{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2958-s0", "verdict_number": "2958", "title": "MRI-first targeted-biopsy pathway · Noninferior significant-cancer detection and biopsy avoidance — Evidence Check", "view_version": "1.0", "view_created_date": "2026-10-12", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "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.", "intervention": "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.", "endpoint": "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.", "excluded_extensions": [ "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" ] }, "requirements": [ { "item_id": "N01", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What are the selected existing question and its record?", "needed": "Wording, Korean/English text and verdict links for noninferior significant-cancer detection and biopsy avoidance", "role": "Required", "role_reason": "A production condition preserving the original scope of Wording, Korean/English text and verdict links for noninferior significant-cancer detection and biopsy avoidance.", "application_exception": "Retain the detection/avoidance components of the one existing question without creating additional subclaim tables.", "criterion": "Wording, Korean/English text and verdict links for noninferior significant-cancer detection and biopsy avoidance; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are our own design", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If the question boundary changes, preserve its existing wording, the complete previous version and the change event.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "No new structural split, invented verdict or independent-claim certification was created.", "uncertainty": "Production scope of the preserved summary. No new structural split, invented verdict or independent-claim certification was created.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Preserved existing subclaim and complete parent review summary" }, { "item_id": "N02", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "How do the subclaim C and parent C56, axes and history differ?", "needed": "Subclaim grade/note, absent score/status/axes and parent values", "role": "Required", "role_reason": "A production condition preserving the original scope of Subclaim grade/note, absent score/status/axes and parent values.", "application_exception": "Do not inherit parent R2/I2 or historical cross-checking as new independence certification, current review or a subclaim score.", "criterion": "Subclaim grade/note, absent score/status/axes and parent values; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Distinguish actual evidence-update events from preservation of original values.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "The selected row's score, status and axes are not recorded and are not filled from parent values.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original subclaim record and parent grade/score/axes and assessment history" }, { "item_id": "N03", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "Which men awaiting an initial biopsy does the pathway concern?", "needed": "Before initial prostate biopsy, biopsy-naive status and actual eligibility", "role": "Required", "role_reason": "A production condition preserving the original scope of Before initial prostate biopsy, biopsy-naive status and actual eligibility.", "application_exception": "Do not generalize to everyone undergoing PSA testing, repeat-biopsy populations or patients with confirmed cancer.", "criterion": "Before initial prostate biopsy, biopsy-naive status and actual eligibility; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M03 §3.2.1; detailed population conditions are Chamgap's own design", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Distinguish application to other populations using actual biopsy history, baseline risk and eligibility records.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Age, PSA/DRE, risk, prostate size, prior MRI, inclusion/exclusion criteria and actual baseline cancer status are unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original recruitment criteria, baseline characteristics and suspected-cancer diagnostic pathway" }, { "item_id": "N04", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What actually makes up the MRI-first pathway?", "needed": "Omitting biopsy after negative MRI and targeted biopsy alone after positive MRI", "role": "Required", "role_reason": "A production condition preserving the original scope of Omitting biopsy after negative MRI and targeted biopsy alone after positive MRI.", "application_exception": "Do not write instructions for MRI reading, target selection, biopsy or other medical procedures.", "criterion": "Omitting biopsy after negative MRI and targeted biopsy alone after positive MRI; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If records are provided, link the planned pathway separately to actual MRI and biopsy performance.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "MRI protocol, positivity criteria, actual adherence, crossover/additional biopsies and reading/targeting procedure details are unverified.", "uncertainty": "Production scope of the preserved summary. MRI protocol, positivity criteria, actual adherence, crossover/additional biopsies and reading/targeting procedure details are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original pathway definitions, actual performance and condition-specific flow" }, { "item_id": "N05", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What is the standard TRUS pathway and comparison direction?", "needed": "Contrast between standard systematic TRUS and MRI-targeted pathways", "role": "Required", "role_reason": "A production condition preserving the original scope of Contrast between standard systematic TRUS and MRI-targeted pathways.", "application_exception": "Do not turn pathway names into direct rankings of every current biopsy composition or procedural guidance.", "criterion": "Contrast between standard systematic TRUS and MRI-targeted pathways; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Do not automatically combine records using different biopsy compositions as the same pathway.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "PRECISE allocated 226 men to standard TRUS biopsy and 227 to the MRI pathway. The citation title compares systematic TRUS with MRI-targeted biopsy.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Biopsy core composition/count, access route, actual performance, shared care and additional-test differences are unverified.", "uncertainty": "Production scope of the preserved summary. Biopsy core composition/count, access route, actual performance, shared care and additional-test differences are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original control/targeted pathways, actual performance and accompanying care" }, { "item_id": "N06", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What defined positive and negative MRI?", "needed": "Reading thresholds, equipment, readers and the actual diagnostic pathway", "role": "Required", "role_reason": "A production condition preserving the original scope of Reading thresholds, equipment, readers and the actual diagnostic pathway.", "application_exception": "Do not assume or prescribe a particular PI-RADS cutoff, MRI method or contrast procedure.", "criterion": "Reading thresholds, equipment, readers and the actual diagnostic pathway; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M03 §3.2.4; our own application", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If records are provided, link actual thresholds, equipment/readers and biopsy attribution.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original record states that 83 men with negative imaging avoided biopsy and records a targeted-biopsy pathway after positive imaging.