{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2958-s1", "verdict_number": "2958", "title": "MRI-first targeted-biopsy pathway · Long-term prostate-cancer mortality equivalence — 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": "Preserve the original PRECISE MRI-first/standard-TRUS population before initial prostate biopsy and the separate PRECISION population. Distinguish PRECISE at 5 Canadian academic centers: 453 randomized, standard 226/MRI 227, detection denominators 225/227, and actual MRI 221/83 (37%) avoiding biopsy. Do not newly sum with PRECISION 500; actual mortality populations/denominators, baseline risk and long-term observation are unverified.", "intervention": "Preserve the original initial pathway of biopsy omission after negative MRI and targeted-only biopsy after positive MRI. Imaging/lesion criteria, actual biopsy/deviations and later tests/treatments are unverified. Do not make this a verified mortality-equivalence intervention or individual MRI/biopsy/cancer-treatment method.", "dose": "Actual test/biopsy counts, composition, adherence/crossover and subsequent treatment/periods are unverified. Preserve PRECISE avoidance of 83/37% among 221 MRI recipients and PRECISION 28% as separate original measures without calculating new denominators, avoidance counts or differences.", "comparator": "PRECISE open-label phase 3 randomized noninferiority comparison of standard TRUS with the MRI pathway. PRECISION is another original trial; control/pathway details beyond the summary are unverified. Arm-specific subsequent diagnosis/treatment, concurrent exposure, long-term mortality/censoring and original analyses are unverified.", "endpoint": "Selected long-term cancer-mortality equivalence retains the existing ? and note that this was not a trial endpoint. Cause/adjudication, time, events/denominators, prespecified equivalence margins, between-arm estimates/CIs and power are unverified. PRECISE GG2 or higher detection 79/227 (35%) versus 67/225 (30%), original +5 percentage points and one-sided 97.5% CI −3.4 percentage points to ∞ meeting a −5 percentage-point noninferiority margin concern another endpoint/specification; they are not mortality estimates or equivalence thresholds.", "duration": "PRECISE initial 2021 and 2024 2-year follow-up reports concern the same trial. Preserve the original narrative of no difference in cumulative GG2 or higher diagnoses with retained initial biopsy omission at 2 years without using it as long-term mortality material. Actual selected-mortality follow-up periods/censoring, events and longer outcomes are unverified.", "excluded_extensions": [ "Turning the GG2-detection −5 percentage-point noninferiority margin, one-sided CI/difference or biopsy avoidance into long-term mortality estimates/equivalence specifications", "Elevating no difference in 2-year cumulative diagnoses or retained biopsy omission into long-term mortality/metastasis equivalence", "Certifying PRECISE initial/follow-up reports as new independent trials or PRECISION detection replication as independent mortality replication", "Newly summing or repurposing 453/500, arms/time points/reports, MRI 221/83 or randomized/detection denominators as mortality denominators", "Elevating original biopsy-symptom rates into new significance/confirmatory harms or using them as mortality effects", "Turning unreported equipment/products/analysis or public/nonprofit funding into no support/COI or current verified independence", "Inheriting parent scores/axes, historical cross-checks or original narratives as subclaim scores, current review or external reading", "New calculations, invented values, effects/CIs, grades, independence certification or instructions for test/biopsy/cancer-treatment selection and other product/symptom care or treatment" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Selected long-term mortality question and original values", "needed": "Selected existing question, grade/note, parent context and presence of score/status/axes", "role": "Required", "role_reason": "A production item distinguishing Selected existing question, grade/note, parent context and presence of score/status/axes to connect the selected question’s needed material with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Selected existing question, grade/note, parent context and presence of score/status/axes: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Update research linking the original question with additional material; no new search, calculation or trial was performed here.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The long-term cancer-mortality-equivalence subclaim is graded ?, with the preserved note that this was not a trial endpoint. Parent C56 is the verdict context for detection and biopsy avoidance.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Subclaim score/status/axes are absent and are not filled from parent values. No new mortality effect, grade or equivalence is certified. Existing content review is incomplete.", "missingness": "Subclaim score/status/axes are absent and are not filled from parent values. No new mortality effect, grade or equivalence is certified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Records distinguishing the selected question from the parent verdict" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Definition of long-term prostate-cancer mortality", "needed": "Definition, adjudication and follow-up time for the selected mortality outcome", "role": "Required", "role_reason": "A production item distinguishing Definition, adjudication and follow-up time for the selected mortality outcome to connect the selected question’s needed material with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Definition, adjudication and follow-up time for the selected mortality outcome: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M08 Table 8.2.a, M03 §3.2.4; custom application; M03 §3.2.4; custom extension boundary; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A follow-up research proposal distinguishing the detection pathway from long-term mortality; no new investigation, calculation or trial is performed in this conversion.