MRI-first targeted-biopsy pathway · Noninferior significant-cancer detection and biopsy avoidance — Evidence Check

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Diagnostic-pathway comparison, detection, avoidance and materialWhat are the selected existing question and its record?Required	The selected existing question is ‘Noninferior significant-cancer detection and biopsy avoidance’. Its verdict record is linked while the parent detection/avoidance context and the separate long-term mortality-equivalence question remain distinct. R01	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. No new structural split, invented verdict or independent-claim certification was created.	Wording, Korean/English text and verdict links for noninferior significant-cancer detection and biopsy avoidance	If the question boundary changes, preserve its existing wording, the complete previous version and the change event.
2	Partly verified	Full text not readStored summary read	N02 · Diagnostic-pathway comparison, detection, avoidance and materialHow do the subclaim C and parent C56, axes and history differ?Required	The subclaim grade is C, with the note ‘The −5 percentage-point margin was met, and 37% of men who underwent MRI avoided biopsy.’ Score/status/axes fields are absent. Parent C56, Caution and B/S/R2/I2/E+/B1 with precision not recorded are parent context. R01	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. The selected row's score, status and axes are not recorded and are not filled from parent values.	Subclaim grade/note, absent score/status/axes and parent values	Distinguish actual evidence-update events from preservation of original values.
3	Partly verified	Full text not readStored summary read	N03 · Diagnostic-pathway comparison, detection, avoidance and materialWhich men awaiting an initial biopsy does the pathway concern?Required	The original pathway uses MRI first before initial prostate biopsy. The PRECISE citation title specifies biopsy-naive men; the study involved men at 5 Canadian academic centers. R01	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Age, PSA/DRE, risk, prostate size, prior MRI, inclusion/exclusion criteria and actual baseline cancer status are unverified.	Before initial prostate biopsy, biopsy-naive status and actual eligibility	Distinguish application to other populations using actual biopsy history, baseline risk and eligibility records.
4	Partly verified	Full text not readStored summary read	N04 · Diagnostic-pathway comparison, detection, avoidance and materialWhat actually makes up the MRI-first pathway?Required	The existing intervention description says biopsy was omitted after negative MRI and only targeted biopsy was performed after positive MRI. This is a randomized pathway comparison rather than the accuracy of a single test. R01	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. MRI protocol, positivity criteria, actual adherence, crossover/additional biopsies and reading/targeting procedure details are unverified.	Omitting biopsy after negative MRI and targeted biopsy alone after positive MRI	If records are provided, link the planned pathway separately to actual MRI and biopsy performance.
5	Partly verified	Full text not readStored summary read	N05 · Diagnostic-pathway comparison, detection, avoidance and materialWhat is the standard TRUS pathway and comparison direction?Required	PRECISE allocated 226 men to standard TRUS biopsy and 227 to the MRI pathway. The citation title compares systematic TRUS with MRI-targeted biopsy. R01	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Biopsy core composition/count, access route, actual performance, shared care and additional-test differences are unverified.	Contrast between standard systematic TRUS and MRI-targeted pathways	Do not automatically combine records using different biopsy compositions as the same pathway.
6	Partly verified	Full text not readStored summary read	N06 · Diagnostic-pathway comparison, detection, avoidance and materialWhat defined positive and negative MRI?Required	The original record states that 83 men with negative imaging avoided biopsy and records a targeted-biopsy pathway after positive imaging. R01	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Specific thresholds such as PI-RADS, field strength/equipment, contrast, lesion criteria, reader experience, rereading and false-positive/false-negative classification are unverified.	Reading thresholds, equipment, readers and the actual diagnostic pathway	If records are provided, link actual thresholds, equipment/readers and biopsy attribution.
7	Partly verified	Full text not readStored summary read	N07 · Diagnostic-pathway comparison, detection, avoidance and materialHow was clinically significant cancer defined?Required	The PRECISE primary endpoint is the proportion with GG2 or higher cancer detected. Significant-cancer detection and noninferiority are linked to that definition. R01	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Detailed Grade Group histological criteria, independent/central reading, specimen/biopsy methods, discrepancy handling and definition-specific detection are unverified.	Detection of GG2 or higher, histological assessment and original measurements	Retain a proposal to link cancer significance, histological assessment and definition-specific counts separately.
8	Partly verified	Full text not readStored summary read	N08 · Diagnostic-pathway comparison, detection, avoidance and materialWhat were PRECISE's design and prespecified noninferiority margin?Required	The summary records PRECISE as an open-label phase 3 randomized noninferiority trial at 5 Canadian academic centers, with a prespecified −5 percentage-point margin. R01	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Sequence generation/concealment, original rationale for the margin, plan dates and analysis/testing procedures are unverified because external materials were not read.	Open-label phase 3, 5 Canadian centers and a −5 percentage-point noninferiority margin	If plans are provided, link the actual prespecified margin, methods and history to the results.
9	Partly verified	Full text not readStored summary read	N09 · Diagnostic-pathway comparison, detection, avoidance and materialWhat are the original significant-cancer numerators, denominators and rates?Required	PRECISE detection was 79/227 (35%) in the MRI pathway versus 67/225 (30%) with standard biopsy. Retain each value with its actual detection-result denominator. R01	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Histological verification, numerator counting, denominator selection and original result-table details are unverified.	MRI 79/227 (35%) and standard biopsy 67/225 (30%)	If records are supplemented, link original numerators/denominators to actual definitions and verification.
10	Partly verified	Full text not readStored summary read	N10 · Diagnostic-pathway comparison, detection, avoidance and materialWhat do +5 percentage points and the one-sided 97.5% CI mean here?Required	The original difference is +5 percentage points; the one-sided 97.5% CI is −3.4 percentage points to ∞. The preserved summary says the lower bound exceeded −5 percentage points and met the noninferiority margin. R01	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Models/adjustment, ITT/PP, variance/margin-testing methods, two-sided intervals and superiority tests are unverified.	Original absolute difference, one-sided lower bound −3.4 percentage points to ∞ and prespecified −5 percentage points	If direct analyses are provided, link the original contrast, one-sided interval, margin and population together.
11	Partly verified	Full text not readStored summary read	N11 · Diagnostic-pathway comparison, detection, avoidance and materialAre noninferiority, equivalence and superiority distinguished?Required	The original result is a statement that significant-cancer detection met noninferiority within the prespecified allowance. The +5 percentage-point difference is preserved alongside it. R01	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Equivalence/superiority tests and margins, validation of clinical importance and long-term mortality equivalence are unverified in this selected material.	Allowed −5 percentage points, significant-cancer detection and other hypotheses	Retain a proposal to distinguish each hypothesis's original design, endpoint and margin in additional analyses.
12	Partly verified	Full text not readStored summary read	N12 · Diagnostic-pathway comparison, detection, avoidance and materialHow do 453 allocated participants and detection denominators 225/227 differ?Required	Allocation was 453 men: standard 226 and MRI 227. Significant-cancer result denominators were standard 225 and MRI 227. Retain the standard arm's allocation and result denominators separately. R01	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Reasons for denominator changes, exclusions, indeterminate tests, crossover, arm-specific nonperformance and analysis populations are unverified.	Standard allocation 226, MRI allocation 227 and standard result denominator 225	If the original flow is added, link actual denominators and reasons at each stage.
13	Partly verified	Full text not readStored summary read	N13 · Diagnostic-pathway comparison, detection, avoidance and materialWhat do 221 actual MRI recipients and 83 biopsy avoidances represent?Required	Among the 221 men who actually underwent MRI, 83 (37%) avoided biopsy because imaging was negative. This denominator is MRI recipients and differs from all 227 allocated men. R01	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Reasons for MRI nonperformance/deviation, negative-imaging/actual-avoidance verification and an avoidance rate for all allocated men are unverified.	Allocation 227, MRI performed in 221 and negative imaging/avoidance 83 (37%)	If records are provided, distinguish denominators for allocation, actual MRI, imaging status and actual biopsy performance.
14	Partly verified	Full text not readStored summary read	N14 · Diagnostic-pathway comparison, detection, avoidance and materialAre biopsy avoidance and actual cancer nondetection/misses distinguished?Required	The pathway omitting biopsy after negative MRI records avoidance of 83/221. Significant-cancer detection is compared separately between pathways. R01	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Initial histological verification of MRI-negative men, missed cancers, TP/FP/FN/TN, sensitivity, specificity and negative predictive value are absent from the preserved summary.	Biopsy omission after negative MRI, reference verification, detection and accuracy	Retain a proposal to record verification pathways separately from actual detection and misses in additional diagnostic data.
15	Partly verified	Full text not readStored summary read	N15 · Diagnostic-pathway comparison, detection, avoidance and materialWhat are the ITT, PP, crossover and actual-performance analyses?Required	The preserved summary provides the randomized noninferiority pathway comparison and original result denominators. R01	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. ITT/PP, as-treated and deviation/crossover definitions, test/biopsy nonperformance, missing-data/supporting analyses and their results are unverified.	Noninferiority analysis populations, pathway deviations and actual tests/biopsies	Link allocation-based, actual-performance and PP definitions and results separately in new material.
16	Partly verified	Full text not readStored summary read	N16 · Diagnostic-pathway comparison, detection, avoidance and materialWhat is the impact of missing data and different verification pathways?Required	The pathways differ: biopsy omission after negative MRI versus standard TRUS biopsy. R01	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Unverified cases, missing data, actual follow-up, independent verification, omission assumptions and sensitivity are unverified.	Different diagnostic verification, omissions and selection/verification bias	Retain a proposal to report detection/avoidance alongside actual methods for differing verification pathways and missing data.
17	Partly verified	Full text not readStored summary read	N17 · Diagnostic-pathway comparison, detection, avoidance and materialWhat are the open-label design and actual reading/assessment masking?Required	PRECISE is recorded as open-label phase 3. R01	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Details of MRI reading/target selection, pathology reading, original detection counts, analyst masking and central assessment are unverified.	Open-label trial, MRI/biopsy/pathology reading and analysis	If original methods are provided, distinguish open-label/masked roles and their verification levels.
18	Partly verified	Full text not readStored summary read	N18 · Diagnostic-pathway comparison, detection, avoidance and materialWhat shared care, additional tests and actual performance accompanied the pathway?Required	The selected comparison concerns the initial-biopsy pathway. The preserved summary retains the main pathways and qualitative 2-year follow-up results. R01	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Shared tests, additional biopsies, antibiotic/analgesic/contrast care, subsequent treatment, adherence and crossover details are unverified.	Shared tests, additional biopsies and treatment/follow-up differences	Retain a proposal to distinguish pathway effects from additional diagnostic/treatment exposures in follow-up material.
19	Partly verified	Full text not readStored summary read	N19 · Diagnostic-pathway comparison, detection, avoidance and materialWhat were the prespecified endpoints, noninferiority plan and multiple-comparison scope?Required	The existing research description lists GG2 or higher detection as the primary endpoint and the −5 percentage-point margin. The original narrative says harm comparisons lacked confirmatory multiplicity-adjusted P values. R01	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Original protocol/SAP dates, avoidance/harm hierarchy, adjustment/multiple testing and analysis-selection details are unverified.	Primary GG2 detection, margin and biopsy-avoidance/harm hierarchy	If planning material is provided, link endpoint/analysis-specific prespecification and confirmatory/supporting distinctions.
20	Partly verified	Full text not readStored summary read	N20 · Diagnostic-pathway comparison, detection, avoidance and materialWhat are the registration identifiers and follow-up family links?Required	The first existing evidence record lists NCT02936258 and R02 lists NCT02380027. The PRECISE 2-year report is recorded as follow-up of the same trial in citation R03. R01 R02 R03	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Current registration contents, dates/changes, consistency with results and an individual registration field for citation R03 are unverified or absent.	PRECISE NCT02936258, PRECISION NCT02380027 and follow-up	If registration material is provided, distinguish different trials from the same follow-up and historical from current reading.
21	Partly verified	Full text not readStored summary read	N21 · Diagnostic-pathway comparison, detection, avoidance and materialWhat are the actual identities of the 3 reports?Required	The preserved summary lists R01 Klotz 2021 JAMA Oncology, PMID 33538782; R02 Kasivisvanathan 2018 NEJM, PMID 29552975; and R03 Klotz 2024 European Urology Oncology 2-year follow-up, PMID 37838556. There are 2 evidence entries and 3 citation entries. R01 R02 R03	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. DOI, PMCID, current external bibliography and R03 original result tables/denominators are not specified.	PRECISE 2021, PRECISION 2018 and PRECISE 2024 follow-up bibliography	If bibliography changes, preserve original text, report-specific identity and the change event.
22	Partly verified	Full text not readStored summary read	N22 · Diagnostic-pathway comparison, detection, avoidance and materialAre historical independent-replication statements distinguished from the same follow-up?Required	The preserved summary describes results in the same direction from Canadian PRECISE and separate European PRECISION, with independent investigators/funding. R03 is the same PRECISE trial's 2-year follow-up. R01 R02 R03	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Original current recruitment, institutional, funding and participant-independence records were not newly verified; unique trial/participant counts are not certified.	Separate PRECISE/PRECISION investigators/funding and PRECISE follow-up	Link historical independence statements separately from direct current verification and the same follow-up in new material.
23	Partly verified	Full text not readStored summary read	N23 · Diagnostic-pathway comparison, detection, avoidance and materialWhat is the scope of PRECISION's 500 participants, 28% and detection result?Required	The original summary describes PRECISION as a European multicenter noninferiority trial with 500 randomized participants, 28% biopsy avoidance in the MRI pathway and significant-cancer detection in the same direction. R02	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Actual avoidance numerator/denominator, arm allocations, detection effects/CIs, margins/definitions/analysis populations and harms are absent from the preserved summary.	R02 allocation 500, MRI-pathway avoidance 28% and significant-cancer detection in the same direction	Link each trial's original definitions, denominators, margins and intervals separately in R02 material.
24	Partly verified	Full text not readStored summary read	N24 · Diagnostic-pathway comparison, detection, avoidance and materialWhat actual result does PRECISE's 2-year follow-up describe?Required	The existing counterview says there was no difference in cumulative GG2 or higher diagnoses between arms at 2 years while initial biopsy omission was retained. R03 is follow-up of the same trial. R03	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Quantitative numerators/denominators, effects/CIs/P values, tests/additional biopsies, analysis definitions and long-term importance are unverified.	Cumulative GG2 or higher diagnosis, retained initial biopsy omission and follow-up timing	If original follow-up data are provided, link baseline detection separately to 2-year cumulative diagnosis/avoidance at each time point.
25	Unverified	Full text not readStored summary read	N25 · Diagnostic-pathway comparison, detection, avoidance and materialWhat are the 2-year follow-up denominators, omissions and additional diagnoses?Required	R03 is a longer-term PRECISE report, but the complete original summary has no actual 2-year response/analysis denominator. R03	Required direct definitions, values and material remain unverified within the preserved-summary/unread-external-material scope. Links between allocation 453/arms 226/227 and 2-year contact/completion/analysis, follow-up loss/imputation and additional-test criteria are unverified.	R03 actual follow-up/analysis n, additional biopsies and missing data	Retain a proposal to distinguish denominators and reasons for allocation, baseline biopsy, follow-up and cumulative outcomes.
26	Partly verified	Full text not readStored summary read	N26 · Diagnostic-pathway comparison, detection, avoidance and materialIs omitting systematic biopsy after positive MRI a separate question?Required	The preserved summary states that this trial did not answer whether systematic biopsy can always be omitted in MRI-positive men. R01	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Direct targeted-only versus targeted-plus-systematic comparisons, missed cancers/harms and condition-specific definitions are unverified.	Pathway comparison versus the optimal biopsy composition for positive cases	Retain a proposal to distinguish direct composition comparisons from the whole-pathway comparison.
27	Partly verified	Full text not readStored summary read	N27 · Diagnostic-pathway comparison, detection, avoidance and materialHow do cancer-detection surrogates and long-term mortality differ?Required	The original verdict rationale and advertising interpretation say cancer detection is not mortality/metastasis. The separate long-term cancer-mortality-equivalence question is graded ? and records that this was not the trial endpoint. R01	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Direct long-term effects/CIs for metastasis, cancer-specific/all-cause mortality, quality of life and post-treatment events are unverified.	Cancer detection, metastasis/death, long-term clinical outcomes and the separate ? subclaim	Retain a proposal to record detection, additional diagnosis, treatment and metastasis/death as different endpoints.
28	Partly verified	Full text not readStored summary read	N28 · Diagnostic-pathway comparison, detection, avoidance and materialWhat application differences arise from centers, populations, readers and technology?Required	The representative material comprises PRECISE at 5 Canadian academic centers and multicenter European PRECISION. R01 R02	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Direct results in nonacademic settings, other diagnostic/risk populations, equipment/reading/performance skills and different biopsy compositions are unverified.	Initial-biopsy academic centers, age/risk and actual MRI/biopsy capability	Retain a proposal to report institutional, threshold, equipment/reader and eligibility-population differences as actual conditions.
29	Partly verified	Full text not readStored summary read	N29 · Diagnostic-pathway comparison, detection, avoidance and materialWhat is the direct evidence scope for contrary results, heterogeneity and subgroups?Required	The preserved summary retains PRECISE quantitative results, PRECISION in the same direction and qualitative PRECISE 2-year follow-up. R01 R02 R03	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Original between-trial condition differences, subgroups/interactions, contrary evidence on the same question, corrections and unpublished material were not searched or verified in this conversion.	Trial-specific definitions/margins, risk/readers and contrary/additional results	Retain a proposal to distinguish different conditions/measures from actual conflict on the same question in new material.
30	Partly verified	Full text not readStored summary read	N30 · Diagnostic-pathway comparison, detection, avoidance and materialWhat is the scope of PRECISE funding and unreported equipment support?Required	The existing research/intervention description records funding from Ontario Institute for Cancer Research and Prostate Cancer Canada, Movember Foundation resources in presentation material, and unreported free equipment/products or outsourced analysis. R01	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Actual provision contracts, author disclosures, analysis/writing/publication costs, current relationships, sponsors and original presentations/declarations were not read.	OICR, Prostate Cancer Canada, Movember presentations and manufacturer roles	Distinguish article, presentation and report-specific roles and historical/current reading scope in support material.
31	Partly verified	Full text not readStored summary read	N31 · Diagnostic-pathway comparison, detection, avoidance and materialIs funding kept separate for other trials and follow-up?Required	Existing evidence R02 says only that European public/nonprofit funding was reported in the PRECISION summary. R03 is the same PRECISE follow-up but has no report-specific funding field. R02 R03	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. R02 specific funding agencies/roles and R03 individual funding/author disclosures are unverified.	PRECISION's original public/nonprofit narrative and PRECISE follow-up-specific declarations	If declarations are provided, link actual report-specific disclosure separately from trial-family context.
32	Partly verified	Full text not readStored summary read	N32 · Diagnostic-pathway comparison, detection, avoidance and materialWhat are the original date, corrections, bilingual text, empty values and history?Required	The original review date is 2026-08-26; correction history is an empty array and deliberation is an empty string. Korean/English text, the existing synthesis, verdict decision, axes, false values and unrecorded precision are preserved in the complete summary. R01 R02 R03	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Classification information and a primary-failed/secondary-positive flag are absent. Empty corrections do not mean a current external check found no corrections/retractions.	2026-08-26, empty correction/deliberation records and existing axes/verdict	Distinguish the complete prechange text, event, version and separate application when changes occur.
33	Partly verified	Full text not readStored summary read	N33 · Diagnostic-pathway comparison, detection, avoidance and materialWhat was actually read, and what is the external-material status?Required	The complete preserved 2958 summary and the selected existing question were read for production. Summary reading is distinguished from unread external-material slots for the 3 reports. R01 R02 R03	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. External abstracts, full texts, registration, plans, original results/harms and funding declarations were not accessed or acquired.	Complete preserved summary, existing selection and unread external material	Distinguish material type, publication/access, acquisition and reading scope/date in new records.
34	Partly verified	Full text not readStored summary read	N34 · Diagnostic-pathway comparison, detection, avoidance and materialHow do report, material-slot, trial and participant counts differ?Required	The summary links R01/R02 and R03 while distinguishing qualitative replication by different trials from follow-up of the same PRECISE trial. Material slots count preserved and needed external records for production. R01 R02 R03	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Unique trial counts, total participants and institutional independence were not newly summed or certified.	2 evidence entries, 3 citation entries, follow-up, allocation/analysis and unrecorded unique counts	Distinguish the same follow-up from a new trial and actual participant relationships in additional material.
35	Partly verified	Full text not readStored summary read	N35 · Diagnostic-pathway comparison, detection, avoidance and materialWhat is linked when new material or corrections become available?Required	The existing question and original verdict are prepared in the same 7-column format. Conditions are saved and frozen before observations are written with a separate application time. R01 R02 R03	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. No new search, clinical calculation, effect/CI, regrading, independence certification or model/self-review was performed.	Condition version, original material, observations, reading and change events	Prepare only actual additions/changes, separating the complete previous text, event, condition version/freeze, application and current handoff.
36	Partly verified	Full text not readStored summary read	H01 · HarmsWhat are the adverse-event, grade and symptom definitions and collection methods?Supporting harm information	The existing research description provides values for at least 1 adverse event, grade 3 or higher, hematuria, hematospermia, pain and prostatitis. R01	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Definitions, grading system, active/passive collection, occurrence/observation periods, attribution and omissions are unverified.	At least 1 adverse event, grade 3 or higher, symptoms and collection	Retain a proposal to distinguish symptoms, serious events and pathway/procedure attribution in follow-up collection.
37	Partly verified	Full text not readStored summary read	H02 · HarmsWhat is the actual observation period for test/biopsy harms?Supporting harm information	The original material records pathway-specific adverse events separately from detection/avoidance at 2-year follow-up. R01	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Original harm-observation periods, test/biopsy timing, long-term collection and repeated additional-biopsy/treatment exposures are unverified.	MRI/contrast, biopsy, follow-up and occurrence timing	Retain a proposal to distinguish test/procedure exposure, actual observation periods and additional interventions in harm material.
38	Partly verified	Full text not readStored summary read	H03 · HarmsWhat are the original overall adverse-event values and arm labels?Supporting harm information	At least 1 adverse event occurred in standard 145/226 (64%) versus MRI 89/227 (40%). Explicitly retain this arm order, which differs from MRI-first versus standard in the detection table. R01	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Overall harm-effect differences/RRs/CIs, confirmatory tests and details of comparable collection/exposure conditions are unverified.	Standard 145/226 (64%) and MRI 89/227 (40%)	If original records are provided, link arm labels, denominators, periods and estimates to actual harms.
39	Partly verified	Full text not readStored summary read	H04 · HarmsWhat are the denominators for grade 3 or higher and symptom values?Supporting harm information	Grade 3 or higher values are standard 10 men (4.4%) versus MRI 8 men (3.5%). Hematuria 48%/19%, hematospermia 42%/22%, pain 32%/15% and prostatitis 4%/<1% are in standard/MRI order. R01	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Original denominators for each symptom/grade, repeats/overlap, actual-biopsy denominators, inclusion of MRI-negative men and omissions are unverified.	Standard 10 (4.4%), MRI 8 (3.5%) and symptom-specific denominators	Retain a proposal to distinguish allocation, actual procedures, collection and category-specific denominators in harm tables.
40	Partly verified	Full text not readStored summary read	H05 · HarmsWhat alternative explanations concern fewer biopsies, shared care and harms?Supporting harm information	The pathways differ in actual exposure: biopsy omission after negative MRI and targeted-only biopsy after positive MRI versus standard biopsy. R01	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Direct comparisons restricted to biopsy recipients, cores/access, medication/infection prevention, MRI/contrast harms and baseline risk/attribution are unverified.	Procedure-exposure differences, pathways/diagnosis and attribution	Retain a proposal to distinguish whole-pathway comparisons from actual procedure/test-exposure comparisons in additional harm material.
41	Partly verified	Full text not readStored summary read	H06 · HarmsWhat is the scope of confirmatory multiple comparisons, nonreporting and unread material?Supporting harm information	The preserved summary says symptom comparisons lacked confirmatory multiplicity-adjusted P values, preventing a firm claim of significantly fewer events. External tables/plans were not read in this conversion. R01	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Actual current supplementary analyses, all harms and distinctions among not collected, not reported, missing and 0 are unverified.	Original narrative of absent symptom-specific P values and currently unread external material	Distinguish values, confirmatory/supporting analyses and missingness only in actually provided material.
42	Partly verified	Full text not readStored summary read	H07 · HarmsAre harms kept from being double-counted across trials and follow-up?Supporting harm information	PRECISE harm values come from the R01 parent summary. R02/PRECISION has no quantitative harm values here, and R03 is follow-up of the same PRECISE trial. R01 R02 R03	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Overlap across reports/events/time points, additional harms and R02/R03 original harm denominators/collection are unverified.	Separate PRECISE/PRECISION trials, PRECISE follow-up and the same events	Retain a proposal to distinguish repeat reporting of the same events from other trials/new events in new harm material.
43	Partly verified	Full text not readStored summary read	H08 · HarmsWhat safety gaps concern longer periods, other risk populations and technology?Supporting harm information	Parent safety is Caution; the original explanation includes context on MRI/contrast and biopsy harms and contraindication assessment. R01	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Direct harms for other populations, technologies, severe risk, repeated/long-term exposure and additional biopsy/treatment are unverified within this summary's scope.	Initial-biopsy pathway, MRI/contrast, biopsy and other populations/periods	Retain a proposal to distinguish harm material together with original populations, actual technology/procedure exposure and periods.
44	Partly verified	Full text not readStored summary read	H09 · HarmsAre detection/avoidance benefits retained alongside harms and long-term gaps?Supporting harm information	Retain the selected C/noninferiority/avoidance and original harm values while distinguishing gaps in confirmatory tests, long-term mortality and biopsy composition after positive MRI. R01	Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. No new overall benefit–harm verdict, medical-procedure/treatment choice or long-term effect/causal certification was made.	Original noninferiority/avoidance, numerical harms and distinct long-term clinical uncertainty	Link each endpoint, risk period, original location and change event separately in actually added material.

