CHAMGAP

Reduced bathing/showering frequency × POEM improvement responders of at least 3 points at 4 weeks: evidence checklist

Select a review item to see its details.
Required evidence, verification status and materials actually read
ItemAVerification statusBReading scopeCReview itemDCurrent findingsEWhy unverifiedFRequired materials and conditionsGFurther research
1 Partly verified Full text not readStored summary read N01 · Evidence conditionWhich existing responder question and original verdict are preserved?Required
The selected question is whether reducing bathing to once or twice weekly increases improvement of at least 3 POEM points. Its D grade and original RR/rate note are preserved. Parent D30 and axes are parent context.
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The subclaim has no score/status/axis fields; parent values do not fill them. Mean POEM D and cream-use days C are other subclaims. The original content review remains incomplete.
Distinction between the selected subclaim, grade/note, and parent context
Keep the question and verdict record separate when updating. This is a proposal; no new investigation, calculation, or trial was performed.
2 Partly verified Full text not readStored summary read N02 · Evidence conditionWho is the actual population for the responder result?Required
The original manuscript describes a UK-wide online trial recruiting 438 people aged at least 1 year with POEM scores of at least 3.
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Diagnostic criteria, age distribution, baseline severity, exclusions, and child respondent/proxy procedures are unverified. The original content review remains incomplete.
Age, diagnosis, baseline POEM, recruitment, and eligibility/exclusions
Connect the actual population scope with differences from other populations. This is a proposal; no new investigation, calculation, or trial was performed.
3 Partly verified Full text not readStored summary read N03 · Evidence conditionWhat were the study frequency and actual bath/shower exposure?Required
The historical study compared once or twice weekly with at least six times weekly over 4 weeks. This is not guidance on bathing or showering frequency.
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Actual frequency, bath/shower proportions, water temperature/duration, and adherence/changes by arm are unverified. The original content review remains incomplete.
Assigned frequency, actual frequency, baths/showers, adherence, and duration
Distinguish nominal assignment from actual exposure. This is a proposal; no new investigation, calculation, or trial was performed.
4 Partly verified Full text not readStored summary read N04 · Evidence conditionWhat were the comparator and treatments common to both arms?Required
The comparator was an active lifestyle regimen of at least six times weekly. Both arms continued usual moisturizers and topical treatment.
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Treatment identity, intensity, adherence, additional/rescue treatment, and changes by arm are unverified. No new effect of common treatment or instruction to change medication is created. The original content review remains incomplete.
Active lifestyle comparator, moisturizers, topical treatment, and arm differences
Separate the contribution of lifestyle frequency from concomitant treatment. This is a proposal; no new investigation, calculation, or trial was performed.
5 Partly verified Full text not readStored summary read N05 · Evidence conditionWhat were the randomized design and allocation?Required
This was an online pragmatic parallel-group randomized superiority trial allocating 438 people as 220/218.
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Allocation sequence, concealment, and detailed baseline balance by arm are unverified in this summary. The original content review remains incomplete.
Parallel groups, superiority, allocation/concealment, and baseline balance
Distinguish the design label from the verified scope of actual conduct. This is a proposal; no new investigation, calculation, or trial was performed.
6 Partly verified Full text not readStored summary read N06 · Evidence conditionWhat were the limits of masking and responder measurement?Required
Participant masking was impossible given assigned bathing frequency. The original manuscript records that it did not count this as a separate defect.
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Assessor/analyst masking, child proxy responses, and differences between weekly and week-4 collection are unverified. Impossibility alone does not create a new verdict of measurement failure. The original content review remains incomplete.
Participants/assessors, respondents, and data-collection procedures
Record limits of symptom measurement and behavior change within the source scope. This is a proposal; no new investigation, calculation, or trial was performed.
7 Partly verified Full text not readStored summary read N07 · Evidence conditionWhat outcomes are POEM and improvement of at least 3 points?Required
POEM has seven symptom items for the previous week, ranging from 0 to 28 points, with higher scores indicating worse symptoms. The selected result is the proportion improving by at least 3 points at 4 weeks.
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Detailed rules for baseline-relative improvement, missing items, the responder analysis plan, and denominator selection are unverified. The original content review remains incomplete.
Scale, direction, baseline-relative response definition, and time point
Keep the continuous mean and threshold response as different estimands. This is a proposal; no new investigation, calculation, or trial was performed.
8 Partly verified Full text not readStored summary read N08 · Evidence conditionAre the 3-point response threshold and 2.2-point power assumption the same?Required
The responder threshold is improvement of at least 3 POEM points. The manuscript explicitly describes 2.2 points as the sample-size assumption for the primary mean result, rather than a validated minimal clinically important difference.
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The basis/prespecification of the 3-point responder threshold and the importance of the responder result are unverified. The two thresholds do not replace one another. The original content review remains incomplete.
Threshold response definition, assumed mean difference, and clinical importance
Record threshold response, mean effect, and power assumption separately. This is a proposal; no new investigation, calculation, or trial was performed.
9 Partly verified Full text not readStored summary read N09 · Evidence conditionWhat were the original responder counts, denominators, and rates?Required
Original values for improvement of at least 3 points at 4 weeks are preserved: 97/169 (57.4%) in the once-or-twice-weekly arm versus 91/171 (53.2%) in the at-least-six-times-weekly arm.
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Selection/attrition reasons for responder denominators, observation/imputation, and baseline correspondence by arm are unverified. No new total, difference, or rate is calculated. The original content review remains incomplete.
Arm correspondence, responders/denominators, time point, and definition
Distinguish responder denominators from allocation/primary-model denominators. This is a proposal; no new investigation, calculation, or trial was performed.
10 Partly verified Full text not readStored summary read N10 · Evidence conditionWhat estimates are the adjusted risk difference and RR?Required
The adjusted risk difference of 3.5 percentage points (95% CI −6.6 to 13.6) and adjusted RR 1.06 (95% CI 0.89 to 1.28) are preserved.
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Adjustment variables, model, actual included denominator, and responder P value are unverified. No new RD/RR/CI is calculated from the original rates. The original content review remains incomplete.
Original RD/RR, intervals, adjusted model, and denominator
Keep original rates and adjusted estimands distinct. This is a proposal; no new investigation, calculation, or trial was performed.
11 Partly verified Full text not readStored summary read N11 · Evidence conditionWhat did the record say the nonsignificant responder result meant?Required
The selected note records the original rate/RR result as null. Its original intervals and D grade are preserved as history.
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. No new conclusion of exactly zero effect, equivalence, or exclusion of all important responder benefits is made. Criteria/plans for responder importance are unverified. The original content review remains incomplete.
Original null interpretation, interval of compatible effects, and importance
Keep observed intervals and the scope of the original conclusion separate. This is a proposal; no new investigation, calculation, or trial was performed.
12 Partly verified Full text not readStored summary read N12 · Evidence conditionIs primary mean POEM being used as a responder value?Required
The primary outcome was the mean of weekly POEM measurements over 4 weeks. The adjusted difference −0.4 points (95% CI −1.3 to 0.4), P=.30, and exclusion of the assumed 2.2-point difference concern the mean result.
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The mean P=.30, interval, power assumption, and 388-person model are not reused as responder results or denominators. The original content review remains incomplete.
Primary endpoint, continuous value/threshold response, time point, and denominator
Record mean POEM, responders, and cream-use days separately. This is a proposal; no new investigation, calculation, or trial was performed.
13 Partly verified Full text not readStored summary read N13 · Evidence conditionHow do allocation, primary-model, and week-4 responder denominators differ?Required
Original denominators are preserved separately: 438 randomized as 220/218; the primary model of 388 people (193/195) with at least one follow-up POEM; and responders 169/171.
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Exact correspondence between responder denominators and primary-model participants, plus missingness reasons/handling by arm, is unverified. No new missing-data count or rate is calculated. The original content review remains incomplete.
Allocation, follow-up responses, model, and endpoint-specific analysis denominators
Distinguish allocation from observed/model/responder analyses. This is a proposal; no new investigation, calculation, or trial was performed.
14 Partly verified Full text not readStored summary read N14 · Evidence conditionWhich endpoint did allocation-based analysis and missing-data sensitivity concern?Required
The original manuscript records the same conclusion from analysis by assigned allocation and missing-data sensitivity analyses.
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Responder-specific models/values, ITT/PP definitions, and missingness assumptions are unverified. The general narrative is not treated as confirmation of every responder sensitivity analysis. The original content review remains incomplete.
Analysis population, missingness assumptions, sensitivity results, and original scope
Separate the original general narrative from the verified scope of the selected responder analysis. This is a proposal; no new investigation, calculation, or trial was performed.
15 Partly verified Full text not readStored summary read N15 · Evidence conditionDoes the cream-use-day result demonstrate responder improvement?Required
Mean cream use of 0.5 fewer days per week (95% CI −0.8 to −0.1) in the once-or-twice-weekly arm was secondary. The manuscript did not elevate this to a symptom benefit.
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The cream-use-day denominator/definition, intent, and linkage by responder are unverified. Reduced medication use is not converted into improved POEM response. The original content review remains incomplete.
Separation of symptom response, treatment behavior, and secondary use days
Keep behavior endpoints and symptom response as different questions. This is a proposal; no new investigation, calculation, or trial was performed.
16 Partly verified Full text not readStored summary read N16 · Evidence conditionWere responder definitions/multiplicity verified in registration and plans?Required
The original registration identifier is ISRCTN12016473. The summaries for the primary mean and week-4 responders are linked.
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Original registration/planning documents, change histories, prespecified responder definitions, and multiple comparisons remain unread; access was not attempted. An identifier does not complete comparison with plans. The original content review remains incomplete.
Registration, protocol, statistical analysis plan, primary/secondary hierarchy, and changes
Distinguish planned/changed endpoints, analyses, and time points. This is a proposal; no new investigation, calculation, or trial was performed.
17 Partly verified Full text not readStored summary read N17 · Evidence conditionWhat is the scope of funding and declared noninvolvement?Required
NIHR Programme Grants for Applied Research, NIHR203279, and the narrative of no role in design, collection, analysis, publication decisions, or writing are preserved.
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Contracts, implementation, checking actual noninvolvement, and additional support are unverified. Public funding/declarations are not converted into certification of independence. The original content review remains incomplete.
NIHR programme/identifier, support, and role disclosures
Separate support sources, declared roles, and actual verification level. This is a proposal; no new investigation, calculation, or trial was performed.
18 Partly verified Full text not readStored summary read N18 · Evidence conditionWhat is the scope of unreported product/device/placebo/commercial analysis support?Required
The manuscript records that product/device/placebo supply and commercial analysis services were not reported.
