{ "schema_version": "chamgap-public-criteria-1.0", "title": "Olistic Women · Direct-evidence gaps for visibly fuller hair", "language": "en", "translation_date": "2026-10-12", "criteria_version": "1.0", "criteria_date": "2026-10-06", "condition_origin": "Chamgap's own application conditions", "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." }, "requirements": [ { "item_id": "N01", "question_type": "Appearance, patient perception, instrumental context and materials", "question": "What are the selected original question and assessment record?", "needed": "Original visibly fuller hair wording, Korean/English texts and link", "role": "Required", "role_reason": "Production condition to record the actual scope of Original visibly fuller hair wording, Korean/English texts and link.", "application_exception": "Do not count instrumental and appearance questions in one report as new independent trials or participants.", "criterion": "Link Original visibly fuller hair wording, Korean/English texts and link to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are our own design", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "If the question changes, retain original wording, the previous complete version and the change event." }, { "item_id": "N02", "question_type": "Appearance, patient perception, instrumental context and materials", "question": "How do the subclaim ? and parent C50, axes and history differ?", "needed": "Subclaim grade/note, absent score/status/axes and actual parent values", "role": "Required", "role_reason": "Production condition to record the actual scope of Subclaim grade/note, absent score/status/axes and actual parent values.", "application_exception": "Do not transfer parent measured-density C50 or historical cross-checks into a new appearance assessment, score or completed content review.", "criterion": "Link Subclaim grade/note, absent score/status/axes and actual parent values to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Distinguish actual evidence-update events from preservation of original values." }, { "item_id": "N03", "question_type": "Appearance, patient perception, instrumental context and materials", "question": "Which selected population of women entered the finished-product trial?", "needed": "Premenopausal status, telogen-effluvium diagnosis and actual recruitment/selection", "role": "Required", "role_reason": "Production condition to record the actual scope of Premenopausal status, telogen-effluvium diagnosis and actual recruitment/selection.", "application_exception": "Do not generalize to all female hair loss, men, postmenopausal women, other hair-loss types or deficiency populations.", "criterion": "Link Premenopausal status, telogen-effluvium diagnosis and actual recruitment/selection to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M03 §3.2.1; detailed population conditions are Chamgap's own design", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Distinguish other-population material by actual diagnosis, menopausal status, baseline characteristics and selection." }, { "item_id": "N04", "question_type": "Appearance, patient perception, instrumental context and materials", "question": "What material describes baseline appearance, hair loss and diagnosis?", "needed": "Telogen-effluvium definition, baseline appearance and diagnostic/differential assessment", "role": "Required", "role_reason": "Production condition to record the actual scope of Telogen-effluvium definition, baseline appearance and diagnostic/differential assessment.", "application_exception": "Do not create clinical hair-loss severity, baseline perception or differential diagnoses from TrichoScan numbers alone.", "criterion": "Link Telogen-effluvium definition, baseline appearance and diagnostic/differential assessment to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M03 §3.2.1; detailed population conditions are Chamgap design; M08 Table 8.2.a, M03 §3.2.4; Chamgap adaptation", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Record actual baseline diagnosis and starting appearance when appearance-change material becomes available." }, { "item_id": "N05", "question_type": "Appearance, patient perception, instrumental context and materials", "question": "What are the finished product and ingredient scope?", "needed": "Olistic Women drinkable multi-ingredient finished product, formulation and composition", "role": "Required", "role_reason": "Production condition to record the actual scope of Olistic Women drinkable multi-ingredient finished product, formulation and composition.", "application_exception": "Do not fill in unrecorded biotin/vitamins/botanicals or attribute an effect to an individual ingredient.", "criterion": "Link Olistic Women drinkable multi-ingredient finished product, formulation and composition to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "If material is provided, distinguish the finished product from individual ingredients and other formulations." }, { "item_id": "N06", "question_type": "Appearance, patient perception, instrumental context and materials", "question": "What were the original trial exposure and actual implementation?", "needed": "One 25-mL vial daily for six months and actual