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44 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-08-26
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population: Men before initial prostate biopsy; PRECISE at 5 Canadian academic centers. Detailed age, PSA, risk and eligibility are unverified. Distinguish the separate European PRECISION population.
Ingredient, formulation and route: MRI-first pathway before initial prostate biopsy with lesion-selected targeted biopsy
Dose: Original MRI-first study pathway: omit biopsy after negative imaging and targeted biopsy alone after positive imaging. Actual thresholds, equipment, procedures and adherence are unverified. This is not procedural guidance.
Comparator: PRECISE standard systematic TRUS-biopsy pathway. Actual cores/access, shared care, deviations and additional biopsies are unverified.
Measured outcome: Original GG2 or higher detection: MRI 79/227 (35%) versus standard 67/225 (30%); difference +5 percentage points, one-sided 97.5% CI −3.4 percentage points to ∞, with the −5 percentage-point margin met. Avoidance of biopsy by 83 (37%) of 221 actual MRI recipients has a separate denominator.
Duration: Initial-pathway detection/avoidance outcomes; original measurement windows unverified. The same PRECISE trial’s 2-year follow-up is qualitative cumulative-GG2-diagnosis/initial-avoidance context, not long-term mortality.
Questions outside this scope: Converting the one-sided 97.5% interval to a two-sided 95% interval or certifying noninferiority as superiority, equivalence or mortality equivalence; Copying 37% among 221 MRI recipients as an avoidance rate for 227 allocated men or all populations; Turning biopsy omission after negative MRI and noninferior detection into 100% sensitivity/negative predictive value or no missed cancers; Copying PRECISE quantitative results, margins or harms into PRECISION, or reverse-calculating avoidance counts from 500×28%; Treating the same PRECISE trial’s 2-year follow-up as a new trial, verified noninferiority/mortality results or confirmed baseline denominators; Newly certifying or calculating significant harm reductions from original symptom differences, including standard 145/226 versus MRI 89/227; Instructions for testing/reading/contrast, biopsy, prophylaxis/infection/bleeding management, or selecting/replacing cancer treatment

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

R01 · Klotz L, et al. Comparison of Multiparametric MRI-Targeted Biopsy With Systematic TRUS Biopsy for Biopsy-Naive Men. JAMA Oncol. 2021;7:534-542. PMID: 33538782.

