{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3026-main", "verdict_number": "3026", "title": "Oral vitamin C alone added to standard wound care × Complete healing and healing-time reduction in pressure ulcers", "view_version": "1.0", "view_created_date": "2026-10-23", "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": "The scope is adults with pressure ulcers in institutional or hospital care. The main trial records 88 people across 11 nursing homes+1 hospital; the early study records 20 surgical patients. Ulcer stage, site, baseline area, infection, selection and nutritional/deficiency details remain unverified.", "intervention": "The intervention is a single-ingredient oral ascorbic acid supplement added to standard wound care. Study-specific salts, tablets/capsules, excipients, feedstock, manufacture and product identity remain unverified. Foods, multinutrient products, intravenous use and topical paste are not included as the same intervention.", "dose": "The main trial records 500 mg versus 10 mg, each 2 times daily. The original record says the early study’s exact dose could not be rechecked in the paper body. Actual use and adherence remain unverified; no daily total, cumulative dose, optimal dose or individual dosing guidance is created.", "comparator": "Low-dose vitamin C in the main trial is an active control, distinct from the early placebo comparison. Main results are not converted into a vitamin-free comparison or an effect of leaving deficiency uncorrected. Arm-specific balance of wound care, concurrent nutrition and infection treatment remains unverified.", "endpoint": "Complete epithelialisation, closure and healing time (H) remain distinct from area reduction (S). The main complete-healing Cox HR’s 90% precision interval is not relabelled 95% CI. The confidence level of the adjusted area-difference PI remains separately unverified.", "duration": "The early 4-week and main 12-week periods are retained separately. Dosing duration, time to healing and area-assessment timing remain distinct; visits, censoring, post-discontinuation follow-up and all endpoint times remain unverified. Long-term or recurrence effects are not added.", "excluded_extensions": [ "The question concerns single-ingredient oral C, complete healing and healing time in pressure ulcers. Multinutrient, diabetic foot, intravenous, topical-paste and food results are not transferred to it.", "The existing D·34 points·Caution, H/R0/I2/E0/B1/C0 and evidence date 2026-09-07 are retained. Historical validation and independence descriptions remain historical records rather than new clinical certification.", "The early 20 and main 88 people remain linked to their respective reports. Arm-specific, endpoint-specific, person/ulcer and event/censoring denominators remain unverified; participant, event and independent-replication totals are not calculated.", "The 90% precision interval0.44–1.39 for main HR0.78 remains distinct from the separately unverified confidence level of adjusted area-difference PI−0.17~0.13. No 95% CI, RR, healing rate, day difference or new effect is calculated.", "The original accounts of early positive area reduction and no improvement with additional high dosing in the main trial are retained together. The inability to separate deficient and nondeficient groups remains; results are not extended to unnecessary deficiency correction, equivalence or complete absence of effect.", "The stored summary’s 2026 topical-paste registration with no results is a historical record. Registry identity, URL and results are not linked; it is not turned into a new positive oral trial or added report.", "Existing caution about diarrhea, gastrointestinal discomfort, stone risk, kidney disease and iron overload with high oral C doses is retained. No new harm rate, causality, contraindication, long-term safety or individual dosing guidance is created." ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "What is the selected original claim?", "needed": "Single-ingredient oral C, adults with pressure ulcers, complete healing/healing time and comparison", "role": "Required", "role_reason": "Material on Single-ingredient oral C, adults with pressure ulcers, complete healing/healing time and comparison is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on Single-ingredient oral C, adults with pressure ulcers, complete healing/healing time and comparison must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original population, intervention, comparator, endpoint and timing material This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The selected claim is complete healing and reduced healing time in pressure ulcers, for single-ingredient oral vitamin C added to standard wound care.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Area reduction, multinutrient, diabetic foot, topical and intravenous results are not converted into the same question.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original population, intervention, comparator, endpoint and timing material" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Are current reading and past abstract checking distinguished?", "needed": "Stored summaries, historical abstract-checking records and current external reading/acquisition", "role": "Required", "role_reason": "Material on Stored summaries, historical abstract-checking records and current external reading/acquisition is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on Stored summaries, historical abstract-checking records and current external reading/acquisition must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original material and actual access, acquisition and reading history This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The complete stored summary, 2 evidence entries, 2 citations and Korean/English content were used. Past abstract checking and unverified registration/protocol wording remain historical records.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "External abstracts, full text, registration, protocols and SAPs are unread and access unattempted here; past abstract checking is not inherited as current reading.