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Specific thresholds such as PI-RADS, field strength/equipment, contrast, lesion criteria, reader experience, rereading and false-positive/false-negative classification are unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "MRI acquisition/reading, thresholds and participant-level results/verification" }, { "item_id": "N07", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "How was clinically significant cancer defined?", "needed": "Detection of GG2 or higher, histological assessment and original measurements", "role": "Required", "role_reason": "A production condition preserving the original scope of Detection of GG2 or higher, histological assessment and original measurements.", "application_exception": "Do not convert GG2 into Gleason numbers absent from the preserved summary, create new criteria or equate it with detection of all cancers.", "criterion": "Detection of GG2 or higher, histological assessment and original measurements; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M03 §3.2.4; our own application", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to link cancer significance, histological assessment and definition-specific counts separately.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The PRECISE primary endpoint is the proportion with GG2 or higher cancer detected. Significant-cancer detection and noninferiority are linked to that definition.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Detailed Grade Group histological criteria, independent/central reading, specimen/biopsy methods, discrepancy handling and definition-specific detection are unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original histological assessment, significant-cancer definition and detection counts" }, { "item_id": "N08", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What were PRECISE's design and prespecified noninferiority margin?", "needed": "Open-label phase 3, 5 Canadian centers and a −5 percentage-point noninferiority margin", "role": "Required", "role_reason": "A production condition preserving the original scope of Open-label phase 3, 5 Canadian centers and a −5 percentage-point noninferiority margin.", "application_exception": "Do not promote historical statements of prespecification or margin fulfillment into current plan review or a new noninferiority calculation.", "criterion": "Open-label phase 3, 5 Canadian centers and a −5 percentage-point noninferiority margin; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M08 §8.1–8.2.3; Chamgap adaptation; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If plans are provided, link the actual prespecified margin, methods and history to the results.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Sequence generation/concealment, original rationale for the margin, plan dates and analysis/testing procedures are unverified because external materials were not read.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original protocol/SAP, margin rationale and allocation methods" }, { "item_id": "N09", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What are the original significant-cancer numerators, denominators and rates?", "needed": "MRI 79/227 (35%) and standard biopsy 67/225 (30%)", "role": "Required", "role_reason": "A production condition preserving the original scope of MRI 79/227 (35%) and standard biopsy 67/225 (30%).", "application_exception": "Do not calculate new RR, NNT, missed-cancer or total-cancer counts, or convert these numbers into cancer prevalence or sensitivity.", "criterion": "MRI 79/227 (35%) and standard biopsy 67/225 (30%); link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M04 §4.6.3 and M15 §§15.3.1–15.3.3; status separation is Chamgap-designed", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If records are supplemented, link original numerators/denominators to actual definitions and verification.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Histological verification, numerator counting, denominator selection and original result-table details are unverified.", "uncertainty": "Production scope of the preserved summary. Histological verification, numerator counting, denominator selection and original result-table details are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original detection tables, definitions/verification and analysis flow" }, { "item_id": "N10", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What do +5 percentage points and the one-sided 97.5% CI mean here?", "needed": "Original absolute difference, one-sided lower bound −3.4 percentage points to ∞ and prespecified −5 percentage points", "role": "Required", "role_reason": "A production condition preserving the original scope of Original absolute difference, one-sided lower bound −3.4 percentage points to ∞ and prespecified −5 percentage points.", "application_exception": "Do not turn the one-sided interval into a two-sided 95% CI or certify +5 percentage points as new superiority or a survival effect.", "criterion": "Original absolute difference, one-sided lower bound −3.4 percentage points to ∞ and prespecified −5 percentage points; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If direct analyses are provided, link the original contrast, one-sided interval, margin and population together.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Models/adjustment, ITT/PP, variance/margin-testing methods, two-sided intervals and superiority tests are unverified.", "uncertainty": "Production scope of the preserved summary. Models/adjustment, ITT/PP, variance/margin-testing methods, two-sided intervals and superiority tests are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original noninferiority results, models, one-sided/two-sided definitions and analysis populations" }, { "item_id": "N11", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "Are noninferiority, equivalence and superiority distinguished?", "needed": "Allowed −5 percentage points, significant-cancer detection and other hypotheses", "role": "Required", "role_reason": "A production condition preserving the original scope of Allowed −5 percentage points, significant-cancer detection and other hypotheses.", "application_exception": "Do not turn noninferiority into complete equivalence, no cancers missed or mortality equivalence.", "criterion": "Allowed −5 percentage points, significant-cancer detection and other hypotheses; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M15 §§15.3.1–15.3.3; Chamgap adaptation", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to distinguish each hypothesis's original design, endpoint and margin in additional analyses.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Equivalence/superiority tests and margins, validation of clinical importance and long-term mortality equivalence are unverified in this selected material.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original noninferiority hypothesis, margin rationale and statistical/clinical interpretation" }, { "item_id": "N12", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "How do 453 allocated participants and detection denominators 225/227 differ?", "needed": "Standard allocation 226, MRI allocation 227 and standard result denominator 225", "role": "Required", "role_reason": "A production condition preserving the original scope of Standard allocation 226, MRI allocation 227 and standard result denominator 225.", "application_exception": "Do not calculate differences such as 226−225 and invent dropout or failure reasons.", "criterion": "Standard allocation 226, MRI allocation 227 and standard result denominator 225; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If the original flow is added, link actual denominators and reasons at each stage.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Reasons for denominator changes, exclusions, indeterminate tests, crossover, arm-specific nonperformance and analysis populations are unverified.", "uncertainty": "Production scope of the preserved summary. Reasons for denominator changes, exclusions, indeterminate tests, crossover, arm-specific nonperformance and analysis populations are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original allocation → testing → biopsy → result/analysis flow" }, { "item_id": "N13", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What do 221 actual MRI recipients and 83 biopsy avoidances represent?", "needed": "Allocation 227, MRI performed in 221 and negative imaging/avoidance 83 (37%)", "role": "Required", "role_reason": "A production condition preserving the original scope of Allocation 227, MRI performed in 221 and negative imaging/avoidance 83 (37%).", "application_exception": "Do not copy 37% as an avoidance rate for all allocated men or all populations, or calculate positive-imaging/nonperformance counts.", "criterion": "Allocation 227, MRI performed in 221 and negative imaging/avoidance 83 (37%); link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If records are provided, distinguish denominators for allocation, actual MRI, imaging status and actual biopsy performance.