{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2947-s0", "verdict_number": "2947", "title": "Bathing and showering frequency × 4-week mean POEM eczema symptoms: evidence checklist", "view_version": "1.0", "view_created_date": "2026-10-11", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "The existing selection record and complete designated stored summary were read for production. External abstracts, full texts, registrations, protocols, statistical analysis plans and other product pages remain unread and were not accessed. Previous cases were used only for methodology history, the status dictionary and format connections. The original production’s content review remains incomplete; its historical absence of screen checks, link checks and searches is separate from current technical checks.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "UK online recruitment, age at least one year, POEM at least 3; mixed age and severity composition and eligibility details unverified", "intervention": "Historical study exposure: bathing or showering once or twice weekly", "dose": "Preserve the original frequency comparison only; actual performance, duration, water temperature and cleansers unverified. No frequency or treatment instructions.", "comparator": "Active lifestyle comparator of at least six times weekly; both groups continued usual moisturizers and topical treatment in the original study", "endpoint": "Adjusted mean symptom difference from POEM measured weekly over 4 weeks; seven items, 0–28 points, higher means worse symptoms", "duration": "4 weeks; long-term, post-discontinuation and specific environmental or high-risk outcomes unverified", "excluded_extensions": [ "Converting the 2.2-point power assumption into a validated MCID", "Converting responders or cream use-days into mean symptom benefit", "Repurposing a different pediatric moisturizer protocol or SCORAD as the same comparison", "Optimal frequency and long-term, climate-specific or high-infection-risk efficacy and safety", "Instructions for bathing, moisturizing, or using or changing treatment" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Does this sheet address mean symptoms over 4 weeks after reducing bathing to once or twice weekly?", "needed": "Original question, parent comparison, endpoint and timing", "role": "Required", "role_reason": "Required to record the original information and gaps for this question as an individual condition: Does this sheet address mean symptoms over 4 weeks after reducing bathing to once or twice weekly?", "application_exception": "Do not turn the related responder or cream questions into a new verdict, split or independent trial.", "criterion": "Preserve the exact question separately from its verdict record.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are our own design / M03 §3.2.4; our own extension boundary", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If the question changes, record the original unit and exclusions separately.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original wording is ‘Reducing bathing to once or twice weekly improves mean eczema symptoms over four weeks.’ This sheet is limited to mean POEM and the active frequency comparator of at least six times weekly.", "condition_status": "Partly verified", "status_reason": "Partial verification links the original narrative in the stored summary for production; it does not constitute clinical verification or completed content review. The final number of independent claims is not established.", "missingness": "The final number of independent claims is not established.", "uncertainty": "Do not turn the related responder or cream questions into a new verdict, split or independent trial. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original question, parent comparison, endpoint and timing" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Are the subclaim grade and parent score and axes separate?", "needed": "Actual subclaim fields, absent fields and locations of original parent values", "role": "Required", "role_reason": "Required to record the original information and gaps for this question as an individual condition: Are the subclaim grade and parent score and axes separate?", "application_exception": "Do not copy parent values such as 30 points, E0 and C0 into subclaim-specific fields.", "criterion": "Separate actual subclaim values from parent values.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are our own design / M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If subclaim fields are added, distinguish the original version from the new event.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "Preserve the selected subclaim grade D and note ‘The adjusted POEM difference was null at −0.4 points (95% CI −1.3 to 0.4), P=0.30.’ Subclaim score, status and axes are absent and remain unrecorded. The parent is D with 30 points and Caution.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. The original record has no subclaim-specific score, status or axes.", "missingness": "The original record has no subclaim-specific score, status or axes.", "uncertainty": "Do not copy parent values such as 30 points, E0 and C0 into subclaim-specific fields. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual subclaim fields, absent fields and locations of original parent values" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Do the historical verdict, design limitations and axes constitute the current review?", "needed": "Korean and English verdicts, axes, original synthesis and correction history", "role": "Required", "role_reason": "Required to record the original information and gaps for this question as an individual condition: Do the historical verdict, design limitations and axes constitute the current review?", "application_exception": "Do not turn R0 into zero actual studies or historical cross-checking into a passed current review.", "criterion": "Distinguish the original verdict and design explanation from the current content review status.", "basis": "M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design / M08 §8.1–8.2.3; our own application", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If new evidence or a verdict request arrives, distinguish the existing version from the update event.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "The parent describes two design limitations, 4-week follow-up and an active lifestyle comparator, and D30. Preserve the historical statement that unavoidable participant unmasking was not counted as a separate defect. R0/I2/E0/B2/C0 and cross-checking are parent history.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. No current RoB 2 assessment, clinical regrading or methodology certification was performed.", "missingness": "No current RoB 2 assessment, clinical regrading or methodology certification was performed.", "uncertainty": "Do not turn R0 into zero actual studies or historical cross-checking into a passed current review. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Korean and English verdicts, axes, original synthesis and correction history" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Which summaries were read and which external materials remain unread?", "needed": "Existence, acquisition, actual reading scope and preservation location of each material", "role": "Required", "role_reason": "Required to record the original information and gaps for this question as an individual condition: Which summaries were read and which external materials remain unread?", "application_exception": "Do not turn a URL or historical public verification narrative into current full-text reading or failed access.", "criterion": "Separate reading the local summary from unread external materials.", "basis": "M04 §4.5–4.6 material-collection and selection principles; separation of access and reading and hyperlink rules are our own design / M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If materials or reading history are added, record only the actual reading level of each material.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "The complete designated stored summary and selected question were read for production. External abstracts, full texts, registrations, plans and links were not accessed.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. External materials remain unread and access was not attempted; no current comprehensive literature search was conducted.", "missingness": "External materials remain unread and access was not attempted; no current comprehensive literature search was conducted.", "uncertainty": "Do not turn a URL or historical public verification narrative into current full-text reading or failed access. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Existence, acquisition, actual reading scope and preservation location of each material" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "What are the original bibliography, registration and report-year entries?", "needed": "Original bibliography and registration, year differences, trial and review identities", "role": "Required", "role_reason": "Required to record the original information and gaps for this question as an individual condition: What are the original bibliography, registration and report-year entries?", "application_exception": "Do not normalize ISRCTN into NCT or invent identifiers for unknown registrations.", "criterion": "Preserve original bibliography and registration entries and verification gaps.", "basis": "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 / M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original lists are provided, record publication and online years and their relationship to trial identity.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "Preserve Bradshaw 2026, Cardona 2019 in the evidence entry versus 2020 in the citation, and Hua 2020 versus 2021. Registration field values are ISRCTN12016473, ‘Could not verify’ and ‘Not applicable.’", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. Reasons for the year differences and external registration identities and contents are unverified.", "missingness": "Reasons for the year differences and external registration identities and contents are unverified.", "uncertainty": "Do not normalize ISRCTN into NCT or invent identifiers for unknown registrations. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original bibliography and registration, year differences, trial and review identities" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Who was selected for the UK online trial?", "needed": "Diagnosis, age composition, baseline severity, eligibility and exclusions, online recruitment", "role": "Required", "role_reason": "Required to record the original information and gaps for this question as an individual condition: Who was selected for the UK online trial?", "application_exception": "Do not transfer the mixed population aged at least one year into a direct effect for a specific child or adult subgroup.", "criterion": "Record the selected population and gaps in detailed representativeness.", "basis": "M03 §3.2.1; detailed population conditions are our own design / M03 §3.2.1–3.2.4; dose, persistence and effect-modification details are our own design", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If the original population table is provided, distinguish mixed age and severity composition from applicability.