{ "schema_version": "chamgap-public-criteria-1.0", "title": "MRI-first targeted-biopsy pathway · Noninferior significant-cancer detection and biopsy avoidance — Evidence Check", "language": "en", "translation_date": "2026-10-12", "criteria_version": "1.0", "criteria_date": "2026-10-06", "condition_origin": "Chamgap's own application conditions", "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "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": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What are the selected existing question and its record?", "needed": "Wording, Korean/English text and verdict links for noninferior significant-cancer detection and biopsy avoidance", "role": "Required", "role_reason": "A production condition preserving the original scope of Wording, Korean/English text and verdict links for noninferior significant-cancer detection and biopsy avoidance.", "application_exception": "Retain the detection/avoidance components of the one existing question without creating additional subclaim tables.", "criterion": "Wording, Korean/English text and verdict links for noninferior significant-cancer detection and biopsy avoidance; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are our own design", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If the question boundary changes, preserve its existing wording, the complete previous version and the change event." }, { "item_id": "N02", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "How do the subclaim C and parent C56, axes and history differ?", "needed": "Subclaim grade/note, absent score/status/axes and parent values", "role": "Required", "role_reason": "A production condition preserving the original scope of Subclaim grade/note, absent score/status/axes and parent values.", "application_exception": "Do not inherit parent R2/I2 or historical cross-checking as new independence certification, current review or a subclaim score.", "criterion": "Subclaim grade/note, absent score/status/axes and parent values; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "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": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Distinguish actual evidence-update events from preservation of original values." }, { "item_id": "N03", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "Which men awaiting an initial biopsy does the pathway concern?", "needed": "Before initial prostate biopsy, biopsy-naive status and actual eligibility", "role": "Required", "role_reason": "A production condition preserving the original scope of Before initial prostate biopsy, biopsy-naive status and actual eligibility.", "application_exception": "Do not generalize to everyone undergoing PSA testing, repeat-biopsy populations or patients with confirmed cancer.", "criterion": "Before initial prostate biopsy, biopsy-naive status and actual eligibility; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M03 §3.2.1; detailed population conditions are Chamgap's own design", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Distinguish application to other populations using actual biopsy history, baseline risk and eligibility records." }, { "item_id": "N04", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What actually makes up the MRI-first pathway?", "needed": "Omitting biopsy after negative MRI and targeted biopsy alone after positive MRI", "role": "Required", "role_reason": "A production condition preserving the original scope of Omitting biopsy after negative MRI and targeted biopsy alone after positive MRI.", "application_exception": "Do not write instructions for MRI reading, target selection, biopsy or other medical procedures.", "criterion": "Omitting biopsy after negative MRI and targeted biopsy alone after positive MRI; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If records are provided, link the planned pathway separately to actual MRI and biopsy performance." }, { "item_id": "N05", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What is the standard TRUS pathway and comparison direction?", "needed": "Contrast between standard systematic TRUS and MRI-targeted pathways", "role": "Required", "role_reason": "A production condition preserving the original scope of Contrast between standard systematic TRUS and MRI-targeted pathways.", "application_exception": "Do not turn pathway names into direct rankings of every current biopsy composition or procedural guidance.", "criterion": "Contrast between standard systematic TRUS and MRI-targeted pathways; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Do not automatically combine records using different biopsy compositions as the same pathway." }, { "item_id": "N06", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What defined positive and negative MRI?", "needed": "Reading thresholds, equipment, readers and the actual diagnostic pathway", "role": "Required", "role_reason": "A production condition preserving the original scope of Reading thresholds, equipment, readers and the actual diagnostic pathway.", "application_exception": "Do not assume or prescribe a particular PI-RADS cutoff, MRI method or contrast procedure.", "criterion": "Reading thresholds, equipment, readers and the actual diagnostic pathway; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M03 §3.2.4; our own application", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If records are provided, link actual thresholds, equipment/readers and biopsy attribution." }, { "item_id": "N07", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "How was clinically significant cancer defined?", "needed": "Detection of GG2 or higher, histological