PubMed

Material type: PRECISE 2021 representative Canadian noninferiority-pathway report
Materials actually read: Summary read; external materials not read
Findings recorded in the stored summary: 79/227 (35%) versus 67/225 (30%), difference +5 percentage points, one-sided 97.5% CI −3.4 percentage points to ∞; the −5 percentage-point noninferiority margin was met. Distinguish avoidance by 83 (37%) of 221 actual MRI recipients from 227 allocated men.
Record level: Original result in the first existing evidence record
Study overlap and independent replication: Distinguish original identities: PRECISE R01/NCT02936258 and the same PRECISE trial’s 2-year R03, versus separate PRECISION R02/NCT02380027. Independent replication is historical summary wording, with no current certification. Bibliographic records, populations, denominators and time points are not summed.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Locally preserved summary	Local copy acquired	Summary read	Read the relevant bibliography, results and boundaries in the complete preserved summary for production; external articles were not read.
External abstract	Current publication and access unverified	Access not attempted; not acquired	Not read	Only the summary’s citation URL is linked; current contents and access are unverified.
External full text	Current publication and access unverified	Access not attempted; not acquired	Not read	Only the summary’s bibliographic-identity link is connected; the current full-text location and publication are unverified.
Registration	Current publication and access unverified	Access not attempted; not acquired	Not read	Original registration identifier and trial-family links; follow-up has no separate registration field. Current registration contents were not read.
Protocol	Current publication and access unverified	Access not attempted; not acquired	Not read	Needed-material slot; actual file existence, publication, thresholds, definitions and plans are unverified.
Statistical analysis plan	Current publication and access unverified	Access not attempted; not acquired	Not read	Needed-material slot for actual populations, margins/intervals, missing data/verification and multiple comparisons.
Results, denominator and harm details	Current publication and access unverified	Access not attempted; not acquired	Not read	Actual denominators, verification, follow-up and original harm tables are needed. Unread material is not changed into 0 records or 0 events.
Support and interests	Current publication and access unverified	Access not attempted; not acquired	Not read	Distinguish trial/presentation/report-specific support and current relationships without copying original funding statements into another trial.

R02 · Kasivisvanathan V, et al. MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 2018. PMID: 29552975.

PubMed

Material type: PRECISION 2018 European noninferiority-pathway report
Materials actually read: Summary read; external materials not read
Findings recorded in the stored summary: In the MRI pathway, 28% avoided biopsy and significant-cancer detection was in the same direction. Avoidance numerators/denominators, quantitative detection, margins/CIs and original harms are unverified; PRECISE values are not copied.
Record level: Original result in existing evidence R02
Study overlap and independent replication: Distinguish original identities: PRECISE R01/NCT02936258 and the same PRECISE trial’s 2-year R03, versus separate PRECISION R02/NCT02380027. Independent replication is historical summary wording, with no current certification. Bibliographic records, populations, denominators and time points are not summed.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Locally preserved summary	Local copy acquired	Summary read	Read the relevant bibliography, results and boundaries in the complete preserved summary for production; external articles were not read.
External abstract	Current publication and access unverified	Access not attempted; not acquired	Not read	Only the summary’s citation URL is linked; current contents and access are unverified.
External full text	Current publication and access unverified	Access not attempted; not acquired	Not read	Only the summary’s bibliographic-identity link is connected; the current full-text location and publication are unverified.
Registration	Current publication and access unverified	Access not attempted; not acquired	Not read	Original registration identifier and trial-family links; follow-up has no separate registration field. Current registration contents were not read.
Protocol	Current publication and access unverified	Access not attempted; not acquired	Not read	Needed-material slot; actual file existence, publication, thresholds, definitions and plans are unverified.
Statistical analysis plan	Current publication and access unverified	Access not attempted; not acquired	Not read	Needed-material slot for actual populations, margins/intervals, missing data/verification and multiple comparisons.
Results, denominator and harm details	Current publication and access unverified	Access not attempted; not acquired	Not read	Actual denominators, verification, follow-up and original harm tables are needed. Unread material is not changed into 0 records or 0 events.
Support and interests	Current publication and access unverified	Access not attempted; not acquired	Not read	Distinguish trial/presentation/report-specific support and current relationships without copying original funding statements into another trial.

R03 · Klotz L, et al. Magnetic Resonance Imaging-Targeted Versus Systematic Prostate Biopsies: 2-year Follow-up of PRECISE. Eur Urol Oncol. 2024. PMID: 37838556.

PubMed

Material type: PRECISE 2024, the same trial’s 2-year follow-up report
Materials actually read: Summary read; external materials not read
Findings recorded in the stored summary: Same PRECISE trial, 2-year follow-up: qualitative statements of no difference in cumulative GG2 or higher diagnoses and retained initial biopsy omission. Actual denominators, effects, CIs, harms and long-term mortality are unverified.
Record level: Qualitative follow-up context in citation R03 and the parent counterview
Study overlap and independent replication: Distinguish original identities: PRECISE R01/NCT02936258 and the same PRECISE trial’s 2-year R03, versus separate PRECISION R02/NCT02380027. Independent replication is historical summary wording, with no current certification. Bibliographic records, populations, denominators and time points are not summed.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Locally preserved summary	Local copy acquired	Summary read	Read the relevant bibliography, results and boundaries in the complete preserved summary for production; external articles were not read.
External abstract	Current publication and access unverified	Access not attempted; not acquired	Not read	Only the summary’s citation URL is linked; current contents and access are unverified.
External full text	Current publication and access unverified	Access not attempted; not acquired	Not read	Only the summary’s bibliographic-identity link is connected; the current full-text location and publication are unverified.
Registration	Current publication and access unverified	Access not attempted; not acquired	Not read	Original registration identifier and trial-family links; follow-up has no separate registration field. Current registration contents were not read.
Protocol	Current publication and access unverified	Access not attempted; not acquired	Not read	Needed-material slot; actual file existence, publication, thresholds, definitions and plans are unverified.
Statistical analysis plan	Current publication and access unverified	Access not attempted; not acquired	Not read	Needed-material slot for actual populations, margins/intervals, missing data/verification and multiple comparisons.
Results, denominator and harm details	Current publication and access unverified	Access not attempted; not acquired	Not read	Actual denominators, verification, follow-up and original harm tables are needed. Unread material is not changed into 0 records or 0 events.
Support and interests	Current publication and access unverified	Access not attempted; not acquired	Not read	Distinguish trial/presentation/report-specific support and current relationships without copying original funding statements into another trial.

Report counts versus independent study counts

Distinguish original identities: PRECISE R01/NCT02936258 and the same PRECISE trial’s 2-year R03, versus separate PRECISION R02/NCT02380027. Independent replication is historical summary wording, with no current certification. Bibliographic records, populations, denominators and time points are not summed.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · What are the selected existing question and its record?

Required materials and conditions: Wording, Korean/English text and verdict links for noninferior significant-cancer detection and biopsy avoidance
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Retain the detection/avoidance components of the one existing question without creating additional subclaim tables.
Why this condition is needed: A production condition preserving the original scope of Wording, Korean/English text and verdict links for noninferior significant-cancer detection and biopsy avoidance.
Referenced methods: Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are our own design

N02 · How do the subclaim C and parent C56, axes and history differ?

Required materials and conditions: Subclaim grade/note, absent score/status/axes and parent values
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Do not inherit parent R2/I2 or historical cross-checking as new independence certification, current review or a subclaim score.
Why this condition is needed: A production condition preserving the original scope of Subclaim grade/note, absent score/status/axes and parent values.
Referenced methods: 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

N03 · Which men awaiting an initial biopsy does the pathway concern?

Required materials and conditions: Before initial prostate biopsy, biopsy-naive status and actual eligibility
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Do not generalize to everyone undergoing PSA testing, repeat-biopsy populations or patients with confirmed cancer.
Why this condition is needed: A production condition preserving the original scope of Before initial prostate biopsy, biopsy-naive status and actual eligibility.
Referenced methods: M03 §3.2.1; detailed population conditions are Chamgap's own design

N04 · What actually makes up the MRI-first pathway?

Required materials and conditions: Omitting biopsy after negative MRI and targeted biopsy alone after positive MRI
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Do not write instructions for MRI reading, target selection, biopsy or other medical procedures.
Why this condition is needed: A production condition preserving the original scope of Omitting biopsy after negative MRI and targeted biopsy alone after positive MRI.
Referenced methods: M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design

N05 · What is the standard TRUS pathway and comparison direction?

Required materials and conditions: Contrast between standard systematic TRUS and MRI-targeted pathways
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Do not turn pathway names into direct rankings of every current biopsy composition or procedural guidance.
Why this condition is needed: A production condition preserving the original scope of Contrast between standard systematic TRUS and MRI-targeted pathways.
Referenced methods: 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

N06 · What defined positive and negative MRI?

Required materials and conditions: Reading thresholds, equipment, readers and the actual diagnostic pathway
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Do not assume or prescribe a particular PI-RADS cutoff, MRI method or contrast procedure.
Why this condition is needed: A production condition preserving the original scope of Reading thresholds, equipment, readers and the actual diagnostic pathway.
Referenced methods: 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

N07 · How was clinically significant cancer defined?

Required materials and conditions: Detection of GG2 or higher, histological assessment and original measurements
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Do not convert GG2 into Gleason numbers absent from the preserved summary, create new criteria or equate it with detection of all cancers.
Why this condition is needed: A production condition preserving the original scope of Detection of GG2 or higher, histological assessment and original measurements.
Referenced methods: 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

N08 · What were PRECISE's design and prespecified noninferiority margin?

Required materials and conditions: Open-label phase 3, 5 Canadian centers and a −5 percentage-point noninferiority margin
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Do not promote historical statements of prespecification or margin fulfillment into current plan review or a new noninferiority calculation.
Why this condition is needed: A production condition preserving the original scope of Open-label phase 3, 5 Canadian centers and a −5 percentage-point noninferiority margin.
Referenced methods: M08 §8.1–8.2.3; Chamgap adaptation; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation

N09 · What are the original significant-cancer numerators, denominators and rates?

Required materials and conditions: MRI 79/227 (35%) and standard biopsy 67/225 (30%)
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Do not calculate new RR, NNT, missed-cancer or total-cancer counts, or convert these numbers into cancer prevalence or sensitivity.
Why this condition is needed: A production condition preserving the original scope of MRI 79/227 (35%) and standard biopsy 67/225 (30%).
Referenced methods: 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

N10 · What do +5 percentage points and the one-sided 97.5% CI mean here?

Required materials and conditions: Original absolute difference, one-sided lower bound −3.4 percentage points to ∞ and prespecified −5 percentage points
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application

N11 · Are noninferiority, equivalence and superiority distinguished?

Required materials and conditions: Allowed −5 percentage points, significant-cancer detection and other hypotheses
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Do not turn noninferiority into complete equivalence, no cancers missed or mortality equivalence.
Why this condition is needed: A production condition preserving the original scope of Allowed −5 percentage points, significant-cancer detection and other hypotheses.
Referenced methods: M15 §§15.3.1–15.3.3; Chamgap adaptation

N12 · How do 453 allocated participants and detection denominators 225/227 differ?

Required materials and conditions: Standard allocation 226, MRI allocation 227 and standard result denominator 225
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Do not calculate differences such as 226−225 and invent dropout or failure reasons.
Why this condition is needed: A production condition preserving the original scope of Standard allocation 226, MRI allocation 227 and standard result denominator 225.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design

N13 · What do 221 actual MRI recipients and 83 biopsy avoidances represent?

