{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2974-s1", "verdict_number": "2974", "title": "PSA-led active monitoring × Claim of equivalent metastasis and clinical progression", "view_version": "1.0", "view_created_date": "2026-10-14", "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": "1,643 men aged 50–69 with PSA-detected localized prostate cancer. Original monitoring 545/surgery 553/radiotherapy 545, complete follow-up for 1,610/1,643 (98%). Endpoint-specific valid/risk denominators, risk/stage, missingness/withdrawal details remain unverified.", "intervention": "ProtecT’s PSA-led active monitoring, not repurposed as identical to contemporary active surveillance with more MRI/regular repeat biopsy. Preserve original rescue/radical-treatment switching by many participants; no testing/surveillance/treatment-selection or implementation instructions.", "dose": "Only assigned strategies and median 15-year follow-up, range 11–21, are preserved. Actual monitoring/treatment, contact/testing, switching counts/durations remain unverified; no individual testing/procedure methods.", "comparator": "Separate assigned surgery/radiotherapy arms. Three-arm randomized superiority comparison, unmasked treatment, independent death committee and ITT are preserved historical descriptions, not complete verification of metastasis/progression adjudication/masking or switching handling.", "endpoint": "Link original metastasis 9.4% versus 4.7%/5.0% and progression 25.9% versus 10.5%/11.0% to the original grade D question of equivalent metastasis/clinical progression. The 15-year metastasis counts 51/26/27 and cancer deaths 17/545 (3.1%), 12/553 (2.2%), 16/545 (2.9%)/overall P=.53 concern separate endpoints/denominators. Mortality nonsignificance is not equivalence; no new metastasis/progression effects/CI.", "duration": "Separate the 15-year report from the same ProtecT cohort’s 10-year report. Do not add 10-year deaths 8/5/4/metastases 33/13/16 to cumulative 15-year counts. Individual follow-up/censoring, outcomes beyond 15 years or contemporary strategies/other populations remain unverified.", "excluded_extensions": [ "Changing mortality P=.53 into equivalent metastasis/progression, zero effect or proof of noninferiority", "Calculating new RR/HR/differences/CI/individual predictions from 15-year metastasis/progression percentages or original roughly twofold/2.5-fold wording", "Adding cumulative 10-year deaths 8/5/4/metastases 33/13/16 and 15-year deaths 17/12/16/metastases 51/26/27 or calculating new interval effects", "Repurposing death-committee/ITT/complete follow-up for 1,610/1,643 (98%) as verification of metastasis/progression adjudication, identical denominators or complete observation", "Changing monitoring assignment into lifelong untreated exposure without rescue/radical-treatment switching", "Generalizing PSA-led ProtecT to contemporary MRI/repeat-biopsy surveillance, other detection populations or individual-treatment selection", "Creating unlinked other-population PIVOT/SPCG-4 mortality as direct selected metastasis/progression evidence or new reports", "Inheriting original parent values/axes and historical cross-checking/registration/allocation/masking/analysis descriptions as subclaim scores or current clinical-content review/full-text reading", "New arithmetic, invented quantities, effects/CI, grades/independence certification or PSA-testing/monitoring/cancer-treatment selection/treatment-replacement instructions" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Selected equivalence claim and original grade", "needed": "Distinguish selected wording/grade/note from parent mortality verdict", "role": "Required", "role_reason": "An application item distinguishing Distinguish selected wording/grade/note from parent mortality verdict to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Relevant originals and analysis scope for Distinguish selected wording/grade/note from parent mortality verdict should be available, with unverified items distinguished. Preserved wording is linked here; 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": "Proposed follow-up research distinguishing each endpoint/comparison specification; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The selected subclaim is equivalent metastasis and clinical progression, grade D, with the note that both were clearly higher with monitoring. Subclaim score/status/axes are absent; parent D34 does not fill the subclaim score.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Subclaim score/status/axes are absent. Mortality nonsignificance is not transferred to equivalent metastasis/progression. Existing content review remains incomplete.", "missingness": "Subclaim score/status/axes are absent. Mortality nonsignificance is not transferred to equivalent metastasis/progression.", "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 selected question/parent verdict and user correction comments" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "PSA detection, localized cancer and population", "needed": "PSA-detected population, eligibility/risk and baseline characteristics", "role": "Required", "role_reason": "An application item distinguishing PSA-detected population, eligibility/risk and baseline characteristics to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Relevant originals and analysis scope for PSA-detected population, eligibility/risk and baseline characteristics should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.1; Detailed population conditions are Chamgap design; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details 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": "Proposed follow-up comparative research specifying population conditions; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "ProtecT involved 1,643 men aged 50–69 with PSA-detected localized prostate cancer. Do not extend metastasis/progression results to clinically detected cancer or other age/risk populations.