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Reasons for MRI nonperformance/deviation, negative-imaging/actual-avoidance verification and an avoidance rate for all allocated men are unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual MRI/negative-imaging and biopsy-adherence flow" }, { "item_id": "N14", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "Are biopsy avoidance and actual cancer nondetection/misses distinguished?", "needed": "Biopsy omission after negative MRI, reference verification, detection and accuracy", "role": "Required", "role_reason": "A production condition preserving the original scope of Biopsy omission after negative MRI, reference verification, detection and accuracy.", "application_exception": "Do not turn 37% biopsy avoidance and noninferior detection into no cancer in MRI-negative men or 100% negative predictive value/sensitivity.", "criterion": "Biopsy omission after negative MRI, reference verification, detection and accuracy; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M08 Table 8.2.a, M03 §3.2.4; own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to record verification pathways separately from actual detection and misses in additional diagnostic data.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The pathway omitting biopsy after negative MRI records avoidance of 83/221. Significant-cancer detection is compared separately between pathways.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual follow-up/reference verification of negative cases and diagnostic-accuracy counts" }, { "item_id": "N15", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What are the ITT, PP, crossover and actual-performance analyses?", "needed": "Noninferiority analysis populations, pathway deviations and actual tests/biopsies", "role": "Required", "role_reason": "A production condition preserving the original scope of Noninferiority analysis populations, pathway deviations and actual tests/biopsies.", "application_exception": "Do not confirm both ITT/PP fulfillment or no missing-data impact merely because the design was randomized.", "criterion": "Noninferiority analysis populations, pathway deviations and actual tests/biopsies; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Link allocation-based, actual-performance and PP definitions and results separately in new material.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The preserved summary provides the randomized noninferiority pathway comparison and original result denominators.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "ITT/PP, as-treated and deviation/crossover definitions, test/biopsy nonperformance, missing-data/supporting analyses and their results are unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original noninferiority population, deviation/crossover and sensitivity-analysis plans/tables" }, { "item_id": "N16", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What is the impact of missing data and different verification pathways?", "needed": "Different diagnostic verification, omissions and selection/verification bias", "role": "Required", "role_reason": "A production condition preserving the original scope of Different diagnostic verification, omissions and selection/verification bias.", "application_exception": "Do not turn verification differences into arbitrary numerical adjustment, recalculated accuracy or a new methodological-defect score.", "criterion": "Different diagnostic verification, omissions and selection/verification bias; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to report detection/avoidance alongside actual methods for differing verification pathways and missing data.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The pathways differ: biopsy omission after negative MRI versus standard TRUS biopsy.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Unverified cases, missing data, actual follow-up, independent verification, omission assumptions and sensitivity are unverified.", "uncertainty": "Production scope of the preserved summary. Unverified cases, missing data, actual follow-up, independent verification, omission assumptions and sensitivity are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Pathway-specific verification/omissions, follow-up and alternative analyses" }, { "item_id": "N17", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What are the open-label design and actual reading/assessment masking?", "needed": "Open-label trial, MRI/biopsy/pathology reading and analysis", "role": "Required", "role_reason": "A production condition preserving the original scope of Open-label trial, MRI/biopsy/pathology reading and analysis.", "application_exception": "Do not infer that every pathological assessment was unmasked or certify new defects beyond the original B1 merely from the open-label design.", "criterion": "Open-label trial, MRI/biopsy/pathology reading and analysis; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If original methods are provided, distinguish open-label/masked roles and their verification levels.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "PRECISE is recorded as open-label phase 3.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Details of MRI reading/target selection, pathology reading, original detection counts, analyst masking and central assessment are unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Reading, performance, pathology/analysis methods and masking" }, { "item_id": "N18", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What shared care, additional tests and actual performance accompanied the pathway?", "needed": "Shared tests, additional biopsies and treatment/follow-up differences", "role": "Required", "role_reason": "A production condition preserving the original scope of Shared tests, additional biopsies and treatment/follow-up differences.", "application_exception": "Do not provide medical-procedure, test-selection, medication or care/treatment-replacement instructions.", "criterion": "Shared tests, additional biopsies and treatment/follow-up differences; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to distinguish pathway effects from additional diagnostic/treatment exposures in follow-up material.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The selected comparison concerns the initial-biopsy pathway. The preserved summary retains the main pathways and qualitative 2-year follow-up results.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Shared tests, additional biopsies, antibiotic/analgesic/contrast care, subsequent treatment, adherence and crossover details are unverified.", "uncertainty": "Production scope of the preserved summary. Shared tests, additional biopsies, antibiotic/analgesic/contrast care, subsequent treatment, adherence and crossover details are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual pathway adherence, shared care and additional diagnosis/treatment/follow-up records" }, { "item_id": "N19", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What were the prespecified endpoints, noninferiority plan and multiple-comparison scope?", "needed": "Primary GG2 detection, margin and biopsy-avoidance/harm hierarchy", "role": "Required", "role_reason": "A production condition preserving the original scope of Primary GG2 detection, margin and biopsy-avoidance/harm hierarchy.", "application_exception": "Do not elevate original prespecification statements or parent axes into current registration/SAP verification.", "criterion": "Primary GG2 detection, margin and biopsy-avoidance/harm hierarchy; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M08 Table 8.2.a, M04 §4.6.3; Chamgap's own application", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If planning material is provided, link endpoint/analysis-specific prespecification and confirmatory/supporting distinctions.