Vaginal-probe EMG biofeedback × Added benefit at 24 months on top of standard PFMT — Evidence checklist

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 the selected added-device effect and parent verdict distinguished?Required	The selected question is added benefit from a device on top of standard PFMT. Preserve subclaim grade D and its note about one confirmatory trial and exclusion of the 1.9-point/2.5-point thresholds. Parent D with 34 points is broader context. S01 S02 S03	Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. The subclaim has no score/status/axis keys; parent values are not inserted. The sibling question about PFMT itself is not merged into this added-device effect. Review of the existing content remains incomplete.	Separate the existing subclaim, grade D and note from parent score and axes	Update the existing question and parent context separately. This is a recorded proposal; no new search, calculation or experiment was performed.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionWhich population of women was included in OPAL?Required	Preserve the manuscript describing 600 women with stress or mixed urinary incontinence at 23 UK centers, excluding urgency-only incontinence and women unable to contract their pelvic floor muscles. S01	Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Age, baseline severity, recruitment/screening procedures and the mixed-incontinence proportion remain unverified in this summary. Review of the existing content remains incomplete.	Incontinence type, contraction ability, eligibility/exclusions and baseline conditions	Link inclusion and exclusion boundaries to the results. This is a recorded proposal; no new search, calculation or experiment was performed.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionWhat are the device and PFMT common to both groups?Required	The vaginal probe displays pelvic-floor electrical activity as an aid. Both groups received supervised PFMT as an active control. S01	Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. The exact device model, shared/group-specific training, support intensity and actual exposure remain unverified. This wording does not create use or training instructions. Review of the existing content remains incomplete.	Home vaginal-probe EMG, supervised PFMT and actual comparator composition	Separate the shared underlying intervention from the added device component. This is a recorded proposal; no new search, calculation or experiment was performed.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionIs the comparison against no treatment, or about added device benefit?Required	The selected comparison is PFMT plus biofeedback versus PFMT. Improvement in both groups is not transferred to added device benefit. S01	Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Improvement during common PFMT is not certified as an independent causal PFMT effect from this comparison alone. Review of the existing content remains incomplete.	Effect of interest, active comparison and attribution of common treatment	Keep the PFMT-itself and added-device-effect questions separate. This is a recorded proposal; no new search, calculation or experiment was performed.
5	Unverified	Full text not readStored summary read	N05 · Evidence conditionWhat is known about study exposure, duration and adherence?Required	Only the preserved scope of a home vaginal probe, supervised PFMT and a 24-month assessment is linked. S01	The currently required information is unverified in the stored summary. Exact training duration/frequency/exposure, device adherence and group-specific treatment changes/rescue treatment remain unverified. Review of the existing content remains incomplete.	Intervention frequency/duration, actual device use, common treatment and rescue treatment	Record actual exposure separately from observation duration. This is a recorded proposal; no new search, calculation or experiment was performed.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionHow were randomization and baseline balance recorded?Required	The manuscript describes OPAL as a multicenter randomized active-control trial allocating 600 participants, 300 per group. S01	Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Details of allocation sequence, concealment and baseline balance between groups remain unverified. Review of the existing content remains incomplete.	Randomization method, concealment and group-specific baseline characteristics	Distinguish the RCT label from actual allocation information. This is a recorded proposal; no new search, calculation or experiment was performed.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionWhich measurement is affected by blinding limitations?Required	Preserve the original Korean account that participant and therapist blinding was impossible because of the intervention. S01	Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. ICIQ collection, assessor/analyst blinding and differences in response collection remain unverified. Inability to blind is not automatically judged a failure. Review of the existing content remains incomplete.	Participant, therapist and assessor blinding and measurement procedures	Link subjective-symptom measurement conditions to the known limitations. This is a recorded proposal; no new search, calculation or experiment was performed.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionWhat does the 24-month ICIQ-UI SF value measure?Required	The selected key result is ICIQ-UI SF at 24 months. The manuscript calls it the 24-month primary analysis. S01	Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Detailed scale collection, baseline values, change analysis and prespecified hierarchy for other time points/outcomes remain unverified. Review of the existing content remains incomplete.	Scale, units, final value/change, time point and primary-outcome definition	Attribute time point, scale, final values and change values separately. This is a recorded proposal; no new search, calculation or experiment was performed.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionAre group means distinguished from the adjusted mean difference?Required	Preserve the 24-month means of 8.2 versus 8.5 and adjusted mean difference −0.09 as original values. No new difference calculated from the two means replaces the adjusted estimate. S01	Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Explicit group-specific results tables, adjustment variables/model and variance were not read. Review of the existing content remains incomplete.	Group correspondence, original means, adjusted estimator and model	Keep original means and the adjusted comparative estimator as different values. This is a recorded proposal; no new search, calculation or experiment was performed.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionWhat are the observed interval, P value and clinical importance?Required	Preserve adjusted difference −0.09, 95% CI −0.92 to 0.75 and P=0.84. Non-significance is not converted into an exact zero effect or equivalence. S01	Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Details of the original interval model, variance and denominator, and original threshold evidence, were not read. Review of the existing content remains incomplete.	Original effect, CI, P value and range of important differences	Record the observed interval and original importance interpretation within their source scope. This is a recorded proposal; no new search, calculation or experiment was performed.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionWhat prespecified criterion is the 2.5-point threshold?Required	Preserve the original account that OPAL used a clinically important between-group difference of 2.5 points for its sample-size calculation. S01	Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Sample-size assumptions, importance rationale and the original protocol were not read. No new threshold is created. Review of the existing content remains incomplete.	Important between-group difference for sample-size calculation, rationale and timing	Link the original prespecified criterion separately from later analytical criteria. This is a recorded proposal; no new search, calculation or experiment was performed.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionIs the 1.9-point MID from another independent trial?Required	Preserve the original account of a later anchor analysis using OPAL data: two-year conservative-treatment MID 1.9 points, 95% CI 1.1 to 2.7. S01	Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. A separate bibliography, anchor method and denominator are not recorded in this stored review summary. The 1.9-point value is not converted into a prespecified criterion or a new independent trial. Review of the existing content remains incomplete.	Data identity, timing, model and precision of the later anchor analysis	Link the later analysis of the same OPAL data to the original trial. This is a recorded proposal; no new search, calculation or experiment was performed.
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionHow far is the original interpretation of excluding both thresholds preserved?Required	The manuscript records that the observed CI excluded the 1.9-point and 2.5-point thresholds. Preserve this as interpretation history for subclaim D and its note and parent D with 34 points. S01	Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. No new interval/threshold calculation, prespecified-criterion comparison, equivalence certification or certification of no effect from all devices is performed. Review of the existing content remains incomplete.	Original observed interval, 1.9/2.5 criteria and interpretation history	Distinguish the original interpretation from decisions based on new material. This is a recorded proposal; no new search, calculation or experiment was performed.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionHow do allocation and 24-month analysis denominators differ?Required	Preserve separately 600 participants, allocation of 300 per group, 225/235 in the 24-month primary analysis and the original evidence-list total of 460. S01	Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Exact correspondence of observed, completed and model-included denominators and group-specific exclusion reasons remain unverified. No new totals or attrition counts are calculated. Review of the existing content remains incomplete.	Allocation, questionnaire observations and outcome-specific analytical denominators	Link original allocation, observation and analysis denominators separately. This is a recorded proposal; no new search, calculation or experiment was performed.
15	Partly verified	Full text not readStored summary read	N15 · Evidence conditionWhat are the language-specific stored descriptions of return and attrition?Required	Preserve the original Korean wording of approximately 78% questionnaire return and original English wording of approximately 22% questionnaire attrition as their respective stored-summary descriptions. S01	Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Exact denominator, timing and definition correspondence of the two descriptions and group-specific missing-data assumptions remain unverified. No new complementary percentage or missing count is calculated. Review of the existing content remains incomplete.	Questionnaire return, missingness/attrition definitions, group-specific reasons and handling	Distinguish historical wording by language from actual observation/analysis definitions. This is a recorded proposal; no new search, calculation or experiment was performed.
16	Unverified	Full text not readStored summary read	N16 · Evidence conditionDoes the actual analysis estimate assignment effects or adherence effects?Required	The original account gives an adjusted mean difference and the 24-month primary-analysis denominators. S01	The currently required information is unverified in the stored summary. This summary does not specify ITT/PP definitions, missing-data models, adherence effects or sensitivity values. ITT is not inserted by assumption. Review of the existing content remains incomplete.	ITT/PP, effect of interest, adjustment, missingness and sensitivity	Link the effect answered by the analysis to the selected question. This is a recorded proposal; no new search, calculation or experiment was performed.
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionWere the registry, protocol and SAP actually compared?Required	The original registration identifier for S01 is ISRCTN57746448. Only the summary of the 24-month primary analysis and thresholds was linked. S01	Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Registration, protocol, SAP and change history were not read or accessed; agreement with plans or selective reporting is not established. Review of the existing content remains incomplete.	Original registration identifier, plans, change history and primary outcome	Distinguish changes if material comparing prespecified plans with actual reporting is provided. This is a recorded proposal; no new search, calculation or experiment was performed.
18	Partly verified	Full text not readStored summary read	N18 · Evidence conditionWhat were the public funding and sponsor institution?Required	Preserve the Korean wording of full funding by NIHR HTA project 11/71/03 and sponsorship by Glasgow Caledonian University. S01	Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Original itemized spending, institutional roles, contracts and additional disclosures were not read. Full funding is not expanded into verification of every independence issue. Review of the existing content remains incomplete.	Separate funding, project, sponsor institution and roles	Link funding, institutions and actual roles separately. This is a recorded proposal; no new search, calculation or experiment was performed.
19	Unverified	Full text not readStored summary read	N19 · Evidence conditionAre the four manufacturer-related items actually absent?Required	The existing product information records that manufacturer cash funding, free supply, employed authors and outsourced analysis were not verified. S01	The currently required information is unverified in the stored summary. Unverified items are not converted into absence of each relationship or independence certification. Original disclosures and actual roles were not read. Review of the existing content remains incomplete.	Cash funding, free equipment, employed authors and outsourced analysis	Update each unverified item separately. This is a recorded proposal; no new search, calculation or experiment was performed.
20	Unverified	Full text not readStored summary read	N20 · Evidence conditionAre other COI, patents and writing/publication support known?Required	A stored summary describes full NIHR funding and four unverified manufacturer-related items. S01	The currently required information is unverified in the stored summary. Other individual COI, patents, writing/publication support and actual non-involvement remain unverified. Review of the existing content remains incomplete.	Individual disclosures, patents, manuscript/publication costs and roles	Link disclosed roles to their funding scope. This is a recorded proposal; no new search, calculation or experiment was performed.
21	Partly verified	Full text not readStored summary read	N21 · Evidence conditionDid Burgio 2002 test the same device added to PFMT?Required	A three-arm RCT compared three different multicomponent behavioral programs in 222 women with urge or urge-predominant mixed urinary incontinence. S02	Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Exact programs, group-specific denominators and duration remain unverified. This is not converted into direct replication of OPAL adding only a device to the same PFMT. Review of the existing content remains incomplete.	Differences in population, three multicomponent behavioral programs, comparison and outcome	Link this as context with different populations and comparison definitions. This is a recorded proposal; no new search, calculation or experiment was performed.
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionWhat are the values from Burgio's three arms?Required	Preserve original incontinence-episode reductions of 63.1% versus 69.4% versus 58.6%, P=0.23. S02	Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Group/program correspondence, person/episode denominators, definitions, CI and timing remain unverified. No new difference, ratio or OPAL device effect is calculated. Review of the existing content remains incomplete.	Episode reduction, group correspondence, original percentages, P value and denominators	Distinguish episode reduction from ICIQ, quality of life and cure rates. This is a recorded proposal; no new search, calculation or experiment was performed.
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionWhat history do Burgio's registration and funding descriptions record?Required	Preserve US NIA/NIH support and the original registration wording that it did not exist because the study preceded the registration system. S02	Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. This is not a current confirmation of absent registration or a detailed funding/product/author-COI comparison. The wording is not used as an identifier. Review of the existing content remains incomplete.	Registration wording, actual identifier and funding/COI	Record historical wording separately from actual identity material provided. This is a recorded proposal; no new search, calculation or experiment was performed.
24	Partly verified	Full text not readStored summary read	N24 · Evidence conditionWhat are Cochrane's overall comparison and outcome-specific denominators?Required	The original 2024 update gives 33 trials and 3,031 participants for PFMT plus biofeedback versus PFMT overall. Quality of life and cure/improvement are different subsets. S03	Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Included-trial tables, OPAL inclusion, subset overlap and denominator correspondence remain unverified. Overall/subset counts or OPAL participants are not newly added together. Review of the existing content remains incomplete.	Whole review, analytical subsets and trial/participant overlap	Link the review to original trials and outcome analyses. This is a recorded proposal; no new search, calculation or experiment was performed.
25	Partly verified	Full text not readStored summary read	N25 · Evidence conditionIs the review quality-of-life value the same as the added ICIQ effect?Required	The original quality-of-life result is 11 trials, 1,169 participants, SMD −0.07, 95% CI −0.18 to 0.05. S03	Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Scale composition, group-specific analyses, heterogeneity and exact population comparisons were not read. This SMD is not converted into an OPAL ICIQ point difference. Review of the existing content remains incomplete.	Quality-of-life outcome, standardized estimator and subset denominator	Keep quality of life separate from 24-month ICIQ scores. This is a recorded proposal; no new search, calculation or experiment was performed.
26	Partly verified	Full text not readStored summary read	N26 · Evidence conditionHow are review cure/improvement and its lower CI bound preserved?Required	The result is 14 trials, 1,383 participants, OR 1.26, 95% CI 1.00 to 1.58. The manuscript records that a lower bound of 1.00 does not establish either a null result or benefit conclusively. S03	Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Definitions, estimation models, individual-trial denominators/events, unrounded intervals and multiplicity remain unverified. No new significance/benefit/null verdict or CI calculation is made. Review of the existing content remains incomplete.	Cure/improvement definitions, OR, interval and subset denominator	Preserve original interval-boundary wording and separate outcome status. This is a recorded proposal; no new search, calculation or experiment was performed.
27	Unverified	Full text not readStored summary read	N27 · Evidence conditionDo the review funding and registration fields represent actual disclosures?Required	The funding description is 'Cochrane review' and the registration field says 'not applicable'. The former describes material type and is not used as identification of an actual funder. S03	The currently required information is unverified in the stored summary. Actual review funding, COI and plans/registration remain unverified; external material is unread. 'Not applicable' does not certify that plans are absent. Review of the existing content remains incomplete.	Review funding/COI, protocol and registration identity	Distinguish material type from funding and identity fields. This is a recorded proposal; no new search, calculation or experiment was performed.
28	Partly verified	Full text not readStored summary read	N28 · Evidence conditionAre independent replication and later analysis of the same data distinguished?Required	The manuscript records OPAL as the only direct confirmatory trial. Burgio and Cochrane provide context under different conditions, while the later MID uses the same OPAL data. S01 S02 S03	Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Identity of included trials and related reports remains externally unverified. Three reports, review trial counts and the MID analysis are not newly counted as independent replications. Review of the existing content remains incomplete.	Report-to-trial-family-to-result linkage and direct/context relationships	Separate report-item counts from unique clinical-trial/participant counts. This is a recorded proposal; no new search, calculation or experiment was performed.
29	Partly verified	Full text not readStored summary read	N29 · Harm-information gaps supplementing the efficacy tableWhat is the reporting scope of non-serious adverse events?Supplementary	Preserve the original account that 48 participants reported non-serious adverse events and events in 23 participants were judged related or possibly related. S01	Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Group-specific person/event counts, exact collection periods, denominators and assessment methods remain unverified. No new frequency or risk difference uses 600 as a denominator. Review of the existing content remains incomplete.	Person/event counts, group-specific denominators, duration and collection	Separate efficacy-analysis denominators from harm-observation denominators. This is a recorded proposal; no new search, calculation or experiment was performed.
30	Partly verified	Full text not readStored summary read	N30 · Harm-information gaps supplementing the efficacy tableHow far do probe-related event and seriousness descriptions extend?Supplementary	Preserve the original account of vaginal-probe discomfort, bleeding and similar events, with no serious related complication reported. S01	Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Event-specific definitions, timing, concomitant/baseline risks and reporting scope remain unverified. This is not expanded into certification that all serious events or long-term harms are absent. Review of the existing content remains incomplete.	Discomfort, bleeding, serious events, timing and relatedness assessment	Record relatedness, seriousness and reporting-scope limitations separately. This is a recorded proposal; no new search, calculation or experiment was performed.
31	Partly verified	Full text not readStored summary read	N31 · Harm-information gaps supplementing the efficacy tableIs the result extended to excluded groups, learning support, PFMT itself or long-term harm?Supplementary	The manuscript places initial learning support for women unable to contract and PFMT itself outside this verdict. The observation concerns added ICIQ benefit at 24 months. S01 S02 S03	Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Excluded groups, other devices, separate learning purposes, effects beyond 24 months and rare harms remain unverified. No new use, training or treatment instructions are created. Review of the existing content remains incomplete.	Selected scope and direct material for separate populations, uses and durations	Separate the current added-device effect from extended questions. This is a recorded proposal; no new search, calculation or experiment was performed.
32	Partly verified	Full text not readStored summary read	N32 · Evidence conditionWhat is the scope of dates, language-specific wording, original axes and correction history?Required	Preserve parent D with 34 points, axes, 2026-08-26, Korean/English manuscripts, empty corrections/deliberation and historical cross-check wording in the whole review summary. The 2024 review update is historical source information. S01 S02 S03	Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. This does not indicate a current review, registration/correction/retraction check or completion of review now. Differences in information by language are not filled with new translated facts. Review of the existing content remains incomplete.	Original verdict date, Korean/English manuscripts, cross-checking and correction/retraction verification level	Distinguish historical values from production/change events. This is a recorded proposal; no new search, calculation or experiment was performed.
33	Partly verified	Full text not readStored summary read	N33 · Evidence conditionWhat was actually read in the summary and external originals?Required	The whole stored summary and three evidence/citation summaries were read for production, and original source links were retained. The summary is labeled 'summary read'; external material is 'unread'. S01 S02 S03	Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. External originals, registry, protocol, SAP and disclosures were not accessed or link-tested. URLs and registration identifiers are not converted into full-text reading or successful access. Review of the existing content remains incomplete.	Access status of the stored summary, papers, registry, protocol, SAP and disclosures	Link existence, acquisition and actual-reading levels separately for each material. This is a recorded proposal; no new search, calculation or experiment was performed.