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Actual absence has not been newly verified. Individual employment/patents, writing/publication costs, and all support are unverified. The original content review remains incomplete.
Product/device/placebo supply, commercial analysis, and writing/publication support
Distinguish unreported and unverified from absent. This is a proposal; no new investigation, calculation, or trial was performed.
19 Partly verified Full text not readStored summary read N19 · Evidence conditionWhat were the consultancy-fee and scale-development disclosures?Required
The manuscript retained as conflicts E.J.M.’s personal fees from AbbVie, H.C.W.’s POEM development, and L.H./K.S.T.’s RECAP development disclosures.
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Amounts, periods, contracts, measurement/analysis roles, and influence are unverified. Disclosures are not converted automatically into bias, result exclusion, or a new independence verdict. The original content review remains incomplete.
Personal consultancy fees, POEM/RECAP development, conflicts, and actual roles
Record each disclosure separately from actual trial roles. This is a proposal; no new investigation, calculation, or trial was performed.
20 Partly verified Full text not readStored summary read N20 · Evidence conditionDoes the earlier pediatric crossover trial ask the same responder question?Required
The stored context describes Cardona’s randomized single-masked crossover trial in 42 children, 40 completers, 2 weeks, with SCORAD primary.
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Age/baseline details, crossover sequence/washout, period-specific denominators, and POEM 3-point responders are unverified. It is not counted as direct replication of the same responder result. The original content review remains incomplete.
Population, crossover design, duration, different protocol, and SCORAD
Do not sum the same children or repeated periods as independent trials/participants. This is a proposal; no new investigation, calculation, or trial was performed.
21 Partly verified Full text not readStored summary read N21 · Evidence conditionWhat were the opposite direction and SCORAD values of the pediatric protocol?Required
The historical pediatric study compared twice-daily 15–20-minute soak-and-seal with immediate occlusive moisturization against twice-weekly bathing for at most 10 minutes. The original 21.2-point greater SCORAD reduction (95% CI 14.9 to 27.6), P<.0001, belongs only to that comparison.
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. This is not the same frequency-only comparison as the current online trial and is not converted into POEM points or response rates. No implementation instructions are created. The original content review remains incomplete.
Differences in historical exposure, immediate occlusive moisturization, scale, and duration
Preserve the opposite result from a different moisturization protocol and scale. This is a proposal; no new investigation, calculation, or trial was performed.
22 Partly verified Full text not readStored summary read N22 · Evidence conditionHow are the pediatric report’s years, registration, and support preserved?Required
The evidence list gives Cardona 2019; the citation gives the 2020 issue and 2019 DOI wording. The original registration field “could not confirm” and historical abstract classification “Research Support, Non-U.S. Gov't” are preserved.
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Publication stages underlying the year difference, actual supporting institution/conflicts, and registration are unverified. These are not turned into a new paper/independent trial or an actual registration identifier. The original content review remains incomplete.
Report identity, evidence-list/citation years, registration records, and funding
Separate year wording, trial identity, and actual verification level. This is a proposal; no new investigation, calculation, or trial was performed.
23 Partly verified Full text not readStored summary read N23 · Evidence conditionDoes the review directly answer the same 3-point responder question?Required
Hua’s review synthesized bathing/showering frequency and eczema severity from 13 prospective studies. Its original conclusion was that daily washing was not associated with worse severity, but studies were few and heterogeneous and the optimal frequency was unclear.
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Direct analysis of the selected POEM 3-point responders/current comparison, trial-specific/population-specific results, and overlap are unverified. The review is not counted as new direct replication. The original content review remains incomplete.
Included protocols, endpoints, heterogeneity, populations, and designs
Distinguish synthesis context from different protocols from the original responder question. This is a proposal; no new investigation, calculation, or trial was performed.
24 Partly verified Full text not readStored summary read N24 · Evidence conditionWhat are the review’s year, registration, and funding statements?Required
The evidence list/manuscript describes the 2020 review; the citation gives the 2021 issue and 2020 DOI. The original registration field “not applicable” and historical statement that specific funding could not be established are preserved.
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Differences in publication stage, actual funding/conflicts, and plans/registration have not been externally verified in this work. Not applicable is not used to certify absence of registration. The original content review remains incomplete.
Citation/evidence-list years, support/plans, and historical access scope
Distinguish original years, identity, and access history from new material. This is a proposal; no new investigation, calculation, or trial was performed.
25 Partly verified Full text not readStored summary read N25 · Harm-information gaps supplementing the efficacy tableWhat are the original rates/denominators for the two safety outcomes?Supplementary
Treatment changes for worsening, 17/165 (10.3%) versus 13/168 (7.7%), and medical advice, 20/165 (12.1%) versus 13/170 (7.6%), are preserved separately. The original narrative describes both as numerically higher in the less-frequent-washing arm.
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. These differ from responder denominators 169/171 and primary-model denominators 193/195. Event definitions/exact periods, overlap, and missingness are unverified; no new incidence or total is calculated. The original content review remains incomplete.
Treatment changes for worsening, medical advice, people/denominators, and time point
Distinguish each outcome’s units from POEM responder units. This is a proposal; no new investigation, calculation, or trial was performed.
26 Partly verified Full text not readStored summary read N26 · Harm-information gaps supplementing the efficacy tableDo numerical safety differences establish significant worsening or causality?Supplementary
The manuscript records that significant worsening cannot be concluded because between-arm CI/P values for the two safety outcomes were not reported.
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The complete external full text was not read in this work. Numerical direction is not converted into significant worsening, causality, or absence of all safety concerns, and no new CI/P is calculated. The original content review remains incomplete.
Original unreported CI/P wording, collection, concomitant treatment, and verdict scope
Separate actual levels of behavior/worsening records, testing, and causality. This is a proposal; no new investigation, calculation, or trial was performed.
27 Partly verified Full text not readStored summary read N27 · Evidence conditionHow are reports, crossover periods, and related sheets shared?Required
The online trial, pediatric crossover trial, and review are distinguished by report. The existing two selected sheets share the same stored summary and direct trial. The pediatric 42/40 participants, crossover periods, and 13-study review do not constitute a new total of independent participants.
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Included/related reports and identity overlap in the review have not been externally compared. Original R0/I2 are not used as new replication/independence certification. The original content review remains incomplete.
Citation-to-trial/review-to-result linkage and repeated/included relationships
Distinguish unrecorded unique clinical totals from report entries. This is a proposal; no new investigation, calculation, or trial was performed.
28 Partly verified Full text not readStored summary read N28 · Harm-information gaps supplementing the efficacy tableAre related manuscript links and other products/long-term scopes combined?Supplementary
Stored links to bath additives 2887 and water softeners 2426 are separate original verdicts and are not additional trials for this question. The manuscript did not generalize beyond 4 weeks, to hot/humid environments, or to people at high infection risk.
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Direct material for related manuscripts, long-term outcomes, other environments, and risk groups was not retrieved in this work. No optimal-frequency or treatment-behavior guidance is created. The original content review remains incomplete.
Selected frequency/4-week response, separate manuscripts, climates, and risk groups
Separate other products, environments, and durations from the selected question. This is a proposal; no new investigation, calculation, or trial was performed.
29 Partly verified Full text not readStored summary read N29 · Evidence conditionWhat is the scope of original verdicts, dates, languages, empty values, and corrections?Required
D30, original axis C0, false flags and empty grade-override reasons, the bilingual manuscript, 2026-08-26, the empty correction array and empty deliberation string, historical cross-checks, original wording, and bibliographic year differences are preserved in the complete stored summary.
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Manuscript wording/typos and year differences are not automatically corrected. This is not a new current search, original-paper review, original-language comparison, or correction check. The original content review remains incomplete.
D30, axes/safety, bilingual manuscript, and historical cross-checks/corrections
Separate original records from production and correction events. This is a proposal; no new investigation, calculation, or trial was performed.
30 Partly verified Full text not readStored summary read N30 · Evidence conditionWhat is the reading level of summaries and external original material?Required
The complete stored summary and 3 evidence entries/3 citations were read for production and original source links connected. Summaries are marked “summary read” and external material “unread.”
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. External abstracts/full texts, registration/plans, and disclosures remain unread; access was not attempted. Historical public-verification wording is not inherited as access/review in this work. The original content review remains incomplete.
Original URLs and status of summaries/papers, registration, protocols, statistical analysis plans, and disclosures
Distinguish existence, acquisition, actual reading, and access history. This is a proposal; no new investigation, calculation, or trial was performed.
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30 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
UK online recruitment; 438 people aged at least 1 year with POEM scores of at least 3; detailed population/respondent information unverified
Ingredient, formulation and route
Original study: baths/showers once or twice weekly for 4 weeks; actual exposure/adherence unverified
Dose
Not recorded
Comparator
Active lifestyle comparator of at least six times weekly; both arms continued usual moisturizers/topical treatment
Measured outcome
Week-4 responders improving by at least 3 POEM points; adjusted risk difference/RR, distinct from mean/use days
Duration
Week-4 responder time point kept separate from the mean of weekly measurements over 4 weeks
Questions outside this scope
Treating 3-point responders, mean POEM, the 2.2-point power assumption, and cream-use days as the same estimand, threshold, or hierarchy; Elevating 2.2 points to a validated minimal clinically important difference or an importance threshold for responders/use days; Calculating new RD/RR/CI/P/totals from original rates/events, doses/frequencies/amounts from use days, or hypothetical values; Reusing allocation 438 (220/218), primary model 388 (193/195), responders 169/171, or safety 165/168/170 as the unverified cream-use denominator; Using mean P=.30 as responder/cream P, or inheriting the general sensitivity narrative as review of all selected endpoints; Converting reduced cream-use days into symptom/worsening/safety benefit or instructions to reduce/stop treatment; Converting numerical directions of the two safety results or original unreported CI/P into significant worsening, causality, or safety certification; Reusing pediatric crossover 42/40 participants, 2 weeks, different frequency/duration with immediate occlusive moisturization, or SCORAD as direct effects for the current frequency/POEM responder/cream question; Converting pediatric evidence-list 2019/citation 2020 or review evidence-list 2020/citation 2021 year differences into new trials, added citations, or automatic corrections; Summing the same people, arms, weeks, crossover periods, citations, review, related sheets, or 2887/2426 links as new independent trials/participants; Converting registration “could not confirm”/“not applicable,” unreported support, historical public checks, or conflicts into current identity, absence, independence, or external-reading certification; Inheriting parent D30, original axes, or cross-checks as subclaim D grades/C scores/axes or current content review; Extending to optimal frequency, long-term/hot-humid/high-infection-risk settings, or effects/safety of other products/devices; New evidence/reassessment or instructions on bathing/showering frequency, application/moisturization, treatment use, or treatment implementation