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original population comprised 438 people aged at least one year with POEM scores of at least 3, recruited online across the UK. Other environments and risk groups were excluded from the original extrapolation scope.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. Exact age composition, diagnostic confirmation and baseline risk distribution are unverified.", "missingness": "Exact age composition, diagnostic confirmation and baseline risk distribution are unverified.", "uncertainty": "Do not transfer the mixed population aged at least one year into a direct effect for a specific child or adult subgroup. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Diagnosis, age composition, baseline severity, eligibility and exclusions, online recruitment" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "What were the original frequency intervention and active comparator?", "needed": "Assigned frequency, actual performance, comparator composition and comparison direction", "role": "Required", "role_reason": "Required to record the original information and gaps for this question as an individual condition: What were the original frequency intervention and active comparator?", "application_exception": "Do not turn the frequency comparator into no bathing, no treatment or an optimal-frequency recommendation.", "criterion": "Preserve the direction of once or twice weekly minus at least six times weekly.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and assessment adaptations are our own design / M03 §3.2.3, M08 §8.2.2–8.2.3; our own application", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original performance records are provided, record assigned versus actual exposure and frequency differences.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "Once or twice weekly was compared with at least six times weekly for 4 weeks. These are historical study conditions, not behavioral instructions for the reader.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. Actual frequency, crossover and cumulative exposure are unverified.", "missingness": "Actual frequency, crossover and cumulative exposure are unverified.", "uncertainty": "Do not turn the frequency comparator into no bathing, no treatment or an optimal-frequency recommendation. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Assigned frequency, actual performance, comparator composition and comparison direction" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Were bathing and showering definitions and other exposures comparable?", "needed": "Activity definition, bathing versus showering, temperature and duration, cleansers and environment", "role": "Required", "role_reason": "Required to record the original information and gaps for this question as an individual condition: Were bathing and showering definitions and other exposures comparable?", "application_exception": "Do not copy duration or moisturizer components of pediatric soak-and-seal into the main trial exposure.", "criterion": "Separate the frequency comparison from gaps in other exposure components.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and assessment adaptations are our own design / M03 §3.2.3, M08 §8.2.2–8.2.3; our own application", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original exposure materials are provided, distinguish frequency from balance in other concurrent components.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "The main trial is preserved as a comparison of bathing and showering frequency. Specific duration, water temperature, cleansers, body sites and the proportion of baths versus showers are absent from the summary.", "condition_status": "Unverified", "status_reason": "Required direct details are absent from the stored summary and remain unverified. External materials remain unread. Activity definitions, bath and shower composition, temperature, duration and cleansers are unverified.", "missingness": "Activity definitions, bath and shower composition, temperature, duration and cleansers are unverified.", "uncertainty": "Do not copy duration or moisturizer components of pediatric soak-and-seal into the main trial exposure. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Activity definition, bathing versus showering, temperature and duration, cleansers and environment" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Which comparison included moisturizers and topical treatment?", "needed": "Shared treatment, actual use, changes and co-treatment, balance", "role": "Required", "role_reason": "Required to record the original information and gaps for this question as an individual condition: Which comparison included moisturizers and topical treatment?", "application_exception": "Do not write the original continued-use condition as an instruction to continue or stop treatment.", "criterion": "Preserve that the frequency comparison included shared treatment.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and assessment adaptations are our own design / M03 §3.2.3, M08 §8.2.2–8.2.3; our own application / M19 §19.2.2–19.2.4 design considerations; detailed confounding records are our own design", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original treatment materials are provided, separate shared conditions from differences in use-days and changes.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "Preserve the original condition that both groups continued usual moisturizers and topical treatment. Product and treatment types, amounts and change rules are absent from the summary.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. Moisturizer and topical treatment types, amounts and actual group-specific use are unverified.", "missingness": "Moisturizer and topical treatment types, amounts and actual group-specific use are unverified.", "uncertainty": "Do not write the original continued-use condition as an instruction to continue or stop treatment. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Shared treatment, actual use, changes and co-treatment, balance" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Are frequency adherence, crossover and analyses directly verified?", "needed": "Actual performance, deviations and crossover, analysis populations, adherence definitions", "role": "Required", "role_reason": "Required to record the original information and gaps for this question as an individual condition: Are frequency adherence, crossover and analyses directly verified?", "application_exception": "Do not certify complete adherence or identical effect estimates from a statement of the same conclusion.", "criterion": "Distinguish the original statement of analytical consistency from gaps in direct details.", "basis": "M08 §8.2.2, M15 §15.3.1; Chamgap adaptation / M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap design / M03 §3.2.2–3.2.3; reverse-direction marker and test adaptations are Chamgap design", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original adherence and analysis materials are provided, record the assigned comparison and actual-exposure analyses separately.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original summary states that analysis by randomized allocation and missing-data sensitivity analyses gave the same conclusion. Actual adherence rates, crossover frequencies and quantitative results of each analysis are absent.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. Adherence and crossover counts and analysis-specific estimates and intervals are unverified.", "missingness": "Adherence and crossover counts and analysis-specific estimates and intervals are unverified.", "uncertainty": "Do not certify complete adherence or identical effect estimates from a statement of the same conclusion. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual performance, deviations and crossover, analysis populations, adherence definitions" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "What was the scope of the pragmatic parallel-group design and masking?", "needed": "Sequence generation, allocation concealment, assessor and analyst masking, data collection", "role": "Required", "role_reason": "Required to record the original information and gaps for this question as an individual condition: What was the scope of the pragmatic parallel-group design and masking?", "application_exception": "Do not recalculate defect counts or grades from unavoidable unmasking or extend it to all assessment roles.", "criterion": "Distinguish the original explanation from current bias-review certification.", "basis": "M08 §8.1–8.2.3; Chamgap adaptation / M08 Table 8.2.a, M03 §3.2.4; Chamgap adaptation", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original methods are provided, record the design label and actual role-specific processes.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "The main study was an online pragmatic parallel-group randomized superiority trial. The original explanation states that participant masking was impossible when assigned washing frequency changed.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. Allocation processes, concealment and masking of other roles are unverified.", "missingness": "Allocation processes, concealment and masking of other roles are unverified.", "uncertainty": "Do not recalculate defect counts or grades from unavoidable unmasking or extend it to all assessment roles. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Sequence generation, allocation concealment, assessor and analyst masking, data collection" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "What were the randomized denominators and group order?", "needed": "Allocation, follow-up and completion, analysis flow, group-specific stages", "role": "Required", "role_reason": "Required to record the original information and gaps for this question as an individual condition: What were the randomized denominators and group order?", "application_exception": "Do not copy 438 randomized participants into every outcome denominator.", "criterion": "Separate the original randomized denominators 220/218 from denominators at other stages.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations by study design are our own design / M08 §8.1–8.2.3; our own application", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If the original flow diagram is provided, connect group allocation with endpoint analysis denominators.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original sample size was 438, allocated as 220 to once or twice weekly and 218 to at least six times weekly.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. Complete group-specific follow-up and endpoint analysis flows are unverified.", "missingness": "Complete group-specific follow-up and endpoint analysis flows are unverified.", "uncertainty": "Do not copy 438 randomized participants into every outcome denominator. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation, follow-up and completion, analysis flow, group-specific stages" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "What inclusion rule defined the 388 participants in the primary model?", "needed": "Primary-analysis inclusion, responses by time, missingness and model handling", "role": "Required", "role_reason": "Required to record the original information and gaps for this question as an individual condition: What inclusion rule defined the 388 participants in the primary model?", "application_exception": "Do not move 388 into responder or safety denominators or newly calculate attrition.", "criterion": "Separate inclusion based on at least one response from each time-specific denominator.