{
  "schema_version": "chamgap-public-evidence-check-1.0",
  "public_id": "v2974-s0",
  "verdict_number": "2974",
  "title": "PSA-detected localized prostate cancer · Three strategies and 15-year prostate-cancer mortality",
  "view_version": "1.0",
  "view_created_date": "2026-10-14",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "review_date": null,
  "legacy_evidence_date": "2026-08-26",
  "review_scope": {
    "materials_read": "Existing review summaries and stored records of methodological application",
    "clinical_papers_directly_read": false,
    "new_clinical_search": false,
    "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.",
    "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature."
  },
  "claim_context": {
    "population": "PSA-detected localized prostate cancer, ages 50–69, 1,643 ProtecT participants; risk/subgroup details remain unverified.",
    "intervention": "PSA-based active monitoring for PSA-detected localized prostate cancer",
    "dose": "Preserve the historical monitoring-strategy study context; testing/follow-up/switching schedules and actual adherence remain unverified. No implementation instructions.",
    "comparator": "Historical assigned prostatectomy/radiotherapy strategies; actual techniques/shared care/crossover details remain unverified.",
    "endpoint": "Original 15-year prostate-cancer-specific mortality comparison, distinguished from all-cause mortality, metastasis/progression and functional harms.",
    "duration": "Median 15 years, original range 11–21; distinguish the same cohort’s 10-year report context.",
    "excluded_extensions": [
      "Converting nonsignificance into equivalence/noninferiority, harmlessness or guaranteed safety",
      "Repurposing prostate-cancer mortality as effects on all-cause mortality, metastasis/progression or functional harms",
      "Adding the same arms/people/events/time and 10/15-year citations/related sheets as independent trials/participants",
      "Extending historical PSA-led monitoring to all contemporary active-surveillance/treatment strategies",
      "PSA-testing/risk-selection/monitoring/surgery/radiotherapy/cancer-treatment selection or treatment-replacement instructions"
    ]
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "How are selected 15-year mortality and related metastasis/progression distinguished?",
      "needed": "Boundary between selected mortality, parent verdict and metastasis/progression results",
      "role": "Required",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: How are selected 15-year mortality and related metastasis/progression distinguished?",
      "application_exception": "Do not transfer related progression results into selected mortality effects, grades or a new verdict.",
      "criterion": "For Boundary between selected mortality, parent verdict and metastasis/progression results, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Plan distinguishing estimands for different clinical outcomes",
      "current_reports": [
        "R01"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The selected original question is significant difference in 15-year prostate-cancer mortality. Link its subclaim record and distinguish the same original verdict’s claim of equivalent metastasis/clinical progression and parent context. No new questions, splits or trials.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Clinical independence was not newly certified.",
      "missingness": "Clinical independence was not newly certified.",
      "uncertainty": "Clinical independence was not newly certified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original question, mortality/metastasis/progression, population/comparison materials"
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "What are subclaim D/note and absent score/status/axes?",
      "needed": "Subclaim D, overall P=.53 versus parent D34 and historical axes",
      "role": "Required",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What are subclaim D/note and absent score/status/axes?",
      "application_exception": "Do not repurpose parent 34 points or E0/C0/B0 axes as subclaim values or passed content review now.",
      "criterion": "For Subclaim D, overall P=.53 versus parent D34 and historical axes, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Separate original-grade preservation from additional evidence/changes",
      "current_reports": [
        "R01"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "Preserve selected D and the note Overall P=.53. Subclaim score/status/axes are absent; parent D34 and axes are separate historical context.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Subclaim score/status/axes are absent in the original.",
      "missingness": "Subclaim score/status/axes are absent in the original.",
      "uncertainty": "Subclaim score/status/axes are absent in the original.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original subclaim or explicit change events"
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "What are PSA-detected localized disease and actual age/population?",
      "needed": "PSA-detected localized prostate cancer, ages 50–69",
      "role": "Required",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What are PSA-detected localized disease and actual age/population?",
      "application_exception": "Do not extend to treatment selection for all prostate-cancer patients or PSA-testing guidance.",
      "criterion": "For PSA-detected localized prostate cancer, ages 50–69, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "basis": "M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research specifying detection method, stage and population",
      "current_reports": [
        "R01"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original records PSA-detected localized prostate cancer and 1,643 ProtecT participants aged 50–69. It is not a direct result for clinically detected/metastatic disease or other ages.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Recruitment/diagnosis, staging, comorbidities and eligibility/exclusion details remain unverified.",
      "missingness": "Recruitment/diagnosis, staging, comorbidities and eligibility/exclusion details remain unverified.",
      "uncertainty": "Recruitment/diagnosis, staging, comorbidities and eligibility/exclusion details remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Eligibility, diagnosis and baseline-characteristic tables"
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Are risk/pathology/baseline status and subgroup denominators verified?",
      "needed": "Risk/pathology, diagnostic criteria and arm/subgroup results",
      "role": "Required",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: Are risk/pathology/baseline status and subgroup denominators verified?",
      "application_exception": "Do not add externally familiar risk proportions/grades or copy overall results to subgroups.",
      "criterion": "For Risk/pathology, diagnostic criteria and arm/subgroup results, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "basis": "M03 §3.2.1; detailed population conditions are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research specifying risk and applicability",
      "current_reports": [
        "R01"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original summary includes localized/PSA-detected scope but provides no separate risk distribution, pathology/grade, baseline PSA or subgroup denominators/mortality effects.",
      "condition_status": "Unverified",
      "status_reason": "Required direct materials were not verified within the current summary/unread-external-material scope. Risk classification, baseline pathology/PSA, subgroup denominators/effects and interactions remain unverified.",
      "missingness": "Risk classification, baseline pathology/PSA, subgroup denominators/effects and interactions remain unverified.",
      "uncertainty": "Risk classification, baseline pathology/PSA, subgroup denominators/effects and interactions remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Baseline/risk/subgroup tables and prespecified analyses"
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "What was the historical PSA-led active-monitoring strategy?",
      "needed": "Historical monitoring, follow-up/switching criteria and contemporary active surveillance",
      "role": "Required",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What was the historical PSA-led active-monitoring strategy?",
      "application_exception": "Do not convert into PSA-testing/risk-selection/monitoring schedules or implementation/efficacy conclusions for all contemporary surveillance.",
      "criterion": "For Historical monitoring, follow-up/switching criteria and contemporary active surveillance, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "basis": "M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research specifying strategies/estimands by period",
      "current_reports": [
        "R01"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original intervention was PSA-led active monitoring. The original distinguishes contemporary active surveillance with more MRI/regular repeat biopsy. Specific testing/treatment-switch schedules are absent from the summary.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Historical testing/reassessment, switching criteria/adherence and direct comparison with contemporary strategies remain unverified.",
      "missingness": "Historical testing/reassessment, switching criteria/adherence and direct comparison with contemporary strategies remain unverified.",
      "uncertainty": "Historical testing/reassessment, switching criteria/adherence and direct comparison with contemporary strategies remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original monitoring specifications and switching/adherence data"