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Detailed eligibility, risk/stage distribution, baseline balance, recruitment/exclusions and generalizability remain unverified. Existing content review remains incomplete.", "missingness": "Detailed eligibility, risk/stage distribution, baseline balance, recruitment/exclusions and generalizability remain 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": "Population/risk, recruitment and baseline-characteristic tables" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Identity of PSA-led monitoring", "needed": "Original monitoring approach, intervention/testing/switching criteria", "role": "Required", "role_reason": "An application item distinguishing Original monitoring approach, intervention/testing/switching criteria to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Relevant originals and analysis scope for Original monitoring approach, intervention/testing/switching criteria should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "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": "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": "Proposed follow-up research separating monitoring approach from applicability; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original intervention was PSA-led active monitoring. It is not treated as identical to contemporary active surveillance with more MRI and regular repeat biopsy.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Original monitoring testing/switching rules, actual delivery and direct correspondence with contemporary approaches remain unverified. Existing content review remains incomplete.", "missingness": "Original monitoring testing/switching rules, actual delivery and direct correspondence with contemporary approaches remain 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": "Study monitoring manual and actual delivery/switching records" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Three arms and comparison specifications", "needed": "Arm correspondence and actual monitoring/surgery/radiotherapy treatment", "role": "Required", "role_reason": "An application item distinguishing Arm correspondence and actual monitoring/surgery/radiotherapy treatment to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Relevant originals and analysis scope for Arm correspondence and actual monitoring/surgery/radiotherapy treatment should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations 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": "Proposed follow-up research distinguishing three comparisons and actual treatment pathways; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Allocation was monitoring 545, surgery 553 and radiotherapy 545 participants. Do not convert the three arms into a pooled comparator or identical treatment exposure.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Treatment details, adjuvant/rescue care, contact, actual delivery/refusal and arm differences remain unverified. Existing content review remains incomplete.", "missingness": "Treatment details, adjuvant/rescue care, contact, actual delivery/refusal and arm differences remain 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": "Arm-specific care/contact, switching and concurrent exposure data" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Central randomization and concealment", "needed": "Historical allocation descriptions versus actual original-text access", "role": "Required", "role_reason": "An application item distinguishing Historical allocation descriptions versus actual original-text access to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Relevant originals and analysis scope for Historical allocation descriptions versus actual original-text access should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 §8.1–8.2.3; internal application; M04 §4.5–4.6 collection/selection principles; access/reading separation and hyperlink specifications 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": "Proposed follow-up trial disclosing allocation procedures; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original records central-computer allocation. Historical B0 evidence descriptions are not upgraded to allocation-record/concealment review now.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Sequence generation, concealment, implementation exceptions, baseline balance and original protocol remain unread. Existing content review remains incomplete.", "missingness": "Sequence generation, concealment, implementation exceptions, baseline balance and original protocol remain unread.", "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 allocation/concealment, baseline tables and protocol" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Masking and endpoint-specific adjudicators", "needed": "Separate cause-of-death committee from metastasis/progression assessment", "role": "Required", "role_reason": "An application item distinguishing Separate cause-of-death committee from metastasis/progression assessment to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Relevant originals and analysis scope for Separate cause-of-death committee from metastasis/progression assessment should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "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": "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": "Proposed research distinguishing endpoint-specific adjudication and measurement differences; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original records that treatment masking was impossible and causes of death were adjudicated by an independent committee. This is not automatically transferred to complete verification of metastasis/clinical-progression assessment, masking or independent adjudication.