{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3016-s2", "verdict_number": "3016", "title": "Food-grade manuka-honey self-instillation: direct-evidence gaps and possible nonsterile harm", "view_version": "1.0", "view_created_date": "2026-10-21", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-09-07", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Existing stored summary and preserved methodology application records. External papers, abstracts, registration, protocols, SAPs, original result tables and support disclosures are unread, and review of existing content remains incomplete.", "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": "Direct food-honey users, conditions, baseline states, eligibility and denominators remain unverified. They are distinguished from medical research in MGD evaporative dry eye.", "intervention": "The selected question is self-instillation of food-grade manuka honey. Medical-grade 16% drops and 98% gel are distinguished from food-grade, nonsterile and self-diluted products.", "dose": "Direct dose, concentration, frequency and actual exposure remain unverified. Food-honey dose, dilution or administration instructions are not derived from medical-product concentrations.", "comparator": "The stored materials contain no direct food-honey comparison. Medical usual-care and regular-lubricant comparisons do not replace comparative food-honey effects or harms.", "endpoint": "The original selected account of no clinical evidence and possible nonsterile harm is preserved. Direct effects, events, measurement, denominators, incidence and individual causality remain unverified. Medical SPEED, staining and meibomian results are not direct evidence.", "duration": "Direct food-honey exposure, latency, observation, stopping and recovery times remain unverified. The principal medical trial over 8 weeks and supporting trial over 3 weeks do not establish food-honey observation, safety or administration periods.", "excluded_extensions": [ "Selected food-honey F and absent separate score, status and axes are distinguished from medical parent C46, symptom C and sign C. The parent no-human-study indicator being disabled does not establish human evidence for food honey.", "Medical 16% drops and 98% gel concentrations or product qualifications are not converted into food-honey dose, sterility or ophthalmic suitability. No new dilution, instillation, use, administration or experiment instructions are created.", "Medical staining P=.035, gel quality P=.005 and expressibility P=.042 and within-group SPEED 2.53(P=.006) and 1.087(P=.183) are not direct food-honey effects or safety. They are not calculated into direct between-group superiority, new differences or CIs.", "The 114 participants and 59 assigned with 55 completed belong to medical reports. They are not transferred into food-honey user or event denominators, independent replication or unique totals, and no new attrition counts or incidence are calculated.", "No clinical evidence is the original selected account. This work has not certified universal absence, lack of effect, no events or safety through an external search; possible harm is not converted into a definitive cause or frequency of individual events.", "Repetition of the two medical reports, original Korean and English accounts and related safety wording is not counted as new food-honey research or independent events. Long-term, rare and vulnerable-population harms and detailed direct materials remain unverified." ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which question does this evidence check cover?", "needed": "The boundary between food-grade manuka-honey self-instillation and medical-grade products", "role": "Required", "role_reason": "Material on The boundary between food-grade manuka-honey self-instillation and medical-grade products is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on The boundary between food-grade manuka-honey self-instillation and medical-grade products must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: Direct materials for the selected question are distinguished from existing records. External verification and content review remain incomplete; this does not recognize a new independent study. This records needed materials; no new research was executed.", "current_reports": [], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "This covers the existing question of self-instillation of food-grade manuka honey. It is separate from symptom or sign improvement with medical-grade products.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Direct materials for the selected question are distinguished from existing records. External verification and content review remain incomplete; this does not recognize a new independent study.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct materials for the selected question are distinguished from existing records. External verification and content review remain incomplete; this does not recognize a new independent study." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "How does food-honey F differ from medical-product C46?", "needed": "Selected F, parent medical-product C46 and absent individual score", "role": "Required", "role_reason": "Material on Selected F, parent medical-product C46 and absent individual score is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on Selected F, parent medical-product C46 and absent individual score must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: The food-honey question has no separate score, status or assessment axes. Parent score or axes are not inherited and no new verdict is created. This records needed materials; no new research was executed.", "current_reports": [], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The existing grade for food-honey self-instillation is F, with an account of no clinical evidence and possible harm from nonsterile ocular use. It is distinguished from medical-product C46.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "The food-honey question has no separate score, status or assessment axes. Parent score or axes are not inherited and no new verdict is created.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The food-honey question has no separate score, status or assessment axes. Parent score or axes are not inherited and no new verdict is created." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What is the scope of the recorded lack of direct clinical evidence?", "needed": "The preserved scope of direct food-honey studies, populations, comparisons and outcomes", "role": "Required", "role_reason": "Material on The preserved scope of direct food-honey studies, populations, comparisons and outcomes is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on The preserved scope of direct food-honey studies, populations, comparisons and outcomes must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: The stored materials contain no direct clinical report, denominator, effect or interval. This work has not established absence across all external materials or lack of effect through a new search. This records needed materials; no new research was executed.", "current_reports": [], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The existing selected account records no clinical evidence. The medical-product account also states that it is not evidence for food-grade honey or honey diluted at home.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "The stored materials contain no direct clinical report, denominator, effect or interval. This work has not established absence across all external materials or lack of effect through a new search.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The stored materials contain no direct clinical report, denominator, effect or interval. This work has not established absence across all external materials or lack of effect through a new search." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Are food-grade honey and medical-grade drops or gel the same product?", "needed": "Product qualifications of food-grade honey and medical-grade 16% drops or 98% gel", "role": "Required", "role_reason": "Material on Product qualifications of food-grade honey and medical-grade 16% drops or 98% gel is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on Product qualifications of food-grade honey and medical-grade 16% drops or 98% gel must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: Food-product identity, ingredients, manufacture, packaging and ophthalmic suitability remain unverified. Medical-grade 16% and 98% are not transferred into food-honey concentrations, doses or instructions. This records needed materials; no new research was executed.", "current_reports": [], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Research on drops or gel manufactured for medical use is distinguished from food-honey self-instillation.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Food-product identity, ingredients, manufacture, packaging and ophthalmic suitability remain unverified. Medical-grade 16% and 98% are not transferred into food-honey concentrations, doses or instructions.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Food-product identity, ingredients, manufacture, packaging and ophthalmic suitability remain unverified. Medical-grade 16% and 98% are not transferred into food-honey concentrations, doses or instructions." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "What does the recorded possibility of harm from nonsterile use mean?", "needed": "Sterility, contamination, manufacture, storage and the original harm account", "role": "Required", "role_reason": "Material on Sterility, contamination, manufacture, storage and the original harm account is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on Sterility, contamination, manufacture, storage and the original harm account must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: Sterility testing, contamination, manufacture, storage and links to individual events for a specific food product remain unverified. The medical-grade label does not guarantee food-product safety. This records needed materials; no new research was executed.", "current_reports": [], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The existing account records possible harm from nonsterile ocular use and distinguishes food-grade, nonsterile and self-diluted products.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Sterility testing, contamination, manufacture, storage and links to individual events for a specific food product remain unverified. The medical-grade label does not guarantee food-product safety.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Sterility testing, contamination, manufacture, storage and links to individual events for a specific food product remain unverified. The medical-grade label does not guarantee food-product safety." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "How does medical ocular-surface use differ from food-honey self-instillation?", "needed": "Original records of product-specific exposure, route and timing", "role": "Required", "role_reason": "Material on Original records of product-specific exposure, route and timing is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on Original records of product-specific exposure, route and timing must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: Direct exposure definitions, products, timing and records remain unverified. No new dilution, instillation sequence, frequency, quantity or administration instructions are written. This records needed materials; no new research was executed.", "current_reports": [], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The selected question is food-honey self-instillation. Parent instillation and ocular-surface routes concern medical-grade formulations.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Direct exposure definitions, products, timing and records remain unverified. No new dilution, instillation sequence, frequency, quantity or administration instructions are written.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct exposure definitions, products, timing and records remain unverified. No new dilution, instillation sequence, frequency, quantity or administration instructions are written." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Is a dose for food-honey self-instillation recorded?", "needed": "Direct dose, concentration and frequency distinguished from medical formulations", "role": "Required", "role_reason": "Material on Direct dose, concentration and frequency distinguished from medical formulations is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on Direct dose, concentration and frequency distinguished from medical formulations must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: Direct food-honey exposure specifications remain unverified. Medical formulation proportions are not used to fill a dose or calculate a safe dose. This records needed materials; no new research was executed.", "current_reports": [], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The food-honey question has no separate dose, concentration or frequency values. The 16% drops and 98% gel describe medical-grade products.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Direct food-honey exposure specifications remain unverified. Medical formulation proportions are not used to fill a dose or calculate a safe dose.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct food-honey exposure specifications remain unverified. Medical formulation proportions are not used to fill a dose or calculate a safe dose." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Who is the direct population for the food-honey question?", "needed": "Direct users' conditions, age, baseline state, selection and denominator", "role": "Required", "role_reason": "Material on Direct users' conditions, age, baseline state, selection and denominator is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on Direct users' conditions, age, baseline state, selection and denominator must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: Direct users' conditions, age, state, inclusion, exclusion and denominator remain unverified. Medical-study participants are not relabeled as food-honey users. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The parent research concerns MGD evaporative dry eye and medical formulations. The food-honey question has no direct population count or eligibility criteria.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Direct users' conditions, age, state, inclusion, exclusion and denominator remain unverified. Medical-study participants are not relabeled as food-honey users.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct users' conditions, age, state, inclusion, exclusion and denominator remain unverified. Medical-study participants are not relabeled as food-honey users." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Is a direct comparator for food honey recorded?", "needed": "Direct comparative exposures, concurrent care, populations and outcomes", "role": "Required", "role_reason": "Material on Direct comparative exposures, concurrent care, populations and outcomes is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on Direct comparative exposures, concurrent care, populations and outcomes must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: Direct food-honey comparisons, concurrent care, recruitment differences, comparative effects and harms remain unverified. Medical-product comparisons do not replace them. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Medical reports compared adding a product to existing care or using regular lubricant. A direct food-honey comparison is absent from the stored materials.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Direct food-honey comparisons, concurrent care, recruitment differences, comparative effects and harms remain unverified. Medical-product comparisons do not replace them.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct food-honey comparisons, concurrent care, recruitment differences, comparative effects and harms remain unverified. Medical-product comparisons do not replace them." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Can medical-product symptoms or signs be transferred to food-honey effects?", "needed": "Product-specific SPEED, staining, meibomian measures and direct outcomes", "role": "Required", "role_reason": "Material on Product-specific SPEED, staining, meibomian measures and direct outcomes is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on Product-specific SPEED, staining, meibomian measures and direct outcomes must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: Food-honey symptoms, signs, clinical injury, measurement, timing, denominators and intervals remain unverified. Medical outcomes are not converted into food-honey treatment efficacy or injury prevention. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Parent symptom and sign outcomes concern medical formulations and are not direct outcomes of food-honey self-instillation.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Food-honey symptoms, signs, clinical injury, measurement, timing, denominators and intervals remain unverified. Medical outcomes are not converted into food-honey treatment efficacy or injury prevention.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Food-honey symptoms, signs, clinical injury, measurement, timing, denominators and intervals remain unverified. Medical outcomes are not converted into food-honey treatment efficacy or injury prevention." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Are the medical trials' 8 weeks and 3 weeks food-honey observation periods?", "needed": "The timeline of direct exposure, latency, observation, stopping and recovery", "role": "Required", "role_reason": "Material on The timeline of direct exposure, latency, observation, stopping and recovery is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on The timeline of direct exposure, latency, observation, stopping and recovery must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: The direct food-honey timeline remains unverified. Parent durations are not presented as safe periods, durable effects or administration periods for food honey. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The principal parent trial's 8 weeks and supporting SPEED result's 3 weeks are medical-report durations. They are not observation periods for food-honey self-instillation.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "The direct food-honey timeline remains unverified. Parent durations are not presented as safe periods, durable effects or administration periods for food honey.