PSA-led active monitoring × Claim of equivalent metastasis and clinical progression

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Evidence conditionSelected equivalence claim and original gradeRequired	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. S01 S02	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.	Distinguish selected wording/grade/note from parent mortality verdict	Proposed follow-up research distinguishing each endpoint/comparison specification; no new investigation, calculation or trial was performed in this production.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionPSA detection, localized cancer and populationRequired	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. S01	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.	PSA-detected population, eligibility/risk and baseline characteristics	Proposed follow-up comparative research specifying population conditions; no new investigation, calculation or trial was performed in this production.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionIdentity of PSA-led monitoringRequired	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. S01	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.	Original monitoring approach, intervention/testing/switching criteria	Proposed follow-up research separating monitoring approach from applicability; no new investigation, calculation or trial was performed in this production.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionThree arms and comparison specificationsRequired	Allocation was monitoring 545, surgery 553 and radiotherapy 545 participants. Do not convert the three arms into a pooled comparator or identical treatment exposure. S01	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.	Arm correspondence and actual monitoring/surgery/radiotherapy treatment	Proposed follow-up research distinguishing three comparisons and actual treatment pathways; no new investigation, calculation or trial was performed in this production.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionCentral randomization and concealmentRequired	The original records central-computer allocation. Historical B0 evidence descriptions are not upgraded to allocation-record/concealment review now. S01	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.	Historical allocation descriptions versus actual original-text access	Proposed follow-up trial disclosing allocation procedures; no new investigation, calculation or trial was performed in this production.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionMasking and endpoint-specific adjudicatorsRequired	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. S01	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.	Separate cause-of-death committee from metastasis/progression assessment	Proposed research distinguishing endpoint-specific adjudication and measurement differences; no new investigation, calculation or trial was performed in this production.
7	Partly verified	Full text not readStored summary read	N07 · Evidence condition15 years and follow-up rangeRequired	Preserve original median 15 years, range 11–21. Do not fill in exactly 15-year observation for everyone or identical event-time/proportion denominators. S01 S02	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.	15-year analysis, median/range and individual observation duration	Proposed research separately reporting time points and actual follow-up duration; no new investigation, calculation or trial was performed in this production.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionDefinition of metastasis eventsRequired	Metastasis is a separate clinical endpoint from mortality. Summary numbers are not made equivalent to diagnostic methods/repeated events or all progression events. S01 S02	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.	Metastasis definition, testing/adjudication, occurrence time and person units	Proposed follow-up research specifying metastasis measurement; no new investigation, calculation or trial was performed in this production.
9	Partly verified	Full text not readStored summary read	N09 · Evidence condition15-year metastasis percentages and cumulative countsRequired	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. S01 S02	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.	Arm-specific metastasis percentages/counts, original time and denominators	Proposed research distinguishing metastasis counts/percentages from estimands; no new investigation, calculation or trial was performed in this production.
10	Partly verified	Full text not readStored summary read	N10 · Evidence condition15-year clinical-progression percentagesRequired	Original clinical progression was monitoring 25.9%, surgery 10.5% and radiotherapy 11.0%. Do not substitute metastasis percentages/cumulative counts or death events. S01	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.	Progression definition, arm-specific percentages and distinction from metastasis	Proposed follow-up research distinguishing metastasis/progression overlap and definitions; no new investigation, calculation or trial was performed in this production.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionMetastasis/progression effects and precisionRequired	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. S01	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.	Original percentages/interpretation versus exact between-arm effects/CI	Proposed follow-up research disclosing exact effects and uncertainty; no new investigation, calculation or trial was performed in this production.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionMortality nonsignificance and other endpointsRequired	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. S01	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.	Separate 15-year cancer-mortality and metastasis/progression results	Proposed follow-up research separating endpoint-specific results; no new investigation, calculation or trial was performed in this production.
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionCancer mortality, all-cause mortality and competing eventsRequired	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. S01	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.	Causes of death versus metastasis/progression competing-event/censoring specifications	Proposed research separating event-specific competing/censoring processes and effects; no new investigation, calculation or trial was performed in this production.
14	Partly verified	Full text not readStored summary read	N14 · Evidence condition10-year cumulative resultsRequired	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. S01 S02	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.	Same-cohort 10/15-year counts and time points	Proposed research distinguishing cumulative/time analyses in the same cohort; no new investigation, calculation or trial was performed in this production.