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Metastasis/progression adjudicators, masking, testing frequency and committee roles/criteria remain unverified. Existing content review remains incomplete.", "missingness": "Metastasis/progression adjudicators, masking, testing frequency and committee roles/criteria remain 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 metastasis/progression adjudication, testing and masking materials" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "15 years and follow-up range", "needed": "15-year analysis, median/range and individual observation duration", "role": "Required", "role_reason": "An application item distinguishing 15-year analysis, median/range and individual observation duration to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Relevant originals and analysis scope for 15-year analysis, median/range and individual observation duration should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design; M08 §8.2.2, M15 §15.3.1; Chamgap adaptation", "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": "Proposed research separately reporting time points and actual follow-up duration; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve original median 15 years, range 11–21. Do not fill in exactly 15-year observation for everyone or identical event-time/proportion denominators.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Individual follow-up, endpoint assessment windows/censoring, risk populations and visit systems remain unverified. Existing content review remains incomplete.", "missingness": "Individual follow-up, endpoint assessment windows/censoring, risk populations and visit systems remain 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": "Follow-up/censoring and endpoint-specific risk-population/timing data" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Definition of metastasis events", "needed": "Metastasis definition, testing/adjudication, occurrence time and person units", "role": "Required", "role_reason": "An application item distinguishing Metastasis definition, testing/adjudication, occurrence time and person units to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Relevant originals and analysis scope for Metastasis definition, testing/adjudication, occurrence time and person units should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M08 §8.2.2, M15 §15.3.1; internal 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": "Proposed follow-up research specifying metastasis measurement; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Metastasis is a separate clinical endpoint from mortality. Summary numbers are not made equivalent to diagnostic methods/repeated events or all progression events.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Metastasis definition, imaging/adjudication, first/cumulative event handling, baseline-metastasis exclusion and testing frequency remain unverified. Existing content review remains incomplete.", "missingness": "Metastasis definition, imaging/adjudication, first/cumulative event handling, baseline-metastasis exclusion and testing frequency remain 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": "Metastasis endpoint definitions, adjudication/testing and event data" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "15-year metastasis percentages and cumulative counts", "needed": "Arm-specific metastasis percentages/counts, original time and denominators", "role": "Required", "role_reason": "An application item distinguishing Arm-specific metastasis percentages/counts, original time and denominators to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Relevant originals and analysis scope for Arm-specific metastasis percentages/counts, original time and denominators should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M15 §15.3.1–15.3.3; internal application; M08 §8.2.2, M15 §15.3.1; internal 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": "Proposed research distinguishing metastasis counts/percentages from estimands; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "In monitoring/surgery/radiotherapy order, original metastasis was 9.4% versus 4.7%/5.0%, with cumulative 15-year counts of 51/26/27. No new percentages, differences/RR/HR or CI.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Exact estimation methods, endpoint-specific valid/risk denominators, CI/models and individual event times remain unverified. Existing content review remains incomplete.", "missingness": "Exact estimation methods, endpoint-specific valid/risk denominators, CI/models and individual event times remain 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": "Metastasis result tables, risk populations and model/CI data" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "15-year clinical-progression percentages", "needed": "Progression definition, arm-specific percentages and distinction from metastasis", "role": "Required", "role_reason": "An application item distinguishing Progression definition, arm-specific percentages and distinction from metastasis to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Relevant originals and analysis scope for Progression definition, arm-specific percentages and distinction from metastasis should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is internally designed; M15 §15.3.1–15.3.3; internal 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": "Proposed follow-up research distinguishing metastasis/progression overlap and definitions; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original clinical progression was monitoring 25.9%, surgery 10.5% and radiotherapy 11.0%. Do not substitute metastasis percentages/cumulative counts or death events.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Progression definitions, component events/overlap, actual counts/denominators and exact models/CI remain unverified. Existing content review remains incomplete.", "missingness": "Progression definitions, component events/overlap, actual counts/denominators and exact models/CI remain 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": "Progression definitions, component events, denominators/results/CI" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Metastasis/progression effects and precision", "needed": "Original percentages/interpretation versus exact between-arm effects/CI", "role": "Required", "role_reason": "An application item distinguishing Original percentages/interpretation versus exact between-arm effects/CI to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Relevant originals and analysis scope for Original percentages/interpretation versus exact between-arm effects/CI should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M15 §15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations 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": "Proposed follow-up research disclosing exact effects and uncertainty; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original interprets metastasis as roughly twice and progression roughly 2.5 times as frequent with monitoring. Historical wording is not converted into new calculations, exact risk ratios/CI or individual predictions.