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33 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: Women with stress/mixed urinary incontinence able to contract; urgency-only incontinence and inability to contract excluded
Ingredient, formulation and route: Home vaginal-probe EMG biofeedback added to supervised PFMT
Dose: Not recorded
Comparator: Supervised PFMT common to both groups; active comparison of added device benefit
Measured outcome: 24-month ICIQ-UI SF and adjusted mean difference; distinct from quality of life, episodes and cure rates
Duration: 24-month assessment; exact study training/device-exposure duration unverified
Questions outside this scope: Relabeling improvement during common PFMT as added device benefit or certification of a causal PFMT effect from this comparison alone; Extending the selected population/use to inability to contract, urgency-only incontinence, learning support or other devices; Replacing adjusted −.09 with a new difference calculated from original means 8.2/8.5; Creating a prespecified criterion, new independent trial or additional bibliographic report from the later 1.9-point MID using the same OPAL data; Calculating new attrition, totals or complementary percentages from 225/235, original 460, approximately 78% in Korean/approximately 22% in English; Inventing unverified correspondence for Burgio three-arm programs/populations or adding whole-review, outcome-subset and OPAL participants; Converting the review cure OR lower CI bound of 1.00 into a new significance, benefit or null verdict; Converting 4 unverified manufacturer-related items into absence of each relationship or independence certification; Adding the same bibliography, participants, groups, time points, sibling sheets, outcomes or later analyses as new independent trials/participants; Converting original registration wording of unverified, historical absence before the registration system or not applicable into an actual registration identifier or current confirmation of absent registration; Inheriting parent score/axes or historical cross-checking as subclaim score, current content review or external reading; New numeric calculations, invented values, effects/CIs, grades, independence certification or treatment/device-use/training instructions