assessment and original measurements", "role": "Required", "role_reason": "A production condition preserving the original scope of Detection of GG2 or higher, histological assessment and original measurements.", "application_exception": "Do not convert GG2 into Gleason numbers absent from the preserved summary, create new criteria or equate it with detection of all cancers.", "criterion": "Detection of GG2 or higher, histological assessment and original measurements; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M03 §3.2.4; our own application", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to link cancer significance, histological assessment and definition-specific counts separately." }, { "item_id": "N08", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What were PRECISE's design and prespecified noninferiority margin?", "needed": "Open-label phase 3, 5 Canadian centers and a −5 percentage-point noninferiority margin", "role": "Required", "role_reason": "A production condition preserving the original scope of Open-label phase 3, 5 Canadian centers and a −5 percentage-point noninferiority margin.", "application_exception": "Do not promote historical statements of prespecification or margin fulfillment into current plan review or a new noninferiority calculation.", "criterion": "Open-label phase 3, 5 Canadian centers and a −5 percentage-point noninferiority margin; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M08 §8.1–8.2.3; Chamgap adaptation; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If plans are provided, link the actual prespecified margin, methods and history to the results." }, { "item_id": "N09", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What are the original significant-cancer numerators, denominators and rates?", "needed": "MRI 79/227 (35%) and standard biopsy 67/225 (30%)", "role": "Required", "role_reason": "A production condition preserving the original scope of MRI 79/227 (35%) and standard biopsy 67/225 (30%).", "application_exception": "Do not calculate new RR, NNT, missed-cancer or total-cancer counts, or convert these numbers into cancer prevalence or sensitivity.", "criterion": "MRI 79/227 (35%) and standard biopsy 67/225 (30%); link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M04 §4.6.3 and M15 §§15.3.1–15.3.3; status separation is Chamgap-designed", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If records are supplemented, link original numerators/denominators to actual definitions and verification." }, { "item_id": "N10", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What do +5 percentage points and the one-sided 97.5% CI mean here?", "needed": "Original absolute difference, one-sided lower bound −3.4 percentage points to ∞ and prespecified −5 percentage points", "role": "Required", "role_reason": "A production condition preserving the original scope of Original absolute difference, one-sided lower bound −3.4 percentage points to ∞ and prespecified −5 percentage points.", "application_exception": "Do not turn the one-sided interval into a two-sided 95% CI or certify +5 percentage points as new superiority or a survival effect.", "criterion": "Original absolute difference, one-sided lower bound −3.4 percentage points to ∞ and prespecified −5 percentage points; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If direct analyses are provided, link the original contrast, one-sided interval, margin and population together." }, { "item_id": "N11", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "Are noninferiority, equivalence and superiority distinguished?", "needed": "Allowed −5 percentage points, significant-cancer detection and other hypotheses", "role": "Required", "role_reason": "A production condition preserving the original scope of Allowed −5 percentage points, significant-cancer detection and other hypotheses.", "application_exception": "Do not turn noninferiority into complete equivalence, no cancers missed or mortality equivalence.", "criterion": "Allowed −5 percentage points, significant-cancer detection and other hypotheses; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M15 §§15.3.1–15.3.3; Chamgap adaptation", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to distinguish each hypothesis's original design, endpoint and margin in additional analyses." }, { "item_id": "N12", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "How do 453 allocated participants and detection denominators 225/227 differ?", "needed": "Standard allocation 226, MRI allocation 227 and standard result denominator 225", "role": "Required", "role_reason": "A production condition preserving the original scope of Standard allocation 226, MRI allocation 227 and standard result denominator 225.", "application_exception": "Do not calculate differences such as 226−225 and invent dropout or failure reasons.", "criterion": "Standard allocation 226, MRI allocation 227 and standard result denominator 225; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If the original flow is added, link actual denominators and reasons at each stage." }, { "item_id": "N13", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What do 221 actual MRI recipients and 83 biopsy avoidances represent?", "needed": "Allocation 227, MRI performed in 221 and negative imaging/avoidance 83 (37%)", "role": "Required", "role_reason": "A production condition preserving the original scope of Allocation 227, MRI performed in 221 and negative imaging/avoidance 83 (37%).", "application_exception": "Do not copy 37% as an avoidance rate for all allocated men or all populations, or calculate positive-imaging/nonperformance counts.", "criterion": "Allocation 