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The direct food-honey timeline remains unverified. Parent durations are not presented as safe periods, durable effects or administration periods for food honey." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "What role does the open 3-group report with 114 participants play here?", "needed": "Medical-report formulations, common care, signs and applicability boundaries", "role": "Background and exclusion boundary; not direct evidence for the selected question", "role_reason": "Material on Medical-report formulations, common care, signs and applicability boundaries is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on Medical-report formulations, common care, signs and applicability boundaries must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: Medical group and outcome denominators, effects, intervals and prespecified hierarchy remain unverified. Staining P=.035 and gel P=.005/.042 are not transferred into food-honey effects or safety. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The open 3-group medical report by Albietz and Lenton 2017 with 114 participants is background material. Its original account distinguishes improvement in all groups from selected formulation-specific between-group signals.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Medical group and outcome denominators, effects, intervals and prespecified hierarchy remain unverified. Staining P=.035 and gel P=.005/.042 are not transferred into food-honey effects or safety.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Medical group and outcome denominators, effects, intervals and prespecified hierarchy remain unverified. Staining P=.035 and gel P=.005/.042 are not transferred into food-honey effects or safety." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "What is the context of the report with 59 randomized and 55 completed?", "needed": "Medical-grade Optimel, assessor masking, 3-week outcomes and registration records", "role": "Background and exclusion boundary; not direct evidence for the selected question", "role_reason": "Material on Medical-grade Optimel, assessor masking, 3-week outcomes and registration records is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on Medical-grade Optimel, assessor masking, 3-week outcomes and registration records must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: Group and outcome denominators, direct between-group symptom effects and registration content remain unverified. The existence of NCT04457648 does not establish food-honey trial registration or registry reading in this work. This records needed materials; no new research was executed.", "current_reports": [ "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Wong et al. 2021 is an assessor-masked randomized medical-product report recording 59 assigned and 55 completed. It is not a direct food-honey trial.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Group and outcome denominators, direct between-group symptom effects and registration content remain unverified. The existence of NCT04457648 does not establish food-honey trial registration or registry reading in this work.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group and outcome denominators, direct between-group symptom effects and registration content remain unverified. The existence of NCT04457648 does not establish food-honey trial registration or registry reading in this work." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Can 16% drops, 98% gel and food honey be combined?", "needed": "Distinguishing the two medical formulations from food-grade products", "role": "Required", "role_reason": "Material on Distinguishing the two medical formulations from food-grade products is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on Distinguishing the two medical formulations from food-grade products must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: Full formulation-specific effects, harms, direct comparisons and food-product equivalence remain unverified. They are not combined into one effect or safety conclusion. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The existing account distinguishes medical-grade 16% drops and 98% gel as different formulations.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Full formulation-specific effects, harms, direct comparisons and food-product equivalence remain unverified. They are not combined into one effect or safety conclusion.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Full formulation-specific effects, harms, direct comparisons and food-product equivalence remain unverified. They are not combined into one effect or safety conclusion." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Does improvement with common lid care show a food-honey effect?", "needed": "Distinguishing common care from the added contribution of medical products", "role": "Required", "role_reason": "Material on Distinguishing common care from the added contribution of medical products is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on Distinguishing common care from the added contribution of medical products must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: Changes in common care, adherence, added formulation contributions and direct food-honey effects remain unverified. Common-care records are not converted into self-instillation instructions. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The parent record explains that common care and lubricant prevent attributing all improvement to honey as an ingredient.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Changes in common care, adherence, added formulation contributions and direct food-honey effects remain unverified. Common-care records are not converted into self-instillation instructions.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Changes in common care, adherence, added formulation contributions and direct food-honey effects remain unverified. Common-care records are not converted into self-instillation instructions." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Do different SPEED P values show food-honey effects?", "needed": "Distinguishing medical within-group changes from direct between-group contrasts and CIs", "role": "Required", "role_reason": "Material on Distinguishing medical within-group changes from direct between-group contrasts and CIs is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on Distinguishing medical within-group changes from direct between-group contrasts and CIs must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: Direct between-group symptom estimates, CIs and direct food-honey effects remain unverified. No new difference between changes, effect or CI is calculated. This records needed materials; no new research was executed.", "current_reports": [ "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "SPEED 2.53(P=.006) and 1.087(P=.183) are within-group changes in a medical-product report. They are neither a direct superiority test nor food-honey effects.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Direct between-group symptom estimates, CIs and direct food-honey effects remain unverified. No new difference between changes, effect or CI is calculated.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct between-group symptom estimates, CIs and direct food-honey effects remain unverified. No new difference between changes, effect or CI is calculated." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Are 114, 59 and 55 denominators for food-honey users or harm events?", "needed": "Report-specific assignment, completion, groups and outcomes versus direct exposure and event denominators", "role": "Required", "role_reason": "Material on Report-specific assignment, completion, groups and outcomes versus direct exposure and event denominators is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on Report-specific assignment, completion, groups and outcomes versus direct exposure and event denominators must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: Valid group and outcome denominators, relationships between reports and food-honey exposure and event denominators remain unverified. No summation, attrition recalculation or certification of independent replication is performed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original 114 and 59 assigned with 55 completed belong to different medical-product reports. They are not food-honey user or event denominators.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Valid group and outcome denominators, relationships between reports and food-honey exposure and event denominators remain unverified. No summation, attrition recalculation or certification of independent replication is performed.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Valid group and outcome denominators, relationships between reports and food-honey exposure and event denominators remain unverified. No summation, attrition recalculation or certification of independent replication is performed." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "How does an infection-risk account differ from direct events?", "needed": "Infection definitions, products, exposures, event sources, denominators and comparisons", "role": "Required", "role_reason": "Material on Infection definitions, products, exposures, event sources, denominators and comparisons is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on Infection definitions, products, exposures, event sources, denominators and comparisons must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: Direct infection diagnosis, products, denominators, comparisons, incidence and established causes remain unverified. Possibility wording is not converted into event counts or established causality. This records needed materials; no new research was executed.", "current_reports": [], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The existing safety account records infection risk with food-grade, nonsterile and self-diluted products; the selected account also retains possible harm.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Direct infection diagnosis, products, denominators, comparisons, incidence and established causes remain unverified. Possibility wording is not converted into event counts or established causality.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct infection diagnosis, products, denominators, comparisons, incidence and established causes remain unverified. Possibility wording is not converted into event counts or established causality." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "At what level is corneal-injury risk recorded?", "needed": "Corneal events, severity, diagnosis, products, timing and alternative causes", "role": "Required", "role_reason": "Material on Corneal events, severity, diagnosis, products, timing and alternative causes is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on Corneal events, severity, diagnosis, products, timing and alternative causes must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: Direct injury events, severity, diagnosis, alternative causes, recovery and comparative risks remain unverified. No new frequency, established causality or recovery time is written. This records needed materials; no new research was executed.", "current_reports": [], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The existing safety account records corneal-injury risk with food-grade, nonsterile and self-diluted products.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Direct injury events, severity, diagnosis, alternative causes, recovery and comparative risks remain unverified. No new frequency, established causality or recovery time is written.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct injury events, severity, diagnosis, alternative causes, recovery and comparative risks remain unverified. No new frequency, established causality or recovery time is written." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Do medical-product stinging or redness establish food-honey safety?", "needed": "Product-specific harm types, event counts, collection, severity and timing", "role": "Required", "role_reason": "Material on Product-specific harm types, event counts, collection, severity and timing is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on Product-specific harm types, event counts, collection, severity and timing must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: Medical group-specific events, severity, collection, timing and direct food-honey harms remain unverified. Medical irritation reports neither describe all food-honey harms nor guarantee safety. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The existing account retains reports of temporary stinging and redness with medical formulations.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Medical group-specific events, severity, collection, timing and direct food-honey harms remain unverified. Medical irritation reports neither describe all food-honey harms nor guarantee safety.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Medical group-specific events, severity, collection, timing and direct food-honey harms remain unverified. Medical irritation reports neither describe all food-honey harms nor guarantee safety." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "How were food-honey harms collected?", "needed": "Direct diagnosis, severity, active or spontaneous reporting and observation systems", "role": "Required", "role_reason": "Material on Direct diagnosis, severity, active or spontaneous reporting and observation systems is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on Direct diagnosis, severity, active or spontaneous reporting and observation systems must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: Direct diagnostic criteria, collection systems, full disclosure scope, severity and detection differences remain unverified. Needed existing event tables and reporting systems are distinguished. This records needed materials; no new research was executed.", "current_reports": [], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The selected account states possible harm but provides neither collection methods nor a direct event table.", "condition_status": "Unverified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Direct diagnostic criteria, collection systems, full disclosure scope, severity and detection differences remain unverified. Needed existing event tables and reporting systems are distinguished.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct diagnostic criteria, collection systems, full disclosure scope, severity and detection differences remain unverified. Needed existing event tables and reporting systems are distinguished." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Is the timeline from exposure to onset, stopping and recovery known?", "needed": "Direct-event exposure, latency, onset, stopping and recovery records", "role": "Required", "role_reason": "Material on Direct-event exposure, latency, onset, stopping and recovery records is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on Direct-event exposure, latency, onset, stopping and recovery records must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: Food-honey event exposure, latency, onset, recovery and re-exposure information remain unverified. Stopping, re-exposure, latency periods and self-use procedures are not proposed. This records needed materials; no new research was executed.", "current_reports": [], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The food-honey question has no direct-event timeline. Early irritation with medical products concerns different products.", "condition_status": "Unverified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Food-honey event exposure, latency, onset, recovery and re-exposure information remain unverified. Stopping, re-exposure, latency periods and self-use procedures are not proposed.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Food-honey event exposure, latency, onset, recovery and re-exposure information remain unverified. Stopping, re-exposure, latency periods and self-use procedures are not proposed." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Were risks compared with other products or an unexposed population?", "needed": "Direct comparator groups, events, baseline risk, concurrent exposures and adjustment", "role": "Required", "role_reason": "Material on Direct comparator groups, events, baseline risk, concurrent exposures and adjustment is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on Direct comparator groups, events, baseline risk, concurrent exposures and adjustment must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: Direct food-honey comparator groups, group-specific events, baseline risks and adjustment remain unverified. Background incidence is not used to fill the size of a risk increase. This records needed materials; no new research was executed.", "current_reports": [], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The existing food-honey account contains no direct harm comparison. Medical lubricant or usual-care comparisons do not replace it.", "condition_status": "Unverified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Direct food-honey comparator groups, group-specific events, baseline risks and adjustment remain unverified. Background incidence is not used to fill the size of a risk increase.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct food-honey comparator groups, group-specific events, baseline risks and adjustment remain unverified. Background incidence is not used to fill the size of a risk increase." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Can the frequency of food-honey harms be calculated?", "needed": "Exposed people, people with events, event counts, time, duplication and denominators", "role": "Required", "role_reason": "Material on Exposed people, people with events, event counts, time, duplication and denominators is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on Exposed people, people with events, event counts, time, duplication and denominators must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: People, counts, denominators, duplication and time for infection, corneal injury and irritation remain unverified. Parent population counts or possibility wording are not used to calculate event absence, incidence or comparative risk. This records needed materials; no new research was executed.", "current_reports": [], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The stored materials contain no direct event count, exposed denominator or follow-up time.", "condition_status": "Unverified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "People, counts, denominators, duplication and time for infection, corneal injury and irritation remain unverified. Parent population counts or possibility wording are not used to calculate event absence, incidence or comparative risk.