15	Partly verified	Full text not readStored summary read	N15 · Evidence conditionSame trial, two reports and independenceRequired	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. S01 S02	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.	15/10-year citations and same-participant follow-up	Proposed follow-up independent comparative research on the same endpoint/strategy; no new investigation, calculation or trial was performed in this production.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionCrossover and rescue treatmentRequired	The original records many participants later switching to rescue/radical treatment. Monitoring assignment is not converted into lifelong untreated exposure. S01	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.	Separate assigned strategies from actual switching/treatment pathways	Proposed follow-up research separating assigned strategies from actual pathways; no new investigation, calculation or trial was performed in this production.
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionITT strategy estimandsRequired	The original records ITT comparison. This is preserved history; no new treatment-specific effects or effects in a never-switching population. S01	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.	Assignment-based analysis versus actual-treatment/switching effects	Proposed research distinguishing strategy estimands from actual-treatment estimands; no new investigation, calculation or trial was performed in this production.
18	Partly verified	Full text not readStored summary read	N18 · Evidence conditionFollow-up completeness and endpoint-specific denominatorsRequired	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. S01	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.	1,610/1,643 (98%) versus actual endpoint/risk populations	Proposed research distinguishing observation/risk denominators and missingness; no new investigation, calculation or trial was performed in this production.
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionRegistration, prespecified hierarchy and composite identifiersRequired	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. S01	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.	Registration IDs, mortality primary endpoint and metastasis/progression hierarchy	Proposed research publicly linking primary/secondary endpoints to actual analysis; no new investigation, calculation or trial was performed in this production.
20	Partly verified	Full text not readStored summary read	N20 · Evidence conditionSuperiority versus equivalence/noninferiorityRequired	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. S01	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.	Testing design, prespecified margins and equivalence-claim scope	Proposed follow-up research distinguishing questions and testing specifications; no new investigation, calculation or trial was performed in this production.
21	Unverified	Full text not readStored summary read	N21 · Evidence conditionMetastasis/progression testing and concurrent careRequired	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. S01	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.	Arm-specific testing intensity, concurrent care/treatment and measurement differences	Proposed research distinguishing testing/treatment pathways from outcome measurement; no new investigation, calculation or trial was performed in this production.
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionContemporary surveillance and other-population applicabilityRequired	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. S01	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.	Original PSA-led approach versus contemporary MRI/repeat biopsy and population differences	Proposed follow-up research specifying approach and population differences; no new investigation, calculation or trial was performed in this production.
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionPIVOT and SPCG-4 mentionsRequired	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. S01	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.	Other trials’ detection methods, endpoints and directness	Proposed follow-up comparative research matching populations/detection methods/endpoints; no new investigation, calculation or trial was performed in this production.
24	Partly verified	Full text not readStored summary read	N24 · Evidence conditionNIHR and MRC supportRequired	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. S01	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.	Separate main/long-term-follow-up funding and roles	Proposed research disclosing support stages and roles; no new investigation, calculation or trial was performed in this production.
25	Partly verified	Full text not readStored summary read	N25 · Evidence conditionOxford sponsorship and author relationshipsRequired	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. S01	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.	Separate study sponsorship from funding/product/COI roles	Proposed research separately disclosing study roles, support and relationships; no new investigation, calculation or trial was performed in this production.
26	Partly verified	Full text not readStored summary read	N26 · Harm-information gaps supplementing the efficacy tableFunctional harms and treatment-specific resultsSupplementary	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. S01 S02	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.	Separate incontinence/erectile/bowel/sexual function from metastasis/progression/mortality	Proposed follow-up research separating survival/metastasis/functional harms; no new investigation, calculation or trial was performed in this production.
27	Partly verified	Full text not readStored summary read	N27 · Harm-information gaps supplementing the efficacy tableNo new treatment-complication reporting at 15 yearsSupplementary	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. S01 S02	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.	Reporting after 10 years versus actual safety scope	Proposed research distinguishing reporting scope from actual occurrence/follow-up; no new investigation, calculation or trial was performed in this production.
28	Partly verified	Full text not readStored summary read	N28 · Evidence conditionOriginal axes, bilingual text, dates, corrections and historyRequired	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. S01 S02	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.	Separate parent mortality axes/score from selected subclaim values	Proposed research distinguishing original values/history from new-material scope; no new investigation, calculation or trial was performed in this production.
29	Partly verified	Full text not readStored summary read	N29 · Evidence conditionActual summary reading, links and gapsRequired	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. S01 S02	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.	Preserved-summary reading versus external reports/registration/plans access	Proposal for updating while distinguishing actual acquisition/timing/scope; no new investigation, calculation or trial was performed in that production.