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are our own design / M08 §8.2.2, M15 §15.3.1; our own application", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original time-specific flow and models are provided, distinguish primary-analysis inclusion from week-4 responses.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original condition states that 388 participants (193/195) with at least one follow-up POEM entered the primary analysis. This is not verified as the response denominator for all 4 weekly measurements.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. Weekly responses, completion and missingness reasons, and model handling details are unverified.", "missingness": "Weekly responses, completion and missingness reasons, and model handling details are unverified.", "uncertainty": "Do not move 388 into responder or safety denominators or newly calculate attrition. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Primary-analysis inclusion, responses by time, missingness and model handling" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "What are the POEM scale, direction and measured content?", "needed": "Original scale, participant or caregiver response, language, entry methods and missing measurements", "role": "Required", "role_reason": "Required to record the original information and gaps for this question as an individual condition: What are the POEM scale, direction and measured content?", "application_exception": "Do not replace POEM with an objective skin examination, SCORAD or infection events.", "criterion": "Preserve the symptom-scale direction and separate measurement gaps.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations by question are our own design / M08 Table 8.2.a, M03 §3.2.4; our own application", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original measurement materials are provided, record the scale, respondent roles and collection processes.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "POEM is a seven-item 0–28 symptom scale for the previous week, with higher scores indicating worse symptoms. It is the main trial’s patient-centered symptom outcome.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. Participant versus caregiver response and detailed online measurement procedures are unverified.", "missingness": "Participant versus caregiver response and detailed online measurement procedures are unverified.", "uncertainty": "Do not replace POEM with an objective skin examination, SCORAD or infection events. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original scale, participant or caregiver response, language, entry methods and missing measurements" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Does the 4-week mean differ from the final week-4 value or change score?", "needed": "Weekly collection and mean model, baseline, final and change values, effect of interest", "role": "Required", "role_reason": "Required to record the original information and gaps for this question as an individual condition: Does the 4-week mean differ from the final week-4 value or change score?", "application_exception": "Do not express the adjusted mean −0.4 as a single final week-4 value or an individual change score.", "criterion": "Distinguish the repeated-measurement mean from final-time responses.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design / M08 §8.2.2, M15 §15.3.1; Chamgap adaptation", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original models and time tables are provided, separate the repeated-measurement mean from week-4 change and responders.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "The primary endpoint was the adjusted mean POEM difference from weekly measurements over 4 weeks. This differs from the related proportion improving by at least 3 points at week 4.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. Weekly values, details of the mean model and baseline-adjusted values are unverified.", "missingness": "Weekly values, details of the mean model and baseline-adjusted values are unverified.", "uncertainty": "Do not express the adjusted mean −0.4 as a single final week-4 value or an individual change score. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Weekly collection and mean model, baseline, final and change values, effect of interest" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "What are the primary adjusted difference, interval and P value?", "needed": "Original difference direction, adjustment, model and interval", "role": "Required", "role_reason": "Required to record the original information and gaps for this question as an individual condition: What are the primary adjusted difference, interval and P value?", "application_exception": "Do not recalculate group differences, CIs or P values or copy them into responder effects.", "criterion": "Assign the original direction, units, 95% CI and P value to the selected mean endpoint.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design / M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are our own design / M15 §15.3.1–15.3.3; our own application", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original analysis methods are provided, connect the original estimate with its observation scope.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "Preserve the adjusted 4-week mean difference for once or twice weekly versus at least six times weekly: −0.4 points (95% CI −1.3 to 0.4), P=0.30.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. Detailed adjustment variables, model and effect of interest are unverified.", "missingness": "Detailed adjustment variables, model and effect of interest are unverified.", "uncertainty": "Do not recalculate group differences, CIs or P values or copy them into responder effects. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original difference direction, adjustment, model and interval" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "What were the adjustment, repeated-measurement and missing-data models?", "needed": "Statistical model, adjustment variables, repeated measures, missingness and sensitivity", "role": "Required", "role_reason": "Required to record the original information and gaps for this question as an individual condition: What were the adjustment, repeated-measurement and missing-data models?", "application_exception": "Do not certify that all confounding or missingness problems are resolved merely because adjustment is stated.", "criterion": "Separate the stored estimate from gaps in direct model details.", "basis": "M08 §8.2.2, M15 §15.3.1; Chamgap adaptation / M15 §15.3.1–15.3.3; Chamgap adaptation", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If the original SAP and model are provided, record actual estimation and missing-data assumptions.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original materials describe an adjusted mean difference and a primary analysis including at least one response. Specific models, covariates, repeated-measure correlation and missing-data assumptions are absent.", "condition_status": "Unverified", "status_reason": "Required direct details are absent from the stored summary and remain unverified. External materials remain unread. Adjustment variables, correlation structure and missing-data assumptions are unverified.", "missingness": "Adjustment variables, correlation structure and missing-data assumptions are unverified.", "uncertainty": "Do not certify that all confounding or missingness problems are resolved merely because adjustment is stated. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Statistical model, adjustment variables, repeated measures, missingness and sensitivity" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Is 2.2 points a clinical threshold or a sample-size assumption?", "needed": "Original sample-size assumption and separate evidence for clinical importance", "role": "Required", "role_reason": "Required to record the original information and gaps for this question as an individual condition: Is 2.2 points a clinical threshold or a sample-size assumption?", "application_exception": "Do not turn 2.2 into a validated MCID, individual response threshold or criterion excluding every benefit.", "criterion": "Preserve both the exclusion of the original assumption and the absence of a validated clinical threshold.", "basis": "M15 §15.3.1–15.3.3; Chamgap adaptation / M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original plans and importance materials are provided, separate the design effect size from a clinical threshold.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original summary explicitly states that the observed interval excluded the 2.2-point difference used for sample-size planning, but that this was a power assumption rather than a validated minimum clinically important difference.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. Direct evidence for a validated minimum clinically important difference is absent from this summary.", "missingness": "Direct evidence for a validated minimum clinically important difference is absent from this summary.", "uncertainty": "Do not turn 2.2 into a validated MCID, individual response threshold or criterion excluding every benefit. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original sample-size assumption and separate evidence for clinical importance" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Does the original null result establish zero effect, equivalence or long-term absence of harm?", "needed": "Superiority hypothesis, uncertainty, importance and applicability", "role": "Required", "role_reason": "Required to record the original information and gaps for this question as an individual condition: Does the original null result establish zero effect, equivalence or long-term absence of harm?", "application_exception": "Do not turn nonsignificance into zero symptom difference, equivalence or safety at any frequency.", "criterion": "Maintain the original null superiority result, interval and 4-week limit.", "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design / M15 §15.3.1–15.3.3; Chamgap adaptation / M03 §3.2.4; Chamgap extrapolation boundary", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original interpretation evidence is provided, distinguish the statistical result from clinical and temporal extrapolations.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original primary endpoint was null and the 4-week benefit anticipated by the trial did not emerge. Preserve the original interval −1.3 to 0.4.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. Long-term equivalence, zero overall effect and absence of all harms were not established.", "missingness": "Long-term equivalence, zero overall effect and absence of all harms were not established.", "uncertainty": "Do not turn nonsignificance into zero symptom difference, equivalence or safety at any frequency. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Superiority hypothesis, uncertainty, importance and applicability" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Is improvement of at least 3 points at week 4 a separate outcome?", "needed": "Response definition, week-4 response denominators, adjustment and intervals", "role": "Supplementary", "role_reason": "Required to record the original information and gaps for this question as an individual condition: Is improvement of at least 3 points at week 4 a separate outcome?", "application_exception": "Do not newly calculate original responder rates or differences or turn them into the mean POEM result.", "criterion": "Distinguish responder denominators 169/171 from the primary model denominators 193/195.