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "People, counts, denominators, duplication and time for infection, corneal injury and irritation remain unverified. Parent population counts or possibility wording are not used to calculate event absence, incidence or comparative risk." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Were underlying eye disease, concurrent exposures and individual causality distinguished?", "needed": "Underlying conditions, other products, concurrent exposures, diagnosis and alternative explanations", "role": "Required", "role_reason": "Material on Underlying conditions, other products, concurrent exposures, diagnosis and alternative explanations is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on Underlying conditions, other products, concurrent exposures, diagnosis and alternative explanations must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: Baseline states, other exposures, timing, alternatives, tests and causal assessments remain unverified. This does not assert that alternatives were absent or that food honey definitively caused a specific event. This records needed materials; no new research was executed.", "current_reports": [], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Possible harm from nonsterile use is the original account. Individual events, concurrent exposures and alternative causes are not preserved.", "condition_status": "Unverified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Baseline states, other exposures, timing, alternatives, tests and causal assessments remain unverified. This does not assert that alternatives were absent or that food honey definitively caused a specific event.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline states, other exposures, timing, alternatives, tests and causal assessments remain unverified. This does not assert that alternatives were absent or that food honey definitively caused a specific event." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Were users missing from reports or follow-up identified?", "needed": "Recruitment, selection, spontaneous reporting, detection, recall and follow-up loss", "role": "Required", "role_reason": "Material on Recruitment, selection, spontaneous reporting, detection, recall and follow-up loss is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on Recruitment, selection, spontaneous reporting, detection, recall and follow-up loss must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: Food-honey user recruitment, selection, reporting, detection, follow-up loss and full event disclosure remain unverified. Absence of reports is not relabeled as absence of events or safety. This records needed materials; no new research was executed.", "current_reports": [], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "There is no direct reporting or follow-up system, and medical-product completion by 55 participants cannot explain food-honey observation loss.", "condition_status": "Unverified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Food-honey user recruitment, selection, reporting, detection, follow-up loss and full event disclosure remain unverified. Absence of reports is not relabeled as absence of events or safety.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Food-honey user recruitment, selection, reporting, detection, follow-up loss and full event disclosure remain unverified. Absence of reports is not relabeled as absence of events or safety." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Were long-term or rare harms and vulnerable populations verified?", "needed": "Long-term and rare events, population-specific baseline risks, exposure and interactions", "role": "Required", "role_reason": "Material on Long-term and rare events, population-specific baseline risks, exposure and interactions is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on Long-term and rare events, population-specific baseline risks, exposure and interactions must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: Long-term and rare harms, population-specific baseline risks, interactions and suitable materials remain unverified. Short-term parent materials do not guarantee safety. This records needed materials; no new research was executed.", "current_reports": [], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "There are no direct long-term or vulnerable-population materials. Limited medical-product observation does not establish long-term food-product safety.", "condition_status": "Unverified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Long-term and rare harms, population-specific baseline risks, interactions and suitable materials remain unverified. Short-term parent materials do not guarantee safety.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Long-term and rare harms, population-specific baseline risks, interactions and suitable materials remain unverified. Short-term parent materials do not guarantee safety." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Can repeated risk wording be counted as independent events?", "needed": "Unique cases, report relationships, repeated citation, regulatory documents and sources", "role": "Required", "role_reason": "Material on Unique cases, report relationships, repeated citation, regulatory documents and sources is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on Unique cases, report relationships, repeated citation, regulatory documents and sources must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: Direct events, related reports, regulatory repeated citation and independent case counts remain unverified. Korean and English repetitions or medical-report counts are not summed as food-honey events. This records needed materials; no new research was executed.", "current_reports": [], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Repeated selected and parent safety wording comes from the same stored account and is not a list of unique events.", "condition_status": "Unverified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Direct events, related reports, regulatory repeated citation and independent case counts remain unverified. Korean and English repetitions or medical-report counts are not summed as food-honey events.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct events, related reports, regulatory repeated citation and independent case counts remain unverified. Korean and English repetitions or medical-report counts are not summed as food-honey events." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Are food-product manufacturing, labeling and quality materials available?", "needed": "Food-product identity, ingredients, manufacture, packaging and ophthalmic suitability", "role": "Required", "role_reason": "Material on Food-product identity, ingredients, manufacture, packaging and ophthalmic suitability is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on Food-product identity, ingredients, manufacture, packaging and ophthalmic suitability must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: Food-product specifications, raw materials, ingredients, manufacture, quality and equivalence to medical products remain unverified. Medical qualifications or concentrations do not fill these gaps. This records needed materials; no new research was executed.", "current_reports": [], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Parent medical-manufacturing wording describes only medical products; omitted manufacturing details remain unverified.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Food-product specifications, raw materials, ingredients, manufacture, quality and equivalence to medical products remain unverified. Medical qualifications or concentrations do not fill these gaps.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Food-product specifications, raw materials, ingredients, manufacture, quality and equivalence to medical products remain unverified. Medical qualifications or concentrations do not fill these gaps." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Does Optimel involvement constitute direct food-honey evidence?", "needed": "Report-specific funding, product provision, interests and roles", "role": "Required", "role_reason": "Material on Report-specific funding, product provision, interests and roles is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on Report-specific funding, product provision, interests and roles must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: Contracts, product, analysis and publication involvement and funding or independence of direct food-honey materials remain unverified. Parent I1 and report counts are not transferred into independent verification. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The two medical-product reports contain accounts of product provision, related involvement or author interests. These are neither direct food-honey materials nor verification of independence.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Contracts, product, analysis and publication involvement and funding or independence of direct food-honey materials remain unverified. Parent I1 and report counts are not transferred into independent verification.