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "What are surgery/radiotherapy comparisons and actual treatment specifications?",
      "needed": "Three arms, original surgery/radiotherapy/concurrent care and historical specifications",
      "role": "Required",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What are surgery/radiotherapy comparisons and actual treatment specifications?",
      "application_exception": "Do not extend to superiority of all contemporary surgery/radiotherapy or treatment-replacement/cancer-treatment selection instructions.",
      "criterion": "For Three arms, original surgery/radiotherapy/concurrent care and historical specifications, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "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": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research specifying exact strategy-specific estimands",
      "current_reports": [
        "R01"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original records allocation of 545 to monitoring, 553 to surgery and 545 to radiotherapy. Detailed historical surgery/radiotherapy techniques, concurrent exposure and adherence/changes are not separately provided.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Treatment methods/adjuvant care, timing/adherence, shared conditions and changes remain unverified.",
      "missingness": "Treatment methods/adjuvant care, timing/adherence, shared conditions and changes remain unverified.",
      "uncertainty": "Treatment methods/adjuvant care, timing/adherence, shared conditions and changes remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Each strategy/shared care and actual exposure/switching records"
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "What time window does 15-year follow-up describe?",
      "needed": "Median 15 years, range 11–21, time/denominators",
      "role": "Required",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What time window does 15-year follow-up describe?",
      "application_exception": "Do not newly calculate a mean/fixed 15-year follow-up or total person-time from the original range.",
      "criterion": "For Median 15 years, range 11–21, time/denominators, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "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": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Plan distinguishing follow-up time from effects at estimation time",
      "current_reports": [
        "R01"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "Preserve original median follow-up of 15 years, range 11–21. This does not mean every participant had exactly 15 years of identical follow-up or a single-time valid denominator.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Time origins, arm-specific distributions, risk sets, censoring/visit windows remain unverified.",
      "missingness": "Time origins, arm-specific distributions, risk sets, censoring/visit windows remain unverified.",
      "uncertainty": "Time origins, arm-specific distributions, risk sets, censoring/visit windows remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Individual/arm-specific follow-up, risk sets and analysis definitions"
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "What are original prostate-cancer-specific death definitions/adjudication?",
      "needed": "Definite/probable prostate-cancer mortality and independent cause-of-death committee",
      "role": "Required",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What are original prostate-cancer-specific death definitions/adjudication?",
      "application_exception": "Do not represent preserved quotations as original-text reading or committee-independence verification now.",
      "criterion": "For Definite/probable prostate-cancer mortality and independent cause-of-death committee, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation to each question is internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research specifying cause-specific mortality and adjudication",
      "current_reports": [
        "R01"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original study description quotes the primary outcome as definite or probable prostate cancer mortality and records independent cause-of-death committee adjudication. This differs from all-cause mortality.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Cause-of-death data/uncertain adjudication, committee procedures, missing causes and original plans remain unread.",
      "missingness": "Cause-of-death data/uncertain adjudication, committee procedures, missing causes and original plans remain unread.",
      "uncertainty": "Cause-of-death data/uncertain adjudication, committee procedures, missing causes and original plans remain unread.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Death definitions/adjudication plans, cause-specific results and protocol"
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "What are 15-year prostate-cancer death events/randomized denominators?",
      "needed": "17/545, 12/553, 16/545, original percentages and overall P",
      "role": "Required",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What are 15-year prostate-cancer death events/randomized denominators?",
      "application_exception": "Do not newly sum deaths/participants/metastasis events or back-calculate HR/RR/risk differences from percentages.",
      "criterion": "For 17/545, 12/553, 16/545, original percentages and overall P, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "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; M15 §15.3.1–15.3.3; Chamgap application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Plan distinguishing events/randomization/time estimands",
      "current_reports": [
        "R01"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original records monitoring 17/545 (3.1%), surgery 12/553 (2.2%) and radiotherapy 16/545 (2.9%), overall P=.53. Preserve original events/denominators/percentages only; no new totals, differences, rates/CI.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Estimand details, observed proportions/time estimates, censoring/models and each comparison’s CI remain unverified.",
      "missingness": "Estimand details, observed proportions/time estimates, censoring/models and each comparison’s CI remain unverified.",
      "uncertainty": "Estimand details, observed proportions/time estimates, censoring/models and each comparison’s CI remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Events/risk sets, estimation methods and comparison-specific analysis tables"
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "What is the conclusion scope of overall P=.53 and nonsignificance?",
      "needed": "Overall three-arm superiority comparison and equivalence/noninferiority boundaries",
      "role": "Required",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What is the conclusion scope of overall P=.53 and nonsignificance?",
      "application_exception": "Do not copy overall P to each pair or newly judge the three strategies equivalent/harmless or all contemporary monitoring ineffective.",
      "criterion": "For Overall three-arm superiority comparison and equivalence/noninferiority boundaries, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "basis": "M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research prespecifying superiority, comparisons of interest and importance thresholds",
      "current_reports": [
        "R01"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original specifies nonsignificant mortality differences in a three-arm superiority comparison and that this was not a noninferiority trial or proof of equivalence. Preserve this context for the selected question.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Testing/models, pairwise comparisons/CI and equivalence/noninferiority margins remain unverified.",
      "missingness": "Testing/models, pairwise comparisons/CI and equivalence/noninferiority margins remain unverified.",
      "uncertainty": "Testing/models, pairwise comparisons/CI and equivalence/noninferiority margins remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Analysis/SAP and comparison-specific estimates/intervals"
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "How does all-cause mortality differ from prostate-cancer-specific mortality?",
      "needed": "All/other-cause deaths, events/denominators/duration",
      "role": "Required",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: How does all-cause mortality differ from prostate-cancer-specific mortality?",
      "application_exception": "Do not transfer 17/12/16 to all-cause deaths or prostate-cancer mortality nonsignificance to equivalent overall survival.",
      "criterion": "For All/other-cause deaths, events/denominators/duration, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "basis": "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; M03 §3.2.4; internal extension boundaries",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Plan separating cause-specific from all-cause mortality",
      "current_reports": [
        "R01"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "Core original-summary numbers concern prostate-cancer mortality. All/other-cause death events/denominators and arm-specific estimates/CI are not separately presented.",
      "condition_status": "Unverified",
      "status_reason": "Required direct materials were not verified within the current summary/unread-external-material scope. All/other-cause death definitions, events/estimates and comparative CI remain unverified.",
      "missingness": "All/other-cause death definitions, events/estimates and comparative CI remain unverified.",
      "uncertainty": "All/other-cause death definitions, events/estimates and comparative CI remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "All/cause-specific mortality tables and time/estimation methods"
