PSA-detected localized prostate cancer · Three strategies and 15-year prostate-cancer mortality

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 conditionHow are selected 15-year mortality and related metastasis/progression distinguished?Required	The selected original question is significant difference in 15-year prostate-cancer mortality. Link its subclaim record and distinguish the same original verdict’s claim of equivalent metastasis/clinical progression and parent context. No new questions, splits or trials. R01	Some original summary information is linked for production; this does not establish clinical verification/completed content review. Clinical independence was not newly certified.	Boundary between selected mortality, parent verdict and metastasis/progression results	Plan distinguishing estimands for different clinical outcomes
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionWhat are subclaim D/note and absent score/status/axes?Required	Preserve selected D and the note Overall P=.53. Subclaim score/status/axes are absent; parent D34 and axes are separate historical context. R01	Some original summary information is linked for production; this does not establish clinical verification/completed content review. Subclaim score/status/axes are absent in the original.	Subclaim D, overall P=.53 versus parent D34 and historical axes	Separate original-grade preservation from additional evidence/changes
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionWhat are PSA-detected localized disease and actual age/population?Required	The original records PSA-detected localized prostate cancer and 1,643 ProtecT participants aged 50–69. It is not a direct result for clinically detected/metastatic disease or other ages. R01	Some original summary information is linked for production; this does not establish clinical verification/completed content review. Recruitment/diagnosis, staging, comorbidities and eligibility/exclusion details remain unverified.	PSA-detected localized prostate cancer, ages 50–69	Research specifying detection method, stage and population
4	Unverified	Full text not readStored summary read	N04 · Evidence conditionAre risk/pathology/baseline status and subgroup denominators verified?Required	The original summary includes localized/PSA-detected scope but provides no separate risk distribution, pathology/grade, baseline PSA or subgroup denominators/mortality effects. R01	Required direct materials were not verified within the current summary/unread-external-material scope. Risk classification, baseline pathology/PSA, subgroup denominators/effects and interactions remain unverified.	Risk/pathology, diagnostic criteria and arm/subgroup results	Research specifying risk and applicability
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionWhat was the historical PSA-led active-monitoring strategy?Required	The original intervention was PSA-led active monitoring. The original distinguishes contemporary active surveillance with more MRI/regular repeat biopsy. Specific testing/treatment-switch schedules are absent from the summary. R01	Some original summary information is linked for production; this does not establish clinical verification/completed content review. Historical testing/reassessment, switching criteria/adherence and direct comparison with contemporary strategies remain unverified.	Historical monitoring, follow-up/switching criteria and contemporary active surveillance	Research specifying strategies/estimands by period
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionWhat are surgery/radiotherapy comparisons and actual treatment specifications?Required	The original records allocation of 545 to monitoring, 553 to surgery and 545 to radiotherapy. Detailed historical surgery/radiotherapy techniques, concurrent exposure and adherence/changes are not separately provided. R01	Some original summary information is linked for production; this does not establish clinical verification/completed content review. Treatment methods/adjuvant care, timing/adherence, shared conditions and changes remain unverified.	Three arms, original surgery/radiotherapy/concurrent care and historical specifications	Research specifying exact strategy-specific estimands
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionWhat time window does 15-year follow-up describe?Required	Preserve original median follow-up of 15 years, range 11–21. This does not mean every participant had exactly 15 years of identical follow-up or a single-time valid denominator. R01	Some original summary information is linked for production; this does not establish clinical verification/completed content review. Time origins, arm-specific distributions, risk sets, censoring/visit windows remain unverified.	Median 15 years, range 11–21, time/denominators	Plan distinguishing follow-up time from effects at estimation time
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionWhat are original prostate-cancer-specific death definitions/adjudication?Required	The original study description quotes the primary outcome as definite or probable prostate cancer mortality and records independent cause-of-death committee adjudication. This differs from all-cause mortality. R01	Some original summary information is linked for production; this does not establish clinical verification/completed content review. Cause-of-death data/uncertain adjudication, committee procedures, missing causes and original plans remain unread.	Definite/probable prostate-cancer mortality and independent cause-of-death committee	Research specifying cause-specific mortality and adjudication
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionWhat are 15-year prostate-cancer death events/randomized denominators?Required	The original records monitoring 17/545 (3.1%), surgery 12/553 (2.2%) and radiotherapy 16/545 (2.9%), overall P=.53. Preserve original events/denominators/percentages only; no new totals, differences, rates/CI. R01	Some original summary information is linked for production; this does not establish clinical verification/completed content review. Estimand details, observed proportions/time estimates, censoring/models and each comparison’s CI remain unverified.	17/545, 12/553, 16/545, original percentages and overall P	Plan distinguishing events/randomization/time estimands
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionWhat is the conclusion scope of overall P=.53 and nonsignificance?Required	The original specifies nonsignificant mortality differences in a three-arm superiority comparison and that this was not a noninferiority trial or proof of equivalence. Preserve this context for the selected question. R01	Some original summary information is linked for production; this does not establish clinical verification/completed content review. Testing/models, pairwise comparisons/CI and equivalence/noninferiority margins remain unverified.	Overall three-arm superiority comparison and equivalence/noninferiority boundaries	Research prespecifying superiority, comparisons of interest and importance thresholds
11	Unverified	Full text not readStored summary read	N11 · Evidence conditionHow does all-cause mortality differ from prostate-cancer-specific mortality?Required	Core original-summary numbers concern prostate-cancer mortality. All/other-cause death events/denominators and arm-specific estimates/CI are not separately presented. R01	Required direct materials were not verified within the current summary/unread-external-material scope. All/other-cause death definitions, events/estimates and comparative CI remain unverified.	All/other-cause deaths, events/denominators/duration	Plan separating cause-specific from all-cause mortality
12	Unverified	Full text not readStored summary read	N12 · Evidence conditionAre time estimates, HR/absolute differences/CI and competing risks verified?Required	Original events/percentages/overall P are available but HR/time-specific absolute differences, CI and censoring/competing-risk model details are absent from the summary. Parent precision C0 is historical. R01	Required direct materials were not verified within the current summary/unread-external-material scope. Estimands/time/models, arm risk sets, CI and importance thresholds remain unverified.	Survival/cause-specific/competing-risk models and estimands	Research specifying estimands, time and competing risks
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionWhat are the related metastasis/clinical-progression results?Supplementary	Original metastasis was 9.4% versus 4.7%/5.0%, and clinical progression 25.9% versus 10.5%/11.0%, described as higher with monitoring. Related subclaim D/note and original roughly twofold/2.5-fold descriptions are preserved as context. R01	Some original summary information is linked for production; this does not establish clinical verification/completed content review. Event definitions/risk sets, estimates/CI, comparisons/multiplicity remain unverified.	Separate metastasis/progression endpoints, original numbers and mortality boundary	Plan separating mortality from progression/metastasis
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionAre the 10/15-year cumulative reports from the same cohort?Supplementary	The original records 10-year deaths 8/5/4 and metastases 33/13/16 accumulating at 15 years to 17/12/16 and 51/26/27. The 2016/2023 reports concern different times in the same trial, not independent replication. R01 R02	Some original summary information is linked for production; this does not establish clinical verification/completed content review. Separate valid 10-year denominators/time estimates and observations/related-report details between times remain unverified.	Original 10/15-year events and same-ProtecT report linkage	Record distinguishing cumulative results/updates by time
15	Partly verified	Full text not readStored summary read	N15 · Evidence conditionAre rescue/radical-treatment switching and assigned strategies distinguished?Required	The original advertising interpretation says many participants later switched to rescue/radical treatment. Exact counts/proportions, arms/timing/reasons and analysis handling are absent from the summary. R01	Some original summary information is linked for production; this does not establish clinical verification/completed content review. Switching/crossover treatment, adherence/actual exposure, timing/criteria/denominators remain unverified.	Monitoring assignment, actual switching/crossover treatment, timing/criteria	Research separating assigned-strategy estimands from switching/actual exposure
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionWhat are 1,643 randomized, arm counts and 1,610/98% follow-up completeness?Required	Preserve original 1,643 (545/553/545) and complete follow-up for 1,610/1,643 (98%). Arm-specific completeness and cause-specific/time-specific valid denominators are not detailed. R01	Some original summary information is linked for production; this does not establish clinical verification/completed content review. Arm/time-specific completeness, causes of death/censoring and missing denominators remain unverified.	Total/arm randomization, follow-up completeness and endpoint denominators	Plan separating randomized/follow-up-complete and endpoint-specific denominators
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionWhat is the scope of loss, unidentified causes and censoring/missingness handling?Required	Original 98% follow-up completeness and ITT descriptions exist, but arm-specific missing counts/reasons, unidentified causes, censoring/missingness handling and sensitivity analyses are absent from the summary. R01	Some original summary information is linked for production; this does not establish clinical verification/completed content review. Missingness/censoring, uncertain causes, sensitivity/imputation and arm flow remain unverified.	Follow-up loss/missing death causes, arm-specific reasons and handling	Research prespecifying missingness/censoring/cause adjudication
18	Partly verified	Full text not readStored summary read	N18 · Evidence conditionAre original ITT and crossover/actual-exposure effects separated?Required	The original study description preserves an intention-to-treat comparison quote. Actual-treatment/post-switch effects, adjustments and adherer-analysis details are absent. R01	Some original summary information is linked for production; this does not establish clinical verification/completed content review. Analysis populations, adjustments/switching/sensitivity and time estimates remain unverified.	Assignment-based ITT and estimands after adherence/switching	Plan separating ITT from other estimands
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionWhat is the original information on concealment, treatment masking and death adjudication?Required	Original B0 evidence in the study description quotes central-computer allocation, impossibility of treatment masking, an independent cause-of-death committee and ITT. Preserved descriptions are not inherited as external procedural verification now. R01	Some original summary information is linked for production; this does not establish clinical verification/completed content review. Allocation/committee details, data access/masking and original protocol remain unread now.	Central-computer allocation, unmasked treatment and independent cause-of-death committee	Research distinguishing treatment from adjudication procedures
20	Partly verified	Full text not readStored summary read	N20 · Evidence conditionHow do original prespecified primary outcome/two registration IDs relate to actual plan reading?Required	The original study description records prespecified prostate-cancer mortality and agreement with two IDs. The original evidence-list registration field remains ISRCTN20141297 · NCT02044172. External registration/protocol/SAP were not read now. R01	Some original summary information is linked for production; this does not establish clinical verification/completed content review. Actual registration versions/plan timing, hierarchy/testing/amendments remain unread.	ISRCTN20141297/NCT02044172, original mortality primary outcome and timing/versions	Plan preserving primary/secondary and long-term-follow-up amendments