adherence/exposure", "role": "Required", "role_reason": "Production condition to record the actual scope of One 25-mL vial daily for six months and actual adherence/exposure.", "application_exception": "Do not write consumption, product-selection, dosing, dose-conversion or treatment instructions.", "criterion": "Link One 25-mL vial daily for six months and actual adherence/exposure to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Distinguish nominal exposure from actual implementation in subsequent material." }, { "item_id": "N07", "question_type": "Appearance, patient perception, instrumental context and materials", "question": "What were the placebo and common conditions?", "needed": "Manufacturer-supplied placebo, actual composition/appearance and comparison direction", "role": "Required", "role_reason": "Production condition to record the actual scope of Manufacturer-supplied placebo, actual composition/appearance and comparison direction.", "application_exception": "Do not change placebo into no treatment or an unrecorded active comparator.", "criterion": "Link Manufacturer-supplied placebo, actual composition/appearance and comparison direction to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Distinguish the actual product/placebo contrast from comparisons with other ingredients." }, { "item_id": "N08", "question_type": "Appearance, patient perception, instrumental context and materials", "question": "What were randomization and actual analysis scopes?", "needed": "106 participants, 53/53 allocation, sequence/concealment and completion/analysis", "role": "Required", "role_reason": "Production condition to record the actual scope of 106 participants, 53/53 allocation, sequence/concealment and completion/analysis.", "application_exception": "Do not copy 53/53 as verified analysis denominators for every time point/appearance endpoint or assign new methodological-defect scores.", "criterion": "Link 106 participants, 53/53 allocation, sequence/concealment and completion/analysis to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M08 §8.1–8.2.3; own application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is our own design", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "If original material is provided, distinguish allocation from actual completion/analysis and measurement level." }, { "item_id": "N09", "question_type": "Appearance, patient perception, instrumental context and materials", "question": "What were double-blinding and appearance-assessor conditions?", "needed": "Participants/measurers, photograph/appearance reading and maintained blinding", "role": "Required", "role_reason": "Production condition to record the actual scope of Participants/measurers, photograph/appearance reading and maintained blinding.", "application_exception": "Do not confirm separate appearance assessment or blinding of every assessor from the design label alone.", "criterion": "Link Participants/measurers, photograph/appearance reading and maintained blinding to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M08 §§8.1–8.2.3; Chamgap adaptation", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Record patient/independent-assessor blinding and consistent assessment conditions in appearance material." }, { "item_id": "N10", "question_type": "Appearance, patient perception, instrumental context and materials", "question": "What were concurrent hair care, treatment and natural course?", "needed": "Washing/cosmetic care, hair-loss management, medication, nutrition and natural recovery", "role": "Required", "role_reason": "Production condition to record the actual scope of Washing/cosmetic care, hair-loss management, medication, nutrition and natural recovery.", "application_exception": "Do not write new treatment, washing/cosmetic or hair-care methods or calculate natural recovery.", "criterion": "Link Washing/cosmetic care, hair-loss management, medication, nutrition and natural recovery to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Distinguish finished-product exposure from concurrent management/natural course in later appearance material." }, { "item_id": "N11", "question_type": "Appearance, patient perception, instrumental context and materials", "question": "What is the direct endpoint for visibly fuller hair?", "needed": "Visible fullness definition, observer and patient perception", "role": "Required", "role_reason": "Production condition to record the actual scope of Visible fullness definition, observer and patient perception.", "application_exception": "Do not present density change or the question wording as observed appearance improvement.", "criterion": "Link Visible fullness definition, observer and patient perception to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "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, M03 §3.2.4; our own application", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Report actual appearance assessor, definition, timing and denominator separately from instrumental counts." }, { "item_id": "N12", "question_type": "Appearance, patient perception, instrumental context and materials", "question": "What are the appearance scale and units of visible change?", "needed": "Visible change, scale, photograph/assessment