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original material and actual access, acquisition and reading history" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What identifies the early report?", "needed": "Taylor1974 title, PMID/DOI and report relationships", "role": "Required", "role_reason": "Material on Taylor1974 title, PMID/DOI and report relationships is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on Taylor1974 title, PMID/DOI and report relationships must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original paper, complete citation and related-report list This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The early report of 20 people by Taylor TV et al., Lancet1974, PMID4140267 and DOI10.1016/S0140-6736(74)91874-1 is preserved.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "The complete original paper, registration and analysis details remain externally unread here.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original paper, complete citation and related-report list" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "What identifies the main report?", "needed": "ter Riet1995 title, PMID/DOI and trial relationships", "role": "Required", "role_reason": "Material on ter Riet1995 title, PMID/DOI and trial relationships is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on ter Riet1995 title, PMID/DOI and trial relationships must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original paper, trial/related reports and plan list This records needed materials; no new research was executed.", "current_reports": [ "S02" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The main report of 88 people by ter Riet G, Kessels AG and Knipschild PG, J Clin Epidemiol1995, PMID8543959 and DOI10.1016/0895-4356(95)00053-4 is preserved.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Complete full text, registration/SAP and related-report families remain unread.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original paper, trial/related reports and plan list" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Are studies, reports, people and ulcers kept separate?", "needed": "Relationships among early/main studies, reports, participants, lesions and endpoint denominators", "role": "Required", "role_reason": "Material on Relationships among early/main studies, reports, participants, lesions and endpoint denominators is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on Relationships among early/main studies, reports, participants, lesions and endpoint denominators must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Study-specific flow, lesion/person correspondence and related reports This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The early 20 and main 88 people remain linked to each report, with periods, populations, comparisons and endpoints distinguished.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "New participant, ulcer, independent-trial and replication totals are not established; person versus lesion analysis remains unverified.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Study-specific flow, lesion/person correspondence and related reports" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Which adults with pressure ulcers are represented?", "needed": "Institutional/hospital care, surgical patients, ulcer stage/site, baseline and selection", "role": "Required", "role_reason": "Material on Institutional/hospital care, surgical patients, ulcer stage/site, baseline and selection is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on Institutional/hospital care, surgical patients, ulcer stage/site, baseline and selection must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Population selection and baseline/ulcer characteristic tables This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The main trial records 88 people across 11 nursing homes+1 hospital; the early study records 20 surgical patients.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Age, ulcer stage/site, baseline area, infection, inclusion/exclusion and applicability across different populations remain unverified.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Population selection and baseline/ulcer characteristic tables" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Are deficiency correction and additional supplementation distinguished?", "needed": "Baseline vitamin C, nutrition, deficiency prevalence and prespecified subgroups", "role": "Required", "role_reason": "Material on Baseline vitamin C, nutrition, deficiency prevalence and prespecified subgroups is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on Baseline vitamin C, nutrition, deficiency prevalence and prespecified subgroups must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Baseline C/nutrition measurements, deficiency-specific denominators and prespecified interactions This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The original account says effects cannot be separated by deficiency or nutritional status, limiting positive and negative generalizations.", "condition_status": "Unverified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Additional high-dose results are not converted into unnecessary deficiency correction or no effect in deficient groups.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline C/nutrition measurements, deficiency-specific denominators and prespecified interactions" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Which vitamin C formulation is represented?", "needed": "Single-ingredient ascorbic acid, oral route, tablets/capsules, salts/excipients", "role": "Required", "role_reason": "Material on Single-ingredient ascorbic acid, oral route, tablets/capsules, salts/excipients is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on Single-ingredient ascorbic acid, oral route, tablets/capsules, salts/excipients must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Trial formulation, feedstock, salt, excipient and manufacturing specifications This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "This is a single-ingredient oral ascorbic acid supplement. No plant part is newly assigned to the purified nutrient.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Study-specific tablets/capsules, salts, excipients, feedstock, manufacturing process/country and marketed-product identity remain unverified.