Required materials and conditions: Allocation 227, MRI performed in 221 and negative imaging/avoidance 83 (37%)
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Do not copy 37% as an avoidance rate for all allocated men or all populations, or calculate positive-imaging/nonperformance counts.
Why this condition is needed: A production condition preserving the original scope of Allocation 227, MRI performed in 221 and negative imaging/avoidance 83 (37%).
Referenced methods: 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

N14 · Are biopsy avoidance and actual cancer nondetection/misses distinguished?

Required materials and conditions: Biopsy omission after negative MRI, reference verification, detection and accuracy
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Do not turn 37% biopsy avoidance and noninferior detection into no cancer in MRI-negative men or 100% negative predictive value/sensitivity.
Why this condition is needed: A production condition preserving the original scope of Biopsy omission after negative MRI, reference verification, detection and accuracy.
Referenced methods: 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

N15 · What are the ITT, PP, crossover and actual-performance analyses?

Required materials and conditions: Noninferiority analysis populations, pathway deviations and actual tests/biopsies
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Do not confirm both ITT/PP fulfillment or no missing-data impact merely because the design was randomized.
Why this condition is needed: A production condition preserving the original scope of Noninferiority analysis populations, pathway deviations and actual tests/biopsies.
Referenced methods: 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.

N16 · What is the impact of missing data and different verification pathways?

Required materials and conditions: Different diagnostic verification, omissions and selection/verification bias
Conditions for verification: Different diagnostic verification, omissions and selection/verification bias; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information
Requirement and applicability: Required
Application exceptions: Do not turn verification differences into arbitrary numerical adjustment, recalculated accuracy or a new methodological-defect score.
Why this condition is needed: A production condition preserving the original scope of Different diagnostic verification, omissions and selection/verification bias.
Referenced methods: 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.

N17 · What are the open-label design and actual reading/assessment masking?

Required materials and conditions: Open-label trial, MRI/biopsy/pathology reading and analysis
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Do not infer that every pathological assessment was unmasked or certify new defects beyond the original B1 merely from the open-label design.
Why this condition is needed: A production condition preserving the original scope of Open-label trial, MRI/biopsy/pathology reading and analysis.
Referenced methods: M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application

N18 · What shared care, additional tests and actual performance accompanied the pathway?

Required materials and conditions: Shared tests, additional biopsies and treatment/follow-up differences
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Do not provide medical-procedure, test-selection, medication or care/treatment-replacement instructions.
Why this condition is needed: A production condition preserving the original scope of Shared tests, additional biopsies and treatment/follow-up differences.
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation

N19 · What were the prespecified endpoints, noninferiority plan and multiple-comparison scope?

Required materials and conditions: Primary GG2 detection, margin and biopsy-avoidance/harm hierarchy
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Do not elevate original prespecification statements or parent axes into current registration/SAP verification.
Why this condition is needed: A production condition preserving the original scope of Primary GG2 detection, margin and biopsy-avoidance/harm hierarchy.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; Chamgap's own application

N20 · What are the registration identifiers and follow-up family links?

Required materials and conditions: PRECISE NCT02936258, PRECISION NCT02380027 and follow-up
Conditions for verification: PRECISE NCT02936258, PRECISION NCT02380027 and follow-up; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information
Requirement and applicability: Required
Application exceptions: Do not combine the two NCT identifiers, create new registration verification for R03 or invent a third evidence-list record.
Why this condition is needed: A production condition preserving the original scope of PRECISE NCT02936258, PRECISION NCT02380027 and follow-up.
Referenced methods: 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

N21 · What are the actual identities of the 3 reports?

Required materials and conditions: PRECISE 2021, PRECISION 2018 and PRECISE 2024 follow-up bibliography
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Do not invent a third evidence-list record for R03 or infer DOI/PMCID from article numbers or PMID.
Why this condition is needed: A production condition preserving the original scope of PRECISE 2021, PRECISION 2018 and PRECISE 2024 follow-up bibliography.
Referenced methods: M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations

N22 · Are historical independent-replication statements distinguished from the same follow-up?

Required materials and conditions: Separate PRECISE/PRECISION investigators/funding and PRECISE follow-up
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Do not elevate parent R2/I2 or an independent-replication label into new independence certification or count R03 as a new trial.
Why this condition is needed: A production condition preserving the original scope of Separate PRECISE/PRECISION investigators/funding and PRECISE follow-up.
Referenced methods: 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

N23 · What is the scope of PRECISION's 500 participants, 28% and detection result?

Required materials and conditions: R02 allocation 500, MRI-pathway avoidance 28% and significant-cancer detection in the same direction
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Do not copy PRECISE's 79/227, −5 percentage points, 37% or safety values into R02, or reverse-calculate counts from 500×28%.
Why this condition is needed: A production condition preserving the original scope of R02 allocation 500, MRI-pathway avoidance 28% and significant-cancer detection in the same direction.
Referenced methods: 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

N24 · What actual result does PRECISE's 2-year follow-up describe?

Required materials and conditions: Cumulative GG2 or higher diagnosis, retained initial biopsy omission and follow-up timing
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Do not turn a qualitative statement of no difference into fulfillment of a 2-year noninferiority test, equivalence, mortality equivalence or a numerical 0.
Why this condition is needed: A production condition preserving the original scope of Cumulative GG2 or higher diagnosis, retained initial biopsy omission and follow-up timing.
Referenced methods: 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

N25 · What are the 2-year follow-up denominators, omissions and additional diagnoses?

Required materials and conditions: R03 actual follow-up/analysis n, additional biopsies and missing data
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Do not copy baseline 453, 225/227 or 221 as verified 2-year denominators.
Why this condition is needed: A production condition preserving the original scope of R03 actual follow-up/analysis n, additional biopsies and missing data.
Referenced methods: 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

N26 · Is omitting systematic biopsy after positive MRI a separate question?

Required materials and conditions: Pathway comparison versus the optimal biopsy composition for positive cases
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Do not turn targeted-only biopsy in the original pathway into medical guidance to omit systematic biopsy in every positive case.
Why this condition is needed: A production condition preserving the original scope of Pathway comparison versus the optimal biopsy composition for positive cases.
Referenced methods: 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

N27 · How do cancer-detection surrogates and long-term mortality differ?

Required materials and conditions: Cancer detection, metastasis/death, long-term clinical outcomes and the separate ? subclaim
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Do not turn initial noninferior detection or no difference in 2-year diagnoses into long-term mortality equivalence, survival benefit or harmlessness.
Why this condition is needed: A production condition preserving the original scope of Cancer detection, metastasis/death, long-term clinical outcomes and the separate ? subclaim.
Referenced methods: 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

N28 · What application differences arise from centers, populations, readers and technology?

Required materials and conditions: Initial-biopsy academic centers, age/risk and actual MRI/biopsy capability
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Do not generalize academic-center pathway results into fixed performance across every MRI or care setting.
Why this condition is needed: A production condition preserving the original scope of Initial-biopsy academic centers, age/risk and actual MRI/biopsy capability.
Referenced methods: 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

N29 · What is the direct evidence scope for contrary results, heterogeneity and subgroups?

Required materials and conditions: Trial-specific definitions/margins, risk/readers and contrary/additional results
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Do not turn absence of a new search into no other trials or complete consensus, or calculate a pooled quantitative effect.
Why this condition is needed: A production condition preserving the original scope of Trial-specific definitions/margins, risk/readers and contrary/additional results.
Referenced methods: 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

N30 · What is the scope of PRECISE funding and unreported equipment support?

Required materials and conditions: OICR, Prostate Cancer Canada, Movember presentations and manufacturer roles
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Do not elevate nonprofit/public support or nonreporting into new certification of no conflicts of interest or no support.
Why this condition is needed: A production condition preserving the original scope of OICR, Prostate Cancer Canada, Movember presentations and manufacturer roles.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

N31 · Is funding kept separate for other trials and follow-up?

Required materials and conditions: PRECISION's original public/nonprofit narrative and PRECISE follow-up-specific declarations
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Do not copy PRECISE funding agencies or unreported-equipment statements into R02 individual disclosures or an allegedly read R03 declaration.
Why this condition is needed: A production condition preserving the original scope of PRECISION's original public/nonprofit narrative and PRECISE follow-up-specific declarations.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

N32 · What are the original date, corrections, bilingual text, empty values and history?

Required materials and conditions: 2026-08-26, empty correction/deliberation records and existing axes/verdict
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Do not fill empty/absent values or historical independent replication/cross-checking with new scores or completed review.
Why this condition is needed: A production condition preserving the original scope of 2026-08-26, empty correction/deliberation records and existing axes/verdict.
Referenced methods: M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design

N33 · What was actually read, and what is the external-material status?

Required materials and conditions: Complete preserved summary, existing selection and unread external material
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Do not elevate URLs, quotations in the summary or the existence of copies into external reading, verified links or successful access.
Why this condition is needed: A production condition preserving the original scope of Complete preserved summary, existing selection and unread external material.
Referenced methods: 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

N34 · How do report, material-slot, trial and participant counts differ?

Required materials and conditions: 2 evidence entries, 3 citation entries, follow-up, allocation/analysis and unrecorded unique counts
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Do not add 453, 500, 221, 225/227, 3 reports or parent/subclaim tables as total sample size or independent replications.
Why this condition is needed: A production condition preserving the original scope of 2 evidence entries, 3 citation entries, follow-up, allocation/analysis and unrecorded unique counts.
Referenced methods: 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

N35 · What is linked when new material or corrections become available?

Required materials and conditions: Condition version, original material, observations, reading and change events
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Original candidate pending/eligible markers are history; do not revive historical review waits as execution or approval.
Why this condition is needed: A production condition preserving the original scope of Condition version, original material, observations, reading and change events.
Referenced methods: M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design

H01 · What are the adverse-event, grade and symptom definitions and collection methods?

Required materials and conditions: At least 1 adverse event, grade 3 or higher, symptoms and collection
Conditions for verification: 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
Requirement and applicability: Supporting harm information
Application exceptions: Prepare only the preserved summary's actual scope without inventing absent definitions, values, denominators or current verification.
Why this condition is needed: A production condition preserving the original scope of At least 1 adverse event, grade 3 or higher, symptoms and collection.
Referenced methods: M19 §§19.1.2–19.2.4; detailed distinctions are Chamgap-designed; M19 §§19.1.2–19.2.4; Chamgap adaptation

H02 · What is the actual observation period for test/biopsy harms?

Required materials and conditions: MRI/contrast, biopsy, follow-up and occurrence timing
Conditions for verification: MRI/contrast, biopsy, follow-up and occurrence timing; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information
Requirement and applicability: Supporting harm information
Application exceptions: Do not inherit 2-year diagnostic follow-up as completed 2-year harm collection or write actual procedural/contraindication guidance.
Why this condition is needed: A production condition preserving the original scope of MRI/contrast, biopsy, follow-up and occurrence timing.
Referenced methods: M19 §19.2 design-specific harm questions; timing details are Chamgap-designed

H03 · What are the original overall adverse-event values and arm labels?

Required materials and conditions: Standard 145/226 (64%) and MRI 89/227 (40%)
Conditions for verification: 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
Requirement and applicability: Supporting harm information
Application exceptions: Do not subtract original rates to create a new risk difference, statistically significant harm reduction or safety equivalence.
Why this condition is needed: A production condition preserving the original scope of Standard 145/226 (64%) and MRI 89/227 (40%).
Referenced methods: M19 §§19.2.2–19.2.4 and M03 §3.2.3; Chamgap adaptation

H04 · What are the denominators for grade 3 or higher and symptom values?

Required materials and conditions: Standard 10 (4.4%), MRI 8 (3.5%) and symptom-specific denominators
Conditions for verification: 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
Requirement and applicability: Supporting harm information
Application exceptions: Do not reverse-calculate event counts from symptom rates, sum categories/grades or create incidence rates without original denominators.
Why this condition is needed: A production condition preserving the original scope of Standard 10 (4.4%), MRI 8 (3.5%) and symptom-specific denominators.
Referenced methods: 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

H05 · What alternative explanations concern fewer biopsies, shared care and harms?

Required materials and conditions: Procedure-exposure differences, pathways/diagnosis and attribution
Conditions for verification: Procedure-exposure differences, pathways/diagnosis and attribution; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information
Requirement and applicability: Supporting harm information
Application exceptions: Do not certify the mechanism of numerical differences or provide test/contrast/infection/bleeding-management instructions.
Why this condition is needed: A production condition preserving the original scope of Procedure-exposure differences, pathways/diagnosis and attribution.
Referenced methods: M19 §§19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap-designed

H06 · What is the scope of confirmatory multiple comparisons, nonreporting and unread material?

Required materials and conditions: Original narrative of absent symptom-specific P values and currently unread external material
Conditions for verification: 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
Requirement and applicability: Supporting harm information
Application exceptions: Do not turn numerically lower original values into newly certified significant reductions, or unread external material into access failure or 0 harms.
Why this condition is needed: A production condition preserving the original scope of Original narrative of absent symptom-specific P values and currently unread external material.
Referenced methods: M19 §§19.1.2–19.2.4 and M04 §4.6.3; Chamgap adaptation

H07 · Are harms kept from being double-counted across trials and follow-up?