Evidence and sources

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

S01 · Hagen S et al. 2020 OPAL

PubMed

Material type: Multicenter randomized active-control trial
Materials actually read: Summary read; external material unread
Findings recorded in the stored summary: 8.2 versus 8.5; adjusted difference −0.09 (95% CI −0.92 to 0.75), P=0.84. Original means and the adjusted difference remain different estimators. The sample-size threshold of 2.5 points, later MID of 1.9 points (95% CI 1.1 to 2.7) using the same OPAL data and original threshold-exclusion interpretation are historical; no new calculation, grade or equivalence certification is made.
Record level: Outcome wording in the stored summary
Study overlap and independent replication: S01 OPAL/ISRCTN57746448 reports a 24-month comparison adding vaginal-probe EMG to supervised PFMT in 600 women with stress/mixed urinary incontinence able to contract, allocated 300 per group. The 225/235, original 460 analysis count and approximately 78% Korean return/approximately 22% English attrition wording remain distinct. The later 1.9-point MID analyzes the same OPAL data; no separate bibliography appears in this stored summary, so no new report/independent trial is created. Report/material-item counts are not totals of unique clinical trials, participants or independent replications; unique clinical totals remain unrecorded. S02 Burgio 2002 compares three different multicomponent behavioral programs in 222 women with urge or urge-predominant mixed incontinence. Exact group/program correspondence is absent from this summary, and population/comparison differ from OPAL. The original wording of absent registration before the registration system is historical, and the actual registration identifier remains null. Report/material-item counts are not unique clinical-trial/participant/independent-replication totals, which remain unrecorded. S03 is the original 2024 Cochrane update synthesis. The different analyses of 33 trials/3031 participants overall, 11 trials/1169 for quality of life and 14 trials/1383 for cure/improvement remain distinct. OPAL inclusion and trial overlap remain unverified; the review is not counted as a new independent RCT or replication. The funding phrase Cochrane review describes material type; actual funding remains unverified. Report/material-item counts are not unique clinical-trial/participant/independent-replication totals, which remain unrecorded.

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

S02 · Burgio KL et al. 2002

PubMed

Material type: Three-arm randomized trial comparing three different multicomponent behavioral programs in urge or urge-predominant mixed urinary incontinence
Materials actually read: Summary read; external material unread
Findings recorded in the stored summary: 63.1% versus 69.4% versus 58.6%, P=0.23. Original episode-reduction values are preserved; program correspondence, CIs and denominators remain unverified. They are not converted into ICIQ point differences, added device benefit or equivalence.
Record level: Outcome wording in the stored summary
Study overlap and independent replication: S01 OPAL/ISRCTN57746448 reports a 24-month comparison adding vaginal-probe EMG to supervised PFMT in 600 women with stress/mixed urinary incontinence able to contract, allocated 300 per group. The 225/235, original 460 analysis count and approximately 78% Korean return/approximately 22% English attrition wording remain distinct. The later 1.9-point MID analyzes the same OPAL data; no separate bibliography appears in this stored summary, so no new report/independent trial is created. Report/material-item counts are not totals of unique clinical trials, participants or independent replications; unique clinical totals remain unrecorded. S02 Burgio 2002 compares three different multicomponent behavioral programs in 222 women with urge or urge-predominant mixed incontinence. Exact group/program correspondence is absent from this summary, and population/comparison differ from OPAL. The original wording of absent registration before the registration system is historical, and the actual registration identifier remains null. Report/material-item counts are not unique clinical-trial/participant/independent-replication totals, which remain unrecorded. S03 is the original 2024 Cochrane update synthesis. The different analyses of 33 trials/3031 participants overall, 11 trials/1169 for quality of life and 14 trials/1383 for cure/improvement remain distinct. OPAL inclusion and trial overlap remain unverified; the review is not counted as a new independent RCT or replication. The funding phrase Cochrane review describes material type; actual funding remains unverified. Report/material-item counts are not unique clinical-trial/participant/independent-replication totals, which remain unrecorded.

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

S03 · Fernandes et al. 2024 Cochrane update

Official source

Material type: Systematic review and meta-analysis
Materials actually read: Summary read; external material unread
Findings recorded in the stored summary: Quality of life: 11 trials, 1,169 participants, SMD −0.07 (95% CI −0.18 to 0.05); cure/improvement: 14 trials, 1,383 participants, OR 1.26 (95% CI 1.00 to 1.58). The manuscript states that a lower cure/improvement CI bound of 1.00 does not conclusively establish either a null result or benefit. No new significance or pooled effect is calculated, and subset/OPAL participants are not added together.
Record level: Outcome wording in the stored summary
Study overlap and independent replication: S01 OPAL/ISRCTN57746448 reports a 24-month comparison adding vaginal-probe EMG to supervised PFMT in 600 women with stress/mixed urinary incontinence able to contract, allocated 300 per group. The 225/235, original 460 analysis count and approximately 78% Korean return/approximately 22% English attrition wording remain distinct. The later 1.9-point MID analyzes the same OPAL data; no separate bibliography appears in this stored summary, so no new report/independent trial is created. Report/material-item counts are not totals of unique clinical trials, participants or independent replications; unique clinical totals remain unrecorded. S02 Burgio 2002 compares three different multicomponent behavioral programs in 222 women with urge or urge-predominant mixed incontinence. Exact group/program correspondence is absent from this summary, and population/comparison differ from OPAL. The original wording of absent registration before the registration system is historical, and the actual registration identifier remains null. Report/material-item counts are not unique clinical-trial/participant/independent-replication totals, which remain unrecorded. S03 is the original 2024 Cochrane update synthesis. The different analyses of 33 trials/3031 participants overall, 11 trials/1169 for quality of life and 14 trials/1383 for cure/improvement remain distinct. OPAL inclusion and trial overlap remain unverified; the review is not counted as a new independent RCT or replication. The funding phrase Cochrane review describes material type; actual funding remains unverified. Report/material-item counts are not unique clinical-trial/participant/independent-replication totals, which remain unrecorded.

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

Report counts versus independent study counts

S01 OPAL/ISRCTN57746448 reports a 24-month comparison adding vaginal-probe EMG to supervised PFMT in 600 women with stress/mixed urinary incontinence able to contract, allocated 300 per group. The 225/235, original 460 analysis count and approximately 78% Korean return/approximately 22% English attrition wording remain distinct. The later 1.9-point MID analyzes the same OPAL data; no separate bibliography appears in this stored summary, so no new report/independent trial is created. Report/material-item counts are not totals of unique clinical trials, participants or independent replications; unique clinical totals remain unrecorded. S02 Burgio 2002 compares three different multicomponent behavioral programs in 222 women with urge or urge-predominant mixed incontinence. Exact group/program correspondence is absent from this summary, and population/comparison differ from OPAL. The original wording of absent registration before the registration system is historical, and the actual registration identifier remains null. Report/material-item counts are not unique clinical-trial/participant/independent-replication totals, which remain unrecorded. S03 is the original 2024 Cochrane update synthesis. The different analyses of 33 trials/3031 participants overall, 11 trials/1169 for quality of life and 14 trials/1383 for cure/improvement remain distinct. OPAL inclusion and trial overlap remain unverified; the review is not counted as a new independent RCT or replication. The funding phrase Cochrane review describes material type; actual funding remains unverified. Report/material-item counts are not unique clinical-trial/participant/independent-replication totals, which remain unrecorded.

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 the selected added-device effect and parent verdict distinguished?

Required materials and conditions: Separate the existing subclaim, grade D and note from parent score and axes
Conditions for verification: Original materials and the applicable analytical scope for Separate the existing subclaim, grade D and note from parent score and axes are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production condition for distinguishing Separate the existing subclaim, grade D and note from parent score and axes and linking required and currently available materials for the selected question.
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

N02 · Which population of women was included in OPAL?

Required materials and conditions: Incontinence type, contraction ability, eligibility/exclusions and baseline conditions
Conditions for verification: Original materials and the applicable analytical scope for Incontinence type, contraction ability, eligibility/exclusions and baseline conditions are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production condition for distinguishing Incontinence type, contraction ability, eligibility/exclusions and baseline conditions and linking required and currently available materials for the selected question.
Referenced methods: M03 §3.2.1; detailed population conditions are Chamgap's own design

N03 · What are the device and PFMT common to both groups?

Required materials and conditions: Home vaginal-probe EMG, supervised PFMT and actual comparator composition
Conditions for verification: Original materials and the applicable analytical scope for Home vaginal-probe EMG, supervised PFMT and actual comparator composition are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production condition for distinguishing Home vaginal-probe EMG, supervised PFMT and actual comparator composition and linking required and currently available materials for the selected question.
Referenced methods: M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application

N04 · Is the comparison against no treatment, or about added device benefit?

Required materials and conditions: Effect of interest, active comparison and attribution of common treatment
Conditions for verification: Original materials and the applicable analytical scope for Effect of interest, active comparison and attribution of common treatment are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production condition for distinguishing Effect of interest, active comparison and attribution of common treatment and linking required and currently available materials for the selected question.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are Chamgap design; M08 §8.2.2, M15 §15.3.1; Chamgap adaptation

N05 · What is known about study exposure, duration and adherence?

Required materials and conditions: Intervention frequency/duration, actual device use, common treatment and rescue treatment
Conditions for verification: Original materials and the applicable analytical scope for Intervention frequency/duration, actual device use, common treatment and rescue treatment are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production condition for distinguishing Intervention frequency/duration, actual device use, common treatment and rescue treatment and linking required and currently available materials for the selected question.
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are our own design

N06 · How were randomization and baseline balance recorded?

Required materials and conditions: Randomization method, concealment and group-specific baseline characteristics
Conditions for verification: Original materials and the applicable analytical scope for Randomization method, concealment and group-specific baseline characteristics are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production condition for distinguishing Randomization method, concealment and group-specific baseline characteristics and linking required and currently available materials for the selected question.
Referenced methods: M08 §8.1–8.2.3; own application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is our own design

N07 · Which measurement is affected by blinding limitations?