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original protocol/SAP dates, avoidance/harm hierarchy, adjustment/multiple testing and analysis-selection details are unverified.", "uncertainty": "Production scope of the preserved summary. Original protocol/SAP dates, avoidance/harm hierarchy, adjustment/multiple testing and analysis-selection details are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Plans, registration history and result hierarchy/testing methods" }, { "item_id": "N20", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What are the registration identifiers and follow-up family links?", "needed": "PRECISE NCT02936258, PRECISION NCT02380027 and follow-up", "role": "Required", "role_reason": "A production condition preserving the original scope of PRECISE NCT02936258, PRECISION NCT02380027 and follow-up.", "application_exception": "Do not combine the two NCT identifiers, create new registration verification for R03 or invent a third evidence-list record.", "criterion": "PRECISE NCT02936258, PRECISION NCT02380027 and follow-up; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/result links are a Chamgap application; M08 Table 8.2.a and M04 §4.6.3; Chamgap application", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If registration material is provided, distinguish different trials from the same follow-up and historical from current reading.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Current registration contents, dates/changes, consistency with results and an individual registration field for citation R03 are unverified or absent.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Each original registration/plan and participant links to follow-up reports" }, { "item_id": "N21", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What are the actual identities of the 3 reports?", "needed": "PRECISE 2021, PRECISION 2018 and PRECISE 2024 follow-up bibliography", "role": "Required", "role_reason": "A production condition preserving the original scope of PRECISE 2021, PRECISION 2018 and PRECISE 2024 follow-up bibliography.", "application_exception": "Do not invent a third evidence-list record for R03 or infer DOI/PMCID from article numbers or PMID.", "criterion": "PRECISE 2021, PRECISION 2018 and PRECISE 2024 follow-up bibliography; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If bibliography changes, preserve original text, report-specific identity and the change event.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "DOI, PMCID, current external bibliography and R03 original result tables/denominators are not specified.", "uncertainty": "Production scope of the preserved summary. DOI, PMCID, current external bibliography and R03 original result tables/denominators are not specified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Each original bibliographic record, full text and trial/follow-up links" }, { "item_id": "N22", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "Are historical independent-replication statements distinguished from the same follow-up?", "needed": "Separate PRECISE/PRECISION investigators/funding and PRECISE follow-up", "role": "Required", "role_reason": "A production condition preserving the original scope of Separate PRECISE/PRECISION investigators/funding and PRECISE follow-up.", "application_exception": "Do not elevate parent R2/I2 or an independent-replication label into new independence certification or count R03 as a new trial.", "criterion": "Separate PRECISE/PRECISION investigators/funding and PRECISE follow-up; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Link historical independence statements separately from direct current verification and the same follow-up in new material.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original current recruitment, institutional, funding and participant-independence records were not newly verified; unique trial/participant counts are not certified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Each trial's registration, recruitment/institutions/funding and follow-up participant links" }, { "item_id": "N23", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What is the scope of PRECISION's 500 participants, 28% and detection result?", "needed": "R02 allocation 500, MRI-pathway avoidance 28% and significant-cancer detection in the same direction", "role": "Required", "role_reason": "A production condition preserving the original scope of R02 allocation 500, MRI-pathway avoidance 28% and significant-cancer detection in the same direction.", "application_exception": "Do not copy PRECISE's 79/227, −5 percentage points, 37% or safety values into R02, or reverse-calculate counts from 500×28%.", "criterion": "R02 allocation 500, MRI-pathway avoidance 28% and significant-cancer detection in the same direction; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are our own design", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Link each trial's original definitions, denominators, margins and intervals separately in R02 material.", "current_reports": [ "R02" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Actual avoidance numerator/denominator, arm allocations, detection effects/CIs, margins/definitions/analysis populations and harms are absent from the preserved summary.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "PRECISION original methods, denominators and detection/avoidance/noninferiority/harm tables" }, { "item_id": "N24", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What actual result does PRECISE's 2-year follow-up describe?", "needed": "Cumulative GG2 or higher diagnosis, retained initial biopsy omission and follow-up timing", "role": "Required", "role_reason": "A production condition preserving the original scope of Cumulative GG2 or higher diagnosis, retained initial biopsy omission and follow-up timing.", "application_exception": "Do not turn a qualitative statement of no difference into fulfillment of a 2-year noninferiority test, equivalence, mortality equivalence or a numerical 0.", "criterion": "Cumulative GG2 or higher diagnosis, retained initial biopsy omission and follow-up timing; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M04 §4.6.3 and M15 §§15.3.1–15.3.3; status separation is Chamgap-designed", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If original follow-up data are provided, link baseline detection separately to 2-year cumulative diagnosis/avoidance at each time point.", "current_reports": [ "R03" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Quantitative numerators/denominators, effects/CIs/P values, tests/additional biopsies, analysis definitions and long-term importance are unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original 2-year follow-up methods, cumulative diagnosis/biopsy and effect intervals" }, { "item_id": "N25", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What are the 2-year follow-up denominators, omissions and additional diagnoses?", "needed": "R03 actual follow-up/analysis n, additional biopsies and missing data", "role": "Required", "role_reason": "A production condition preserving the original scope of R03 actual follow-up/analysis n, additional biopsies and missing data.", "application_exception": "Do not copy baseline 453, 225/227 or 221 as verified 2-year denominators.", "criterion": "R03 actual follow-up/analysis n, additional biopsies and missing data; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to distinguish denominators and reasons for allocation, baseline biopsy, follow-up and cumulative outcomes.", "current_reports": [ "R03" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "R03 is a longer-term PRECISE report, but the complete original summary has no actual 2-year response/analysis denominator.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Links between allocation 453/arms 226/227 and 2-year contact/completion/analysis, follow-up loss/imputation and additional-test criteria are unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Follow-up flow, actual denominators, omissions/missing data and additional diagnosis/biopsy records" }, { "item_id": "N26", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "Is omitting systematic biopsy after positive MRI a separate question?", "needed": "Pathway comparison versus the optimal biopsy composition for positive cases", "role": "Required", "role_reason": "A production condition preserving the original scope of Pathway comparison versus the optimal biopsy composition for positive cases.", "application_exception": "Do not turn targeted-only biopsy in the original pathway into medical guidance to omit systematic biopsy in every positive case.", "criterion": "Pathway comparison versus the optimal biopsy composition for positive cases; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M03 §3.2.4; Chamgap's own limits on extension", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to distinguish direct composition comparisons from the whole-pathway comparison.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The preserved summary states that this trial did not answer whether systematic biopsy can always be omitted in MRI-positive men.