and direction", "role": "Required", "role_reason": "Production condition to record the actual scope of Visible change, scale, photograph/assessment and direction.", "application_exception": "Do not convert hairs/cm² into appearance scores, fullness percentages or perceived change.", "criterion": "Link Visible change, scale, photograph/assessment and direction to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M08 Table 8.2.a, M03 §3.2.4; own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "State scale direction, observer and change definition in appearance material." }, { "item_id": "N13", "question_type": "Appearance, patient perception, instrumental context and materials", "question": "Is actual standardized-photograph or independent-assessment material available?", "needed": "Photographs/independent observation, consistent conditions, blinding and judgment", "role": "Required", "role_reason": "Production condition to record the actual scope of Photographs/independent observation, consistent conditions, blinding and judgment.", "application_exception": "Do not assert that photographic assessment existed or did not exist, or provide photography/hair-care procedures.", "criterion": "Link Photographs/independent observation, consistent conditions, blinding and judgment to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M08 Table 8.2.a, M03 §3.2.4; internal application", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "State assessment conditions, independence and judgment level in later appearance material." }, { "item_id": "N14", "question_type": "Appearance, patient perception, instrumental context and materials", "question": "What are the direct patient-perception, satisfaction and quality-of-life values?", "needed": "Distinguish patient perception, appearance/satisfaction and symptoms/quality of life", "role": "Required", "role_reason": "Production condition to record the actual scope of Distinguish patient perception, appearance/satisfaction and symptoms/quality of life.", "application_exception": "Do not attribute positive density numbers to improved satisfaction or quality of life.", "criterion": "Link Distinguish patient perception, appearance/satisfaction and symptoms/quality of life to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "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, M03 §3.2.4; our own application", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Record instrumental counts, appearance observation, satisfaction and quality of life as separate endpoints." }, { "item_id": "N15", "question_type": "Appearance, patient perception, instrumental context and materials", "question": "What are appearance-assessment timing and durability?", "needed": "Days 90/180, six-month trial and actual appearance/post-discontinuation follow-up", "role": "Required", "role_reason": "Production condition to record the actual scope of Days 90/180, six-month trial and actual appearance/post-discontinuation follow-up.", "application_exception": "Do not use day-90/day-180 instrumental signals to fill appearance improvement, long-term maintenance or recurrence prevention.", "criterion": "Link Days 90/180, six-month trial and actual appearance/post-discontinuation follow-up to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Distinguish on-treatment measurement from post-discontinuation persistence by actual timing and denominator." }, { "item_id": "N16", "question_type": "Appearance, patient perception, instrumental context and materials", "question": "What separate measurement is the TrichoScan endpoint?", "needed": "Phototrichoscopy, change from baseline density and hairs/cm²", "role": "Required", "role_reason": "Production condition to record the actual scope of Phototrichoscopy, change from baseline density and hairs/cm².", "application_exception": "Do not convert measured hair counts into total scalp hair count, thickness/appearance or clinical recovery.", "criterion": "Link Phototrichoscopy, change from baseline density and hairs/cm² to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M03 §3.2.4; Chamgap's own limits on extension", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Record hair counts, sites/areas and separate appearance/perception definitions together." }, { "item_id": "N17", "question_type": "Appearance, patient perception, instrumental context and materials", "question": "What are the original day-180 density-change values?", "needed": "Product +27.31±2.61, placebo +18.23±2.98 hairs/cm² and P<.01", "role": "Required", "role_reason": "Production condition to record the actual scope of Product +27.31±2.61, placebo +18.23±2.98 hairs/cm² and P<.01.", "application_exception": "Do not subtract the numbers to create a new net effect or appearance increase, or treat ± as a CI.", "criterion": "Link Product +27.31±2.61, placebo +18.23±2.98 hairs/cm² and P<.01 to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M04 §4.6.3 and M15 §§15.3.1–15.3.3; status separation is Chamgap-designed", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Link changes, group contrasts, variability and actual n separately in original results tables." }, { "item_id": "N18", "question_type": "Appearance, patient perception, instrumental context