Required materials and conditions: Separate PRECISE/PRECISION trials, PRECISE follow-up and the same events
Conditions for verification: 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
Requirement and applicability: Supporting harm information
Application exceptions: Do not copy PRECISE safety values into R02/R03 or add participants/events across multiple reports/time points.
Why this condition is needed: A production condition preserving the original scope of Separate PRECISE/PRECISION trials, PRECISE follow-up and the same events.
Referenced methods: 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

H08 · What safety gaps concern longer periods, other risk populations and technology?

Required materials and conditions: Initial-biopsy pathway, MRI/contrast, biopsy and other populations/periods
Conditions for verification: 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
Requirement and applicability: Supporting harm information
Application exceptions: Do not expand original clinical-assessment wording into new test/biopsy-selection, contraindication or treatment-management guidance.
Why this condition is needed: A production condition preserving the original scope of Initial-biopsy pathway, MRI/contrast, biopsy and other populations/periods.
Referenced methods: M19 §§19.1.2–19.2.4; Chamgap adaptation

H09 · Are detection/avoidance benefits retained alongside harms and long-term gaps?

Required materials and conditions: Original noninferiority/avoidance, numerical harms and distinct long-term clinical uncertainty
Conditions for verification: 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
Requirement and applicability: Supporting harm information
Application exceptions: Do not turn noninferior detection into equivalence of all harms/mortality, survival benefit or procedural recommendations.
Why this condition is needed: A production condition preserving the original scope of Original noninferiority/avoidance, numerical harms and distinct long-term clinical uncertainty.
Referenced methods: Chamgap interpretive boundary informed by M19 principles; no formal causality tool was run

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

What the statuses mean

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.

Change history

2026-10-12 · Public page/material version 1.0

A public view and materials were prepared from the existing 44 items. No new clinical search, verification-status change or scoring was performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-08-26) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · What are the selected existing question and its record?

Current findings: The selected existing question is ‘Noninferior significant-cancer detection and biopsy avoidance’. Its verdict record is linked while the parent detection/avoidance context and the separate long-term mortality-equivalence question remain distinct.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. No new structural split, invented verdict or independent-claim certification was created.
Reason for missing information: No new structural split, invented verdict or independent-claim certification was created.
Required materials and conditions: Wording, Korean/English text and verdict links for noninferior significant-cancer detection and biopsy avoidance
Materials to obtain first: Preserved existing subclaim and complete parent review summary
Further research: If the question boundary changes, preserve its existing wording, the complete previous version and the change event.
Remaining uncertainty: Production scope of the preserved summary. No new structural split, invented verdict or independent-claim certification was created.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of Wording, Korean/English text and verdict links for noninferior significant-cancer detection and biopsy avoidance.
Application exceptions: Retain the detection/avoidance components of the one existing question without creating additional subclaim tables.
Referenced methods: Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are our own design

Related sources R01

N02 · How do the subclaim C and parent C56, axes and history differ?

Current findings: The subclaim grade is C, with the note ‘The −5 percentage-point margin was met, and 37% of men who underwent MRI avoided biopsy.’ Score/status/axes fields are absent. Parent C56, Caution and B/S/R2/I2/E+/B1 with precision not recorded are parent context.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. The selected row's score, status and axes are not recorded and are not filled from parent values.
Reason for missing information: The selected row's score, status and axes are not recorded and are not filled from parent values.
Required materials and conditions: Subclaim grade/note, absent score/status/axes and parent values
Materials to obtain first: Original subclaim record and parent grade/score/axes and assessment history
Further research: Distinguish actual evidence-update events from preservation of original values.
Remaining uncertainty: Production scope of the preserved summary. The selected row's score, status and axes are not recorded and are not filled from parent values.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of Subclaim grade/note, absent score/status/axes and parent values.
Application exceptions: Do not inherit parent R2/I2 or historical cross-checking as new independence certification, current review or a subclaim score.
Referenced methods: 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

Related sources R01

N03 · Which men awaiting an initial biopsy does the pathway concern?

Current findings: The original pathway uses MRI first before initial prostate biopsy. The PRECISE citation title specifies biopsy-naive men; the study involved men at 5 Canadian academic centers.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Age, PSA/DRE, risk, prostate size, prior MRI, inclusion/exclusion criteria and actual baseline cancer status are unverified.
Reason for missing information: Age, PSA/DRE, risk, prostate size, prior MRI, inclusion/exclusion criteria and actual baseline cancer status are unverified.
Required materials and conditions: Before initial prostate biopsy, biopsy-naive status and actual eligibility
Materials to obtain first: Original recruitment criteria, baseline characteristics and suspected-cancer diagnostic pathway
Further research: Distinguish application to other populations using actual biopsy history, baseline risk and eligibility records.
Remaining uncertainty: Production scope of the preserved summary. Age, PSA/DRE, risk, prostate size, prior MRI, inclusion/exclusion criteria and actual baseline cancer status are unverified.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of Before initial prostate biopsy, biopsy-naive status and actual eligibility.
Application exceptions: Do not generalize to everyone undergoing PSA testing, repeat-biopsy populations or patients with confirmed cancer.
Referenced methods: M03 §3.2.1; detailed population conditions are Chamgap's own design

Related sources R01

N04 · What actually makes up the MRI-first pathway?

Current findings: The existing intervention description says biopsy was omitted after negative MRI and only targeted biopsy was performed after positive MRI. This is a randomized pathway comparison rather than the accuracy of a single test.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. MRI protocol, positivity criteria, actual adherence, crossover/additional biopsies and reading/targeting procedure details are unverified.
Reason for missing information: MRI protocol, positivity criteria, actual adherence, crossover/additional biopsies and reading/targeting procedure details are unverified.
Required materials and conditions: Omitting biopsy after negative MRI and targeted biopsy alone after positive MRI
Materials to obtain first: Original pathway definitions, actual performance and condition-specific flow
Further research: If records are provided, link the planned pathway separately to actual MRI and biopsy performance.
Remaining uncertainty: Production scope of the preserved summary. MRI protocol, positivity criteria, actual adherence, crossover/additional biopsies and reading/targeting procedure details are unverified.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of Omitting biopsy after negative MRI and targeted biopsy alone after positive MRI.
Application exceptions: Do not write instructions for MRI reading, target selection, biopsy or other medical procedures.
Referenced methods: M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design

Related sources R01

N05 · What is the standard TRUS pathway and comparison direction?

Current findings: PRECISE allocated 226 men to standard TRUS biopsy and 227 to the MRI pathway. The citation title compares systematic TRUS with MRI-targeted biopsy.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Biopsy core composition/count, access route, actual performance, shared care and additional-test differences are unverified.
Reason for missing information: Biopsy core composition/count, access route, actual performance, shared care and additional-test differences are unverified.
Required materials and conditions: Contrast between standard systematic TRUS and MRI-targeted pathways
Materials to obtain first: Original control/targeted pathways, actual performance and accompanying care
Further research: Do not automatically combine records using different biopsy compositions as the same pathway.
Remaining uncertainty: Production scope of the preserved summary. Biopsy core composition/count, access route, actual performance, shared care and additional-test differences are unverified.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of Contrast between standard systematic TRUS and MRI-targeted pathways.
Application exceptions: Do not turn pathway names into direct rankings of every current biopsy composition or procedural guidance.
Referenced methods: 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

Related sources R01

N06 · What defined positive and negative MRI?

Current findings: The original record states that 83 men with negative imaging avoided biopsy and records a targeted-biopsy pathway after positive imaging.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Specific thresholds such as PI-RADS, field strength/equipment, contrast, lesion criteria, reader experience, rereading and false-positive/false-negative classification are unverified.
Reason for missing information: Specific thresholds such as PI-RADS, field strength/equipment, contrast, lesion criteria, reader experience, rereading and false-positive/false-negative classification are unverified.
Required materials and conditions: Reading thresholds, equipment, readers and the actual diagnostic pathway
Materials to obtain first: MRI acquisition/reading, thresholds and participant-level results/verification
Further research: If records are provided, link actual thresholds, equipment/readers and biopsy attribution.
Remaining uncertainty: Production scope of the preserved summary. Specific thresholds such as PI-RADS, field strength/equipment, contrast, lesion criteria, reader experience, rereading and false-positive/false-negative classification are unverified.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of Reading thresholds, equipment, readers and the actual diagnostic pathway.
Application exceptions: Do not assume or prescribe a particular PI-RADS cutoff, MRI method or contrast procedure.
Referenced methods: 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

Related sources R01

N07 · How was clinically significant cancer defined?

Current findings: The PRECISE primary endpoint is the proportion with GG2 or higher cancer detected. Significant-cancer detection and noninferiority are linked to that definition.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Detailed Grade Group histological criteria, independent/central reading, specimen/biopsy methods, discrepancy handling and definition-specific detection are unverified.
Reason for missing information: Detailed Grade Group histological criteria, independent/central reading, specimen/biopsy methods, discrepancy handling and definition-specific detection are unverified.
Required materials and conditions: Detection of GG2 or higher, histological assessment and original measurements
Materials to obtain first: Original histological assessment, significant-cancer definition and detection counts
Further research: Retain a proposal to link cancer significance, histological assessment and definition-specific counts separately.
Remaining uncertainty: Production scope of the preserved summary. Detailed Grade Group histological criteria, independent/central reading, specimen/biopsy methods, discrepancy handling and definition-specific detection are unverified.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of Detection of GG2 or higher, histological assessment and original measurements.
Application exceptions: Do not convert GG2 into Gleason numbers absent from the preserved summary, create new criteria or equate it with detection of all cancers.
Referenced methods: 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

Related sources R01

N08 · What were PRECISE's design and prespecified noninferiority margin?

Current findings: The summary records PRECISE as an open-label phase 3 randomized noninferiority trial at 5 Canadian academic centers, with a prespecified −5 percentage-point margin.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Sequence generation/concealment, original rationale for the margin, plan dates and analysis/testing procedures are unverified because external materials were not read.
Reason for missing information: Sequence generation/concealment, original rationale for the margin, plan dates and analysis/testing procedures are unverified because external materials were not read.
Required materials and conditions: Open-label phase 3, 5 Canadian centers and a −5 percentage-point noninferiority margin
Materials to obtain first: Original protocol/SAP, margin rationale and allocation methods
Further research: If plans are provided, link the actual prespecified margin, methods and history to the results.
Remaining uncertainty: Production scope of the preserved summary. Sequence generation/concealment, original rationale for the margin, plan dates and analysis/testing procedures are unverified because external materials were not read.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of Open-label phase 3, 5 Canadian centers and a −5 percentage-point noninferiority margin.
Application exceptions: Do not promote historical statements of prespecification or margin fulfillment into current plan review or a new noninferiority calculation.
Referenced methods: M08 §8.1–8.2.3; Chamgap adaptation; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation

Related sources R01

N09 · What are the original significant-cancer numerators, denominators and rates?

Current findings: PRECISE detection was 79/227 (35%) in the MRI pathway versus 67/225 (30%) with standard biopsy. Retain each value with its actual detection-result denominator.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Histological verification, numerator counting, denominator selection and original result-table details are unverified.
Reason for missing information: Histological verification, numerator counting, denominator selection and original result-table details are unverified.
Required materials and conditions: MRI 79/227 (35%) and standard biopsy 67/225 (30%)
Materials to obtain first: Original detection tables, definitions/verification and analysis flow
Further research: If records are supplemented, link original numerators/denominators to actual definitions and verification.
Remaining uncertainty: Production scope of the preserved summary. Histological verification, numerator counting, denominator selection and original result-table details are unverified.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of MRI 79/227 (35%) and standard biopsy 67/225 (30%).
Application exceptions: Do not calculate new RR, NNT, missed-cancer or total-cancer counts, or convert these numbers into cancer prevalence or sensitivity.
Referenced methods: 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

Related sources R01

N10 · What do +5 percentage points and the one-sided 97.5% CI mean here?

Current findings: The original difference is +5 percentage points; the one-sided 97.5% CI is −3.4 percentage points to ∞. The preserved summary says the lower bound exceeded −5 percentage points and met the noninferiority margin.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Models/adjustment, ITT/PP, variance/margin-testing methods, two-sided intervals and superiority tests are unverified.
Reason for missing information: Models/adjustment, ITT/PP, variance/margin-testing methods, two-sided intervals and superiority tests are unverified.
Required materials and conditions: Original absolute difference, one-sided lower bound −3.4 percentage points to ∞ and prespecified −5 percentage points
Materials to obtain first: Original noninferiority results, models, one-sided/two-sided definitions and analysis populations
Further research: If direct analyses are provided, link the original contrast, one-sided interval, margin and population together.
Remaining uncertainty: Production scope of the preserved summary. Models/adjustment, ITT/PP, variance/margin-testing methods, two-sided intervals and superiority tests are unverified.
Conditions for verification: 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
Why this condition is needed: 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 exceptions: 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.
Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application

Related sources R01

N11 · Are noninferiority, equivalence and superiority distinguished?