No items match your search or filter.

29 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-08-26
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population: 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.
Ingredient, formulation and route: 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.
Measured outcome: 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.
Questions outside this scope: 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

Evidence and sources

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

S01 · Hamdy FC et al. 2023 ProtecT 15-year follow-up

PubMed

Material type: Three-arm randomized superiority comparison with long-term follow-up
Materials actually read: Summary read; external material unread
Findings recorded in the stored summary: 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.
Record level: Outcome wording in the stored summary
Study overlap and independent replication: 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.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Stored file	Stored summary	Summary read	Only stored-summary and bibliographic content was used for production. External material verification/review is not complete.
External paper	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Registration material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Protocol	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Statistical analysis plan	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Funding, product-support and COI material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.

S02 · Hamdy FC, et al. 10-Year Outcomes after Monitoring, Surgery, or Radiotherapy. N Engl J Med. 2016. PMID: 27626136.

PubMed

Material type: Citation-only cumulative 10-year report from the same ProtecT cohort; no original evidence-list row
Materials actually read: Summary read; external material unread
Findings recorded in the stored summary: 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.
Record level: Outcome wording in the stored summary
Study overlap and independent replication: 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.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Stored file	Stored summary	Summary read	Only stored-summary and bibliographic content was used for production. External material verification/review is not complete.
External paper	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Registration material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Protocol	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Statistical analysis plan	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Funding, product-support and COI material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.

Report counts versus independent study counts

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.

Review criteria

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

N01 · Selected equivalence claim and original grade

Required materials and conditions: Distinguish selected wording/grade/note from parent mortality verdict
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: An application item distinguishing Distinguish selected wording/grade/note from parent mortality verdict to connect materials needed for the selected question with available materials.
Referenced methods: 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

N02 · PSA detection, localized cancer and population

Required materials and conditions: PSA-detected population, eligibility/risk and baseline characteristics
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: An application item distinguishing PSA-detected population, eligibility/risk and baseline characteristics to connect materials needed for the selected question with available materials.
Referenced methods: 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

N03 · Identity of PSA-led monitoring

Required materials and conditions: Original monitoring approach, intervention/testing/switching criteria
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: An application item distinguishing Original monitoring approach, intervention/testing/switching criteria to connect materials needed for the selected question with available materials.
Referenced methods: M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application

N04 · Three arms and comparison specifications

Required materials and conditions: Arm correspondence and actual monitoring/surgery/radiotherapy treatment
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: An application item distinguishing Arm correspondence and actual monitoring/surgery/radiotherapy treatment to connect materials needed for the selected question with available materials.
Referenced methods: 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

N05 · Central randomization and concealment

Required materials and conditions: Historical allocation descriptions versus actual original-text access
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: An application item distinguishing Historical allocation descriptions versus actual original-text access to connect materials needed for the selected question with available materials.
Referenced methods: 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

N06 · Masking and endpoint-specific adjudicators

Required materials and conditions: Separate cause-of-death committee from metastasis/progression assessment
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: An application item distinguishing Separate cause-of-death committee from metastasis/progression assessment to connect materials needed for the selected question with available materials.
Referenced methods: M08 Table 8.2.a, M03 §3.2.4; own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design

N07 · 15 years and follow-up range

Required materials and conditions: 15-year analysis, median/range and individual observation duration
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: An application item distinguishing 15-year analysis, median/range and individual observation duration to connect materials needed for the selected question with available materials.
Referenced methods: 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

N08 · Definition of metastasis events

Required materials and conditions: Metastasis definition, testing/adjudication, occurrence time and person units
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: An application item distinguishing Metastasis definition, testing/adjudication, occurrence time and person units to connect materials needed for the selected question with available materials.
Referenced methods: 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

N09 · 15-year metastasis percentages and cumulative counts

Required materials and conditions: Arm-specific metastasis percentages/counts, original time and denominators
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: An application item distinguishing Arm-specific metastasis percentages/counts, original time and denominators to connect materials needed for the selected question with available materials.
Referenced methods: 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

N10 · 15-year clinical-progression percentages

Required materials and conditions: Progression definition, arm-specific percentages and distinction from metastasis
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: An application item distinguishing Progression definition, arm-specific percentages and distinction from metastasis to connect materials needed for the selected question with available materials.
Referenced methods: 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