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Exact comparison-specific effects, CI/testing, adjustments/competing-risk models remain unverified. Existing content review remains incomplete.", "missingness": "Exact comparison-specific effects, CI/testing, adjustments/competing-risk models remain 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 effects/CI, comparisons/models and importance thresholds" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Mortality nonsignificance and other endpoints", "needed": "Separate 15-year cancer-mortality and metastasis/progression results", "role": "Required", "role_reason": "An application item distinguishing Separate 15-year cancer-mortality and metastasis/progression results to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Relevant originals and analysis scope for Separate 15-year cancer-mortality and metastasis/progression results should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap's own design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M15 §15.3.1–15.3.3; 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": "Proposed follow-up research separating endpoint-specific results; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Cancer mortality was 17/545 (3.1%), 12/553 (2.2%) and 16/545 (2.9%), overall P=.53. Mortality nonsignificance does not establish equivalent metastasis/progression, zero effect or equivalence.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Comparison-specific mortality effects/CI, equivalence margins and analysis specifications relating to metastasis/progression remain unverified. Existing content review remains incomplete.", "missingness": "Comparison-specific mortality effects/CI, equivalence margins and analysis specifications relating to metastasis/progression remain 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/metastasis/progression-specific results, CI and plans" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Cancer mortality, all-cause mortality and competing events", "needed": "Causes of death versus metastasis/progression competing-event/censoring specifications", "role": "Required", "role_reason": "An application item distinguishing Causes of death versus metastasis/progression competing-event/censoring specifications to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Relevant originals and analysis scope for Causes of death versus metastasis/progression competing-event/censoring specifications should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptation is a custom design; M08 §8.2.2, M15 §15.3.1; Custom application; 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": "Proposed research separating event-specific competing/censoring processes and effects; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The parent primary endpoint was definite/probable prostate-cancer mortality. Do not convert it to all-cause/other mortality, functional outcomes or an identical metastasis/progression endpoint.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. All-cause/other-cause death, competing-event handling and censoring/overlap details remain unverified. Existing content review remains incomplete.", "missingness": "All-cause/other-cause death, competing-event handling and censoring/overlap details remain 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": "Endpoint/cause-of-death, competing-risk and censoring materials" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "10-year cumulative results", "needed": "Same-cohort 10/15-year counts and time points", "role": "Required", "role_reason": "An application item distinguishing Same-cohort 10/15-year counts and time points to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Relevant originals and analysis scope for Same-cohort 10/15-year counts and time points should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations 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": "Proposed research distinguishing cumulative/time analyses in the same cohort; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original 10-year deaths were 8/5/4 and metastases 33/13/16; 15-year deaths were 17/12/16 and metastases 51/26/27. Do not add the two times or calculate new annual events/changes.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. 10-year endpoints/denominators/CI, progression counts and detailed correspondence between analyses remain unverified. Existing content review remains incomplete.", "missingness": "10-year endpoints/denominators/CI, progression counts and detailed correspondence between analyses remain 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 10/15-year results and time/endpoint correspondence" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Same trial, two reports and independence", "needed": "15/10-year citations and same-participant follow-up", "role": "Required", "role_reason": "An application item distinguishing 15/10-year citations and same-participant follow-up to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Relevant originals and analysis scope for 15/10-year citations and same-participant follow-up should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "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": "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": "Proposed follow-up independent comparative research on the same endpoint/strategy; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "S01 Hamdy 2023 at 15 years and S02 Hamdy 2016 at 10 years concern the same ProtecT cohort. Times, three arms, citations/registration and related sheets are not newly added as independent trials/participants.