Current findings: The original result is a statement that significant-cancer detection met noninferiority within the prespecified allowance. The +5 percentage-point difference is preserved alongside it.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Equivalence/superiority tests and margins, validation of clinical importance and long-term mortality equivalence are unverified in this selected material.
Reason for missing information: Equivalence/superiority tests and margins, validation of clinical importance and long-term mortality equivalence are unverified in this selected material.
Required materials and conditions: Allowed −5 percentage points, significant-cancer detection and other hypotheses
Materials to obtain first: Original noninferiority hypothesis, margin rationale and statistical/clinical interpretation
Further research: Retain a proposal to distinguish each hypothesis's original design, endpoint and margin in additional analyses.
Remaining uncertainty: Production scope of the preserved summary. Equivalence/superiority tests and margins, validation of clinical importance and long-term mortality equivalence are unverified in this selected material.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of Allowed −5 percentage points, significant-cancer detection and other hypotheses.
Application exceptions: Do not turn noninferiority into complete equivalence, no cancers missed or mortality equivalence.
Referenced methods: M15 §§15.3.1–15.3.3; Chamgap adaptation

Related sources R01

N12 · How do 453 allocated participants and detection denominators 225/227 differ?

Current findings: Allocation was 453 men: standard 226 and MRI 227. Significant-cancer result denominators were standard 225 and MRI 227. Retain the standard arm's allocation and result denominators separately.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Reasons for denominator changes, exclusions, indeterminate tests, crossover, arm-specific nonperformance and analysis populations are unverified.
Reason for missing information: Reasons for denominator changes, exclusions, indeterminate tests, crossover, arm-specific nonperformance and analysis populations are unverified.
Required materials and conditions: Standard allocation 226, MRI allocation 227 and standard result denominator 225
Materials to obtain first: Original allocation → testing → biopsy → result/analysis flow
Further research: If the original flow is added, link actual denominators and reasons at each stage.
Remaining uncertainty: Production scope of the preserved summary. Reasons for denominator changes, exclusions, indeterminate tests, crossover, arm-specific nonperformance and analysis populations are unverified.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of Standard allocation 226, MRI allocation 227 and standard result denominator 225.
Application exceptions: Do not calculate differences such as 226−225 and invent dropout or failure reasons.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design

Related sources R01

N13 · What do 221 actual MRI recipients and 83 biopsy avoidances represent?

Current findings: Among the 221 men who actually underwent MRI, 83 (37%) avoided biopsy because imaging was negative. This denominator is MRI recipients and differs from all 227 allocated men.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Reasons for MRI nonperformance/deviation, negative-imaging/actual-avoidance verification and an avoidance rate for all allocated men are unverified.
Reason for missing information: Reasons for MRI nonperformance/deviation, negative-imaging/actual-avoidance verification and an avoidance rate for all allocated men are unverified.
Required materials and conditions: Allocation 227, MRI performed in 221 and negative imaging/avoidance 83 (37%)
Materials to obtain first: Actual MRI/negative-imaging and biopsy-adherence flow
Further research: If records are provided, distinguish denominators for allocation, actual MRI, imaging status and actual biopsy performance.
Remaining uncertainty: Production scope of the preserved summary. Reasons for MRI nonperformance/deviation, negative-imaging/actual-avoidance verification and an avoidance rate for all allocated men are unverified.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of Allocation 227, MRI performed in 221 and negative imaging/avoidance 83 (37%).
Application exceptions: Do not copy 37% as an avoidance rate for all allocated men or all populations, or calculate positive-imaging/nonperformance counts.
Referenced methods: 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

Related sources R01

N14 · Are biopsy avoidance and actual cancer nondetection/misses distinguished?

Current findings: The pathway omitting biopsy after negative MRI records avoidance of 83/221. Significant-cancer detection is compared separately between pathways.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Initial histological verification of MRI-negative men, missed cancers, TP/FP/FN/TN, sensitivity, specificity and negative predictive value are absent from the preserved summary.
Reason for missing information: Initial histological verification of MRI-negative men, missed cancers, TP/FP/FN/TN, sensitivity, specificity and negative predictive value are absent from the preserved summary.
Required materials and conditions: Biopsy omission after negative MRI, reference verification, detection and accuracy
Materials to obtain first: Actual follow-up/reference verification of negative cases and diagnostic-accuracy counts
Further research: Retain a proposal to record verification pathways separately from actual detection and misses in additional diagnostic data.
Remaining uncertainty: Production scope of the preserved summary. Initial histological verification of MRI-negative men, missed cancers, TP/FP/FN/TN, sensitivity, specificity and negative predictive value are absent from the preserved summary.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of Biopsy omission after negative MRI, reference verification, detection and accuracy.
Application exceptions: Do not turn 37% biopsy avoidance and noninferior detection into no cancer in MRI-negative men or 100% negative predictive value/sensitivity.
Referenced methods: 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

Related sources R01

N15 · What are the ITT, PP, crossover and actual-performance analyses?

Current findings: The preserved summary provides the randomized noninferiority pathway comparison and original result denominators.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. ITT/PP, as-treated and deviation/crossover definitions, test/biopsy nonperformance, missing-data/supporting analyses and their results are unverified.
Reason for missing information: ITT/PP, as-treated and deviation/crossover definitions, test/biopsy nonperformance, missing-data/supporting analyses and their results are unverified.
Required materials and conditions: Noninferiority analysis populations, pathway deviations and actual tests/biopsies
Materials to obtain first: Original noninferiority population, deviation/crossover and sensitivity-analysis plans/tables
Further research: Link allocation-based, actual-performance and PP definitions and results separately in new material.
Remaining uncertainty: Production scope of the preserved summary. ITT/PP, as-treated and deviation/crossover definitions, test/biopsy nonperformance, missing-data/supporting analyses and their results are unverified.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of Noninferiority analysis populations, pathway deviations and actual tests/biopsies.
Application exceptions: Do not confirm both ITT/PP fulfillment or no missing-data impact merely because the design was randomized.
Referenced methods: 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.

Related sources R01

N16 · What is the impact of missing data and different verification pathways?

Current findings: The pathways differ: biopsy omission after negative MRI versus standard TRUS biopsy.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Unverified cases, missing data, actual follow-up, independent verification, omission assumptions and sensitivity are unverified.
Reason for missing information: Unverified cases, missing data, actual follow-up, independent verification, omission assumptions and sensitivity are unverified.
Required materials and conditions: Different diagnostic verification, omissions and selection/verification bias
Materials to obtain first: Pathway-specific verification/omissions, follow-up and alternative analyses
Further research: Retain a proposal to report detection/avoidance alongside actual methods for differing verification pathways and missing data.
Remaining uncertainty: Production scope of the preserved summary. Unverified cases, missing data, actual follow-up, independent verification, omission assumptions and sensitivity are unverified.
Conditions for verification: Different diagnostic verification, omissions and selection/verification bias; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information
Why this condition is needed: A production condition preserving the original scope of Different diagnostic verification, omissions and selection/verification bias.
Application exceptions: Do not turn verification differences into arbitrary numerical adjustment, recalculated accuracy or a new methodological-defect score.
Referenced methods: 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.

Related sources R01

N17 · What are the open-label design and actual reading/assessment masking?

Current findings: PRECISE is recorded as open-label phase 3.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Details of MRI reading/target selection, pathology reading, original detection counts, analyst masking and central assessment are unverified.
Reason for missing information: Details of MRI reading/target selection, pathology reading, original detection counts, analyst masking and central assessment are unverified.
Required materials and conditions: Open-label trial, MRI/biopsy/pathology reading and analysis
Materials to obtain first: Reading, performance, pathology/analysis methods and masking
Further research: If original methods are provided, distinguish open-label/masked roles and their verification levels.
Remaining uncertainty: Production scope of the preserved summary. Details of MRI reading/target selection, pathology reading, original detection counts, analyst masking and central assessment are unverified.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of Open-label trial, MRI/biopsy/pathology reading and analysis.
Application exceptions: Do not infer that every pathological assessment was unmasked or certify new defects beyond the original B1 merely from the open-label design.
Referenced methods: M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application

Related sources R01

N18 · What shared care, additional tests and actual performance accompanied the pathway?

Current findings: The selected comparison concerns the initial-biopsy pathway. The preserved summary retains the main pathways and qualitative 2-year follow-up results.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Shared tests, additional biopsies, antibiotic/analgesic/contrast care, subsequent treatment, adherence and crossover details are unverified.
Reason for missing information: Shared tests, additional biopsies, antibiotic/analgesic/contrast care, subsequent treatment, adherence and crossover details are unverified.
Required materials and conditions: Shared tests, additional biopsies and treatment/follow-up differences
Materials to obtain first: Actual pathway adherence, shared care and additional diagnosis/treatment/follow-up records
Further research: Retain a proposal to distinguish pathway effects from additional diagnostic/treatment exposures in follow-up material.
Remaining uncertainty: Production scope of the preserved summary. Shared tests, additional biopsies, antibiotic/analgesic/contrast care, subsequent treatment, adherence and crossover details are unverified.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of Shared tests, additional biopsies and treatment/follow-up differences.
Application exceptions: Do not provide medical-procedure, test-selection, medication or care/treatment-replacement instructions.
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation

Related sources R01

N19 · What were the prespecified endpoints, noninferiority plan and multiple-comparison scope?

Current findings: The existing research description lists GG2 or higher detection as the primary endpoint and the −5 percentage-point margin. The original narrative says harm comparisons lacked confirmatory multiplicity-adjusted P values.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Original protocol/SAP dates, avoidance/harm hierarchy, adjustment/multiple testing and analysis-selection details are unverified.
Reason for missing information: Original protocol/SAP dates, avoidance/harm hierarchy, adjustment/multiple testing and analysis-selection details are unverified.
Required materials and conditions: Primary GG2 detection, margin and biopsy-avoidance/harm hierarchy
Materials to obtain first: Plans, registration history and result hierarchy/testing methods
Further research: If planning material is provided, link endpoint/analysis-specific prespecification and confirmatory/supporting distinctions.
Remaining uncertainty: Production scope of the preserved summary. Original protocol/SAP dates, avoidance/harm hierarchy, adjustment/multiple testing and analysis-selection details are unverified.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of Primary GG2 detection, margin and biopsy-avoidance/harm hierarchy.
Application exceptions: Do not elevate original prespecification statements or parent axes into current registration/SAP verification.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; Chamgap's own application

Related sources R01

N20 · What are the registration identifiers and follow-up family links?

Current findings: The first existing evidence record lists NCT02936258 and R02 lists NCT02380027. The PRECISE 2-year report is recorded as follow-up of the same trial in citation R03.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Current registration contents, dates/changes, consistency with results and an individual registration field for citation R03 are unverified or absent.
Reason for missing information: Current registration contents, dates/changes, consistency with results and an individual registration field for citation R03 are unverified or absent.
Required materials and conditions: PRECISE NCT02936258, PRECISION NCT02380027 and follow-up
Materials to obtain first: Each original registration/plan and participant links to follow-up reports
Further research: If registration material is provided, distinguish different trials from the same follow-up and historical from current reading.
Remaining uncertainty: Production scope of the preserved summary. Current registration contents, dates/changes, consistency with results and an individual registration field for citation R03 are unverified or absent.
Conditions for verification: PRECISE NCT02936258, PRECISION NCT02380027 and follow-up; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information
Why this condition is needed: A production condition preserving the original scope of PRECISE NCT02936258, PRECISION NCT02380027 and follow-up.
Application exceptions: Do not combine the two NCT identifiers, create new registration verification for R03 or invent a third evidence-list record.
Referenced methods: 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

Related sources R01 R02 R03

N21 · What are the actual identities of the 3 reports?

Current findings: The preserved summary lists R01 Klotz 2021 JAMA Oncology, PMID 33538782; R02 Kasivisvanathan 2018 NEJM, PMID 29552975; and R03 Klotz 2024 European Urology Oncology 2-year follow-up, PMID 37838556. There are 2 evidence entries and 3 citation entries.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. DOI, PMCID, current external bibliography and R03 original result tables/denominators are not specified.
Reason for missing information: DOI, PMCID, current external bibliography and R03 original result tables/denominators are not specified.
Required materials and conditions: PRECISE 2021, PRECISION 2018 and PRECISE 2024 follow-up bibliography
Materials to obtain first: Each original bibliographic record, full text and trial/follow-up links
Further research: If bibliography changes, preserve original text, report-specific identity and the change event.
Remaining uncertainty: Production scope of the preserved summary. DOI, PMCID, current external bibliography and R03 original result tables/denominators are not specified.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of PRECISE 2021, PRECISION 2018 and PRECISE 2024 follow-up bibliography.
Application exceptions: Do not invent a third evidence-list record for R03 or infer DOI/PMCID from article numbers or PMID.
Referenced methods: M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations

Related sources R01 R02 R03

N22 · Are historical independent-replication statements distinguished from the same follow-up?

Current findings: The preserved summary describes results in the same direction from Canadian PRECISE and separate European PRECISION, with independent investigators/funding. R03 is the same PRECISE trial's 2-year follow-up.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Original current recruitment, institutional, funding and participant-independence records were not newly verified; unique trial/participant counts are not certified.
Reason for missing information: Original current recruitment, institutional, funding and participant-independence records were not newly verified; unique trial/participant counts are not certified.
Required materials and conditions: Separate PRECISE/PRECISION investigators/funding and PRECISE follow-up
Materials to obtain first: Each trial's registration, recruitment/institutions/funding and follow-up participant links
Further research: Link historical independence statements separately from direct current verification and the same follow-up in new material.
Remaining uncertainty: Production scope of the preserved summary. Original current recruitment, institutional, funding and participant-independence records were not newly verified; unique trial/participant counts are not certified.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of Separate PRECISE/PRECISION investigators/funding and PRECISE follow-up.
Application exceptions: Do not elevate parent R2/I2 or an independent-replication label into new independence certification or count R03 as a new trial.
Referenced methods: 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

Related sources R01 R02 R03

N23 · What is the scope of PRECISION's 500 participants, 28% and detection result?