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Direct targeted-only versus targeted-plus-systematic comparisons, missed cancers/harms and condition-specific definitions are unverified.", "uncertainty": "Production scope of the preserved summary. Direct targeted-only versus targeted-plus-systematic comparisons, missed cancers/harms and condition-specific definitions are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct comparisons by actual biopsy composition, definitions, denominators and harms" }, { "item_id": "N27", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "How do cancer-detection surrogates and long-term mortality differ?", "needed": "Cancer detection, metastasis/death, long-term clinical outcomes and the separate ? subclaim", "role": "Required", "role_reason": "A production condition preserving the original scope of Cancer detection, metastasis/death, long-term clinical outcomes and the separate ? subclaim.", "application_exception": "Do not turn initial noninferior detection or no difference in 2-year diagnoses into long-term mortality equivalence, survival benefit or harmlessness.", "criterion": "Cancer detection, metastasis/death, long-term clinical outcomes and the separate ? subclaim; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M03 §3.2.4; internally defined extension boundary; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to record detection, additional diagnosis, treatment and metastasis/death as different endpoints.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Direct long-term effects/CIs for metastasis, cancer-specific/all-cause mortality, quality of life and post-treatment events are unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Long-term clinical events and actual diagnostic/treatment-pathway follow-up" }, { "item_id": "N28", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What application differences arise from centers, populations, readers and technology?", "needed": "Initial-biopsy academic centers, age/risk and actual MRI/biopsy capability", "role": "Required", "role_reason": "A production condition preserving the original scope of Initial-biopsy academic centers, age/risk and actual MRI/biopsy capability.", "application_exception": "Do not generalize academic-center pathway results into fixed performance across every MRI or care setting.", "criterion": "Initial-biopsy academic centers, age/risk and actual MRI/biopsy capability; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap’s own design; M03 §3.2.1; detailed population conditions are Chamgap’s own design", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to report institutional, threshold, equipment/reader and eligibility-population differences as actual conditions.", "current_reports": [ "R01", "R02" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The representative material comprises PRECISE at 5 Canadian academic centers and multicenter European PRECISION.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Direct results in nonacademic settings, other diagnostic/risk populations, equipment/reading/performance skills and different biopsy compositions are unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct comparisons by actual setting, threshold and care pathway" }, { "item_id": "N29", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What is the direct evidence scope for contrary results, heterogeneity and subgroups?", "needed": "Trial-specific definitions/margins, risk/readers and contrary/additional results", "role": "Required", "role_reason": "A production condition preserving the original scope of Trial-specific definitions/margins, risk/readers and contrary/additional results.", "application_exception": "Do not turn absence of a new search into no other trials or complete consensus, or calculate a pooled quantitative effect.", "criterion": "Trial-specific definitions/margins, risk/readers and contrary/additional results; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap’s own design; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to distinguish different conditions/measures from actual conflict on the same question in new material.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The preserved summary retains PRECISE quantitative results, PRECISION in the same direction and qualitative PRECISE 2-year follow-up.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original trial conditions, prespecified subgroups and direct material on the same question" }, { "item_id": "N30", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What is the scope of PRECISE funding and unreported equipment support?", "needed": "OICR, Prostate Cancer Canada, Movember presentations and manufacturer roles", "role": "Required", "role_reason": "A production condition preserving the original scope of OICR, Prostate Cancer Canada, Movember presentations and manufacturer roles.", "application_exception": "Do not elevate nonprofit/public support or nonreporting into new certification of no conflicts of interest or no support.", "criterion": "OICR, Prostate Cancer Canada, Movember presentations and manufacturer roles; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Distinguish article, presentation and report-specific roles and historical/current reading scope in support material.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Actual provision contracts, author disclosures, analysis/writing/publication costs, current relationships, sponsors and original presentations/declarations were not read.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original support/disclosure statements and product/equipment/analysis/publication-role records" }, { "item_id": "N31", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "Is funding kept separate for other trials and follow-up?", "needed": "PRECISION's original public/nonprofit narrative and PRECISE follow-up-specific declarations", "role": "Required", "role_reason": "A production condition preserving the original scope of PRECISION's original public/nonprofit narrative and PRECISE follow-up-specific declarations.", "application_exception": "Do not copy PRECISE funding agencies or unreported-equipment statements into R02 individual disclosures or an allegedly read R03 declaration.", "criterion": "PRECISION's original public/nonprofit narrative and PRECISE follow-up-specific declarations; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If declarations are provided, link actual report-specific disclosure separately from trial-family context.", "current_reports": [ "R02", "R03" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "R02 specific funding agencies/roles and R03 individual funding/author disclosures are unverified.", "uncertainty": "Production scope of the preserved summary. R02 specific funding agencies/roles and R03 individual funding/author disclosures are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report-specific funding/COI and trial/follow-up relationship records" }, { "item_id": "N32", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What are the original date, corrections, bilingual text, empty values and history?", "needed": "2026-08-26, empty correction/deliberation records and existing axes/verdict", "role": "Required", "role_reason": "A production condition preserving the original scope of 2026-08-26, empty correction/deliberation records and existing axes/verdict.", "application_exception": "Do not fill empty/absent values or historical independent replication/cross-checking with new scores or completed review.", "criterion": "2026-08-26, empty correction/deliberation records and existing axes/verdict; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Distinguish the complete prechange text, event, version and separate application when changes occur.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Classification information and a primary-failed/secondary-positive flag are absent. Empty corrections do not mean a current external check found no corrections/retractions.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Complete previous review summary and actual change/correction events" }, { "item_id": "N33", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What was actually read, and what is the external-material status?", "needed": "Complete preserved summary, existing selection and unread external material", "role": "Required", "role_reason": "A production condition preserving the original scope of Complete preserved summary, existing selection and unread external material.", "application_exception": "Do not elevate URLs, quotations in the summary or the existence of copies into external reading, verified links or successful access.", "criterion": "Complete preserved summary, existing selection and unread external material; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Distinguish material type, publication/access, acquisition and reading scope/date in new records.