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original text says reduced biopsy does not establish equal long-term prostate-cancer mortality. Distinguish cancer-detection rates, cumulative diagnosis and biopsy avoidance.", "condition_status": "Unverified", "status_reason": "Currently needed information is unverified in the preserved summary. Cause-specific/all-cause mortality, adjudication procedures, event counts, long-term periods and censoring/omissions are unverified. Existing content review is incomplete.", "missingness": "Cause-specific/all-cause mortality, adjudication procedures, event counts, long-term periods and censoring/omissions are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Mortality definitions, adjudication/registry linkage and long-term follow-up material" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Initial biopsy and actual population", "needed": "Pathway-trial recruitment conditions and the mortality-question population", "role": "Required", "role_reason": "A production item distinguishing Pathway-trial recruitment conditions and the mortality-question population to connect the selected question’s needed material with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Pathway-trial recruitment conditions and the mortality-question population: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.", "basis": "M03 §3.2.1; detailed population conditions are custom design; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A follow-up research proposal on population conditions and the application scope of long-term outcomes; no new investigation, calculation or trial is performed in this conversion.", "current_reports": [ "S01", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "PRECISE compared an MRI pathway before initial biopsy with standard TRUS at 5 Canadian academic centers. The population in direct mortality material is currently unverified.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Detailed eligibility, baseline risk/PSA, age, MRI/pathology and arm characteristics, and mortality analysis populations are unverified. Existing content review is incomplete.", "missingness": "Detailed eligibility, baseline risk/PSA, age, MRI/pathology and arm characteristics, and mortality analysis populations are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original recruitment/baseline material and long-term follow-up populations" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "MRI-first targeted pathway", "needed": "Initial testing/biopsy pathway and actual exposure", "role": "Required", "role_reason": "A production item distinguishing Initial testing/biopsy pathway and actual exposure to connect the selected question’s needed material with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Initial testing/biopsy pathway and actual exposure: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are Chamgap’s own design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application; M08 §8.2.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A research proposal on relationships between the initial pathway and subsequent exposure; no new investigation, calculation or trial is performed in this conversion.", "current_reports": [ "S01", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve the original pathway omitting biopsy after negative MRI and using only targeted biopsy for visible lesions. Do not turn it into long-term mortality reduction/equivalence or individual test/biopsy guidance.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Imaging criteria, actual performance/deviations, targeted/systematic biopsy composition and subsequent tests/treatments are unverified. Existing content review is incomplete.", "missingness": "Imaging criteria, actual performance/deviations, targeted/systematic biopsy composition and subsequent tests/treatments are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original pathway, actual tests/biopsies, deviations and follow-up material" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Standard TRUS and comparison specification", "needed": "Actual control pathway and subsequent care/treatment", "role": "Required", "role_reason": "A production item distinguishing Actual control pathway and subsequent care/treatment to connect the selected question’s needed material with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Actual control pathway and subsequent care/treatment: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are Chamgap’s own design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application; M08 §8.2.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A research proposal distinguishing pathways from attribution of subsequent outcomes; no new investigation, calculation or trial is performed in this conversion.", "current_reports": [ "S01", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve PRECISE allocation of standard TRUS 226 versus MRI 227 men. Do not fill in identical postdiagnosis treatment for the two pathways.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Control test/biopsy details, repeated/structural testing, additional treatment, adherence/crossover and long-term exposures are unverified. Existing content review is incomplete.", "missingness": "Control test/biopsy details, repeated/structural testing, additional treatment, adherence/crossover and long-term exposures are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Control/follow-up pathways, actual care/treatment and deviation records" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Mortality equivalence and prespecified specification", "needed": "Prespecified mortality-equivalence margins and two-sided estimates/precision", "role": "Required", "role_reason": "A production item distinguishing Prespecified mortality-equivalence margins and two-sided estimates/precision to connect the selected question’s needed material with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Prespecified mortality-equivalence margins and two-sided estimates/precision: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.", "basis": "M08 Table 8.2.a and M04 §4.6.3; Chamgap application; M15 §15.3.1–15.3.3; 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; M03 §3.2.4; Chamgap extension boundary", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A research proposal distinguishing equivalence specifications from uncertainty; no new investigation, calculation or trial is performed in this conversion.