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Are time estimates, HR/absolute differences/CI and competing risks verified?",
      "needed": "Survival/cause-specific/competing-risk models and estimands",
      "role": "Required",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: Are time estimates, HR/absolute differences/CI and competing risks verified?",
      "application_exception": "Do not calculate new HR/CI, equivalence/power or risk differences from original P/events.",
      "criterion": "For Survival/cause-specific/competing-risk models and estimands, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "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; M15 §15.3.1–15.3.3; Chamgap application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research specifying estimands, time and competing risks",
      "current_reports": [
        "R01"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "Original events/percentages/overall P are available but HR/time-specific absolute differences, CI and censoring/competing-risk model details are absent from the summary. Parent precision C0 is historical.",
      "condition_status": "Unverified",
      "status_reason": "Required direct materials were not verified within the current summary/unread-external-material scope. Estimands/time/models, arm risk sets, CI and importance thresholds remain unverified.",
      "missingness": "Estimands/time/models, arm risk sets, CI and importance thresholds remain unverified.",
      "uncertainty": "Estimands/time/models, arm risk sets, CI and importance thresholds remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Survival/competing-risk analysis, SAP and estimates/interval tables"
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "What are the related metastasis/clinical-progression results?",
      "needed": "Separate metastasis/progression endpoints, original numbers and mortality boundary",
      "role": "Supplementary",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What are the related metastasis/clinical-progression results?",
      "application_exception": "Do not add metastasis/progression to mortality or rejudge selected mortality effects from metastasis patterns.",
      "criterion": "For Separate metastasis/progression endpoints, original numbers and mortality boundary, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.4; internal extension boundaries",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Plan separating mortality from progression/metastasis",
      "current_reports": [
        "R01"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "Original metastasis was 9.4% versus 4.7%/5.0%, and clinical progression 25.9% versus 10.5%/11.0%, described as higher with monitoring. Related subclaim D/note and original roughly twofold/2.5-fold descriptions are preserved as context.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Event definitions/risk sets, estimates/CI, comparisons/multiplicity remain unverified.",
      "missingness": "Event definitions/risk sets, estimates/CI, comparisons/multiplicity remain unverified.",
      "uncertainty": "Event definitions/risk sets, estimates/CI, comparisons/multiplicity remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Metastasis/progression definitions, results and SAP"
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "Are the 10/15-year cumulative reports from the same cohort?",
      "needed": "Original 10/15-year events and same-ProtecT report linkage",
      "role": "Supplementary",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: Are the 10/15-year cumulative reports from the same cohort?",
      "application_exception": "Do not newly add 10/15-year events or calculate interval event/participant totals.",
      "criterion": "For Original 10/15-year events and same-ProtecT report linkage, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "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; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Record distinguishing cumulative results/updates by time",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original records 10-year deaths 8/5/4 and metastases 33/13/16 accumulating at 15 years to 17/12/16 and 51/26/27. The 2016/2023 reports concern different times in the same trial, not independent replication.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Separate valid 10-year denominators/time estimates and observations/related-report details between times remain unverified.",
      "missingness": "Separate valid 10-year denominators/time estimates and observations/related-report details between times remain unverified.",
      "uncertainty": "Separate valid 10-year denominators/time estimates and observations/related-report details between times remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Same-cohort/report identity and time-specific results/denominators"
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Are rescue/radical-treatment switching and assigned strategies distinguished?",
      "needed": "Monitoring assignment, actual switching/crossover treatment, timing/criteria",
      "role": "Required",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: Are rescue/radical-treatment switching and assigned strategies distinguished?",
      "application_exception": "Do not represent monitoring assignment as a group only watched without treatment or create treatment-selection/switching guidance.",
      "criterion": "For Monitoring assignment, actual switching/crossover treatment, timing/criteria, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "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 §3.2.1–3.2.4; dose/duration/effect-modification details are internally designed",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research separating assigned-strategy estimands from switching/actual exposure",
      "current_reports": [
        "R01"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original advertising interpretation says many participants later switched to rescue/radical treatment. Exact counts/proportions, arms/timing/reasons and analysis handling are absent from the summary.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Switching/crossover treatment, adherence/actual exposure, timing/criteria/denominators remain unverified.",
      "missingness": "Switching/crossover treatment, adherence/actual exposure, timing/criteria/denominators remain unverified.",
      "uncertainty": "Switching/crossover treatment, adherence/actual exposure, timing/criteria/denominators remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Arm-specific actual-treatment/switching, SAP and timing data"
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "What are 1,643 randomized, arm counts and 1,610/98% follow-up completeness?",
      "needed": "Total/arm randomization, follow-up completeness and endpoint denominators",
      "role": "Required",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What are 1,643 randomized, arm counts and 1,610/98% follow-up completeness?",
      "application_exception": "Do not calculate new missing/withdrawal counts/rates from randomized/complete totals or copy 98% to completeness for all endpoints.",
      "criterion": "For Total/arm randomization, follow-up completeness and endpoint denominators, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "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": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Plan separating randomized/follow-up-complete and endpoint-specific denominators",
      "current_reports": [
        "R01"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "Preserve original 1,643 (545/553/545) and complete follow-up for 1,610/1,643 (98%). Arm-specific completeness and cause-specific/time-specific valid denominators are not detailed.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Arm/time-specific completeness, causes of death/censoring and missing denominators remain unverified.",
      "missingness": "Arm/time-specific completeness, causes of death/censoring and missing denominators remain unverified.",
      "uncertainty": "Arm/time-specific completeness, causes of death/censoring and missing denominators remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Participant flow, follow-up/risk sets and cause-specific data"
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "What is the scope of loss, unidentified causes and censoring/missingness handling?",
      "needed": "Follow-up loss/missing death causes, arm-specific reasons and handling",
      "role": "Required",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What is the scope of loss, unidentified causes and censoring/missingness handling?",
      "application_exception": "Do not newly declare zero missingness, all causes certain or no bias from follow-up-completeness descriptions.",
      "criterion": "For Follow-up loss/missing death causes, arm-specific reasons and handling, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "basis": "M08 §8.2.2, M15 §15.3.1; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research prespecifying missingness/censoring/cause adjudication",
      "current_reports": [
        "R01"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "Original 98% follow-up completeness and ITT descriptions exist, but arm-specific missing counts/reasons, unidentified causes, censoring/missingness handling and sensitivity analyses are absent from the summary.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Missingness/censoring, uncertain causes, sensitivity/imputation and arm flow remain unverified.",
      "missingness": "Missingness/censoring, uncertain causes, sensitivity/imputation and arm flow remain unverified.",
      "uncertainty": "Missingness/censoring, uncertain causes, sensitivity/imputation and arm flow remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Follow-up/cause-of-death flow, SAP and sensitivity data"
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Are original ITT and crossover/actual-exposure effects separated?",