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 · Bradshaw L et al. 2026 Eczema Bathing Study

PubMed

Material type
UK-wide online pragmatic parallel-group randomized superiority trial
Materials actually read
Summary read; external material unread
Findings recorded in the stored summary
Original responder values are preserved: 97/169 (57.4%) versus 91/171 (53.2%); adjusted risk difference 3.5 percentage points (95% CI −6.6 to 13.6); adjusted RR 1.06 (95% CI 0.89 to 1.28). The subclaim D grade and original null note are historical verdicts, rather than new certification of exactly zero effect, equivalence, or exclusion of all important benefit. Original primary mean −0.4 points (95% CI −1.3 to 0.4), P=0.30, the 2.2-point power assumption, and the 388-person model are separate context and are not used as responder P values or denominators.
Record level
Outcome wording in the stored summary
Study overlap and independent replication
The UK online Eczema Bathing Study and ISRCTN12016473 describe a parallel-group superiority trial of 438 people (220/218), aged at least 1 year with POEM scores of at least 3, comparing once or twice weekly with at least six times weekly for 4 weeks. Both arms continued usual moisturizers/topical treatment, participant masking was impossible, and the primary model contained 388 people (193/195). Week-4 responders 169/171, the unverified cream-use-day denominator, and safety-specific denominators 165/168/170 are distinct. The same trial, reports, participants, arms, weeks, and selected sheets sharing the same material are not summed as independent trials/participants. Report/material entries are not totals of unique clinical trials, participants, or independent replications; unique totals remain unrecorded. Cardona’s pediatric single-masked crossover trial preserves the evidence-list year 2019 separately from the citation’s 2020 issue and 2019 DOI. Its 42 allocated participants, 40 completers, 2 weeks, primary SCORAD, and combined bathing frequency/duration with immediate moisturization describe a different protocol. It is not direct replication of the current comparison, POEM responders, or cream-use days. Crossover periods, sequence, washout, publication stage, funding, and registration details are unverified. Selected sheets sharing material and report/material entries are not summed as unique trials, participants, or independent replications; unique totals remain unrecorded. Hua’s synthesis of 13 prospective studies preserves evidence-list/manuscript 2020 separately from citation issue 2021 and DOI 2020. Its original conclusion of few, heterogeneous protocols, eczema severity, and unclear optimal frequency is retained. Included/related trial overlap, population/endpoint denominators, and publication stages remain unverified; it is not counted as independent RCT, responder, or cream-use-day replication. Selected sheets sharing material and report/material entries are not summed as unique trials, participants, or independent replications; unique totals remain unrecorded.
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
Stored summaryStored fileStored summarySummary readOnly stored-summary and bibliographic content was used for production. External material verification/review is not complete.
External paperPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Registration materialPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
ProtocolPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Statistical analysis planPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo 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 materialPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.

S02 · Cardona ID et al. 2019 pediatric soak-and-seal trial

PubMed

Material type
Pediatric randomized single-masked crossover trial
Materials actually read
Summary read; external material unread
Findings recorded in the stored summary
In the historical study, twice-daily 15–20-minute soak-and-seal produced a 21.2-point greater SCORAD reduction than twice-weekly bathing for at most 10 minutes (95% CI 14.9 to 27.6), P<0.0001. These values belong to a different protocol/scale and are not converted into POEM points, response rates, or cream-use days. Unverified registration, abstract support classification with supporting institution unestablished, and evidence-list/citation year differences are preserved and not backdated as external verification in this work.
Record level
Outcome wording in the stored summary
Study overlap and independent replication
The UK online Eczema Bathing Study and ISRCTN12016473 describe a parallel-group superiority trial of 438 people (220/218), aged at least 1 year with POEM scores of at least 3, comparing once or twice weekly with at least six times weekly for 4 weeks. Both arms continued usual moisturizers/topical treatment, participant masking was impossible, and the primary model contained 388 people (193/195). Week-4 responders 169/171, the unverified cream-use-day denominator, and safety-specific denominators 165/168/170 are distinct. The same trial, reports, participants, arms, weeks, and selected sheets sharing the same material are not summed as independent trials/participants. Report/material entries are not totals of unique clinical trials, participants, or independent replications; unique totals remain unrecorded. Cardona’s pediatric single-masked crossover trial preserves the evidence-list year 2019 separately from the citation’s 2020 issue and 2019 DOI. Its 42 allocated participants, 40 completers, 2 weeks, primary SCORAD, and combined bathing frequency/duration with immediate moisturization describe a different protocol. It is not direct replication of the current comparison, POEM responders, or cream-use days. Crossover periods, sequence, washout, publication stage, funding, and registration details are unverified. Selected sheets sharing material and report/material entries are not summed as unique trials, participants, or independent replications; unique totals remain unrecorded. Hua’s synthesis of 13 prospective studies preserves evidence-list/manuscript 2020 separately from citation issue 2021 and DOI 2020. Its original conclusion of few, heterogeneous protocols, eczema severity, and unclear optimal frequency is retained. Included/related trial overlap, population/endpoint denominators, and publication stages remain unverified; it is not counted as independent RCT, responder, or cream-use-day replication. Selected sheets sharing material and report/material entries are not summed as unique trials, participants, or independent replications; unique totals remain unrecorded.
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
Stored summaryStored fileStored summarySummary readOnly stored-summary and bibliographic content was used for production. External material verification/review is not complete.
External paperPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Registration materialPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
ProtocolPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Statistical analysis planPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo 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 materialPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.

S03 · Hua T et al. 2020 systematic review and meta-analysis

PubMed

Material type
Systematic review and meta-analysis of bathing/showering frequency studies
Materials actually read
Summary read; external material unread
Findings recorded in the stored summary
The original conclusion was that daily washing was not associated with worse severity, but studies were few and heterogeneous, leaving optimal frequency unclear. This does not verify optimal frequency, all safety, or the selected responder/use-day effects. Gaps in included studies, endpoint-specific values, review support/conflicts/plans, and original year differences are retained.
Record level
Outcome wording in the stored summary
Study overlap and independent replication
The UK online Eczema Bathing Study and ISRCTN12016473 describe a parallel-group superiority trial of 438 people (220/218), aged at least 1 year with POEM scores of at least 3, comparing once or twice weekly with at least six times weekly for 4 weeks. Both arms continued usual moisturizers/topical treatment, participant masking was impossible, and the primary model contained 388 people (193/195). Week-4 responders 169/171, the unverified cream-use-day denominator, and safety-specific denominators 165/168/170 are distinct. The same trial, reports, participants, arms, weeks, and selected sheets sharing the same material are not summed as independent trials/participants. Report/material entries are not totals of unique clinical trials, participants, or independent replications; unique totals remain unrecorded. Cardona’s pediatric single-masked crossover trial preserves the evidence-list year 2019 separately from the citation’s 2020 issue and 2019 DOI. Its 42 allocated participants, 40 completers, 2 weeks, primary SCORAD, and combined bathing frequency/duration with immediate moisturization describe a different protocol. It is not direct replication of the current comparison, POEM responders, or cream-use days. Crossover periods, sequence, washout, publication stage, funding, and registration details are unverified. Selected sheets sharing material and report/material entries are not summed as unique trials, participants, or independent replications; unique totals remain unrecorded. Hua’s synthesis of 13 prospective studies preserves evidence-list/manuscript 2020 separately from citation issue 2021 and DOI 2020. Its original conclusion of few, heterogeneous protocols, eczema severity, and unclear optimal frequency is retained. Included/related trial overlap, population/endpoint denominators, and publication stages remain unverified; it is not counted as independent RCT, responder, or cream-use-day replication. Selected sheets sharing material and report/material entries are not summed as unique trials, participants, or independent replications; unique totals remain unrecorded.
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
Stored summaryStored fileStored summarySummary readOnly stored-summary and bibliographic content was used for production. External material verification/review is not complete.
External paperPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Registration materialPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
ProtocolPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Statistical analysis planPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo 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 materialPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo 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