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial formulation, feedstock, salt, excipient and manufacturing specifications" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Are main and early doses distinguished?", "needed": "Main500 mg 2 times daily versus10 mg 2 times daily; exact early dose", "role": "Required", "role_reason": "Material on Main500 mg 2 times daily versus10 mg 2 times daily; exact early dose is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on Main500 mg 2 times daily versus10 mg 2 times daily; exact early dose must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Study-specific dose, administration and adherence specifications This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The main trial’s500 mg versus10 mg, each2 times daily, is preserved. The early dose was not rechecked in the original paper body, according to the citation record.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "The early dose, actual use/adherence and product ingredients are not filled with the main dose; no new daily total is calculated.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Study-specific dose, administration and adherence specifications" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Does active low-dose control differ from the early placebo?", "needed": "Main low-dose C, early placebo and actual standard-care comparisons", "role": "Required", "role_reason": "Material on Main low-dose C, early placebo and actual standard-care comparisons is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on Main low-dose C, early placebo and actual standard-care comparisons must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Study-specific comparator, administration and ingredient specifications This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The main comparator is active low-dose C rather than a vitamin-free placebo. The early placebo comparison remains separate.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Main results are not transferred to a comparison with no C or effects of leaving deficiency untreated; early placebo specifications remain unverified.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Study-specific comparator, administration and ingredient specifications" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "What common wound care and nutrition were provided?", "needed": "Arm-specific dressings, pressure relief, standard care, nutrition and other treatment", "role": "Required", "role_reason": "Material on Arm-specific dressings, pressure relief, standard care, nutrition and other treatment is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on Arm-specific dressings, pressure relief, standard care, nutrition and other treatment must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Arm-specific care/nutrition, changes and rescue-treatment records This records needed materials; no new research was executed.", "current_reports": [ "S02" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The original account compares high/low-dose C added to standard wound care and says this is not a multinutrient ingredient-attribution trial.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Specific wound care, concurrent nutrition, infection treatment, arm-specific changes/adherence and balance remain unverified.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific care/nutrition, changes and rescue-treatment records" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "How were the early and main studies allocated?", "needed": "Early double-blind controlled design; main multicentre blinded randomized design; allocation/concealment", "role": "Required", "role_reason": "Material on Early double-blind controlled design; main multicentre blinded randomized design; allocation/concealment is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on Early double-blind controlled design; main multicentre blinded randomized design; allocation/concealment must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original methods, allocation/concealment and baseline tables This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The early study is double-blind controlled with randomization/analysis details unverified; the main trial is preserved as multicentre blinded randomized·ITT.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "The early study is not promoted to verified randomization; sequence generation, concealment and baseline balance in both studies remain unverified.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original methods, allocation/concealment and baseline tables" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "How were ulcer measurement and healing assessment masked?", "needed": "Assessors, complete-epithelialisation criteria, area methods and arm-specific measurement", "role": "Required", "role_reason": "Material on Assessors, complete-epithelialisation criteria, area methods and arm-specific measurement is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on Assessors, complete-epithelialisation criteria, area methods and arm-specific measurement must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Measurement/assessment rules, assessor procedures and measurement records This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The masked-design wording and complete-healing/area results are preserved.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Assessor masking, measurement tools, complete-epithelialisation assessment, repeated measures and visit differences remain unverified.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Measurement/assessment rules, assessor procedures and measurement records" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Are4 weeks,12 weeks and time to healing distinguished?", "needed": "Early4 weeks, main12 weeks and healing observation/censoring schedules", "role": "Required", "role_reason": "Material on Early4 weeks, main12 weeks and healing observation/censoring schedules is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on Early4 weeks, main12 weeks and healing observation/censoring schedules must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Dosing, observation, visit and censoring schedules This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "Main12-week and early4-week periods are preserved separately, distinguishing treatment duration, time to healing and area-assessment timing.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Visit schedules, end of observation, censoring, post-discontinuation follow-up and all endpoint times remain unverified.