      "needed": "Assignment-based ITT and estimands after adherence/switching",
      "role": "Required",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: Are original ITT and crossover/actual-exposure effects separated?",
      "application_exception": "Do not convert randomized ITT results into effects of untreated monitoring itself or equivalence certification.",
      "criterion": "For Assignment-based ITT and estimands after adherence/switching, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "basis": "M08 §8.2.2, M15 §15.3.1; our own application; M03 §3.2.3, M08 §8.2.2–8.2.3; our own application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Plan separating ITT from other estimands",
      "current_reports": [
        "R01"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original study description preserves an intention-to-treat comparison quote. Actual-treatment/post-switch effects, adjustments and adherer-analysis details are absent.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Analysis populations, adjustments/switching/sensitivity and time estimates remain unverified.",
      "missingness": "Analysis populations, adjustments/switching/sensitivity and time estimates remain unverified.",
      "uncertainty": "Analysis populations, adjustments/switching/sensitivity and time estimates remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "SAP and randomized/actual-treatment analyses"
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "What is the original information on concealment, treatment masking and death adjudication?",
      "needed": "Central-computer allocation, unmasked treatment and independent cause-of-death committee",
      "role": "Required",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What is the original information on concealment, treatment masking and death adjudication?",
      "application_exception": "Do not certify historical B0 as passed current QA or absence of all measurement bias.",
      "criterion": "For Central-computer allocation, unmasked treatment and independent cause-of-death committee, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "basis": "M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research distinguishing treatment from adjudication procedures",
      "current_reports": [
        "R01"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "Original B0 evidence in the study description quotes central-computer allocation, impossibility of treatment masking, an independent cause-of-death committee and ITT. Preserved descriptions are not inherited as external procedural verification now.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Allocation/committee details, data access/masking and original protocol remain unread now.",
      "missingness": "Allocation/committee details, data access/masking and original protocol remain unread now.",
      "uncertainty": "Allocation/committee details, data access/masking and original protocol remain unread now.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Allocation/committee/adjudication, protocol and SAP"
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "How do original prespecified primary outcome/two registration IDs relate to actual plan reading?",
      "needed": "ISRCTN20141297/NCT02044172, original mortality primary outcome and timing/versions",
      "role": "Required",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: How do original prespecified primary outcome/two registration IDs relate to actual plan reading?",
      "application_exception": "Do not normalize the two IDs into one NCT or upgrade original agreement descriptions into registration-content verification now.",
      "criterion": "For ISRCTN20141297/NCT02044172, original mortality primary outcome and timing/versions, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.5–4.6 collection/selection principles; access/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; current conversion limitations reflect review scope and internal design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Plan preserving primary/secondary and long-term-follow-up amendments",
      "current_reports": [
        "R01"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original study description records prespecified prostate-cancer mortality and agreement with two IDs. The original evidence-list registration field remains ISRCTN20141297 · NCT02044172. External registration/protocol/SAP were not read now.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Actual registration versions/plan timing, hierarchy/testing/amendments remain unread.",
      "missingness": "Actual registration versions/plan timing, hierarchy/testing/amendments remain unread.",
      "uncertainty": "Actual registration versions/plan timing, hierarchy/testing/amendments remain unread.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Registration versions, protocol/SAP and result–plan comparison"
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Are baseline disease, shared follow-up care/exposure and risk separated?",
      "needed": "Arm-specific history, concurrent care/follow-up and risk",
      "role": "Required",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: Are baseline disease, shared follow-up care/exposure and risk separated?",
      "application_exception": "Do not add treatment techniques/drugs absent from the summary or risk-selection/treatment-selection instructions.",
      "criterion": "For Arm-specific history, concurrent care/follow-up and risk, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1; detailed population conditions are internally designed; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are internally designed",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research specifying shared conditions, assigned strategies and crossover care",
      "current_reports": [
        "R01"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "Original PSA-detected localized disease/three-strategy information exists, but arm-specific history/drugs, shared follow-up care and changing-risk details are absent from the summary.",
      "condition_status": "Unverified",
      "status_reason": "Required direct materials were not verified within the current summary/unread-external-material scope. Baseline/changing history, care/support and arm differences/risk information remain unverified.",
      "missingness": "Baseline/changing history, care/support and arm differences/risk information remain unverified.",
      "uncertainty": "Baseline/changing history, care/support and arm differences/risk information remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Baseline/arm follow-up and concurrent exposure/care data"
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "What is the original scope of funding/sponsorship and adjudication-independence descriptions?",
      "needed": "NIHR HTA/NIHR/MRC, Oxford sponsorship and roles",
      "role": "Required",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What is the original scope of funding/sponsorship and adjudication-independence descriptions?",
      "application_exception": "Do not convert public funding into absence of all involvement/bias or copy it as individual 2016-report disclosures.",
      "criterion": "For NIHR HTA/NIHR/MRC, Oxford sponsorship and roles, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "basis": "Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item; M08 §8.1–8.2.3; internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Record specifying funding and adjudication/analysis roles",
      "current_reports": [
        "R01"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original records main NIHR HTA Programme funding, NIHR/MRC support for long-term follow-up and University of Oxford sponsorship. Public funding/original independent-adjudication descriptions do not replace current disclosure/role review.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Original disclosure/support and design/analysis/data-access/adjudication roles remain unread in detail.",
      "missingness": "Original disclosure/support and design/analysis/data-access/adjudication roles remain unread in detail.",
      "uncertainty": "Original disclosure/support and design/analysis/data-access/adjudication roles remain unread in detail.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Support/sponsor/conflict-of-interest and role disclosures"
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "How are the same trial/citations, arms/time and related sheets linked?",
      "needed": "15/10-year reports, same ProtecT population and observation relationships",
      "role": "Required",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: How are the same trial/citations, arms/time and related sheets linked?",
      "application_exception": "Two reports do not mean two independent trials or twice as many participants.",
      "criterion": "For 15/10-year reports, same ProtecT population and observation relationships, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "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": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Record distinguishing reports from trial families",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "One original evidence-list row and two citations are separated into R01 (15 years) and R02 (10 years). The same cohort, arms/deaths/metastases/times and related sheets are not added as independent trials/participants.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. New certification of related-report overlap and unique trial/participant totals remains unverified.",
      "missingness": "New certification of related-report overlap and unique trial/participant totals remains unverified.",
      "uncertainty": "New certification of related-report overlap and unique trial/participant totals remains unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Trial/cohort/report identities and observation-unit data"