227, MRI performed in 221 and negative imaging/avoidance 83 (37%); link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "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": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If records are provided, distinguish denominators for allocation, actual MRI, imaging status and actual biopsy performance." }, { "item_id": "N14", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "Are biopsy avoidance and actual cancer nondetection/misses distinguished?", "needed": "Biopsy omission after negative MRI, reference verification, detection and accuracy", "role": "Required", "role_reason": "A production condition preserving the original scope of Biopsy omission after negative MRI, reference verification, detection and accuracy.", "application_exception": "Do not turn 37% biopsy avoidance and noninferior detection into no cancer in MRI-negative men or 100% negative predictive value/sensitivity.", "criterion": "Biopsy omission after negative MRI, reference verification, detection and accuracy; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M08 Table 8.2.a, M03 §3.2.4; own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to record verification pathways separately from actual detection and misses in additional diagnostic data." }, { "item_id": "N15", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What are the ITT, PP, crossover and actual-performance analyses?", "needed": "Noninferiority analysis populations, pathway deviations and actual tests/biopsies", "role": "Required", "role_reason": "A production condition preserving the original scope of Noninferiority analysis populations, pathway deviations and actual tests/biopsies.", "application_exception": "Do not confirm both ITT/PP fulfillment or no missing-data impact merely because the design was randomized.", "criterion": "Noninferiority analysis populations, pathway deviations and actual tests/biopsies; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Link allocation-based, actual-performance and PP definitions and results separately in new material." }, { "item_id": "N16", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What is the impact of missing data and different verification pathways?", "needed": "Different diagnostic verification, omissions and selection/verification bias", "role": "Required", "role_reason": "A production condition preserving the original scope of Different diagnostic verification, omissions and selection/verification bias.", "application_exception": "Do not turn verification differences into arbitrary numerical adjustment, recalculated accuracy or a new methodological-defect score.", "criterion": "Different diagnostic verification, omissions and selection/verification bias; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to report detection/avoidance alongside actual methods for differing verification pathways and missing data." }, { "item_id": "N17", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What are the open-label design and actual reading/assessment masking?", "needed": "Open-label trial, MRI/biopsy/pathology reading and analysis", "role": "Required", "role_reason": "A production condition preserving the original scope of Open-label trial, MRI/biopsy/pathology reading and analysis.", "application_exception": "Do not infer that every pathological assessment was unmasked or certify new defects beyond the original B1 merely from the open-label design.", "criterion": "Open-label trial, MRI/biopsy/pathology reading and analysis; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If original methods are provided, distinguish open-label/masked roles and their verification levels." }, { "item_id": "N18", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What shared care, additional tests and actual performance accompanied the pathway?", "needed": "Shared tests, additional biopsies and treatment/follow-up differences", "role": "Required", "role_reason": "A production condition preserving the original scope of Shared tests, additional biopsies and treatment/follow-up differences.", "application_exception": "Do not provide medical-procedure, test-selection, medication or care/treatment-replacement instructions.", "criterion": "Shared tests, additional biopsies and treatment/follow-up differences; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to distinguish pathway effects from additional diagnostic/treatment exposures in follow-up material." }, { "item_id": "N19", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What were the prespecified endpoints, noninferiority plan and multiple-comparison scope?", "needed": "Primary GG2 detection, margin and biopsy-avoidance/harm hierarchy", "role": "Required", "role_reason": "A production condition preserving the original scope of Primary GG2 detection, margin and biopsy-avoidance/harm hierarchy.", "application_exception": "Do not elevate original prespecification statements or parent axes into current registration/SAP verification.", "criterion": "Primary GG2 detection, margin and biopsy-avoidance/harm hierarchy; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M08 Table 8.2.a, M04 §4.6.3; Chamgap's own application", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If planning material is provided, link endpoint/analysis-specific prespecification and confirmatory/supporting distinctions." }, { "item_id": "N20", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What are the registration identifiers and follow-up family links?", "needed": "PRECISE NCT02936258, PRECISION NCT02380027 and follow-up", "role": "Required", "role_reason": "A production condition preserving