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Dosing, observation, visit and censoring schedules" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Are complete healing and area reduction the same endpoint?", "needed": "Hierarchy of complete epithelialisation/closure and healing time H versus area S", "role": "Required", "role_reason": "Material on Hierarchy of complete epithelialisation/closure and healing time H versus area S is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on Hierarchy of complete epithelialisation/closure and healing time H versus area S must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Endpoint definitions, prespecified hierarchy, complete-healing events and area tables This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "Complete epithelialisation/healing time (H) remains distinct from area reduction (S). The early report is positive for area; the main trial includes complete-healing survival analysis.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Area reduction is not substituted for complete-healing events or reduced healing time.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Endpoint definitions, prespecified hierarchy, complete-healing events and area tables" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "What are the early positive area results?", "needed": "20 people,4 weeks, mean area reduction, dispersion/denominators/intervals", "role": "Required", "role_reason": "Material on 20 people,4 weeks, mean area reduction, dispersion/denominators/intervals is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on 20 people,4 weeks, mean area reduction, dispersion/denominators/intervals must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Early original result tables, dispersion, denominators and intervals This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "Mean area reduction84% versus42.7%, P<.005 is retained as originally recorded.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Original-trial95%CI, complete-healing event counts, arm-specific/lesion analysis denominators and dispersion remain unverified; review-calculated CI is not used as an original value.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Early original result tables, dispersion, denominators and intervals" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "What do the main HR and90% interval represent?", "needed": "Cox complete-healing HR, original90% precision interval and denominators", "role": "Required", "role_reason": "Material on Cox complete-healing HR, original90% precision interval and denominators is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on Cox complete-healing HR, original90% precision interval and denominators must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original Cox methods/results, events/censoring and original intervals This records needed materials; no new research was executed.", "current_reports": [ "S02" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "Complete-healing Cox HR0.78,90% precision interval0.44–1.39 is preserved.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "90% is not promoted to95%CI; exact P, original95%CI and arm-specific healing/censoring denominators remain unverified; no new interval is calculated.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original Cox methods/results, events/censoring and original intervals" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "What are the main area-healing and adjusted-difference interval results?", "needed": "0.21 versus0.27cm²/week, adjusted-difference PI and interval level", "role": "Required", "role_reason": "Material on 0.21 versus0.27cm²/week, adjusted-difference PI and interval level is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on 0.21 versus0.27cm²/week, adjusted-difference PI and interval level must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original area model/results, adjustment terms and interval level This records needed materials; no new research was executed.", "current_reports": [ "S02" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "Mean area healing0.21 versus0.27cm²/week and adjusted-difference PI−0.17~0.13 are preserved.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "The confidence level of that adjusted-difference PI remains separately unverified; the HR’s90% is not automatically inherited, and no point estimate, P or95%CI is newly calculated.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original area model/results, adjustment terms and interval level" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Is the HR kept distinct from other treatment-effect measures?", "needed": "Time-to-event effect, observation/censoring, proportional hazards and interpretation direction", "role": "Required", "role_reason": "Material on Time-to-event effect, observation/censoring, proportional hazards and interpretation direction is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on Time-to-event effect, observation/censoring, proportional hazards and interpretation direction must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Cox model, censoring, adjustment, assumptions and original results This records needed materials; no new research was executed.", "current_reports": [ "S02" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The main result is a Cox HR from healing survival analysis, distinct from area in cm²/week.", "condition_status": "Unverified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "The HR is not converted into healing rate, RR, time difference or area effect; proportional hazards, censoring and adjustment details remain unverified.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Cox model, censoring, adjustment, assumptions and original results" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "What are the88-person, arm/endpoint and person/lesion denominators?", "needed": "88 people overall, institutions, allocation/measurement/analysis, complete-healing events and ulcer denominators", "role": "Required", "role_reason": "Material on 88 people overall, institutions, allocation/measurement/analysis, complete-healing events and ulcer denominators is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on 88 people overall, institutions, allocation/measurement/analysis, complete-healing events and ulcer denominators must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Participant flow and person/ulcer, endpoint-specific event/denominator tables This records needed materials; no new research was executed.", "current_reports": [ "S02" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The original main record of88 people across11 nursing homes+1 hospital is retained.", "condition_status": "Unverified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "The account leaves arm/endpoint denominators, healing events/censoring and person/lesion correspondence unverified; no new event counts or totals are calculated.