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "What are original PIVOT/SPCG-4 descriptions versus the current report list?",
      "needed": "Other-study names/detection methods, direct applicability and reading scope",
      "role": "Supplementary",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What are original PIVOT/SPCG-4 descriptions versus the current report list?",
      "application_exception": "Do not add invented reports/independent replication from name mentions or rejudge current mortality with other-population results.",
      "criterion": "For Other-study names/detection methods, direct applicability and reading scope, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Separate research question with explicit detection method/population",
      "current_reports": [
        "R01"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original counterview describes PIVOT’s nonsignificant observation/surgery comparison and SPCG-4’s surgery advantage in a clinically detected population with 10% PSA detection, a different scope. Current citations are two ProtecT reports; originals from the other trials were not read now.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Those studies’ citations/original results, populations/comparators/follow-up/CI remain unverified.",
      "missingness": "Those studies’ citations/original results, populations/comparators/follow-up/CI remain unverified.",
      "uncertainty": "Those studies’ citations/original results, populations/comparators/follow-up/CI remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Those studies’ originals and applicability/identity data"
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "What is the extrapolation boundary between contemporary surveillance and historical monitoring?",
      "needed": "Historical PSA-led strategy versus contemporary MRI/repeat-biopsy descriptions",
      "role": "Supplementary",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What is the extrapolation boundary between contemporary surveillance and historical monitoring?",
      "application_exception": "Do not newly claim all current monitoring ineffective/equivalent or create testing/repeat-biopsy/treatment instructions.",
      "criterion": "For Historical PSA-led strategy versus contemporary MRI/repeat-biopsy descriptions, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are internally designed",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research specifying strategy scope",
      "current_reports": [
        "R01"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original describes contemporary active surveillance as using more MRI/regular repeat biopsy than ProtecT. Direct contemporary-strategy effects/comparisons are absent from the summary.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Contemporary-strategy specifications, direct comparisons/risk populations/follow-up remain unverified.",
      "missingness": "Contemporary-strategy specifications, direct comparisons/risk populations/follow-up remain unverified.",
      "uncertainty": "Contemporary-strategy specifications, direct comparisons/risk populations/follow-up remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Direct strategy/period/population-specific data"
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Are independent confirmation in the selected scope and same-cohort updates separated?",
      "needed": "Direct independent reports versus 10/15-year updates and original R1/I2",
      "role": "Required",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: Are independent confirmation in the selected scope and same-cohort updates separated?",
      "application_exception": "Do not inherit parent axes as current independence certification or count cumulative reports at different times as replication.",
      "criterion": "For Direct independent reports versus 10/15-year updates and original R1/I2, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "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": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Separate research specifying the same question/population/strategies",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "Parent R1/I2 are historical axes and the 10/15-year reports concern the same cohort. Additional direct-study identity/independence was not searched/certified now.",
      "condition_status": "Unverified",
      "status_reason": "Required direct materials were not verified within the current summary/unread-external-material scope. Separate direct studies’ populations/strategies/times and overlap/independence remain unverified.",
      "missingness": "Separate direct studies’ populations/strategies/times and overlap/independence remain unverified.",
      "uncertainty": "Separate direct studies’ populations/strategies/times and overlap/independence remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Direct confirmation/trial-identity materials"
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "How are mortality, metastasis/progression and functional harms different questions?",
      "needed": "Hard mortality/progression versus urinary/sexual/bowel function",
      "role": "Supplementary",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: How are mortality, metastasis/progression and functional harms different questions?",
      "application_exception": "Do not newly conclude overall strategy superiority, individual treatment selection/replacement or harmlessness from nonsignificance.",
      "criterion": "For Hard mortality/progression versus urinary/sexual/bowel function, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "basis": "M03 §3.2.4; internally defined extension boundaries; Chamgap’s interpretation boundaries, referring to M19 principles without executing an official causality tool; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Plan separating different clinical outcomes and estimands",
      "current_reports": [
        "R01"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original separately records nonsignificant mortality, increased monitoring metastasis/progression, surgery-related incontinence/erectile effects and radiotherapy-related bowel/sexual effects. No new overall balance assessment of different outcomes.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Each functional/quality-of-life outcome’s event definitions/effects/denominators/CI remain unverified.",
      "missingness": "Each functional/quality-of-life outcome’s event definitions/effects/denominators/CI remain unverified.",
      "uncertainty": "Each functional/quality-of-life outcome’s event definitions/effects/denominators/CI remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Separate mortality/progression/patient-important/harm outcome data"
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "What is the scope of harm updates in the 15-year material?",
      "needed": "No new treatment complications reported after 10 years and current access",
      "role": "Supplementary",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What is the scope of harm updates in the 15-year material?",
      "application_exception": "Do not turn no-new-complication reporting into zero adverse effects at 15 years or guaranteed long-term safety.",
      "criterion": "For No new treatment complications reported after 10 years and current access, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "basis": "M04 §4.5, §4.6.3; current conversion limitations reflect review scope and internal design; M19 §19.1.2–19.2.4; detailed discrimination is internally designed; M19 §19.1.2–19.2.4; internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Record separating cumulative efficacy updates from harm-observation scope",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original study facts describe no new treatment-complication reporting in the 15-year paper after the 10-year analysis. This is not a current nonreporting determination from external-paper reading and does not mean zero harms/no follow-up.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Actual harm collection/results/updates by interval/report remain unread.",
      "missingness": "Actual harm collection/results/updates by interval/report remain unread.",
      "uncertainty": "Actual harm collection/results/updates by interval/report remain unread.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "10/15-year harm reporting/collection data"
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "What is the scope of preserved summaries, unread external materials and links?",
      "needed": "Complete preserved summary and 15/10-year citations/abstracts/full texts/plans",
      "role": "Required",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What is the scope of preserved summaries, unread external materials and links?",
      "application_exception": "Preserve absent DOI/PMCID and unread external material; URLs/IDs do not establish acquisition or access success/failure.",
      "criterion": "For Complete preserved summary and 15/10-year citations/abstracts/full texts/plans, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "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": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Records separating summaries/identities from new acquisition",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The complete preserved 2974 summary was read and saved for production. Two original PubMed URLs/registration IDs link original sources; external content/link access/click/testing was not performed.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Current verification of external original methods/results, registration/plans/disclosures is incomplete.",
      "missingness": "Current verification of external original methods/results, registration/plans/disclosures is incomplete.",