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The detection −5 percentage-point noninferiority margin is not an equivalence margin for selected long-term mortality. Preserve the original record that mortality was not a trial endpoint.", "condition_status": "Unverified", "status_reason": "Currently needed information is unverified in the preserved summary. Prespecified mortality-equivalence thresholds, design/power, between-arm estimates/CIs and tests/models are unverified. No new margins, effects or CIs are created. Existing content review is incomplete.", "missingness": "Prespecified mortality-equivalence thresholds, design/power, between-arm estimates/CIs and tests/models are unverified. No new margins, effects or CIs are created.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original mortality-equivalence plans, power and estimate/CI material" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Separate GG2 detection from mortality", "needed": "Detection-endpoint definitions/measurements and their relationship to mortality material", "role": "Required", "role_reason": "A production item distinguishing Detection-endpoint definitions/measurements and their relationship to mortality material to connect the selected question’s needed material with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Detection-endpoint definitions/measurements and their relationship to mortality material: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.", "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a and M03 §3.2.4; Chamgap application; M03 §3.2.4; Chamgap interpretation boundary", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A research proposal on relationships between detection measures and long-term clinical outcomes; no new investigation, calculation or trial is performed in this conversion.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "PRECISE's primary endpoint is the proportion with GG2 or higher cancer detected. PRECISION also concerned significant-cancer detection/biopsy avoidance. Detection is a different outcome from mortality or metastasis.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Detection composition, pathology/adjudication procedures, missed cancers/subsequent diagnoses and links to long-term mortality are unverified. Existing content review is incomplete.", "missingness": "Detection composition, pathology/adjudication procedures, missed cancers/subsequent diagnoses and links to long-term mortality are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Pathology/detection definitions and links between subsequent diagnosis and mortality" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "PRECISE original detection values", "needed": "Detection comparison, denominators, original estimates and scope", "role": "Required", "role_reason": "A production item distinguishing Detection comparison, denominators, original estimates and scope to connect the selected question’s needed material with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Detection comparison, denominators, original estimates and scope: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.", "basis": "M15 §15.3.1–15.3.3; Chamgap application; M08 §8.2.2 and M15 §15.3.1; 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; M04 §4.6.3 and M15 §15.3.1–15.3.3; separation of statuses is Chamgap’s own design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A research proposal distinguishing estimates/specifications for different endpoints; no new investigation, calculation or trial is performed in this conversion.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve MRI 79/227 (35%) versus standard 67/225 (30%), difference +5 percentage points, one-sided 97.5% CI lower bound −3.4 percentage points to ∞ and fulfillment of the −5 percentage-point margin. Do not repurpose these as mortality effects/CIs.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Original detection models, denominators/missing data/overlap and mortality events/denominators are unverified. No new differences, rates or estimates are calculated. Existing content review is incomplete.", "missingness": "Original detection models, denominators/missing data/overlap and mortality events/denominators are unverified. No new differences, rates or estimates are calculated.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original detection analyses/populations and separate mortality material" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "MRI221·83/37%", "needed": "Actual MRI and biopsy-avoidance denominators/timing", "role": "Required", "role_reason": "A production item distinguishing Actual MRI and biopsy-avoidance denominators/timing to connect the selected question’s needed material with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Actual MRI and biopsy-avoidance denominators/timing: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; design-specific adaptation is Chamgap’s own design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/result links are a Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A research proposal on relationships between test/biopsy exposure and long-term observation; no new investigation, calculation or trial is performed in this conversion.", "current_reports": [ "S01", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve the original statement that 83 (37%) of 221 actual MRI recipients avoided biopsy after negative imaging. This denominator differs from the 227 randomized men. Do not use it as mortality-equivalence events.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Details of MRI nonperformance/negative imaging, biopsy adherence, timing/repeats and follow-up/analysis flow are unverified. No new rates or omission counts are calculated. Existing content review is incomplete.", "missingness": "Details of MRI nonperformance/negative imaging, biopsy adherence, timing/repeats and follow-up/analysis flow are unverified. No new rates or omission counts are calculated.