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Participant flow and person/ulcer, endpoint-specific event/denominator tables" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "How were attrition, ITT and facility structure handled?", "needed": "ITT/missingness, attrition, facility/lesion clustering and analysis units", "role": "Required", "role_reason": "Material on ITT/missingness, attrition, facility/lesion clustering and analysis units is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on ITT/missingness, attrition, facility/lesion clustering and analysis units must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original analysis, missingness/attrition, facilities/analysis units and sensitivity This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The main multicentre ITT design and unverified early randomization/analysis details are preserved.", "condition_status": "Unverified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Specific ITT handling, attrition reasons, facility differences, lesion clustering/repeated measures and sensitivity remain unverified; ITT alone does not establish completed robustness checks.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original analysis, missingness/attrition, facilities/analysis units and sensitivity" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Were prespecified endpoints, registration and plans checked?", "needed": "Registration, protocol, SAP and endpoints/timing/analysis/changes", "role": "Required", "role_reason": "Material on Registration, protocol, SAP and endpoints/timing/analysis/changes is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on Registration, protocol, SAP and endpoints/timing/analysis/changes must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Registration history, protocol, SAP and complete results This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "Both reports record registration numbers as not found. Early complete-healing prespecification and main official registration/SAP remain unverified.", "condition_status": "Unverified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Current registration/plans are unread and access unattempted; absence of registration or a specific prespecified1st endpoint is not newly established.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration history, protocol, SAP and complete results" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Are early positive and main negative results both preserved?", "needed": "Differences in population, duration, comparison, area/complete healing and positive/null findings", "role": "Required", "role_reason": "Material on Differences in population, duration, comparison, area/complete healing and positive/null findings is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on Differences in population, duration, comparison, area/complete healing and positive/null findings must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Study-specific results, formulation/population/nutrition, denominators and plans This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "Early positive area reduction and the original main account of no improvement in complete healing/area remain together. The original conflict interpretation is preserved as historical wording.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Results for different endpoints/comparisons are not combined as one effect, and nonsignificance is not newly judged as effect0 or equivalence.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Study-specific results, formulation/population/nutrition, denominators and plans" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "What is the precision of the main null and important difference?", "needed": "Plausible effect range,90% interval and justified important difference", "role": "Required", "role_reason": "Material on Plausible effect range,90% interval and justified important difference is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on Plausible effect range,90% interval and justified important difference must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original intervals, sample-size plan, important difference and nutrition-specific results This records needed materials; no new research was executed.", "current_reports": [ "S02" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The original account says exaggerating a90% interval as95% misrepresents precision and limits generalization by deficiency status.", "condition_status": "Unverified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Exact95%CI, important difference, adequate power and deficiency-specific effects remain unverified; complete absence of effect is not newly established.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original intervals, sample-size plan, important difference and nutrition-specific results" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "What are independence, original funding and product support?", "needed": "Original funding, manufacturer, product provision, employee authors and COI records", "role": "Required", "role_reason": "Material on Original funding, manufacturer, product provision, employee authors and COI records is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on Original funding, manufacturer, product provision, employee authors and COI records must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Funding, product, employment and COI specifications for each report This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "Early funding is unverified; main funding, manufacturer and employee authors are unverified. The original independent-trial/I2 descriptions remain historical values.", "condition_status": "Unverified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Original funding, product/free support, employment, patents and COI remain unread here; unverified is not converted into none or current independence certification.