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations by question are our own design / M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations by study design are our own design / M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is our own design", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If the original responder table is provided, connect the mean, responders and their denominators separately.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "Week-4 POEM improvement of at least 3 points was 97/169 (57.4%) versus 91/171 (53.2%), adjusted risk difference 3.5%p (95% CI −6.6 to 13.6) and adjusted RR 1.06. The related note states a null result with 95% CI 0.89 to 1.28.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. Details of responder-analysis adjustment and missing-data rules are unverified.", "missingness": "Details of responder-analysis adjustment and missing-data rules are unverified.", "uncertainty": "Do not newly calculate original responder rates or differences or turn them into the mean POEM result. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Response definition, week-4 response denominators, adjustment and intervals" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Are the 3-point responder definition and 2.2-point planning assumption the same?", "needed": "Planned and validated response threshold, mean-difference assumption", "role": "Supplementary", "role_reason": "Required to record the original information and gaps for this question as an individual condition: Are the 3-point responder definition and 2.2-point planning assumption the same?", "application_exception": "Do not promote the original 3-point responder threshold into a newly validated MCID declaration.", "criterion": "Separate the responder definition from the sample-size assumption.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design / M15 §15.3.1–15.3.3; Chamgap adaptation / M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original plans and validation materials are provided, record the role and evidence level of each threshold.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "Improvement of at least 3 points at week 4 is a separate responder definition; 2.2 points is the sample-size assumption for the mean difference. Preserve the different roles of both numbers.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. External validation and detailed prespecification of the 3-point threshold remain unread.", "missingness": "External validation and detailed prespecification of the 3-point threshold remain unread.", "uncertainty": "Do not promote the original 3-point responder threshold into a newly validated MCID declaration. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Planned and validated response threshold, mean-difference assumption" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Do days of flare-control cream use establish symptom benefit?", "needed": "Cream types, use-day definitions, denominators, adjustment and endpoint hierarchy", "role": "Supplementary", "role_reason": "Required to record the original information and gaps for this question as an individual condition: Do days of flare-control cream use establish symptom benefit?", "application_exception": "Do not convert use-days into treatment dose reductions, stopping instructions or symptom benefit.", "criterion": "Preserve the secondary use-day outcome together with the null primary endpoint.", "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design / M03 §3.2.4; Chamgap extrapolation boundary / M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original use materials are provided, distinguish use-days, medicine types and amounts, and symptom outcomes.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "The once- or twice-weekly group used flare-control cream on an average 0.5 fewer days per week (95% CI −0.8 to −0.1). The original explanation identifies this as secondary and does not promote it into mean POEM benefit.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. Cream types and doses, actual analysis denominators and details of measuring use-days are unverified.", "missingness": "Cream types and doses, actual analysis denominators and details of measuring use-days are unverified.", "uncertainty": "Do not convert use-days into treatment dose reductions, stopping instructions or symptom benefit. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Cream types, use-day definitions, denominators, adjustment and endpoint hierarchy" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Were registration, primary and secondary hierarchy, and multiplicity read directly?", "needed": "Registration timing, prespecified endpoints and analyses, changes and multiplicity", "role": "Required", "role_reason": "Required to record the original information and gaps for this question as an individual condition: Were registration, primary and secondary hierarchy, and multiplicity read directly?", "application_exception": "Do not turn a registration string or original primary label into direct certification of prespecified plans.", "criterion": "Separate original role labels from unread external plans.", "basis": "M08 Table 8.2.a, M04 §4.6.3; our own application / M04 §4.5–4.6 material-collection and selection principles; separation of access and reading and hyperlink rules are our own design", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original registration and plans are provided, distinguish reporting from prespecification.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "Preserve the original primary mean POEM, secondary cream use-days and registration ISRCTN12016473. Original registration, protocol and SAP were not read during this production.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. Prespecified registration timing, responder hierarchy, multiplicity and changes are unverified.", "missingness": "Prespecified registration timing, responder hierarchy, multiplicity and changes are unverified.", "uncertainty": "Do not turn a registration string or original primary label into direct certification of prespecified plans. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration timing, prespecified endpoints and analyses, changes and multiplicity" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "How far does the original consistency of missing-data and assigned analyses extend?", "needed": "Weekly missingness and attrition reasons, analysis definitions and sensitivity assumptions", "role": "Required", "role_reason": "Required to record the original information and gaps for this question as an individual condition: How far does the original consistency of missing-data and assigned analyses extend?", "application_exception": "Do not turn the same conclusion into identical values for every outcome or absence of missing data.", "criterion": "Preserve the original sensitivity narrative together with gaps in missing-data details.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are our own design / M08 §8.2.2, M15 §15.3.1; our own application / M19 §19.1.2–19.2.4, M04 §4.6.3; our own application", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original analyses and flow materials are provided, record denominators, methods and results for each analysis.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original summary states that analysis by randomized allocation and missing-data sensitivity analyses gave the same conclusion. Weekly missingness and analysis-specific quantitative estimates and assumptions are absent.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. Analysis-specific effects and intervals and missingness reasons and assumptions are unverified.", "missingness": "Analysis-specific effects and intervals and missingness reasons and assumptions are unverified.", "uncertainty": "Do not turn the same conclusion into identical values for every outcome or absence of missing data. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Weekly missingness and attrition reasons, analysis definitions and sensitivity assumptions" }, { "item_id": "N25", "question_type": "Harm information", "question": "What was the outcome of changing treatment because of worsening?", "needed": "Worsening and treatment-change definitions, original safety denominators, duration and ascertainment", "role": "Supplementary", "role_reason": "Required to record the original information and gaps for this question as an individual condition: What was the outcome of changing treatment because of worsening?", "application_exception": "Do not recalculate change rates or infer treatment types or severity.", "criterion": "Preserve safety denominators 165/168 and the numerical direction.", "basis": "M19 §19.1.2–19.2.4; Chamgap adaptation / M19 §19.1.2–19.2.4; detailed distinctions are Chamgap design / M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation / M19 §19.1.2–19.2.4; Chamgap adaptation", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If the original safety table is provided, record treatment-change events, analysis denominators and definitions.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "Treatment changes for worsening were 17/165 (10.3%) with once or twice weekly versus 13/168 (7.7%) with at least six times weekly. The original safety summary states that the numerical proportion was higher with less washing.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. Between-group CIs and P values, actual event ascertainment and missing-data rules are unverified.", "missingness": "Between-group CIs and P values, actual event ascertainment and missing-data rules are unverified.", "uncertainty": "Do not recalculate change rates or infer treatment types or severity. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Worsening and treatment-change definitions, original safety denominators, duration and ascertainment" }, { "item_id": "N26", "question_type": "Harm information", "question": "What was the outcome of seeking medical advice?", "needed": "Medical-advice definition, people versus events, denominator and duration, reporting methods", "role": "Supplementary", "role_reason": "Required to record the original information and gaps for this question as an individual condition: What was the outcome of seeking medical advice?", "application_exception": "Do not turn advice counts into diagnosed worsening, infection or hospitalization or add them to treatment-change events.", "criterion": "Preserve denominators 165/170 and the separate event.", "basis": "M19 §19.1.2–19.2.4; Chamgap adaptation / M19 §19.1.2–19.2.4; detailed distinctions are Chamgap design / M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation / M19 §19.1.2–19.2.4; Chamgap adaptation", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If the original safety table is provided, distinguish advice requests from treatment changes and symptom outcomes.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "Requests for medical advice were 20/165 (12.1%) versus 13/170 (7.6%). These are different events and denominators from treatment changes.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. Actual advice, ascertainment methods, between-group CIs and P values, and missingness are unverified.", "missingness": "Actual advice, ascertainment methods, between-group CIs and P values, and missingness are unverified.", "uncertainty": "Do not turn advice counts into diagnosed worsening, infection or hospitalization or add them to treatment-change events. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Medical-advice definition, people versus events, denominator and duration, reporting methods" }, { "item_id": "N27", "question_type": "Harm information", "question": "Do numerical safety differences establish statistically significant worsening?", "needed": "Between-group estimates and intervals, tests and safety-event definitions", "role": "Supplementary", "role_reason": "Required to record the original information and gaps for this question as an individual condition: Do numerical safety differences establish statistically significant worsening?", "application_exception": "Do not calculate or invent new CIs, P values, significance, causal conclusions or absence of harm.", "criterion": "Separate the original numerical direction from limits on statistical conclusions.", "basis": "Chamgap interpretation boundary; M19 is a reference principle, not execution of an official causality tool / M15 §15.3.1–15.3.3; Chamgap adaptation / M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original safety analyses are provided, distinguish numerical values from statistical uncertainty.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original safety explanation explicitly states that statistically significant worsening cannot be claimed because between-group CIs and P values were not reported. Original external tables remain unread.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. Direct materials for between-group CIs and P values remain unread.", "missingness": "Direct materials for between-group CIs and P values remain unread.", "uncertainty": "Do not calculate or invent new CIs, P values, significance, causal conclusions or absence of harm. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Between-group estimates and intervals, tests and safety-event definitions" }, { "item_id": "N28", "question_type": "Harm information", "question": "What is known about other harms, collection, discontinuation and complete safety records?", "needed": "Harm definitions, collection methods, severity, discontinuation and all-event tables", "role": "Supplementary", "role_reason": "Required to record the original information and gaps for this question as an individual condition: What is known about other harms, collection, discontinuation and complete safety records?", "application_exception": "Do not infer complete harm collection or zero other events from the presence of two outcomes.", "criterion": "Distinguish the stored safety history from gaps in direct evidence on all harms.", "basis": "M19 §19.1.2–19.2.4; detailed distinctions are Chamgap design / M19 §19.1.2–19.2.4, M04 §4.6.3; Chamgap adaptation / M19 §19.1.2–19.2.4; Chamgap adaptation", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original safety materials are provided, distinguish the actual collection scope from unread or unreported information.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "Parent Caution and two safety outcomes are preserved. The summary has no complete list of all adverse events, discontinuations, infections, or spontaneous versus systematic collection.", "condition_status": "Unverified", "status_reason": "Required direct details are absent from the stored summary and remain unverified. External materials remain unread. Collection of all harms and infections, discontinuation and reporting completeness are unverified.", "missingness": "Collection of all harms and infections, discontinuation and reporting completeness are unverified.", "uncertainty": "Do not infer complete harm collection or zero other events from the presence of two outcomes. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Harm definitions, collection methods, severity, discontinuation and all-event tables" }, { "item_id": "N29", "question_type": "Harm information", "question": "How far are harm timing, follow-up and recovery documented?", "needed": "Safety-event timing, exposure and follow-up windows, discontinuation, recovery and long term", "role": "Supplementary", "role_reason": "Required to record the original information and gaps for this question as an individual condition: How far are harm timing, follow-up and recovery documented?", "application_exception": "Do not turn a null 4-week symptom result into long-term safety or temporal causality certification.", "criterion": "Separate short observation from gaps in harm timing and long-term outcomes.", "basis": "M19 §19.2 concerns harm questions by study design; temporal-relationship details are our own design / M19 §19.1.2–19.2.4; our own application", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original timing materials are provided, record the relationship of 4 weeks to long-term and individual-event timing.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "The main trial had 4-week follow-up. The summary lacks timing of safety-event onset and recovery, discontinuation timing and risks after 4 weeks.", "condition_status": "Unverified", "status_reason": "Required direct details are absent from the stored summary and remain unverified. External materials remain unread. Event-specific timing, recovery, and long-term or rare harms are unverified.", "missingness": "Event-specific timing, recovery, and long-term or rare harms are unverified.", "uncertainty": "Do not turn a null 4-week symptom result into long-term safety or temporal causality certification. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Safety-event timing, exposure and follow-up windows, discontinuation, recovery and long term" }, { "item_id": "N30", "question_type": "Harm information", "question": "What were the harm comparator, concurrent treatment and alternative explanations?", "needed": "Baseline risk, concurrent treatment and environment, event attribution and comparison conditions", "role": "Supplementary", "role_reason": "Required to record the original information and gaps for this question as an individual condition: What were the harm comparator, concurrent treatment and alternative explanations?", "application_exception": "Do not attribute treatment changes or advice requests exclusively and conclusively to bathing frequency.", "criterion": "Preserve the actual comparator and gaps in alternative causes.", "basis": "M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation / M19 §19.2.2–19.2.4 on design considerations; detailed confounding records are a Chamgap design / M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original event and co-treatment materials are provided, record the relationship between frequency and other changes.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "Safety was also compared between active frequencies while usual moisturizers and topical treatment continued. Actual treatment changes, baseline worsening, environmental factors, infection and alternative explanations are absent from the summary.", "condition_status": "Unverified", "status_reason": "Required direct details are absent from the stored summary and remain unverified. External materials remain unread. Event attribution, alternative factors and actual changes in concurrent treatment are unverified.", "missingness": "Event attribution, alternative factors and actual changes in concurrent treatment are unverified.", "uncertainty": "Do not attribute treatment changes or advice requests exclusively and conclusively to bathing frequency. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline risk, concurrent treatment and environment, event attribution and comparison conditions" }, { "item_id": "N31", "question_type": "Harm information", "question": "Do safety denominators and missingness differ from efficacy denominators?", "needed": "Endpoint-specific responses, missingness, risk populations, duration and aggregation", "role": "Supplementary", "role_reason": "Required to record the original information and gaps for this question as an individual condition: Do safety denominators and missingness differ from efficacy denominators?", "application_exception": "Do not add differing denominators or safety and responder events or turn them into one completion count.", "criterion": "Distinguish original endpoint-specific denominators from missing-data gaps.", "basis": "M19 §19.1.2–19.2.4; Chamgap adaptation / M19 §19.1.2–19.2.4, M04 §4.6.3; Chamgap adaptation / M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original flow tables are provided, record inclusion rules and missingness for each denominator.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "Original denominators differ: 165/168 for treatment changes, 165/170 for medical advice, 169/171 for responders and 193/195 for the mean model. Preserve each role separately.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. Reasons for denominator differences, people missing from safety analyses and duplicate events are unverified.", "missingness": "Reasons for denominator differences, people missing from safety analyses and duplicate events are unverified.", "uncertainty": "Do not add differing denominators or safety and responder events or turn them into one completion count. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Endpoint-specific responses, missingness, risk populations, duration and aggregation" }, { "item_id": "N32", "question_type": "Evidence condition", "question": "Did the pediatric crossover trial use the same frequency comparison?", "needed": "Original pediatric protocol, population, accompanying moisturizer and comparison differences", "role": "Supplementary", "role_reason": "Required to record the original information and gaps for this question as an individual condition: Did the pediatric crossover trial use the same frequency comparison?", "application_exception": "Do not rewrite the original protocol as treatment steps or copy it into the main trial intervention.", "criterion": "Maintain the opposite-direction context of a different protocol with moisturizer.", "basis": "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 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design / M03 §3.2.4; Chamgap extrapolation boundary", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original protocols are provided, distinguish intervention components and direct versus indirect scope.", "current_reports": [ "R02" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "Cardona used a different pediatric soak-and-seal protocol combining frequency, duration and immediate occlusive moisturizer. It is not the main trial’s general bathing and showering frequency comparison with usual treatment.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. Matching exposures, populations and outcome measures with the main trial were not verified.", "missingness": "Matching exposures, populations and outcome measures with the main trial were not verified.", "uncertainty": "Do not rewrite the original protocol as treatment steps or copy it into the main trial intervention. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original pediatric protocol, population, accompanying moisturizer and comparison differences" }, { "item_id": "N33", "question_type": "Evidence condition", "question": "What were the pediatric trial size and SCORAD result?", "needed": "SCORAD analysis denominators, difference direction, period-specific and sequence-specific results", "role": "Supplementary", "role_reason": "Required to record the original information and gaps for this question as an individual condition: What were the pediatric trial size and SCORAD result?", "application_exception": "Do not turn SCORAD 21.2 into a POEM effect or main-trial result or aggregate people and periods.", "criterion": "Preserve original pediatric size, scale, opposite direction and different conditions.