21	Unverified	Full text not readStored summary read	N21 · Evidence conditionAre baseline disease, shared follow-up care/exposure and risk separated?Required	Original PSA-detected localized disease/three-strategy information exists, but arm-specific history/drugs, shared follow-up care and changing-risk details are absent from the summary. R01	Required direct materials were not verified within the current summary/unread-external-material scope. Baseline/changing history, care/support and arm differences/risk information remain unverified.	Arm-specific history, concurrent care/follow-up and risk	Research specifying shared conditions, assigned strategies and crossover care
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionWhat is the original scope of funding/sponsorship and adjudication-independence descriptions?Required	The original records main NIHR HTA Programme funding, NIHR/MRC support for long-term follow-up and University of Oxford sponsorship. Public funding/original independent-adjudication descriptions do not replace current disclosure/role review. R01	Some original summary information is linked for production; this does not establish clinical verification/completed content review. Original disclosure/support and design/analysis/data-access/adjudication roles remain unread in detail.	NIHR HTA/NIHR/MRC, Oxford sponsorship and roles	Record specifying funding and adjudication/analysis roles
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionHow are the same trial/citations, arms/time and related sheets linked?Required	One original evidence-list row and two citations are separated into R01 (15 years) and R02 (10 years). The same cohort, arms/deaths/metastases/times and related sheets are not added as independent trials/participants. R01 R02	Some original summary information is linked for production; this does not establish clinical verification/completed content review. New certification of related-report overlap and unique trial/participant totals remains unverified.	15/10-year reports, same ProtecT population and observation relationships	Record distinguishing reports from trial families
24	Partly verified	Full text not readStored summary read	N24 · Evidence conditionWhat are original PIVOT/SPCG-4 descriptions versus the current report list?Supplementary	The original counterview describes PIVOT’s nonsignificant observation/surgery comparison and SPCG-4’s surgery advantage in a clinically detected population with 10% PSA detection, a different scope. Current citations are two ProtecT reports; originals from the other trials were not read now. R01	Some original summary information is linked for production; this does not establish clinical verification/completed content review. Those studies’ citations/original results, populations/comparators/follow-up/CI remain unverified.	Other-study names/detection methods, direct applicability and reading scope	Separate research question with explicit detection method/population
25	Partly verified	Full text not readStored summary read	N25 · Evidence conditionWhat is the extrapolation boundary between contemporary surveillance and historical monitoring?Supplementary	The original describes contemporary active surveillance as using more MRI/regular repeat biopsy than ProtecT. Direct contemporary-strategy effects/comparisons are absent from the summary. R01	Some original summary information is linked for production; this does not establish clinical verification/completed content review. Contemporary-strategy specifications, direct comparisons/risk populations/follow-up remain unverified.	Historical PSA-led strategy versus contemporary MRI/repeat-biopsy descriptions	Research specifying strategy scope
26	Unverified	Full text not readStored summary read	N26 · Evidence conditionAre independent confirmation in the selected scope and same-cohort updates separated?Required	Parent R1/I2 are historical axes and the 10/15-year reports concern the same cohort. Additional direct-study identity/independence was not searched/certified now. R01 R02	Required direct materials were not verified within the current summary/unread-external-material scope. Separate direct studies’ populations/strategies/times and overlap/independence remain unverified.	Direct independent reports versus 10/15-year updates and original R1/I2	Separate research specifying the same question/population/strategies
27	Partly verified	Full text not readStored summary read	N27 · Evidence conditionHow are mortality, metastasis/progression and functional harms different questions?Supplementary	The original separately records nonsignificant mortality, increased monitoring metastasis/progression, surgery-related incontinence/erectile effects and radiotherapy-related bowel/sexual effects. No new overall balance assessment of different outcomes. R01	Some original summary information is linked for production; this does not establish clinical verification/completed content review. Each functional/quality-of-life outcome’s event definitions/effects/denominators/CI remain unverified.	Hard mortality/progression versus urinary/sexual/bowel function	Plan separating different clinical outcomes and estimands
28	Partly verified	Full text not readStored summary read	N28 · Evidence conditionWhat is the scope of harm updates in the 15-year material?Supplementary	The original study facts describe no new treatment-complication reporting in the 15-year paper after the 10-year analysis. This is not a current nonreporting determination from external-paper reading and does not mean zero harms/no follow-up. R01 R02	Some original summary information is linked for production; this does not establish clinical verification/completed content review. Actual harm collection/results/updates by interval/report remain unread.	No new treatment complications reported after 10 years and current access	Record separating cumulative efficacy updates from harm-observation scope
29	Partly verified	Full text not readStored summary read	N29 · Evidence conditionWhat is the scope of preserved summaries, unread external materials and links?Required	The complete preserved 2974 summary was read and saved for production. Two original PubMed URLs/registration IDs link original sources; external content/link access/click/testing was not performed. R01 R02	Some original summary information is linked for production; this does not establish clinical verification/completed content review. Current verification of external original methods/results, registration/plans/disclosures is incomplete.	Complete preserved summary and 15/10-year citations/abstracts/full texts/plans	Records separating summaries/identities from new acquisition
30	Partly verified	Full text not readStored summary read	N30 · Evidence conditionWhat are original bilingual text, dates, corrections/axes/absences and history?Required	Preserve bilingual text, original date 2026-08-26 and empty corrections/deliberation. Parent B/H/R1/I2/E0/B0/C0, true large-hard-endpoint RCT, two other false indicators and empty grade-override reasons are historical context. Separate classification and failed-primary/positive-secondary indicators are unrecorded. R01	Some original summary information is linked for production; this does not establish clinical verification/completed content review. External original quotations/translations and detailed registration/correction comparisons were not performed this time.	Parent D34, languages/dates, empty values, axes/citations	Separate original values/absences from new evidence updates
31	Unverified	Full text not readStored summary read	N31 · Evidence conditionAre harm collection, severity and event definitions verified?Supplementary	The original describes different strategy-specific harms/progression. Collection methods, severity, event definitions and scales/completion are not detailed in the summary. R01	Required direct materials were not verified within the current summary/unread-external-material scope. Harm definitions/collection, severity and each outcome’s original tables remain unverified.	Collection of surgery/radiotherapy functional effects and monitoring progression	Plan specifying strategy-specific harms and progression
32	Unverified	Full text not readStored summary read	N32 · Evidence conditionAre arm-specific harm denominators/comparisons/CI distinguished from mortality denominators?Supplementary	Original treatment-specific functional effects are described, but arm-specific denominators/effects/CI for those tests/questionnaires/events are absent. Randomized mortality denominators do not automatically become valid harm denominators. R01	Required direct materials were not verified within the current summary/unread-external-material scope. Collection/denominators, comparisons/CI for each harm/time remain unverified.	Valid harm/function observations, arm/time denominators and effects	Research distinguishing efficacy from harm-observation populations
33	Unverified	Full text not readStored summary read	N33 · Evidence conditionWhat are harm timing, post-crossover effects and long-term observation?Supplementary	Original long-term follow-up/switching context exists, but post-treatment/post-switch functional-harm timing, persistence/recovery and long-term collection details are absent. R01 R02	Required direct materials were not verified within the current summary/unread-external-material scope. Exposure/switching, harm occurrence and interval-specific/delayed observation remain unverified.	Treatment/switching timing, function/events and interval-specific follow-up	Plan distinguishing efficacy follow-up from harm-occurrence timing
34	Unverified	Full text not readStored summary read	N34 · Evidence conditionHow are harms attributed to assignment, actual treatment or medical history?Supplementary	Original ITT assigned-strategy and subsequent treatment-switching context exists. Models/assessments attributing individual harms to assignment/actual treatment/baseline disease are not detailed in the summary. R01	Required direct materials were not verified within the current summary/unread-external-material scope. Event-specific actual exposure/history, relatedness/confounding/alternative causes remain unverified.	Original strategies, switching/shared exposure, alternative causes and causality	Plan separating assignment from actual exposure/alternative causes
35	Unverified	Full text not readStored summary read	N35 · Evidence conditionAre loss/death/crossover and harm missingness distinguished?Supplementary	Original 98% follow-up completeness and mortality ITT descriptions exist, but function/harm collection completeness, arm-specific missingness/stopping and observation handling after death are not detailed. R01	Required direct materials were not verified within the current summary/unread-external-material scope. Harm-specific missingness/stopping, competing events/death and handling/sensitivity remain unverified.	Functional-questionnaire/harm missingness, follow-up completeness and stopping reasons	Plan distinguishing harm missingness from mortality follow-up
36	Unverified	Full text not readStored summary read	N36 · Evidence conditionAre independent harm data distinguished from same-cohort reports?Supplementary	Current preserved citations concern ProtecT’s same-cohort 10/15-year reports. Separate independent harm originals were not searched/acquired now; times/reports/related sheets are not counted as independent harm trials. R01 R02	Required direct materials were not verified within the current summary/unread-external-material scope. Independent harm data identities/populations/strategies and overlap remain unverified.	Identity/overlap of 10/15-year and separate harm reports	Record separating the same cohort from independent materials
37	Unverified	Full text not readStored summary read	N37 · Evidence conditionWhat is the scope for risk/vulnerable populations, contemporary treatments and long-term safety?Supplementary	Original PSA-detected localized disease, ages 50–69 and historical strategies are not repurposed as direct safety for other risks/diseases/ages or contemporary strategies. R01	Required direct materials were not verified within the current summary/unread-external-material scope. Direct population/strategy-specific harms and long-term/risk-population data remain unverified.	Historical localized disease/age versus other risks/strategies and follow-up harms	Research specifying population and long-term safety questions
38	Partly verified	Full text not readStored summary read	N38 · Evidence conditionHow do nonsignificance, metastasis/function harms and harmlessness/equivalence relate?Supplementary	Separately preserve overall mortality P=.53, absence of noninferiority design, increased monitoring metastasis/progression, treatment-specific functional harms and parent caution. Nonsignificance does not establish harmlessness/equivalence. R01	Some original summary information is linked for production; this does not establish clinical verification/completed content review. Comparative/causal safety, each effect’s CI/importance and direct contemporary data remain unverified.	Original ineffective prostate-cancer mortality comparison versus separate progression/harms and causality	Plan separating different outcomes/estimands
39	Partly verified	Full text not readStored summary read	N39 · Evidence conditionHow are subsequent originals, candidate history/versions and incomplete content review linked?Supplementary	Conditions were preserved/frozen before separate application. Candidate review-pending/production-eligibility labels remain historical records; current content/question-boundary review is incomplete. Zero new units and unrecorded confirmed independent totals are retained. R01 R02	Some original summary information is linked for production; this does not establish clinical verification/completed content review. Subsequent originals, actual reading, changes/content review and independence decisions do not yet exist.	Original summary/conditions, time/denominators/estimands and new evidence/change decisions	Research addressing direct gaps in selected 15-year mortality