The UK online Eczema Bathing Study and ISRCTN12016473 describe a parallel-group superiority trial of 438 people (220/218), aged at least 1 year with POEM scores of at least 3, comparing once or twice weekly with at least six times weekly for 4 weeks. Both arms continued usual moisturizers/topical treatment, participant masking was impossible, and the primary model contained 388 people (193/195). Week-4 responders 169/171, the unverified cream-use-day denominator, and safety-specific denominators 165/168/170 are distinct. The same trial, reports, participants, arms, weeks, and selected sheets sharing the same material are not summed as independent trials/participants. Report/material entries are not totals of unique clinical trials, participants, or independent replications; unique totals remain unrecorded. Cardona’s pediatric single-masked crossover trial preserves the evidence-list year 2019 separately from the citation’s 2020 issue and 2019 DOI. Its 42 allocated participants, 40 completers, 2 weeks, primary SCORAD, and combined bathing frequency/duration with immediate moisturization describe a different protocol. It is not direct replication of the current comparison, POEM responders, or cream-use days. Crossover periods, sequence, washout, publication stage, funding, and registration details are unverified. Selected sheets sharing material and report/material entries are not summed as unique trials, participants, or independent replications; unique totals remain unrecorded. Hua’s synthesis of 13 prospective studies preserves evidence-list/manuscript 2020 separately from citation issue 2021 and DOI 2020. Its original conclusion of few, heterogeneous protocols, eczema severity, and unclear optimal frequency is retained. Included/related trial overlap, population/endpoint denominators, and publication stages remain unverified; it is not counted as independent RCT, responder, or cream-use-day replication. Selected sheets sharing material and report/material entries are not summed as unique trials, participants, or independent replications; unique totals 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 · Which existing responder question and original verdict are preserved?
Required materials and conditions
Distinction between the selected subclaim, grade/note, and parent context
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Distinction between the selected subclaim, grade/note, and parent context. Stored wording is linked here; the original content review 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
A production item connecting required and available material for the selected question by distinguishing: Distinction between the selected subclaim, grade/note, and parent context.
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 · Who is the actual population for the responder result?
Required materials and conditions
Age, diagnosis, baseline POEM, recruitment, and eligibility/exclusions
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Age, diagnosis, baseline POEM, recruitment, and eligibility/exclusions. Stored wording is linked here; the original content review 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
A production item connecting required and available material for the selected question by distinguishing: Age, diagnosis, baseline POEM, recruitment, and eligibility/exclusions.
Referenced methods
M03 §3.2.1; detailed population conditions are Chamgap's own design
N03 · What were the study frequency and actual bath/shower exposure?
Required materials and conditions
Assigned frequency, actual frequency, baths/showers, adherence, and duration
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Assigned frequency, actual frequency, baths/showers, adherence, and duration. Stored wording is linked here; the original content review 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
A production item connecting required and available material for the selected question by distinguishing: Assigned frequency, actual frequency, baths/showers, adherence, and duration.
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 · What were the comparator and treatments common to both arms?
Required materials and conditions
Active lifestyle comparator, moisturizers, topical treatment, and arm differences
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Active lifestyle comparator, moisturizers, topical treatment, and arm differences. Stored wording is linked here; the original content review 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
A production item connecting required and available material for the selected question by distinguishing: Active lifestyle comparator, moisturizers, topical treatment, and arm differences.
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
N05 · What were the randomized design and allocation?
Required materials and conditions
Parallel groups, superiority, allocation/concealment, and baseline balance
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Parallel groups, superiority, allocation/concealment, and baseline balance. Stored wording is linked here; the original content review 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
A production item connecting required and available material for the selected question by distinguishing: Parallel groups, superiority, allocation/concealment, and baseline balance.
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
N06 · What were the limits of masking and responder measurement?
Required materials and conditions
Participants/assessors, respondents, and data-collection procedures
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Participants/assessors, respondents, and data-collection procedures. Stored wording is linked here; the original content review 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
A production item connecting required and available material for the selected question by distinguishing: Participants/assessors, respondents, and data-collection procedures.
Referenced methods
M08 Table 8.2.a, M03 §3.2.4; internal application
N07 · What outcomes are POEM and improvement of at least 3 points?
Required materials and conditions
Scale, direction, baseline-relative response definition, and time point
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Scale, direction, baseline-relative response definition, and time point. Stored wording is linked here; the original content review 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
A production item connecting required and available material for the selected question by distinguishing: Scale, direction, baseline-relative response definition, and time point.
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
N08 · Are the 3-point response threshold and 2.2-point power assumption the same?
Required materials and conditions
Threshold response definition, assumed mean difference, and clinical importance
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Threshold response definition, assumed mean difference, and clinical importance. Stored wording is linked here; the original content review 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
A production item connecting required and available material for the selected question by distinguishing: Threshold response definition, assumed mean difference, and clinical importance.
Referenced methods
M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design; M15 §15.3.1–15.3.3; own application; M08 Table 8.2.a, M04 §4.6.3; own application
N09 · What were the original responder counts, denominators, and rates?
Required materials and conditions
Arm correspondence, responders/denominators, time point, and definition
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Arm correspondence, responders/denominators, time point, and definition. Stored wording is linked here; the original content review 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
A production item connecting required and available material for the selected question by distinguishing: Arm correspondence, responders/denominators, time point, and definition.
Referenced methods
M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap's own design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design
N10 · What estimates are the adjusted risk difference and RR?
Required materials and conditions
Original RD/RR, intervals, adjusted model, and denominator
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Original RD/RR, intervals, adjusted model, and denominator. Stored wording is linked here; the original content review 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
A production item connecting required and available material for the selected question by distinguishing: Original RD/RR, intervals, adjusted model, and denominator.
Referenced methods
M08 §8.2.2, M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap's own design
N11 · What did the record say the nonsignificant responder result meant?
Required materials and conditions
Original null interpretation, interval of compatible effects, and importance
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Original null interpretation, interval of compatible effects, and importance. Stored wording is linked here; the original content review 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
A production item connecting required and available material for the selected question by distinguishing: Original null interpretation, interval of compatible effects, and importance.
Referenced methods
M15 §15.3.1–15.3.3; Chamgap application; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap's own design
N12 · Is primary mean POEM being used as a responder value?
Required materials and conditions
Primary endpoint, continuous value/threshold response, time point, and denominator
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Primary endpoint, continuous value/threshold response, time point, and denominator. Stored wording is linked here; the original content review 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
A production item connecting required and available material for the selected question by distinguishing: Primary endpoint, continuous value/threshold response, time point, and denominator.
Referenced methods
M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design
N13 · How do allocation, primary-model, and week-4 responder denominators differ?
Required materials and conditions
Allocation, follow-up responses, model, and endpoint-specific analysis denominators
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Allocation, follow-up responses, model, and endpoint-specific analysis denominators. Stored wording is linked here; the original content review 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
A production item connecting required and available material for the selected question by distinguishing: Allocation, follow-up responses, model, and endpoint-specific analysis denominators.
Referenced methods
M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application
N14 · Which endpoint did allocation-based analysis and missing-data sensitivity concern?
Required materials and conditions
Analysis population, missingness assumptions, sensitivity results, and original scope
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Analysis population, missingness assumptions, sensitivity results, and original scope. Stored wording is linked here; the original content review 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
A production item connecting required and available material for the selected question by distinguishing: Analysis population, missingness assumptions, sensitivity results, and original scope.
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.
N15 · Does the cream-use-day result demonstrate responder improvement?
Required materials and conditions
Separation of symptom response, treatment behavior, and secondary use days
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Separation of symptom response, treatment behavior, and secondary use days. Stored wording is linked here; the original content review 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
A production item connecting required and available material for the selected question by distinguishing: Separation of symptom response, treatment behavior, and secondary use days.
Referenced methods
M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design; M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation
N16 · Were responder definitions/multiplicity verified in registration and plans?
Required materials and conditions
Registration, protocol, statistical analysis plan, primary/secondary hierarchy, and changes
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Registration, protocol, statistical analysis plan, primary/secondary hierarchy, and changes. Stored wording is linked here; the original content review 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
A production item connecting required and available material for the selected question by distinguishing: Registration, protocol, statistical analysis plan, primary/secondary hierarchy, and changes.
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
N17 · What is the scope of funding and declared noninvolvement?
Required materials and conditions
NIHR programme/identifier, support, and role disclosures
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: NIHR programme/identifier, support, and role disclosures. Stored wording is linked here; the original content review 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
A production item connecting required and available material for the selected question by distinguishing: NIHR programme/identifier, support, and role disclosures.
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.
N18 · What is the scope of unreported product/device/placebo/commercial analysis support?
Required materials and conditions
Product/device/placebo supply, commercial analysis, and writing/publication support
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Product/device/placebo supply, commercial analysis, and writing/publication support. Stored wording is linked here; the original content review 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
A production item connecting required and available material for the selected question by distinguishing: Product/device/placebo supply, commercial analysis, and writing/publication support.
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 · What were the consultancy-fee and scale-development disclosures?
Required materials and conditions
Personal consultancy fees, POEM/RECAP development, conflicts, and actual roles
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Personal consultancy fees, POEM/RECAP development, conflicts, and actual roles. Stored wording is linked here; the original content review 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
A production item connecting required and available material for the selected question by distinguishing: Personal consultancy fees, POEM/RECAP development, conflicts, and actual roles.
Referenced methods
Chamgap independence and attribution conditions; the official methodology sections used in this example do not certify all these detailed items; M08 Table 8.2.a, M03 §3.2.4; Chamgap adaptation
N20 · Does the earlier pediatric crossover trial ask the same responder question?
Required materials and conditions
Population, crossover design, duration, different protocol, and SCORAD
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Population, crossover design, duration, different protocol, and SCORAD. Stored wording is linked here; the original content review 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
A production item connecting required and available material for the selected question by distinguishing: Population, crossover design, duration, different protocol, and SCORAD.
Referenced methods
M04 §4.6.1–4.6.2; distinction between studies and reports; cohort and outcome connections are Chamgap adaptations; M03 §3.2.1; detailed population conditions are Chamgap design; M08 §8.1–8.2.3; Chamgap adaptation; M04 §4.6.1–4.6.2, M15 §15.3.1; Chamgap adaptation
N21 · What were the opposite direction and SCORAD values of the pediatric protocol?
Required materials and conditions
Differences in historical exposure, immediate occlusive moisturization, scale, and duration
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Differences in historical exposure, immediate occlusive moisturization, scale, and duration. Stored wording is linked here; the original content review 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
A production item connecting required and available material for the selected question by distinguishing: Differences in historical exposure, immediate occlusive moisturization, scale, and duration.
Referenced methods
M03 §3.2.2–3.2.3; reverse-direction marker and test adaptations are Chamgap design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; 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
N22 · How are the pediatric report’s years, registration, and support preserved?
Required materials and conditions
Report identity, evidence-list/citation years, registration records, and funding
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Report identity, evidence-list/citation years, registration records, and funding. Stored wording is linked here; the original content review 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
A production item connecting required and available material for the selected question by distinguishing: Report identity, evidence-list/citation years, registration records, and funding.
Referenced methods
M04 §4.6.1–4.6.2; distinction between studies and reports; cohort and outcome connections are Chamgap adaptations; M04 §4.5, §4.6.3; limitations of this conversion follow the review scope and Chamgap design; Chamgap independence and attribution conditions; the official methodology sections used in this example do not certify all these detailed items; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation
N23 · Does the review directly answer the same 3-point responder question?
Required materials and conditions
Included protocols, endpoints, heterogeneity, populations, and designs
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Included protocols, endpoints, heterogeneity, populations, and designs. Stored wording is linked here; the original content review 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
A production item connecting required and available material for the selected question by distinguishing: Included protocols, endpoints, heterogeneity, populations, and designs.
Referenced methods
M04 §4.6.1–4.6.2; distinction between studies and reports; cohort and outcome connections are Chamgap adaptations; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; 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
N24 · What are the review’s year, registration, and funding statements?
Required materials and conditions
Citation/evidence-list years, support/plans, and historical access scope
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Citation/evidence-list years, support/plans, and historical access scope. Stored wording is linked here; the original content review 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
A production item connecting required and available material for the selected question by distinguishing: Citation/evidence-list years, support/plans, and historical access scope.
Referenced methods
M04 §4.5, §4.6.3; limitations of this conversion follow the review scope and Chamgap design; Chamgap independence and attribution conditions; the official methodology sections used in this example do not certify all these detailed items; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation; M04 §4.5–4.6; material collection/selection principles; access/reading separation and hyperlink contract are Chamgap design
N25 · What are the original rates/denominators for the two safety outcomes?
Required materials and conditions
Treatment changes for worsening, medical advice, people/denominators, and time point
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Treatment changes for worsening, medical advice, people/denominators, and time point. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability
Supplementary
Application exceptions
Addresses safety-material gaps for the selected subclaim. POEM, cream-use days, or parent safety wording do not establish safety or generate new harm incidence or instructions on bathing frequency/treatment behavior.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Treatment changes for worsening, medical advice, people/denominators, and time point.
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
N26 · Do numerical safety differences establish significant worsening or causality?
Required materials and conditions
Original unreported CI/P wording, collection, concomitant treatment, and verdict scope
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Original unreported CI/P wording, collection, concomitant treatment, and verdict scope. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability
Supplementary
Application exceptions
Addresses safety-material gaps for the selected subclaim. POEM, cream-use days, or parent safety wording do not establish safety or generate new harm incidence or instructions on bathing frequency/treatment behavior.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Original unreported CI/P wording, collection, concomitant treatment, and verdict scope.
Referenced methods
M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; M19 §19.2.2–19.2.4; design considerations; detailed confounding records are Chamgap design; Chamgap interpretation boundary; M19 is a reference principle, not execution of an official causality tool
N27 · How are reports, crossover periods, and related sheets shared?
Required materials and conditions
Citation-to-trial/review-to-result linkage and repeated/included relationships
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Citation-to-trial/review-to-result linkage and repeated/included relationships. Stored wording is linked here; the original content review 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
A production item connecting required and available material for the selected question by distinguishing: Citation-to-trial/review-to-result linkage and repeated/included relationships.
Referenced methods
Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application
N28 · Are related manuscript links and other products/long-term scopes combined?
Required materials and conditions
Selected frequency/4-week response, separate manuscripts, climates, and risk groups
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Selected frequency/4-week response, separate manuscripts, climates, and risk groups. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability
Supplementary
Application exceptions
Addresses safety-material gaps for the selected subclaim. POEM, cream-use days, or parent safety wording do not establish safety or generate new harm incidence or instructions on bathing frequency/treatment behavior.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Selected frequency/4-week response, separate manuscripts, climates, and risk groups.
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
N29 · What is the scope of original verdicts, dates, languages, empty values, and corrections?
Required materials and conditions
D30, axes/safety, bilingual manuscript, and historical cross-checks/corrections
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: D30, axes/safety, bilingual manuscript, and historical cross-checks/corrections. Stored wording is linked here; the original content review 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
A production item connecting required and available material for the selected question by distinguishing: D30, axes/safety, bilingual manuscript, and historical cross-checks/corrections.
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
N30 · What is the reading level of summaries and external original material?
Required materials and conditions
Original URLs and status of summaries/papers, registration, protocols, statistical analysis plans, and disclosures
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Original URLs and status of summaries/papers, registration, protocols, statistical analysis plans, and disclosures. Stored wording is linked here; the original content review 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
A production item connecting required and available material for the selected question by distinguishing: Original URLs and status of summaries/papers, registration, protocols, statistical analysis plans, and disclosures.
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