Required materials and conditions: Participant, therapist and assessor blinding and measurement procedures
Conditions for verification: Original materials and the applicable analytical scope for Participant, therapist and assessor blinding and measurement procedures are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production condition for distinguishing Participant, therapist and assessor blinding and measurement procedures and linking required and currently available materials for the selected question.
Referenced methods: M08 Table 8.2.a, M03 §3.2.4; internal application

N08 · What does the 24-month ICIQ-UI SF value measure?

Required materials and conditions: Scale, units, final value/change, time point and primary-outcome definition
Conditions for verification: Original materials and the applicable analytical scope for Scale, units, final value/change, time point and primary-outcome definition are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production condition for distinguishing Scale, units, final value/change, time point and primary-outcome definition and linking required and currently available materials for the selected question.
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 · Are group means distinguished from the adjusted mean difference?

Required materials and conditions: Group correspondence, original means, adjusted estimator and model
Conditions for verification: Original materials and the applicable analytical scope for Group correspondence, original means, adjusted estimator and model are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production condition for distinguishing Group correspondence, original means, adjusted estimator and model and linking required and currently available materials for the selected question.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 §8.2.2, M15 §15.3.1; our own application

N10 · What are the observed interval, P value and clinical importance?

Required materials and conditions: Original effect, CI, P value and range of important differences
Conditions for verification: Original materials and the applicable analytical scope for Original effect, CI, P value and range of important differences are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production condition for distinguishing Original effect, CI, P value and range of important differences and linking required and currently available materials for the selected question.
Referenced methods: M15 §15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design

N11 · What prespecified criterion is the 2.5-point threshold?

Required materials and conditions: Important between-group difference for sample-size calculation, rationale and timing
Conditions for verification: Original materials and the applicable analytical scope for Important between-group difference for sample-size calculation, rationale and timing are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production condition for distinguishing Important between-group difference for sample-size calculation, rationale and timing and linking required and currently available materials for the selected question.
Referenced methods: M15 §15.3.1–15.3.3; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application

N12 · Is the 1.9-point MID from another independent trial?

Required materials and conditions: Data identity, timing, model and precision of the later anchor analysis
Conditions for verification: Original materials and the applicable analytical scope for Data identity, timing, model and precision of the later anchor analysis are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production condition for distinguishing Data identity, timing, model and precision of the later anchor analysis and linking required and currently available materials for the selected question.
Referenced methods: M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linking is Chamgap adaptation; M15 §15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation

N13 · How far is the original interpretation of excluding both thresholds preserved?

Required materials and conditions: Original observed interval, 1.9/2.5 criteria and interpretation history
Conditions for verification: Original materials and the applicable analytical scope for Original observed interval, 1.9/2.5 criteria and interpretation history are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production condition for distinguishing Original observed interval, 1.9/2.5 criteria and interpretation history and linking required and currently available materials for the selected question.
Referenced methods: M15 §15.3.1–15.3.3; Chamgap adaptation; M04 §4.5, §4.6.3; limitations of the current material conversion follow the review scope and Chamgap design

N14 · How do allocation and 24-month analysis denominators differ?

Required materials and conditions: Allocation, questionnaire observations and outcome-specific analytical denominators
Conditions for verification: Original materials and the applicable analytical scope for Allocation, questionnaire observations and outcome-specific analytical denominators are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production condition for distinguishing Allocation, questionnaire observations and outcome-specific analytical denominators and linking required and currently available materials for the selected question.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design

N15 · What are the language-specific stored descriptions of return and attrition?

Required materials and conditions: Questionnaire return, missingness/attrition definitions, group-specific reasons and handling
Conditions for verification: Original materials and the applicable analytical scope for Questionnaire return, missingness/attrition definitions, group-specific reasons and handling are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production condition for distinguishing Questionnaire return, missingness/attrition definitions, group-specific reasons and handling and linking required and currently available materials for the selected question.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design; M04 §4.5, §4.6.3; limitations of the current material conversion follow the review scope and Chamgap design; M08 §8.2.2, M15 §15.3.1; Chamgap adaptation

N16 · Does the actual analysis estimate assignment effects or adherence effects?

Required materials and conditions: ITT/PP, effect of interest, adjustment, missingness and sensitivity
Conditions for verification: Original materials and the applicable analytical scope for ITT/PP, effect of interest, adjustment, missingness and sensitivity are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production condition for distinguishing ITT/PP, effect of interest, adjustment, missingness and sensitivity and linking required and currently available materials for the selected question.
Referenced methods: M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.

N17 · Were the registry, protocol and SAP actually compared?

Required materials and conditions: Original registration identifier, plans, change history and primary outcome
Conditions for verification: Original materials and the applicable analytical scope for Original registration identifier, plans, change history and primary outcome are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production condition for distinguishing Original registration identifier, plans, change history and primary outcome and linking required and currently available materials for the selected question.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; Chamgap application; M04 §4.5–4.6 principles for collecting and selecting materials; separation of access and reading and hyperlink rules are Chamgap's own design

N18 · What were the public funding and sponsor institution?

Required materials and conditions: Separate funding, project, sponsor institution and roles
Conditions for verification: Original materials and the applicable analytical scope for Separate funding, project, sponsor institution and roles are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production condition for distinguishing Separate funding, project, sponsor institution and roles and linking required and currently available materials for the selected question.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

N19 · Are the four manufacturer-related items actually absent?

Required materials and conditions: Cash funding, free equipment, employed authors and outsourced analysis
Conditions for verification: Original materials and the applicable analytical scope for Cash funding, free equipment, employed authors and outsourced analysis are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production condition for distinguishing Cash funding, free equipment, employed authors and outsourced analysis and linking required and currently available materials for the selected question.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

N20 · Are other COI, patents and writing/publication support known?

Required materials and conditions: Individual disclosures, patents, manuscript/publication costs and roles
Conditions for verification: Original materials and the applicable analytical scope for Individual disclosures, patents, manuscript/publication costs and roles are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production condition for distinguishing Individual disclosures, patents, manuscript/publication costs and roles and linking required and currently available materials for the selected question.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

N21 · Did Burgio 2002 test the same device added to PFMT?

Required materials and conditions: Differences in population, three multicomponent behavioral programs, comparison and outcome
Conditions for verification: Original materials and the applicable analytical scope for Differences in population, three multicomponent behavioral programs, comparison and outcome are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production condition for distinguishing Differences in population, three multicomponent behavioral programs, comparison and outcome and linking required and currently available materials for the selected question.
Referenced methods: M04 §4.6.1–4.6.2 and M15 §15.3.1: in-house application; M03 §3.2.1: detailed population conditions are in-house; M03 §3.2.2–3.2.3: reverse-direction labeling and test adaptation are in-house.

N22 · What are the values from Burgio's three arms?

Required materials and conditions: Episode reduction, group correspondence, original percentages, P value and denominators
Conditions for verification: Original materials and the applicable analytical scope for Episode reduction, group correspondence, original percentages, P value and denominators are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production condition for distinguishing Episode reduction, group correspondence, original percentages, P value and denominators and linking required and currently available materials for the selected question.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations by question are our own design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations by study design are our own design; M08 §8.2.2, M15 §15.3.1; our own application; M04 §4.6.1–4.6.2, M15 §15.3.1; our own application

N23 · What history do Burgio's registration and funding descriptions record?

Required materials and conditions: Registration wording, actual identifier and funding/COI
Conditions for verification: Original materials and the applicable analytical scope for Registration wording, actual identifier and funding/COI are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production condition for distinguishing Registration wording, actual identifier and funding/COI and linking required and currently available materials for the selected question.
Referenced methods: Chamgap’s own independence/attribution conditions. The official methodological sections in this pilot do not warrant all these detailed items; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation; M04 §4.5, §4.6.3; limitations of the current material conversion follow the review scope and Chamgap design

N24 · What are Cochrane's overall comparison and outcome-specific denominators?

Required materials and conditions: Whole review, analytical subsets and trial/participant overlap
Conditions for verification: Original materials and the applicable analytical scope for Whole review, analytical subsets and trial/participant overlap are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production condition for distinguishing Whole review, analytical subsets and trial/participant overlap and linking required and currently available materials for the selected question.
Referenced methods: Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linking is Chamgap adaptation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design; M04 §4.6.1–4.6.2, M15 §15.3.1; Chamgap adaptation

N25 · Is the review quality-of-life value the same as the added ICIQ effect?

Required materials and conditions: Quality-of-life outcome, standardized estimator and subset denominator
Conditions for verification: Original materials and the applicable analytical scope for Quality-of-life outcome, standardized estimator and subset denominator are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production condition for distinguishing Quality-of-life outcome, standardized estimator and subset denominator and linking required and currently available materials for the selected question.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; M15 §15.3.1–15.3.3; Chamgap adaptation; M04 §4.6.1–4.6.2, M15 §15.3.1; Chamgap adaptation

N26 · How are review cure/improvement and its lower CI bound preserved?

Required materials and conditions: Cure/improvement definitions, OR, interval and subset denominator
Conditions for verification: Original materials and the applicable analytical scope for Cure/improvement definitions, OR, interval and subset denominator are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production condition for distinguishing Cure/improvement definitions, OR, interval and subset denominator and linking required and currently available materials for the selected question.
Referenced methods: M15 §15.3.1–15.3.3; Chamgap adaptation; 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; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design

N27 · Do the review funding and registration fields represent actual disclosures?

Required materials and conditions: Review funding/COI, protocol and registration identity
Conditions for verification: Original materials and the applicable analytical scope for Review funding/COI, protocol and registration identity are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production condition for distinguishing Review funding/COI, protocol and registration identity and linking required and currently available materials for the selected question.
Referenced methods: Chamgap’s own independence/attribution conditions. The official methodological sections in this pilot do not warrant all these detailed items; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation; material-collection/selection principles in M04 §4.5–4.6; separation of access/reading and the hyperlink contract are Chamgap design

N28 · Are independent replication and later analysis of the same data distinguished?