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design / M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design / M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original crossover tables are provided, assign people, periods, denominators and SCORAD to their own materials.", "current_reports": [ "R02" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "The pediatric single-blind crossover trial randomized 42 and had 40 completers, in a 2-week context. Preserve that the different, more frequent exposure protocol reduced SCORAD by 21.2 points more (95% CI 14.9 to 27.6), P<0.0001.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. Actual analysis-specific denominators, period and sequence results, and interval models are unverified.", "missingness": "Actual analysis-specific denominators, period and sequence results, and interval models are unverified.", "uncertainty": "Do not turn SCORAD 21.2 into a POEM effect or main-trial result or aggregate people and periods. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "SCORAD analysis denominators, difference direction, period-specific and sequence-specific results" }, { "item_id": "N34", "question_type": "Evidence condition", "question": "What is known about crossover sequence, carryover, registration and funding?", "needed": "Allocation sequence, washout and carryover, role-specific masking, original registration and funding", "role": "Supplementary", "role_reason": "Required to record the original information and gaps for this question as an individual condition: What is known about crossover sequence, carryover, registration and funding?", "application_exception": "Do not inherit historical abstract verification as current abstract reading or certification of noncommercial independence.", "criterion": "Preserve original unverified registration and funding entries and crossover-detail gaps.", "basis": "M08 §8.1–8.2.3; Chamgap adaptation / M08 §8.2.2, M15 §15.3.1; Chamgap adaptation / M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation / Chamgap independence and attribution conditions; the official methodology sections used in this example do not certify all these detailed items", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original methods and declarations are provided, record crossover, institutional and registration details and the verification scope.", "current_reports": [ "R02" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "The pediatric trial was single-blind crossover and its registration field was ‘Could not verify.’ The original funding narrative cites the abstract indexing ‘Research Support, Non-U.S. Gov’t’ but could not establish a specific institution in the historically checked public materials.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. Crossover sequence, carryover, original registration, specific funding and COI are currently unverified.", "missingness": "Crossover sequence, carryover, original registration, specific funding and COI are currently unverified.", "uncertainty": "Do not inherit historical abstract verification as current abstract reading or certification of noncommercial independence. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation sequence, washout and carryover, role-specific masking, original registration and funding" }, { "item_id": "N35", "question_type": "Evidence condition", "question": "Does the review of 13 studies establish 13 independent direct RCTs?", "needed": "Review inclusion table, original study and population identities, designs and outcome lists", "role": "Supplementary", "role_reason": "Required to record the original information and gaps for this question as an individual condition: Does the review of 13 studies establish 13 independent direct RCTs?", "application_exception": "Do not count 13 studies as 13 independent RCTs or add them to direct trials as a replication total.", "criterion": "Distinguish original paper and study wording from unique trial counts.", "basis": "M04 §4.6.1–4.6.2; distinction between studies and reports; cohort and outcome connections are Chamgap adaptations / M04 §4.6.1–4.6.2, M15 §15.3.1; Chamgap adaptation / M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original inclusion lists are provided, connect the review report with individual unique study families.", "current_reports": [ "R03" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "The Hua review concerns bathing and showering frequency and eczema severity in 13 prospective studies. Designs, overlapping populations and individual inclusion lists were not read from this summary.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. Actual composition and overlap of the 13 studies and totals of independent trials and participants are undetermined.", "missingness": "Actual composition and overlap of the 13 studies and totals of independent trials and participants are undetermined.", "uncertainty": "Do not count 13 studies as 13 independent RCTs or add them to direct trials as a replication total. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Review inclusion table, original study and population identities, designs and outcome lists" }, { "item_id": "N36", "question_type": "Evidence condition", "question": "What did the review conclude about heterogeneity and optimal frequency?", "needed": "Condition and design differences, study-specific results, pooled models and intervals, heterogeneity", "role": "Supplementary", "role_reason": "Required to record the original information and gaps for this question as an individual condition: What did the review conclude about heterogeneity and optimal frequency?", "application_exception": "Do not turn background associations into optimal-frequency recommendations or safety advice for all populations.", "criterion": "Preserve the original uncertain conclusion and heterogeneous background evidence.", "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design / M04 §4.6.1–4.6.2, M15 §15.3.1; Chamgap adaptation / M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap design", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original review tables are provided, separate results for the same question from those under different conditions.", "current_reports": [ "R03" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original review summary states that daily bathing was not associated with worse severity, but sparse heterogeneous studies left optimal frequency unclear.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. Pooled effects and CIs, quantitative heterogeneity and direct evidence on optimal frequency are unverified.", "missingness": "Pooled effects and CIs, quantitative heterogeneity and direct evidence on optimal frequency are unverified.", "uncertainty": "Do not turn background associations into optimal-frequency recommendations or safety advice for all populations. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Condition and design differences, study-specific results, pooled models and intervals, heterogeneity" }, { "item_id": "N37", "question_type": "Evidence condition", "question": "Is independent replication across reports, reviews and populations established?", "needed": "Related reports, included trials and populations, repeat citations and independent harm records", "role": "Required", "role_reason": "Required to record the original information and gaps for this question as an individual condition: Is independent replication across reports, reviews and populations established?", "application_exception": "Do not count the same people, periods, review, related tables or material slots as new independent trials.", "criterion": "Keep report slots separate from undetermined unique trial and participant counts.", "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort and outcome linking is our own application / M04 §4.6.1–4.6.2, M15 §15.3.1; our own application / M04 §4.6.1–4.6.2; harm-material adaptations are our own design", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original lists are provided, distinguish reports, unique study families and overlap.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "Main-trial, pediatric crossover and review reports are linked, but review citation and inclusion relationships were not directly compared. Parent R0 is verdict history and does not mean zero actual studies exist.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. Totals of unique trials, participants and independent harm replications are undetermined.", "missingness": "Totals of unique trials, participants and independent harm replications are undetermined.", "uncertainty": "Do not count the same people, periods, review, related tables or material slots as new independent trials. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Related reports, included trials and populations, repeat citations and independent harm records" }, { "item_id": "N38", "question_type": "Evidence condition", "question": "Does the evidence answer persistence, discontinuation or long-term symptoms after 4 weeks?", "needed": "Long-term follow-up, discontinuation and frequency changes, symptoms and harms, same-cohort follow-up", "role": "Supplementary", "role_reason": "Required to record the original information and gaps for this question as an individual condition: Does the evidence answer persistence, discontinuation or long-term symptoms after 4 weeks?", "application_exception": "Do not expand a null 4-week result into null effects or equivalence under every long-term condition.", "criterion": "Distinguish the selected duration from gaps in direct long-term evidence.", "basis": "M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap design / M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design / M19 §19.1.2–19.2.4; Chamgap adaptation", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If long-term materials are provided, record same-family follow-up separately from new trials.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original main trial describes a 4-week follow-up limitation and states that results were not generalized to longer periods.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. Persistence after 4 weeks, post-discontinuation effects and long-term harms are unverified.", "missingness": "Persistence after 4 weeks, post-discontinuation effects and long-term harms are unverified.", "uncertainty": "Do not expand a null 4-week result into null effects or equivalence under every long-term condition. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Long-term follow-up, discontinuation and frequency changes, symptoms and harms, same-cohort follow-up" }, { "item_id": "N39", "question_type": "Evidence condition", "question": "What is known about hot and humid environments, infection risk and subgroups?", "needed": "Environment, infection risk, age and severity denominators, prespecified interactions", "role": "Supplementary", "role_reason": "Required to record the original information and gaps for this question as an individual condition: What is known about hot and humid environments, infection risk and subgroups?", "application_exception": "Do not copy general online-trial results into specific infection, climate or subgroup effects.", "criterion": "Preserve original applicability limits and gaps in direct evidence.", "basis": "M03 §3.2.1; detailed population conditions are Chamgap design / M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap design / M19 §19.1.2–19.2.4; Chamgap adaptation", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If direct materials for these populations are provided, distinguish overall results from effects and harms under separate conditions.