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Contracts, product, analysis and publication involvement and funding or independence of direct food-honey materials remain unverified. Parent I1 and report counts are not transferred into independent verification." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "How does stored-summary reading differ from reading external originals?", "needed": "The actual reading scope of stored materials, external abstracts, full texts and registration", "role": "Required", "role_reason": "Material on The actual reading scope of stored materials, external abstracts, full texts and registration is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on The actual reading scope of stored materials, external abstracts, full texts and registration must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: External content, public availability, acquisition, direct food-honey materials and registry content remain unverified. URLs or historical verification wording are not converted into current reading or access failure. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The complete existing stored summary and selected question were read. Medical reports are linked through stored summaries and bibliography; external originals and registration remain unread with access unattempted in this work.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "External content, public availability, acquisition, direct food-honey materials and registry content remain unverified. URLs or historical verification wording are not converted into current reading or access failure.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "External content, public availability, acquisition, direct food-honey materials and registry content remain unverified. URLs or historical verification wording are not converted into current reading or access failure." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "What do the existing evidence date and empty correction history mean?", "needed": "Distinguishing the existing 2026-09-07 from production, access and correction times", "role": "Required", "role_reason": "Material on Distinguishing the existing 2026-09-07 from production, access and correction times is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on Distinguishing the existing 2026-09-07 from production, access and correction times must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: Current external content, search end, historical access locations, times and correction details remain unverified. The evidence date is not converted into completed external reading or content review in this work. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The existing evidence date is 2026-09-07 and the correction history is an empty list. Historical verification and cross-check wording are preserved in the original.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Current external content, search end, historical access locations, times and correction details remain unverified. The evidence date is not converted into completed external reading or content review in this work.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Current external content, search end, historical access locations, times and correction details remain unverified. The evidence date is not converted into completed external reading or content review in this work." }, { "item_id": "N33", "question_type": "Evidence condition", "question": "How do the selected Korean and English originals relate to the medical account?", "needed": "Original food-honey grade, account, translation and medical context", "role": "Required", "role_reason": "Material on Original food-honey grade, account, translation and medical context is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on Original food-honey grade, account, translation and medical context must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: Detailed external translation comparison and content review remain incomplete. No new food-honey status, score, use instructions or administration guidance are written. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The existing English question is Self-instillation of food-grade manuka honey. Its account also records no clinical evidence and possible nonsterile harm; the medical explanation is background.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Detailed external translation comparison and content review remain incomplete. No new food-honey status, score, use instructions or administration guidance are written.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Detailed external translation comparison and content review remain incomplete. No new food-honey status, score, use instructions or administration guidance are written." }, { "item_id": "N34", "question_type": "Evidence condition", "question": "Do parent assessment axes establish human evidence for food honey?", "needed": "Medical assessment axes versus absent food-honey clinical evidence and fields", "role": "Required", "role_reason": "Material on Medical assessment axes versus absent food-honey clinical evidence and fields is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on Medical assessment axes versus absent food-honey clinical evidence and fields must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: The food-honey question has no independent axes, score or status. Parent B/P/R1/I1/EX/B2/CX are neither inherited nor converted into a new official assessment. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Parent assessment axes and the disabled no-human-study indicator belong to the medical clinical context. This is a separate original record from the absence of clinical evidence for food honey.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "The food-honey question has no independent axes, score or status. Parent B/P/R1/I1/EX/B2/CX are neither inherited nor converted into a new official assessment.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The food-honey question has no independent axes, score or status. Parent B/P/R1/I1/EX/B2/CX are neither inherited nor converted into a new official assessment." }, { "item_id": "N35", "question_type": "Evidence condition", "question": "Do limited medical signals establish food-honey effects or safety?", "needed": "Products, populations, comparisons, symptoms, signs, events and interpretation levels", "role": "Required", "role_reason": "Material on Products, populations, comparisons, symptoms, signs, events and interpretation levels is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on Products, populations, comparisons, symptoms, signs, events and interpretation levels must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: Direct food-honey efficacy, precision, comparative harms and causality remain unverified. Original lack-of-evidence and possible-harm wording are not converted into lack of effect, safety figures or a new causal verdict. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The existing synthesis records that limited medical-product signals do not support food-honey self-instillation or established symptom effects.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Direct food-honey efficacy, precision, comparative harms and causality remain unverified. Original lack-of-evidence and possible-harm wording are not converted into lack of effect, safety figures or a new causal verdict.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct food-honey efficacy, precision, comparative harms and causality remain unverified. Original lack-of-evidence and possible-harm wording are not converted into lack of effect, safety figures or a new causal verdict." }, { "item_id": "N36", "question_type": "Evidence condition", "question": "What do design names, registration IDs and methodological links verify?", "needed": "Medical designs, original outcomes, registry records and methodological scope", "role": "Required", "role_reason": "Material on Medical designs, original outcomes, registry records and methodological scope is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on Medical designs, original outcomes, registry records and methodological scope must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: Prespecified hierarchy, registry content, official risk-of-bias or evidence-certainty assessment and direct food-honey design remain unverified. Design names or historical verification wording do not mean an assessment was passed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Open 3-group and assessor-masked designs and original registry strings are preserved. Links to methodology and existing conditions are not a new clinical assessment.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Prespecified hierarchy, registry content, official risk-of-bias or evidence-certainty assessment and direct food-honey design remain unverified. Design names or historical verification wording do not mean an assessment was passed.