the original scope of PRECISE NCT02936258, PRECISION NCT02380027 and follow-up.", "application_exception": "Do not combine the two NCT identifiers, create new registration verification for R03 or invent a third evidence-list record.", "criterion": "PRECISE NCT02936258, PRECISION NCT02380027 and follow-up; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/result links are a Chamgap application; M08 Table 8.2.a and M04 §4.6.3; Chamgap application", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If registration material is provided, distinguish different trials from the same follow-up and historical from current reading." }, { "item_id": "N21", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What are the actual identities of the 3 reports?", "needed": "PRECISE 2021, PRECISION 2018 and PRECISE 2024 follow-up bibliography", "role": "Required", "role_reason": "A production condition preserving the original scope of PRECISE 2021, PRECISION 2018 and PRECISE 2024 follow-up bibliography.", "application_exception": "Do not invent a third evidence-list record for R03 or infer DOI/PMCID from article numbers or PMID.", "criterion": "PRECISE 2021, PRECISION 2018 and PRECISE 2024 follow-up bibliography; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If bibliography changes, preserve original text, report-specific identity and the change event." }, { "item_id": "N22", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "Are historical independent-replication statements distinguished from the same follow-up?", "needed": "Separate PRECISE/PRECISION investigators/funding and PRECISE follow-up", "role": "Required", "role_reason": "A production condition preserving the original scope of Separate PRECISE/PRECISION investigators/funding and PRECISE follow-up.", "application_exception": "Do not elevate parent R2/I2 or an independent-replication label into new independence certification or count R03 as a new trial.", "criterion": "Separate PRECISE/PRECISION investigators/funding and PRECISE follow-up; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "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": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Link historical independence statements separately from direct current verification and the same follow-up in new material." }, { "item_id": "N23", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What is the scope of PRECISION's 500 participants, 28% and detection result?", "needed": "R02 allocation 500, MRI-pathway avoidance 28% and significant-cancer detection in the same direction", "role": "Required", "role_reason": "A production condition preserving the original scope of R02 allocation 500, MRI-pathway avoidance 28% and significant-cancer detection in the same direction.", "application_exception": "Do not copy PRECISE's 79/227, −5 percentage points, 37% or safety values into R02, or reverse-calculate counts from 500×28%.", "criterion": "R02 allocation 500, MRI-pathway avoidance 28% and significant-cancer detection in the same direction; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are our own design", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Link each trial's original definitions, denominators, margins and intervals separately in R02 material." }, { "item_id": "N24", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What actual result does PRECISE's 2-year follow-up describe?", "needed": "Cumulative GG2 or higher diagnosis, retained initial biopsy omission and follow-up timing", "role": "Required", "role_reason": "A production condition preserving the original scope of Cumulative GG2 or higher diagnosis, retained initial biopsy omission and follow-up timing.", "application_exception": "Do not turn a qualitative statement of no difference into fulfillment of a 2-year noninferiority test, equivalence, mortality equivalence or a numerical 0.", "criterion": "Cumulative GG2 or higher diagnosis, retained initial biopsy omission and follow-up timing; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M04 §4.6.3 and M15 §§15.3.1–15.3.3; status separation is Chamgap-designed", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If original follow-up data are provided, link baseline detection separately to 2-year cumulative diagnosis/avoidance at each time point." }, { "item_id": "N25", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What are the 2-year follow-up denominators, omissions and additional diagnoses?", "needed": "R03 actual follow-up/analysis n, additional biopsies and missing data", "role": "Required", "role_reason": "A production condition preserving the original scope of R03 actual follow-up/analysis n, additional biopsies and missing data.", "application_exception": "Do not copy baseline 453, 225/227 or 221 as verified 2-year denominators.", "criterion": "R03 actual follow-up/analysis n, additional biopsies and missing data; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "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": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to distinguish denominators and reasons for allocation, baseline biopsy, follow-up and cumulative outcomes." }, { "item_id": "N26", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "Is omitting systematic biopsy after positive MRI a separate question?", "needed": "Pathway comparison versus the optimal biopsy composition for positive cases", "role": "Required", "role_reason": "A production condition preserving the original scope of Pathway comparison versus the optimal biopsy composition for positive cases.", "application_exception": "Do not turn targeted-only biopsy in the original pathway into medical guidance to