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39 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: PSA-detected localized prostate cancer, ages 50–69, 1,643 ProtecT participants; risk/subgroup details remain unverified.
Ingredient, formulation and route: PSA-based active monitoring for PSA-detected localized prostate cancer
Dose: Preserve the historical monitoring-strategy study context; testing/follow-up/switching schedules and actual adherence remain unverified. No implementation instructions.
Comparator: Historical assigned prostatectomy/radiotherapy strategies; actual techniques/shared care/crossover details remain unverified.
Measured outcome: Original 15-year prostate-cancer-specific mortality comparison, distinguished from all-cause mortality, metastasis/progression and functional harms.
Duration: Median 15 years, original range 11–21; distinguish the same cohort’s 10-year report context.
Questions outside this scope: Converting nonsignificance into equivalence/noninferiority, harmlessness or guaranteed safety; Repurposing prostate-cancer mortality as effects on all-cause mortality, metastasis/progression or functional harms; Adding the same arms/people/events/time and 10/15-year citations/related sheets as independent trials/participants; Extending historical PSA-led monitoring to all contemporary active-surveillance/treatment strategies; PSA-testing/risk-selection/monitoring/surgery/radiotherapy/cancer-treatment selection or 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.

R01 · Hamdy FC, et al. Fifteen-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer. N Engl J Med. 2023;388:1547-1558. PMID: 36912538.

PubMed

Material type: ProtecT 15-year cumulative report of selected mortality/progression
Materials actually read: Summary read; external materials unread, access not attempted
Findings recorded in the stored summary: 17/545 (3.1%) versus 12/553 (2.2%) versus 16/545 (2.9%); overall P=.53
Record level: 15-year prostate-cancer-specific death events/original percentages, overall P=.53. Comparative/time estimates/CI remain unverified; equivalence/noninferiority was not proved.
Study overlap and independent replication: ProtecT same-cohort cumulative 10/15-year reports. People/arms/deaths/metastases/time and parent/related sheets are not newly added as independent trials/participants.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Local preserved summary	Summary read	Summary read	Only the corresponding report/citation scope in the preserved parent summary was read; external papers/original registration were not acquired.
Abstract	External materials unread/needed	Unread; access not attempted	Not read	Only the original citation URL is linked. External content/access and link tests were not attempted.
Full paper	External materials unread/needed	Unread; access not attempted	Not read	Original DOI/PMCID not provided. No new acquisition/reading of the full text/content.
Registration material	External materials unread/needed	Unread; access not attempted	Not read	Two IDs occur in the 15-year evidence list/parent’s same-trial history. Individual registration content/versions for this report remain unread; the direct 10-year citation contains no ID.
Protocol	External materials unread/needed	Unread; access not attempted	Not read	Population/strategy and mortality/progression/harm plans for the report/time are needed. Existence/publication status remains unverified.
Statistical analysis plan	External materials unread/needed	Unread; access not attempted	Not read	Original ITT/switching, time/censoring/competing-risk, estimation/interval, hierarchy/missingness plans are needed.
Result tables and mortality/time/denominator/harm materials	External materials unread/needed	Unread; access not attempted	Not read	Events/denominators, cause-specific/all-cause mortality, switching/risk sets/missingness and harms for the corresponding time are needed. No new calculations.
Funding/conflict-of-interest disclosures	External materials unread/needed	Unread; access not attempted	Not read	Original NIHR/MRC/Oxford information concerns parent/15-year context. Individual disclosures for this report remain unread now.

R02 · Hamdy FC, et al. 10-Year Outcomes after Monitoring, Surgery, or Radiotherapy. N Engl J Med. 2016. PMID: 27626136.

PubMed

Material type: Same ProtecT cohort’s cumulative 10-year context report; not independent replication
Materials actually read: Summary read; external materials unread, access not attempted
Findings recorded in the stored summary: Same-cohort cumulative 10-year results: deaths 8/5/4, metastases 33/13/16, from the original study description. Valid 10-year denominators/estimates/CI remain unverified.
Record level: Original description of same-cohort cumulative 10-year mortality/metastases. Do not copy 15-year mortality denominators/effects. No separate 10-year evidence-list row/denominators/CI.
Study overlap and independent replication: ProtecT same-cohort cumulative 10/15-year reports. People/arms/deaths/metastases/time and parent/related sheets are not newly added as independent trials/participants.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Local preserved summary	Summary read	Summary read	Only the corresponding report/citation scope in the preserved parent summary was read; external papers/original registration were not acquired.
Abstract	External materials unread/needed	Unread; access not attempted	Not read	Only the original citation URL is linked. External content/access and link tests were not attempted.
Full paper	External materials unread/needed	Unread; access not attempted	Not read	Original DOI/PMCID not provided. No new acquisition/reading of the full text/content.
Registration material	External materials unread/needed	Unread; access not attempted	Not read	Two IDs occur in the 15-year evidence list/parent’s same-trial history. Individual registration content/versions for this report remain unread; the direct 10-year citation contains no ID.
Protocol	External materials unread/needed	Unread; access not attempted	Not read	Population/strategy and mortality/progression/harm plans for the report/time are needed. Existence/publication status remains unverified.
Statistical analysis plan	External materials unread/needed	Unread; access not attempted	Not read	Original ITT/switching, time/censoring/competing-risk, estimation/interval, hierarchy/missingness plans are needed.
Result tables and mortality/time/denominator/harm materials	External materials unread/needed	Unread; access not attempted	Not read	Events/denominators, cause-specific/all-cause mortality, switching/risk sets/missingness and harms for the corresponding time are needed. No new calculations.
Funding/conflict-of-interest disclosures	External materials unread/needed	Unread; access not attempted	Not read	Original NIHR/MRC/Oxford information concerns parent/15-year context. Individual disclosures for this report remain unread now.

Report counts versus independent study counts

ProtecT same-cohort cumulative 10/15-year reports. People/arms/deaths/metastases/time and parent/related sheets are not newly added as independent trials/participants.

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 · How are selected 15-year mortality and related metastasis/progression distinguished?

Required materials and conditions: Boundary between selected mortality, parent verdict and metastasis/progression results
Conditions for verification: For Boundary between selected mortality, parent verdict and metastasis/progression results, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Required
Application exceptions: Do not transfer related progression results into selected mortality effects, grades or a new verdict.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: How are selected 15-year mortality and related metastasis/progression distinguished?
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application

N02 · What are subclaim D/note and absent score/status/axes?

Required materials and conditions: Subclaim D, overall P=.53 versus parent D34 and historical axes
Conditions for verification: For Subclaim D, overall P=.53 versus parent D34 and historical axes, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Required
Application exceptions: Do not repurpose parent 34 points or E0/C0/B0 axes as subclaim values or passed content review now.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What are subclaim D/note and absent score/status/axes?
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

N03 · What are PSA-detected localized disease and actual age/population?

Required materials and conditions: PSA-detected localized prostate cancer, ages 50–69
Conditions for verification: For PSA-detected localized prostate cancer, ages 50–69, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Required
Application exceptions: Do not extend to treatment selection for all prostate-cancer patients or PSA-testing guidance.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What are PSA-detected localized disease and actual age/population?
Referenced methods: M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application

N04 · Are risk/pathology/baseline status and subgroup denominators verified?

Required materials and conditions: Risk/pathology, diagnostic criteria and arm/subgroup results
Conditions for verification: For Risk/pathology, diagnostic criteria and arm/subgroup results, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Required
Application exceptions: Do not add externally familiar risk proportions/grades or copy overall results to subgroups.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: Are risk/pathology/baseline status and subgroup denominators verified?
Referenced methods: M03 §3.2.1; detailed population conditions are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application

N05 · What was the historical PSA-led active-monitoring strategy?

Required materials and conditions: Historical monitoring, follow-up/switching criteria and contemporary active surveillance
Conditions for verification: For Historical monitoring, follow-up/switching criteria and contemporary active surveillance, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Required
Application exceptions: Do not convert into PSA-testing/risk-selection/monitoring schedules or implementation/efficacy conclusions for all contemporary surveillance.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What was the historical PSA-led active-monitoring strategy?
Referenced methods: M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed

N06 · What are surgery/radiotherapy comparisons and actual treatment specifications?

Required materials and conditions: Three arms, original surgery/radiotherapy/concurrent care and historical specifications
Conditions for verification: For Three arms, original surgery/radiotherapy/concurrent care and historical specifications, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Required
Application exceptions: Do not extend to superiority of all contemporary surgery/radiotherapy or treatment-replacement/cancer-treatment selection instructions.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What are surgery/radiotherapy comparisons and actual treatment specifications?
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labels and checking adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed

N07 · What time window does 15-year follow-up describe?

Required materials and conditions: Median 15 years, range 11–21, time/denominators
Conditions for verification: For Median 15 years, range 11–21, time/denominators, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Required
Application exceptions: Do not newly calculate a mean/fixed 15-year follow-up or total person-time from the original range.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What time window does 15-year follow-up describe?
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 · What are original prostate-cancer-specific death definitions/adjudication?

Required materials and conditions: Definite/probable prostate-cancer mortality and independent cause-of-death committee
Conditions for verification: For Definite/probable prostate-cancer mortality and independent cause-of-death committee, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Required
Application exceptions: Do not represent preserved quotations as original-text reading or committee-independence verification now.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What are original prostate-cancer-specific death definitions/adjudication?
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation to each question is internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application

N09 · What are 15-year prostate-cancer death events/randomized denominators?

Required materials and conditions: 17/545, 12/553, 16/545, original percentages and overall P
Conditions for verification: For 17/545, 12/553, 16/545, original percentages and overall P, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Required
Application exceptions: Do not newly sum deaths/participants/metastasis events or back-calculate HR/RR/risk differences from percentages.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What are 15-year prostate-cancer death events/randomized denominators?
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; M15 §15.3.1–15.3.3; Chamgap application

N10 · What is the conclusion scope of overall P=.53 and nonsignificance?

Required materials and conditions: Overall three-arm superiority comparison and equivalence/noninferiority boundaries
Conditions for verification: For Overall three-arm superiority comparison and equivalence/noninferiority boundaries, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Required
Application exceptions: Do not copy overall P to each pair or newly judge the three strategies equivalent/harmless or all contemporary monitoring ineffective.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What is the conclusion scope of overall P=.53 and nonsignificance?
Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application

N11 · How does all-cause mortality differ from prostate-cancer-specific mortality?

Required materials and conditions: All/other-cause deaths, events/denominators/duration
Conditions for verification: For All/other-cause deaths, events/denominators/duration, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Required
Application exceptions: Do not transfer 17/12/16 to all-cause deaths or prostate-cancer mortality nonsignificance to equivalent overall survival.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: How does all-cause mortality differ from prostate-cancer-specific mortality?
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, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M03 §3.2.4; internal extension boundaries

N12 · Are time estimates, HR/absolute differences/CI and competing risks verified?

Required materials and conditions: Survival/cause-specific/competing-risk models and estimands
Conditions for verification: For Survival/cause-specific/competing-risk models and estimands, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Required
Application exceptions: Do not calculate new HR/CI, equivalence/power or risk differences from original P/events.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: Are time estimates, HR/absolute differences/CI and competing risks verified?
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; M15 §15.3.1–15.3.3; Chamgap application

N13 · What are the related metastasis/clinical-progression results?

Required materials and conditions: Separate metastasis/progression endpoints, original numbers and mortality boundary
Conditions for verification: For Separate metastasis/progression endpoints, original numbers and mortality boundary, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Supplementary
Application exceptions: Do not add metastasis/progression to mortality or rejudge selected mortality effects from metastasis patterns.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What are the related metastasis/clinical-progression results?
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.4; internal extension boundaries

N14 · Are the 10/15-year cumulative reports from the same cohort?

Required materials and conditions: Original 10/15-year events and same-ProtecT report linkage
Conditions for verification: For Original 10/15-year events and same-ProtecT report linkage, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Supplementary
Application exceptions: Do not newly add 10/15-year events or calculate interval event/participant totals.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: Are the 10/15-year cumulative reports from the same cohort?
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; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application

N15 · Are rescue/radical-treatment switching and assigned strategies distinguished?

Required materials and conditions: Monitoring assignment, actual switching/crossover treatment, timing/criteria
Conditions for verification: For Monitoring assignment, actual switching/crossover treatment, timing/criteria, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Required
Application exceptions: Do not represent monitoring assignment as a group only watched without treatment or create treatment-selection/switching guidance.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: Are rescue/radical-treatment switching and assigned strategies distinguished?
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 §3.2.1–3.2.4; dose/duration/effect-modification details are internally designed

N16 · What are 1,643 randomized, arm counts and 1,610/98% follow-up completeness?