      "uncertainty": "Current verification of external original methods/results, registration/plans/disclosures is incomplete.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Acquired originals and actual-reading/additional-evidence events"
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "What are original bilingual text, dates, corrections/axes/absences and history?",
      "needed": "Parent D34, languages/dates, empty values, axes/citations",
      "role": "Required",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What are original bilingual text, dates, corrections/axes/absences and history?",
      "application_exception": "Do not inherit B0 evidence quotations/applied cross-checking as current model review or bias/independence certification.",
      "criterion": "For Parent D34, languages/dates, empty values, axes/citations, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Separate original values/absences from new evidence updates",
      "current_reports": [
        "R01"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "Preserve bilingual text, original date 2026-08-26 and empty corrections/deliberation. Parent B/H/R1/I2/E0/B0/C0, true large-hard-endpoint RCT, two other false indicators and empty grade-override reasons are historical context. Separate classification and failed-primary/positive-secondary indicators are unrecorded.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. External original quotations/translations and detailed registration/correction comparisons were not performed this time.",
      "missingness": "External original quotations/translations and detailed registration/correction comparisons were not performed this time.",
      "uncertainty": "External original quotations/translations and detailed registration/correction comparisons were not performed this time.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Language-specific originals/revisions and date/correction events"
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "Are harm collection, severity and event definitions verified?",
      "needed": "Collection of surgery/radiotherapy functional effects and monitoring progression",
      "role": "Supplementary",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: Are harm collection, severity and event definitions verified?",
      "application_exception": "Do not convert mortality nonsignificance into no safety signals, zero harms or equivalent tolerability.",
      "criterion": "For Collection of surgery/radiotherapy functional effects and monitoring progression, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "basis": "M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Plan specifying strategy-specific harms and progression",
      "current_reports": [
        "R01"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original describes different strategy-specific harms/progression. Collection methods, severity, event definitions and scales/completion are not detailed in the summary.",
      "condition_status": "Unverified",
      "status_reason": "Required direct materials were not verified within the current summary/unread-external-material scope. Harm definitions/collection, severity and each outcome’s original tables remain unverified.",
      "missingness": "Harm definitions/collection, severity and each outcome’s original tables remain unverified.",
      "uncertainty": "Harm definitions/collection, severity and each outcome’s original tables remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Harm plans/scales and event/functional-outcome data"
    },
    {
      "item_id": "N32",
      "question_type": "Evidence condition",
      "question": "Are arm-specific harm denominators/comparisons/CI distinguished from mortality denominators?",
      "needed": "Valid harm/function observations, arm/time denominators and effects",
      "role": "Supplementary",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: Are arm-specific harm denominators/comparisons/CI distinguished from mortality denominators?",
      "application_exception": "Do not calculate/add unrecorded incontinence/erectile/bowel/sexual-function events, proportions or CI.",
      "criterion": "For Valid harm/function observations, arm/time denominators and effects, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "basis": "M19 §19.2.2–19.2.4, M03 §3.2.3; internal application; M19 §19.1.2–19.2.4; internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research distinguishing efficacy from harm-observation populations",
      "current_reports": [
        "R01"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "Original treatment-specific functional effects are described, but arm-specific denominators/effects/CI for those tests/questionnaires/events are absent. Randomized mortality denominators do not automatically become valid harm denominators.",
      "condition_status": "Unverified",
      "status_reason": "Required direct materials were not verified within the current summary/unread-external-material scope. Collection/denominators, comparisons/CI for each harm/time remain unverified.",
      "missingness": "Collection/denominators, comparisons/CI for each harm/time remain unverified.",
      "uncertainty": "Collection/denominators, comparisons/CI for each harm/time remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Arm-specific harm/function tables and observation flow"
    },
    {
      "item_id": "N33",
      "question_type": "Evidence condition",
      "question": "What are harm timing, post-crossover effects and long-term observation?",
      "needed": "Treatment/switching timing, function/events and interval-specific follow-up",
      "role": "Supplementary",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What are harm timing, post-crossover effects and long-term observation?",
      "application_exception": "Do not copy 15-year mortality follow-up as complete 15-year observation/safety verification for all harms.",
      "criterion": "For Treatment/switching timing, function/events and interval-specific follow-up, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "basis": "M19 §19.2 design-specific harm questions; temporal-relationship details are internally designed; M19 §19.1.2–19.2.4; internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Plan distinguishing efficacy follow-up from harm-occurrence timing",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "Original long-term follow-up/switching context exists, but post-treatment/post-switch functional-harm timing, persistence/recovery and long-term collection details are absent.",
      "condition_status": "Unverified",
      "status_reason": "Required direct materials were not verified within the current summary/unread-external-material scope. Exposure/switching, harm occurrence and interval-specific/delayed observation remain unverified.",
      "missingness": "Exposure/switching, harm occurrence and interval-specific/delayed observation remain unverified.",
      "uncertainty": "Exposure/switching, harm occurrence and interval-specific/delayed observation remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Exposure/switching and harm/function timing data"
    },
    {
      "item_id": "N34",
      "question_type": "Evidence condition",
      "question": "How are harms attributed to assignment, actual treatment or medical history?",
      "needed": "Original strategies, switching/shared exposure, alternative causes and causality",
      "role": "Supplementary",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: How are harms attributed to assignment, actual treatment or medical history?",
      "application_exception": "Do not combine mortality/metastasis/functional harms into one causal effect or newly give cancer-treatment/procedure instructions.",
      "criterion": "For Original strategies, switching/shared exposure, alternative causes and causality, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "basis": "M19 §19.2.2–19.2.4 design considerations; detailed confounding records are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Plan separating assignment from actual exposure/alternative causes",
      "current_reports": [
        "R01"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "Original ITT assigned-strategy and subsequent treatment-switching context exists. Models/assessments attributing individual harms to assignment/actual treatment/baseline disease are not detailed in the summary.",
      "condition_status": "Unverified",
      "status_reason": "Required direct materials were not verified within the current summary/unread-external-material scope. Event-specific actual exposure/history, relatedness/confounding/alternative causes remain unverified.",
      "missingness": "Event-specific actual exposure/history, relatedness/confounding/alternative causes remain unverified.",
      "uncertainty": "Event-specific actual exposure/history, relatedness/confounding/alternative causes remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Individual exposure/switching, events/relatedness and analysis data"
    },
    {
      "item_id": "N35",
      "question_type": "Evidence condition",
      "question": "Are loss/death/crossover and harm missingness distinguished?",
      "needed": "Functional-questionnaire/harm missingness, follow-up completeness and stopping reasons",
      "role": "Supplementary",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: Are loss/death/crossover and harm missingness distinguished?",
      "application_exception": "Do not copy complete follow-up for 1,610 into all valid functional/harm denominators or fill missingness as zero harms.",
      "criterion": "For Functional-questionnaire/harm missingness, follow-up completeness and stopping reasons, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "basis": "M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Plan distinguishing harm missingness from mortality follow-up",