and materials", "question": "What hierarchy applies to day-90 and hair-cycle-ratio results?", "needed": "Qualitative day-90 difference, secondary cycle ratio and separate endpoint", "role": "Required", "role_reason": "Production condition to record the actual scope of Qualitative day-90 difference, secondary cycle ratio and separate endpoint.", "application_exception": "Do not transfer cycle ratios or qualitative day-90 findings into direct visible-fullness values, effects or duration.", "criterion": "Link Qualitative day-90 difference, secondary cycle ratio and separate endpoint to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design; M08 Table 8.2.a, M04 §4.6.3; own application", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Distinguish density, cycle ratio and appearance endpoints, timing and hierarchy." }, { "item_id": "N19", "question_type": "Appearance, patient perception, instrumental context and materials", "question": "Are direct between-group appearance effects and CIs provided?", "needed": "Actual appearance contrast, numerator/scale, intervals and adjustment", "role": "Required", "role_reason": "Production condition to record the actual scope of Actual appearance contrast, numerator/scale, intervals and adjustment.", "application_exception": "Do not calculate appearance effects, CIs or response rates from instrumental P values, ± or density changes.", "criterion": "Link Actual appearance contrast, numerator/scale, intervals and adjustment to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "If original appearance material is provided, link its measure, unit, population and estimated interval." }, { "item_id": "N20", "question_type": "Appearance, patient perception, instrumental context and materials", "question": "What are clinically important instrumental/appearance thresholds?", "needed": "Importance of hairs/cm² and direct visible/perceived-change criteria", "role": "Required", "role_reason": "Production condition to record the actual scope of Importance of hairs/cm² and direct visible/perceived-change criteria.", "application_exception": "Do not establish meaningful visible recovery solely from positive P values or hairs/cm² increase size.", "criterion": "Link Importance of hairs/cm² and direct visible/perceived-change criteria to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M15 §§15.3.1–15.3.3; Chamgap adaptation", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Distinguish measure, population and prespecified/post-hoc importance criteria." }, { "item_id": "N21", "question_type": "Appearance, patient perception, instrumental context and materials", "question": "How do appearance-assessment denominators differ from 106 randomized participants?", "needed": "53/53 allocation, valid appearance/responses and actual analysis by time point", "role": "Required", "role_reason": "Production condition to record the actual scope of 53/53 allocation, valid appearance/responses and actual analysis by time point.", "application_exception": "Do not copy 53/53 allocation as appearance-results n or add measurement areas/time points as people.", "criterion": "Link 53/53 allocation, valid appearance/responses and actual analysis by time point to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Distinguish people, measurement areas, time points and instrumental/appearance denominators." }, { "item_id": "N22", "question_type": "Appearance, patient perception, instrumental context and materials", "question": "What records describe missingness, attrition and analysis populations?", "needed": "Instrumental/appearance analysis populations, missingness/attrition and supporting analyses", "role": "Required", "role_reason": "Production condition to record the actual scope of Instrumental/appearance analysis populations, missingness/attrition and supporting analyses.", "application_exception": "Do not change historical missing-data uncertainty into zero dropout, complete ITT or new defect counts/scores.", "criterion": "Link Instrumental/appearance analysis populations, missingness/attrition and supporting analyses to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Distinguish allocation, measurement, completion, response/analysis and missingness assumptions." }, { "item_id": "N23", "question_type": "Appearance, patient perception, instrumental context and materials", "question": "What actual prospective plans apply to appearance/instrumental endpoints?", "needed": "Instrumental primary endpoint, appearance hierarchy/plans and retrospective registration", "role": "Required", "role_reason": "Production condition to record the actual scope of Instrumental primary endpoint, appearance hierarchy/plans and retrospective registration.", "application_exception": "Do not promote retrospective-registration outcomes to prospective registration or original prespecified-secondary wording to current plan verification.", "criterion": "Link Instrumental primary endpoint, appearance hierarchy/plans and retrospective registration to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M08 Table 8.2.a, M04 §4.6.3; Chamgap's own application", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "If plans are provided, distinguish actual prospective/retrospective timing, endpoints