Current findings: The original summary describes PRECISION as a European multicenter noninferiority trial with 500 randomized participants, 28% biopsy avoidance in the MRI pathway and significant-cancer detection in the same direction.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Actual avoidance numerator/denominator, arm allocations, detection effects/CIs, margins/definitions/analysis populations and harms are absent from the preserved summary.
Reason for missing information: Actual avoidance numerator/denominator, arm allocations, detection effects/CIs, margins/definitions/analysis populations and harms are absent from the preserved summary.
Required materials and conditions: R02 allocation 500, MRI-pathway avoidance 28% and significant-cancer detection in the same direction
Materials to obtain first: PRECISION original methods, denominators and detection/avoidance/noninferiority/harm tables
Further research: Link each trial's original definitions, denominators, margins and intervals separately in R02 material.
Remaining uncertainty: Production scope of the preserved summary. Actual avoidance numerator/denominator, arm allocations, detection effects/CIs, margins/definitions/analysis populations and harms are absent from the preserved summary.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of R02 allocation 500, MRI-pathway avoidance 28% and significant-cancer detection in the same direction.
Application exceptions: Do not copy PRECISE's 79/227, −5 percentage points, 37% or safety values into R02, or reverse-calculate counts from 500×28%.
Referenced methods: 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

Related sources R02

N24 · What actual result does PRECISE's 2-year follow-up describe?

Current findings: The existing counterview says there was no difference in cumulative GG2 or higher diagnoses between arms at 2 years while initial biopsy omission was retained. R03 is follow-up of the same trial.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Quantitative numerators/denominators, effects/CIs/P values, tests/additional biopsies, analysis definitions and long-term importance are unverified.
Reason for missing information: Quantitative numerators/denominators, effects/CIs/P values, tests/additional biopsies, analysis definitions and long-term importance are unverified.
Required materials and conditions: Cumulative GG2 or higher diagnosis, retained initial biopsy omission and follow-up timing
Materials to obtain first: Original 2-year follow-up methods, cumulative diagnosis/biopsy and effect intervals
Further research: If original follow-up data are provided, link baseline detection separately to 2-year cumulative diagnosis/avoidance at each time point.
Remaining uncertainty: Production scope of the preserved summary. Quantitative numerators/denominators, effects/CIs/P values, tests/additional biopsies, analysis definitions and long-term importance are unverified.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of Cumulative GG2 or higher diagnosis, retained initial biopsy omission and follow-up timing.
Application exceptions: Do not turn a qualitative statement of no difference into fulfillment of a 2-year noninferiority test, equivalence, mortality equivalence or a numerical 0.
Referenced methods: 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

Related sources R03

N25 · What are the 2-year follow-up denominators, omissions and additional diagnoses?

Current findings: R03 is a longer-term PRECISE report, but the complete original summary has no actual 2-year response/analysis denominator.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct definitions, values and material remain unverified within the preserved-summary/unread-external-material scope. Links between allocation 453/arms 226/227 and 2-year contact/completion/analysis, follow-up loss/imputation and additional-test criteria are unverified.
Reason for missing information: Links between allocation 453/arms 226/227 and 2-year contact/completion/analysis, follow-up loss/imputation and additional-test criteria are unverified.
Required materials and conditions: R03 actual follow-up/analysis n, additional biopsies and missing data
Materials to obtain first: Follow-up flow, actual denominators, omissions/missing data and additional diagnosis/biopsy records
Further research: Retain a proposal to distinguish denominators and reasons for allocation, baseline biopsy, follow-up and cumulative outcomes.
Remaining uncertainty: Production scope of the preserved summary. Links between allocation 453/arms 226/227 and 2-year contact/completion/analysis, follow-up loss/imputation and additional-test criteria are unverified.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of R03 actual follow-up/analysis n, additional biopsies and missing data.
Application exceptions: Do not copy baseline 453, 225/227 or 221 as verified 2-year denominators.
Referenced methods: 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

Related sources R03

N26 · Is omitting systematic biopsy after positive MRI a separate question?

Current findings: The preserved summary states that this trial did not answer whether systematic biopsy can always be omitted in MRI-positive men.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Direct targeted-only versus targeted-plus-systematic comparisons, missed cancers/harms and condition-specific definitions are unverified.
Reason for missing information: Direct targeted-only versus targeted-plus-systematic comparisons, missed cancers/harms and condition-specific definitions are unverified.
Required materials and conditions: Pathway comparison versus the optimal biopsy composition for positive cases
Materials to obtain first: Direct comparisons by actual biopsy composition, definitions, denominators and harms
Further research: Retain a proposal to distinguish direct composition comparisons from the whole-pathway comparison.
Remaining uncertainty: Production scope of the preserved summary. Direct targeted-only versus targeted-plus-systematic comparisons, missed cancers/harms and condition-specific definitions are unverified.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of Pathway comparison versus the optimal biopsy composition for positive cases.
Application exceptions: Do not turn targeted-only biopsy in the original pathway into medical guidance to omit systematic biopsy in every positive case.
Referenced methods: 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

Related sources R01

N27 · How do cancer-detection surrogates and long-term mortality differ?

Current findings: The original verdict rationale and advertising interpretation say cancer detection is not mortality/metastasis. The separate long-term cancer-mortality-equivalence question is graded ? and records that this was not the trial endpoint.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Direct long-term effects/CIs for metastasis, cancer-specific/all-cause mortality, quality of life and post-treatment events are unverified.
Reason for missing information: Direct long-term effects/CIs for metastasis, cancer-specific/all-cause mortality, quality of life and post-treatment events are unverified.
Required materials and conditions: Cancer detection, metastasis/death, long-term clinical outcomes and the separate ? subclaim
Materials to obtain first: Long-term clinical events and actual diagnostic/treatment-pathway follow-up
Further research: Retain a proposal to record detection, additional diagnosis, treatment and metastasis/death as different endpoints.
Remaining uncertainty: Production scope of the preserved summary. Direct long-term effects/CIs for metastasis, cancer-specific/all-cause mortality, quality of life and post-treatment events are unverified.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of Cancer detection, metastasis/death, long-term clinical outcomes and the separate ? subclaim.
Application exceptions: Do not turn initial noninferior detection or no difference in 2-year diagnoses into long-term mortality equivalence, survival benefit or harmlessness.
Referenced methods: 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

Related sources R01

N28 · What application differences arise from centers, populations, readers and technology?

Current findings: The representative material comprises PRECISE at 5 Canadian academic centers and multicenter European PRECISION.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Direct results in nonacademic settings, other diagnostic/risk populations, equipment/reading/performance skills and different biopsy compositions are unverified.
Reason for missing information: Direct results in nonacademic settings, other diagnostic/risk populations, equipment/reading/performance skills and different biopsy compositions are unverified.
Required materials and conditions: Initial-biopsy academic centers, age/risk and actual MRI/biopsy capability
Materials to obtain first: Direct comparisons by actual setting, threshold and care pathway
Further research: Retain a proposal to report institutional, threshold, equipment/reader and eligibility-population differences as actual conditions.
Remaining uncertainty: Production scope of the preserved summary. Direct results in nonacademic settings, other diagnostic/risk populations, equipment/reading/performance skills and different biopsy compositions are unverified.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of Initial-biopsy academic centers, age/risk and actual MRI/biopsy capability.
Application exceptions: Do not generalize academic-center pathway results into fixed performance across every MRI or care setting.
Referenced methods: 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

Related sources R01 R02

N29 · What is the direct evidence scope for contrary results, heterogeneity and subgroups?

Current findings: The preserved summary retains PRECISE quantitative results, PRECISION in the same direction and qualitative PRECISE 2-year follow-up.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Original between-trial condition differences, subgroups/interactions, contrary evidence on the same question, corrections and unpublished material were not searched or verified in this conversion.
Reason for missing information: Original between-trial condition differences, subgroups/interactions, contrary evidence on the same question, corrections and unpublished material were not searched or verified in this conversion.
Required materials and conditions: Trial-specific definitions/margins, risk/readers and contrary/additional results
Materials to obtain first: Original trial conditions, prespecified subgroups and direct material on the same question
Further research: Retain a proposal to distinguish different conditions/measures from actual conflict on the same question in new material.
Remaining uncertainty: Production scope of the preserved summary. Original between-trial condition differences, subgroups/interactions, contrary evidence on the same question, corrections and unpublished material were not searched or verified in this conversion.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of Trial-specific definitions/margins, risk/readers and contrary/additional results.
Application exceptions: Do not turn absence of a new search into no other trials or complete consensus, or calculate a pooled quantitative effect.
Referenced methods: 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

Related sources R01 R02 R03

N30 · What is the scope of PRECISE funding and unreported equipment support?

Current findings: The existing research/intervention description records funding from Ontario Institute for Cancer Research and Prostate Cancer Canada, Movember Foundation resources in presentation material, and unreported free equipment/products or outsourced analysis.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Actual provision contracts, author disclosures, analysis/writing/publication costs, current relationships, sponsors and original presentations/declarations were not read.
Reason for missing information: Actual provision contracts, author disclosures, analysis/writing/publication costs, current relationships, sponsors and original presentations/declarations were not read.
Required materials and conditions: OICR, Prostate Cancer Canada, Movember presentations and manufacturer roles
Materials to obtain first: Original support/disclosure statements and product/equipment/analysis/publication-role records
Further research: Distinguish article, presentation and report-specific roles and historical/current reading scope in support material.
Remaining uncertainty: Production scope of the preserved summary. Actual provision contracts, author disclosures, analysis/writing/publication costs, current relationships, sponsors and original presentations/declarations were not read.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of OICR, Prostate Cancer Canada, Movember presentations and manufacturer roles.
Application exceptions: Do not elevate nonprofit/public support or nonreporting into new certification of no conflicts of interest or no support.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

Related sources R01

N31 · Is funding kept separate for other trials and follow-up?

Current findings: Existing evidence R02 says only that European public/nonprofit funding was reported in the PRECISION summary. R03 is the same PRECISE follow-up but has no report-specific funding field.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. R02 specific funding agencies/roles and R03 individual funding/author disclosures are unverified.
Reason for missing information: R02 specific funding agencies/roles and R03 individual funding/author disclosures are unverified.
Required materials and conditions: PRECISION's original public/nonprofit narrative and PRECISE follow-up-specific declarations
Materials to obtain first: Report-specific funding/COI and trial/follow-up relationship records
Further research: If declarations are provided, link actual report-specific disclosure separately from trial-family context.
Remaining uncertainty: Production scope of the preserved summary. R02 specific funding agencies/roles and R03 individual funding/author disclosures are unverified.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of PRECISION's original public/nonprofit narrative and PRECISE follow-up-specific declarations.
Application exceptions: Do not copy PRECISE funding agencies or unreported-equipment statements into R02 individual disclosures or an allegedly read R03 declaration.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

Related sources R02 R03

N32 · What are the original date, corrections, bilingual text, empty values and history?

Current findings: The original review date is 2026-08-26; correction history is an empty array and deliberation is an empty string. Korean/English text, the existing synthesis, verdict decision, axes, false values and unrecorded precision are preserved in the complete summary.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Classification information and a primary-failed/secondary-positive flag are absent. Empty corrections do not mean a current external check found no corrections/retractions.
Reason for missing information: Classification information and a primary-failed/secondary-positive flag are absent. Empty corrections do not mean a current external check found no corrections/retractions.
Required materials and conditions: 2026-08-26, empty correction/deliberation records and existing axes/verdict
Materials to obtain first: Complete previous review summary and actual change/correction events
Further research: Distinguish the complete prechange text, event, version and separate application when changes occur.
Remaining uncertainty: Production scope of the preserved summary. Classification information and a primary-failed/secondary-positive flag are absent. Empty corrections do not mean a current external check found no corrections/retractions.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of 2026-08-26, empty correction/deliberation records and existing axes/verdict.
Application exceptions: Do not fill empty/absent values or historical independent replication/cross-checking with new scores or completed review.
Referenced methods: M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design

Related sources R01 R02 R03

N33 · What was actually read, and what is the external-material status?

Current findings: The complete preserved 2958 summary and the selected existing question were read for production. Summary reading is distinguished from unread external-material slots for the 3 reports.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. External abstracts, full texts, registration, plans, original results/harms and funding declarations were not accessed or acquired.
Reason for missing information: External abstracts, full texts, registration, plans, original results/harms and funding declarations were not accessed or acquired.
Required materials and conditions: Complete preserved summary, existing selection and unread external material
Materials to obtain first: User-provided material and actual acquisition/reading records
Further research: Distinguish material type, publication/access, acquisition and reading scope/date in new records.
Remaining uncertainty: Production scope of the preserved summary. External abstracts, full texts, registration, plans, original results/harms and funding declarations were not accessed or acquired.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of Complete preserved summary, existing selection and unread external material.
Application exceptions: Do not elevate URLs, quotations in the summary or the existence of copies into external reading, verified links or successful access.
Referenced methods: 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

Related sources R01 R02 R03

N34 · How do report, material-slot, trial and participant counts differ?

