis scope for Original percentages/interpretation versus exact between-arm effects/CI should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M15 §15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations 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 disclosing exact effects and uncertainty; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Mortality nonsignificance and other endpoints",
      "needed": "Separate 15-year cancer-mortality and metastasis/progression results",
      "role": "Required",
      "role_reason": "An application item distinguishing Separate 15-year cancer-mortality and metastasis/progression results to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Relevant originals and analysis scope for Separate 15-year cancer-mortality and metastasis/progression results should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap's own design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M15 §15.3.1–15.3.3; Chamgap 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 separating endpoint-specific results; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "Cancer mortality, all-cause mortality and competing events",
      "needed": "Causes of death versus metastasis/progression competing-event/censoring specifications",
      "role": "Required",
      "role_reason": "An application item distinguishing Causes of death versus metastasis/progression competing-event/censoring specifications to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Relevant originals and analysis scope for Causes of death versus metastasis/progression competing-event/censoring specifications should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptation is a custom design; M08 §8.2.2, M15 §15.3.1; 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 research separating event-specific competing/censoring processes and effects; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "10-year cumulative results",
      "needed": "Same-cohort 10/15-year counts and time points",
      "role": "Required",
      "role_reason": "An application item distinguishing Same-cohort 10/15-year counts and time points to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Relevant originals and analysis scope for Same-cohort 10/15-year counts and time points should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations 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 research distinguishing cumulative/time analyses in the same cohort; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Same trial, two reports and independence",
      "needed": "15/10-year citations and same-participant follow-up",
      "role": "Required",
      "role_reason": "An application item distinguishing 15/10-year citations and same-participant follow-up to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Relevant originals and analysis scope for 15/10-year citations and same-participant follow-up should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap 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 independent comparative research on the same endpoint/strategy; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "Crossover and rescue treatment",
      "needed": "Separate assigned strategies from actual switching/treatment pathways",
      "role": "Required",
      "role_reason": "An application item distinguishing Separate assigned strategies from actual switching/treatment pathways to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Relevant originals and analysis scope for Separate assigned strategies from actual switching/treatment pathways should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations 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 separating assigned strategies from actual pathways; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "ITT strategy estimands",
      "needed": "Assignment-based analysis versus actual-treatment/switching effects",
      "role": "Required",
      "role_reason": "An application item distinguishing Assignment-based analysis versus actual-treatment/switching effects to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Relevant originals and analysis scope for Assignment-based analysis versus actual-treatment/switching effects should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M08 §8.2.2, M15 §15.3.1; internal application; M04 §4.5–4.6 collection/selection principles; access/reading separation and hyperlink specifications 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 research distinguishing strategy estimands from actual-treatment estimands; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Follow-up completeness and endpoint-specific denominators",
      "needed": "1,610/1,643 (98%) versus actual endpoint/risk populations",
      "role": "Required",
      "role_reason": "An application item distinguishing 1,610/1,643 (98%) versus actual endpoint/risk populations to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Relevant originals and analysis scope for 1,610/1,643 (98%) versus actual endpoint/risk populations should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap 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 research distinguishing observation/risk denominators and missingness; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Registration, prespecified hierarchy and composite identifiers",
      "needed": "Registration IDs, mortality primary endpoint and metastasis/progression hierarchy",
      "role": "Required",
      "role_reason": "An application item distinguishing Registration IDs, mortality primary endpoint and metastasis/progression hierarchy to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Relevant originals and analysis scope for Registration IDs, mortality primary endpoint and metastasis/progression hierarchy should be available, with unverified items distinguished. Preserved wording is linked here; existing 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 research publicly linking primary/secondary endpoints to actual analysis; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Superiority versus equivalence/noninferiority",
      "needed": "Testing design, prespecified margins and equivalence-claim scope",
      "role": "Required",
      "role_reason": "An application item distinguishing Testing design, prespecified margins and equivalence-claim scope to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Relevant originals and analysis scope for Testing design, prespecified margins and equivalence-claim scope should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; internal application; M15 §15.3.1–15.3.3; internal application; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is 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 questions and testing specifications; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Metastasis/progression testing and concurrent care",
      "needed": "Arm-specific testing intensity, concurrent care/treatment and measurement differences",
      "role": "Required",