N11 · Metastasis/progression effects and precision

Required materials and conditions: Original percentages/interpretation versus exact between-arm effects/CI
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: An application item distinguishing Original percentages/interpretation versus exact between-arm effects/CI to connect materials needed for the selected question with available materials.
Referenced methods: 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

N12 · Mortality nonsignificance and other endpoints

Required materials and conditions: Separate 15-year cancer-mortality and metastasis/progression results
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: An application item distinguishing Separate 15-year cancer-mortality and metastasis/progression results to connect materials needed for the selected question with available materials.
Referenced methods: 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

N13 · Cancer mortality, all-cause mortality and competing events

Required materials and conditions: Causes of death versus metastasis/progression competing-event/censoring specifications
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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

N14 · 10-year cumulative results

Required materials and conditions: Same-cohort 10/15-year counts and time points
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: An application item distinguishing Same-cohort 10/15-year counts and time points to connect materials needed for the selected question with available materials.
Referenced methods: 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

N15 · Same trial, two reports and independence

Required materials and conditions: 15/10-year citations and same-participant follow-up
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: An application item distinguishing 15/10-year citations and same-participant follow-up to connect materials needed for the selected question with available materials.
Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

N16 · Crossover and rescue treatment

Required materials and conditions: Separate assigned strategies from actual switching/treatment pathways
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: An application item distinguishing Separate assigned strategies from actual switching/treatment pathways to connect materials needed for the selected question with available materials.
Referenced methods: 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

N17 · ITT strategy estimands

Required materials and conditions: Assignment-based analysis versus actual-treatment/switching effects
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: An application item distinguishing Assignment-based analysis versus actual-treatment/switching effects to connect materials needed for the selected question with available materials.
Referenced methods: 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

N18 · Follow-up completeness and endpoint-specific denominators

Required materials and conditions: 1,610/1,643 (98%) versus actual endpoint/risk populations
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application

N19 · Registration, prespecified hierarchy and composite identifiers

Required materials and conditions: Registration IDs, mortality primary endpoint and metastasis/progression hierarchy
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: An application item distinguishing Registration IDs, mortality primary endpoint and metastasis/progression hierarchy to connect materials needed for the selected question with available materials.
Referenced methods: 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

N20 · Superiority versus equivalence/noninferiority

Required materials and conditions: Testing design, prespecified margins and equivalence-claim scope
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: An application item distinguishing Testing design, prespecified margins and equivalence-claim scope to connect materials needed for the selected question with available materials.
Referenced methods: 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

N21 · Metastasis/progression testing and concurrent care

Required materials and conditions: Arm-specific testing intensity, concurrent care/treatment and measurement differences
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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

N22 · Contemporary surveillance and other-population applicability

Required materials and conditions: Original PSA-led approach versus contemporary MRI/repeat biopsy and population differences
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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

N23 · PIVOT and SPCG-4 mentions

Required materials and conditions: Other trials’ detection methods, endpoints and directness
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: An application item distinguishing Other trials’ detection methods, endpoints and directness to connect materials needed for the selected question with available materials.
Referenced methods: 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

N24 · NIHR and MRC support

Required materials and conditions: Separate main/long-term-follow-up funding and roles
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: An application item distinguishing Separate main/long-term-follow-up funding and roles to connect materials needed for the selected question with available materials.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

N25 · Oxford sponsorship and author relationships

Required materials and conditions: Separate study sponsorship from funding/product/COI roles
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: An application item distinguishing Separate study sponsorship from funding/product/COI roles to connect materials needed for the selected question with available materials.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

N26 · Functional harms and treatment-specific results

Required materials and conditions: Separate incontinence/erectile/bowel/sexual function from metastasis/progression/mortality
Conditions for verification: 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.
Requirement and applicability: Supplementary
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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

N27 · No new treatment-complication reporting at 15 years

Required materials and conditions: Reporting after 10 years versus actual safety scope
Conditions for verification: 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.
Requirement and applicability: Supplementary
Application exceptions: 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.
Why this condition is needed: An application item distinguishing Reporting after 10 years versus actual safety scope to connect materials needed for the selected question with available materials.
Referenced methods: 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

N28 · Original axes, bilingual text, dates, corrections and history

Required materials and conditions: Separate parent mortality axes/score from selected subclaim values
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: An application item distinguishing Separate parent mortality axes/score from selected subclaim values to connect materials needed for the selected question with available materials.
Referenced methods: 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

N29 · Actual summary reading, links and gaps

Required materials and conditions: Preserved-summary reading versus external reports/registration/plans access
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: An application item distinguishing Preserved-summary reading versus external reports/registration/plans access to connect materials needed for the selected question with available materials.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

Referenced methods and the sections actually reviewed

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

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

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Preserved method HTML copies; no current method-content re-review or official tool execution

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

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

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Preserved method HTML copies; no current method-content re-review or official tool execution

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

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

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Preserved method HTML copies; no current method-content re-review or official tool execution

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

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Preserved method HTML copies; no current method-content re-review or official tool execution

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

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Preserved method HTML copies; no current method-content re-review or official tool execution

What the statuses mean

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.