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Unique clinical-trial/participant totals and separate independent-replication counts are not confirmed. Existing content review remains incomplete.", "missingness": "Unique clinical-trial/participant totals and separate independent-replication counts are not confirmed.", "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/cohort, registration/protocol relationships and separate-study materials" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Crossover and rescue treatment", "needed": "Separate assigned strategies from actual switching/treatment pathways", "role": "Required", "role_reason": "An application item distinguishing Separate assigned strategies from actual switching/treatment pathways to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Relevant originals and analysis scope for Separate assigned strategies from actual switching/treatment pathways should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations 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": "Proposed follow-up research separating assigned strategies from actual pathways; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original records many participants later switching to rescue/radical treatment. Monitoring assignment is not converted into lifelong untreated exposure.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Switching counts/timing/reasons, arm-specific actual treatment, adherence and treatment-specific analyses remain unverified. Existing content review remains incomplete.", "missingness": "Switching counts/timing/reasons, arm-specific actual treatment, adherence and treatment-specific analyses remain 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": "Assigned/actual treatment, switching and rescue-treatment materials" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "ITT strategy estimands", "needed": "Assignment-based analysis versus actual-treatment/switching effects", "role": "Required", "role_reason": "An application item distinguishing Assignment-based analysis versus actual-treatment/switching effects to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Relevant originals and analysis scope for Assignment-based analysis versus actual-treatment/switching effects should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 §8.2.2, M15 §15.3.1; internal application; M04 §4.5–4.6 collection/selection principles; access/reading separation and hyperlink specifications 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": "Proposed research distinguishing strategy estimands from actual-treatment estimands; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original records ITT comparison. This is preserved history; no new treatment-specific effects or effects in a never-switching population.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Endpoint-specific ITT populations, switching handling, adjustments/sensitivity and actual-treatment analyses remain unread. Existing content review remains incomplete.", "missingness": "Endpoint-specific ITT populations, switching handling, adjustments/sensitivity and actual-treatment analyses remain unread.", "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 ITT, switching/sensitivity and endpoint-specific models" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Follow-up completeness and endpoint-specific denominators", "needed": "1,610/1,643 (98%) versus actual endpoint/risk populations", "role": "Required", "role_reason": "An application item distinguishing 1,610/1,643 (98%) versus actual endpoint/risk populations to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Relevant originals and analysis scope for 1,610/1,643 (98%) versus actual endpoint/risk populations should be available, with unverified items distinguished. Preserved wording is linked here; 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 design; 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": "Proposed research distinguishing observation/risk denominators and missingness; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve original follow-up completeness of 1,610/1,643 (98%). Do not fill all-time universal metastasis/progression observation or identical denominators from it, or calculate new missing counts.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Endpoint-specific valid/risk denominators, missingness/withdrawal reasons, times and arm-specific completeness/handling remain unverified. Existing content review remains incomplete.", "missingness": "Endpoint-specific valid/risk denominators, missingness/withdrawal reasons, times and arm-specific completeness/handling remain 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": "Follow-up flow, endpoint/arm denominators and missingness-handling data" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Registration, prespecified hierarchy and composite identifiers", "needed": "Registration IDs, mortality primary endpoint and metastasis/progression hierarchy", "role": "Required", "role_reason": "An application item distinguishing Registration IDs, mortality primary endpoint and metastasis/progression hierarchy to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Relevant originals and analysis scope for Registration IDs, mortality primary endpoint and metastasis/progression hierarchy should be available, with unverified items distinguished. Preserved wording is linked here; 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": "Proposed research publicly linking primary/secondary endpoints to actual analysis; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original evidence-list registration field is ISRCTN20141297 · NCT02044172. Historical matching with the mortality primary endpoint does not replace complete verification of prespecified metastasis/progression analyses.