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original explanation explicitly avoids generalizing to hot and humid settings or people at high infection risk. Age and severity interactions are also absent from the summary.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. Direct environmental, high-risk, age-specific and severity-specific results are unverified.", "missingness": "Direct environmental, high-risk, age-specific and severity-specific results are unverified.", "uncertainty": "Do not copy general online-trial results into specific infection, climate or subgroup effects. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Environment, infection risk, age and severity denominators, prespecified interactions" }, { "item_id": "N40", "question_type": "Evidence condition", "question": "What was the scope of public funding, supplies and analysis roles?", "needed": "Original funding and role declarations, supply and analysis contracts, data access", "role": "Required", "role_reason": "Required to record the original information and gaps for this question as an individual condition: What was the scope of public funding, supplies and analysis roles?", "application_exception": "Do not turn public funding or I2 into current independence review or certification of no interests.", "criterion": "Separate original support and noninvolvement statements from unread external declarations.", "basis": "CHAMGAP's own independence and attribution conditions. Official methodological sections used in this pilot do not guarantee every detail of this item / M04 §4.6.1–4.6.2, M15 §15.3.1; our own application", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original declarations are provided, record institutions, roles and disclosure scopes for supplies and analysis.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original statement identifies NIHR Programme Grants for Applied Research, NIHR203279, as funder, with no role in design, collection, analysis, publication decisions or writing. Statements that product, device or placebo supplies and commercial analysis services were unreported are historical.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. Original declarations were not directly compared and complete current roles remain unread.", "missingness": "Original declarations were not directly compared and complete current roles remain unread.", "uncertainty": "Do not turn public funding or I2 into current independence review or certification of no interests. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original funding and role declarations, supply and analysis contracts, data access" }, { "item_id": "N41", "question_type": "Evidence condition", "question": "What were the author consulting fees and scale-development disclosures?", "needed": "Original author declarations, scale development and use, consulting relationships and roles", "role": "Required", "role_reason": "Required to record the original information and gaps for this question as an individual condition: What were the author consulting fees and scale-development disclosures?", "application_exception": "Do not automatically infer bias magnitude, null effects or absence of disclosure from scale development or consulting disclosures.", "criterion": "Record original disclosures and their verification level unchanged.", "basis": "Chamgap's own independence and attribution conditions. The official method sections used in this pilot do not endorse all of these detailed items / M04 §4.5, §4.6.3; limitations in the current material conversion concern review scope and Chamgap design", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original declarations are provided, record author-specific disclosures and actual research roles.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "Preserve the original COI disclosures of E.J.M.’s personal consulting fees from AbbVie, H.C.W.’s POEM development, and L.H. and K.S.T.’s RECAP development.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. The full original declarations and their historical scope and roles were not read directly during this production.", "missingness": "The full original declarations and their historical scope and roles were not read directly during this production.", "uncertainty": "Do not automatically infer bias magnitude, null effects or absence of disclosure from scale development or consulting disclosures. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original author declarations, scale development and use, consulting relationships and roles" }, { "item_id": "N42", "question_type": "Evidence condition", "question": "How is unverified review funding preserved?", "needed": "Original review funding, COI and role declarations", "role": "Supplementary", "role_reason": "Required to record the original information and gaps for this question as an individual condition: How is unverified review funding preserved?", "application_exception": "Do not infer public funding, no funding or independence from an unknown funding source.", "criterion": "Maintain unverified original funding and registration entries.", "basis": "Chamgap's own independence and attribution conditions. The official method sections used in this pilot do not endorse all of these detailed items / M04 §4.5, §4.6.3; limitations in the current material conversion concern review scope and Chamgap design", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original declarations are provided, distinguish previous unverified information from new material contents.", "current_reports": [ "R03" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original narrative states that the Hua review’s specific funder could not be established in historically checked public materials. The original review and declarations remain unread.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. Specific funding, complete COI and interests relating to included materials are unverified.", "missingness": "Specific funding, complete COI and interests relating to included materials are unverified.", "uncertainty": "Do not infer public funding, no funding or independence from an unknown funding source. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original review funding, COI and role declarations" }, { "item_id": "N43", "question_type": "Evidence condition", "question": "Are links to other product verdicts evidence for this trial?", "needed": "Intervention-specific questions, original links and separate contexts", "role": "Supplementary", "role_reason": "Required to record the original information and gaps for this question as an individual condition: Are links to other product verdicts evidence for this trial?", "application_exception": "Do not click or test the original links or repurpose other product results as new frequency effects.", "criterion": "Preserve only the separate original product context without creating new questions or trials.", "basis": "M03 §3.1, §3.2.1–3.2.4; question-clarification principle; detailed separation rules are Chamgap design / M04 §4.6.1–4.6.2; distinction between studies and reports; cohort and outcome connections are Chamgap adaptations / M03 §3.2.4; Chamgap extrapolation boundary", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If separate materials are requested, distinguish the original unit of each intervention and question.", "current_reports": [ "R01" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original product information links separate D30 verdicts for bath additives 2887 and water softeners 2426. These are not combined with the frequency trial’s results or trials.", "condition_status": "Partly verified", "status_reason": "The original narrative in the stored summary is linked for production as partly verified; this is not completed clinical verification or review. Other product pages and materials were not read or link-tested during the original production.", "missingness": "Other product pages and materials were not read or link-tested during the original production.", "uncertainty": "Do not click or test the original links or repurpose other product results as new frequency effects. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Intervention-specific questions, original links and separate contexts" }, { "item_id": "N44", "question_type": "Evidence condition", "question": "How are dates, corrections, Korean and English wording, and empty values preserved?", "needed": "Original dates and empty values, corrections, current reading and update scope", "role": "Required", "role_reason": "Required to record the original information and gaps for this question as an individual condition: How are dates, corrections, Korean and English wording, and empty values preserved?", "application_exception": "Do not reuse historical dates or cross-checking as a current clinical verification date or certify absence of all corrections from an empty correction array.", "criterion": "Preserve the original history together with current content-review status and work scope.", "basis": "M04 §4.5, §4.6.3; limitations of this conversion follow the review scope and Chamgap design / M03 §3.1, §3.2.1–3.2.4; question-clarification principle; detailed separation rules are Chamgap design / Chamgap interpretation boundary; M19 is a reference principle, not execution of an official causality tool", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If actual evidence updates are provided, separate the complete original version from new correction events.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Original preserved-summary and bibliography links; existence and content of necessary external details remain unverified", "acquired_read": "Summary read; external materials not read", "observation": "Preserve reference date 2026-08-26, an empty correction array, an empty deliberation string, original Korean and English wording, and false or empty axis values. Original typos are not changed in the stored original.", "condition_status": "Partly verified", "status_reason": "This is partial confirmation linking the original stored account for production; clinical verification and review are not complete. There are no separate evidence-cutoff or classification records, and no current correction or retraction search has been performed.", "missingness": "There are no separate evidence-cutoff or classification records, and no current correction or retraction search has been performed.", "uncertainty": "Do not reuse historical dates or cross-checking as a current clinical verification date or certify absence of all corrections from an empty correction array. The original content review remains incomplete and external original materials were not verified directly.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original dates and empty values, corrections, current reading and update scope" } ], "reports": [ { "report_id": "R01", "title": "Bradshaw L, Howells LM, Muller I, et al. Weekly versus daily bathing for people with eczema: results of the Eczema Bathing online randomized controlled trial. Br J Dermatol. 