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans, original results/harms and funding declarations were not accessed or acquired.", "uncertainty": "Production scope of the preserved summary. External abstracts, full texts, registration, plans, original results/harms and funding declarations were not accessed or acquired.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "User-provided material and actual acquisition/reading records" }, { "item_id": "N34", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "How do report, material-slot, trial and participant counts differ?", "needed": "2 evidence entries, 3 citation entries, follow-up, allocation/analysis and unrecorded unique counts", "role": "Required", "role_reason": "A production condition preserving the original scope of 2 evidence entries, 3 citation entries, follow-up, allocation/analysis and unrecorded unique counts.", "application_exception": "Do not add 453, 500, 221, 225/227, 3 reports or parent/subclaim tables as total sample size or independent replications.", "criterion": "2 evidence entries, 3 citation entries, follow-up, allocation/analysis and unrecorded unique counts; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/result links are a Chamgap application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; design-specific adaptation is Chamgap’s own design", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Distinguish the same follow-up from a new trial and actual participant relationships in additional material.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Unique trial counts, total participants and institutional independence were not newly summed or certified.", "uncertainty": "Production scope of the preserved summary. Unique trial counts, total participants and institutional independence were not newly summed or certified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report–trial–population–time point–endpoint–material links" }, { "item_id": "N35", "question_type": "Diagnostic-pathway comparison, detection, avoidance and material", "question": "What is linked when new material or corrections become available?", "needed": "Condition version, original material, observations, reading and change events", "role": "Required", "role_reason": "A production condition preserving the original scope of Condition version, original material, observations, reading and change events.", "application_exception": "Original candidate pending/eligible markers are history; do not revive historical review waits as execution or approval.", "criterion": "Condition version, original material, observations, reading and change events; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Prepare only actual additions/changes, separating the complete previous text, event, condition version/freeze, application and current handoff.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "No new search, clinical calculation, effect/CI, regrading, independence certification or model/self-review was performed.", "uncertainty": "Production scope of the preserved summary. No new search, clinical calculation, effect/CI, regrading, independence certification or model/self-review was performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "User-provided detection/avoidance, original plans, follow-up/clinical events and harm/correction material" }, { "item_id": "H01", "question_type": "Harms", "question": "What are the adverse-event, grade and symptom definitions and collection methods?", "needed": "At least 1 adverse event, grade 3 or higher, symptoms and collection", "role": "Supporting harm information", "role_reason": "A production condition preserving the original scope of At least 1 adverse event, grade 3 or higher, symptoms and collection.", "application_exception": "Prepare only the preserved summary's actual scope without inventing absent definitions, values, denominators or current verification.", "criterion": "At least 1 adverse event, grade 3 or higher, symptoms and collection; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M19 §§19.1.2–19.2.4; detailed distinctions are Chamgap-designed; M19 §§19.1.2–19.2.4; Chamgap adaptation", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to distinguish symptoms, serious events and pathway/procedure attribution in follow-up collection.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The existing research description provides values for at least 1 adverse event, grade 3 or higher, hematuria, hematospermia, pain and prostatitis.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Definitions, grading system, active/passive collection, occurrence/observation periods, attribution and omissions are unverified.", "uncertainty": "Production scope of the preserved summary. Definitions, grading system, active/passive collection, occurrence/observation periods, attribution and omissions are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original harm definitions, collection/grading and period-specific result tables" }, { "item_id": "H02", "question_type": "Harms", "question": "What is the actual observation period for test/biopsy harms?", "needed": "MRI/contrast, biopsy, follow-up and occurrence timing", "role": "Supporting harm information", "role_reason": "A production condition preserving the original scope of MRI/contrast, biopsy, follow-up and occurrence timing.", "application_exception": "Do not inherit 2-year diagnostic follow-up as completed 2-year harm collection or write actual procedural/contraindication guidance.", "criterion": "MRI/contrast, biopsy, follow-up and occurrence timing; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M19 §19.2 design-specific harm questions; timing details are Chamgap-designed", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to distinguish test/procedure exposure, actual observation periods and additional interventions in harm material.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original material records pathway-specific adverse events separately from detection/avoidance at 2-year follow-up.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original harm-observation periods, test/biopsy timing, long-term collection and repeated additional-biopsy/treatment exposures are unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Procedure/exposure, harm-occurrence timing and follow-up collection periods" }, { "item_id": "H03", "question_type": "Harms", "question": "What are the original overall adverse-event values and arm labels?", "needed": "Standard 145/226 (64%) and MRI 89/227 (40%)", "role": "Supporting harm information", "role_reason": "A production condition preserving the original scope of Standard 145/226 (64%) and MRI 89/227 (40%).", "application_exception": "Do not subtract original rates to create a new risk difference, statistically significant harm reduction or safety equivalence.", "criterion": "Standard 145/226 (64%) and MRI 89/227 (40%); link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M19 §§19.2.2–19.2.4 and M03 §3.2.3; Chamgap adaptation", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "If original records are provided, link arm labels, denominators, periods and estimates to actual harms.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Overall harm-effect differences/RRs/CIs, confirmatory tests and details of comparable collection/exposure conditions are unverified.", "uncertainty": "Production scope of the preserved summary. Overall harm-effect differences/RRs/CIs, confirmatory tests and details of comparable collection/exposure conditions are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific overall harms, definitions/exposure denominators and intervals/tests" }, { "item_id": "H04", "question_type": "Harms", "question": "What are the denominators for grade 3 or higher and symptom values?", "needed": "Standard 10 (4.4%), MRI 8 (3.5%) and symptom-specific denominators", "role": "Supporting harm information", "role_reason": "A production condition preserving the original scope of Standard 10 (4.4%), MRI 8 (3.5%) and symptom-specific denominators.", "application_exception": "Do not reverse-calculate event counts from symptom rates, sum categories/grades or create incidence rates without original denominators.", "criterion": "Standard 10 (4.4%), MRI 8 (3.5%) and symptom-specific denominators; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M19 §§19.1.2–19.2.4; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3 and M19 §§19.1.2–19.2.4; design-specific adaptation is Chamgap-designed", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to distinguish allocation, actual procedures, collection and category-specific denominators in harm tables.