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Registration histories, protocol/SAP, prespecified metastasis/progression hierarchy, amendments/multiplicity plans remain unread. Existing content review remains incomplete.", "missingness": "Registration histories, protocol/SAP, prespecified metastasis/progression hierarchy, amendments/multiplicity plans remain unread.", "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": "Both registration histories, protocol and SAP" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Superiority versus equivalence/noninferiority", "needed": "Testing design, prespecified margins and equivalence-claim scope", "role": "Required", "role_reason": "An application item distinguishing Testing design, prespecified margins and equivalence-claim scope to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Relevant originals and analysis scope for Testing design, prespecified margins and equivalence-claim scope should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; internal application; M15 §15.3.1–15.3.3; internal application; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is 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": "Proposed follow-up research distinguishing questions and testing specifications; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original trial was a three-arm superiority comparison, not a noninferiority trial. Mortality P=.53 is not proof of equivalence and is separated from increased metastasis/progression.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Equivalence/noninferiority margins and corresponding estimands/CI are not presented in preserved materials. Existing content review remains incomplete.", "missingness": "Equivalence/noninferiority margins and corresponding estimands/CI are not presented in preserved materials.", "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 design/testing specifications and effect/CI materials" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Metastasis/progression testing and concurrent care", "needed": "Arm-specific testing intensity, concurrent care/treatment and measurement differences", "role": "Required", "role_reason": "An application item distinguishing Arm-specific testing intensity, concurrent care/treatment and measurement differences to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Relevant originals and analysis scope for Arm-specific testing intensity, concurrent care/treatment and measurement differences should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application; M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations 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": "Proposed research distinguishing testing/treatment pathways from outcome measurement; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original records a long-term comparison of three strategies. Do not fill in equal testing frequency, rescue/adjuvant treatment, lifestyle/drug care or absence of their influence on differences.", "condition_status": "Unverified", "status_reason": "Required current information remains unverified in the preserved summary. Arm-specific testing/contact, concurrent treatment, confirmation frequency and analysis-handling details remain unverified. Existing content review remains incomplete.", "missingness": "Arm-specific testing/contact, concurrent treatment, confirmation frequency and analysis-handling details remain 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": "Testing/concurrent treatment, endpoint adjudication and analysis data" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Contemporary surveillance and other-population applicability", "needed": "Original PSA-led approach versus contemporary MRI/repeat biopsy and population differences", "role": "Required", "role_reason": "An application item distinguishing Original PSA-led approach versus contemporary MRI/repeat biopsy and population differences to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Relevant originals and analysis scope for Original PSA-led approach versus contemporary MRI/repeat biopsy and population differences should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed; M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation 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": "Proposed follow-up research specifying approach and population differences; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original describes contemporary active surveillance as using more MRI/regular repeat biopsy than ProtecT. Original metastasis/progression rates do not provide contemporary-management or individual-treatment-selection instructions.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Direct comparison with contemporary approaches/populations, long-term results and switching correspondence remain unverified. Existing content review remains incomplete.", "missingness": "Direct comparison with contemporary approaches/populations, long-term results and switching correspondence remain 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": "Strategy/population definitions, direct comparisons and follow-up data" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "PIVOT and SPCG-4 mentions", "needed": "Other trials’ detection methods, endpoints and directness", "role": "Required", "role_reason": "An application item distinguishing Other trials’ detection methods, endpoints and directness to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Relevant originals and analysis scope for Other trials’ detection methods, endpoints and directness should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application; M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is 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": "Proposed follow-up comparative research matching populations/detection methods/endpoints; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original records same-direction PIVOT mortality and SPCG-4 surgery advantage/10% PSA detection. Mortality in clinically detected populations is not combined as a direct comparison/new independent replication of selected metastasis/progression.