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Funding, product, employment and COI specifications for each report" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "What unique replication addresses the same oral question?", "needed": "Family relationships for the same formulation, population, comparison and complete healing/time", "role": "Required", "role_reason": "Material on Family relationships for the same formulation, population, comparison and complete healing/time is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on Family relationships for the same formulation, population, comparison and complete healing/time must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Related reports and direct trials addressing the same question This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The two stored reports distinguish early4-week area/placebo and main12-week complete-healing/area/active-low-dose comparisons.", "condition_status": "Unverified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "The2 reports are not established as independent positive replications of the same outcome; current complete study/participant totals have not been searched.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Related reports and direct trials addressing the same question" }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Is the topical-registration summary kept separate from an oral trial?", "needed": "Topical registration/results, route/formulation and oral directness", "role": "Required", "role_reason": "Material on Topical registration/results, route/formulation and oral directness is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on Topical registration/results, route/formulation and oral directness must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original topical registration/results and exact formulation/route This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The stored summary describes a2026 new registration as topical paste with no results yet. It is not counted as a new positive oral trial.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Registry identity/URL/results are not linked in this summary and external registration was not read here; no new S03 is created.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original topical registration/results and exact formulation/route" }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Is the question kept separate from combinations, diabetic foot and intravenous use?", "needed": "Single-ingredient oral pressure-ulcer question versus other ingredient/route/wound questions", "role": "Required", "role_reason": "Material on Single-ingredient oral pressure-ulcer question versus other ingredient/route/wound questions is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on Single-ingredient oral pressure-ulcer question versus other ingredient/route/wound questions must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Separate direct material for each combination, route and wound This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The account does not substitute multinutrient or diabetic foot ulcer results and does not automatically include foods, combination products or intravenous use.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Numbers for other wounds, combinations or routes are not transferred to this question.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate direct material for each combination, route and wound" }, { "item_id": "N29", "question_type": "Evidence condition", "question": "What are long-term, dose-specific and nutrition-specific effects?", "needed": "Direct dose, deficiency/nutrition, long-term/recurrence and prespecified subgroups", "role": "Required", "role_reason": "Material on Direct dose, deficiency/nutrition, long-term/recurrence and prespecified subgroups is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on Direct dose, deficiency/nutrition, long-term/recurrence and prespecified subgroups must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Direct dose, long-term and baseline nutrition/subgroup material This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The main12-week and early4-week scope and inability to separate deficiency strata are retained.", "condition_status": "Unverified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Optimality of other doses, long-term recurrence/persistence and nutritional-subgroup effects/interactions remain unverified.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct dose, long-term and baseline nutrition/subgroup material" }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Are collagen mechanisms distinguished from clinical healing?", "needed": "Mechanism, area, complete healing and separate quality-of-life/infection outcomes", "role": "Required", "role_reason": "Material on Mechanism, area, complete healing and separate quality-of-life/infection outcomes is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on Mechanism, area, complete healing and separate quality-of-life/infection outcomes must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Direct material for selected endpoints and separate clinical outcomes This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The account says a need for collagen synthesis does not establish accelerated clinical healing with additional high dosing.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Mechanisms do not fill clinical-effect gaps, and infection, quality-of-life, mortality or recurrence effects are not newly extended from healing/area material.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct material for selected endpoints and separate clinical outcomes" }, { "item_id": "N31", "question_type": "Evidence condition", "question": "How were harms of high-dose oral C collected?", "needed": "Event definitions/collection, arm/exposure denominators and discontinuation", "role": "Supplementary", "role_reason": "Material on Event definitions/collection, arm/exposure denominators and discontinuation is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on Event definitions/collection, arm/exposure denominators and discontinuation must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Adverse-event, collection and discontinuation tables for each study This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The original safety state is Caution. Original wording on possible diarrhea/gastrointestinal discomfort and limited study-specific event counts is preserved.", "condition_status": "Unverified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Arm-specific events, collection, severity, discontinuation and denominators/periods remain unverified; unreported is not converted into0 or safe.