The public page and data were prepared from the existing 30 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 · Which existing responder question and original verdict are preserved?

Current findings
The selected question is whether reducing bathing to once or twice weekly increases improvement of at least 3 POEM points. Its D grade and original RR/rate note are preserved. Parent D30 and axes are parent context.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The subclaim has no score/status/axis fields; parent values do not fill them. Mean POEM D and cream-use days C are other subclaims. The original content review remains incomplete.
Reason for missing information
The subclaim has no score/status/axis fields; parent values do not fill them. Mean POEM D and cream-use days C are other subclaims.
Required materials and conditions
Distinction between the selected subclaim, grade/note, and parent context
Materials to obtain first
Correction records for the selected claim and parent assessment
Further research
Keep the question and verdict record separate when updating. This is a proposal; no new investigation, calculation, or trial 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
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Distinction between the selected subclaim, grade/note, and parent context. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Distinction between the selected subclaim, grade/note, and parent context.
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 · Who is the actual population for the responder result?

Current findings
The original manuscript describes a UK-wide online trial recruiting 438 people aged at least 1 year with POEM scores of at least 3.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Diagnostic criteria, age distribution, baseline severity, exclusions, and child respondent/proxy procedures are unverified. The original content review remains incomplete.
Reason for missing information
Diagnostic criteria, age distribution, baseline severity, exclusions, and child respondent/proxy procedures are unverified.
Required materials and conditions
Age, diagnosis, baseline POEM, recruitment, and eligibility/exclusions
Materials to obtain first
Recruitment/eligibility criteria and baseline/respondent characteristics
Further research
Connect the actual population scope with differences from other populations. This is a proposal; no new investigation, calculation, or trial 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
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Age, diagnosis, baseline POEM, recruitment, and eligibility/exclusions. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Age, diagnosis, baseline POEM, recruitment, and eligibility/exclusions.
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 were the study frequency and actual bath/shower exposure?

Current findings
The historical study compared once or twice weekly with at least six times weekly over 4 weeks. This is not guidance on bathing or showering frequency.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Actual frequency, bath/shower proportions, water temperature/duration, and adherence/changes by arm are unverified. The original content review remains incomplete.
Reason for missing information
Actual frequency, bath/shower proportions, water temperature/duration, and adherence/changes by arm are unverified.
Required materials and conditions
Assigned frequency, actual frequency, baths/showers, adherence, and duration
Materials to obtain first
Exposure, adherence, and change records
Further research
Distinguish nominal assignment from actual exposure. This is a proposal; no new investigation, calculation, or trial 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
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Assigned frequency, actual frequency, baths/showers, adherence, and duration. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Assigned frequency, actual frequency, baths/showers, adherence, and duration.
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 · What were the comparator and treatments common to both arms?