Current findings: The summary links R01/R02 and R03 while distinguishing qualitative replication by different trials from follow-up of the same PRECISE trial. Material slots count preserved and needed external records for production.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Unique trial counts, total participants and institutional independence were not newly summed or certified.
Reason for missing information: Unique trial counts, total participants and institutional independence were not newly summed or certified.
Required materials and conditions: 2 evidence entries, 3 citation entries, follow-up, allocation/analysis and unrecorded unique counts
Materials to obtain first: Report–trial–population–time point–endpoint–material links
Further research: Distinguish the same follow-up from a new trial and actual participant relationships in additional material.
Remaining uncertainty: Production scope of the preserved summary. Unique trial counts, total participants and institutional independence were not newly summed or certified.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of 2 evidence entries, 3 citation entries, follow-up, allocation/analysis and unrecorded unique counts.
Application exceptions: Do not add 453, 500, 221, 225/227, 3 reports or parent/subclaim tables as total sample size or independent replications.
Referenced methods: 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

Related sources R01 R02 R03

N35 · What is linked when new material or corrections become available?

Current findings: The existing question and original verdict are prepared in the same 7-column format. Conditions are saved and frozen before observations are written with a separate application time.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. No new search, clinical calculation, effect/CI, regrading, independence certification or model/self-review was performed.
Reason for missing information: No new search, clinical calculation, effect/CI, regrading, independence certification or model/self-review was performed.
Required materials and conditions: Condition version, original material, observations, reading and change events
Materials to obtain first: User-provided detection/avoidance, original plans, follow-up/clinical events and harm/correction material
Further research: Prepare only actual additions/changes, separating the complete previous text, event, condition version/freeze, application and current handoff.
Remaining uncertainty: Production scope of the preserved summary. No new search, clinical calculation, effect/CI, regrading, independence certification or model/self-review was performed.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of Condition version, original material, observations, reading and change events.
Application exceptions: Original candidate pending/eligible markers are history; do not revive historical review waits as execution or approval.
Referenced methods: M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design

Related sources R01 R02 R03

H01 · What are the adverse-event, grade and symptom definitions and collection methods?

Current findings: The existing research description provides values for at least 1 adverse event, grade 3 or higher, hematuria, hematospermia, pain and prostatitis.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Definitions, grading system, active/passive collection, occurrence/observation periods, attribution and omissions are unverified.
Reason for missing information: Definitions, grading system, active/passive collection, occurrence/observation periods, attribution and omissions are unverified.
Required materials and conditions: At least 1 adverse event, grade 3 or higher, symptoms and collection
Materials to obtain first: Original harm definitions, collection/grading and period-specific result tables
Further research: Retain a proposal to distinguish symptoms, serious events and pathway/procedure attribution in follow-up collection.
Remaining uncertainty: Production scope of the preserved summary. Definitions, grading system, active/passive collection, occurrence/observation periods, attribution and omissions are unverified.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of At least 1 adverse event, grade 3 or higher, symptoms and collection.
Application exceptions: Prepare only the preserved summary's actual scope without inventing absent definitions, values, denominators or current verification.
Referenced methods: M19 §§19.1.2–19.2.4; detailed distinctions are Chamgap-designed; M19 §§19.1.2–19.2.4; Chamgap adaptation

Related sources R01

H02 · What is the actual observation period for test/biopsy harms?

Current findings: The original material records pathway-specific adverse events separately from detection/avoidance at 2-year follow-up.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Original harm-observation periods, test/biopsy timing, long-term collection and repeated additional-biopsy/treatment exposures are unverified.
Reason for missing information: Original harm-observation periods, test/biopsy timing, long-term collection and repeated additional-biopsy/treatment exposures are unverified.
Required materials and conditions: MRI/contrast, biopsy, follow-up and occurrence timing
Materials to obtain first: Procedure/exposure, harm-occurrence timing and follow-up collection periods
Further research: Retain a proposal to distinguish test/procedure exposure, actual observation periods and additional interventions in harm material.
Remaining uncertainty: Production scope of the preserved summary. Original harm-observation periods, test/biopsy timing, long-term collection and repeated additional-biopsy/treatment exposures are unverified.
Conditions for verification: MRI/contrast, biopsy, follow-up and occurrence timing; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information
Why this condition is needed: A production condition preserving the original scope of MRI/contrast, biopsy, follow-up and occurrence timing.
Application exceptions: Do not inherit 2-year diagnostic follow-up as completed 2-year harm collection or write actual procedural/contraindication guidance.
Referenced methods: M19 §19.2 design-specific harm questions; timing details are Chamgap-designed

Related sources R01

H03 · What are the original overall adverse-event values and arm labels?

Current findings: At least 1 adverse event occurred in standard 145/226 (64%) versus MRI 89/227 (40%). Explicitly retain this arm order, which differs from MRI-first versus standard in the detection table.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Overall harm-effect differences/RRs/CIs, confirmatory tests and details of comparable collection/exposure conditions are unverified.
Reason for missing information: Overall harm-effect differences/RRs/CIs, confirmatory tests and details of comparable collection/exposure conditions are unverified.
Required materials and conditions: Standard 145/226 (64%) and MRI 89/227 (40%)
Materials to obtain first: Arm-specific overall harms, definitions/exposure denominators and intervals/tests
Further research: If original records are provided, link arm labels, denominators, periods and estimates to actual harms.
Remaining uncertainty: Production scope of the preserved summary. Overall harm-effect differences/RRs/CIs, confirmatory tests and details of comparable collection/exposure conditions are unverified.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of Standard 145/226 (64%) and MRI 89/227 (40%).
Application exceptions: Do not subtract original rates to create a new risk difference, statistically significant harm reduction or safety equivalence.
Referenced methods: M19 §§19.2.2–19.2.4 and M03 §3.2.3; Chamgap adaptation

Related sources R01

H04 · What are the denominators for grade 3 or higher and symptom values?

Current findings: Grade 3 or higher values are standard 10 men (4.4%) versus MRI 8 men (3.5%). Hematuria 48%/19%, hematospermia 42%/22%, pain 32%/15% and prostatitis 4%/<1% are in standard/MRI order.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Original denominators for each symptom/grade, repeats/overlap, actual-biopsy denominators, inclusion of MRI-negative men and omissions are unverified.
Reason for missing information: Original denominators for each symptom/grade, repeats/overlap, actual-biopsy denominators, inclusion of MRI-negative men and omissions are unverified.
Required materials and conditions: Standard 10 (4.4%), MRI 8 (3.5%) and symptom-specific denominators
Materials to obtain first: Actual grade/symptom denominators, procedure exposure and overlapping counts
Further research: Retain a proposal to distinguish allocation, actual procedures, collection and category-specific denominators in harm tables.
Remaining uncertainty: Production scope of the preserved summary. Original denominators for each symptom/grade, repeats/overlap, actual-biopsy denominators, inclusion of MRI-negative men and omissions are unverified.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of Standard 10 (4.4%), MRI 8 (3.5%) and symptom-specific denominators.
Application exceptions: Do not reverse-calculate event counts from symptom rates, sum categories/grades or create incidence rates without original denominators.
Referenced methods: 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

Related sources R01

H05 · What alternative explanations concern fewer biopsies, shared care and harms?

Current findings: The pathways differ in actual exposure: biopsy omission after negative MRI and targeted-only biopsy after positive MRI versus standard biopsy.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Direct comparisons restricted to biopsy recipients, cores/access, medication/infection prevention, MRI/contrast harms and baseline risk/attribution are unverified.
Reason for missing information: Direct comparisons restricted to biopsy recipients, cores/access, medication/infection prevention, MRI/contrast harms and baseline risk/attribution are unverified.
Required materials and conditions: Procedure-exposure differences, pathways/diagnosis and attribution
Materials to obtain first: Analyses by pathway/actual procedure, accompanying care and harm attribution
Further research: Retain a proposal to distinguish whole-pathway comparisons from actual procedure/test-exposure comparisons in additional harm material.
Remaining uncertainty: Production scope of the preserved summary. Direct comparisons restricted to biopsy recipients, cores/access, medication/infection prevention, MRI/contrast harms and baseline risk/attribution are unverified.
Conditions for verification: Procedure-exposure differences, pathways/diagnosis and attribution; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information
Why this condition is needed: A production condition preserving the original scope of Procedure-exposure differences, pathways/diagnosis and attribution.
Application exceptions: Do not certify the mechanism of numerical differences or provide test/contrast/infection/bleeding-management instructions.
Referenced methods: M19 §§19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap-designed

Related sources R01

H06 · What is the scope of confirmatory multiple comparisons, nonreporting and unread material?

Current findings: The preserved summary says symptom comparisons lacked confirmatory multiplicity-adjusted P values, preventing a firm claim of significantly fewer events. External tables/plans were not read in this conversion.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Actual current supplementary analyses, all harms and distinctions among not collected, not reported, missing and 0 are unverified.
Reason for missing information: Actual current supplementary analyses, all harms and distinctions among not collected, not reported, missing and 0 are unverified.
Required materials and conditions: Original narrative of absent symptom-specific P values and currently unread external material
Materials to obtain first: Original harm tables, multiple-comparison plans, supplements and collection/omission records
Further research: Distinguish values, confirmatory/supporting analyses and missingness only in actually provided material.
Remaining uncertainty: Production scope of the preserved summary. Actual current supplementary analyses, all harms and distinctions among not collected, not reported, missing and 0 are unverified.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of Original narrative of absent symptom-specific P values and currently unread external material.
Application exceptions: Do not turn numerically lower original values into newly certified significant reductions, or unread external material into access failure or 0 harms.
Referenced methods: M19 §§19.1.2–19.2.4 and M04 §4.6.3; Chamgap adaptation

Related sources R01

H07 · Are harms kept from being double-counted across trials and follow-up?

Current findings: PRECISE harm values come from the R01 parent summary. R02/PRECISION has no quantitative harm values here, and R03 is follow-up of the same PRECISE trial.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Overlap across reports/events/time points, additional harms and R02/R03 original harm denominators/collection are unverified.
Reason for missing information: Overlap across reports/events/time points, additional harms and R02/R03 original harm denominators/collection are unverified.
Required materials and conditions: Separate PRECISE/PRECISION trials, PRECISE follow-up and the same events
Materials to obtain first: Trial/report–procedure–event–period links
Further research: Retain a proposal to distinguish repeat reporting of the same events from other trials/new events in new harm material.
Remaining uncertainty: Production scope of the preserved summary. Overlap across reports/events/time points, additional harms and R02/R03 original harm denominators/collection are unverified.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of Separate PRECISE/PRECISION trials, PRECISE follow-up and the same events.
Application exceptions: Do not copy PRECISE safety values into R02/R03 or add participants/events across multiple reports/time points.
Referenced methods: 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

Related sources R01 R02 R03

H08 · What safety gaps concern longer periods, other risk populations and technology?

Current findings: Parent safety is Caution; the original explanation includes context on MRI/contrast and biopsy harms and contraindication assessment.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. Direct harms for other populations, technologies, severe risk, repeated/long-term exposure and additional biopsy/treatment are unverified within this summary's scope.
Reason for missing information: Direct harms for other populations, technologies, severe risk, repeated/long-term exposure and additional biopsy/treatment are unverified within this summary's scope.
Required materials and conditions: Initial-biopsy pathway, MRI/contrast, biopsy and other populations/periods
Materials to obtain first: Direct harms by population/pathway/technology/period and long-term material
Further research: Retain a proposal to distinguish harm material together with original populations, actual technology/procedure exposure and periods.
Remaining uncertainty: Production scope of the preserved summary. Direct harms for other populations, technologies, severe risk, repeated/long-term exposure and additional biopsy/treatment are unverified within this summary's scope.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of Initial-biopsy pathway, MRI/contrast, biopsy and other populations/periods.
Application exceptions: Do not expand original clinical-assessment wording into new test/biopsy-selection, contraindication or treatment-management guidance.
Referenced methods: M19 §§19.1.2–19.2.4; Chamgap adaptation

Related sources R01

H09 · Are detection/avoidance benefits retained alongside harms and long-term gaps?

Current findings: Retain the selected C/noninferiority/avoidance and original harm values while distinguishing gaps in confirmatory tests, long-term mortality and biopsy composition after positive MRI.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Links information in the preserved summary; this does not mean new clinical verification, fulfillment of a condition or completed content review. No new overall benefit–harm verdict, medical-procedure/treatment choice or long-term effect/causal certification was made.
Reason for missing information: No new overall benefit–harm verdict, medical-procedure/treatment choice or long-term effect/causal certification was made.
Required materials and conditions: Original noninferiority/avoidance, numerical harms and distinct long-term clinical uncertainty
Materials to obtain first: Direct detection/avoidance, harm and long-term clinical material
Further research: Link each endpoint, risk period, original location and change event separately in actually added material.
Remaining uncertainty: Production scope of the preserved summary. No new overall benefit–harm verdict, medical-procedure/treatment choice or long-term effect/causal certification was made.
Conditions for verification: 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
Why this condition is needed: A production condition preserving the original scope of Original noninferiority/avoidance, numerical harms and distinct long-term clinical uncertainty.
Application exceptions: Do not turn noninferior detection into equivalence of all harms/mortality, survival benefit or procedural recommendations.
Referenced methods: Chamgap interpretive boundary informed by M19 principles; no formal causality tool was run

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