Change history

2026-10-14 · Public page/material version 1.0

Public pages and materials were created from the existing 29 items. No new clinical search, verification-status change or scoring was performed.

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

Researcher downloads

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

View all item details

N01 · Selected equivalence claim and original grade

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: 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.
Reason for missing information: Subclaim score/status/axes are absent. Mortality nonsignificance is not transferred to equivalent metastasis/progression.
Required materials and conditions: Distinguish selected wording/grade/note from parent mortality verdict
Materials to obtain first: Original selected question/parent verdict and user correction comments
Further research: Proposed follow-up research distinguishing each endpoint/comparison specification; no new investigation, calculation or trial was performed in this production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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

Related sources S01 S02

N02 · PSA detection, localized cancer and population

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: 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.
Reason for missing information: Detailed eligibility, risk/stage distribution, baseline balance, recruitment/exclusions and generalizability remain unverified.
Required materials and conditions: PSA-detected population, eligibility/risk and baseline characteristics
Materials to obtain first: Population/risk, recruitment and baseline-characteristic tables
Further research: Proposed follow-up comparative research specifying population conditions; no new investigation, calculation or trial was performed in this production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: 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.
Why this condition is needed: An application item distinguishing PSA-detected population, eligibility/risk and baseline characteristics to connect materials needed for the selected question with available materials.
Application exceptions: 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.
Referenced methods: 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

Related sources S01

N03 · Identity of PSA-led monitoring

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: 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.
Reason for missing information: Original monitoring testing/switching rules, actual delivery and direct correspondence with contemporary approaches remain unverified.
Required materials and conditions: Original monitoring approach, intervention/testing/switching criteria
Materials to obtain first: Study monitoring manual and actual delivery/switching records
Further research: Proposed follow-up research separating monitoring approach from applicability; no new investigation, calculation or trial was performed in this production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: 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.
Why this condition is needed: An application item distinguishing Original monitoring approach, intervention/testing/switching criteria to connect materials needed for the selected question with available materials.
Application exceptions: 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.
Referenced methods: M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application

Related sources S01

N04 · Three arms and comparison specifications

Current findings: Allocation was monitoring 545, surgery 553 and radiotherapy 545 participants. Do not convert the three arms into a pooled comparator or identical treatment exposure.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: 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.
Reason for missing information: Treatment details, adjuvant/rescue care, contact, actual delivery/refusal and arm differences remain unverified.
Required materials and conditions: Arm correspondence and actual monitoring/surgery/radiotherapy treatment
Materials to obtain first: Arm-specific care/contact, switching and concurrent exposure data
Further research: Proposed follow-up research distinguishing three comparisons and actual treatment pathways; no new investigation, calculation or trial was performed in this production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: 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.
Why this condition is needed: An application item distinguishing Arm correspondence and actual monitoring/surgery/radiotherapy treatment to connect materials needed for the selected question with available materials.
Application exceptions: 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.
Referenced methods: 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

Related sources S01

N05 · Central randomization and concealment

Current findings: The original records central-computer allocation. Historical B0 evidence descriptions are not upgraded to allocation-record/concealment review now.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: 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.
Reason for missing information: Sequence generation, concealment, implementation exceptions, baseline balance and original protocol remain unread.
Required materials and conditions: Historical allocation descriptions versus actual original-text access
Materials to obtain first: Original allocation/concealment, baseline tables and protocol
Further research: Proposed follow-up trial disclosing allocation procedures; no new investigation, calculation or trial was performed in this production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: 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.
Why this condition is needed: An application item distinguishing Historical allocation descriptions versus actual original-text access to connect materials needed for the selected question with available materials.
Application exceptions: 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.
Referenced methods: 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

