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

Verdict 2958 · Evidence Check

Stored-material review date: Not recorded  
Original evidence cut-off: 2026-08-26  
Review-criteria version: 1.0  
Public page/material preparation date: 2026-10-12

Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect.

## Assessment scope

- 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

## Checklist items

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

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- Remaining uncertainty: Production scope of the preserved summary. No new structural split, invented verdict or independent-claim certification was created.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- Remaining uncertainty: Production scope of the preserved summary. MRI protocol, positivity criteria, actual adherence, crossover/additional biopsies and reading/targeting procedure details are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- Remaining uncertainty: Production scope of the preserved summary. Biopsy core composition/count, access route, actual performance, shared care and additional-test differences are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The original record states that 83 men with negative imaging avoided biopsy and records a targeted-biopsy pathway after positive imaging.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- Remaining uncertainty: Production scope of the preserved summary. Histological verification, numerator counting, denominator selection and original result-table details are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- Remaining uncertainty: Production scope of the preserved summary. Models/adjustment, ITT/PP, variance/margin-testing methods, two-sided intervals and superiority tests are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- Remaining uncertainty: Production scope of the preserved summary. Reasons for denominator changes, exclusions, indeterminate tests, crossover, arm-specific nonperformance and analysis populations are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The pathway omitting biopsy after negative MRI records avoidance of 83/221. Significant-cancer detection is compared separately between pathways.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The preserved summary provides the randomized noninferiority pathway comparison and original result denominators.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The pathways differ: biopsy omission after negative MRI versus standard TRUS biopsy.
- 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.
- 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.
- Remaining uncertainty: Production scope of the preserved summary. Unverified cases, missing data, actual follow-up, independent verification, omission assumptions and sensitivity are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: PRECISE is recorded as open-label phase 3.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The selected comparison concerns the initial-biopsy pathway. The preserved summary retains the main pathways and qualitative 2-year follow-up results.
- 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.
- 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.
- Remaining uncertainty: Production scope of the preserved summary. Shared tests, additional biopsies, antibiotic/analgesic/contrast care, subsequent treatment, adherence and crossover details are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- Remaining uncertainty: Production scope of the preserved summary. Original protocol/SAP dates, avoidance/harm hierarchy, adjustment/multiple testing and analysis-selection details are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- Remaining uncertainty: Production scope of the preserved summary. DOI, PMCID, current external bibliography and R03 original result tables/denominators are not specified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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%.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: Summary read; external materials not read

- Current findings: R03 is a longer-term PRECISE report, but the complete original summary has no actual 2-year response/analysis denominator.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The preserved summary states that this trial did not answer whether systematic biopsy can always be omitted in MRI-positive men.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The representative material comprises PRECISE at 5 Canadian academic centers and multicenter European PRECISION.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The preserved summary retains PRECISE quantitative results, PRECISION in the same direction and qualitative PRECISE 2-year follow-up.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- Remaining uncertainty: Production scope of the preserved summary. R02 specific funding agencies/roles and R03 individual funding/author disclosures are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- Remaining uncertainty: Production scope of the preserved summary. Unique trial counts, total participants and institutional independence were not newly summed or certified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- Remaining uncertainty: Production scope of the preserved summary. No new search, clinical calculation, effect/CI, regrading, independence certification or model/self-review was performed.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The existing research description provides values for at least 1 adverse event, grade 3 or higher, hematuria, hematospermia, pain and prostatitis.
- 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.
- 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.
- Remaining uncertainty: Production scope of the preserved summary. Definitions, grading system, active/passive collection, occurrence/observation periods, attribution and omissions are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The original material records pathway-specific adverse events separately from detection/avoidance at 2-year follow-up.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The pathways differ in actual exposure: biopsy omission after negative MRI and targeted-only biopsy after positive MRI versus standard biopsy.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: Parent safety is Caution; the original explanation includes context on MRI/contrast and biopsy harms and contraindication assessment.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- 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.
- Referenced methods: Chamgap interpretive boundary informed by M19 principles; no formal causality tool was run
- Related sources: R01

## Evidence and sources

### 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](https://pubmed.ncbi.nlm.nih.gov/33538782/)

Materials actually read: Summary read; external materials not read  
Findings recorded in the 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  
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.

| 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](https://pubmed.ncbi.nlm.nih.gov/29552975/)

Materials actually read: Summary read; external materials not read  
Findings recorded in the 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  
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.

| 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](https://pubmed.ncbi.nlm.nih.gov/37838556/)

Materials actually read: Summary read; external materials not read  
Findings recorded in the 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  
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.

| 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. |

## Review criteria and methods

These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score.

- M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · 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/materials 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.