Required materials and conditions: Report-to-trial-family-to-result linkage and direct/context relationships
Conditions for verification: Original materials and the applicable analytical scope for Report-to-trial-family-to-result linkage and direct/context relationships are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production condition for distinguishing Report-to-trial-family-to-result linkage and direct/context relationships and linking required and currently available materials for the selected question.
Referenced methods: M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linking is Chamgap adaptation; M04 §4.6.1–4.6.2, M15 §15.3.1; Chamgap adaptation; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design

N29 · What is the reporting scope of non-serious adverse events?

Required materials and conditions: Person/event counts, group-specific denominators, duration and collection
Conditions for verification: Original materials and the applicable analytical scope for Person/event counts, group-specific denominators, duration and collection are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Requirement and applicability: Supplementary
Application exceptions: Supplement safety-information gaps for the selected subclaim. Incontinence-symptom results or parent safety wording do not establish safety, harm incidence or new device-use instructions.
Why this condition is needed: Production condition for distinguishing Person/event counts, group-specific denominators, duration and collection and linking required and currently available materials for the selected question.
Referenced methods: M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.1.2–19.2.4; detailed distinctions are Chamgap design; M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.1.2–19.2.4, M04 §4.6.3; Chamgap adaptation

N30 · How far do probe-related event and seriousness descriptions extend?

Required materials and conditions: Discomfort, bleeding, serious events, timing and relatedness assessment
Conditions for verification: Original materials and the applicable analytical scope for Discomfort, bleeding, serious events, timing and relatedness assessment are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Requirement and applicability: Supplementary
Application exceptions: Supplement safety-information gaps for the selected subclaim. Incontinence-symptom results or parent safety wording do not establish safety, harm incidence or new device-use instructions.
Why this condition is needed: Production condition for distinguishing Discomfort, bleeding, serious events, timing and relatedness assessment and linking required and currently available materials for the selected question.
Referenced methods: M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.2 design-specific harm questions; temporal-relationship details are Chamgap design; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool

N31 · Is the result extended to excluded groups, learning support, PFMT itself or long-term harm?

Required materials and conditions: Selected scope and direct material for separate populations, uses and durations
Conditions for verification: Original materials and the applicable analytical scope for Selected scope and direct material for separate populations, uses and durations are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Requirement and applicability: Supplementary
Application exceptions: Supplement safety-information gaps for the selected subclaim. Incontinence-symptom results or parent safety wording do not establish safety, harm incidence or new device-use instructions.
Why this condition is needed: Production condition for distinguishing Selected scope and direct material for separate populations, uses and durations and linking required and currently available materials for the selected question.
Referenced methods: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap design; M03 §3.2.4; Chamgap extrapolation boundary; M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation

N32 · What is the scope of dates, language-specific wording, original axes and correction history?

Required materials and conditions: Original verdict date, Korean/English manuscripts, cross-checking and correction/retraction verification level
Conditions for verification: Original materials and the applicable analytical scope for Original verdict date, Korean/English manuscripts, cross-checking and correction/retraction verification level are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production condition for distinguishing Original verdict date, Korean/English manuscripts, cross-checking and correction/retraction verification level and linking required and currently available materials for the selected question.
Referenced methods: M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design; M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are our own design

N33 · What was actually read in the summary and external originals?

Required materials and conditions: Access status of the stored summary, papers, registry, protocol, SAP and disclosures
Conditions for verification: Original materials and the applicable analytical scope for Access status of the stored summary, papers, registry, protocol, SAP and disclosures are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production condition for distinguishing Access status of the stored summary, papers, registry, protocol, SAP and disclosures and linking required and currently available materials for the selected question.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

Referenced methods and the sections actually reviewed

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

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

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

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

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

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

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

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

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

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

Official methodology · §15.2.4, §15.3.1–15.3.3

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

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

Official methodology · §19.1.2, §19.2.1–19.2.4

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

What the statuses mean

Met: Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.
Partly verified: Some information in the stored summary is linked into the table. External comparison/content review is not complete.
Unverified: The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.
Review incomplete: Existing content review remains incomplete.
Not reported: Not reported within the stored material actually read; not extended to the entire primary paper.
Inaccessible: Means an actual access failure. Access not attempted here is not assigned this state.
Not applicable: Not used as a substitute for an evidence gap.
Conflicting data: Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.
Insufficient evidence for the conditions: Marks a gap in additional material required by the selected conditions; not a new efficacy grade.

Change history

2026-10-11 · Public page/material version 1.0

Public reader views and materials were prepared from the existing 33 items. No new clinical search, verification-status change or scoring was performed.

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

Researcher downloads

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

View all item details

N01 · How are the selected added-device effect and parent verdict distinguished?

Current findings: The selected question is added benefit from a device on top of standard PFMT. Preserve subclaim grade D and its note about one confirmatory trial and exclusion of the 1.9-point/2.5-point thresholds. Parent D with 34 points is broader context.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. The subclaim has no score/status/axis keys; parent values are not inserted. The sibling question about PFMT itself is not merged into this added-device effect. Review of the existing content remains incomplete.
Reason for missing information: The subclaim has no score/status/axis keys; parent values are not inserted. The sibling question about PFMT itself is not merged into this added-device effect.
Required materials and conditions: Separate the existing subclaim, grade D and note from parent score and axes
Materials to obtain first: Correction records for the selected claim and parent assessment
Further research: Update the existing question and parent context separately. This is a recorded proposal; no new search, calculation or experiment was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and the applicable analytical scope for Separate the existing subclaim, grade D and note from parent score and axes are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Why this condition is needed: Production condition for distinguishing Separate the existing subclaim, grade D and note from parent score and axes and linking required and currently available materials for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
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 S01 S02 S03

N02 · Which population of women was included in OPAL?

Current findings: Preserve the manuscript describing 600 women with stress or mixed urinary incontinence at 23 UK centers, excluding urgency-only incontinence and women unable to contract their pelvic floor muscles.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Age, baseline severity, recruitment/screening procedures and the mixed-incontinence proportion remain unverified in this summary. Review of the existing content remains incomplete.
Reason for missing information: Age, baseline severity, recruitment/screening procedures and the mixed-incontinence proportion remain unverified in this summary.
Required materials and conditions: Incontinence type, contraction ability, eligibility/exclusions and baseline conditions
Materials to obtain first: OPAL recruitment criteria and baseline characteristics table
Further research: Link inclusion and exclusion boundaries to the results. This is a recorded proposal; no new search, calculation or experiment was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and the applicable analytical scope for Incontinence type, contraction ability, eligibility/exclusions and baseline conditions are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Why this condition is needed: Production condition for distinguishing Incontinence type, contraction ability, eligibility/exclusions and baseline conditions and linking required and currently available materials for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.1; detailed population conditions are Chamgap's own design

Related sources S01

N03 · What are the device and PFMT common to both groups?

Current findings: The vaginal probe displays pelvic-floor electrical activity as an aid. Both groups received supervised PFMT as an active control.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. The exact device model, shared/group-specific training, support intensity and actual exposure remain unverified. This wording does not create use or training instructions. Review of the existing content remains incomplete.
Reason for missing information: The exact device model, shared/group-specific training, support intensity and actual exposure remain unverified. This wording does not create use or training instructions.
Required materials and conditions: Home vaginal-probe EMG, supervised PFMT and actual comparator composition
Materials to obtain first: Device identity and group-specific intervention plans
Further research: Separate the shared underlying intervention from the added device component. This is a recorded proposal; no new search, calculation or experiment was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and the applicable analytical scope for Home vaginal-probe EMG, supervised PFMT and actual comparator composition are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Why this condition is needed: Production condition for distinguishing Home vaginal-probe EMG, supervised PFMT and actual comparator composition and linking required and currently available materials for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application

Related sources S01

N04 · Is the comparison against no treatment, or about added device benefit?

Current findings: The selected comparison is PFMT plus biofeedback versus PFMT. Improvement in both groups is not transferred to added device benefit.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Improvement during common PFMT is not certified as an independent causal PFMT effect from this comparison alone. Review of the existing content remains incomplete.
Reason for missing information: Improvement during common PFMT is not certified as an independent causal PFMT effect from this comparison alone.
Required materials and conditions: Effect of interest, active comparison and attribution of common treatment
Materials to obtain first: Definition of the effect of interest and comparative analysis
Further research: Keep the PFMT-itself and added-device-effect questions separate. This is a recorded proposal; no new search, calculation or experiment was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and the applicable analytical scope for Effect of interest, active comparison and attribution of common treatment are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Why this condition is needed: Production condition for distinguishing Effect of interest, active comparison and attribution of common treatment and linking required and currently available materials for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are Chamgap design; M08 §8.2.2, M15 §15.3.1; Chamgap adaptation

Related sources S01

N05 · What is known about study exposure, duration and adherence?

Current findings: Only the preserved scope of a home vaginal probe, supervised PFMT and a 24-month assessment is linked.
Verification status: Unverified
Materials actually read: Summary read; external material unread
Why unverified: The currently required information is unverified in the stored summary. Exact training duration/frequency/exposure, device adherence and group-specific treatment changes/rescue treatment remain unverified. Review of the existing content remains incomplete.
Reason for missing information: Exact training duration/frequency/exposure, device adherence and group-specific treatment changes/rescue treatment remain unverified.
Required materials and conditions: Intervention frequency/duration, actual device use, common treatment and rescue treatment
Materials to obtain first: Intervention, adherence, concomitant treatment and change records
Further research: Record actual exposure separately from observation duration. This is a recorded proposal; no new search, calculation or experiment was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and the applicable analytical scope for Intervention frequency/duration, actual device use, common treatment and rescue treatment are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Why this condition is needed: Production condition for distinguishing Intervention frequency/duration, actual device use, common treatment and rescue treatment and linking required and currently available materials for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are our own design

Related sources S01

N06 · How were randomization and baseline balance recorded?

Current findings: The manuscript describes OPAL as a multicenter randomized active-control trial allocating 600 participants, 300 per group.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Details of allocation sequence, concealment and baseline balance between groups remain unverified. Review of the existing content remains incomplete.
Reason for missing information: Details of allocation sequence, concealment and baseline balance between groups remain unverified.
Required materials and conditions: Randomization method, concealment and group-specific baseline characteristics
Materials to obtain first: Allocation methods and baseline characteristics
Further research: Distinguish the RCT label from actual allocation information. This is a recorded proposal; no new search, calculation or experiment was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and the applicable analytical scope for Randomization method, concealment and group-specific baseline characteristics are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Why this condition is needed: Production condition for distinguishing Randomization method, concealment and group-specific baseline characteristics and linking required and currently available materials for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 §8.1–8.2.3; own application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is our own design

Related sources S01

N07 · Which measurement is affected by blinding limitations?