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Specific citations, populations/denominators, metastasis/progression/CI and direct correspondence remain unlinked. Existing content review remains incomplete.", "missingness": "Specific citations, populations/denominators, metastasis/progression/CI and direct correspondence remain unlinked.", "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": "Other-trial originals and detection/endpoint/strategy relationships" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "NIHR and MRC support", "needed": "Separate main/long-term-follow-up funding and roles", "role": "Required", "role_reason": "An application item distinguishing Separate main/long-term-follow-up funding and roles to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Relevant originals and analysis scope for Separate main/long-term-follow-up funding and roles should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "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": "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": "Proposed research disclosing support stages and roles; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original records main NIHR HTA Programme funding and NIHR/MRC long-term-follow-up support. Public funding does not newly certify all support/author relationships or analytical independence.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Supporting institutions’ roles, contracts and other in-kind/analysis/writing/publication support remain unread. Existing content review remains incomplete.", "missingness": "Supporting institutions’ roles, contracts and other in-kind/analysis/writing/publication support remain unread.", "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 support/funding, roles and other support" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Oxford sponsorship and author relationships", "needed": "Separate study sponsorship from funding/product/COI roles", "role": "Required", "role_reason": "An application item distinguishing Separate study sponsorship from funding/product/COI roles to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Relevant originals and analysis scope for Separate study sponsorship from funding/product/COI roles should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "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": "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": "Proposed research separately disclosing study roles, support and relationships; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original records University of Oxford sponsorship. This role does not become commercial-product support, absence of all author COI or an identical role to public funders.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Sponsor responsibilities/authority, author relationships, product/analysis/writing support and original COI remain unread. Existing content review remains incomplete.", "missingness": "Sponsor responsibilities/authority, author relationships, product/analysis/writing support and original COI remain unread.", "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 sponsor, author contributions/COI and support roles" }, { "item_id": "N26", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Functional harms and treatment-specific results", "needed": "Separate incontinence/erectile/bowel/sexual function from metastasis/progression/mortality", "role": "Supplementary", "role_reason": "An application item distinguishing Separate incontinence/erectile/bowel/sexual function from metastasis/progression/mortality to connect materials needed for the selected question with available materials.", "application_exception": "Supplements safety-information gaps for the selected subclaim. Metastasis/progression/mortality results or parent caution wording do not yield safety verdicts, harm incidence or new use instructions.", "criterion": "Relevant originals and analysis scope for Separate incontinence/erectile/bowel/sexual function from metastasis/progression/mortality should be available, with unverified items distinguished. Preserved wording is linked here; 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": "Proposed follow-up research separating survival/metastasis/functional harms; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original records different harms: surgery-related incontinence/erectile effects, radiotherapy bowel/sexual effects and monitoring metastasis/progression. No individual-treatment/implementation instructions or quantitative comparison of all harms.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Exact functional-endpoint definitions, denominators/times/values, collection/adjudication and individual-choice effects remain unverified. Existing content review remains incomplete.", "missingness": "Exact functional-endpoint definitions, denominators/times/values, collection/adjudication and individual-choice effects remain 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": "Function/harm-specific results, definitions and follow-up data" }, { "item_id": "N27", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "No new treatment-complication reporting at 15 years", "needed": "Reporting after 10 years versus actual safety scope", "role": "Supplementary", "role_reason": "An application item distinguishing Reporting after 10 years versus actual safety scope to connect materials needed for the selected question with available materials.", "application_exception": "Supplements safety-information gaps for the selected subclaim. Metastasis/progression/mortality results or parent caution wording do not yield safety verdicts, harm incidence or new use instructions.", "criterion": "Relevant originals and analysis scope for Reporting after 10 years versus actual safety scope should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M19 §19.1.2–19.2.4; detailed discrimination is internally designed; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; internal 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": "Proposed research distinguishing reporting scope from actual occurrence/follow-up; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original records that the 15-year paper reported no new treatment complications after the 10-year analysis. This does not establish no complications or equivalent long-term safety.