      "current_reports": [
        "R01"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "Original 98% follow-up completeness and mortality ITT descriptions exist, but function/harm collection completeness, arm-specific missingness/stopping and observation handling after death are not detailed.",
      "condition_status": "Unverified",
      "status_reason": "Required direct materials were not verified within the current summary/unread-external-material scope. Harm-specific missingness/stopping, competing events/death and handling/sensitivity remain unverified.",
      "missingness": "Harm-specific missingness/stopping, competing events/death and handling/sensitivity remain unverified.",
      "uncertainty": "Harm-specific missingness/stopping, competing events/death and handling/sensitivity remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Harm flow/missingness/death and handling data"
    },
    {
      "item_id": "N36",
      "question_type": "Evidence condition",
      "question": "Are independent harm data distinguished from same-cohort reports?",
      "needed": "Identity/overlap of 10/15-year and separate harm reports",
      "role": "Supplementary",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: Are independent harm data distinguished from same-cohort reports?",
      "application_exception": "Do not sum two reports as two independent safety trials or extend to verified absence of all external harm data.",
      "criterion": "For Identity/overlap of 10/15-year and separate harm reports, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "basis": "M04 §§4.6.1–4.6.2; harm-material adaptation is Chamgap-designed; M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Record separating the same cohort from independent materials",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "Current preserved citations concern ProtecT’s same-cohort 10/15-year reports. Separate independent harm originals were not searched/acquired now; times/reports/related sheets are not counted as independent harm trials.",
      "condition_status": "Unverified",
      "status_reason": "Required direct materials were not verified within the current summary/unread-external-material scope. Independent harm data identities/populations/strategies and overlap remain unverified.",
      "missingness": "Independent harm data identities/populations/strategies and overlap remain unverified.",
      "uncertainty": "Independent harm data identities/populations/strategies and overlap remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Related/separate harm reports and identity data"
    },
    {
      "item_id": "N37",
      "question_type": "Evidence condition",
      "question": "What is the scope for risk/vulnerable populations, contemporary treatments and long-term safety?",
      "needed": "Historical localized disease/age versus other risks/strategies and follow-up harms",
      "role": "Supplementary",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What is the scope for risk/vulnerable populations, contemporary treatments and long-term safety?",
      "application_exception": "Do not newly propose risk-selection/PSA-testing or monitoring/surgery/radiotherapy/treatment-replacement methods.",
      "criterion": "For Historical localized disease/age versus other risks/strategies and follow-up harms, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "basis": "M19 §19.1.2–19.2.4; internal application; M03 §3.2.1; detailed population conditions are internally designed; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are internally designed",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research specifying population and long-term safety questions",
      "current_reports": [
        "R01"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "Original PSA-detected localized disease, ages 50–69 and historical strategies are not repurposed as direct safety for other risks/diseases/ages or contemporary strategies.",
      "condition_status": "Unverified",
      "status_reason": "Required direct materials were not verified within the current summary/unread-external-material scope. Direct population/strategy-specific harms and long-term/risk-population data remain unverified.",
      "missingness": "Direct population/strategy-specific harms and long-term/risk-population data remain unverified.",
      "uncertainty": "Direct population/strategy-specific harms and long-term/risk-population data remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Direct risk/strategy/disease-specific harm data"
    },
    {
      "item_id": "N38",
      "question_type": "Evidence condition",
      "question": "How do nonsignificance, metastasis/function harms and harmlessness/equivalence relate?",
      "needed": "Original ineffective prostate-cancer mortality comparison versus separate progression/harms and causality",
      "role": "Supplementary",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: How do nonsignificance, metastasis/function harms and harmlessness/equivalence relate?",
      "application_exception": "Do not newly conclude the three strategies identical, all contemporary surveillance ineffective, guaranteed safety or an individual’s best treatment.",
      "criterion": "For Original ineffective prostate-cancer mortality comparison versus separate progression/harms and causality, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "basis": "Chamgap’s own interpretation boundaries. M19 principles are referenced; no official causality tool was run; M03 §3.2.4; internal extension boundaries; M15 §15.3.1–15.3.3; internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Plan separating different outcomes/estimands",
      "current_reports": [
        "R01"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "Separately preserve overall mortality P=.53, absence of noninferiority design, increased monitoring metastasis/progression, treatment-specific functional harms and parent caution. Nonsignificance does not establish harmlessness/equivalence.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Comparative/causal safety, each effect’s CI/importance and direct contemporary data remain unverified.",
      "missingness": "Comparative/causal safety, each effect’s CI/importance and direct contemporary data remain unverified.",
      "uncertainty": "Comparative/causal safety, each effect’s CI/importance and direct contemporary data remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Outcome/harm estimates and direct comparisons"
    },
    {
      "item_id": "N39",
      "question_type": "Evidence condition",
      "question": "How are subsequent originals, candidate history/versions and incomplete content review linked?",
      "needed": "Original summary/conditions, time/denominators/estimands and new evidence/change decisions",
      "role": "Supplementary",
      "role_reason": "Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: How are subsequent originals, candidate history/versions and incomplete content review linked?",
      "application_exception": "Do not invent current completed clinical-content review/publication from historical cross-checking or original production completion.",
      "criterion": "For Original summary/conditions, time/denominators/estimands and new evidence/change decisions, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research addressing direct gaps in selected 15-year mortality",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "ProtecT preserved summaries/citations exist; external details/plans/harms remain unread and materials are needed.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "Conditions were preserved/frozen before separate application. Candidate review-pending/production-eligibility labels remain historical records; current content/question-boundary review is incomplete. Zero new units and unrecorded confirmed independent totals are retained.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Subsequent originals, actual reading, changes/content review and independence decisions do not yet exist.",
      "missingness": "Subsequent originals, actual reading, changes/content review and independence decisions do not yet exist.",
      "uncertainty": "Subsequent originals, actual reading, changes/content review and independence decisions do not yet exist.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Additional originals, before/after values, versions and change-decision records"
    }
  ],
  "reports": [
    {
      "report_id": "R01",
      "title": "Hamdy FC, et al. Fifteen-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer. N Engl J Med. 2023;388:1547-1558. PMID: 36912538.",
      "url": "https://pubmed.ncbi.nlm.nih.gov/36912538/",
      "report_type": "ProtecT 15-year cumulative report of selected mortality/progression",
      "existence": "Citations/preserved summaries exist; external original text/registration/details remain unread.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "study_family": "SF01",
      "independent_replication": "The same ProtecT cohort’s 10/15-year reports, arms/events/time/related sheets are not newly added as independent trials/participants.",
      "observed_result": "17/545 (3.1%) versus 12/553 (2.2%) versus 16/545 (2.9%); overall P=.53",
      "result_level": "15-year prostate-cancer-specific death events/original percentages, overall P=.53. Comparative/time estimates/CI remain unverified; equivalence/noninferiority was not proved.",
      "source_evidence_date": "2026-08-26",
      "materials": [
        {
          "material_type": "Stored summary",
          "public_status": "Local preserved summary",
          "access_status": "Summary read",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-08-26",
          "qualification": "Only the corresponding report/citation scope in the preserved parent summary was read; external papers/original registration were not acquired."