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Adverse-event, collection and discontinuation tables for each study" }, { "item_id": "N32", "question_type": "Evidence condition", "question": "What are the harm comparisons, timing and baseline predispositions?", "needed": "High/low dose/placebo, cointerventions, kidney/stone/iron risks, timeline and alternatives", "role": "Supplementary", "role_reason": "Material on High/low dose/placebo, cointerventions, kidney/stone/iron risks, timeline and alternatives is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on High/low dose/placebo, cointerventions, kidney/stone/iron risks, timeline and alternatives must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Arm-specific exposure/events, timelines and baseline/cointervention material This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "Original caution about gastrointestinal discomfort with high oral doses, stone predisposition, kidney disease and iron overload is preserved.", "condition_status": "Unverified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Between-group harm size, specific causes, withdrawal/recovery, re-exposure and cointervention effects remain unverified; no new incidence or causality judgment is made.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific exposure/events, timelines and baseline/cointervention material" }, { "item_id": "N33", "question_type": "Evidence condition", "question": "What are long-term/rare harms and special populations?", "needed": "Long-term/rare events, population-specific direct exposure and interactions", "role": "Supplementary", "role_reason": "Material on Long-term/rare events, population-specific direct exposure and interactions is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on Long-term/rare events, population-specific direct exposure and interactions must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Long-term and baseline-disease-specific exposure/harm material This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The short pressure-ulcer studies and original safety-caution scope are retained.", "condition_status": "Unverified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Limited study-specific event counts do not establish absence of long-term/rare harms or safety in all special populations.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Long-term and baseline-disease-specific exposure/harm material" }, { "item_id": "N34", "question_type": "Evidence condition", "question": "How are original D34, assessment values, evidence date and change records preserved?", "needed": "Original grade/score, assessment values, Korean/English, evidence date, change history and past validation", "role": "Required", "role_reason": "Material on Original grade/score, assessment values, Korean/English, evidence date, change history and past validation is needed to connect the selected oral monotherapy and pressure-ulcer question to its population, comparison, endpoint, timing, denominator or harms.", "application_exception": "Oral monotherapy pressure-ulcer healing remains separate from topical paste, intravenous use, multinutrient products, diabetic foot ulcers and mechanisms. Complete healing and area, people and ulcers, and early and main studies are not combined; no new effects, intervals, P values, event counts, harm rates or dose totals are calculated.", "criterion": "Original records on Original grade/score, assessment values, Korean/English, evidence date, change history and past validation must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish populations, oral monotherapy, active low-dose control, standard care, complete healing and area, timing, reports and trials, person and lesion denominators, and harms.", "condition_origin": "These existing conditions concern single-ingredient oral vitamin C added to standard wound care, complete healing and healing time in adults with pressure ulcers. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original verdict/change history, additional material and user comments This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for both reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "D34, original assessment values, past independent cross-checking wording, original verdict date2026-09-07 and Korean/English content are preserved. Original correction, subclaim and deliberation records are empty. The current production date is not converted into a completed review date.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Past H/I2/R0/E0 values are not inherited as current review completion; current withdrawals, new papers and registrations have not been searched; empty corrections are not extended into a complete search finding no corrections.", "uncertainty": "Gaps in original products, nutritional status, arm-specific and endpoint-specific denominators, plans, support and harms remain. Area reduction is not converted into complete healing, active low-dose control into a vitamin-free placebo, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original verdict/change history, additional material and user comments" } ], "reports": [ { "report_id": "S01", "title": "Taylor et al. 1974 · Early pressure-sore area study", "url": "https://pubmed.ncbi.nlm.nih.gov/4140267/", "report_type": "Double-blind controlled study; randomization and analysis details unverified", "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Summary read; external material unread", "study_family": "TF3026-01", "independent_replication": null, "observed_result": "Mean area reduction84% versus42.7%, P<.005. Original-trial95%CI and complete-healing event counts remain unverified. Review-calculated CI is not used as an original-trial value.", "result_level": "The record concerns 20 surgical patients. Randomization, analysis details and arm-specific/lesion analysis denominators remain unverified.", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete existing review summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07", "qualification": "PMID4140267; DOI10.1016/S0140-6736(74)91874-1. Past abstract checking is a historical