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original denominators for each symptom/grade, repeats/overlap, actual-biopsy denominators, inclusion of MRI-negative men and omissions are unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual grade/symptom denominators, procedure exposure and overlapping counts" }, { "item_id": "H05", "question_type": "Harms", "question": "What alternative explanations concern fewer biopsies, shared care and harms?", "needed": "Procedure-exposure differences, pathways/diagnosis and attribution", "role": "Supporting harm information", "role_reason": "A production condition preserving the original scope of Procedure-exposure differences, pathways/diagnosis and attribution.", "application_exception": "Do not certify the mechanism of numerical differences or provide test/contrast/infection/bleeding-management instructions.", "criterion": "Procedure-exposure differences, pathways/diagnosis and attribution; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M19 §§19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap-designed", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to distinguish whole-pathway comparisons from actual procedure/test-exposure comparisons in additional harm material.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The pathways differ in actual exposure: biopsy omission after negative MRI and targeted-only biopsy after positive MRI versus standard biopsy.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Direct comparisons restricted to biopsy recipients, cores/access, medication/infection prevention, MRI/contrast harms and baseline risk/attribution are unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Analyses by pathway/actual procedure, accompanying care and harm attribution" }, { "item_id": "H06", "question_type": "Harms", "question": "What is the scope of confirmatory multiple comparisons, nonreporting and unread material?", "needed": "Original narrative of absent symptom-specific P values and currently unread external material", "role": "Supporting harm information", "role_reason": "A production condition preserving the original scope of Original narrative of absent symptom-specific P values and currently unread external material.", "application_exception": "Do not turn numerically lower original values into newly certified significant reductions, or unread external material into access failure or 0 harms.", "criterion": "Original narrative of absent symptom-specific P values and currently unread external material; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M19 §§19.1.2–19.2.4 and M04 §4.6.3; Chamgap adaptation", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Distinguish values, confirmatory/supporting analyses and missingness only in actually provided material.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Actual current supplementary analyses, all harms and distinctions among not collected, not reported, missing and 0 are unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original harm tables, multiple-comparison plans, supplements and collection/omission records" }, { "item_id": "H07", "question_type": "Harms", "question": "Are harms kept from being double-counted across trials and follow-up?", "needed": "Separate PRECISE/PRECISION trials, PRECISE follow-up and the same events", "role": "Supporting harm information", "role_reason": "A production condition preserving the original scope of Separate PRECISE/PRECISION trials, PRECISE follow-up and the same events.", "application_exception": "Do not copy PRECISE safety values into R02/R03 or add participants/events across multiple reports/time points.", "criterion": "Separate PRECISE/PRECISION trials, PRECISE follow-up and the same events; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M04 §§4.6.1–4.6.2; harm-material adaptation is Chamgap-designed; M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to distinguish repeat reporting of the same events from other trials/new events in new harm material.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Overlap across reports/events/time points, additional harms and R02/R03 original harm denominators/collection are unverified.", "uncertainty": "Production scope of the preserved summary. Overlap across reports/events/time points, additional harms and R02/R03 original harm denominators/collection are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial/report–procedure–event–period links" }, { "item_id": "H08", "question_type": "Harms", "question": "What safety gaps concern longer periods, other risk populations and technology?", "needed": "Initial-biopsy pathway, MRI/contrast, biopsy and other populations/periods", "role": "Supporting harm information", "role_reason": "A production condition preserving the original scope of Initial-biopsy pathway, MRI/contrast, biopsy and other populations/periods.", "application_exception": "Do not expand original clinical-assessment wording into new test/biopsy-selection, contraindication or treatment-management guidance.", "criterion": "Initial-biopsy pathway, MRI/contrast, biopsy and other populations/periods; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "M19 §§19.1.2–19.2.4; Chamgap adaptation", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Retain a proposal to distinguish harm material together with original populations, actual technology/procedure exposure and periods.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "Parent safety is Caution; the original explanation includes context on MRI/contrast and biopsy harms and contraindication assessment.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Direct harms for other populations, technologies, severe risk, repeated/long-term exposure and additional biopsy/treatment are unverified within this summary's scope.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct harms by population/pathway/technology/period and long-term material" }, { "item_id": "H09", "question_type": "Harms", "question": "Are detection/avoidance benefits retained alongside harms and long-term gaps?", "needed": "Original noninferiority/avoidance, numerical harms and distinct long-term clinical uncertainty", "role": "Supporting harm information", "role_reason": "A production condition preserving the original scope of Original noninferiority/avoidance, numerical harms and distinct long-term clinical uncertainty.", "application_exception": "Do not turn noninferior detection into equivalence of all harms/mortality, survival benefit or procedural recommendations.", "criterion": "Original noninferiority/avoidance, numerical harms and distinct long-term clinical uncertainty; link to actual pathways, trials, endpoints, time points, denominators/analyses and reading scope, distinguishing unverified information", "basis": "Chamgap interpretive boundary informed by M19 principles; no formal causality tool was run", "condition_origin": "Chamgap’s own design and production from original material; content review is separately assigned", "proposed_research": "Link each endpoint, risk period, original location and change event separately in actually added material.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "No new overall benefit–harm verdict, medical-procedure/treatment choice or long-term effect/causal certification was made.