Current findings
The comparator was an active lifestyle regimen of at least six times weekly. Both arms continued usual moisturizers and topical treatment.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Treatment identity, intensity, adherence, additional/rescue treatment, and changes by arm are unverified. No new effect of common treatment or instruction to change medication is created. The original content review remains incomplete.
Reason for missing information
Treatment identity, intensity, adherence, additional/rescue treatment, and changes by arm are unverified. No new effect of common treatment or instruction to change medication is created.
Required materials and conditions
Active lifestyle comparator, moisturizers, topical treatment, and arm differences
Materials to obtain first
Common/changed treatments by arm and material on the effect of interest
Further research
Separate the contribution of lifestyle frequency from concomitant treatment. This is a proposal; no new investigation, calculation, or trial 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
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Active lifestyle comparator, moisturizers, topical treatment, and arm differences. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Active lifestyle comparator, moisturizers, topical treatment, and arm differences.
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

N05 · What were the randomized design and allocation?

Current findings
This was an online pragmatic parallel-group randomized superiority trial allocating 438 people as 220/218.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Allocation sequence, concealment, and detailed baseline balance by arm are unverified in this summary. The original content review remains incomplete.
Reason for missing information
Allocation sequence, concealment, and detailed baseline balance by arm are unverified in this summary.
Required materials and conditions
Parallel groups, superiority, allocation/concealment, and baseline balance
Materials to obtain first
Allocation methods and baseline characteristics
Further research
Distinguish the design label from the verified scope of actual conduct. This is a proposal; no new investigation, calculation, or trial 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
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Parallel groups, superiority, allocation/concealment, and baseline balance. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Parallel groups, superiority, allocation/concealment, and baseline balance.
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

N06 · What were the limits of masking and responder measurement?

Current findings
Participant masking was impossible given assigned bathing frequency. The original manuscript records that it did not count this as a separate defect.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Assessor/analyst masking, child proxy responses, and differences between weekly and week-4 collection are unverified. Impossibility alone does not create a new verdict of measurement failure. The original content review remains incomplete.
Reason for missing information
Assessor/analyst masking, child proxy responses, and differences between weekly and week-4 collection are unverified. Impossibility alone does not create a new verdict of measurement failure.
Required materials and conditions
Participants/assessors, respondents, and data-collection procedures
Materials to obtain first
Masking and response-collection procedures
Further research
Record limits of symptom measurement and behavior change within the source scope. This is a proposal; no new investigation, calculation, or trial 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
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Participants/assessors, respondents, and data-collection procedures. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Participants/assessors, respondents, and data-collection procedures.
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

N07 · What outcomes are POEM and improvement of at least 3 points?

Current findings
POEM has seven symptom items for the previous week, ranging from 0 to 28 points, with higher scores indicating worse symptoms. The selected result is the proportion improving by at least 3 points at 4 weeks.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Detailed rules for baseline-relative improvement, missing items, the responder analysis plan, and denominator selection are unverified. The original content review remains incomplete.
Reason for missing information
Detailed rules for baseline-relative improvement, missing items, the responder analysis plan, and denominator selection are unverified.
Required materials and conditions
Scale, direction, baseline-relative response definition, and time point
Materials to obtain first
Response definition, scale collection, and analysis plan
Further research
Keep the continuous mean and threshold response as different estimands. This is a proposal; no new investigation, calculation, or trial 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
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Scale, direction, baseline-relative response definition, and time point. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Scale, direction, baseline-relative response definition, and time point.
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

N08 · Are the 3-point response threshold and 2.2-point power assumption the same?

Current findings
The responder threshold is improvement of at least 3 POEM points. The manuscript explicitly describes 2.2 points as the sample-size assumption for the primary mean result, rather than a validated minimal clinically important difference.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The basis/prespecification of the 3-point responder threshold and the importance of the responder result are unverified. The two thresholds do not replace one another. The original content review remains incomplete.
Reason for missing information
The basis/prespecification of the 3-point responder threshold and the importance of the responder result are unverified. The two thresholds do not replace one another.
Required materials and conditions
Threshold response definition, assumed mean difference, and clinical importance
Materials to obtain first
Original basis for the response threshold and sample-size/planning material
Further research
Record threshold response, mean effect, and power assumption separately. This is a proposal; no new investigation, calculation, or trial 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
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Threshold response definition, assumed mean difference, and clinical importance. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Threshold response definition, assumed mean difference, and clinical importance.
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 result adaptation is our own design; M15 §15.3.1–15.3.3; own application; M08 Table 8.2.a, M04 §4.6.3; own application

Related sources S01

N09 · What were the original responder counts, denominators, and rates?

Current findings
Original values for improvement of at least 3 points at 4 weeks are preserved: 97/169 (57.4%) in the once-or-twice-weekly arm versus 91/171 (53.2%) in the at-least-six-times-weekly arm.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Selection/attrition reasons for responder denominators, observation/imputation, and baseline correspondence by arm are unverified. No new total, difference, or rate is calculated. The original content review remains incomplete.
Reason for missing information
Selection/attrition reasons for responder denominators, observation/imputation, and baseline correspondence by arm are unverified. No new total, difference, or rate is calculated.
Required materials and conditions
Arm correspondence, responders/denominators, time point, and definition
Materials to obtain first
Week-4 responder flow/results table
Further research
Distinguish responder denominators from allocation/primary-model denominators. This is a proposal; no new investigation, calculation, or trial 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
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Arm correspondence, responders/denominators, time point, and definition. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Arm correspondence, responders/denominators, time point, and definition.
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's own design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design

Related sources S01

N10 · What estimates are the adjusted risk difference and RR?

Current findings
The adjusted risk difference of 3.5 percentage points (95% CI −6.6 to 13.6) and adjusted RR 1.06 (95% CI 0.89 to 1.28) are preserved.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Adjustment variables, model, actual included denominator, and responder P value are unverified. No new RD/RR/CI is calculated from the original rates. The original content review remains incomplete.
Reason for missing information
Adjustment variables, model, actual included denominator, and responder P value are unverified. No new RD/RR/CI is calculated from the original rates.
Required materials and conditions
Original RD/RR, intervals, adjusted model, and denominator
Materials to obtain first
Adjusted responder analysis table and statistical analysis plan
Further research
Keep original rates and adjusted estimands distinct. This is a proposal; no new investigation, calculation, or trial 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
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Original RD/RR, intervals, adjusted model, and denominator. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Original RD/RR, intervals, adjusted model, and denominator.
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, M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap's own design

Related sources S01

N11 · What did the record say the nonsignificant responder result meant?

Current findings
The selected note records the original rate/RR result as null. Its original intervals and D grade are preserved as history.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. No new conclusion of exactly zero effect, equivalence, or exclusion of all important responder benefits is made. Criteria/plans for responder importance are unverified. The original content review remains incomplete.
Reason for missing information
No new conclusion of exactly zero effect, equivalence, or exclusion of all important responder benefits is made. Criteria/plans for responder importance are unverified.
Required materials and conditions
Original null interpretation, interval of compatible effects, and importance
Materials to obtain first
Responder importance, hypotheses, and original conclusions
Further research
Keep observed intervals and the scope of the original conclusion separate. This is a proposal; no new investigation, calculation, or trial 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
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Original null interpretation, interval of compatible effects, and importance. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Original null interpretation, interval of compatible effects, and importance.
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 application; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap's own design

Related sources S01

N12 · Is primary mean POEM being used as a responder value?

Current findings
The primary outcome was the mean of weekly POEM measurements over 4 weeks. The adjusted difference −0.4 points (95% CI −1.3 to 0.4), P=.30, and exclusion of the assumed 2.2-point difference concern the mean result.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The mean P=.30, interval, power assumption, and 388-person model are not reused as responder results or denominators. The original content review remains incomplete.
Reason for missing information
The mean P=.30, interval, power assumption, and 388-person model are not reused as responder results or denominators.
Required materials and conditions
Primary endpoint, continuous value/threshold response, time point, and denominator
Materials to obtain first
Primary/secondary endpoint hierarchy and separate result tables
Further research
Record mean POEM, responders, and cream-use days separately. This is a proposal; no new investigation, calculation, or trial 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
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Primary endpoint, continuous value/threshold response, time point, and denominator. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Primary endpoint, continuous value/threshold response, time point, and denominator.
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; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design

Related sources S01

N13 · How do allocation, primary-model, and week-4 responder denominators differ?

Current findings
Original denominators are preserved separately: 438 randomized as 220/218; the primary model of 388 people (193/195) with at least one follow-up POEM; and responders 169/171.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Exact correspondence between responder denominators and primary-model participants, plus missingness reasons/handling by arm, is unverified. No new missing-data count or rate is calculated. The original content review remains incomplete.
Reason for missing information
Exact correspondence between responder denominators and primary-model participants, plus missingness reasons/handling by arm, is unverified. No new missing-data count or rate is calculated.
Required materials and conditions
Allocation, follow-up responses, model, and endpoint-specific analysis denominators
Materials to obtain first
Endpoint-specific flow diagrams and missingness/denominator tables
Further research
Distinguish allocation from observed/model/responder analyses. This is a proposal; no new investigation, calculation, or trial 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
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Allocation, follow-up responses, model, and endpoint-specific analysis denominators. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Allocation, follow-up responses, model, and endpoint-specific analysis denominators.
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 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application

Related sources S01

N14 · Which endpoint did allocation-based analysis and missing-data sensitivity concern?