Required materials and conditions: Total/arm randomization, follow-up completeness and endpoint denominators
Conditions for verification: For Total/arm randomization, follow-up completeness and endpoint denominators, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Required
Application exceptions: Do not calculate new missing/withdrawal counts/rates from randomized/complete totals or copy 98% to completeness for all endpoints.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What are 1,643 randomized, arm counts and 1,610/98% follow-up completeness?
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

N17 · What is the scope of loss, unidentified causes and censoring/missingness handling?

Required materials and conditions: Follow-up loss/missing death causes, arm-specific reasons and handling
Conditions for verification: For Follow-up loss/missing death causes, arm-specific reasons and handling, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Required
Application exceptions: Do not newly declare zero missingness, all causes certain or no bias from follow-up-completeness descriptions.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What is the scope of loss, unidentified causes and censoring/missingness handling?
Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application

N18 · Are original ITT and crossover/actual-exposure effects separated?

Required materials and conditions: Assignment-based ITT and estimands after adherence/switching
Conditions for verification: For Assignment-based ITT and estimands after adherence/switching, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Required
Application exceptions: Do not convert randomized ITT results into effects of untreated monitoring itself or equivalence certification.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: Are original ITT and crossover/actual-exposure effects separated?
Referenced methods: M08 §8.2.2, M15 §15.3.1; our own application; M03 §3.2.3, M08 §8.2.2–8.2.3; our own application

N19 · What is the original information on concealment, treatment masking and death adjudication?

Required materials and conditions: Central-computer allocation, unmasked treatment and independent cause-of-death committee
Conditions for verification: For Central-computer allocation, unmasked treatment and independent cause-of-death committee, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Required
Application exceptions: Do not certify historical B0 as passed current QA or absence of all measurement bias.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What is the original information on concealment, treatment masking and death adjudication?
Referenced methods: M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application

N20 · How do original prespecified primary outcome/two registration IDs relate to actual plan reading?

Required materials and conditions: ISRCTN20141297/NCT02044172, original mortality primary outcome and timing/versions
Conditions for verification: For ISRCTN20141297/NCT02044172, original mortality primary outcome and timing/versions, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Required
Application exceptions: Do not normalize the two IDs into one NCT or upgrade original agreement descriptions into registration-content verification now.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: How do original prespecified primary outcome/two registration IDs relate to actual plan reading?
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.5–4.6 collection/selection principles; access/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; current conversion limitations reflect review scope and internal design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed

N21 · Are baseline disease, shared follow-up care/exposure and risk separated?

Required materials and conditions: Arm-specific history, concurrent care/follow-up and risk
Conditions for verification: For Arm-specific history, concurrent care/follow-up and risk, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Required
Application exceptions: Do not add treatment techniques/drugs absent from the summary or risk-selection/treatment-selection instructions.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: Are baseline disease, shared follow-up care/exposure and risk separated?
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1; detailed population conditions are internally designed; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are internally designed

N22 · What is the original scope of funding/sponsorship and adjudication-independence descriptions?

Required materials and conditions: NIHR HTA/NIHR/MRC, Oxford sponsorship and roles
Conditions for verification: For NIHR HTA/NIHR/MRC, Oxford sponsorship and roles, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Required
Application exceptions: Do not convert public funding into absence of all involvement/bias or copy it as individual 2016-report disclosures.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What is the original scope of funding/sponsorship and adjudication-independence descriptions?
Referenced methods: Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item; M08 §8.1–8.2.3; internal application

N23 · How are the same trial/citations, arms/time and related sheets linked?

Required materials and conditions: 15/10-year reports, same ProtecT population and observation relationships
Conditions for verification: For 15/10-year reports, same ProtecT population and observation relationships, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Required
Application exceptions: Two reports do not mean two independent trials or twice as many participants.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: How are the same trial/citations, arms/time and related sheets linked?
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

N24 · What are original PIVOT/SPCG-4 descriptions versus the current report list?

Required materials and conditions: Other-study names/detection methods, direct applicability and reading scope
Conditions for verification: For Other-study names/detection methods, direct applicability and reading scope, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Supplementary
Application exceptions: Do not add invented reports/independent replication from name mentions or rejudge current mortality with other-population results.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What are original PIVOT/SPCG-4 descriptions versus the current report list?
Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application

N25 · What is the extrapolation boundary between contemporary surveillance and historical monitoring?

Required materials and conditions: Historical PSA-led strategy versus contemporary MRI/repeat-biopsy descriptions
Conditions for verification: For Historical PSA-led strategy versus contemporary MRI/repeat-biopsy descriptions, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Supplementary
Application exceptions: Do not newly claim all current monitoring ineffective/equivalent or create testing/repeat-biopsy/treatment instructions.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What is the extrapolation boundary between contemporary surveillance and historical monitoring?
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are internally designed

N26 · Are independent confirmation in the selected scope and same-cohort updates separated?

Required materials and conditions: Direct independent reports versus 10/15-year updates and original R1/I2
Conditions for verification: For Direct independent reports versus 10/15-year updates and original R1/I2, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Required
Application exceptions: Do not inherit parent axes as current independence certification or count cumulative reports at different times as replication.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: Are independent confirmation in the selected scope and same-cohort updates separated?
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

N27 · How are mortality, metastasis/progression and functional harms different questions?

Required materials and conditions: Hard mortality/progression versus urinary/sexual/bowel function
Conditions for verification: For Hard mortality/progression versus urinary/sexual/bowel function, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Supplementary
Application exceptions: Do not newly conclude overall strategy superiority, individual treatment selection/replacement or harmlessness from nonsignificance.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: How are mortality, metastasis/progression and functional harms different questions?
Referenced methods: M03 §3.2.4; internally defined extension boundaries; Chamgap’s interpretation boundaries, referring to M19 principles without executing an official causality tool; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed

N28 · What is the scope of harm updates in the 15-year material?

Required materials and conditions: No new treatment complications reported after 10 years and current access
Conditions for verification: For No new treatment complications reported after 10 years and current access, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Supplementary
Application exceptions: Do not turn no-new-complication reporting into zero adverse effects at 15 years or guaranteed long-term safety.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What is the scope of harm updates in the 15-year material?
Referenced methods: M04 §4.5, §4.6.3; current conversion limitations reflect review scope and internal design; M19 §19.1.2–19.2.4; detailed discrimination is internally designed; M19 §19.1.2–19.2.4; internal application

N29 · What is the scope of preserved summaries, unread external materials and links?

Required materials and conditions: Complete preserved summary and 15/10-year citations/abstracts/full texts/plans
Conditions for verification: For Complete preserved summary and 15/10-year citations/abstracts/full texts/plans, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Required
Application exceptions: Preserve absent DOI/PMCID and unread external material; URLs/IDs do not establish acquisition or access success/failure.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What is the scope of preserved summaries, unread external materials and links?
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

N30 · What are original bilingual text, dates, corrections/axes/absences and history?

Required materials and conditions: Parent D34, languages/dates, empty values, axes/citations
Conditions for verification: For Parent D34, languages/dates, empty values, axes/citations, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Required
Application exceptions: Do not inherit B0 evidence quotations/applied cross-checking as current model review or bias/independence certification.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What are original bilingual text, dates, corrections/axes/absences and history?
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item

N31 · Are harm collection, severity and event definitions verified?

Required materials and conditions: Collection of surgery/radiotherapy functional effects and monitoring progression
Conditions for verification: For Collection of surgery/radiotherapy functional effects and monitoring progression, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Supplementary
Application exceptions: Do not convert mortality nonsignificance into no safety signals, zero harms or equivalent tolerability.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: Are harm collection, severity and event definitions verified?
Referenced methods: M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP

N32 · Are arm-specific harm denominators/comparisons/CI distinguished from mortality denominators?

Required materials and conditions: Valid harm/function observations, arm/time denominators and effects
Conditions for verification: For Valid harm/function observations, arm/time denominators and effects, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Supplementary
Application exceptions: Do not calculate/add unrecorded incontinence/erectile/bowel/sexual-function events, proportions or CI.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: Are arm-specific harm denominators/comparisons/CI distinguished from mortality denominators?
Referenced methods: M19 §19.2.2–19.2.4, M03 §3.2.3; internal application; M19 §19.1.2–19.2.4; internal application

N33 · What are harm timing, post-crossover effects and long-term observation?

Required materials and conditions: Treatment/switching timing, function/events and interval-specific follow-up
Conditions for verification: For Treatment/switching timing, function/events and interval-specific follow-up, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Supplementary
Application exceptions: Do not copy 15-year mortality follow-up as complete 15-year observation/safety verification for all harms.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What are harm timing, post-crossover effects and long-term observation?
Referenced methods: M19 §19.2 design-specific harm questions; temporal-relationship details are internally designed; M19 §19.1.2–19.2.4; internal application

N34 · How are harms attributed to assignment, actual treatment or medical history?

Required materials and conditions: Original strategies, switching/shared exposure, alternative causes and causality
Conditions for verification: For Original strategies, switching/shared exposure, alternative causes and causality, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Supplementary
Application exceptions: Do not combine mortality/metastasis/functional harms into one causal effect or newly give cancer-treatment/procedure instructions.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: How are harms attributed to assignment, actual treatment or medical history?
Referenced methods: M19 §19.2.2–19.2.4 design considerations; detailed confounding records are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application

N35 · Are loss/death/crossover and harm missingness distinguished?

Required materials and conditions: Functional-questionnaire/harm missingness, follow-up completeness and stopping reasons
Conditions for verification: For Functional-questionnaire/harm missingness, follow-up completeness and stopping reasons, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Supplementary
Application exceptions: Do not copy complete follow-up for 1,610 into all valid functional/harm denominators or fill missingness as zero harms.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: Are loss/death/crossover and harm missingness distinguished?
Referenced methods: M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application

N36 · Are independent harm data distinguished from same-cohort reports?

Required materials and conditions: Identity/overlap of 10/15-year and separate harm reports
Conditions for verification: For Identity/overlap of 10/15-year and separate harm reports, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Supplementary
Application exceptions: Do not sum two reports as two independent safety trials or extend to verified absence of all external harm data.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: Are independent harm data distinguished from same-cohort reports?
Referenced methods: M04 §§4.6.1–4.6.2; harm-material adaptation is Chamgap-designed; M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations

N37 · What is the scope for risk/vulnerable populations, contemporary treatments and long-term safety?

Required materials and conditions: Historical localized disease/age versus other risks/strategies and follow-up harms
Conditions for verification: For Historical localized disease/age versus other risks/strategies and follow-up harms, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Supplementary
Application exceptions: Do not newly propose risk-selection/PSA-testing or monitoring/surgery/radiotherapy/treatment-replacement methods.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What is the scope for risk/vulnerable populations, contemporary treatments and long-term safety?
Referenced methods: M19 §19.1.2–19.2.4; internal application; M03 §3.2.1; detailed population conditions are internally designed; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are internally designed

N38 · How do nonsignificance, metastasis/function harms and harmlessness/equivalence relate?

