{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "PSA-detected localized prostate cancer · Three strategies and 15-year prostate-cancer mortality",
  "language": "en",
  "translation_date": "2026-10-14",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "condition_origin": "Chamgap's own application conditions",
  "method_sources": [
    {
      "id": "M03",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03",
      "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13",
      "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.",
      "review_level": "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."
  },
  "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    }
  ]
}