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "MRI/biopsy, denominators/timing and actual implementation/follow-up material" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "453·226/227·225/227", "needed": "Separate randomized, observed, analyzed and mortality populations", "role": "Required", "role_reason": "A production item distinguishing Separate randomized, observed, analyzed and mortality populations to connect the selected question’s needed material with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Separate randomized, observed, analyzed and mortality populations: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design; M08 §8.2.2, M15 §15.3.1; custom application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A follow-up research proposal on analysis populations and omission assumptions; no new investigation, calculation or trial is performed in this conversion.", "current_reports": [ "S01", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve PRECISE's 453 randomized men, allocation 226/227 and detection results 225/227 separately. Do not fill these in as verified mortality-analysis denominators or ITT for everyone.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Exclusions/omissions, deaths/censoring, arm-specific analyses/follow-up and ITT/PP are unverified. Existing content review is incomplete.", "missingness": "Exclusions/omissions, deaths/censoring, arm-specific analyses/follow-up and ITT/PP are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Randomization → endpoint-specific observation/analysis and long-term follow-up flow" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Open-label design and mortality adjudication", "needed": "Allocation/concealment and role-specific test/pathology/mortality procedures", "role": "Required", "role_reason": "A production item distinguishing Allocation/concealment and role-specific test/pathology/mortality procedures to connect the selected question’s needed material with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Allocation/concealment and role-specific test/pathology/mortality procedures: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.", "basis": "M08 §§8.1–8.2.3; Chamgap adaptation; M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M04 §§4.5–4.6 material collection/selection principles; access/reading separation and hyperlink rules are Chamgap-designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A research proposal on procedures and the bias scope of long-term outcomes; no new investigation, calculation or trial is performed in this conversion.", "current_reports": [ "S01", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve PRECISE's multicenter open-label phase 3 randomized noninferiority design. Distinguish the open-label design from direct long-term mortality-adjudication material.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Allocation/concealment, assessor/analyst masking and long-term cause-specific mortality measurement/linkage procedures are unverified. Existing content review is incomplete.", "missingness": "Allocation/concealment, assessor/analyst masking and long-term cause-specific mortality measurement/linkage procedures are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation, measurement/adjudication and long-term mortality-linkage records" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "PRECISE 2-year follow-up", "needed": "Diagnosis/biopsy follow-up of the same trial and the mortality question", "role": "Required", "role_reason": "A production item distinguishing Diagnosis/biopsy follow-up of the same trial and the mortality question to connect the selected question’s needed material with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Diagnosis/biopsy follow-up of the same trial and the mortality question: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.", "basis": "M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/result links are a Chamgap application; M03 §3.2.4 and M15 §15.3.1–15.3.3; question-specific result adaptation is Chamgap’s own design; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; design-specific adaptation is Chamgap’s own design; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap’s own design; M03 §3.2.4; Chamgap extension boundary", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A time-point/endpoint-specific follow-up research proposal within the same trial; no new investigation, calculation or trial is performed in this conversion.", "current_reports": [ "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "S03 is the same PRECISE trial's 2024 report of 2-year follow-up. The original context describes no difference in cumulative GG2 or higher diagnoses with retained initial biopsy omission; it is not long-term mortality material.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Details of 2-year arm-specific diagnosis/observation denominators, timing/omissions, mortality outcomes and later follow-up are unverified. No new events, effects or independent trials are created. Existing content review is incomplete.", "missingness": "Details of 2-year arm-specific diagnosis/observation denominators, timing/omissions, mortality outcomes and later follow-up are unverified. No new events, effects or independent trials are created.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original follow-up report, populations/diagnosis/biopsy and long-term mortality material" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "PRECISION500·28%", "needed": "Separate pathway trial and its relationship to selected mortality", "role": "Required", "role_reason": "A production item distinguishing Separate pathway trial and its relationship to selected mortality to connect the selected question’s needed material with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Separate pathway trial and its relationship to selected mortality: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.", "basis": "M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/result links are a Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; 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; M03 §3.2.4; Chamgap extension boundary", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A research proposal distinguishing pathway replication from mortality evidence; no new investigation, calculation or trial is performed in this conversion.", "current_reports": [ "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve the original narrative of European PRECISION with 500 participants, 28% biopsy avoidance in the MRI pathway and detection in the same direction. It is a separate original trial from PRECISE but not direct replication of mortality equivalence.