Current findings: Preserve the original Korean account that participant and therapist blinding was impossible because of the intervention.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. ICIQ collection, assessor/analyst blinding and differences in response collection remain unverified. Inability to blind is not automatically judged a failure. Review of the existing content remains incomplete.
Reason for missing information: ICIQ collection, assessor/analyst blinding and differences in response collection remain unverified. Inability to blind is not automatically judged a failure.
Required materials and conditions: Participant, therapist and assessor blinding and measurement procedures
Materials to obtain first: Measurement and blinding procedures
Further research: Link subjective-symptom measurement conditions to the known limitations. This is a recorded proposal; no new search, calculation or experiment was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and the applicable analytical scope for Participant, therapist and assessor blinding and measurement procedures are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Why this condition is needed: Production condition for distinguishing Participant, therapist and assessor blinding and measurement procedures and linking required and currently available materials for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a, M03 §3.2.4; internal application

Related sources S01

N08 · What does the 24-month ICIQ-UI SF value measure?

Current findings: The selected key result is ICIQ-UI SF at 24 months. The manuscript calls it the 24-month primary analysis.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Detailed scale collection, baseline values, change analysis and prespecified hierarchy for other time points/outcomes remain unverified. Review of the existing content remains incomplete.
Reason for missing information: Detailed scale collection, baseline values, change analysis and prespecified hierarchy for other time points/outcomes remain unverified.
Required materials and conditions: Scale, units, final value/change, time point and primary-outcome definition
Materials to obtain first: Scale description and prespecified outcome/results tables
Further research: Attribute time point, scale, final values and change values separately. This is a recorded proposal; no new search, calculation or experiment was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and the applicable analytical scope for Scale, units, final value/change, time point and primary-outcome definition are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Why this condition is needed: Production condition for distinguishing Scale, units, final value/change, time point and primary-outcome definition and linking required and currently available materials for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
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 S01

N09 · Are group means distinguished from the adjusted mean difference?

Current findings: Preserve the 24-month means of 8.2 versus 8.5 and adjusted mean difference −0.09 as original values. No new difference calculated from the two means replaces the adjusted estimate.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Explicit group-specific results tables, adjustment variables/model and variance were not read. Review of the existing content remains incomplete.
Reason for missing information: Explicit group-specific results tables, adjustment variables/model and variance were not read.
Required materials and conditions: Group correspondence, original means, adjusted estimator and model
Materials to obtain first: Group-specific results tables and adjusted analysis
Further research: Keep original means and the adjusted comparative estimator as different values. This is a recorded proposal; no new search, calculation or experiment was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and the applicable analytical scope for Group correspondence, original means, adjusted estimator and model are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Why this condition is needed: Production condition for distinguishing Group correspondence, original means, adjusted estimator and model and linking required and currently available materials for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 §8.2.2, M15 §15.3.1; our own application

Related sources S01

N10 · What are the observed interval, P value and clinical importance?

Current findings: Preserve adjusted difference −0.09, 95% CI −0.92 to 0.75 and P=0.84. Non-significance is not converted into an exact zero effect or equivalence.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Details of the original interval model, variance and denominator, and original threshold evidence, were not read. Review of the existing content remains incomplete.
Reason for missing information: Details of the original interval model, variance and denominator, and original threshold evidence, were not read.
Required materials and conditions: Original effect, CI, P value and range of important differences
Materials to obtain first: Analysis tables and importance criteria
Further research: Record the observed interval and original importance interpretation within their source scope. This is a recorded proposal; no new search, calculation or experiment was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and the applicable analytical scope for Original effect, CI, P value and range of important differences are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Why this condition is needed: Production condition for distinguishing Original effect, CI, P value and range of important differences and linking required and currently available materials for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M15 §15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design

Related sources S01

N11 · What prespecified criterion is the 2.5-point threshold?

Current findings: Preserve the original account that OPAL used a clinically important between-group difference of 2.5 points for its sample-size calculation.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Sample-size assumptions, importance rationale and the original protocol were not read. No new threshold is created. Review of the existing content remains incomplete.
Reason for missing information: Sample-size assumptions, importance rationale and the original protocol were not read. No new threshold is created.
Required materials and conditions: Important between-group difference for sample-size calculation, rationale and timing
Materials to obtain first: Sample-size plan and rationale for 2.5 points
Further research: Link the original prespecified criterion separately from later analytical criteria. This is a recorded proposal; no new search, calculation or experiment was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and the applicable analytical scope for Important between-group difference for sample-size calculation, rationale and timing are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Why this condition is needed: Production condition for distinguishing Important between-group difference for sample-size calculation, rationale and timing and linking required and currently available materials for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M15 §15.3.1–15.3.3; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application

Related sources S01

N12 · Is the 1.9-point MID from another independent trial?

Current findings: Preserve the original account of a later anchor analysis using OPAL data: two-year conservative-treatment MID 1.9 points, 95% CI 1.1 to 2.7.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. A separate bibliography, anchor method and denominator are not recorded in this stored review summary. The 1.9-point value is not converted into a prespecified criterion or a new independent trial. Review of the existing content remains incomplete.
Reason for missing information: A separate bibliography, anchor method and denominator are not recorded in this stored review summary. The 1.9-point value is not converted into a prespecified criterion or a new independent trial.
Required materials and conditions: Data identity, timing, model and precision of the later anchor analysis
Materials to obtain first: Later anchor-analysis bibliography, methods and data linkage
Further research: Link the later analysis of the same OPAL data to the original trial. This is a recorded proposal; no new search, calculation or experiment was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and the applicable analytical scope for Data identity, timing, model and precision of the later anchor analysis are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Why this condition is needed: Production condition for distinguishing Data identity, timing, model and precision of the later anchor analysis and linking required and currently available materials for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linking is Chamgap adaptation; M15 §15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation

Related sources S01

N13 · How far is the original interpretation of excluding both thresholds preserved?

Current findings: The manuscript records that the observed CI excluded the 1.9-point and 2.5-point thresholds. Preserve this as interpretation history for subclaim D and its note and parent D with 34 points.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. No new interval/threshold calculation, prespecified-criterion comparison, equivalence certification or certification of no effect from all devices is performed. Review of the existing content remains incomplete.
Reason for missing information: No new interval/threshold calculation, prespecified-criterion comparison, equivalence certification or certification of no effect from all devices is performed.
Required materials and conditions: Original observed interval, 1.9/2.5 criteria and interpretation history
Materials to obtain first: Threshold evidence and original analysis/plans
Further research: Distinguish the original interpretation from decisions based on new material. This is a recorded proposal; no new search, calculation or experiment was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and the applicable analytical scope for Original observed interval, 1.9/2.5 criteria and interpretation history are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Why this condition is needed: Production condition for distinguishing Original observed interval, 1.9/2.5 criteria and interpretation history and linking required and currently available materials for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M15 §15.3.1–15.3.3; Chamgap adaptation; M04 §4.5, §4.6.3; limitations of the current material conversion follow the review scope and Chamgap design

Related sources S01

N14 · How do allocation and 24-month analysis denominators differ?

Current findings: Preserve separately 600 participants, allocation of 300 per group, 225/235 in the 24-month primary analysis and the original evidence-list total of 460.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Exact correspondence of observed, completed and model-included denominators and group-specific exclusion reasons remain unverified. No new totals or attrition counts are calculated. Review of the existing content remains incomplete.
Reason for missing information: Exact correspondence of observed, completed and model-included denominators and group-specific exclusion reasons remain unverified. No new totals or attrition counts are calculated.
Required materials and conditions: Allocation, questionnaire observations and outcome-specific analytical denominators
Materials to obtain first: Outcome-specific flow diagrams and denominator tables
Further research: Link original allocation, observation and analysis denominators separately. This is a recorded proposal; no new search, calculation or experiment was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and the applicable analytical scope for Allocation, questionnaire observations and outcome-specific analytical denominators are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Why this condition is needed: Production condition for distinguishing Allocation, questionnaire observations and outcome-specific analytical denominators and linking required and currently available materials for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design

Related sources S01

N15 · What are the language-specific stored descriptions of return and attrition?

Current findings: Preserve the original Korean wording of approximately 78% questionnaire return and original English wording of approximately 22% questionnaire attrition as their respective stored-summary descriptions.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Exact denominator, timing and definition correspondence of the two descriptions and group-specific missing-data assumptions remain unverified. No new complementary percentage or missing count is calculated. Review of the existing content remains incomplete.
Reason for missing information: Exact denominator, timing and definition correspondence of the two descriptions and group-specific missing-data assumptions remain unverified. No new complementary percentage or missing count is calculated.
Required materials and conditions: Questionnaire return, missingness/attrition definitions, group-specific reasons and handling
Materials to obtain first: Group-specific questionnaire flow and missing-data handling
Further research: Distinguish historical wording by language from actual observation/analysis definitions. This is a recorded proposal; no new search, calculation or experiment was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and the applicable analytical scope for Questionnaire return, missingness/attrition definitions, group-specific reasons and handling are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Why this condition is needed: Production condition for distinguishing Questionnaire return, missingness/attrition definitions, group-specific reasons and handling and linking required and currently available materials for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design; M04 §4.5, §4.6.3; limitations of the current material conversion follow the review scope and Chamgap design; M08 §8.2.2, M15 §15.3.1; Chamgap adaptation

Related sources S01

N16 · Does the actual analysis estimate assignment effects or adherence effects?