Current findings
The original manuscript records the same conclusion from analysis by assigned allocation and missing-data sensitivity analyses.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Responder-specific models/values, ITT/PP definitions, and missingness assumptions are unverified. The general narrative is not treated as confirmation of every responder sensitivity analysis. The original content review remains incomplete.
Reason for missing information
Responder-specific models/values, ITT/PP definitions, and missingness assumptions are unverified. The general narrative is not treated as confirmation of every responder sensitivity analysis.
Required materials and conditions
Analysis population, missingness assumptions, sensitivity results, and original scope
Materials to obtain first
Analysis populations, statistical analysis plan, and endpoint-specific sensitivity results
Further research
Separate the original general narrative from the verified scope of the selected responder analysis. This is a proposal; no new investigation, calculation, or trial 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
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Analysis population, missingness assumptions, sensitivity results, and original scope. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Analysis population, missingness assumptions, sensitivity results, and original scope.
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

N15 · Does the cream-use-day result demonstrate responder improvement?

Current findings
Mean cream use of 0.5 fewer days per week (95% CI −0.8 to −0.1) in the once-or-twice-weekly arm was secondary. The manuscript did not elevate this to a symptom benefit.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The cream-use-day denominator/definition, intent, and linkage by responder are unverified. Reduced medication use is not converted into improved POEM response. The original content review remains incomplete.
Reason for missing information
The cream-use-day denominator/definition, intent, and linkage by responder are unverified. Reduced medication use is not converted into improved POEM response.
Required materials and conditions
Separation of symptom response, treatment behavior, and secondary use days
Materials to obtain first
Cream-use days, responder linkage, and prespecified hierarchy
Further research
Keep behavior endpoints and symptom response as different questions. This is a proposal; no new investigation, calculation, or trial 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
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Separation of symptom response, treatment behavior, and secondary use days. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Separation of symptom response, treatment behavior, and secondary use days.
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; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design; M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation

Related sources S01

N16 · Were responder definitions/multiplicity verified in registration and plans?

Current findings
The original registration identifier is ISRCTN12016473. The summaries for the primary mean and week-4 responders are linked.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Original registration/planning documents, change histories, prespecified responder definitions, and multiple comparisons remain unread; access was not attempted. An identifier does not complete comparison with plans. The original content review remains incomplete.
Reason for missing information
Original registration/planning documents, change histories, prespecified responder definitions, and multiple comparisons remain unread; access was not attempted. An identifier does not complete comparison with plans.
Required materials and conditions
Registration, protocol, statistical analysis plan, primary/secondary hierarchy, and changes
Materials to obtain first
Registration history, protocol, and SAP
Further research
Distinguish planned/changed endpoints, analyses, and time points. This is a proposal; no new investigation, calculation, or trial 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
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Registration, protocol, statistical analysis plan, primary/secondary hierarchy, and changes. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Registration, protocol, statistical analysis plan, primary/secondary hierarchy, and changes.
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

N17 · What is the scope of funding and declared noninvolvement?

Current findings
NIHR Programme Grants for Applied Research, NIHR203279, and the narrative of no role in design, collection, analysis, publication decisions, or writing are preserved.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Contracts, implementation, checking actual noninvolvement, and additional support are unverified. Public funding/declarations are not converted into certification of independence. The original content review remains incomplete.
Reason for missing information
Contracts, implementation, checking actual noninvolvement, and additional support are unverified. Public funding/declarations are not converted into certification of independence.
Required materials and conditions
NIHR programme/identifier, support, and role disclosures
Materials to obtain first
Original funding and role disclosures
Further research
Separate support sources, declared roles, and actual verification level. This is a proposal; no new investigation, calculation, or trial 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
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: NIHR programme/identifier, support, and role disclosures. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: NIHR programme/identifier, support, and role disclosures.
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

N18 · What is the scope of unreported product/device/placebo/commercial analysis support?

Current findings
The manuscript records that product/device/placebo supply and commercial analysis services were not reported.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Actual absence has not been newly verified. Individual employment/patents, writing/publication costs, and all support are unverified. The original content review remains incomplete.
Reason for missing information
Actual absence has not been newly verified. Individual employment/patents, writing/publication costs, and all support are unverified.
Required materials and conditions
Product/device/placebo supply, commercial analysis, and writing/publication support
Materials to obtain first
Support, author, analysis/writing/publication disclosures
Further research
Distinguish unreported and unverified from absent. This is a proposal; no new investigation, calculation, or trial 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
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Product/device/placebo supply, commercial analysis, and writing/publication support. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Product/device/placebo supply, commercial analysis, and writing/publication support.
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 · What were the consultancy-fee and scale-development disclosures?

Current findings
The manuscript retained as conflicts E.J.M.’s personal fees from AbbVie, H.C.W.’s POEM development, and L.H./K.S.T.’s RECAP development disclosures.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Amounts, periods, contracts, measurement/analysis roles, and influence are unverified. Disclosures are not converted automatically into bias, result exclusion, or a new independence verdict. The original content review remains incomplete.
Reason for missing information
Amounts, periods, contracts, measurement/analysis roles, and influence are unverified. Disclosures are not converted automatically into bias, result exclusion, or a new independence verdict.
Required materials and conditions
Personal consultancy fees, POEM/RECAP development, conflicts, and actual roles
Materials to obtain first
Original personal conflict and scale/analysis role documents
Further research
Record each disclosure separately from actual trial roles. This is a proposal; no new investigation, calculation, or trial 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
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Personal consultancy fees, POEM/RECAP development, conflicts, and actual roles. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Personal consultancy fees, POEM/RECAP development, conflicts, and actual roles.
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 independence and attribution conditions; the official methodology sections used in this example do not certify all these detailed items; M08 Table 8.2.a, M03 §3.2.4; Chamgap adaptation

Related sources S01

N20 · Does the earlier pediatric crossover trial ask the same responder question?

Current findings
The stored context describes Cardona’s randomized single-masked crossover trial in 42 children, 40 completers, 2 weeks, with SCORAD primary.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Age/baseline details, crossover sequence/washout, period-specific denominators, and POEM 3-point responders are unverified. It is not counted as direct replication of the same responder result. The original content review remains incomplete.
Reason for missing information
Age/baseline details, crossover sequence/washout, period-specific denominators, and POEM 3-point responders are unverified. It is not counted as direct replication of the same responder result.
Required materials and conditions
Population, crossover design, duration, different protocol, and SCORAD
Materials to obtain first
Pediatric trial methods and period-specific result tables
Further research
Do not sum the same children or repeated periods as independent trials/participants. This is a proposal; no new investigation, calculation, or trial 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
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Population, crossover design, duration, different protocol, and SCORAD. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Population, crossover design, duration, different protocol, and SCORAD.
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 and outcome connections are Chamgap adaptations; M03 §3.2.1; detailed population conditions are Chamgap design; M08 §8.1–8.2.3; Chamgap adaptation; M04 §4.6.1–4.6.2, M15 §15.3.1; Chamgap adaptation

Related sources S02

N21 · What were the opposite direction and SCORAD values of the pediatric protocol?

Current findings
The historical pediatric study compared twice-daily 15–20-minute soak-and-seal with immediate occlusive moisturization against twice-weekly bathing for at most 10 minutes. The original 21.2-point greater SCORAD reduction (95% CI 14.9 to 27.6), P<.0001, belongs only to that comparison.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. This is not the same frequency-only comparison as the current online trial and is not converted into POEM points or response rates. No implementation instructions are created. The original content review remains incomplete.
Reason for missing information
This is not the same frequency-only comparison as the current online trial and is not converted into POEM points or response rates. No implementation instructions are created.
Required materials and conditions
Differences in historical exposure, immediate occlusive moisturization, scale, and duration
Materials to obtain first
Exposure/moisturization, scale, and crossover analysis material
Further research
Preserve the opposite result from a different moisturization protocol and scale. This is a proposal; no new investigation, calculation, or trial 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
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Differences in historical exposure, immediate occlusive moisturization, scale, and duration. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Differences in historical exposure, immediate occlusive moisturization, scale, and duration.
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 marker and test adaptations are Chamgap design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; 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 S02

N22 · How are the pediatric report’s years, registration, and support preserved?

Current findings
The evidence list gives Cardona 2019; the citation gives the 2020 issue and 2019 DOI wording. The original registration field “could not confirm” and historical abstract classification “Research Support, Non-U.S. Gov't” are preserved.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Publication stages underlying the year difference, actual supporting institution/conflicts, and registration are unverified. These are not turned into a new paper/independent trial or an actual registration identifier. The original content review remains incomplete.
Reason for missing information
Publication stages underlying the year difference, actual supporting institution/conflicts, and registration are unverified. These are not turned into a new paper/independent trial or an actual registration identifier.
Required materials and conditions
Report identity, evidence-list/citation years, registration records, and funding
Materials to obtain first
Original bibliographic/publication history and registration/support material
Further research
Separate year wording, trial identity, and actual verification level. This is a proposal; no new investigation, calculation, or trial 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
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Report identity, evidence-list/citation years, registration records, and funding. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Report identity, evidence-list/citation years, registration records, and funding.
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 and outcome connections are Chamgap adaptations; M04 §4.5, §4.6.3; limitations of this conversion follow the review scope and Chamgap design; Chamgap independence and attribution conditions; the official methodology sections used in this example do not certify all these detailed items; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation

Related sources S02

N23 · Does the review directly answer the same 3-point responder question?