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Arm-specific denominators, exact detection/effects/CIs, margins, mortality definitions/events and long-term follow-up are unverified. Do not newly sum it with 453 men. Existing content review is incomplete.", "missingness": "Arm-specific denominators, exact detection/effects/CIs, margins, mortality definitions/events and long-term follow-up are unverified. Do not newly sum it with 453 men.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "PRECISION original plans/results and mortality/follow-up material" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Registration, prespecified endpoints and SAP", "needed": "Original registration questions/periods, plans/changes and correspondence with reports", "role": "Required", "role_reason": "A production item distinguishing Original registration questions/periods, plans/changes and correspondence with reports to connect the selected question’s needed material with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original registration questions/periods, plans/changes and correspondence with reports: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; custom application; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A research proposal linking prespecified plans to endpoint-specific reports; no new investigation, calculation or trial is performed in this conversion.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve PRECISE NCT02936258 and PRECISION NCT02380027. Distinguish the selected note that mortality was not a trial endpoint from detection plans.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Each registration history, protocol/SAP, long-term mortality plans/follow-up/changes and multiplicity were not read. Existing content review is incomplete.", "missingness": "Each registration history, protocol/SAP, long-term mortality plans/follow-up/changes and multiplicity were not read.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Each registration/plan, mortality follow-up specification and report correspondence" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Postdiagnosis treatment and concurrent exposure", "needed": "Arm-specific diagnosis, subsequent treatment/tests and mortality attribution", "role": "Required", "role_reason": "A production item distinguishing Arm-specific diagnosis, subsequent treatment/tests and mortality attribution to connect the selected question’s needed material with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Arm-specific diagnosis, subsequent treatment/tests and mortality attribution: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.", "basis": "M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are Chamgap’s own design; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap’s own design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A research proposal on diagnostic pathways, subsequent exposure and mortality attribution; no new investigation, calculation or trial is performed in this conversion.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve the original comparison of the initial MRI/targeted pathway with standard biopsy.", "condition_status": "Unverified", "status_reason": "Currently needed information is unverified in the preserved summary. Subsequent treatment/monitoring, other tests, crossover/adherence, cause-specific mortality/competing events and accompanying exposure are unverified. No test/cancer-treatment selection guidance is created. Existing content review is incomplete.", "missingness": "Subsequent treatment/monitoring, other tests, crossover/adherence, cause-specific mortality/competing events and accompanying exposure are unverified. No test/cancer-treatment selection guidance is created.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific subsequent testing/treatment, exposure and long-term event material" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "PRECISE funding and presentation resources", "needed": "Original funding/roles and the scope of presentation resources", "role": "Required", "role_reason": "A production item distinguishing Original funding/roles and the scope of presentation resources to connect the selected question’s needed material with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original funding/roles and the scope of presentation resources: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.", "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A research proposal distinguishing support roles and report relationships; no new investigation, calculation or trial is performed in this conversion.", "current_reports": [ "S01", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve mentions of Ontario Institute for Cancer Research and Prostate Cancer Canada funding and Movember Foundation resources in presentation material.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Contracts, support roles, original presentations, analysis/writing/publication costs and authors/COI were not read. Presentation resources are not certified as direct mortality-funding evidence. Existing content review is incomplete.", "missingness": "Contracts, support roles, original presentations, analysis/writing/publication costs and authors/COI were not read. Presentation resources are not certified as direct mortality-funding evidence.