Current findings: The original account gives an adjusted mean difference and the 24-month primary-analysis denominators.
Verification status: Unverified
Materials actually read: Summary read; external material unread
Why unverified: The currently required information is unverified in the stored summary. This summary does not specify ITT/PP definitions, missing-data models, adherence effects or sensitivity values. ITT is not inserted by assumption. Review of the existing content remains incomplete.
Reason for missing information: This summary does not specify ITT/PP definitions, missing-data models, adherence effects or sensitivity values. ITT is not inserted by assumption.
Required materials and conditions: ITT/PP, effect of interest, adjustment, missingness and sensitivity
Materials to obtain first: SAP, analysis-population definitions and sensitivity results
Further research: Link the effect answered by the analysis to the selected question. This is a recorded proposal; no new search, calculation or experiment was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and the applicable analytical scope for ITT/PP, effect of interest, adjustment, missingness and sensitivity are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Why this condition is needed: Production condition for distinguishing ITT/PP, effect of interest, adjustment, missingness and sensitivity and linking required and currently available materials for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.

Related sources S01

N17 · Were the registry, protocol and SAP actually compared?

Current findings: The original registration identifier for S01 is ISRCTN57746448. Only the summary of the 24-month primary analysis and thresholds was linked.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Registration, protocol, SAP and change history were not read or accessed; agreement with plans or selective reporting is not established. Review of the existing content remains incomplete.
Reason for missing information: Registration, protocol, SAP and change history were not read or accessed; agreement with plans or selective reporting is not established.
Required materials and conditions: Original registration identifier, plans, change history and primary outcome
Materials to obtain first: Registration history, protocol, and SAP
Further research: Distinguish changes if material comparing prespecified plans with actual reporting is provided. This is a recorded proposal; no new search, calculation or experiment was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and the applicable analytical scope for Original registration identifier, plans, change history and primary outcome are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Why this condition is needed: Production condition for distinguishing Original registration identifier, plans, change history and primary outcome and linking required and currently available materials for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; Chamgap application; M04 §4.5–4.6 principles for collecting and selecting materials; separation of access and reading and hyperlink rules are Chamgap's own design

Related sources S01

N18 · What were the public funding and sponsor institution?

Current findings: Preserve the Korean wording of full funding by NIHR HTA project 11/71/03 and sponsorship by Glasgow Caledonian University.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Original itemized spending, institutional roles, contracts and additional disclosures were not read. Full funding is not expanded into verification of every independence issue. Review of the existing content remains incomplete.
Reason for missing information: Original itemized spending, institutional roles, contracts and additional disclosures were not read. Full funding is not expanded into verification of every independence issue.
Required materials and conditions: Separate funding, project, sponsor institution and roles
Materials to obtain first: NIHR/sponsor and COI disclosures
Further research: Link funding, institutions and actual roles separately. This is a recorded proposal; no new search, calculation or experiment was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and the applicable analytical scope for Separate funding, project, sponsor institution and roles are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Why this condition is needed: Production condition for distinguishing Separate funding, project, sponsor institution and roles and linking required and currently available materials for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

Related sources S01

N19 · Are the four manufacturer-related items actually absent?

Current findings: The existing product information records that manufacturer cash funding, free supply, employed authors and outsourced analysis were not verified.
Verification status: Unverified
Materials actually read: Summary read; external material unread
Why unverified: The currently required information is unverified in the stored summary. Unverified items are not converted into absence of each relationship or independence certification. Original disclosures and actual roles were not read. Review of the existing content remains incomplete.
Reason for missing information: Unverified items are not converted into absence of each relationship or independence certification. Original disclosures and actual roles were not read.
Required materials and conditions: Cash funding, free equipment, employed authors and outsourced analysis
Materials to obtain first: Manufacturer provision, author affiliations and analysis contracts
Further research: Update each unverified item separately. This is a recorded proposal; no new search, calculation or experiment was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and the applicable analytical scope for Cash funding, free equipment, employed authors and outsourced analysis are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Why this condition is needed: Production condition for distinguishing Cash funding, free equipment, employed authors and outsourced analysis and linking required and currently available materials for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

Related sources S01

N20 · Are other COI, patents and writing/publication support known?

Current findings: A stored summary describes full NIHR funding and four unverified manufacturer-related items.
Verification status: Unverified
Materials actually read: Summary read; external material unread
Why unverified: The currently required information is unverified in the stored summary. Other individual COI, patents, writing/publication support and actual non-involvement remain unverified. Review of the existing content remains incomplete.
Reason for missing information: Other individual COI, patents, writing/publication support and actual non-involvement remain unverified.
Required materials and conditions: Individual disclosures, patents, manuscript/publication costs and roles
Materials to obtain first: Individual COI and writing/publication-support disclosures
Further research: Link disclosed roles to their funding scope. This is a recorded proposal; no new search, calculation or experiment was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and the applicable analytical scope for Individual disclosures, patents, manuscript/publication costs and roles are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Why this condition is needed: Production condition for distinguishing Individual disclosures, patents, manuscript/publication costs and roles and linking required and currently available materials for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

Related sources S01

N21 · Did Burgio 2002 test the same device added to PFMT?

Current findings: A three-arm RCT compared three different multicomponent behavioral programs in 222 women with urge or urge-predominant mixed urinary incontinence.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Exact programs, group-specific denominators and duration remain unverified. This is not converted into direct replication of OPAL adding only a device to the same PFMT. Review of the existing content remains incomplete.
Reason for missing information: Exact programs, group-specific denominators and duration remain unverified. This is not converted into direct replication of OPAL adding only a device to the same PFMT.
Required materials and conditions: Differences in population, three multicomponent behavioral programs, comparison and outcome
Materials to obtain first: Burgio intervention/comparator, population and methods tables
Further research: Link this as context with different populations and comparison definitions. This is a recorded proposal; no new search, calculation or experiment was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and the applicable analytical scope for Differences in population, three multicomponent behavioral programs, comparison and outcome are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Why this condition is needed: Production condition for distinguishing Differences in population, three multicomponent behavioral programs, comparison and outcome and linking required and currently available materials for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.6.1–4.6.2 and M15 §15.3.1: in-house application; M03 §3.2.1: detailed population conditions are in-house; M03 §3.2.2–3.2.3: reverse-direction labeling and test adaptation are in-house.

Related sources S02

N22 · What are the values from Burgio's three arms?

Current findings: Preserve original incontinence-episode reductions of 63.1% versus 69.4% versus 58.6%, P=0.23.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Group/program correspondence, person/episode denominators, definitions, CI and timing remain unverified. No new difference, ratio or OPAL device effect is calculated. Review of the existing content remains incomplete.
Reason for missing information: Group/program correspondence, person/episode denominators, definitions, CI and timing remain unverified. No new difference, ratio or OPAL device effect is calculated.
Required materials and conditions: Episode reduction, group correspondence, original percentages, P value and denominators
Materials to obtain first: Three-arm results tables, definitions and denominators
Further research: Distinguish episode reduction from ICIQ, quality of life and cure rates. This is a recorded proposal; no new search, calculation or experiment was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and the applicable analytical scope for Episode reduction, group correspondence, original percentages, P value and denominators are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Why this condition is needed: Production condition for distinguishing Episode reduction, group correspondence, original percentages, P value and denominators and linking required and currently available materials for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations by question are our own design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations by study design are our own design; M08 §8.2.2, M15 §15.3.1; our own application; M04 §4.6.1–4.6.2, M15 §15.3.1; our own application

Related sources S02

N23 · What history do Burgio's registration and funding descriptions record?

Current findings: Preserve US NIA/NIH support and the original registration wording that it did not exist because the study preceded the registration system.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. This is not a current confirmation of absent registration or a detailed funding/product/author-COI comparison. The wording is not used as an identifier. Review of the existing content remains incomplete.
Reason for missing information: This is not a current confirmation of absent registration or a detailed funding/product/author-COI comparison. The wording is not used as an identifier.
Required materials and conditions: Registration wording, actual identifier and funding/COI
Materials to obtain first: Original trial plans, funding and COI
Further research: Record historical wording separately from actual identity material provided. This is a recorded proposal; no new search, calculation or experiment was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and the applicable analytical scope for Registration wording, actual identifier and funding/COI are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Why this condition is needed: Production condition for distinguishing Registration wording, actual identifier and funding/COI and linking required and currently available materials for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Chamgap’s own independence/attribution conditions. The official methodological sections in this pilot do not warrant all these detailed items; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation; M04 §4.5, §4.6.3; limitations of the current material conversion follow the review scope and Chamgap design

Related sources S02

N24 · What are Cochrane's overall comparison and outcome-specific denominators?

Current findings: The original 2024 update gives 33 trials and 3,031 participants for PFMT plus biofeedback versus PFMT overall. Quality of life and cure/improvement are different subsets.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Included-trial tables, OPAL inclusion, subset overlap and denominator correspondence remain unverified. Overall/subset counts or OPAL participants are not newly added together. Review of the existing content remains incomplete.
Reason for missing information: Included-trial tables, OPAL inclusion, subset overlap and denominator correspondence remain unverified. Overall/subset counts or OPAL participants are not newly added together.
Required materials and conditions: Whole review, analytical subsets and trial/participant overlap
Materials to obtain first: Review included-trial tables and outcome-specific linkage tables
Further research: Link the review to original trials and outcome analyses. This is a recorded proposal; no new search, calculation or experiment was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and the applicable analytical scope for Whole review, analytical subsets and trial/participant overlap are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Why this condition is needed: Production condition for distinguishing Whole review, analytical subsets and trial/participant overlap and linking required and currently available materials for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linking is Chamgap adaptation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design; M04 §4.6.1–4.6.2, M15 §15.3.1; Chamgap adaptation

Related sources S03

N25 · Is the review quality-of-life value the same as the added ICIQ effect?

Current findings: The original quality-of-life result is 11 trials, 1,169 participants, SMD −0.07, 95% CI −0.18 to 0.05.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Scale composition, group-specific analyses, heterogeneity and exact population comparisons were not read. This SMD is not converted into an OPAL ICIQ point difference. Review of the existing content remains incomplete.
Reason for missing information: Scale composition, group-specific analyses, heterogeneity and exact population comparisons were not read. This SMD is not converted into an OPAL ICIQ point difference.
Required materials and conditions: Quality-of-life outcome, standardized estimator and subset denominator
Materials to obtain first: Outcome-specific forest plots and scale/denominator material
Further research: Keep quality of life separate from 24-month ICIQ scores. This is a recorded proposal; no new search, calculation or experiment was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and the applicable analytical scope for Quality-of-life outcome, standardized estimator and subset denominator are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Why this condition is needed: Production condition for distinguishing Quality-of-life outcome, standardized estimator and subset denominator and linking required and currently available materials for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; M15 §15.3.1–15.3.3; Chamgap adaptation; M04 §4.6.1–4.6.2, M15 §15.3.1; Chamgap adaptation

Related sources S03

N26 · How are review cure/improvement and its lower CI bound preserved?