Related sources S01

N06 · Masking and endpoint-specific adjudicators

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: 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.
Reason for missing information: Metastasis/progression adjudicators, masking, testing frequency and committee roles/criteria remain unverified.
Required materials and conditions: Separate cause-of-death committee from metastasis/progression assessment
Materials to obtain first: Original metastasis/progression adjudication, testing and masking materials
Further research: Proposed research distinguishing endpoint-specific adjudication and measurement differences; no new investigation, calculation or trial was performed in this production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: M08 Table 8.2.a, M03 §3.2.4; own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design

Related sources S01

N07 · 15 years and follow-up range

Current findings: Preserve original median 15 years, range 11–21. Do not fill in exactly 15-year observation for everyone or identical event-time/proportion denominators.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: 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.
Reason for missing information: Individual follow-up, endpoint assessment windows/censoring, risk populations and visit systems remain unverified.
Required materials and conditions: 15-year analysis, median/range and individual observation duration
Materials to obtain first: Follow-up/censoring and endpoint-specific risk-population/timing data
Further research: Proposed research separately reporting time points and actual follow-up duration; no new investigation, calculation or trial was performed in this production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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

Related sources S01 S02

N08 · Definition of metastasis events

Current findings: Metastasis is a separate clinical endpoint from mortality. Summary numbers are not made equivalent to diagnostic methods/repeated events or all progression events.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: 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.
Reason for missing information: Metastasis definition, imaging/adjudication, first/cumulative event handling, baseline-metastasis exclusion and testing frequency remain unverified.
Required materials and conditions: Metastasis definition, testing/adjudication, occurrence time and person units
Materials to obtain first: Metastasis endpoint definitions, adjudication/testing and event data
Further research: Proposed follow-up research specifying metastasis measurement; no new investigation, calculation or trial was performed in this production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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

Related sources S01 S02

N09 · 15-year metastasis percentages and cumulative counts

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: 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.
Reason for missing information: Exact estimation methods, endpoint-specific valid/risk denominators, CI/models and individual event times remain unverified.
Required materials and conditions: Arm-specific metastasis percentages/counts, original time and denominators
Materials to obtain first: Metastasis result tables, risk populations and model/CI data
Further research: Proposed research distinguishing metastasis counts/percentages from estimands; no new investigation, calculation or trial was performed in this production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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

Related sources S01 S02

N10 · 15-year clinical-progression percentages

Current findings: Original clinical progression was monitoring 25.9%, surgery 10.5% and radiotherapy 11.0%. Do not substitute metastasis percentages/cumulative counts or death events.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: 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.
Reason for missing information: Progression definitions, component events/overlap, actual counts/denominators and exact models/CI remain unverified.
Required materials and conditions: Progression definition, arm-specific percentages and distinction from metastasis
Materials to obtain first: Progression definitions, component events, denominators/results/CI
Further research: Proposed follow-up research distinguishing metastasis/progression overlap and definitions; no new investigation, calculation or trial was performed in this production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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

Related sources S01

N11 · Metastasis/progression effects and precision

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: 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.
Reason for missing information: Exact comparison-specific effects, CI/testing, adjustments/competing-risk models remain unverified.
Required materials and conditions: Original percentages/interpretation versus exact between-arm effects/CI
Materials to obtain first: Original effects/CI, comparisons/models and importance thresholds
Further research: Proposed follow-up research disclosing exact effects and uncertainty; no new investigation, calculation or trial was performed in this production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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

Related sources S01

N12 · Mortality nonsignificance and other endpoints

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: 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.
Reason for missing information: Comparison-specific mortality effects/CI, equivalence margins and analysis specifications relating to metastasis/progression remain unverified.
Required materials and conditions: Separate 15-year cancer-mortality and metastasis/progression results
Materials to obtain first: Mortality/metastasis/progression-specific results, CI and plans
Further research: Proposed follow-up research separating endpoint-specific results; no new investigation, calculation or trial was performed in this production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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

Related sources S01

N13 · Cancer mortality, all-cause mortality and competing events

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: 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.
Reason for missing information: All-cause/other-cause death, competing-event handling and censoring/overlap details remain unverified.
Required materials and conditions: Causes of death versus metastasis/progression competing-event/censoring specifications
Materials to obtain first: Endpoint/cause-of-death, competing-risk and censoring materials
Further research: Proposed research separating event-specific competing/censoring processes and effects; no new investigation, calculation or trial was performed in this production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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

Related sources S01

N14 · 10-year cumulative results

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: 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.
Reason for missing information: 10-year endpoints/denominators/CI, progression counts and detailed correspondence between analyses remain unverified.
Required materials and conditions: Same-cohort 10/15-year counts and time points
Materials to obtain first: Original 10/15-year results and time/endpoint correspondence
Further research: Proposed research distinguishing cumulative/time analyses in the same cohort; no new investigation, calculation or trial was performed in this production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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