Required materials and conditions: Original ineffective prostate-cancer mortality comparison versus separate progression/harms and causality
Conditions for verification: For Original ineffective prostate-cancer mortality comparison versus separate progression/harms and causality, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Supplementary
Application exceptions: Do not newly conclude the three strategies identical, all contemporary surveillance ineffective, guaranteed safety or an individual’s best treatment.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: How do nonsignificance, metastasis/function harms and harmlessness/equivalence relate?
Referenced methods: Chamgap’s own interpretation boundaries. M19 principles are referenced; no official causality tool was run; M03 §3.2.4; internal extension boundaries; M15 §15.3.1–15.3.3; internal application

N39 · How are subsequent originals, candidate history/versions and incomplete content review linked?

Required materials and conditions: Original summary/conditions, time/denominators/estimands and new evidence/change decisions
Conditions for verification: For Original summary/conditions, time/denominators/estimands and new evidence/change decisions, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Requirement and applicability: Supplementary
Application exceptions: Do not invent current completed clinical-content review/publication from historical cross-checking or original production completion.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: How are subsequent originals, candidate history/versions and incomplete content review linked?
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application

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: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

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

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: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

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

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: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

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

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: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

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

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: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

What the statuses mean

Met: The original content has been reviewed as meeting the conditions. This status is not used in this preparation.
Partly verified: Some information in the stored summary was linked during preparation; clinical verification or review is not complete.
Unverified: Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.
Review incomplete: Review of existing content or actual review incomplete.
Not reported: Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.
Inaccessible: Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.
Insufficient evidence for the conditions: Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.
Not applicable: Used when the reason it does not apply to the original question is stated.
Conflicting data: Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment.

Change history

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

Public reader pages and materials were prepared from the existing 39 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.

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N01 · How are selected 15-year mortality and related metastasis/progression distinguished?

Current findings: The selected original question is significant difference in 15-year prostate-cancer mortality. Link its subclaim record and distinguish the same original verdict’s claim of equivalent metastasis/clinical progression and parent context. No new questions, splits or trials.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish clinical verification/completed content review. Clinical independence was not newly certified.
Reason for missing information: Clinical independence was not newly certified.
Required materials and conditions: Boundary between selected mortality, parent verdict and metastasis/progression results
Materials to obtain first: Original question, mortality/metastasis/progression, population/comparison materials
Further research: Plan distinguishing estimands for different clinical outcomes
Remaining uncertainty: Clinical independence was not newly certified.
Conditions for verification: For Boundary between selected mortality, parent verdict and metastasis/progression results, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: How are selected 15-year mortality and related metastasis/progression distinguished?
Application exceptions: Do not transfer related progression results into selected mortality effects, grades or a new verdict.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application

Related sources R01

N02 · What are subclaim D/note and absent score/status/axes?

Current findings: Preserve selected D and the note Overall P=.53. Subclaim score/status/axes are absent; parent D34 and axes are separate historical context.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish clinical verification/completed content review. Subclaim score/status/axes are absent in the original.
Reason for missing information: Subclaim score/status/axes are absent in the original.
Required materials and conditions: Subclaim D, overall P=.53 versus parent D34 and historical axes
Materials to obtain first: Original subclaim or explicit change events
Further research: Separate original-grade preservation from additional evidence/changes
Remaining uncertainty: Subclaim score/status/axes are absent in the original.
Conditions for verification: For Subclaim D, overall P=.53 versus parent D34 and historical axes, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What are subclaim D/note and absent score/status/axes?
Application exceptions: Do not repurpose parent 34 points or E0/C0/B0 axes as subclaim values or passed content review now.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

Related sources R01

N03 · What are PSA-detected localized disease and actual age/population?

Current findings: The original records PSA-detected localized prostate cancer and 1,643 ProtecT participants aged 50–69. It is not a direct result for clinically detected/metastatic disease or other ages.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish clinical verification/completed content review. Recruitment/diagnosis, staging, comorbidities and eligibility/exclusion details remain unverified.
Reason for missing information: Recruitment/diagnosis, staging, comorbidities and eligibility/exclusion details remain unverified.
Required materials and conditions: PSA-detected localized prostate cancer, ages 50–69
Materials to obtain first: Eligibility, diagnosis and baseline-characteristic tables
Further research: Research specifying detection method, stage and population
Remaining uncertainty: Recruitment/diagnosis, staging, comorbidities and eligibility/exclusion details remain unverified.
Conditions for verification: For PSA-detected localized prostate cancer, ages 50–69, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What are PSA-detected localized disease and actual age/population?
Application exceptions: Do not extend to treatment selection for all prostate-cancer patients or PSA-testing guidance.
Referenced methods: M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application

Related sources R01

N04 · Are risk/pathology/baseline status and subgroup denominators verified?

Current findings: The original summary includes localized/PSA-detected scope but provides no separate risk distribution, pathology/grade, baseline PSA or subgroup denominators/mortality effects.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct materials were not verified within the current summary/unread-external-material scope. Risk classification, baseline pathology/PSA, subgroup denominators/effects and interactions remain unverified.
Reason for missing information: Risk classification, baseline pathology/PSA, subgroup denominators/effects and interactions remain unverified.
Required materials and conditions: Risk/pathology, diagnostic criteria and arm/subgroup results
Materials to obtain first: Baseline/risk/subgroup tables and prespecified analyses
Further research: Research specifying risk and applicability
Remaining uncertainty: Risk classification, baseline pathology/PSA, subgroup denominators/effects and interactions remain unverified.
Conditions for verification: For Risk/pathology, diagnostic criteria and arm/subgroup results, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: Are risk/pathology/baseline status and subgroup denominators verified?
Application exceptions: Do not add externally familiar risk proportions/grades or copy overall results to subgroups.
Referenced methods: M03 §3.2.1; detailed population conditions are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application

Related sources R01

N05 · What was the historical PSA-led active-monitoring strategy?

Current findings: The original intervention was PSA-led active monitoring. The original distinguishes contemporary active surveillance with more MRI/regular repeat biopsy. Specific testing/treatment-switch schedules are absent from the summary.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish clinical verification/completed content review. Historical testing/reassessment, switching criteria/adherence and direct comparison with contemporary strategies remain unverified.
Reason for missing information: Historical testing/reassessment, switching criteria/adherence and direct comparison with contemporary strategies remain unverified.
Required materials and conditions: Historical monitoring, follow-up/switching criteria and contemporary active surveillance
Materials to obtain first: Original monitoring specifications and switching/adherence data
Further research: Research specifying strategies/estimands by period
Remaining uncertainty: Historical testing/reassessment, switching criteria/adherence and direct comparison with contemporary strategies remain unverified.
Conditions for verification: For Historical monitoring, follow-up/switching criteria and contemporary active surveillance, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What was the historical PSA-led active-monitoring strategy?
Application exceptions: Do not convert into PSA-testing/risk-selection/monitoring schedules or implementation/efficacy conclusions for all contemporary surveillance.
Referenced methods: M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed

Related sources R01

N06 · What are surgery/radiotherapy comparisons and actual treatment specifications?

Current findings: The original records allocation of 545 to monitoring, 553 to surgery and 545 to radiotherapy. Detailed historical surgery/radiotherapy techniques, concurrent exposure and adherence/changes are not separately provided.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish clinical verification/completed content review. Treatment methods/adjuvant care, timing/adherence, shared conditions and changes remain unverified.
Reason for missing information: Treatment methods/adjuvant care, timing/adherence, shared conditions and changes remain unverified.
Required materials and conditions: Three arms, original surgery/radiotherapy/concurrent care and historical specifications
Materials to obtain first: Each strategy/shared care and actual exposure/switching records
Further research: Research specifying exact strategy-specific estimands
Remaining uncertainty: Treatment methods/adjuvant care, timing/adherence, shared conditions and changes remain unverified.
Conditions for verification: For Three arms, original surgery/radiotherapy/concurrent care and historical specifications, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What are surgery/radiotherapy comparisons and actual treatment specifications?
Application exceptions: Do not extend to superiority of all contemporary surgery/radiotherapy or treatment-replacement/cancer-treatment selection instructions.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labels and checking adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed

Related sources R01

N07 · What time window does 15-year follow-up describe?

Current findings: Preserve original median follow-up of 15 years, range 11–21. This does not mean every participant had exactly 15 years of identical follow-up or a single-time valid denominator.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish clinical verification/completed content review. Time origins, arm-specific distributions, risk sets, censoring/visit windows remain unverified.
Reason for missing information: Time origins, arm-specific distributions, risk sets, censoring/visit windows remain unverified.
Required materials and conditions: Median 15 years, range 11–21, time/denominators
Materials to obtain first: Individual/arm-specific follow-up, risk sets and analysis definitions
Further research: Plan distinguishing follow-up time from effects at estimation time
Remaining uncertainty: Time origins, arm-specific distributions, risk sets, censoring/visit windows remain unverified.
Conditions for verification: For Median 15 years, range 11–21, time/denominators, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What time window does 15-year follow-up describe?
Application exceptions: Do not newly calculate a mean/fixed 15-year follow-up or total person-time from the original range.
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 R01

N08 · What are original prostate-cancer-specific death definitions/adjudication?

Current findings: The original study description quotes the primary outcome as definite or probable prostate cancer mortality and records independent cause-of-death committee adjudication. This differs from all-cause mortality.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish clinical verification/completed content review. Cause-of-death data/uncertain adjudication, committee procedures, missing causes and original plans remain unread.
Reason for missing information: Cause-of-death data/uncertain adjudication, committee procedures, missing causes and original plans remain unread.
Required materials and conditions: Definite/probable prostate-cancer mortality and independent cause-of-death committee
Materials to obtain first: Death definitions/adjudication plans, cause-specific results and protocol
Further research: Research specifying cause-specific mortality and adjudication
Remaining uncertainty: Cause-of-death data/uncertain adjudication, committee procedures, missing causes and original plans remain unread.
Conditions for verification: For Definite/probable prostate-cancer mortality and independent cause-of-death committee, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What are original prostate-cancer-specific death definitions/adjudication?
Application exceptions: Do not represent preserved quotations as original-text reading or committee-independence verification now.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation to each question is internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application

Related sources R01

N09 · What are 15-year prostate-cancer death events/randomized denominators?

Current findings: The original records monitoring 17/545 (3.1%), surgery 12/553 (2.2%) and radiotherapy 16/545 (2.9%), overall P=.53. Preserve original events/denominators/percentages only; no new totals, differences, rates/CI.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish clinical verification/completed content review. Estimand details, observed proportions/time estimates, censoring/models and each comparison’s CI remain unverified.
Reason for missing information: Estimand details, observed proportions/time estimates, censoring/models and each comparison’s CI remain unverified.
Required materials and conditions: 17/545, 12/553, 16/545, original percentages and overall P
Materials to obtain first: Events/risk sets, estimation methods and comparison-specific analysis tables
Further research: Plan distinguishing events/randomization/time estimands
Remaining uncertainty: Estimand details, observed proportions/time estimates, censoring/models and each comparison’s CI remain unverified.
Conditions for verification: For 17/545, 12/553, 16/545, original percentages and overall P, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What are 15-year prostate-cancer death events/randomized denominators?
Application exceptions: Do not newly sum deaths/participants/metastasis events or back-calculate HR/RR/risk differences from percentages.
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; M15 §15.3.1–15.3.3; Chamgap application

Related sources R01

N10 · What is the conclusion scope of overall P=.53 and nonsignificance?