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Funding contracts, presentations/original disclosures and contribution records" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "PRECISION funding-identity gap", "needed": "Actual providers, roles and disclosures for the separate original trial", "role": "Required", "role_reason": "A production item distinguishing Actual providers, roles and disclosures for the separate original trial to connect the selected question’s needed material with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Actual providers, roles and disclosures for the separate original trial: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.", "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A research proposal distinguishing trial-specific support and role scopes; no new investigation, calculation or trial is performed in this conversion.", "current_reports": [ "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve PRECISION funding as the original narrative of European public/nonprofit funding. Do not transfer PRECISE funders or roles.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Original details of providers, contracts/roles, product/analysis/writing/publication costs and author relationships/COI were not read. Existing content review is incomplete.", "missingness": "Original details of providers, contracts/roles, product/analysis/writing/publication costs and author relationships/COI were not read.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "PRECISION original funding/support and author/COI disclosures" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Equipment, free support and COI", "needed": "Individual disclosures of equipment/products, analysis, writing/publication and author relationships", "role": "Required", "role_reason": "A production item distinguishing Individual disclosures of equipment/products, analysis, writing/publication and author relationships to connect the selected question’s needed material with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Individual disclosures of equipment/products, analysis, writing/publication and author relationships: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.", "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A research proposal distinguishing gaps in individual support and declarations; no new investigation, calculation or trial is performed in this conversion.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The preserved narrative says free equipment/products from equipment manufacturers or outsourced analysis were not reported in the original text.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Do not turn nonreporting into no support, no employee authors/COI or verified independence. Detailed original disclosures for each trial/report were not read. Existing content review is incomplete.", "missingness": "Do not turn nonreporting into no support, no employee authors/COI or verified independence. Detailed original disclosures for each trial/report were not read.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-specific equipment/products, support/contributions and employment/COI material" }, { "item_id": "N19", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Separate biopsy harms from mortality", "needed": "Harm collection/denominators versus long-term mortality endpoints", "role": "Supplementary", "role_reason": "A production item distinguishing Harm collection/denominators versus long-term mortality endpoints to connect the selected question’s needed material with current material.", "application_exception": "Supplement safety-evidence gaps for the selected subclaim. Do not judge safety from detection, other measure/symptom outcomes or parent safety wording, or generate harm incidence or new usage instructions.", "criterion": "Harm collection/denominators versus long-term mortality endpoints: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.", "basis": "M19 §19.1.2–19.2.4; detailed distinctions are Chamgap’s own design; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A research proposal distinguishing biopsy burden from long-term mortality/harms; no new investigation, calculation or trial is performed in this conversion.", "current_reports": [ "S01", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve PRECISE standard/MRI values: at least 1 adverse event 145/226 (64%) versus 89/227 (40%); grade 3 or higher 10 men (4.4%) versus 8 men (3.5%). Hematuria 48%/19%, hematospermia 42%/22%, pain 32%/15% and prostatitis 4%/<1% are original rates. Retain the interpretation that confirmatory multiplicity-adjusted P values were absent.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Actual harm definitions/adjudication, repeats, follow-up/arm-specific denominators and long-term mortality/treatment harms are unverified. Numerical differences are not turned into newly certified significance or causality. Existing content review is incomplete.", "missingness": "Actual harm definitions/adjudication, repeats, follow-up/arm-specific denominators and long-term mortality/treatment harms are unverified. Numerical differences are not turned into newly certified significance or causality.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original harm collection, arm-specific events/denominators and multiplicity/follow-up material" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Trials/reports, independence and summation", "needed": "Original report–trial–population–endpoint relationships", "role": "Required", "role_reason": "A production item distinguishing Original report–trial–population–endpoint relationships to connect the selected question’s needed material with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original report–trial–population–endpoint relationships: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.", "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application; M04 §4.6.1–4.6.2, M15 §15.3.1; custom application; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A research proposal distinguishing the same material from separate clinical evidence; no new investigation, calculation or trial is performed in this conversion.