Related sources S01 S02

N15 · Same trial, two reports and independence

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: 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.
Reason for missing information: Unique clinical-trial/participant totals and separate independent-replication counts are not confirmed.
Required materials and conditions: 15/10-year citations and same-participant follow-up
Materials to obtain first: Report/cohort, registration/protocol relationships and separate-study materials
Further research: Proposed follow-up independent comparative research on the same endpoint/strategy; no new investigation, calculation or trial was performed in this production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

Related sources S01 S02

N16 · Crossover and rescue treatment

Current findings: The original records many participants later switching to rescue/radical treatment. Monitoring assignment is not converted into lifelong untreated exposure.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: 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.
Reason for missing information: Switching counts/timing/reasons, arm-specific actual treatment, adherence and treatment-specific analyses remain unverified.
Required materials and conditions: Separate assigned strategies from actual switching/treatment pathways
Materials to obtain first: Assigned/actual treatment, switching and rescue-treatment materials
Further research: Proposed follow-up research separating assigned strategies from actual pathways; no new investigation, calculation or trial was performed in this production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: 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.
Why this condition is needed: An application item distinguishing Separate assigned strategies from actual switching/treatment pathways to connect materials needed for the selected question with available materials.
Application exceptions: 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.
Referenced methods: 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

Related sources S01

N17 · ITT strategy estimands

Current findings: The original records ITT comparison. This is preserved history; no new treatment-specific effects or effects in a never-switching population.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: 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.
Reason for missing information: Endpoint-specific ITT populations, switching handling, adjustments/sensitivity and actual-treatment analyses remain unread.
Required materials and conditions: Assignment-based analysis versus actual-treatment/switching effects
Materials to obtain first: Original ITT, switching/sensitivity and endpoint-specific models
Further research: Proposed research distinguishing strategy estimands from actual-treatment estimands; no new investigation, calculation or trial was performed in this production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: 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.
Why this condition is needed: An application item distinguishing Assignment-based analysis versus actual-treatment/switching effects to connect materials needed for the selected question with available materials.
Application exceptions: 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.
Referenced methods: 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

Related sources S01

N18 · Follow-up completeness and endpoint-specific denominators

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: 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.
Reason for missing information: Endpoint-specific valid/risk denominators, missingness/withdrawal reasons, times and arm-specific completeness/handling remain unverified.
Required materials and conditions: 1,610/1,643 (98%) versus actual endpoint/risk populations
Materials to obtain first: Follow-up flow, endpoint/arm denominators and missingness-handling data
Further research: Proposed research distinguishing observation/risk denominators and missingness; no new investigation, calculation or trial was performed in this production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application

Related sources S01

N19 · Registration, prespecified hierarchy and composite identifiers

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: 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.
Reason for missing information: Registration histories, protocol/SAP, prespecified metastasis/progression hierarchy, amendments/multiplicity plans remain unread.
Required materials and conditions: Registration IDs, mortality primary endpoint and metastasis/progression hierarchy
Materials to obtain first: Both registration histories, protocol and SAP
Further research: Proposed research publicly linking primary/secondary endpoints to actual analysis; no new investigation, calculation or trial was performed in this production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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

Related sources S01

N20 · Superiority versus equivalence/noninferiority

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: 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.
Reason for missing information: Equivalence/noninferiority margins and corresponding estimands/CI are not presented in preserved materials.
Required materials and conditions: Testing design, prespecified margins and equivalence-claim scope
Materials to obtain first: Original design/testing specifications and effect/CI materials
Further research: Proposed follow-up research distinguishing questions and testing specifications; no new investigation, calculation or trial was performed in this production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: 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.
Why this condition is needed: An application item distinguishing Testing design, prespecified margins and equivalence-claim scope to connect materials needed for the selected question with available materials.
Application exceptions: 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.
Referenced methods: 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

Related sources S01

N21 · Metastasis/progression testing and concurrent care

Current findings: 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.
Verification status: Unverified
Materials actually read: Summary read; external material unread
Why unverified: 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.
Reason for missing information: Arm-specific testing/contact, concurrent treatment, confirmation frequency and analysis-handling details remain unverified.
Required materials and conditions: Arm-specific testing intensity, concurrent care/treatment and measurement differences
Materials to obtain first: Testing/concurrent treatment, endpoint adjudication and analysis data
Further research: Proposed research distinguishing testing/treatment pathways from outcome measurement; no new investigation, calculation or trial was performed in this production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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