and hierarchy." }, { "item_id": "N24", "question_type": "Appearance, patient perception, instrumental context and materials", "question": "What original records give registration, posting and completion dates?", "needed": "NCT07111312, posting 2025-08-08 and completion 2024-05-10", "role": "Required", "role_reason": "Production condition to record the actual scope of NCT07111312, posting 2025-08-08 and completion 2024-05-10.", "application_exception": "Do not calculate elapsed time or change retrospective/original-date history into a registration lookup performed here.", "criterion": "Link NCT07111312, posting 2025-08-08 and completion 2024-05-10 to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M08 Table 8.2.a, M04 §4.6.3; Chamgap application; M04 §4.5, §4.6.3; limits to this material conversion reflect the review scope and Chamgap's own design", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "If material is provided, distinguish original dates, current reading and condition/assessment-change events." }, { "item_id": "N25", "question_type": "Appearance, patient perception, instrumental context and materials", "question": "What are the report identity and actual preserved-summary locations?", "needed": "SáezMoya2025·CT-OW-02·PMID41288927", "role": "Required", "role_reason": "Production condition to record the actual scope of Sáez Moya 2025, CT-OW-02 and PMID 41288927.", "application_exception": "Do not infer DOI/PMCID from PMID or create additional slots/trials from other-product reports.", "criterion": "Link Sáez Moya 2025, CT-OW-02 and PMID 41288927 to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "When bibliography is supplemented, preserve original wording, report identity and change events." }, { "item_id": "N26", "question_type": "Appearance, patient perception, instrumental context and materials", "question": "Are subquestions, time points and hair measures kept separate from independent replication?", "needed": "The same CT-OW-02, 106 participants, days 90/180 and density/cycle ratio/appearance", "role": "Required", "role_reason": "Production condition to record the actual scope of The same CT-OW-02, 106 participants, days 90/180 and density/cycle ratio/appearance.", "application_exception": "Do not add days 90/180, hair cycle/areas, parent/sibling sheets or report/material slots as independent trials/participants.", "criterion": "Link The same CT-OW-02, 106 participants, days 90/180 and density/cycle ratio/appearance to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Distinguish the same population/re-reporting from different recruitment/trials in additional reports." }, { "item_id": "N27", "question_type": "Appearance, patient perception, instrumental context and materials", "question": "What were actual manufacturer roles and author relationships?", "needed": "Olistic Research Labs full research/publication funding, sponsor/responsibility, product/placebo and employee author", "role": "Required", "role_reason": "Production condition to record the actual scope of Olistic Research Labs full research/publication funding, sponsor/responsibility, product/placebo and employee author.", "application_exception": "Do not hide manufacturer roles or turn one manufacturer trial into current independence certification or a data-manipulation finding.", "criterion": "Link Olistic Research Labs full research/publication funding, sponsor/responsibility, product/placebo and employee author to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "If disclosures are provided, distinguish product supply, funding, sponsor, employee author and analysis/publication." }, { "item_id": "N28", "question_type": "Appearance, patient perception, instrumental context and materials", "question": "Can this extend to other products, formulations, ingredients, populations or durability?", "needed": "Olistic Women finished product, selected population and other products/long-term outcomes", "role": "Required", "role_reason": "Production condition to record the actual scope of Olistic Women finished product, selected population and other products/long-term outcomes.", "application_exception": "Do not write other-brand/ingredient or general hair-loss benefit/safety, consumption or treatment guidance.", "criterion": "Link Olistic Women finished product, selected population and other products/long-term outcomes to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed; M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Link actual finished product, population, exposure and endpoints separately in new material." }, { "item_id": "N29", "question_type": "Appearance, patient perception, instrumental context and materials", "question": "How are original dates, corrections, Korean/English texts, axes and history preserved?", "needed": "2026-08-26, empty corrections/deliberation and original assessment", "role": "Required", "role_reason": "Production condition to record the actual scope of 2026-08-26, empty corrections/deliberation and original assessment.", "application_exception": "Do not fill absent/empty values or historical cross-checks with new scores/axes or completed review.", "criterion": "Link 2026-08-26, empty corrections/deliberation and original assessment