omit systematic biopsy in every positive case.", "criterion": "Pathway comparison versus the optimal biopsy composition for positive cases; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M03 §3.2.4; Chamgap's own limits on extension", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to distinguish direct composition comparisons from the whole-pathway comparison." }, { "item_id": "N27", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "How do cancer-detection surrogates and long-term mortality differ?", "needed": "Cancer detection, metastasis/death, long-term clinical outcomes and the separate ? subclaim", "role": "Required", "role_reason": "A production condition preserving the original scope of Cancer detection, metastasis/death, long-term clinical outcomes and the separate ? subclaim.", "application_exception": "Do not turn initial noninferior detection or no difference in 2-year diagnoses into long-term mortality equivalence, survival benefit or harmlessness.", "criterion": "Cancer detection, metastasis/death, long-term clinical outcomes and the separate ? subclaim; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M03 §3.2.4; internally defined extension boundary; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to record detection, additional diagnosis, treatment and metastasis/death as different endpoints." }, { "item_id": "N28", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What application differences arise from centers, populations, readers and technology?", "needed": "Initial-biopsy academic centers, age/risk and actual MRI/biopsy capability", "role": "Required", "role_reason": "A production condition preserving the original scope of Initial-biopsy academic centers, age/risk and actual MRI/biopsy capability.", "application_exception": "Do not generalize academic-center pathway results into fixed performance across every MRI or care setting.", "criterion": "Initial-biopsy academic centers, age/risk and actual MRI/biopsy capability; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap’s own design; M03 §3.2.1; detailed population conditions are Chamgap’s own design", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to report institutional, threshold, equipment/reader and eligibility-population differences as actual conditions." }, { "item_id": "N29", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What is the direct evidence scope for contrary results, heterogeneity and subgroups?", "needed": "Trial-specific definitions/margins, risk/readers and contrary/additional results", "role": "Required", "role_reason": "A production condition preserving the original scope of Trial-specific definitions/margins, risk/readers and contrary/additional results.", "application_exception": "Do not turn absence of a new search into no other trials or complete consensus, or calculate a pooled quantitative effect.", "criterion": "Trial-specific definitions/margins, risk/readers and contrary/additional results; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap’s own design; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to distinguish different conditions/measures from actual conflict on the same question in new material." }, { "item_id": "N30", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What is the scope of PRECISE funding and unreported equipment support?", "needed": "OICR, Prostate Cancer Canada, Movember presentations and manufacturer roles", "role": "Required", "role_reason": "A production condition preserving the original scope of OICR, Prostate Cancer Canada, Movember presentations and manufacturer roles.", "application_exception": "Do not elevate nonprofit/public support or nonreporting into new certification of no conflicts of interest or no support.", "criterion": "OICR, Prostate Cancer Canada, Movember presentations and manufacturer roles; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Distinguish article, presentation and report-specific roles and historical/current reading scope in support material." }, { "item_id": "N31", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "Is funding kept separate for other trials and follow-up?", "needed": "PRECISION's original public/nonprofit narrative and PRECISE follow-up-specific declarations", "role": "Required", "role_reason": "A production condition preserving the original scope of PRECISION's original public/nonprofit narrative and PRECISE follow-up-specific declarations.", "application_exception": "Do not copy PRECISE funding agencies or unreported-equipment statements into R02 individual disclosures or an allegedly read R03 declaration.", "criterion": "PRECISION's original public/nonprofit narrative and PRECISE follow-up-specific declarations; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If declarations are provided, link actual report-specific disclosure separately from trial-family context." }, { "item_id": "N32", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What are the original date, corrections, bilingual text, empty values and history?", "needed": "2026-08-26, empty correction/deliberation records and existing axes/verdict", "role": "Required", "role_reason": "A production condition preserving the original scope of 2026-08-26, empty correction/deliberation records and existing axes/verdict.", "application_exception": "Do not fill empty/absent values or historical independent replication/cross-checking with new scores or completed review.", "criterion": "2026-08-26, empty correction/deliberation records and existing axes/verdict; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Distinguish the complete prechange text, event, version and separate application