        },
        {
          "material_type": "Abstract",
          "public_status": "External materials unread/needed",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Only the original citation URL is linked. External content/access and link tests were not attempted."
        },
        {
          "material_type": "Full paper",
          "public_status": "External materials unread/needed",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Original DOI/PMCID not provided. No new acquisition/reading of the full text/content."
        },
        {
          "material_type": "Registration material",
          "public_status": "External materials unread/needed",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Two IDs occur in the 15-year evidence list/parent’s same-trial history. Individual registration content/versions for this report remain unread; the direct 10-year citation contains no ID."
        },
        {
          "material_type": "Protocol",
          "public_status": "External materials unread/needed",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Population/strategy and mortality/progression/harm plans for the report/time are needed. Existence/publication status remains unverified."
        },
        {
          "material_type": "Statistical analysis plan",
          "public_status": "External materials unread/needed",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Original ITT/switching, time/censoring/competing-risk, estimation/interval, hierarchy/missingness plans are needed."
        },
        {
          "material_type": "Result tables and mortality/time/denominator/harm materials",
          "public_status": "External materials unread/needed",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Events/denominators, cause-specific/all-cause mortality, switching/risk sets/missingness and harms for the corresponding time are needed. No new calculations."
        },
        {
          "material_type": "Funding/conflict-of-interest disclosures",
          "public_status": "External materials unread/needed",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Original NIHR/MRC/Oxford information concerns parent/15-year context. Individual disclosures for this report remain unread now."
        }
      ],
      "links": [
        {
          "label": "PubMed",
          "url": "https://pubmed.ncbi.nlm.nih.gov/36912538/"
        }
      ]
    },
    {
      "report_id": "R02",
      "title": "Hamdy FC, et al. 10-Year Outcomes after Monitoring, Surgery, or Radiotherapy. N Engl J Med. 2016. PMID: 27626136.",
      "url": "https://pubmed.ncbi.nlm.nih.gov/27626136/",
      "report_type": "Same ProtecT cohort’s cumulative 10-year context report; not independent replication",
      "existence": "Citations/preserved summaries exist; external original text/registration/details remain unread.",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "study_family": "SF01",
      "independent_replication": "The same ProtecT cohort’s 10/15-year reports, arms/events/time/related sheets are not newly added as independent trials/participants.",
      "observed_result": "Same-cohort cumulative 10-year results: deaths 8/5/4, metastases 33/13/16, from the original study description. Valid 10-year denominators/estimates/CI remain unverified.",
      "result_level": "Original description of same-cohort cumulative 10-year mortality/metastases. Do not copy 15-year mortality denominators/effects. No separate 10-year evidence-list row/denominators/CI.",
      "source_evidence_date": "2026-08-26",
      "materials": [
        {
          "material_type": "Stored summary",
          "public_status": "Local preserved summary",
          "access_status": "Summary read",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-08-26",
          "qualification": "Only the corresponding report/citation scope in the preserved parent summary was read; external papers/original registration were not acquired."
        },
        {
          "material_type": "Abstract",
          "public_status": "External materials unread/needed",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Only the original citation URL is linked. External content/access and link tests were not attempted."
        },
        {
          "material_type": "Full paper",
          "public_status": "External materials unread/needed",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Original DOI/PMCID not provided. No new acquisition/reading of the full text/content."
        },
        {
          "material_type": "Registration material",
          "public_status": "External materials unread/needed",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Two IDs occur in the 15-year evidence list/parent’s same-trial history. Individual registration content/versions for this report remain unread; the direct 10-year citation contains no ID."
        },
        {
          "material_type": "Protocol",
          "public_status": "External materials unread/needed",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Population/strategy and mortality/progression/harm plans for the report/time are needed. Existence/publication status remains unverified."
        },
        {
          "material_type": "Statistical analysis plan",
          "public_status": "External materials unread/needed",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Original ITT/switching, time/censoring/competing-risk, estimation/interval, hierarchy/missingness plans are needed."
        },
        {
          "material_type": "Result tables and mortality/time/denominator/harm materials",
          "public_status": "External materials unread/needed",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Events/denominators, cause-specific/all-cause mortality, switching/risk sets/missingness and harms for the corresponding time are needed. No new calculations."
        },
        {
          "material_type": "Funding/conflict-of-interest disclosures",
          "public_status": "External materials unread/needed",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Original NIHR/MRC/Oxford information concerns parent/15-year context. Individual disclosures for this report remain unread now."
        }
      ],
      "links": [
        {
          "label": "PubMed",
          "url": "https://pubmed.ncbi.nlm.nih.gov/27626136/"
        }
      ]
    }
  ],
  "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    }
  ],
  "status_dictionary": {
    "Met": "The original content has been reviewed as meeting the conditions. This status is not used in this preparation.",
    "Partly verified": "Some information in the stored summary was linked during preparation; clinical verification or review is not complete.",
    "Unverified": "Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.",
    "Review incomplete": "Review of existing content or actual review incomplete.",
    "Not reported": "Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.",
    "Inaccessible": "Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.",
    "Insufficient evidence for the conditions": "Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.",
    "Not applicable": "Used when the reason it does not apply to the original question is stated.",
    "Conflicting data": "Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment."
  },
  "study_overlap": {
    "state": "Unverified",
    "unique_trial_count": null,
    "unique_participant_count": null,
    "reason": "ProtecT same-cohort cumulative 10/15-year reports. People/arms/deaths/metastases/time and parent/related sheets are not newly added as independent trials/participants."
  },
  "history": [
    {
      "date": "2026-10-14",
      "kind": "Separation of public-facing pages and materials",
      "view_version": "1.0",
      "change": "Public reader pages and materials were prepared from the existing 39 items. No new clinical search, verification-status change or scoring was performed."
    }
  ],
  "language": "en",
  "translation_date": "2026-10-14"
}