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. New reporting/collection scope, long-term adverse events, denominators and adjudication/missingness remain unverified. Existing content review remains incomplete.", "missingness": "New reporting/collection scope, long-term adverse events, denominators and adjudication/missingness remain 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": "10/15-year safety collection and all-complication/follow-up data" }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Original axes, bilingual text, dates, corrections and history", "needed": "Separate parent mortality axes/score from selected subclaim values", "role": "Required", "role_reason": "An application item distinguishing Separate parent mortality axes/score from selected subclaim values to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Relevant originals and analysis scope for Separate parent mortality axes/score from selected subclaim values should be available, with unverified items distinguished. Preserved wording is linked here; existing 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": "Proposed research distinguishing original values/history from new-material scope; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve parent D34, B/H/R1/I2/E0/B0/C0, true large-hard-endpoint RCT, two false indicators, empty grade-override reasons and subclaim D/note. Bilingual text, 2026-08-26, empty corrections/deliberation and cross-checking are not completed clinical review now or subclaim axes.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Parent E0/score and mortality-verdict axes do not fill metastasis/progression effects/scores. Existing content review remains incomplete.", "missingness": "Parent E0/score and mortality-verdict axes do not fill metastasis/progression effects/scores.", "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 corrections, versions and user correction comments" }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Actual summary reading, links and gaps", "needed": "Preserved-summary reading versus external reports/registration/plans access", "role": "Required", "role_reason": "An application item distinguishing Preserved-summary reading versus external reports/registration/plans access to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Relevant originals and analysis scope for Preserved-summary reading versus external reports/registration/plans access should be available, with unverified items distinguished. Preserved wording is linked here; 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": "Proposal for updating while distinguishing actual acquisition/timing/scope; no new investigation, calculation or trial was performed in that production.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The complete preserved summary/citations were used for production and 10/15-year links retained. Original papers, both registrations, protocol, SAP and support/COI remain unread; access and external-link testing were not attempted.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. External original content, exact definitions/CI and actual accessibility remain unverified. Existing content review remains incomplete.", "missingness": "External original content, exact definitions/CI and actual accessibility remain 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 paper, registration, protocol, SAP and support materials or user comments" } ], "reports": [ { "report_id": "S01", "title": "Hamdy FC et al. 2023 ProtecT 15-year follow-up", "url": "https://pubmed.ncbi.nlm.nih.gov/36912538/", "report_type": "Three-arm randomized superiority comparison with long-term follow-up", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2974-PROTECT", "independent_replication": null, "observed_result": "17/545 (3.1%) versus 12/553 (2.2%) versus 16/545 (2.9%); overall P=.53. Parent D with 34 points. The mortality primary endpoint was null in a superiority comparison. Metastasis was 9.4% versus 4.7%/5.0%, and clinical progression 25.9% versus 10.5%/11.0%, roughly twice and 2.5 times as frequent with monitoring. Fifteen-year prostate-cancer mortality did not differ significantly, but monitoring had much more metastasis/clinical progression.", "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/36912538/" } ] }, { "report_id": "S02", "title": "Hamdy FC, et al. 10-Year Outcomes after Monitoring, Surgery, or Radiotherapy. N Engl J Med. 2016. PMID: 27626136.", "url": "https://pubmed.ncbi.nlm.nih.gov/27626136/", "report_type": "Citation-only cumulative 10-year report from the same ProtecT cohort; no original evidence-list row", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2974-PROTECT", "independent_replication": null, "observed_result": "Same ProtecT cohort’s 10-year deaths 8/5/4 and metastases 33/13/16, in monitoring/surgery/radiotherapy order. Cumulative 10-year report of the same cohort.", "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/27626136/" } ] } ], "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 Hamdy 2023 at 15 years and S02 Hamdy 2016 at 10 years are cumulative reports of the same ProtecT cohort. Original 1,643 men aged 50–69 with PSA-detected localized cancer, monitoring 545/surgery 553/radiotherapy 545, and complete follow-up for 1,610/1,643 (98%) do not automatically fill endpoint-specific valid/risk denominators. Distinguish 15-year metastasis 9.4% versus 4.7%/5.0%, counts 51/26/27, progression 25.9% versus 10.5%/11.0%, and deaths 17/545, 12/553, 16/545/P=.53. Do not add 10-year deaths 8/5/4/metastases 33/13/16 to 15-year counts. The same people, arms, times, citations, registration and related sheets are not newly added as independent trials/participants. PIVOT/SPCG-4 and contemporary-surveillance differences remain unlinked/scope context, not newly created reports or direct metastasis evidence. Report items are not unique clinical totals." }, "history": [ { "date": "2026-10-14", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public pages and materials were created from the existing 29 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-14" }