when changes occur." }, { "item_id": "N33", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What was actually read, and what is the external-material status?", "needed": "Complete preserved summary, existing selection and unread external material", "role": "Required", "role_reason": "A production condition preserving the original scope of Complete preserved summary, existing selection and unread external material.", "application_exception": "Do not elevate URLs, quotations in the summary or the existence of copies into external reading, verified links or successful access.", "criterion": "Complete preserved summary, existing selection and unread external material; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "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": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Distinguish material type, publication/access, acquisition and reading scope/date in new records." }, { "item_id": "N34", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "How do report, material-slot, trial and participant counts differ?", "needed": "2 evidence entries, 3 citation entries, follow-up, allocation/analysis and unrecorded unique counts", "role": "Required", "role_reason": "A production condition preserving the original scope of 2 evidence entries, 3 citation entries, follow-up, allocation/analysis and unrecorded unique counts.", "application_exception": "Do not add 453, 500, 221, 225/227, 3 reports or parent/subclaim tables as total sample size or independent replications.", "criterion": "2 evidence entries, 3 citation entries, follow-up, allocation/analysis and unrecorded unique counts; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/result links are a Chamgap application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; design-specific adaptation is Chamgap’s own design", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Distinguish the same follow-up from a new trial and actual participant relationships in additional material." }, { "item_id": "N35", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What is linked when new material or corrections become available?", "needed": "Condition version, original material, observations, reading and change events", "role": "Required", "role_reason": "A production condition preserving the original scope of Condition version, original material, observations, reading and change events.", "application_exception": "Original candidate pending/eligible markers are history; do not revive historical review waits as execution or approval.", "criterion": "Condition version, original material, observations, reading and change events; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Prepare only actual additions/changes, separating the complete previous text, event, condition version/freeze, application and current handoff." }, { "item_id": "H01", "question_type": "Harms", "question": "What are the adverse-event, grade and symptom definitions and collection methods?", "needed": "At least 1 adverse event, grade 3 or higher, symptoms and collection", "role": "Supporting harm information", "role_reason": "A production condition preserving the original scope of At least 1 adverse event, grade 3 or higher, symptoms and collection.", "application_exception": "Prepare only the preserved summary's actual scope without inventing absent definitions, values, denominators or current verification.", "criterion": "At least 1 adverse event, grade 3 or higher, symptoms and collection; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M19 §§19.1.2–19.2.4; detailed distinctions are Chamgap-designed; M19 §§19.1.2–19.2.4; Chamgap adaptation", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to distinguish symptoms, serious events and pathway/procedure attribution in follow-up collection." }, { "item_id": "H02", "question_type": "Harms", "question": "What is the actual observation period for test/biopsy harms?", "needed": "MRI/contrast, biopsy, follow-up and occurrence timing", "role": "Supporting harm information", "role_reason": "A production condition preserving the original scope of MRI/contrast, biopsy, follow-up and occurrence timing.", "application_exception": "Do not inherit 2-year diagnostic follow-up as completed 2-year harm collection or write actual procedural/contraindication guidance.", "criterion": "MRI/contrast, biopsy, follow-up and occurrence timing; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M19 §19.2 design-specific harm questions; timing details are Chamgap-designed", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to distinguish test/procedure exposure, actual observation periods and additional interventions in harm material." }, { "item_id": "H03", "question_type": "Harms", "question": "What are the original overall adverse-event values and arm labels?", "needed": "Standard 145/226 (64%) and MRI 89/227 (40%)", "role": "Supporting harm information", "role_reason": "A production condition preserving the original scope of Standard 145/226 (64%) and MRI 89/227 (40%).", "application_exception": "Do not subtract original rates to create a new risk difference, statistically significant harm reduction or safety equivalence.", "criterion": "Standard 145/226 (64%) and MRI 89/227 (40%); link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M19 §§19.2.2–19.2.4 and M03 §3.2.3; Chamgap adaptation", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If original records are provided, link arm labels, denominators, periods and estimates to actual harms." }, { "item_id": "H04", "question_type": "Harms", "question": "What are the denominators for grade 3 or higher and symptom