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "S01/S03 are the same PRECISE trial's initial/2-year reports, and S02 is PRECISION. Original independent replication is a historical detection/biopsy-pathway verdict and is not inherited as mortality replication.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Unique people, report/follow-up correspondence, long-term mortality material and external checks of actual independence are unverified. Do not newly sum arms, time points, bibliographic records or related subclaim tables. Existing content review is incomplete.", "missingness": "Unique people, report/follow-up correspondence, long-term mortality material and external checks of actual independence are unverified. Do not newly sum arms, time points, bibliographic records or related subclaim tables.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report/registration/population/time-point/endpoint relationships and mortality evidence" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Other biopsy compositions and generalization", "needed": "Biopsy composition after positive MRI and outcomes beyond original populations/periods", "role": "Required", "role_reason": "A production item distinguishing Biopsy composition after positive MRI and outcomes beyond original populations/periods to connect the selected question’s needed material with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Biopsy composition after positive MRI and outcomes beyond original populations/periods: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.", "basis": "M03 §3.2.1; detailed population conditions are custom design; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are custom design; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design; M03 §3.2.4; custom extension boundary", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A research proposal distinguishing the selected question from other conditions; no new investigation, calculation or trial is performed in this conversion.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve the original narrative that always omitting systematic biopsy in MRI-positive men and long-term mortality equivalence are separate questions. Do not expand detection benefits to every survival/metastasis outcome or care pathway.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Direct comparisons of biopsy compositions/standards, other populations/institutions and long-term events are unverified. No new test/biopsy/treatment guidance is created. Existing content review is incomplete.", "missingness": "Direct comparisons of biopsy compositions/standards, other populations/institutions and long-term events are unverified. No new test/biopsy/treatment guidance is created.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Material by population/pathway/biopsy composition and long-term outcome" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Original axes, Korean/English text, dates and corrections", "needed": "Distinguish subclaim/parent values, dates/corrections and history", "role": "Required", "role_reason": "Distinguish Distinguish subclaim/parent values, dates/corrections and history to connect materials needed for the selected question with the current materials in this production item.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Distinguish subclaim/parent values, dates/corrections and history requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.", "basis": "M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A research proposal updating original-material changes and production versions; no new investigation, calculation or trial is performed in this conversion.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve the subclaim ?/note, parent C56/Caution, B/S/R2/I2/E+/B1, precision not recorded, three false flags, empty override reasons, Korean/English text, 2026-08-26 and empty corrections/deliberation in the complete summary.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Historical independent replication/cross-checking and margin-fulfillment narratives do not mean current mortality review, external reading or fulfillment of new conditions. Do not fill absent subclaim score/status/axes or parent classification fields. Existing content review is incomplete.", "missingness": "Historical independent replication/cross-checking and margin-fulfillment narratives do not mean current mortality review, external reading or fulfillment of new conditions. Do not fill absent subclaim score/status/axes or parent classification fields.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original verdict, correction/change text and user comments" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Summary read; external material unread", "needed": "Actual reading by material, bibliography/URLs and additional-material gaps", "role": "Required", "role_reason": "A production item distinguishing Actual reading by material, bibliography/URLs and additional-material gaps to connect the selected question’s needed material with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Actual reading by material, bibliography/URLs and additional-material gaps: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.", "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": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A research proposal for scope-specific updates based on actually acquired material; no new investigation, calculation or trial is performed in this conversion.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The preserved summary was read for production, and bibliography/URLs for PRECISE, PRECISION and the 2-year report are linked. External articles, registration, protocol/SAP and disclosures were unread; access was not attempted.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. URLs, registration or historical narrative do not elevate external acquisition/reading/review status; external link/click checks were not performed. Existing content review is incomplete.", "missingness": "URLs, registration or historical narrative do not elevate external acquisition/reading/review status; external link/click checks were not performed.