to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Distinguish complete pre-change text, events, versions and separate application when changes occur." }, { "item_id": "N30", "question_type": "Appearance, patient perception, instrumental context and materials", "question": "What was actually read and what are external-material states?", "needed": "Complete preserved 2956 summary, selected original record and summary/external distinction", "role": "Required", "role_reason": "Production condition to record the actual scope of Complete preserved 2956 summary, selected original record and summary/external distinction.", "application_exception": "Do not promote URLs, historical paper/registration wording or copies into full-text reading, successful access or link checks.", "criterion": "Link Complete preserved 2956 summary, selected original record and summary/external distinction to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Distinguish material type, publication/access, acquisition and actual reading scope/dates in new material." }, { "item_id": "N31", "question_type": "Appearance, patient perception, instrumental context and materials", "question": "What is linked when new material or corrections become available?", "needed": "Condition version, originals, observations, reading and change event", "role": "Required", "role_reason": "Production condition to record the actual scope of Condition version, originals, observations, reading and change event.", "application_exception": "Original candidate pending/eligibility states are historical; do not revive active model/content/boundary-review waits.", "criterion": "Link Condition version, originals, observations, reading and change event to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Separate actual additions/changes into complete prior versions, events, condition versions/freezing, separate application and current handoff." }, { "item_id": "H01", "question_type": "Harms", "question": "Were minor adverse events actually collected?", "needed": "Original minor-AE noncollection, definitions/collection and relatedness", "role": "Supporting harm information", "role_reason": "Production condition to record the actual scope of Original minor-AE noncollection, definitions/collection and relatedness.", "application_exception": "Do not change minor-event noncollection into no events, good tolerability or access failure.", "criterion": "Link Original minor-AE noncollection, definitions/collection and relatedness to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M19 §§19.1.2–19.2.4; detailed distinctions are Chamgap-designed; M19 §§19.1.2–19.2.4; Chamgap adaptation", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Distinguish minor/serious events by actual collection scope and relatedness in subsequent material." }, { "item_id": "H02", "question_type": "Harms", "question": "What were actual safety-observation periods and exposure?", "needed": "Six-month trial exposure, harm-collection periods and post-discontinuation follow-up", "role": "Supporting harm information", "role_reason": "Production condition to record the actual scope of Six-month trial exposure, harm-collection periods and post-discontinuation follow-up.", "application_exception": "Do not turn six-month follow-up alone into comprehensive safety collection or long-term safety assurance.", "criterion": "Link Six-month trial exposure, harm-collection periods and post-discontinuation follow-up to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M19 §19.2 design-specific harm questions; timing details are Chamgap-designed", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Report the original trial period and actual collection/follow-up periods separately." }, { "item_id": "H03", "question_type": "Harms", "question": "Are group-specific product/placebo harm comparisons available?", "needed": "Related/all, serious/minor, group-specific events and comparison", "role": "Supporting harm information", "role_reason": "Production condition to record the actual scope of Related/all, serious/minor, group-specific events and comparison.", "application_exception": "Do not confirm zero serious events or safety equivalence from absent group-specific quantities.", "criterion": "Link Related/all, serious/minor, group-specific events and comparison to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M19 §§19.2.2–19.2.4 and M03 §3.2.3; Chamgap adaptation", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Link group definitions, collection, periods and effects/intervals separately in direct harm material." }, { "item_id": "H04", "question_type": "Harms", "question": "How do safety denominators differ from allocation/analysis denominators?", "needed": "53/53 allocation, actual exposure/safety collection and endpoint-specific n", "role": "Supporting harm information", "role_reason": "Production condition to record the actual scope of 53/53 allocation, actual exposure/safety collection and endpoint-specific n.", "application_exception": "Do not copy 53/53 allocation as collection denominators for all harms or calculate incidence.", "criterion": "Link 53/53 allocation, actual exposure/safety collection and endpoint-specific n to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M19 §§19.1.2–19.2.4; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3 and M19 §§19.1.2–19.2.4; design-specific adaptation is Chamgap-designed", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Distinguish allocation, exposure, collection and completion/analysis denominators in harm material." }, { "item_id": "H05", "question_type": "Harms", "question": "What are multi-ingredient, baseline, concurrent-exposure and relatedness records?", "needed": "Finished product, individual ingredients, baseline/concurrent management and harm relatedness", "role": "Supporting harm information", "role_reason": "Production condition to record the actual scope of Finished product, individual ingredients, baseline/concurrent management and harm relatedness.", "application_exception": "Do not invent unrecorded allergy/interaction cases as observed events or newly attribute product harm to an ingredient.", "criterion": "Link Finished product, individual ingredients, baseline/concurrent management and harm relatedness to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M19 §§19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap-designed", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Distinguish finished product, individual ingredients and baseline/concurrent factors in direct harm material." }, { "item_id": "H06", "question_type": "Harms", "question": "Are noncollection, nonreporting, unread material and zero events distinguished?", "needed": "Original minor-AE noncollection, currently unread external material and other-harm states", "role": "Supporting harm information", "role_reason": "Production condition to record the actual scope of Original minor-AE noncollection, currently unread external material and other-harm states.", "application_exception": "Do not change minor-AE noncollection or current nonreading into all events zero, absent papers or access failure.", "criterion": "Link Original minor-AE noncollection, currently unread external material and other-harm states to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M19 §§19.1.2–19.2.4 and M04 §4.6.3; Chamgap adaptation", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Distinguish collection scope, nonreporting/missingness and actual zero only within provided material." }, { "item_id": "H07", "question_type": "Harms", "question": "Are manufacturer reports, time points and questions kept separate from duplicate totals?", "needed": "The same CT-OW-02, 106 participants and instrumental/appearance/harm family", "role": "Supporting harm information", "role_reason": "Production condition to record the actual scope of The same CT-OW-02, 106 participants and instrumental/appearance/harm family.", "application_exception": "Do not add material slots, two subquestions, time points or areas as independent trials, participants or events.", "criterion": "Link The same CT-OW-02, 106 participants and instrumental/appearance/harm family to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M04 §§4.6.1–4.6.2; harm-material adaptation is Chamgap-designed; M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Distinguish re-reporting of the same events from new trials/events in additional harm material." }, { "item_id": "H08", "question_type": "Harms", "question": "What long-term safety gaps concern other populations, periods and products?", "needed": "Premenopausal telogen effluvium, finished product, six months and other conditions", "role": "Supporting harm information", "role_reason": "Production condition to record the actual scope of Premenopausal telogen effluvium, finished product, six months and other conditions.", "application_exception": "Do not turn positive instrumental findings into long-term supplement safety or consumption/treatment guidance.", "criterion": "Link Premenopausal telogen effluvium, finished product, six months and other conditions to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "M19 §§19.1.2–19.2.4; Chamgap adaptation", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "State actual population, finished product/exposure, period and collection level in new harm material." }, { "item_id": "H09", "question_type": "Harms", "question": "Are instrumental signals, appearance gaps and Unknown safety retained together?", "needed": "Original instrumental C, selected appearance ?, minor-AE noncollection and harm gaps", "role": "Supporting harm information", "role_reason": "Production condition to record the actual scope of Original instrumental C, selected appearance ?, minor-AE noncollection and harm gaps.", "application_exception": "Do not change instrumental positivity into appearance benefit or safety assurance, or appearance gaps into zero effect or treatment recommendations.", "criterion": "Link Original instrumental C, selected appearance ?, minor-AE noncollection and harm gaps to the actual finished product, population, endpoint, timing, denominator/analysis and reading scope; distinguish unverified matters.", "basis": "Chamgap interpretive boundary informed by M19 principles; no formal causality tool was run", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Link each instrumental, appearance and harm endpoint, original location and change event separately in additional material." } ] }