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct detection/avoidance, harm and long-term clinical material" } ], "reports": [ { "report_id": "R01", "title": "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.", "url": "https://pubmed.ncbi.nlm.nih.gov/33538782/", "report_type": "PRECISE 2021 representative Canadian noninferiority-pathway report", "existence": "Bibliography and URL preserved from the summary’s citation list", "acquired_read": "Summary read; external materials not read", "study_family": "PRECISE · NCT02936258, the same original population", "independent_replication": false, "observed_result": "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.", "result_level": "Original result in the first existing evidence record", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Locally preserved summary", "access_status": "Local copy acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-06T16:42:29.497226+09:00", "qualification": "Read the relevant bibliography, results and boundaries in the complete preserved summary for production; external articles were not read." }, { "material_type": "External abstract", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Only the summary’s citation URL is linked; current contents and access are unverified." }, { "material_type": "External full text", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Only the summary’s bibliographic-identity link is connected; the current full-text location and publication are unverified." }, { "material_type": "Registration", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original registration identifier and trial-family links; follow-up has no separate registration field. Current registration contents were not read." }, { "material_type": "Protocol", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Needed-material slot; actual file existence, publication, thresholds, definitions and plans are unverified." }, { "material_type": "Statistical analysis plan", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Needed-material slot for actual populations, margins/intervals, missing data/verification and multiple comparisons." }, { "material_type": "Results, denominator and harm details", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Actual denominators, verification, follow-up and original harm tables are needed. Unread material is not changed into 0 records or 0 events." }, { "material_type": "Support and interests", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Distinguish trial/presentation/report-specific support and current relationships without copying original funding statements into another trial." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/33538782/" } ] }, { "report_id": "R02", "title": "Kasivisvanathan V, et al. MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 2018. PMID: 29552975.", "url": "https://pubmed.ncbi.nlm.nih.gov/29552975/", "report_type": "PRECISION 2018 European noninferiority-pathway report", "existence": "Bibliography and URL preserved from the summary’s citation list", "acquired_read": "Summary read; external materials not read", "study_family": "PRECISION · NCT02380027, original identity of a separate European trial", "independent_replication": false, "observed_result": "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.", "result_level": "Original result in existing evidence R02", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Locally preserved summary", "access_status": "Local copy acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-06T16:42:29.497226+09:00", "qualification": "Read the relevant bibliography, results and boundaries in the complete preserved summary for production; external articles were not read." }, { "material_type": "External abstract", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Only the summary’s citation URL is linked; current contents and access are unverified." }, { "material_type": "External full text", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Only the summary’s bibliographic-identity link is connected; the current full-text location and publication are unverified." }, { "material_type": "Registration", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original registration identifier and trial-family links; follow-up has no separate registration field. Current registration contents were not read." }, { "material_type": "Protocol", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Needed-material slot; actual file existence, publication, thresholds, definitions and plans are unverified." }, { "material_type": "Statistical analysis plan", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Needed-material slot for actual populations, margins/intervals, missing data/verification and multiple comparisons." }, { "material_type": "Results, denominator and harm details", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Actual denominators, verification, follow-up and original harm tables are needed. Unread material is not changed into 0 records or 0 events." }, { "material_type": "Support and interests", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Distinguish trial/presentation/report-specific support and current relationships without copying original funding statements into another trial." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/29552975/" } ] }, { "report_id": "R03", "title": "Klotz L, et al. Magnetic Resonance Imaging-Targeted Versus Systematic Prostate Biopsies: 2-year Follow-up of PRECISE. Eur Urol Oncol. 2024. PMID: 37838556.", "url": "https://pubmed.ncbi.nlm.nih.gov/37838556/", "report_type": "PRECISE 2024, the same trial’s 2-year follow-up report", "existence": "Bibliography and URL preserved from the summary’s citation list", "acquired_read": "Summary read; external materials not read", "study_family": "PRECISE · NCT02936258, the same original population", "independent_replication": false, "observed_result": "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.", "result_level": "Qualitative follow-up context in citation R03 and the parent counterview", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Locally preserved summary", "access_status": "Local copy acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-06T16:42:29.497226+09:00", "qualification": "Read the relevant bibliography, results and boundaries in the complete preserved summary for production; external articles were not read." }, { "material_type": "External abstract", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Only the summary’s citation URL is linked; current contents and access are unverified." }, { "material_type": "External full text", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Only the summary’s bibliographic-identity link is connected; the current full-text location and publication are unverified." }, { "material_type": "Registration", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original registration identifier and trial-family links; follow-up has no separate registration field. Current registration contents were not read." }, { "material_type": "Protocol", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Needed-material slot; actual file existence, publication, thresholds, definitions and plans are unverified." }, { "material_type": "Statistical analysis plan", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Needed-material slot for actual populations, margins/intervals, missing data/verification and multiple comparisons." }, { "material_type": "Results, denominator and harm details", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Actual denominators, verification, follow-up and original harm tables are needed. Unread material is not changed into 0 records or 0 events." }, { "material_type": "Support and interests", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Distinguish trial/presentation/report-specific support and current relationships without copying original funding statements into another trial." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/37838556/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." } ], "status_dictionary": { "Met": "The original content has been reviewed as meeting the conditions. This status is not used in this preparation.", "Partly verified": "Some information in the stored summary was linked during preparation; clinical verification or review is not complete.", "Unverified": "Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.", "Review incomplete": "Review of existing content or actual review incomplete.", "Not reported": "Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.", "Inaccessible": "Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.", "Insufficient evidence for the conditions": "Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.", "Not applicable": "Used when the reason it does not apply to the original question is stated.", "Conflicting data": "Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "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." }, "history": [ { "date": "2026-10-12", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "A public view and materials were prepared from the existing 44 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-12" }