bibliography record. Stored summaries are read here; external abstracts, full text, registration and plans remain unread. Original material-specific dates and absent dates are retained without conversion into current external-reading dates." }, { "material_type": "External paper", "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": "PMID4140267; DOI10.1016/S0140-6736(74)91874-1. Past abstract checking is a historical bibliography record. Stored summaries are read here; external abstracts, full text, registration and plans remain unread. Original material-specific dates and absent dates are retained without conversion into current external-reading dates." }, { "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": "PMID4140267; DOI10.1016/S0140-6736(74)91874-1. Past abstract checking is a historical bibliography record. Stored summaries are read here; external abstracts, full text, registration and plans remain unread. Original material-specific dates and absent dates are retained without conversion into current external-reading dates." }, { "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": "PMID4140267; DOI10.1016/S0140-6736(74)91874-1. Past abstract checking is a historical bibliography record. Stored summaries are read here; external abstracts, full text, registration and plans remain unread. Original material-specific dates and absent dates are retained without conversion into current external-reading dates." }, { "material_type": "Statistical analysis plan", "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": "PMID4140267; DOI10.1016/S0140-6736(74)91874-1. Past abstract checking is a historical bibliography record. Stored summaries are read here; external abstracts, full text, registration and plans remain unread. Original material-specific dates and absent dates are retained without conversion into current external-reading dates." }, { "material_type": "Funding, product support and COI 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": "PMID4140267; DOI10.1016/S0140-6736(74)91874-1. Past abstract checking is a historical bibliography record. Stored summaries are read here; external abstracts, full text, registration and plans remain unread. Original material-specific dates and absent dates are retained without conversion into current external-reading dates." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/4140267/" } ] }, { "report_id": "S02", "title": "ter Riet et al. 1995 · Main pressure-ulcer healing trial", "url": "https://pubmed.ncbi.nlm.nih.gov/8543959/", "report_type": "Multicentre blinded randomized trial·ITT", "existence": "The information is recorded in stored summaries and citations for the early area study and main healing trial. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Summary read; external material unread", "study_family": "TF3026-02", "independent_replication": null, "observed_result": "Complete-healing Cox HR0.78 [90% precision interval0.44–1.39]. Mean area healing0.21 versus0.27cm²/week. The confidence level of adjusted-difference PI−0.17~0.13 remains separately unverified. ExactP and95%CI remain unverified.", "result_level": "The record concerns 88 people in 11 nursing homes+1 hospital. Arm-specific, endpoint-specific, person/ulcer and event/censoring denominators remain unverified.", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete existing review summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07", "qualification": "PMID8543959; DOI10.1016/0895-4356(95)00053-4. Past abstract checking is a historical bibliography record. Stored summaries are read here; external abstracts, full text, registration and plans remain unread. Original material-specific dates and absent dates are retained without conversion into current external-reading dates." }, { "material_type": "External paper", "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": "PMID8543959; DOI10.1016/0895-4356(95)00053-4. Past abstract checking is a historical bibliography record. Stored summaries are read here; external abstracts, full text, registration and plans remain unread. Original material-specific dates and absent dates are retained without conversion into current external-reading dates." }, { "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": "PMID8543959; DOI10.1016/0895-4356(95)00053-4. Past abstract checking is a historical bibliography record. Stored summaries are read here; external abstracts, full text, registration and plans remain unread. Original material-specific dates and absent dates are retained without conversion into current external-reading dates." }, { "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": "PMID8543959; DOI10.1016/0895-4356(95)00053-4. Past abstract checking is a historical bibliography record. Stored summaries are read here; external abstracts, full text, registration and plans remain unread. Original material-specific dates and absent dates are retained without conversion into current external-reading dates." }, { "material_type": "Statistical analysis plan", "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": "PMID8543959; DOI10.1016/0895-4356(95)00053-4. Past abstract checking is a historical bibliography record. Stored summaries are read here; external abstracts, full text, registration and plans remain unread. Original material-specific dates and absent dates are retained without conversion into current external-reading dates." }, { "material_type": "Funding, product support and COI 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": "PMID8543959; DOI10.1016/0895-4356(95)00053-4. Past abstract checking is a historical bibliography record. Stored summaries are read here; external abstracts, full text, registration and plans remain unread. Original material-specific dates and absent dates are retained without conversion into current external-reading dates." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/8543959/" } ] } ], "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 two stored reports remain distinct as the early area/placebo study and main complete-healing/area/active-low-dose trial. Report counts are not converted into independent positive replications of the same question. Unique trial, participant and independent-replication totals remain unverified." }, "history": [ { "date": "2026-10-23", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 34 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-23" }