values?", "needed": "Standard 10 (4.4%), MRI 8 (3.5%) and symptom-specific denominators", "role": "Supporting harm information", "role_reason": "A production condition preserving the original scope of Standard 10 (4.4%), MRI 8 (3.5%) and symptom-specific denominators.", "application_exception": "Do not reverse-calculate event counts from symptom rates, sum categories/grades or create incidence rates without original denominators.", "criterion": "Standard 10 (4.4%), MRI 8 (3.5%) and symptom-specific denominators; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M19 §§19.1.2–19.2.4; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3 and M19 §§19.1.2–19.2.4; design-specific adaptation is Chamgap-designed", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to distinguish allocation, actual procedures, collection and category-specific denominators in harm tables." }, { "item_id": "H05", "question_type": "Harms", "question": "What alternative explanations concern fewer biopsies, shared care and harms?", "needed": "Procedure-exposure differences, pathways/diagnosis and attribution", "role": "Supporting harm information", "role_reason": "A production condition preserving the original scope of Procedure-exposure differences, pathways/diagnosis and attribution.", "application_exception": "Do not certify the mechanism of numerical differences or provide test/contrast/infection/bleeding-management instructions.", "criterion": "Procedure-exposure differences, pathways/diagnosis and attribution; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M19 §§19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap-designed", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to distinguish whole-pathway comparisons from actual procedure/test-exposure comparisons in additional harm material." }, { "item_id": "H06", "question_type": "Harms", "question": "What is the scope of confirmatory multiple comparisons, nonreporting and unread material?", "needed": "Original narrative of absent symptom-specific P values and currently unread external material", "role": "Supporting harm information", "role_reason": "A production condition preserving the original scope of Original narrative of absent symptom-specific P values and currently unread external material.", "application_exception": "Do not turn numerically lower original values into newly certified significant reductions, or unread external material into access failure or 0 harms.", "criterion": "Original narrative of absent symptom-specific P values and currently unread external material; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M19 §§19.1.2–19.2.4 and M04 §4.6.3; Chamgap adaptation", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Distinguish values, confirmatory/supporting analyses and missingness only in actually provided material." }, { "item_id": "H07", "question_type": "Harms", "question": "Are harms kept from being double-counted across trials and follow-up?", "needed": "Separate PRECISE/PRECISION trials, PRECISE follow-up and the same events", "role": "Supporting harm information", "role_reason": "A production condition preserving the original scope of Separate PRECISE/PRECISION trials, PRECISE follow-up and the same events.", "application_exception": "Do not copy PRECISE safety values into R02/R03 or add participants/events across multiple reports/time points.", "criterion": "Separate PRECISE/PRECISION trials, PRECISE follow-up and the same events; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "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": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to distinguish repeat reporting of the same events from other trials/new events in new harm material." }, { "item_id": "H08", "question_type": "Harms", "question": "What safety gaps concern longer periods, other risk populations and technology?", "needed": "Initial-biopsy pathway, MRI/contrast, biopsy and other populations/periods", "role": "Supporting harm information", "role_reason": "A production condition preserving the original scope of Initial-biopsy pathway, MRI/contrast, biopsy and other populations/periods.", "application_exception": "Do not expand original clinical-assessment wording into new test/biopsy-selection, contraindication or treatment-management guidance.", "criterion": "Initial-biopsy pathway, MRI/contrast, biopsy and other populations/periods; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M19 §§19.1.2–19.2.4; Chamgap adaptation", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to distinguish harm material together with original populations, actual technology/procedure exposure and periods." }, { "item_id": "H09", "question_type": "Harms", "question": "Are detection/avoidance benefits retained alongside harms and long-term gaps?", "needed": "Original noninferiority/avoidance, numerical harms and distinct long-term clinical uncertainty", "role": "Supporting harm information", "role_reason": "A production condition preserving the original scope of Original noninferiority/avoidance, numerical harms and distinct long-term clinical uncertainty.", "application_exception": "Do not turn noninferior detection into equivalence of all harms/mortality, survival benefit or procedural recommendations.", "criterion": "Original noninferiority/avoidance, numerical harms and distinct long-term clinical uncertainty; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "Chamgap interpretive boundary informed by M19 principles; no formal causality tool was run", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Link each endpoint, risk period, original location and change event separately in actually added material." } ] }