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Prespecified hierarchy, registry content, official risk-of-bias or evidence-certainty assessment and direct food-honey design remain unverified. Design names or historical verification wording do not mean an assessment was passed." }, { "item_id": "N37", "question_type": "Evidence condition", "question": "Which existing materials could update this record?", "needed": "Products, sterility, existing direct events, comparisons, denominators, originals and change events", "role": "Required", "role_reason": "Material on Products, sterility, existing direct events, comparisons, denominators, originals and change events is needed to distinguish direct food-product evidence, exposure, comparison, events, denominators and time from medical-product background.", "application_exception": "Food-honey F and absent separate score, status and assessment axes are distinguished from medical parent C46, symptom C and sign C. Medical 16%, 98%, denominators, durations and results are not transferred into food-honey effects, safety, dose or sterility qualifications. No new incidence, causality, effects, CIs, totals, scores or self-instillation, dilution, administration or experiment instructions are created.", "criterion": "Original records on Products, sterility, existing direct events, comparisons, denominators, originals and change events must link to the same product, question, population, comparator, outcome, time point and denominator, distinguishing direct material from medical-product background and unread external materials.", "basis": "Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.", "condition_origin": "These conditions concern the existing direct-evidence gaps and possible nonsterile harm for food-grade manuka-honey self-instillation. They do not transfer medical research, create a new clinical verdict or certify an official assessment.", "proposed_research": "Material needed: Direct clinical materials, events, product qualifications, frequency, causality and external content remain unverified. Receipt of existing materials and condition changes are recorded separately; new self-instillation or experiments are not proposed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The existing F, direct-evidence gap and possible nonsterile harm account have been carried over. Direct content review and external verification remain incomplete.", "condition_status": "Partly verified", "status_reason": "This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Direct clinical materials, events, product qualifications, frequency, causality and external content remain unverified. Receipt of existing materials and condition changes are recorded separately; new self-instillation or experiments are not proposed.", "uncertainty": "Direct food-honey product qualifications, exposure, populations, comparisons, events, collection, denominators, frequency, timing, causality, long-term harms and harms in vulnerable populations remain unverified. Original lack-of-evidence and possible-harm wording is not converted into certification of absence through a new search, no events, lack of effect or safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct clinical materials, events, product qualifications, frequency, causality and external content remain unverified. Receipt of existing materials and condition changes are recorded separately; new self-instillation or experiments are not proposed." } ], "reports": [ { "report_id": "R01", "title": "Albietz JM·Lenton LM. 2017", "url": "https://pubmed.ncbi.nlm.nih.gov/28585260/", "report_type": "Stored summary of an open 3-group randomized medical-product trial; not direct food-honey evidence", "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "The complete parent stored summary and original citation for the medical report were read. External abstracts, full text, registration, plans, product and support documents remain unread.", "study_family": "SF01-AlbietzLenton-2017-medical-context", "independent_replication": "Only parent R1/I1 and the two-report account are retained; independent food-honey replication and unique counts are not certified", "observed_result": "This records common care and selected formulation-specific sign signals in 114 medical-product participants across 3 groups. All groups improved, with staining with drops P=.035, gel meibum quality P=.005 and expressibility P=.042.", "result_level": "This is background for medical 16% drops and 98% gel. It is not direct food-honey effects, harms or denominators. Exact group-specific outcomes, CIs, prespecified hierarchy and product-specific harms remain unverified.", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete parent-verdict stored summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07", "qualification": "PMID28585260, DOI10.1111/cxo.12524 and the original record of Optimel product provision and related involvement are retained. Registration details, product contracts, funding and author roles are unread externally; unverified information is not converted into absence. This report and its product documents are not direct evidence of food-honey clinical effects, sterility or ophthalmic suitability. The material date 2026-09-07 is the original evidence date retained for every material entry. It is neither an actual external reading date nor completed content review in this work." }, { "material_type": "External abstract", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID28585260, DOI10.1111/cxo.12524 and the original record of Optimel product provision and related involvement are retained. Registration details, product contracts, funding and author roles are unread externally; unverified information is not converted into absence. This report and its product documents are not direct evidence of food-honey clinical effects, sterility or ophthalmic suitability. The material date 2026-09-07 is the original evidence date retained for every material entry. It is neither an actual external reading date nor completed content review in this work." }, { "material_type": "External full text", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID28585260, DOI10.1111/cxo.12524 and the original record of Optimel product provision and related involvement are retained. Registration details, product contracts, funding and author roles are unread externally; unverified information is not converted into absence. This report and its product documents are not direct evidence of food-honey clinical effects, sterility or ophthalmic suitability. The material date 2026-09-07 is the original evidence date retained for every material entry. It is neither an actual external reading date nor completed content review in this work." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID28585260, DOI10.1111/cxo.12524 and the original record of Optimel product provision and related involvement are retained. Registration details, product contracts, funding and author roles are unread externally; unverified information is not converted into absence. This report and its product documents are not direct evidence of food-honey clinical effects, sterility or ophthalmic suitability. The material date 2026-09-07 is the original evidence date retained for every material entry. It is neither an actual external reading date nor completed content review in this work." }, { "material_type": "Protocol", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID28585260, DOI10.1111/cxo.12524 and the original record of Optimel product provision and related involvement are retained. Registration details, product contracts, funding and author roles are unread externally; unverified information is not converted into absence. This report and its product documents are not direct evidence of food-honey clinical effects, sterility or ophthalmic suitability. The material date 2026-09-07 is the original evidence date retained for every material entry. It is neither an actual external reading date nor completed content review in this work." }, { "material_type": "Analysis plan and full result tables", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID28585260, DOI10.1111/cxo.12524 and the original record of Optimel product provision and related involvement are retained. Registration details, product contracts, funding and author roles are unread externally; unverified information is not converted into absence. This report and its product documents are not direct evidence of food-honey clinical effects, sterility or ophthalmic suitability. The material date 2026-09-07 is the original evidence date retained for every material entry. It is neither an actual external reading date nor completed content review in this work." }, { "material_type": "Product and quality", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID28585260, DOI10.1111/cxo.12524 and the original record of Optimel product provision and related involvement are retained. Registration details, product contracts, funding and author roles are unread externally; unverified information is not converted into absence. This report and its product documents are not direct evidence of food-honey clinical effects, sterility or ophthalmic suitability. The material date 2026-09-07 is the original evidence date retained for every material entry. It is neither an actual external reading date nor completed content review in this work." }, { "material_type": "Funding and interests", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID28585260, DOI10.1111/cxo.12524 and the original record of Optimel product provision and related involvement are retained. Registration details, product contracts, funding and author roles are unread externally; unverified information is not converted into absence. This report and its product documents are not direct evidence of food-honey clinical effects, sterility or ophthalmic suitability. The material date 2026-09-07 is the original evidence date retained for every material entry. It is neither an actual external reading date nor completed content review in this work." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/28585260/" } ] }, { "report_id": "R02", "title": "Wong D et al. 2021", "url": "https://pubmed.ncbi.nlm.nih.gov/33419788/", "report_type": "Stored summary of an assessor-masked randomized medical-product trial; not direct food-honey evidence", "existence": "Displayed selected and parent records exist in the stored summary. External availability, acquisition, content and reading of detailed materials remain separately unverified.", "acquired_read": "The complete parent stored summary and original citation for the medical report were read. External abstracts, full text, registration, plans, product and support documents remain unread.", "study_family": "SF02-Wong-2021-medical-context", "independent_replication": "Only parent R1/I1 and the two-report account are retained; independent food-honey replication and unique counts are not certified", "observed_result": "This records 59 assigned, 55 completed and within-group SPEED changes over 3 weeks of 2.53(P=.006) versus 1.087(P=.183). The original summary states that the abstract did not present a direct between-group symptom effect.", "result_level": "This is background for a specific Optimel medical product, not a direct food-honey trial. Within-group changes, assessor masking and registration ID are not converted into direct between-group superiority, double masking or food-honey registration. Group-specific outcomes, CIs, harms and registry content remain unverified.", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete parent-verdict stored summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07", "qualification": "PMID33419788, DOI10.1136/bjophthalmol-2020-317506, NCT04457648, specific Optimel product provision and author conflict disclosure are retained. The number does not establish registration reading in this work, prespecification or plan adherence; disclosure details are unread. The medical report, registration and product involvement are not transferred into direct food-honey materials. The material date 2026-09-07 is the original evidence date retained for every material entry. It is neither an actual external reading date nor completed content review in this work." }, { "material_type": "External abstract", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID33419788, DOI10.1136/bjophthalmol-2020-317506, NCT04457648, specific Optimel product provision and author conflict disclosure are retained. The number does not establish registration reading in this work, prespecification or plan adherence; disclosure details are unread. The medical report, registration and product involvement are not transferred into direct food-honey materials. The material date 2026-09-07 is the original evidence date retained for every material entry. It is neither an actual external reading date nor completed content review in this work." }, { "material_type": "External full text", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID33419788, DOI10.1136/bjophthalmol-2020-317506, NCT04457648, specific Optimel product provision and author conflict disclosure are retained. The number does not establish registration reading in this work, prespecification or plan adherence; disclosure details are unread. The medical report, registration and product involvement are not transferred into direct food-honey materials. The material date 2026-09-07 is the original evidence date retained for every material entry. It is neither an actual external reading date nor completed content review in this work." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID33419788, DOI10.1136/bjophthalmol-2020-317506, NCT04457648, specific Optimel product provision and author conflict disclosure are retained. The number does not establish registration reading in this work, prespecification or plan adherence; disclosure details are unread. The medical report, registration and product involvement are not transferred into direct food-honey materials. The material date 2026-09-07 is the original evidence date retained for every material entry. It is neither an actual external reading date nor completed content review in this work." }, { "material_type": "Protocol", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID33419788, DOI10.1136/bjophthalmol-2020-317506, NCT04457648, specific Optimel product provision and author conflict disclosure are retained. The number does not establish registration reading in this work, prespecification or plan adherence; disclosure details are unread. The medical report, registration and product involvement are not transferred into direct food-honey materials. The material date 2026-09-07 is the original evidence date retained for every material entry. It is neither an actual external reading date nor completed content review in this work." }, { "material_type": "Analysis plan and full result tables", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID33419788, DOI10.1136/bjophthalmol-2020-317506, NCT04457648, specific Optimel product provision and author conflict disclosure are retained. The number does not establish registration reading in this work, prespecification or plan adherence; disclosure details are unread. The medical report, registration and product involvement are not transferred into direct food-honey materials. The material date 2026-09-07 is the original evidence date retained for every material entry. It is neither an actual external reading date nor completed content review in this work." }, { "material_type": "Product and quality", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID33419788, DOI10.1136/bjophthalmol-2020-317506, NCT04457648, specific Optimel product provision and author conflict disclosure are retained. The number does not establish registration reading in this work, prespecification or plan adherence; disclosure details are unread. The medical report, registration and product involvement are not transferred into direct food-honey materials. The material date 2026-09-07 is the original evidence date retained for every material entry. It is neither an actual external reading date nor completed content review in this work." }, { "material_type": "Funding and interests", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "PMID33419788, DOI10.1136/bjophthalmol-2020-317506, NCT04457648, specific Optimel product provision and author conflict disclosure are retained. The number does not establish registration reading in this work, prespecification or plan adherence; disclosure details are unread. The medical report, registration and product involvement are not transferred into direct food-honey materials. The material date 2026-09-07 is the original evidence date retained for every material entry. It is neither an actual external reading date nor completed content review in this work." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/33419788/" } ] } ], "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": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "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": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "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": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "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": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "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": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." } ], "status_dictionary": { "Partly verified": "Partial information from the stored summary is linked; detailed originals and content review remain incomplete.", "Unverified": "Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety.", "Review incomplete": "Review of existing content remains incomplete.", "Met": "This state is used only within the relevant conditions after material verification and content review. It was not automatically assigned in this work.", "Not reported": "Unreported within material actually read. Unread external material is not relabeled as unreported.", "Inaccessible": "This means actual access failure. External access was not attempted in this work, so this state was not assigned.", "Not applicable": "Used only with an application exception and reason based on the question scope.", "Conflicting data": "This requires actual comparison of materials; no new conflict judgment was made in this work.", "Insufficient evidence for the conditions": "This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "The medical symptom, sign and food-honey questions under 3016 link 2 reports, Albietz 2017 and Wong 2021, as background. The two medical reports and Korean and English safety accounts are not direct food-honey research or independent harm cases. Unique trial, participant and event totals and exact relationships between reports remain unverified." }, "history": [ { "date": "2026-10-21", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public-facing views and materials were prepared from the existing 37 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-21" }