2026;194(3):450-460. PMID: 41208015. DOI: 10.1093/bjd/ljaf417.", "url": "https://pubmed.ncbi.nlm.nih.gov/41208015/", "report_type": "UK Eczema Bathing online pragmatic parallel-group superiority trial report", "existence": "Report linked to the original preserved evidence and citation lists", "acquired_read": "Summary read; external abstracts and full texts not read", "study_family": "F01", "independent_replication": false, "observed_result": "438 allocated (220/218); 388 in the primary model (193/195). Adjusted 4-week mean POEM −0.4 points (95% CI −1.3 to 0.4), P=.30. The 2.2-point value was a power assumption, not a validated MCID. Responders, cream use-days and safety outcomes retain separate endpoints and denominators.", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Local preserved copy", "access_status": "Local preserved summary acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-06T17:26:56.039490+09:00", "qualification": "The corresponding evidence list, bibliography and related Korean and English context in the complete designated stored summary were linked for production. This is not external original-text reading." }, { "material_type": "External abstract", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "The original bibliographic URL is preserved. Historical public or abstract verification narratives do not mean the abstract was read in this production." }, { "material_type": "External full text", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "The original source link connects bibliographic identity; it does not establish direct full-text acquisition, reading or link verification." }, { "material_type": "External registration", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Only the original ISRCTN string is preserved. External registration timing, endpoints, changes and plans were not read in this production." }, { "material_type": "Required materials: protocol or review plan", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Needed: repeated-mean model, weekly responses and missingness, actual performance, endpoint hierarchy and denominators, safety, original funding and COI. Existence, public availability and acquisition of original planning materials are unverified." }, { "material_type": "Required material: SAP and analysis methods", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Models, effects of interest, missing-data, crossover and pooled analyses, and prespecified plans for these materials remain unread." }, { "material_type": "Required material: outcomes, denominators, and harms", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original tables of each result, denominator, time point, harm and included material are needed; values from other trials or endpoints are not used to fill gaps." }, { "material_type": "Required materials: funding and COI", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original funding and author declarations were not read directly. Unknown specific funding and historical public funding are maintained separately." } ], "links": [ { "label": "Publisher", "url": "https://doi.org/10.1093/bjd/ljaf417" }, { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/41208015/" } ] }, { "report_id": "R02", "title": "Cardona ID, Kempe EE, Lary C, et al. Frequent Versus Infrequent Bathing in Pediatric Atopic Dermatitis: A Randomized Clinical Trial. J Allergy Clin Immunol Pract. 2020;8(3):1014-1021. PMID: 31733336. DOI: 10.1016/j.jaip.2019.10.043.", "url": "https://pubmed.ncbi.nlm.nih.gov/31733336/", "report_type": "Pediatric single-blind crossover soak-and-seal trial report", "existence": "Report linked to the original preserved evidence and citation lists", "acquired_read": "Summary read; external abstracts and full texts not read", "study_family": "F02", "independent_replication": false, "observed_result": "42 randomized and 40 completed in a 2-week crossover context. A different protocol combining frequency, duration and immediate occlusive moisturizer had a SCORAD difference of 21.2 points (95% CI 14.9 to 27.6), P<.0001. This is not repurposed as a direct POEM result of the main trial.", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Local preserved copy", "access_status": "Local preserved summary acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-06T17:26:56.039490+09:00", "qualification": "The corresponding evidence list, bibliography and related Korean and English context in the complete designated stored summary were linked for production. This is not external original-text reading." }, { "material_type": "External abstract", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "The original bibliographic URL is preserved. Historical public or abstract verification narratives do not mean the abstract was read in this production." }, { "material_type": "External full text", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "The original source link connects bibliographic identity; it does not establish direct full-text acquisition, reading or link verification." }, { "material_type": "External registration", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Preserve the original registration field ‘Could not verify’; actual registration information and contents are unverified." }, { "material_type": "Required materials: protocol or review plan", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Needed: crossover sequence, carryover, actual analysis denominators, different moisturizer protocol, registration, specific funding and COI. Existence, public availability and acquisition of original planning materials are unverified." }, { "material_type": "Required material: SAP and analysis methods", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Models, effects of interest, missing-data, crossover and pooled analyses, and prespecified plans for these materials remain unread." }, { "material_type": "Required material: outcomes, denominators, and harms", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original tables of each result, denominator, time point, harm and included material are needed; values from other trials or endpoints are not used to fill gaps." }, { "material_type": "Required materials: funding and COI", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original funding and author declarations were not read directly. Unknown specific funding and historical public funding are maintained separately." } ], "links": [ { "label": "Publisher", "url": "https://doi.org/10.1016/j.jaip.2019.10.043" }, { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/31733336/" } ] }, { "report_id": "R03", "title": "Hua T, Yousaf M, Gwillim E, et al. Does daily bathing or showering worsen atopic dermatitis severity? A systematic review and meta-analysis. Arch Dermatol Res. 2021;313(9):729-735. PMID: 33196889. DOI: 10.1007/s00403-020-02164-0.", "url": "https://pubmed.ncbi.nlm.nih.gov/33196889/", "report_type": "Systematic review and meta-analysis report of bathing and showering frequency", "existence": "Report linked to the original preserved evidence and citation lists", "acquired_read": "Summary read; external abstracts and full texts not read", "study_family": "F03", "independent_replication": false, "observed_result": "13 prospective studies. The original background conclusion states that daily bathing was not associated with worse severity, but sparse heterogeneous evidence left optimal frequency unclear. No new unique independent RCT count, effect or CI is created.", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Local preserved copy", "access_status": "Local preserved summary acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-06T17:26:56.039490+09:00", "qualification": "The corresponding evidence list, bibliography and related Korean and English context in the complete designated stored summary were linked for production. This is not external original-text reading." }, { "material_type": "External abstract", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "The original bibliographic URL is preserved. Historical public or abstract verification narratives do not mean the abstract was read in this production." }, { "material_type": "External full text", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "The original source link connects bibliographic identity; it does not establish direct full-text acquisition, reading or link verification." }, { "material_type": "External registration", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Preserve the original registration field ‘Not applicable’; actual registration information and contents are unverified." }, { "material_type": "Required materials: protocol or review plan", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Needed: original inclusion tables, designs, study families, overlapping populations, study-specific and pooled results, heterogeneity, funding and COI. Existence, public availability and acquisition of original planning materials are unverified." }, { "material_type": "Required material: SAP and analysis methods", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Models, effects of interest, missing-data, crossover and pooled analyses, and prespecified plans for these materials remain unread." }, { "material_type": "Required material: outcomes, denominators, and harms", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original tables of each result, denominator, time point, harm and included material are needed; values from other trials or endpoints are not used to fill gaps." }, { "material_type": "Required materials: funding and COI", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original funding and author declarations were not read directly. Unknown specific funding and historical public funding are maintained separately." } ], "links": [ { "label": "Publisher", "url": "https://doi.org/10.1007/s00403-020-02164-0" }, { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/33196889/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." } ], "status_dictionary": { "Met": "The original content has been reviewed as meeting the conditions. This status is not used in this preparation.", "Partly verified": "Some information in the stored summary was linked during preparation; clinical verification or review is not complete.", "Unverified": "Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.", "Review incomplete": "Review of existing content or actual review incomplete.", "Not reported": "Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.", "Inaccessible": "Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.", "Insufficient evidence for the conditions": "Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.", "Not applicable": "Used when the reason it does not apply to the original question is stated.", "Conflicting data": "Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "Mean, responder, cream, safety, timing and related tables share the Bradshaw UK Eczema Bathing main-trial context and are not added as new trials or participants. The pediatric crossover uses a different soak-and-seal protocol and SCORAD, with crossover periods in the same people; it is not repurposed as the main trial’s direct comparison or new people. Included families and overlap among the review’s 13 prospective studies remain unread externally; the review report is not counted as a new independent trial." }, "history": [ { "date": "2026-10-11", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "A public view and materials were prepared from the existing 44 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-11" }