Current findings: The result is 14 trials, 1,383 participants, OR 1.26, 95% CI 1.00 to 1.58. The manuscript records that a lower bound of 1.00 does not establish either a null result or benefit conclusively.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Definitions, estimation models, individual-trial denominators/events, unrounded intervals and multiplicity remain unverified. No new significance/benefit/null verdict or CI calculation is made. Review of the existing content remains incomplete.
Reason for missing information: Definitions, estimation models, individual-trial denominators/events, unrounded intervals and multiplicity remain unverified. No new significance/benefit/null verdict or CI calculation is made.
Required materials and conditions: Cure/improvement definitions, OR, interval and subset denominator
Materials to obtain first: Cure/improvement definitions and review analysis tables
Further research: Preserve original interval-boundary wording and separate outcome status. This is a recorded proposal; no new search, calculation or experiment was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and the applicable analytical scope for Cure/improvement definitions, OR, interval and subset denominator are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Why this condition is needed: Production condition for distinguishing Cure/improvement definitions, OR, interval and subset denominator and linking required and currently available materials for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M15 §15.3.1–15.3.3; Chamgap adaptation; 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; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design

Related sources S03

N27 · Do the review funding and registration fields represent actual disclosures?

Current findings: The funding description is 'Cochrane review' and the registration field says 'not applicable'. The former describes material type and is not used as identification of an actual funder.
Verification status: Unverified
Materials actually read: Summary read; external material unread
Why unverified: The currently required information is unverified in the stored summary. Actual review funding, COI and plans/registration remain unverified; external material is unread. 'Not applicable' does not certify that plans are absent. Review of the existing content remains incomplete.
Reason for missing information: Actual review funding, COI and plans/registration remain unverified; external material is unread. 'Not applicable' does not certify that plans are absent.
Required materials and conditions: Review funding/COI, protocol and registration identity
Materials to obtain first: Review funding/COI and protocol material
Further research: Distinguish material type from funding and identity fields. This is a recorded proposal; no new search, calculation or experiment was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and the applicable analytical scope for Review funding/COI, protocol and registration identity are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Why this condition is needed: Production condition for distinguishing Review funding/COI, protocol and registration identity and linking required and currently available materials for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Chamgap’s own independence/attribution conditions. The official methodological sections in this pilot do not warrant all these detailed items; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation; material-collection/selection principles in M04 §4.5–4.6; separation of access/reading and the hyperlink contract are Chamgap design

Related sources S03

N28 · Are independent replication and later analysis of the same data distinguished?

Current findings: The manuscript records OPAL as the only direct confirmatory trial. Burgio and Cochrane provide context under different conditions, while the later MID uses the same OPAL data.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Identity of included trials and related reports remains externally unverified. Three reports, review trial counts and the MID analysis are not newly counted as independent replications. Review of the existing content remains incomplete.
Reason for missing information: Identity of included trials and related reports remains externally unverified. Three reports, review trial counts and the MID analysis are not newly counted as independent replications.
Required materials and conditions: Report-to-trial-family-to-result linkage and direct/context relationships
Materials to obtain first: Related reports, registrations and review included-trial linkage
Further research: Separate report-item counts from unique clinical-trial/participant counts. This is a recorded proposal; no new search, calculation or experiment was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and the applicable analytical scope for Report-to-trial-family-to-result linkage and direct/context relationships are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Why this condition is needed: Production condition for distinguishing Report-to-trial-family-to-result linkage and direct/context relationships and linking required and currently available materials for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linking is Chamgap adaptation; M04 §4.6.1–4.6.2, M15 §15.3.1; Chamgap adaptation; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design

Related sources S01 S02 S03

N29 · What is the reporting scope of non-serious adverse events?

Current findings: Preserve the original account that 48 participants reported non-serious adverse events and events in 23 participants were judged related or possibly related.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Group-specific person/event counts, exact collection periods, denominators and assessment methods remain unverified. No new frequency or risk difference uses 600 as a denominator. Review of the existing content remains incomplete.
Reason for missing information: Group-specific person/event counts, exact collection periods, denominators and assessment methods remain unverified. No new frequency or risk difference uses 600 as a denominator.
Required materials and conditions: Person/event counts, group-specific denominators, duration and collection
Materials to obtain first: Group-specific adverse-event tables and collection/assessment plans
Further research: Separate efficacy-analysis denominators from harm-observation denominators. This is a recorded proposal; no new search, calculation or experiment was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and the applicable analytical scope for Person/event counts, group-specific denominators, duration and collection are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Why this condition is needed: Production condition for distinguishing Person/event counts, group-specific denominators, duration and collection and linking required and currently available materials for the selected question.
Application exceptions: Supplement safety-information gaps for the selected subclaim. Incontinence-symptom results or parent safety wording do not establish safety, harm incidence or new device-use instructions.
Referenced methods: M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.1.2–19.2.4; detailed distinctions are Chamgap design; M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.1.2–19.2.4, M04 §4.6.3; Chamgap adaptation

Related sources S01

N30 · How far do probe-related event and seriousness descriptions extend?

Current findings: Preserve the original account of vaginal-probe discomfort, bleeding and similar events, with no serious related complication reported.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Event-specific definitions, timing, concomitant/baseline risks and reporting scope remain unverified. This is not expanded into certification that all serious events or long-term harms are absent. Review of the existing content remains incomplete.
Reason for missing information: Event-specific definitions, timing, concomitant/baseline risks and reporting scope remain unverified. This is not expanded into certification that all serious events or long-term harms are absent.
Required materials and conditions: Discomfort, bleeding, serious events, timing and relatedness assessment
Materials to obtain first: Event details and relatedness-assessment material
Further research: Record relatedness, seriousness and reporting-scope limitations separately. This is a recorded proposal; no new search, calculation or experiment was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and the applicable analytical scope for Discomfort, bleeding, serious events, timing and relatedness assessment are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Why this condition is needed: Production condition for distinguishing Discomfort, bleeding, serious events, timing and relatedness assessment and linking required and currently available materials for the selected question.
Application exceptions: Supplement safety-information gaps for the selected subclaim. Incontinence-symptom results or parent safety wording do not establish safety, harm incidence or new device-use instructions.
Referenced methods: M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.2 design-specific harm questions; temporal-relationship details are Chamgap design; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool

Related sources S01

N31 · Is the result extended to excluded groups, learning support, PFMT itself or long-term harm?

Current findings: The manuscript places initial learning support for women unable to contract and PFMT itself outside this verdict. The observation concerns added ICIQ benefit at 24 months.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Excluded groups, other devices, separate learning purposes, effects beyond 24 months and rare harms remain unverified. No new use, training or treatment instructions are created. Review of the existing content remains incomplete.
Reason for missing information: Excluded groups, other devices, separate learning purposes, effects beyond 24 months and rare harms remain unverified. No new use, training or treatment instructions are created.
Required materials and conditions: Selected scope and direct material for separate populations, uses and durations
Materials to obtain first: Separate population/purpose trials and long-term follow-up
Further research: Separate the current added-device effect from extended questions. This is a recorded proposal; no new search, calculation or experiment was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and the applicable analytical scope for Selected scope and direct material for separate populations, uses and durations are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Why this condition is needed: Production condition for distinguishing Selected scope and direct material for separate populations, uses and durations and linking required and currently available materials for the selected question.
Application exceptions: Supplement safety-information gaps for the selected subclaim. Incontinence-symptom results or parent safety wording do not establish safety, harm incidence or new device-use instructions.
Referenced methods: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap design; M03 §3.2.4; Chamgap extrapolation boundary; M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation

Related sources S01 S02 S03

N32 · What is the scope of dates, language-specific wording, original axes and correction history?

Current findings: Preserve parent D with 34 points, axes, 2026-08-26, Korean/English manuscripts, empty corrections/deliberation and historical cross-check wording in the whole review summary. The 2024 review update is historical source information.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. This does not indicate a current review, registration/correction/retraction check or completion of review now. Differences in information by language are not filled with new translated facts. Review of the existing content remains incomplete.
Reason for missing information: This does not indicate a current review, registration/correction/retraction check or completion of review now. Differences in information by language are not filled with new translated facts.
Required materials and conditions: Original verdict date, Korean/English manuscripts, cross-checking and correction/retraction verification level
Materials to obtain first: New correction records, user comments and originals provided
Further research: Distinguish historical values from production/change events. This is a recorded proposal; no new search, calculation or experiment was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and the applicable analytical scope for Original verdict date, Korean/English manuscripts, cross-checking and correction/retraction verification level are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Why this condition is needed: Production condition for distinguishing Original verdict date, Korean/English manuscripts, cross-checking and correction/retraction verification level and linking required and currently available materials for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design; M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are our own design

Related sources S01 S02 S03

N33 · What was actually read in the summary and external originals?

Current findings: The whole stored summary and three evidence/citation summaries were read for production, and original source links were retained. The summary is labeled 'summary read'; external material is 'unread'.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. External originals, registry, protocol, SAP and disclosures were not accessed or link-tested. URLs and registration identifiers are not converted into full-text reading or successful access. Review of the existing content remains incomplete.
Reason for missing information: External originals, registry, protocol, SAP and disclosures were not accessed or link-tested. URLs and registration identifiers are not converted into full-text reading or successful access.
Required materials and conditions: Access status of the stored summary, papers, registry, protocol, SAP and disclosures
Materials to obtain first: Original material and actual reading history for each report
Further research: Link existence, acquisition and actual-reading levels separately for each material. This is a recorded proposal; no new search, calculation or experiment was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and the applicable analytical scope for Access status of the stored summary, papers, registry, protocol, SAP and disclosures are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.
Why this condition is needed: Production condition for distinguishing Access status of the stored summary, papers, registry, protocol, SAP and disclosures and linking required and currently available materials for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

Related sources S01 S02 S03