      "role_reason": "An application item distinguishing Arm-specific testing intensity, concurrent care/treatment and measurement differences to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Relevant originals and analysis scope for Arm-specific testing intensity, concurrent care/treatment and measurement differences should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application; M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations 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 research distinguishing testing/treatment pathways from outcome measurement; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Contemporary surveillance and other-population applicability",
      "needed": "Original PSA-led approach versus contemporary MRI/repeat biopsy and population differences",
      "role": "Required",
      "role_reason": "An application item distinguishing Original PSA-led approach versus contemporary MRI/repeat biopsy and population differences to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Relevant originals and analysis scope for Original PSA-led approach versus contemporary MRI/repeat biopsy and population differences should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed; M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation 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 specifying approach and population differences; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "PIVOT and SPCG-4 mentions",
      "needed": "Other trials’ detection methods, endpoints and directness",
      "role": "Required",
      "role_reason": "An application item distinguishing Other trials’ detection methods, endpoints and directness to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Relevant originals and analysis scope for Other trials’ detection methods, endpoints and directness should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application; M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is 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 comparative research matching populations/detection methods/endpoints; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "NIHR and MRC support",
      "needed": "Separate main/long-term-follow-up funding and roles",
      "role": "Required",
      "role_reason": "An application item distinguishing Separate main/long-term-follow-up funding and roles to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Relevant originals and analysis scope for Separate main/long-term-follow-up funding and roles should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.",
      "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 research disclosing support stages and roles; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "Oxford sponsorship and author relationships",
      "needed": "Separate study sponsorship from funding/product/COI roles",
      "role": "Required",
      "role_reason": "An application item distinguishing Separate study sponsorship from funding/product/COI roles to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Relevant originals and analysis scope for Separate study sponsorship from funding/product/COI roles should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.",
      "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 research separately disclosing study roles, support and relationships; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N26",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Functional harms and treatment-specific results",
      "needed": "Separate incontinence/erectile/bowel/sexual function from metastasis/progression/mortality",
      "role": "Supplementary",
      "role_reason": "An application item distinguishing Separate incontinence/erectile/bowel/sexual function from metastasis/progression/mortality to connect materials needed for the selected question with available materials.",
      "application_exception": "Supplements safety-information gaps for the selected subclaim. Metastasis/progression/mortality results or parent caution wording do not yield safety verdicts, harm incidence or new use instructions.",
      "criterion": "Relevant originals and analysis scope for Separate incontinence/erectile/bowel/sexual function from metastasis/progression/mortality should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; detailed distinctions are Chamgap’s own design; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap 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 separating survival/metastasis/functional harms; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N27",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "No new treatment-complication reporting at 15 years",
      "needed": "Reporting after 10 years versus actual safety scope",
      "role": "Supplementary",
      "role_reason": "An application item distinguishing Reporting after 10 years versus actual safety scope to connect materials needed for the selected question with available materials.",
      "application_exception": "Supplements safety-information gaps for the selected subclaim. Metastasis/progression/mortality results or parent caution wording do not yield safety verdicts, harm incidence or new use instructions.",
      "criterion": "Relevant originals and analysis scope for Reporting after 10 years versus actual safety scope should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; detailed discrimination is internally designed; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; internal 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 research distinguishing reporting scope from actual occurrence/follow-up; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "Original axes, bilingual text, dates, corrections and history",
      "needed": "Separate parent mortality axes/score from selected subclaim values",
      "role": "Required",
      "role_reason": "An application item distinguishing Separate parent mortality axes/score from selected subclaim values to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Relevant originals and analysis scope for Separate parent mortality axes/score from selected subclaim values should be available, with unverified items distinguished. Preserved wording is linked here; existing 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 research distinguishing original values/history from new-material scope; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "Actual summary reading, links and gaps",
      "needed": "Preserved-summary reading versus external reports/registration/plans access",
      "role": "Required",
      "role_reason": "An application item distinguishing Preserved-summary reading versus external reports/registration/plans access to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Relevant originals and analysis scope for Preserved-summary reading versus external reports/registration/plans access should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal 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": "Proposal for updating while distinguishing actual acquisition/timing/scope; no new investigation, calculation or trial was performed in that production."
    }
  ]
}