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Each original report/registration/plan, long-term mortality/disclosures and user comments" } ], "reports": [ { "report_id": "S01", "title": "Klotz L et al. 2021 PRECISE", "url": "https://pubmed.ncbi.nlm.nih.gov/33538782/", "report_type": "Multicenter open-label phase 3 randomized noninferiority trial", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2958-PRECISE", "independent_replication": null, "observed_result": "79/227 (35%) versus 67/225 (30%), difference +5 percentage points, one-sided 97.5% CI −3.4 percentage points to ∞; −5 percentage-point noninferiority margin met. These are original detection/biopsy or diagnostic-follow-up records, not effects on selected long-term mortality. Preserve the existing ?/note that mortality was not a trial endpoint and unverified direct mortality material/specifications.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only stored-summary and bibliographic content was used for production. External material verification/review is not complete." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/33538782/" } ] }, { "report_id": "S02", "title": "Kasivisvanathan V et al. 2018 PRECISION", "url": "https://pubmed.ncbi.nlm.nih.gov/29552975/", "report_type": "European multicenter randomized noninferiority trial", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2958-PRECISION", "independent_replication": null, "observed_result": "In the MRI pathway, 28% avoided biopsy and significant-cancer detection was in the same direction. These are original detection/biopsy or diagnostic-follow-up records, not effects on selected long-term mortality. Preserve the existing ?/note that mortality was not a trial endpoint and unverified direct mortality material/specifications.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only stored-summary and bibliographic content was used for production. External material verification/review is not complete." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/29552975/" } ] }, { "report_id": "S03", "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": "The same PRECISE trial’s 2-year follow-up report; preserved contextual citation", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2958-PRECISE", "independent_replication": null, "observed_result": "Initial biopsy omission was retained at 2-year follow-up of the same trial. Reduced biopsy does not establish equal long-term prostate-cancer mortality. The trial also did not answer whether systematic biopsy can always be omitted in MRI-positive men. At 2 years, cumulative GG2 or higher diagnoses did not differ between arms while initial biopsy omission was retained; this is not long-term mortality material. These original detection/biopsy/diagnostic-follow-up records are not selected long-term mortality effects. Preserve the existing ?/note that mortality was not a trial endpoint and unverified direct mortality material/specifications.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only stored-summary and bibliographic content was used for production. External material verification/review is not complete." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "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": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "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": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "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": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "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": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "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": "Preserved method HTML copies; no current method-content re-review or official tool execution" } ], "status_dictionary": { "Met": "Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.", "Partly verified": "Some information in the stored summary is linked into the table. External comparison/content review is not complete.", "Unverified": "The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.", "Review incomplete": "Existing content review remains incomplete.", "Not reported": "Not reported within the stored material actually read; not extended to the entire primary paper.", "Inaccessible": "Means an actual access failure. Access not attempted here is not assigned this state.", "Not applicable": "Not used as a substitute for an evidence gap.", "Conflicting data": "Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.", "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "S01 PRECISE 2021 and S03 PRECISE 2024 2-year follow-up are reports from the same Canadian trial. Distinguish 453 randomized, standard 226/MRI 227, detection denominators 225/227 and actual MRI 221/83 (37%) avoiding biopsy. GG2 detection 79/227 (35%) versus 67/225 (30%), original +5 percentage points, one-sided 97.5% CI −3.4 percentage points to ∞ and fulfillment of the −5 percentage-point detection margin are not long-term mortality estimates/margins. The 2-year cumulative-GG2-diagnosis/initial-biopsy-omission findings are not mortality material. S02 PRECISION 2018 is a separate European MRI-pathway trial with 500 participants, 28% biopsy avoidance and detection in the same direction. Original independence/replication wording concerns historical detection/biopsy pathways, not direct mortality effects/equivalence replication. Arm-specific detection/precision and long-term mortality events/denominators/timing are unverified. The selected mortality subclaim remains ? with the note that this was not a trial endpoint. Do not repurpose detection/biopsy/2-year diagnosis records as mortality effects or sum the same people/arms, time points/endpoints, bibliographic records or related subclaim tables as new independent trials/participants. Report/material-slot counts are not unique clinical trial, participant or independent-replication totals; no new totals or independence certification are created." }, "history": [ { "date": "2026-10-12", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Reader pages and materials were prepared from the existing 23 items. No new clinical search, change in verification status or scoring was performed." } ], "language": "en", "translation_date": "2026-10-12" }