{ "schema_version": "chamgap-public-criteria-1.0", "title": "Oral vitamin C alone added to standard wound care × Complete healing and healing-time reduction in pressure ulcers", "language": "en", "translation_date": "2026-10-23", "criteria_version": "1.0", "criteria_date": "2026-10-06", "condition_origin": "Chamgap's own application conditions", "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "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." }, "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." } ] }