Current findings
Hua’s review synthesized bathing/showering frequency and eczema severity from 13 prospective studies. Its original conclusion was that daily washing was not associated with worse severity, but studies were few and heterogeneous and the optimal frequency was unclear.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Direct analysis of the selected POEM 3-point responders/current comparison, trial-specific/population-specific results, and overlap are unverified. The review is not counted as new direct replication. The original content review remains incomplete.
Reason for missing information
Direct analysis of the selected POEM 3-point responders/current comparison, trial-specific/population-specific results, and overlap are unverified. The review is not counted as new direct replication.
Required materials and conditions
Included protocols, endpoints, heterogeneity, populations, and designs
Materials to obtain first
Included studies and protocol/endpoint-specific result tables
Further research
Distinguish synthesis context from different protocols from the original responder question. This is a proposal; no new investigation, calculation, or trial 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
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Included protocols, endpoints, heterogeneity, populations, and designs. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Included protocols, endpoints, heterogeneity, populations, and designs.
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 and outcome connections are Chamgap adaptations; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; 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 S03

N24 · What are the review’s year, registration, and funding statements?

Current findings
The evidence list/manuscript describes the 2020 review; the citation gives the 2021 issue and 2020 DOI. The original registration field “not applicable” and historical statement that specific funding could not be established are preserved.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Differences in publication stage, actual funding/conflicts, and plans/registration have not been externally verified in this work. Not applicable is not used to certify absence of registration. The original content review remains incomplete.
Reason for missing information
Differences in publication stage, actual funding/conflicts, and plans/registration have not been externally verified in this work. Not applicable is not used to certify absence of registration.
Required materials and conditions
Citation/evidence-list years, support/plans, and historical access scope
Materials to obtain first
Bibliographic/publication history and review plans/disclosures
Further research
Distinguish original years, identity, and access history from new material. This is a proposal; no new investigation, calculation, or trial 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
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Citation/evidence-list years, support/plans, and historical access scope. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Citation/evidence-list years, support/plans, and historical access scope.
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; limitations of this conversion follow the review scope and Chamgap design; Chamgap independence and attribution conditions; the official methodology sections used in this example do not certify all these detailed items; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation; M04 §4.5–4.6; material collection/selection principles; access/reading separation and hyperlink contract are Chamgap design

Related sources S03

N25 · What are the original rates/denominators for the two safety outcomes?

Current findings
Treatment changes for worsening, 17/165 (10.3%) versus 13/168 (7.7%), and medical advice, 20/165 (12.1%) versus 13/170 (7.6%), are preserved separately. The original narrative describes both as numerically higher in the less-frequent-washing arm.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. These differ from responder denominators 169/171 and primary-model denominators 193/195. Event definitions/exact periods, overlap, and missingness are unverified; no new incidence or total is calculated. The original content review remains incomplete.
Reason for missing information
These differ from responder denominators 169/171 and primary-model denominators 193/195. Event definitions/exact periods, overlap, and missingness are unverified; no new incidence or total is calculated.
Required materials and conditions
Treatment changes for worsening, medical advice, people/denominators, and time point
Materials to obtain first
Outcome-specific safety/behavior definitions and denominator tables
Further research
Distinguish each outcome’s units from POEM responder units. This is a proposal; no new investigation, calculation, or trial 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
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Treatment changes for worsening, medical advice, people/denominators, and time point. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Treatment changes for worsening, medical advice, people/denominators, and time point.
Application exceptions
Addresses safety-material gaps for the selected subclaim. POEM, cream-use days, or parent safety wording do not establish safety or generate new harm incidence or instructions on bathing frequency/treatment behavior.
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

N26 · Do numerical safety differences establish significant worsening or causality?

Current findings
The manuscript records that significant worsening cannot be concluded because between-arm CI/P values for the two safety outcomes were not reported.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The complete external full text was not read in this work. Numerical direction is not converted into significant worsening, causality, or absence of all safety concerns, and no new CI/P is calculated. The original content review remains incomplete.
Reason for missing information
The complete external full text was not read in this work. Numerical direction is not converted into significant worsening, causality, or absence of all safety concerns, and no new CI/P is calculated.
Required materials and conditions
Original unreported CI/P wording, collection, concomitant treatment, and verdict scope
Materials to obtain first
Safety analysis, collection, and concomitant treatment material
Further research
Separate actual levels of behavior/worsening records, testing, and causality. This is a proposal; no new investigation, calculation, or trial 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
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Original unreported CI/P wording, collection, concomitant treatment, and verdict scope. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Original unreported CI/P wording, collection, concomitant treatment, and verdict scope.
Application exceptions
Addresses safety-material gaps for the selected subclaim. POEM, cream-use days, or parent safety wording do not establish safety or generate new harm incidence or instructions on bathing frequency/treatment behavior.
Referenced methods
M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; M19 §19.2.2–19.2.4; design considerations; detailed confounding records are Chamgap design; Chamgap interpretation boundary; M19 is a reference principle, not execution of an official causality tool

Related sources S01

N27 · How are reports, crossover periods, and related sheets shared?

Current findings
The online trial, pediatric crossover trial, and review are distinguished by report. The existing two selected sheets share the same stored summary and direct trial. The pediatric 42/40 participants, crossover periods, and 13-study review do not constitute a new total of independent participants.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Included/related reports and identity overlap in the review have not been externally compared. Original R0/I2 are not used as new replication/independence certification. The original content review remains incomplete.
Reason for missing information
Included/related reports and identity overlap in the review have not been externally compared. Original R0/I2 are not used as new replication/independence certification.
Required materials and conditions
Citation-to-trial/review-to-result linkage and repeated/included relationships
Materials to obtain first
Included/related report tables and registration linkage
Further research
Distinguish unrecorded unique clinical totals from report entries. This is a proposal; no new investigation, calculation, or trial 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
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Citation-to-trial/review-to-result linkage and repeated/included relationships. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Citation-to-trial/review-to-result linkage and repeated/included relationships.
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
Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

Related sources S01 S02 S03

N28 · Are related manuscript links and other products/long-term scopes combined?

Current findings
Stored links to bath additives 2887 and water softeners 2426 are separate original verdicts and are not additional trials for this question. The manuscript did not generalize beyond 4 weeks, to hot/humid environments, or to people at high infection risk.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Direct material for related manuscripts, long-term outcomes, other environments, and risk groups was not retrieved in this work. No optimal-frequency or treatment-behavior guidance is created. The original content review remains incomplete.
Reason for missing information
Direct material for related manuscripts, long-term outcomes, other environments, and risk groups was not retrieved in this work. No optimal-frequency or treatment-behavior guidance is created.
Required materials and conditions
Selected frequency/4-week response, separate manuscripts, climates, and risk groups
Materials to obtain first
Material on separate exposures/populations and long-term outcomes
Further research
Separate other products, environments, and durations from the selected question. This is a proposal; no new investigation, calculation, or trial 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
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Selected frequency/4-week response, separate manuscripts, climates, and risk groups. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Selected frequency/4-week response, separate manuscripts, climates, and risk groups.
Application exceptions
Addresses safety-material gaps for the selected subclaim. POEM, cream-use days, or parent safety wording do not establish safety or generate new harm incidence or instructions on bathing frequency/treatment behavior.
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

N29 · What is the scope of original verdicts, dates, languages, empty values, and corrections?

Current findings
D30, original axis C0, false flags and empty grade-override reasons, the bilingual manuscript, 2026-08-26, the empty correction array and empty deliberation string, historical cross-checks, original wording, and bibliographic year differences are preserved in the complete stored summary.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Manuscript wording/typos and year differences are not automatically corrected. This is not a new current search, original-paper review, original-language comparison, or correction check. The original content review remains incomplete.
Reason for missing information
Manuscript wording/typos and year differences are not automatically corrected. This is not a new current search, original-paper review, original-language comparison, or correction check.
Required materials and conditions
D30, axes/safety, bilingual manuscript, and historical cross-checks/corrections
Materials to obtain first
New correction records and user feedback
Further research
Separate original records from production and correction events. This is a proposal; no new investigation, calculation, or trial 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
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: D30, axes/safety, bilingual manuscript, and historical cross-checks/corrections. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: D30, axes/safety, bilingual manuscript, and historical cross-checks/corrections.
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

N30 · What is the reading level of summaries and external original material?

Current findings
The complete stored summary and 3 evidence entries/3 citations were read for production and original source links connected. Summaries are marked “summary read” and external material “unread.”
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. External abstracts/full texts, registration/plans, and disclosures remain unread; access was not attempted. Historical public-verification wording is not inherited as access/review in this work. The original content review remains incomplete.
Reason for missing information
External abstracts/full texts, registration/plans, and disclosures remain unread; access was not attempted. Historical public-verification wording is not inherited as access/review in this work.
Required materials and conditions
Original URLs and status of summaries/papers, registration, protocols, statistical analysis plans, and disclosures
Materials to obtain first
Original material and actual reading history for each material
Further research
Distinguish existence, acquisition, actual reading, and access history. This is a proposal; no new investigation, calculation, or trial 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
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Original URLs and status of summaries/papers, registration, protocols, statistical analysis plans, and disclosures. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Original URLs and status of summaries/papers, registration, protocols, statistical analysis plans, and disclosures.
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