Current findings: The original specifies nonsignificant mortality differences in a three-arm superiority comparison and that this was not a noninferiority trial or proof of equivalence. Preserve this context for the selected question.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish clinical verification/completed content review. Testing/models, pairwise comparisons/CI and equivalence/noninferiority margins remain unverified.
Reason for missing information: Testing/models, pairwise comparisons/CI and equivalence/noninferiority margins remain unverified.
Required materials and conditions: Overall three-arm superiority comparison and equivalence/noninferiority boundaries
Materials to obtain first: Analysis/SAP and comparison-specific estimates/intervals
Further research: Research prespecifying superiority, comparisons of interest and importance thresholds
Remaining uncertainty: Testing/models, pairwise comparisons/CI and equivalence/noninferiority margins remain unverified.
Conditions for verification: For Overall three-arm superiority comparison and equivalence/noninferiority boundaries, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What is the conclusion scope of overall P=.53 and nonsignificance?
Application exceptions: Do not copy overall P to each pair or newly judge the three strategies equivalent/harmless or all contemporary monitoring ineffective.
Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application

Related sources R01

N11 · How does all-cause mortality differ from prostate-cancer-specific mortality?

Current findings: Core original-summary numbers concern prostate-cancer mortality. All/other-cause death events/denominators and arm-specific estimates/CI are not separately presented.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct materials were not verified within the current summary/unread-external-material scope. All/other-cause death definitions, events/estimates and comparative CI remain unverified.
Reason for missing information: All/other-cause death definitions, events/estimates and comparative CI remain unverified.
Required materials and conditions: All/other-cause deaths, events/denominators/duration
Materials to obtain first: All/cause-specific mortality tables and time/estimation methods
Further research: Plan separating cause-specific from all-cause mortality
Remaining uncertainty: All/other-cause death definitions, events/estimates and comparative CI remain unverified.
Conditions for verification: For All/other-cause deaths, events/denominators/duration, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: How does all-cause mortality differ from prostate-cancer-specific mortality?
Application exceptions: Do not transfer 17/12/16 to all-cause deaths or prostate-cancer mortality nonsignificance to equivalent overall survival.
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, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M03 §3.2.4; internal extension boundaries

Related sources R01

N12 · Are time estimates, HR/absolute differences/CI and competing risks verified?

Current findings: Original events/percentages/overall P are available but HR/time-specific absolute differences, CI and censoring/competing-risk model details are absent from the summary. Parent precision C0 is historical.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct materials were not verified within the current summary/unread-external-material scope. Estimands/time/models, arm risk sets, CI and importance thresholds remain unverified.
Reason for missing information: Estimands/time/models, arm risk sets, CI and importance thresholds remain unverified.
Required materials and conditions: Survival/cause-specific/competing-risk models and estimands
Materials to obtain first: Survival/competing-risk analysis, SAP and estimates/interval tables
Further research: Research specifying estimands, time and competing risks
Remaining uncertainty: Estimands/time/models, arm risk sets, CI and importance thresholds remain unverified.
Conditions for verification: For Survival/cause-specific/competing-risk models and estimands, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: Are time estimates, HR/absolute differences/CI and competing risks verified?
Application exceptions: Do not calculate new HR/CI, equivalence/power or risk differences from original P/events.
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; M15 §15.3.1–15.3.3; Chamgap application

Related sources R01

N13 · What are the related metastasis/clinical-progression results?

Current findings: Original metastasis was 9.4% versus 4.7%/5.0%, and clinical progression 25.9% versus 10.5%/11.0%, described as higher with monitoring. Related subclaim D/note and original roughly twofold/2.5-fold descriptions are preserved as context.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish clinical verification/completed content review. Event definitions/risk sets, estimates/CI, comparisons/multiplicity remain unverified.
Reason for missing information: Event definitions/risk sets, estimates/CI, comparisons/multiplicity remain unverified.
Required materials and conditions: Separate metastasis/progression endpoints, original numbers and mortality boundary
Materials to obtain first: Metastasis/progression definitions, results and SAP
Further research: Plan separating mortality from progression/metastasis
Remaining uncertainty: Event definitions/risk sets, estimates/CI, comparisons/multiplicity remain unverified.
Conditions for verification: For Separate metastasis/progression endpoints, original numbers and mortality boundary, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What are the related metastasis/clinical-progression results?
Application exceptions: Do not add metastasis/progression to mortality or rejudge selected mortality effects from metastasis patterns.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.4; internal extension boundaries

Related sources R01

N14 · Are the 10/15-year cumulative reports from the same cohort?

Current findings: The original records 10-year deaths 8/5/4 and metastases 33/13/16 accumulating at 15 years to 17/12/16 and 51/26/27. The 2016/2023 reports concern different times in the same trial, not independent replication.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish clinical verification/completed content review. Separate valid 10-year denominators/time estimates and observations/related-report details between times remain unverified.
Reason for missing information: Separate valid 10-year denominators/time estimates and observations/related-report details between times remain unverified.
Required materials and conditions: Original 10/15-year events and same-ProtecT report linkage
Materials to obtain first: Same-cohort/report identity and time-specific results/denominators
Further research: Record distinguishing cumulative results/updates by time
Remaining uncertainty: Separate valid 10-year denominators/time estimates and observations/related-report details between times remain unverified.
Conditions for verification: For Original 10/15-year events and same-ProtecT report linkage, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: Are the 10/15-year cumulative reports from the same cohort?
Application exceptions: Do not newly add 10/15-year events or calculate interval event/participant totals.
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; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application

Related sources R01 R02

N15 · Are rescue/radical-treatment switching and assigned strategies distinguished?

Current findings: The original advertising interpretation says many participants later switched to rescue/radical treatment. Exact counts/proportions, arms/timing/reasons and analysis handling are absent from the summary.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish clinical verification/completed content review. Switching/crossover treatment, adherence/actual exposure, timing/criteria/denominators remain unverified.
Reason for missing information: Switching/crossover treatment, adherence/actual exposure, timing/criteria/denominators remain unverified.
Required materials and conditions: Monitoring assignment, actual switching/crossover treatment, timing/criteria
Materials to obtain first: Arm-specific actual-treatment/switching, SAP and timing data
Further research: Research separating assigned-strategy estimands from switching/actual exposure
Remaining uncertainty: Switching/crossover treatment, adherence/actual exposure, timing/criteria/denominators remain unverified.
Conditions for verification: For Monitoring assignment, actual switching/crossover treatment, timing/criteria, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: Are rescue/radical-treatment switching and assigned strategies distinguished?
Application exceptions: Do not represent monitoring assignment as a group only watched without treatment or create treatment-selection/switching guidance.
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 §3.2.1–3.2.4; dose/duration/effect-modification details are internally designed

Related sources R01

N16 · What are 1,643 randomized, arm counts and 1,610/98% follow-up completeness?

Current findings: Preserve original 1,643 (545/553/545) and complete follow-up for 1,610/1,643 (98%). Arm-specific completeness and cause-specific/time-specific valid denominators are not detailed.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish clinical verification/completed content review. Arm/time-specific completeness, causes of death/censoring and missing denominators remain unverified.
Reason for missing information: Arm/time-specific completeness, causes of death/censoring and missing denominators remain unverified.
Required materials and conditions: Total/arm randomization, follow-up completeness and endpoint denominators
Materials to obtain first: Participant flow, follow-up/risk sets and cause-specific data
Further research: Plan separating randomized/follow-up-complete and endpoint-specific denominators
Remaining uncertainty: Arm/time-specific completeness, causes of death/censoring and missing denominators remain unverified.
Conditions for verification: For Total/arm randomization, follow-up completeness and endpoint denominators, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What are 1,643 randomized, arm counts and 1,610/98% follow-up completeness?
Application exceptions: Do not calculate new missing/withdrawal counts/rates from randomized/complete totals or copy 98% to completeness for all endpoints.
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application

Related sources R01

N17 · What is the scope of loss, unidentified causes and censoring/missingness handling?

Current findings: Original 98% follow-up completeness and ITT descriptions exist, but arm-specific missing counts/reasons, unidentified causes, censoring/missingness handling and sensitivity analyses are absent from the summary.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish clinical verification/completed content review. Missingness/censoring, uncertain causes, sensitivity/imputation and arm flow remain unverified.
Reason for missing information: Missingness/censoring, uncertain causes, sensitivity/imputation and arm flow remain unverified.
Required materials and conditions: Follow-up loss/missing death causes, arm-specific reasons and handling
Materials to obtain first: Follow-up/cause-of-death flow, SAP and sensitivity data
Further research: Research prespecifying missingness/censoring/cause adjudication
Remaining uncertainty: Missingness/censoring, uncertain causes, sensitivity/imputation and arm flow remain unverified.
Conditions for verification: For Follow-up loss/missing death causes, arm-specific reasons and handling, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What is the scope of loss, unidentified causes and censoring/missingness handling?
Application exceptions: Do not newly declare zero missingness, all causes certain or no bias from follow-up-completeness descriptions.
Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application

Related sources R01

N18 · Are original ITT and crossover/actual-exposure effects separated?

Current findings: The original study description preserves an intention-to-treat comparison quote. Actual-treatment/post-switch effects, adjustments and adherer-analysis details are absent.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish clinical verification/completed content review. Analysis populations, adjustments/switching/sensitivity and time estimates remain unverified.
Reason for missing information: Analysis populations, adjustments/switching/sensitivity and time estimates remain unverified.
Required materials and conditions: Assignment-based ITT and estimands after adherence/switching
Materials to obtain first: SAP and randomized/actual-treatment analyses
Further research: Plan separating ITT from other estimands
Remaining uncertainty: Analysis populations, adjustments/switching/sensitivity and time estimates remain unverified.
Conditions for verification: For Assignment-based ITT and estimands after adherence/switching, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: Are original ITT and crossover/actual-exposure effects separated?
Application exceptions: Do not convert randomized ITT results into effects of untreated monitoring itself or equivalence certification.
Referenced methods: M08 §8.2.2, M15 §15.3.1; our own application; M03 §3.2.3, M08 §8.2.2–8.2.3; our own application

Related sources R01

N19 · What is the original information on concealment, treatment masking and death adjudication?

Current findings: Original B0 evidence in the study description quotes central-computer allocation, impossibility of treatment masking, an independent cause-of-death committee and ITT. Preserved descriptions are not inherited as external procedural verification now.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish clinical verification/completed content review. Allocation/committee details, data access/masking and original protocol remain unread now.
Reason for missing information: Allocation/committee details, data access/masking and original protocol remain unread now.
Required materials and conditions: Central-computer allocation, unmasked treatment and independent cause-of-death committee
Materials to obtain first: Allocation/committee/adjudication, protocol and SAP
Further research: Research distinguishing treatment from adjudication procedures
Remaining uncertainty: Allocation/committee details, data access/masking and original protocol remain unread now.
Conditions for verification: For Central-computer allocation, unmasked treatment and independent cause-of-death committee, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What is the original information on concealment, treatment masking and death adjudication?
Application exceptions: Do not certify historical B0 as passed current QA or absence of all measurement bias.
Referenced methods: M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application

Related sources R01

N20 · How do original prespecified primary outcome/two registration IDs relate to actual plan reading?