Related sources S01

N22 · Contemporary surveillance and other-population applicability

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: 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.
Reason for missing information: Direct comparison with contemporary approaches/populations, long-term results and switching correspondence remain unverified.
Required materials and conditions: Original PSA-led approach versus contemporary MRI/repeat biopsy and population differences
Materials to obtain first: Strategy/population definitions, direct comparisons and follow-up data
Further research: Proposed follow-up research specifying approach and population differences; no new investigation, calculation or trial was performed in this production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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

Related sources S01

N23 · PIVOT and SPCG-4 mentions

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: 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.
Reason for missing information: Specific citations, populations/denominators, metastasis/progression/CI and direct correspondence remain unlinked.
Required materials and conditions: Other trials’ detection methods, endpoints and directness
Materials to obtain first: Other-trial originals and detection/endpoint/strategy relationships
Further research: Proposed follow-up comparative research matching populations/detection methods/endpoints; no new investigation, calculation or trial was performed in this production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: 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.
Why this condition is needed: An application item distinguishing Other trials’ detection methods, endpoints and directness to connect materials needed for the selected question with available materials.
Application exceptions: 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.
Referenced methods: 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

Related sources S01

N24 · NIHR and MRC support

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: 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.
Reason for missing information: Supporting institutions’ roles, contracts and other in-kind/analysis/writing/publication support remain unread.
Required materials and conditions: Separate main/long-term-follow-up funding and roles
Materials to obtain first: Original support/funding, roles and other support
Further research: Proposed research disclosing support stages and roles; no new investigation, calculation or trial was performed in this production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

Related sources S01

N25 · Oxford sponsorship and author relationships

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: 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.
Reason for missing information: Sponsor responsibilities/authority, author relationships, product/analysis/writing support and original COI remain unread.
Required materials and conditions: Separate study sponsorship from funding/product/COI roles
Materials to obtain first: Original sponsor, author contributions/COI and support roles
Further research: Proposed research separately disclosing study roles, support and relationships; no new investigation, calculation or trial was performed in this production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: 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.
Why this condition is needed: An application item distinguishing Separate study sponsorship from funding/product/COI roles to connect materials needed for the selected question with available materials.
Application exceptions: 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.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

Related sources S01

N26 · Functional harms and treatment-specific results

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: 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.
Reason for missing information: Exact functional-endpoint definitions, denominators/times/values, collection/adjudication and individual-choice effects remain unverified.
Required materials and conditions: Separate incontinence/erectile/bowel/sexual function from metastasis/progression/mortality
Materials to obtain first: Function/harm-specific results, definitions and follow-up data
Further research: Proposed follow-up research separating survival/metastasis/functional harms; no new investigation, calculation or trial was performed in this production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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

Related sources S01 S02

N27 · No new treatment-complication reporting at 15 years

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: 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.
Reason for missing information: New reporting/collection scope, long-term adverse events, denominators and adjudication/missingness remain unverified.
Required materials and conditions: Reporting after 10 years versus actual safety scope
Materials to obtain first: 10/15-year safety collection and all-complication/follow-up data
Further research: Proposed research distinguishing reporting scope from actual occurrence/follow-up; no new investigation, calculation or trial was performed in this production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: 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.
Why this condition is needed: An application item distinguishing Reporting after 10 years versus actual safety scope to connect materials needed for the selected question with available materials.
Application exceptions: 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.
Referenced methods: 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

Related sources S01 S02

N28 · Original axes, bilingual text, dates, corrections and history

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: 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.
Reason for missing information: Parent E0/score and mortality-verdict axes do not fill metastasis/progression effects/scores.
Required materials and conditions: Separate parent mortality axes/score from selected subclaim values
Materials to obtain first: Original corrections, versions and user correction comments
Further research: Proposed research distinguishing original values/history from new-material scope; no new investigation, calculation or trial was performed in this production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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

Related sources S01 S02

N29 · Actual summary reading, links and gaps

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: 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.
Reason for missing information: External original content, exact definitions/CI and actual accessibility remain unverified.
Required materials and conditions: Preserved-summary reading versus external reports/registration/plans access
Materials to obtain first: Original paper, registration, protocol, SAP and support materials or user comments
Further research: Proposal for updating while distinguishing actual acquisition/timing/scope; no new investigation, calculation or trial was performed in that production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

Related sources S01 S02