Current findings: The original study description records prespecified prostate-cancer mortality and agreement with two IDs. The original evidence-list registration field remains ISRCTN20141297 · NCT02044172. External registration/protocol/SAP were not read now.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish clinical verification/completed content review. Actual registration versions/plan timing, hierarchy/testing/amendments remain unread.
Reason for missing information: Actual registration versions/plan timing, hierarchy/testing/amendments remain unread.
Required materials and conditions: ISRCTN20141297/NCT02044172, original mortality primary outcome and timing/versions
Materials to obtain first: Registration versions, protocol/SAP and result–plan comparison
Further research: Plan preserving primary/secondary and long-term-follow-up amendments
Remaining uncertainty: Actual registration versions/plan timing, hierarchy/testing/amendments remain unread.
Conditions for verification: For ISRCTN20141297/NCT02044172, original mortality primary outcome and timing/versions, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: How do original prespecified primary outcome/two registration IDs relate to actual plan reading?
Application exceptions: Do not normalize the two IDs into one NCT or upgrade original agreement descriptions into registration-content verification now.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.5–4.6 collection/selection principles; access/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; current conversion limitations reflect review scope and internal design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed

Related sources R01

N21 · Are baseline disease, shared follow-up care/exposure and risk separated?

Current findings: Original PSA-detected localized disease/three-strategy information exists, but arm-specific history/drugs, shared follow-up care and changing-risk details are absent from the summary.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct materials were not verified within the current summary/unread-external-material scope. Baseline/changing history, care/support and arm differences/risk information remain unverified.
Reason for missing information: Baseline/changing history, care/support and arm differences/risk information remain unverified.
Required materials and conditions: Arm-specific history, concurrent care/follow-up and risk
Materials to obtain first: Baseline/arm follow-up and concurrent exposure/care data
Further research: Research specifying shared conditions, assigned strategies and crossover care
Remaining uncertainty: Baseline/changing history, care/support and arm differences/risk information remain unverified.
Conditions for verification: For Arm-specific history, concurrent care/follow-up and risk, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: Are baseline disease, shared follow-up care/exposure and risk separated?
Application exceptions: Do not add treatment techniques/drugs absent from the summary or risk-selection/treatment-selection instructions.
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1; detailed population conditions are internally designed; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are internally designed

Related sources R01

N22 · What is the original scope of funding/sponsorship and adjudication-independence descriptions?

Current findings: The original records main NIHR HTA Programme funding, NIHR/MRC support for long-term follow-up and University of Oxford sponsorship. Public funding/original independent-adjudication descriptions do not replace current disclosure/role review.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish clinical verification/completed content review. Original disclosure/support and design/analysis/data-access/adjudication roles remain unread in detail.
Reason for missing information: Original disclosure/support and design/analysis/data-access/adjudication roles remain unread in detail.
Required materials and conditions: NIHR HTA/NIHR/MRC, Oxford sponsorship and roles
Materials to obtain first: Support/sponsor/conflict-of-interest and role disclosures
Further research: Record specifying funding and adjudication/analysis roles
Remaining uncertainty: Original disclosure/support and design/analysis/data-access/adjudication roles remain unread in detail.
Conditions for verification: For NIHR HTA/NIHR/MRC, Oxford sponsorship and roles, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What is the original scope of funding/sponsorship and adjudication-independence descriptions?
Application exceptions: Do not convert public funding into absence of all involvement/bias or copy it as individual 2016-report disclosures.
Referenced methods: Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item; M08 §8.1–8.2.3; internal application

Related sources R01

N23 · How are the same trial/citations, arms/time and related sheets linked?

Current findings: One original evidence-list row and two citations are separated into R01 (15 years) and R02 (10 years). The same cohort, arms/deaths/metastases/times and related sheets are not added as independent trials/participants.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish clinical verification/completed content review. New certification of related-report overlap and unique trial/participant totals remains unverified.
Reason for missing information: New certification of related-report overlap and unique trial/participant totals remains unverified.
Required materials and conditions: 15/10-year reports, same ProtecT population and observation relationships
Materials to obtain first: Trial/cohort/report identities and observation-unit data
Further research: Record distinguishing reports from trial families
Remaining uncertainty: New certification of related-report overlap and unique trial/participant totals remains unverified.
Conditions for verification: For 15/10-year reports, same ProtecT population and observation relationships, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: How are the same trial/citations, arms/time and related sheets linked?
Application exceptions: Two reports do not mean two independent trials or twice as many participants.
Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

Related sources R01 R02

N24 · What are original PIVOT/SPCG-4 descriptions versus the current report list?

Current findings: The original counterview describes PIVOT’s nonsignificant observation/surgery comparison and SPCG-4’s surgery advantage in a clinically detected population with 10% PSA detection, a different scope. Current citations are two ProtecT reports; originals from the other trials were not read now.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish clinical verification/completed content review. Those studies’ citations/original results, populations/comparators/follow-up/CI remain unverified.
Reason for missing information: Those studies’ citations/original results, populations/comparators/follow-up/CI remain unverified.
Required materials and conditions: Other-study names/detection methods, direct applicability and reading scope
Materials to obtain first: Those studies’ originals and applicability/identity data
Further research: Separate research question with explicit detection method/population
Remaining uncertainty: Those studies’ citations/original results, populations/comparators/follow-up/CI remain unverified.
Conditions for verification: For Other-study names/detection methods, direct applicability and reading scope, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What are original PIVOT/SPCG-4 descriptions versus the current report list?
Application exceptions: Do not add invented reports/independent replication from name mentions or rejudge current mortality with other-population results.
Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application

Related sources R01

N25 · What is the extrapolation boundary between contemporary surveillance and historical monitoring?

Current findings: The original describes contemporary active surveillance as using more MRI/regular repeat biopsy than ProtecT. Direct contemporary-strategy effects/comparisons are absent from the summary.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish clinical verification/completed content review. Contemporary-strategy specifications, direct comparisons/risk populations/follow-up remain unverified.
Reason for missing information: Contemporary-strategy specifications, direct comparisons/risk populations/follow-up remain unverified.
Required materials and conditions: Historical PSA-led strategy versus contemporary MRI/repeat-biopsy descriptions
Materials to obtain first: Direct strategy/period/population-specific data
Further research: Research specifying strategy scope
Remaining uncertainty: Contemporary-strategy specifications, direct comparisons/risk populations/follow-up remain unverified.
Conditions for verification: For Historical PSA-led strategy versus contemporary MRI/repeat-biopsy descriptions, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What is the extrapolation boundary between contemporary surveillance and historical monitoring?
Application exceptions: Do not newly claim all current monitoring ineffective/equivalent or create testing/repeat-biopsy/treatment instructions.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are internally designed

Related sources R01

N26 · Are independent confirmation in the selected scope and same-cohort updates separated?

Current findings: Parent R1/I2 are historical axes and the 10/15-year reports concern the same cohort. Additional direct-study identity/independence was not searched/certified now.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct materials were not verified within the current summary/unread-external-material scope. Separate direct studies’ populations/strategies/times and overlap/independence remain unverified.
Reason for missing information: Separate direct studies’ populations/strategies/times and overlap/independence remain unverified.
Required materials and conditions: Direct independent reports versus 10/15-year updates and original R1/I2
Materials to obtain first: Direct confirmation/trial-identity materials
Further research: Separate research specifying the same question/population/strategies
Remaining uncertainty: Separate direct studies’ populations/strategies/times and overlap/independence remain unverified.
Conditions for verification: For Direct independent reports versus 10/15-year updates and original R1/I2, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: Are independent confirmation in the selected scope and same-cohort updates separated?
Application exceptions: Do not inherit parent axes as current independence certification or count cumulative reports at different times as replication.
Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

Related sources R01 R02

N27 · How are mortality, metastasis/progression and functional harms different questions?

Current findings: The original separately records nonsignificant mortality, increased monitoring metastasis/progression, surgery-related incontinence/erectile effects and radiotherapy-related bowel/sexual effects. No new overall balance assessment of different outcomes.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish clinical verification/completed content review. Each functional/quality-of-life outcome’s event definitions/effects/denominators/CI remain unverified.
Reason for missing information: Each functional/quality-of-life outcome’s event definitions/effects/denominators/CI remain unverified.
Required materials and conditions: Hard mortality/progression versus urinary/sexual/bowel function
Materials to obtain first: Separate mortality/progression/patient-important/harm outcome data
Further research: Plan separating different clinical outcomes and estimands
Remaining uncertainty: Each functional/quality-of-life outcome’s event definitions/effects/denominators/CI remain unverified.
Conditions for verification: For Hard mortality/progression versus urinary/sexual/bowel function, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: How are mortality, metastasis/progression and functional harms different questions?
Application exceptions: Do not newly conclude overall strategy superiority, individual treatment selection/replacement or harmlessness from nonsignificance.
Referenced methods: M03 §3.2.4; internally defined extension boundaries; Chamgap’s interpretation boundaries, referring to M19 principles without executing an official causality tool; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed

Related sources R01

N28 · What is the scope of harm updates in the 15-year material?

Current findings: The original study facts describe no new treatment-complication reporting in the 15-year paper after the 10-year analysis. This is not a current nonreporting determination from external-paper reading and does not mean zero harms/no follow-up.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish clinical verification/completed content review. Actual harm collection/results/updates by interval/report remain unread.
Reason for missing information: Actual harm collection/results/updates by interval/report remain unread.
Required materials and conditions: No new treatment complications reported after 10 years and current access
Materials to obtain first: 10/15-year harm reporting/collection data
Further research: Record separating cumulative efficacy updates from harm-observation scope
Remaining uncertainty: Actual harm collection/results/updates by interval/report remain unread.
Conditions for verification: For No new treatment complications reported after 10 years and current access, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What is the scope of harm updates in the 15-year material?
Application exceptions: Do not turn no-new-complication reporting into zero adverse effects at 15 years or guaranteed long-term safety.
Referenced methods: M04 §4.5, §4.6.3; current conversion limitations reflect review scope and internal design; M19 §19.1.2–19.2.4; detailed discrimination is internally designed; M19 §19.1.2–19.2.4; internal application

Related sources R01 R02

N29 · What is the scope of preserved summaries, unread external materials and links?

Current findings: The complete preserved 2974 summary was read and saved for production. Two original PubMed URLs/registration IDs link original sources; external content/link access/click/testing was not performed.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish clinical verification/completed content review. Current verification of external original methods/results, registration/plans/disclosures is incomplete.
Reason for missing information: Current verification of external original methods/results, registration/plans/disclosures is incomplete.
Required materials and conditions: Complete preserved summary and 15/10-year citations/abstracts/full texts/plans
Materials to obtain first: Acquired originals and actual-reading/additional-evidence events
Further research: Records separating summaries/identities from new acquisition
Remaining uncertainty: Current verification of external original methods/results, registration/plans/disclosures is incomplete.
Conditions for verification: For Complete preserved summary and 15/10-year citations/abstracts/full texts/plans, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What is the scope of preserved summaries, unread external materials and links?
Application exceptions: Preserve absent DOI/PMCID and unread external material; URLs/IDs do not establish acquisition or access success/failure.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

Related sources R01 R02

N30 · What are original bilingual text, dates, corrections/axes/absences and history?

Current findings: Preserve bilingual text, original date 2026-08-26 and empty corrections/deliberation. Parent B/H/R1/I2/E0/B0/C0, true large-hard-endpoint RCT, two other false indicators and empty grade-override reasons are historical context. Separate classification and failed-primary/positive-secondary indicators are unrecorded.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish clinical verification/completed content review. External original quotations/translations and detailed registration/correction comparisons were not performed this time.
Reason for missing information: External original quotations/translations and detailed registration/correction comparisons were not performed this time.
Required materials and conditions: Parent D34, languages/dates, empty values, axes/citations
Materials to obtain first: Language-specific originals/revisions and date/correction events
Further research: Separate original values/absences from new evidence updates
Remaining uncertainty: External original quotations/translations and detailed registration/correction comparisons were not performed this time.
Conditions for verification: For Parent D34, languages/dates, empty values, axes/citations, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What are original bilingual text, dates, corrections/axes/absences and history?
Application exceptions: Do not inherit B0 evidence quotations/applied cross-checking as current model review or bias/independence certification.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item

Related sources R01

N31 · Are harm collection, severity and event definitions verified?

Current findings: The original describes different strategy-specific harms/progression. Collection methods, severity, event definitions and scales/completion are not detailed in the summary.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct materials were not verified within the current summary/unread-external-material scope. Harm definitions/collection, severity and each outcome’s original tables remain unverified.
Reason for missing information: Harm definitions/collection, severity and each outcome’s original tables remain unverified.
Required materials and conditions: Collection of surgery/radiotherapy functional effects and monitoring progression
Materials to obtain first: Harm plans/scales and event/functional-outcome data
Further research: Plan specifying strategy-specific harms and progression
Remaining uncertainty: Harm definitions/collection, severity and each outcome’s original tables remain unverified.
Conditions for verification: For Collection of surgery/radiotherapy functional effects and monitoring progression, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: Are harm collection, severity and event definitions verified?
Application exceptions: Do not convert mortality nonsignificance into no safety signals, zero harms or equivalent tolerability.
Referenced methods: M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP

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N32 · Are arm-specific harm denominators/comparisons/CI distinguished from mortality denominators?

Current findings: Original treatment-specific functional effects are described, but arm-specific denominators/effects/CI for those tests/questionnaires/events are absent. Randomized mortality denominators do not automatically become valid harm denominators.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct materials were not verified within the current summary/unread-external-material scope. Collection/denominators, comparisons/CI for each harm/time remain unverified.
Reason for missing information: Collection/denominators, comparisons/CI for each harm/time remain unverified.
Required materials and conditions: Valid harm/function observations, arm/time denominators and effects
Materials to obtain first: Arm-specific harm/function tables and observation flow
Further research: Research distinguishing efficacy from harm-observation populations
Remaining uncertainty: Collection/denominators, comparisons/CI for each harm/time remain unverified.
Conditions for verification: For Valid harm/function observations, arm/time denominators and effects, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: Are arm-specific harm denominators/comparisons/CI distinguished from mortality denominators?
Application exceptions: Do not calculate/add unrecorded incontinence/erectile/bowel/sexual-function events, proportions or CI.
Referenced methods: M19 §19.2.2–19.2.4, M03 §3.2.3; internal application; M19 §19.1.2–19.2.4; internal application

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N33 · What are harm timing, post-crossover effects and long-term observation?

Current findings: Original long-term follow-up/switching context exists, but post-treatment/post-switch functional-harm timing, persistence/recovery and long-term collection details are absent.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct materials were not verified within the current summary/unread-external-material scope. Exposure/switching, harm occurrence and interval-specific/delayed observation remain unverified.
Reason for missing information: Exposure/switching, harm occurrence and interval-specific/delayed observation remain unverified.
Required materials and conditions: Treatment/switching timing, function/events and interval-specific follow-up
Materials to obtain first: Exposure/switching and harm/function timing data
Further research: Plan distinguishing efficacy follow-up from harm-occurrence timing
Remaining uncertainty: Exposure/switching, harm occurrence and interval-specific/delayed observation remain unverified.
Conditions for verification: For Treatment/switching timing, function/events and interval-specific follow-up, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What are harm timing, post-crossover effects and long-term observation?
Application exceptions: Do not copy 15-year mortality follow-up as complete 15-year observation/safety verification for all harms.
Referenced methods: M19 §19.2 design-specific harm questions; temporal-relationship details are internally designed; M19 §19.1.2–19.2.4; internal application

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N34 · How are harms attributed to assignment, actual treatment or medical history?

Current findings: Original ITT assigned-strategy and subsequent treatment-switching context exists. Models/assessments attributing individual harms to assignment/actual treatment/baseline disease are not detailed in the summary.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct materials were not verified within the current summary/unread-external-material scope. Event-specific actual exposure/history, relatedness/confounding/alternative causes remain unverified.
Reason for missing information: Event-specific actual exposure/history, relatedness/confounding/alternative causes remain unverified.
Required materials and conditions: Original strategies, switching/shared exposure, alternative causes and causality
Materials to obtain first: Individual exposure/switching, events/relatedness and analysis data
Further research: Plan separating assignment from actual exposure/alternative causes
Remaining uncertainty: Event-specific actual exposure/history, relatedness/confounding/alternative causes remain unverified.
Conditions for verification: For Original strategies, switching/shared exposure, alternative causes and causality, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: How are harms attributed to assignment, actual treatment or medical history?
Application exceptions: Do not combine mortality/metastasis/functional harms into one causal effect or newly give cancer-treatment/procedure instructions.
Referenced methods: M19 §19.2.2–19.2.4 design considerations; detailed confounding records are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application

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N35 · Are loss/death/crossover and harm missingness distinguished?

Current findings: Original 98% follow-up completeness and mortality ITT descriptions exist, but function/harm collection completeness, arm-specific missingness/stopping and observation handling after death are not detailed.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct materials were not verified within the current summary/unread-external-material scope. Harm-specific missingness/stopping, competing events/death and handling/sensitivity remain unverified.
Reason for missing information: Harm-specific missingness/stopping, competing events/death and handling/sensitivity remain unverified.
Required materials and conditions: Functional-questionnaire/harm missingness, follow-up completeness and stopping reasons
Materials to obtain first: Harm flow/missingness/death and handling data
Further research: Plan distinguishing harm missingness from mortality follow-up
Remaining uncertainty: Harm-specific missingness/stopping, competing events/death and handling/sensitivity remain unverified.
Conditions for verification: For Functional-questionnaire/harm missingness, follow-up completeness and stopping reasons, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: Are loss/death/crossover and harm missingness distinguished?
Application exceptions: Do not copy complete follow-up for 1,610 into all valid functional/harm denominators or fill missingness as zero harms.
Referenced methods: M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application

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N36 · Are independent harm data distinguished from same-cohort reports?

Current findings: Current preserved citations concern ProtecT’s same-cohort 10/15-year reports. Separate independent harm originals were not searched/acquired now; times/reports/related sheets are not counted as independent harm trials.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct materials were not verified within the current summary/unread-external-material scope. Independent harm data identities/populations/strategies and overlap remain unverified.
Reason for missing information: Independent harm data identities/populations/strategies and overlap remain unverified.
Required materials and conditions: Identity/overlap of 10/15-year and separate harm reports
Materials to obtain first: Related/separate harm reports and identity data
Further research: Record separating the same cohort from independent materials
Remaining uncertainty: Independent harm data identities/populations/strategies and overlap remain unverified.
Conditions for verification: For Identity/overlap of 10/15-year and separate harm reports, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: Are independent harm data distinguished from same-cohort reports?
Application exceptions: Do not sum two reports as two independent safety trials or extend to verified absence of all external harm data.
Referenced methods: M04 §§4.6.1–4.6.2; harm-material adaptation is Chamgap-designed; M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations

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N37 · What is the scope for risk/vulnerable populations, contemporary treatments and long-term safety?

Current findings: Original PSA-detected localized disease, ages 50–69 and historical strategies are not repurposed as direct safety for other risks/diseases/ages or contemporary strategies.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct materials were not verified within the current summary/unread-external-material scope. Direct population/strategy-specific harms and long-term/risk-population data remain unverified.
Reason for missing information: Direct population/strategy-specific harms and long-term/risk-population data remain unverified.
Required materials and conditions: Historical localized disease/age versus other risks/strategies and follow-up harms
Materials to obtain first: Direct risk/strategy/disease-specific harm data
Further research: Research specifying population and long-term safety questions
Remaining uncertainty: Direct population/strategy-specific harms and long-term/risk-population data remain unverified.
Conditions for verification: For Historical localized disease/age versus other risks/strategies and follow-up harms, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: What is the scope for risk/vulnerable populations, contemporary treatments and long-term safety?
Application exceptions: Do not newly propose risk-selection/PSA-testing or monitoring/surgery/radiotherapy/treatment-replacement methods.
Referenced methods: M19 §19.1.2–19.2.4; internal application; M03 §3.2.1; detailed population conditions are internally designed; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are internally designed

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N38 · How do nonsignificance, metastasis/function harms and harmlessness/equivalence relate?

Current findings: Separately preserve overall mortality P=.53, absence of noninferiority design, increased monitoring metastasis/progression, treatment-specific functional harms and parent caution. Nonsignificance does not establish harmlessness/equivalence.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish clinical verification/completed content review. Comparative/causal safety, each effect’s CI/importance and direct contemporary data remain unverified.
Reason for missing information: Comparative/causal safety, each effect’s CI/importance and direct contemporary data remain unverified.
Required materials and conditions: Original ineffective prostate-cancer mortality comparison versus separate progression/harms and causality
Materials to obtain first: Outcome/harm estimates and direct comparisons
Further research: Plan separating different outcomes/estimands
Remaining uncertainty: Comparative/causal safety, each effect’s CI/importance and direct contemporary data remain unverified.
Conditions for verification: For Original ineffective prostate-cancer mortality comparison versus separate progression/harms and causality, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: How do nonsignificance, metastasis/function harms and harmlessness/equivalence relate?
Application exceptions: Do not newly conclude the three strategies identical, all contemporary surveillance ineffective, guaranteed safety or an individual’s best treatment.
Referenced methods: Chamgap’s own interpretation boundaries. M19 principles are referenced; no official causality tool was run; M03 §3.2.4; internal extension boundaries; M15 §15.3.1–15.3.3; internal application

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N39 · How are subsequent originals, candidate history/versions and incomplete content review linked?

Current findings: Conditions were preserved/frozen before separate application. Candidate review-pending/production-eligibility labels remain historical records; current content/question-boundary review is incomplete. Zero new units and unrecorded confirmed independent totals are retained.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish clinical verification/completed content review. Subsequent originals, actual reading, changes/content review and independence decisions do not yet exist.
Reason for missing information: Subsequent originals, actual reading, changes/content review and independence decisions do not yet exist.
Required materials and conditions: Original summary/conditions, time/denominators/estimands and new evidence/change decisions
Materials to obtain first: Additional originals, before/after values, versions and change-decision records
Further research: Research addressing direct gaps in selected 15-year mortality
Remaining uncertainty: Subsequent originals, actual reading, changes/content review and independence decisions do not yet exist.
Conditions for verification: For Original summary/conditions, time/denominators/estimands and new evidence/change decisions, separate original information from unverified details and boundaries on extension to all-cause mortality/progression, harms or contemporary strategies.
Why this condition is needed: Distinguish original population/strategies, mortality/time/denominators and unverified scope for this question: How are subsequent originals, candidate history/versions and incomplete content review linked?
Application exceptions: Do not invent current completed clinical-content review/publication from historical cross-checking or original production completion.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application

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