{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3022-main", "verdict_number": "3022", "title": "Perioperative Oral Vitamin C for Postoperative Atrial Fibrillation—Results Are Inconsistent", "view_version": "1.0", "view_created_date": "2026-10-22", "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 record mainly concerns adults undergoing elective on-pump CABG. Study-specific surgery, baseline rhythm, age, risk, eligibility and background beta-blocker or amiodarone prophylaxis remain separate rather than generalized to all cardiac-surgery patients.", "intervention": "The selected route is single-ingredient oral ascorbic acid. The original tablet/solution and unverified IV salt, buffering and excipient records are retained without converting IV products into oral formulations. Feedstock, manufacture and oral tablet/solution, salt, excipients and product specifications remain unverified.", "dose": "The original grouped IV schedules are 2 g at 24 h and 2 h before surgery, followed by 1 g 2 times daily for 5 days(A2), and another IV 2 g before surgery +500 mg 2 times daily for 5 days(A3). They are not applied as oral schedules. The unverified oral A1 dose remains separate from S03: 1 g 2 times daily from 5 days before through 10 days after surgery; no cumulative dose is calculated.", "comparator": "Oral placebo comparisons remain separate from effects added to usual background prophylaxis. A beta-blocker-alone comparison is not converted into the same placebo for every report; drug types, doses, amiodarone, changes, rescue treatment and group balance remain unverified.", "endpoint": "The endpoint is new POAF/flutter. Report-specific AF/flutter grouping, duration thresholds, continuous or intermittent rhythm surveillance, assessment and observation windows remain separate. Hospital stay, other complications and treatment of existing atrial fibrillation do not substitute for this prevention endpoint.", "duration": "The original general scope of about 5 perioperative days and early inpatient rhythm surveillance is retained separately from S03’s oral schedule from 5 days before through 10 days after surgery. Study-specific dosing, surveillance windows and post-discharge events remain unverified; total days and cumulative doses are not newly calculated.", "excluded_extensions": [ "This question concerns single-ingredient oral vitamin C around cardiac surgery for prevention of new POAF. It is not extended to foods, combinations, intravenous or mixed routes, treatment of existing atrial fibrillation or all surgical populations.", "The existing grade D·34 points, stored assessment values, Korean and English explanations and evidence date 2026-09-07 are retained. Historical cross-checking and past descriptions as recent do not establish current reading of original material, regrading or a completed comprehensive literature search.", "S01’s 185 completers(C 89/control 96) are not converted into initial randomization or exact event denominators. The rounded rates 30.3% versus 30.2%, P=.985 are not back-calculated into event counts, and no new 95%CI is created.", "The original IV-dose labels A2/A3 are not automatically mapped to current oral reports S02/S03. The unverified oral A1 dose and gaps in each trial’s actual schedule remain.", "S03’s 253 participants, 1 g 2 times daily and schedule from 5 days before through 10 days after surgery are not replaced by the original general description of about 5 days. Reports are not summed and cumulative doses are not calculated without verifying the same background drugs, events and surgical populations.", "Older positive oral add-on findings and oral null reports are both retained. Shorter hospital stay or positive findings from one region are not turned into POAF prevention for every patient, and other clinical outcomes do not substitute.", "Nonsignificance does not establish an effect of exactly 0 or equivalence. The target and details of sample-size criticism are unlinked; methodological commentary, withdrawn registry records and retracted publications remain separate. A registry identifier alone does not verify prespecification or agreement with plans.", "Existing caution about gastrointestinal discomfort, diarrhea, kidney disease, stone risk and iron overload with oral vitamin C is retained. Limited event counts and POAF results are not converted into an absence of harm or established safety, and no new incidence rate, interaction or individual dosing guidance is created." ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "What is the scope of the oral POAF prevention question?", "needed": "Perioperative oral single-ingredient C; new POAF; background prophylaxis; comparison", "role": "Required", "role_reason": "Material on Perioperative oral single-ingredient C; new POAF; background prophylaxis; comparison is needed to connect the selected oral prevention question to its surgical population, formulation, dosing, background drugs, comparison, events, surveillance window, denominator, precision and harms.", "application_exception": "Oral and intravenous or mixed routes, allocation and completer/event denominators, and placebo versus add-on prophylaxis remain separate. Other routes’ doses, rounded rates, hospital stay, commentary or registry status do not substitute for oral effects, event counts, publication retraction or overall safety; no new effects, intervals, incidence rates, cumulative doses or individual dosing guidance are created.", "criterion": "Original records on Perioperative oral single-ingredient C; new POAF; background prophylaxis; comparison must link to the same oral route, surgical population, background drugs, comparison, event, time point and analysis population, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish questions, routes, direct comparisons, reports and trials, background prophylaxis, event definitions, denominators, precision and harms.", "condition_origin": "These evidence conditions apply to the existing question of single-ingredient oral vitamin C around cardiac surgery for postoperative atrial fibrillation prevention. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Intravenous or mixed routes, shorter hospital stay and prevention across all surgical populations are not converted into the same question. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "The information comes from stored oral-trial summaries, bibliography and Korean and English explanations. Original papers, registration, plans and current reading of external material remain separately unverified.", "acquired_read": "Existing Korean and English stored summary, trial records and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The selected claim is prevention of atrial fibrillation after cardiac surgery, as an add-on effect of single-ingredient oral vitamin C.", "condition_status": "Partly verified", "status_reason": "The stored summary’s information is linked to its unverified scope. External verification and clinical content review remain incomplete; this does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Intravenous or mixed routes, shorter hospital stay and prevention across all surgical populations are not converted into the same question.", "uncertainty": "Gaps in study-specific surgical populations, oral doses, background drugs, event definitions, allocation/analysis denominators, prespecified plans, support and harms remain. Conflicting results and nonsignificance are not converted into established prevention, a precise null effect, equivalence or overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Intravenous or mixed routes, shorter hospital stay and prevention across all surgical populations are not converted into the same question." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "How does current reading differ from historical checks?", "needed": "Stored summaries; historical abstract/cross-check records; current external material", "role": "Required", "role_reason": "Material on Stored summaries; historical abstract/cross-check records; current external material is needed to connect the selected oral prevention question to its surgical population, formulation, dosing, background drugs, comparison, events, surveillance window, denominator, precision and harms.", "application_exception": "Oral and intravenous or mixed routes, allocation and completer/event denominators, and placebo versus add-on prophylaxis remain separate. Other routes’ doses, rounded rates, hospital stay, commentary or registry status do not substitute for oral effects, event counts, publication retraction or overall safety; no new effects, intervals, incidence rates, cumulative doses or individual dosing guidance are created.", "criterion": "Original records on Stored summaries; historical abstract/cross-check records; current external material must link to the same oral route, surgical population, background drugs, comparison, event, time point and analysis population, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish questions, routes, direct comparisons, reports and trials, background prophylaxis, event definitions, denominators, precision and harms.", "condition_origin": "These evidence conditions apply to the existing question of single-ingredient oral vitamin C around cardiac surgery for postoperative atrial fibrillation prevention. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: External papers, registration, protocols and SAPs are currently unread and access was not attempted. Bibliographic links and historical verification are not promoted to current reading of original material. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "The information comes from stored oral-trial summaries, bibliography and Korean and English explanations. Original papers, registration, plans and current reading of external material remain separately unverified.", "acquired_read": "Existing Korean and English stored summary, trial records and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The complete stored summary, 3 evidence entries, 3 citations and Korean and English explanations were read. Citation wording about abstract checks or independent cross-checks remains historical.", "condition_status": "Partly verified", "status_reason": "The stored summary’s information is linked to its unverified scope. External verification and clinical content review remain incomplete; this does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "External papers, registration, protocols and SAPs are currently unread and access was not attempted. Bibliographic links and historical verification are not promoted to current reading of original material.", "uncertainty": "Gaps in study-specific surgical populations, oral doses, background drugs, event definitions, allocation/analysis denominators, prespecified plans, support and harms remain. Conflicting results and nonsignificance are not converted into established prevention, a precise null effect, equivalence or overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "External papers, registration, protocols and SAPs are currently unread and access was not attempted. Bibliographic links and historical verification are not promoted to current reading of original material." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What identifies the main oral null report?", "needed": "Bjordahl 2012 title; PMID/DOI; report and trial linkage", "role": "Required", "role_reason": "Material on Bjordahl 2012 title; PMID/DOI; report and trial linkage is needed to connect the selected oral prevention question to its surgical population, formulation, dosing, background drugs, comparison, events, surveillance window, denominator, precision and harms.", "application_exception": "Oral and intravenous or mixed routes, allocation and completer/event denominators, and placebo versus add-on prophylaxis remain separate. Other routes’ doses, rounded rates, hospital stay, commentary or registry status do not substitute for oral effects, event counts, publication retraction or overall safety; no new effects, intervals, incidence rates, cumulative doses or individual dosing guidance are created.", "criterion": "Original records on Bjordahl 2012 title; PMID/DOI; report and trial linkage must link to the same oral route, surgical population, background drugs, comparison, event, time point and analysis population, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish questions, routes, direct comparisons, reports and trials, background prophylaxis, event definitions, denominators, precision and harms.", "condition_origin": "These evidence conditions apply to the existing question of single-ingredient oral vitamin C around cardiac surgery for postoperative atrial fibrillation prevention. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: The full original paper, registration, initial allocation, exact dose and report-identity linkage remain unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored oral-trial summaries, bibliography and Korean and English explanations. Original papers, registration, plans and current reading of external material remain separately unverified.", "acquired_read": "Existing Korean and English stored summary, trial records and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The oral report by Bjordahl et al., Am J Surg 2012, PMID23022248 and DOI10.1016/j.amjsurg.2012.03.012 is retained.", "condition_status": "Partly verified", "status_reason": "The stored summary’s information is linked to its unverified scope. External verification and clinical content review remain incomplete; this does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "The full original paper, registration, initial allocation, exact dose and report-identity linkage remain unverified.", "uncertainty": "Gaps in study-specific surgical populations, oral doses, background drugs, event definitions, allocation/analysis denominators, prespecified plans, support and harms remain. Conflicting results and nonsignificance are not converted into established prevention, a precise null effect, equivalence or overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The full original paper, registration, initial allocation, exact dose and report-identity linkage remain unverified." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "What is the older positive oral add-on report?", "needed": "Eslami 2007; oral C plus beta-blocker; 100 participants; comparison", "role": "Required", "role_reason": "Material on Eslami 2007; oral C plus beta-blocker; 100 participants; comparison is needed to connect the selected oral prevention question to its surgical population, formulation, dosing, background drugs, comparison, events, surveillance window, denominator, precision and harms.", "application_exception": "Oral and intravenous or mixed routes, allocation and completer/event denominators, and placebo versus add-on prophylaxis remain separate. Other routes’ doses, rounded rates, hospital stay, commentary or registry status do not substitute for oral effects, event counts, publication retraction or overall safety; no new effects, intervals, incidence rates, cumulative doses or individual dosing guidance are created.", "criterion": "Original records on Eslami 2007; oral C plus beta-blocker; 100 participants; comparison must link to the same oral route, surgical population, background drugs, comparison, event, time point and analysis population, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish questions, routes, direct comparisons, reports and trials, background prophylaxis, event definitions, denominators, precision and harms.", "condition_origin": "These evidence conditions apply to the existing question of single-ingredient oral vitamin C around cardiac surgery for postoperative atrial fibrillation prevention. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Exact events, denominators, intervals, modern background care and registration boundaries remain unverified and are not filled with values from the main null report. This records needed materials; no new research was executed.", "current_reports": [ "S02" ], "existence": "The information comes from stored oral-trial summaries, bibliography and Korean and English explanations. Original papers, registration, plans and current reading of external material remain separately unverified.", "acquired_read": "Existing Korean and English stored summary, trial records and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Eslami et al., Tex Heart Inst J 2007, PMID17948074 and PMCIDPMC1995047 report a randomized oral C plus beta-blocker versus beta-blocker add-on comparison in 100 participants.", "condition_status": "Partly verified", "status_reason": "The stored summary’s information is linked to its unverified scope. External verification and clinical content review remain incomplete; this does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Exact events, denominators, intervals, modern background care and registration boundaries remain unverified and are not filled with values from the main null report.", "uncertainty": "Gaps in study-specific surgical populations, oral doses, background drugs, event definitions, allocation/analysis denominators, prespecified plans, support and harms remain. Conflicting results and nonsignificance are not converted into established prevention, a precise null effect, equivalence or overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact events, denominators, intervals, modern background care and registration boundaries remain unverified and are not filled with values from the main null report." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "What is the 2023 registered oral report?", "needed": "253 participants; oral schedule; PMID/registration; complete bibliography", "role": "Required", "role_reason": "Material on 253 participants; oral schedule; PMID/registration; complete bibliography is needed to connect the selected oral prevention question to its surgical population, formulation, dosing, background drugs, comparison, events, surveillance window, denominator, precision and harms.", "application_exception": "Oral and intravenous or mixed routes, allocation and completer/event denominators, and placebo versus add-on prophylaxis remain separate. Other routes’ doses, rounded rates, hospital stay, commentary or registry status do not substitute for oral effects, event counts, publication retraction or overall safety; no new effects, intervals, incidence rates, cumulative doses or individual dosing guidance are created.", "criterion": "Original records on 253 participants; oral schedule; PMID/registration; complete bibliography must link to the same oral route, surgical population, background drugs, comparison, event, time point and analysis population, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish questions, routes, direct comparisons, reports and trials, background prophylaxis, event definitions, denominators, precision and harms.", "condition_origin": "These evidence conditions apply to the existing question of single-ingredient oral vitamin C around cardiac surgery for postoperative atrial fibrillation prevention. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: A generic title is not converted into full original-bibliography verification. Registry contents, change history, denominators and COI remain currently unread or unverified. This records needed materials; no new research was executed.", "current_reports": [ "S03" ], "existence": "The information comes from stored oral-trial summaries, bibliography and Korean and English explanations. Original papers, registration, plans and current reading of external material remain separately unverified.", "acquired_read": "Existing Korean and English stored summary, trial records and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The existing manuscript links the 2023 oral trial with 253 participants to PMID37039967 and NCT03592680.", "condition_status": "Partly verified", "status_reason": "The stored summary’s information is linked to its unverified scope. External verification and clinical content review remain incomplete; this does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "A generic title is not converted into full original-bibliography verification. Registry contents, change history, denominators and COI remain currently unread or unverified.", "uncertainty": "Gaps in study-specific surgical populations, oral doses, background drugs, event definitions, allocation/analysis denominators, prespecified plans, support and harms remain. Conflicting results and nonsignificance are not converted into established prevention, a precise null effect, equivalence or overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "A generic title is not converted into full original-bibliography verification. Registry contents, change history, denominators and COI remain currently unread or unverified." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Are reports, participants and events kept separate?", "needed": "185 completers; 100 participants; 253 participants; analysis and reporting relationships", "role": "Required", "role_reason": "Material on 185 completers; 100 participants; 253 participants; analysis and reporting relationships is needed to connect the selected oral prevention question to its surgical population, formulation, dosing, background drugs, comparison, events, surveillance window, denominator, precision and harms.", "application_exception": "Oral and intravenous or mixed routes, allocation and completer/event denominators, and placebo versus add-on prophylaxis remain separate. Other routes’ doses, rounded rates, hospital stay, commentary or registry status do not substitute for oral effects, event counts, publication retraction or overall safety; no new effects, intervals, incidence rates, cumulative doses or individual dosing guidance are created.", "criterion": "Original records on 185 completers; 100 participants; 253 participants; analysis and reporting relationships must link to the same oral route, surgical population, background drugs, comparison, event, time point and analysis population, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish questions, routes, direct comparisons, reports and trials, background prophylaxis, event definitions, denominators, precision and harms.", "condition_origin": "These evidence conditions apply to the existing question of single-ingredient oral vitamin C around cardiac surgery for postoperative atrial fibrillation prevention. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Initial allocation and denominator types differ or remain unverified; no new participant total, unique trial count, independent-replication count or POAF event total is summed or established. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "The information comes from stored oral-trial summaries, bibliography and Korean and English explanations. Original papers, registration, plans and current reading of external material remain separately unverified.", "acquired_read": "Existing Korean and English stored summary, trial records and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Each oral report is linked separately, retaining the original records of 185 completers, 100 participants and 253 participants.", "condition_status": "Partly verified", "status_reason": "The stored summary’s information is linked to its unverified scope. External verification and clinical content review remain incomplete; this does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Initial allocation and denominator types differ or remain unverified; no new participant total, unique trial count, independent-replication count or POAF event total is summed or established.", "uncertainty": "Gaps in study-specific surgical populations, oral doses, background drugs, event definitions, allocation/analysis denominators, prespecified plans, support and harms remain. Conflicting results and nonsignificance are not converted into established prevention, a precise null effect, equivalence or overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Initial allocation and denominator types differ or remain unverified; no new participant total, unique trial count, independent-replication count or POAF event total is summed or established." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "What are the surgical and baseline-population boundaries?", "needed": "Elective on-pump CABG; surgery; baseline rhythm/risk; eligibility", "role": "Required", "role_reason": "Material on Elective on-pump CABG; surgery; baseline rhythm/risk; eligibility is needed to connect the selected oral prevention question to its surgical population, formulation, dosing, background drugs, comparison, events, surveillance window, denominator, precision and harms.", "application_exception": "Oral and intravenous or mixed routes, allocation and completer/event denominators, and placebo versus add-on prophylaxis remain separate. Other routes’ doses, rounded rates, hospital stay, commentary or registry status do not substitute for oral effects, event counts, publication retraction or overall safety; no new effects, intervals, incidence rates, cumulative doses or individual dosing guidance are created.", "criterion": "Original records on Elective on-pump CABG; surgery; baseline rhythm/risk; eligibility must link to the same oral route, surgical population, background drugs, comparison, event, time point and analysis population, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish questions, routes, direct comparisons, reports and trials, background prophylaxis, event definitions, denominators, precision and harms.", "condition_origin": "These evidence conditions apply to the existing question of single-ingredient oral vitamin C around cardiac surgery for postoperative atrial fibrillation prevention. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Report-specific surgery, pre-existing arrhythmia, age, risk, eligibility/exclusions and applicability to other operations remain unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "The information comes from stored oral-trial summaries, bibliography and Korean and English explanations. Original papers, registration, plans and current reading of external material remain separately unverified.", "acquired_read": "Existing Korean and English stored summary, trial records and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original population information mainly concerns adults undergoing elective on-pump CABG, with background beta-blocker and amiodarone prophylaxis distinguished.", "condition_status": "Partly verified", "status_reason": "The stored summary’s information is linked to its unverified scope. External verification and clinical content review remain incomplete; this does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Report-specific surgery, pre-existing arrhythmia, age, risk, eligibility/exclusions and applicability to other operations remain unverified.", "uncertainty": "Gaps in study-specific surgical populations, oral doses, background drugs, event definitions, allocation/analysis denominators, prespecified plans, support and harms remain. Conflicting results and nonsignificance are not converted into established prevention, a precise null effect, equivalence or overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report-specific surgery, pre-existing arrhythmia, age, risk, eligibility/exclusions and applicability to other operations remain unverified." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Are oral and IV formulations distinguished?", "needed": "Oral ascorbic acid; formulation/components; IV kept separate", "role": "Required", "role_reason": "Material on Oral ascorbic acid; formulation/components; IV kept separate is needed to connect the selected oral prevention question to its surgical population, formulation, dosing, background drugs, comparison, events, surveillance window, denominator, precision and harms.", "application_exception": "Oral and intravenous or mixed routes, allocation and completer/event denominators, and placebo versus add-on prophylaxis remain separate. Other routes’ doses, rounded rates, hospital stay, commentary or registry status do not substitute for oral effects, event counts, publication retraction or overall safety; no new effects, intervals, incidence rates, cumulative doses or individual dosing guidance are created.", "criterion": "Original records on Oral ascorbic acid; formulation/components; IV kept separate must link to the same oral route, surgical population, background drugs, comparison, event, time point and analysis population, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish questions, routes, direct comparisons, reports and trials, background prophylaxis, event definitions, denominators, precision and harms.", "condition_origin": "These evidence conditions apply to the existing question of single-ingredient oral vitamin C around cardiac surgery for postoperative atrial fibrillation prevention. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: IV or mixed-route results and product specifications are not transferred to oral formulations. Oral tablet/solution, salt, excipients and manufacturing details remain unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "The information comes from stored oral-trial summaries, bibliography and Korean and English explanations. Original papers, registration, plans and current reading of external material remain separately unverified.", "acquired_read": "Existing Korean and English stored summary, trial records and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The selected route is oral. The original tablet/solution wording and unverified IV salts, buffers and excipients are retained.", "condition_status": "Partly verified", "status_reason": "The stored summary’s information is linked to its unverified scope. External verification and clinical content review remain incomplete; this does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "IV or mixed-route results and product specifications are not transferred to oral formulations. Oral tablet/solution, salt, excipients and manufacturing details remain unverified.", "uncertainty": "Gaps in study-specific surgical populations, oral doses, background drugs, event definitions, allocation/analysis denominators, prespecified plans, support and harms remain. Conflicting results and nonsignificance are not converted into established prevention, a precise null effect, equivalence or overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "IV or mixed-route results and product specifications are not transferred to oral formulations. Oral tablet/solution, salt, excipients and manufacturing details remain unverified." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Are IV doses kept separate from oral reports?", "needed": "Original IV A2/A3 labels; actual dose in each oral report", "role": "Required", "role_reason": "Material on Original IV A2/A3 labels; actual dose in each oral report is needed to connect the selected oral prevention question to its surgical population, formulation, dosing, background drugs, comparison, events, surveillance window, denominator, precision and harms.", "application_exception": "Oral and intravenous or mixed routes, allocation and completer/event denominators, and placebo versus add-on prophylaxis remain separate. Other routes’ doses, rounded rates, hospital stay, commentary or registry status do not substitute for oral effects, event counts, publication retraction or overall safety; no new effects, intervals, incidence rates, cumulative doses or individual dosing guidance are created.", "criterion": "Original records on Original IV A2/A3 labels; actual dose in each oral report must link to the same oral route, surgical population, background drugs, comparison, event, time point and analysis population, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish questions, routes, direct comparisons, reports and trials, background prophylaxis, event definitions, denominators, precision and harms.", "condition_origin": "These evidence conditions apply to the existing question of single-ingredient oral vitamin C around cardiac surgery for postoperative atrial fibrillation prevention. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: The original A2/A3 labels are not automatically mapped to current oral S02/S03 or used as oral doses. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "The information comes from stored oral-trial summaries, bibliography and Korean and English explanations. Original papers, registration, plans and current reading of external material remain separately unverified.", "acquired_read": "Existing Korean and English stored summary, trial records and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original IV 2 g/1 g and other IV 2 g/500 mg schedules are retained. The oral A1 dose remains unverified.", "condition_status": "Partly verified", "status_reason": "The stored summary’s information is linked to its unverified scope. External verification and clinical content review remain incomplete; this does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "The original A2/A3 labels are not automatically mapped to current oral S02/S03 or used as oral doses.", "uncertainty": "Gaps in study-specific surgical populations, oral doses, background drugs, event definitions, allocation/analysis denominators, prespecified plans, support and harms remain. Conflicting results and nonsignificance are not converted into established prevention, a precise null effect, equivalence or overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The original A2/A3 labels are not automatically mapped to current oral S02/S03 or used as oral doses." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "What is the 2023 oral dose and schedule?", "needed": "1 g 2 times daily; 5 days before through 10 days after surgery; actual use/adherence", "role": "Required", "role_reason": "Material on 1 g 2 times daily; 5 days before through 10 days after surgery; actual use/adherence is needed to connect the selected oral prevention question to its surgical population, formulation, dosing, background drugs, comparison, events, surveillance window, denominator, precision and harms.", "application_exception": "Oral and intravenous or mixed routes, allocation and completer/event denominators, and placebo versus add-on prophylaxis remain separate. Other routes’ doses, rounded rates, hospital stay, commentary or registry status do not substitute for oral effects, event counts, publication retraction or overall safety; no new effects, intervals, incidence rates, cumulative doses or individual dosing guidance are created.", "criterion": "Original records on 1 g 2 times daily; 5 days before through 10 days after surgery; actual use/adherence must link to the same oral route, surgical population, background drugs, comparison, event, time point and analysis population, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish questions, routes, direct comparisons, reports and trials, background prophylaxis, event definitions, denominators, precision and harms.", "condition_origin": "These evidence conditions apply to the existing question of single-ingredient oral vitamin C around cardiac surgery for postoperative atrial fibrillation prevention. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: The original general duration of about 5 days is not applied to this report. Cumulative dose, total days and actual adherence are not newly calculated or filled as verified values. This records needed materials; no new research was executed.", "current_reports": [ "S03" ], "existence": "The information comes from stored oral-trial summaries, bibliography and Korean and English explanations. Original papers, registration, plans and current reading of external material remain separately unverified.", "acquired_read": "Existing Korean and English stored summary, trial records and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "S03 records that oral 1 g 2 times daily from 5 days before through 10 days after surgery did not confirm a POAF difference.", "condition_status": "Partly verified", "status_reason": "The stored summary’s information is linked to its unverified scope. External verification and clinical content review remain incomplete; this does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "The original general duration of about 5 days is not applied to this report. Cumulative dose, total days and actual adherence are not newly calculated or filled as verified values.", "uncertainty": "Gaps in study-specific surgical populations, oral doses, background drugs, event definitions, allocation/analysis denominators, prespecified plans, support and harms remain. Conflicting results and nonsignificance are not converted into established prevention, a precise null effect, equivalence or overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The original general duration of about 5 days is not applied to this report. Cumulative dose, total days and actual adherence are not newly calculated or filled as verified values." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Are older oral doses and durations verified?", "needed": "S01/S02 oral doses; perioperative schedules; actual exposure", "role": "Required", "role_reason": "Material on S01/S02 oral doses; perioperative schedules; actual exposure is needed to connect the selected oral prevention question to its surgical population, formulation, dosing, background drugs, comparison, events, surveillance window, denominator, precision and harms.", "application_exception": "Oral and intravenous or mixed routes, allocation and completer/event denominators, and placebo versus add-on prophylaxis remain separate. Other routes’ doses, rounded rates, hospital stay, commentary or registry status do not substitute for oral effects, event counts, publication retraction or overall safety; no new effects, intervals, incidence rates, cumulative doses or individual dosing guidance are created.", "criterion": "Original records on S01/S02 oral doses; perioperative schedules; actual exposure must link to the same oral route, surgical population, background drugs, comparison, event, time point and analysis population, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish questions, routes, direct comparisons, reports and trials, background prophylaxis, event definitions, denominators, precision and harms.", "condition_origin": "These evidence conditions apply to the existing question of single-ingredient oral vitamin C around cardiac surgery for postoperative atrial fibrillation prevention. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Older oral doses and durations are not filled with IV schedules or the S03 dose. Actual adherence and adjustments remain unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information comes from stored oral-trial summaries, bibliography and Korean and English explanations. Original papers, registration, plans and current reading of external material remain separately unverified.", "acquired_read": "Existing Korean and English stored summary, trial records and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "S01’s exact dose and initial allocation remain unverified. S02’s oral C plus beta-blocker exposure is retained.", "condition_status": "Unverified", "status_reason": "The stored summary’s information is linked to its unverified scope. External verification and clinical content review remain incomplete; this does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Older oral doses and durations are not filled with IV schedules or the S03 dose. Actual adherence and adjustments remain unverified.", "uncertainty": "Gaps in study-specific surgical populations, oral doses, background drugs, event definitions, allocation/analysis denominators, prespecified plans, support and harms remain. Conflicting results and nonsignificance are not converted into established prevention, a precise null effect, equivalence or overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Older oral doses and durations are not filled with IV schedules or the S03 dose. Actual adherence and adjustments remain unverified." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Is the effect additional to background prophylaxis?", "needed": "Beta-blocker; amiodarone; common care; changes/rescue", "role": "Required", "role_reason": "Material on Beta-blocker; amiodarone; common care; changes/rescue is needed to connect the selected oral prevention question to its surgical population, formulation, dosing, background drugs, comparison, events, surveillance window, denominator, precision and harms.", "application_exception": "Oral and intravenous or mixed routes, allocation and completer/event denominators, and placebo versus add-on prophylaxis remain separate. Other routes’ doses, rounded rates, hospital stay, commentary or registry status do not substitute for oral effects, event counts, publication retraction or overall safety; no new effects, intervals, incidence rates, cumulative doses or individual dosing guidance are created.", "criterion": "Original records on Beta-blocker; amiodarone; common care; changes/rescue must link to the same oral route, surgical population, background drugs, comparison, event, time point and analysis population, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish questions, routes, direct comparisons, reports and trials, background prophylaxis, event definitions, denominators, precision and harms.", "condition_origin": "These evidence conditions apply to the existing question of single-ingredient oral vitamin C around cardiac surgery for postoperative atrial fibrillation prevention. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Report-specific drug types, doses, amiodarone use, group changes, rescue treatment, balance and correspondence to modern care remain unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "The information comes from stored oral-trial summaries, bibliography and Korean and English explanations. Original papers, registration, plans and current reading of external material remain separately unverified.", "acquired_read": "Existing Korean and English stored summary, trial records and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The existing manuscript concerns oral effects added to background prophylaxis. S02 compares C plus beta-blocker with beta-blocker.", "condition_status": "Partly verified", "status_reason": "The stored summary’s information is linked to its unverified scope. External verification and clinical content review remain incomplete; this does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Report-specific drug types, doses, amiodarone use, group changes, rescue treatment, balance and correspondence to modern care remain unverified.", "uncertainty": "Gaps in study-specific surgical populations, oral doses, background drugs, event definitions, allocation/analysis denominators, prespecified plans, support and harms remain. Conflicting results and nonsignificance are not converted into established prevention, a precise null effect, equivalence or overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report-specific drug types, doses, amiodarone use, group changes, rescue treatment, balance and correspondence to modern care remain unverified." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Are placebo and usual-prophylaxis comparisons distinguished?", "needed": "Placebo components; masking; usual care; comparison direction", "role": "Required", "role_reason": "Material on Placebo components; masking; usual care; comparison direction is needed to connect the selected oral prevention question to its surgical population, formulation, dosing, background drugs, comparison, events, surveillance window, denominator, precision and harms.", "application_exception": "Oral and intravenous or mixed routes, allocation and completer/event denominators, and placebo versus add-on prophylaxis remain separate. Other routes’ doses, rounded rates, hospital stay, commentary or registry status do not substitute for oral effects, event counts, publication retraction or overall safety; no new effects, intervals, incidence rates, cumulative doses or individual dosing guidance are created.", "criterion": "Original records on Placebo components; masking; usual care; comparison direction must link to the same oral route, surgical population, background drugs, comparison, event, time point and analysis population, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish questions, routes, direct comparisons, reports and trials, background prophylaxis, event definitions, denominators, precision and harms.", "condition_origin": "These evidence conditions apply to the existing question of single-ingredient oral vitamin C around cardiac surgery for postoperative atrial fibrillation prevention. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Reports are not all converted into the same placebo comparison. Placebo and control details remain separately unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "The information comes from stored oral-trial summaries, bibliography and Korean and English explanations. Original papers, registration, plans and current reading of external material remain separately unverified.", "acquired_read": "Existing Korean and English stored summary, trial records and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "S01 is a triple-blind oral placebo trial, S02 compares with beta-blocker alone, and S03 is a registered controlled oral trial.", "condition_status": "Partly verified", "status_reason": "The stored summary’s information is linked to its unverified scope. External verification and clinical content review remain incomplete; this does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Reports are not all converted into the same placebo comparison. Placebo and control details remain separately unverified.", "uncertainty": "Gaps in study-specific surgical populations, oral doses, background drugs, event definitions, allocation/analysis denominators, prespecified plans, support and harms remain. Conflicting results and nonsignificance are not converted into established prevention, a precise null effect, equivalence or overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Reports are not all converted into the same placebo comparison. Placebo and control details remain separately unverified." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "How far are allocation, concealment and masking verified?", "needed": "Report-specific sequence generation; concealment; masked parties; baseline balance", "role": "Required", "role_reason": "Material on Report-specific sequence generation; concealment; masked parties; baseline balance is needed to connect the selected oral prevention question to its surgical population, formulation, dosing, background drugs, comparison, events, surveillance window, denominator, precision and harms.", "application_exception": "Oral and intravenous or mixed routes, allocation and completer/event denominators, and placebo versus add-on prophylaxis remain separate. Other routes’ doses, rounded rates, hospital stay, commentary or registry status do not substitute for oral effects, event counts, publication retraction or overall safety; no new effects, intervals, incidence rates, cumulative doses or individual dosing guidance are created.", "criterion": "Original records on Report-specific sequence generation; concealment; masked parties; baseline balance must link to the same oral route, surgical population, background drugs, comparison, event, time point and analysis population, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish questions, routes, direct comparisons, reports and trials, background prophylaxis, event definitions, denominators, precision and harms.", "condition_origin": "These evidence conditions apply to the existing question of single-ingredient oral vitamin C around cardiac surgery for postoperative atrial fibrillation prevention. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Design labels alone do not verify allocation, concealment, maintenance of masking or baseline balance. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "The information comes from stored oral-trial summaries, bibliography and Korean and English explanations. Original papers, registration, plans and current reading of external material remain separately unverified.", "acquired_read": "Existing Korean and English stored summary, trial records and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original descriptions of triple-blind oral placebo, randomized add-on treatment and a registered randomized oral trial are retained.", "condition_status": "Partly verified", "status_reason": "The stored summary’s information is linked to its unverified scope. External verification and clinical content review remain incomplete; this does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Design labels alone do not verify allocation, concealment, maintenance of masking or baseline balance.", "uncertainty": "Gaps in study-specific surgical populations, oral doses, background drugs, event definitions, allocation/analysis denominators, prespecified plans, support and harms remain. Conflicting results and nonsignificance are not converted into established prevention, a precise null effect, equivalence or overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Design labels alone do not verify allocation, concealment, maintenance of masking or baseline balance." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "How were POAF/flutter events defined?", "needed": "New AF/flutter; duration threshold; surveillance method/window; assessment", "role": "Required", "role_reason": "Material on New AF/flutter; duration threshold; surveillance method/window; assessment is needed to connect the selected oral prevention question to its surgical population, formulation, dosing, background drugs, comparison, events, surveillance window, denominator, precision and harms.", "application_exception": "Oral and intravenous or mixed routes, allocation and completer/event denominators, and placebo versus add-on prophylaxis remain separate. Other routes’ doses, rounded rates, hospital stay, commentary or registry status do not substitute for oral effects, event counts, publication retraction or overall safety; no new effects, intervals, incidence rates, cumulative doses or individual dosing guidance are created.", "criterion": "Original records on New AF/flutter; duration threshold; surveillance method/window; assessment must link to the same oral route, surgical population, background drugs, comparison, event, time point and analysis population, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish questions, routes, direct comparisons, reports and trials, background prophylaxis, event definitions, denominators, precision and harms.", "condition_origin": "These evidence conditions apply to the existing question of single-ingredient oral vitamin C around cardiac surgery for postoperative atrial fibrillation prevention. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Report-specific AF/flutter grouping, duration thresholds, continuous/intermittent monitoring, masking, time windows and post-discharge events remain unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "The information comes from stored oral-trial summaries, bibliography and Korean and English explanations. Original papers, registration, plans and current reading of external material remain separately unverified.", "acquired_read": "Existing Korean and English stored summary, trial records and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The selected endpoint is new POAF/flutter, retaining the scope of early inpatient rhythm surveillance.", "condition_status": "Partly verified", "status_reason": "The stored summary’s information is linked to its unverified scope. External verification and clinical content review remain incomplete; this does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Report-specific AF/flutter grouping, duration thresholds, continuous/intermittent monitoring, masking, time windows and post-discharge events remain unverified.", "uncertainty": "Gaps in study-specific surgical populations, oral doses, background drugs, event definitions, allocation/analysis denominators, prespecified plans, support and harms remain. Conflicting results and nonsignificance are not converted into established prevention, a precise null effect, equivalence or overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report-specific AF/flutter grouping, duration thresholds, continuous/intermittent monitoring, masking, time windows and post-discharge events remain unverified." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "What denominators are 185 completers and 89/96?", "needed": "Initial allocation; completion; POAF/analysis; group attrition", "role": "Required", "role_reason": "Material on Initial allocation; completion; POAF/analysis; group attrition is needed to connect the selected oral prevention question to its surgical population, formulation, dosing, background drugs, comparison, events, surveillance window, denominator, precision and harms.", "application_exception": "Oral and intravenous or mixed routes, allocation and completer/event denominators, and placebo versus add-on prophylaxis remain separate. Other routes’ doses, rounded rates, hospital stay, commentary or registry status do not substitute for oral effects, event counts, publication retraction or overall safety; no new effects, intervals, incidence rates, cumulative doses or individual dosing guidance are created.", "criterion": "Original records on Initial allocation; completion; POAF/analysis; group attrition must link to the same oral route, surgical population, background drugs, comparison, event, time point and analysis population, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish questions, routes, direct comparisons, reports and trials, background prophylaxis, event definitions, denominators, precision and harms.", "condition_origin": "These evidence conditions apply to the existing question of single-ingredient oral vitamin C around cardiac surgery for postoperative atrial fibrillation prevention. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Completer counts are not converted into randomization. Group event and analysis denominators, attrition and missingness remain unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored oral-trial summaries, bibliography and Korean and English explanations. Original papers, registration, plans and current reading of external material remain separately unverified.", "acquired_read": "Existing Korean and English stored summary, trial records and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "S01 records 185 completers(C 89/control 96), with the exact initial randomized denominators unverified.", "condition_status": "Partly verified", "status_reason": "The stored summary’s information is linked to its unverified scope. External verification and clinical content review remain incomplete; this does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Completer counts are not converted into randomization. Group event and analysis denominators, attrition and missingness remain unverified.", "uncertainty": "Gaps in study-specific surgical populations, oral doses, background drugs, event definitions, allocation/analysis denominators, prespecified plans, support and harms remain. Conflicting results and nonsignificance are not converted into established prevention, a precise null effect, equivalence or overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Completer counts are not converted into randomization. Group event and analysis denominators, attrition and missingness remain unverified." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "What does 30.3% versus 30.2% describe?", "needed": "S01 reported rates; P; group events/denominators; interval", "role": "Required", "role_reason": "Material on S01 reported rates; P; group events/denominators; interval is needed to connect the selected oral prevention question to its surgical population, formulation, dosing, background drugs, comparison, events, surveillance window, denominator, precision and harms.", "application_exception": "Oral and intravenous or mixed routes, allocation and completer/event denominators, and placebo versus add-on prophylaxis remain separate. Other routes’ doses, rounded rates, hospital stay, commentary or registry status do not substitute for oral effects, event counts, publication retraction or overall safety; no new effects, intervals, incidence rates, cumulative doses or individual dosing guidance are created.", "criterion": "Original records on S01 reported rates; P; group events/denominators; interval must link to the same oral route, surgical population, background drugs, comparison, event, time point and analysis population, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish questions, routes, direct comparisons, reports and trials, background prophylaxis, event definitions, denominators, precision and harms.", "condition_origin": "These evidence conditions apply to the existing question of single-ingredient oral vitamin C around cardiac surgery for postoperative atrial fibrillation prevention. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Event counts are not back-calculated from rounded rates. Exact95%CI, effects in the randomized population and original testing remain unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored oral-trial summaries, bibliography and Korean and English explanations. Original papers, registration, plans and current reading of external material remain separately unverified.", "acquired_read": "Existing Korean and English stored summary, trial records and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original 30.3% versus 30.2%, P=.985 is retained.", "condition_status": "Partly verified", "status_reason": "The stored summary’s information is linked to its unverified scope. External verification and clinical content review remain incomplete; this does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Event counts are not back-calculated from rounded rates. Exact95%CI, effects in the randomized population and original testing remain unverified.", "uncertainty": "Gaps in study-specific surgical populations, oral doses, background drugs, event definitions, allocation/analysis denominators, prespecified plans, support and harms remain. Conflicting results and nonsignificance are not converted into established prevention, a precise null effect, equivalence or overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Event counts are not back-calculated from rounded rates. Exact95%CI, effects in the randomized population and original testing remain unverified." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "What do the positive and null S02/S03 findings establish?", "needed": "Each event/denominator; effect/CI; prespecified analysis; wording scope", "role": "Required", "role_reason": "Material on Each event/denominator; effect/CI; prespecified analysis; wording scope is needed to connect the selected oral prevention question to its surgical population, formulation, dosing, background drugs, comparison, events, surveillance window, denominator, precision and harms.", "application_exception": "Oral and intravenous or mixed routes, allocation and completer/event denominators, and placebo versus add-on prophylaxis remain separate. Other routes’ doses, rounded rates, hospital stay, commentary or registry status do not substitute for oral effects, event counts, publication retraction or overall safety; no new effects, intervals, incidence rates, cumulative doses or individual dosing guidance are created.", "criterion": "Original records on Each event/denominator; effect/CI; prespecified analysis; wording scope must link to the same oral route, surgical population, background drugs, comparison, event, time point and analysis population, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish questions, routes, direct comparisons, reports and trials, background prophylaxis, event definitions, denominators, precision and harms.", "condition_origin": "These evidence conditions apply to the existing question of single-ingredient oral vitamin C around cardiac surgery for postoperative atrial fibrillation prevention. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Exact event counts, group denominators, effects, P values and CIs are not newly created. Directional wording is not converted into precise estimates. This records needed materials; no new research was executed.", "current_reports": [ "S02", "S03" ], "existence": "The information comes from stored oral-trial summaries, bibliography and Korean and English explanations. Original papers, registration, plans and current reading of external material remain separately unverified.", "acquired_read": "Existing Korean and English stored summary, trial records and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "S02’s older positive oral add-on result and S03’s unconfirmed POAF difference retain their original directions.", "condition_status": "Partly verified", "status_reason": "The stored summary’s information is linked to its unverified scope. External verification and clinical content review remain incomplete; this does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Exact event counts, group denominators, effects, P values and CIs are not newly created. Directional wording is not converted into precise estimates.", "uncertainty": "Gaps in study-specific surgical populations, oral doses, background drugs, event definitions, allocation/analysis denominators, prespecified plans, support and harms remain. Conflicting results and nonsignificance are not converted into established prevention, a precise null effect, equivalence or overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact event counts, group denominators, effects, P values and CIs are not newly created. Directional wording is not converted into precise estimates." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "How were analysis populations, attrition and rescue handled?", "needed": "ITT/PP/completers; missingness; attrition; concurrent changes/adjustment", "role": "Required", "role_reason": "Material on ITT/PP/completers; missingness; attrition; concurrent changes/adjustment is needed to connect the selected oral prevention question to its surgical population, formulation, dosing, background drugs, comparison, events, surveillance window, denominator, precision and harms.", "application_exception": "Oral and intravenous or mixed routes, allocation and completer/event denominators, and placebo versus add-on prophylaxis remain separate. Other routes’ doses, rounded rates, hospital stay, commentary or registry status do not substitute for oral effects, event counts, publication retraction or overall safety; no new effects, intervals, incidence rates, cumulative doses or individual dosing guidance are created.", "criterion": "Original records on ITT/PP/completers; missingness; attrition; concurrent changes/adjustment must link to the same oral route, surgical population, background drugs, comparison, event, time point and analysis population, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish questions, routes, direct comparisons, reports and trials, background prophylaxis, event definitions, denominators, precision and harms.", "condition_origin": "These evidence conditions apply to the existing question of single-ingredient oral vitamin C around cardiac surgery for postoperative atrial fibrillation prevention. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Report-specific ITT/PP, reasons for missingness/attrition, rescue, adjustment and sensitivity analyses remain unverified. Total sample sizes do not fill analysis denominators. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "The information comes from stored oral-trial summaries, bibliography and Korean and English explanations. Original papers, registration, plans and current reading of external material remain separately unverified.", "acquired_read": "Existing Korean and English stored summary, trial records and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original records of S01 completers, S02’s 100 participants and S03’s 253 participants are retained.", "condition_status": "Unverified", "status_reason": "The stored summary’s information is linked to its unverified scope. External verification and clinical content review remain incomplete; this does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Report-specific ITT/PP, reasons for missingness/attrition, rescue, adjustment and sensitivity analyses remain unverified. Total sample sizes do not fill analysis denominators.", "uncertainty": "Gaps in study-specific surgical populations, oral doses, background drugs, event definitions, allocation/analysis denominators, prespecified plans, support and harms remain. Conflicting results and nonsignificance are not converted into established prevention, a precise null effect, equivalence or overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report-specific ITT/PP, reasons for missingness/attrition, rescue, adjustment and sensitivity analyses remain unverified. Total sample sizes do not fill analysis denominators." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "What is the scope of nonsignificance and sample-size criticism?", "needed": "Original CI; important effect; sample-size plan; target/details of criticism", "role": "Required", "role_reason": "Material on Original CI; important effect; sample-size plan; target/details of criticism is needed to connect the selected oral prevention question to its surgical population, formulation, dosing, background drugs, comparison, events, surveillance window, denominator, precision and harms.", "application_exception": "Oral and intravenous or mixed routes, allocation and completer/event denominators, and placebo versus add-on prophylaxis remain separate. Other routes’ doses, rounded rates, hospital stay, commentary or registry status do not substitute for oral effects, event counts, publication retraction or overall safety; no new effects, intervals, incidence rates, cumulative doses or individual dosing guidance are created.", "criterion": "Original records on Original CI; important effect; sample-size plan; target/details of criticism must link to the same oral route, surgical population, background drugs, comparison, event, time point and analysis population, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish questions, routes, direct comparisons, reports and trials, background prophylaxis, event definitions, denominators, precision and harms.", "condition_origin": "These evidence conditions apply to the existing question of single-ingredient oral vitamin C around cardiac surgery for postoperative atrial fibrillation prevention. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: The target, bibliography and calculation details of the criticism are not linked in this summary. No current reading of the commentary or recalculation was performed. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "The information comes from stored oral-trial summaries, bibliography and Korean and English explanations. Original papers, registration, plans and current reading of external material remain separately unverified.", "acquired_read": "Existing Korean and English stored summary, trial records and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The existing manuscript states that a null P value does not establish exactly 0 effect and limits the interpretation that a trial with sample-size criticism excluded a small effect.", "condition_status": "Unverified", "status_reason": "The stored summary’s information is linked to its unverified scope. External verification and clinical content review remain incomplete; this does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "The target, bibliography and calculation details of the criticism are not linked in this summary. No current reading of the commentary or recalculation was performed.", "uncertainty": "Gaps in study-specific surgical populations, oral doses, background drugs, event definitions, allocation/analysis denominators, prespecified plans, support and harms remain. Conflicting results and nonsignificance are not converted into established prevention, a precise null effect, equivalence or overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The target, bibliography and calculation details of the criticism are not linked in this summary. No current reading of the commentary or recalculation was performed." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Are registration, prespecified endpoints and SAPs verified?", "needed": "Registration; change history; endpoint/time-point/analysis hierarchy", "role": "Required", "role_reason": "Material on Registration; change history; endpoint/time-point/analysis hierarchy is needed to connect the selected oral prevention question to its surgical population, formulation, dosing, background drugs, comparison, events, surveillance window, denominator, precision and harms.", "application_exception": "Oral and intravenous or mixed routes, allocation and completer/event denominators, and placebo versus add-on prophylaxis remain separate. Other routes’ doses, rounded rates, hospital stay, commentary or registry status do not substitute for oral effects, event counts, publication retraction or overall safety; no new effects, intervals, incidence rates, cumulative doses or individual dosing guidance are created.", "criterion": "Original records on Registration; change history; endpoint/time-point/analysis hierarchy must link to the same oral route, surgical population, background drugs, comparison, event, time point and analysis population, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish questions, routes, direct comparisons, reports and trials, background prophylaxis, event definitions, denominators, precision and harms.", "condition_origin": "These evidence conditions apply to the existing question of single-ingredient oral vitamin C around cardiac surgery for postoperative atrial fibrillation prevention. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: An identifier alone does not verify endpoint prespecification or agreement with plans. Registration, protocols and SAPs are currently unread. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "The information comes from stored oral-trial summaries, bibliography and Korean and English explanations. Original papers, registration, plans and current reading of external material remain separately unverified.", "acquired_read": "Existing Korean and English stored summary, trial records and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "S01/S02 registration remains unverified; S03’s NCT03592680 is retained.", "condition_status": "Unverified", "status_reason": "The stored summary’s information is linked to its unverified scope. External verification and clinical content review remain incomplete; this does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "An identifier alone does not verify endpoint prespecification or agreement with plans. Registration, protocols and SAPs are currently unread.", "uncertainty": "Gaps in study-specific surgical populations, oral doses, background drugs, event definitions, allocation/analysis denominators, prespecified plans, support and harms remain. Conflicting results and nonsignificance are not converted into established prevention, a precise null effect, equivalence or overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "An identifier alone does not verify endpoint prespecification or agreement with plans. Registration, protocols and SAPs are currently unread." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Are commentary, withdrawn registration and publication retraction distinguished?", "needed": "Event type; target identity; original material; historical search scope", "role": "Required", "role_reason": "Material on Event type; target identity; original material; historical search scope is needed to connect the selected oral prevention question to its surgical population, formulation, dosing, background drugs, comparison, events, surveillance window, denominator, precision and harms.", "application_exception": "Oral and intravenous or mixed routes, allocation and completer/event denominators, and placebo versus add-on prophylaxis remain separate. Other routes’ doses, rounded rates, hospital stay, commentary or registry status do not substitute for oral effects, event counts, publication retraction or overall safety; no new effects, intervals, incidence rates, cumulative doses or individual dosing guidance are created.", "criterion": "Original records on Event type; target identity; original material; historical search scope must link to the same oral route, surgical population, background drugs, comparison, event, time point and analysis population, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish questions, routes, direct comparisons, reports and trials, background prophylaxis, event definitions, denominators, precision and harms.", "condition_origin": "These evidence conditions apply to the existing question of single-ingredient oral vitamin C around cardiac surgery for postoperative atrial fibrillation prevention. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Current integrity of all literature is not guaranteed. Unlinked targets or original material are not newly verified or converted into a claim that everything is problem-free. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "The information comes from stored oral-trial summaries, bibliography and Korean and English explanations. Original papers, registration, plans and current reading of external material remain separately unverified.", "acquired_read": "Existing Korean and English stored summary, trial records and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The existing manuscript states that sample-size criticism is not publication retraction, and a withdrawn trial registration also differs from a retracted publication.", "condition_status": "Partly verified", "status_reason": "The stored summary’s information is linked to its unverified scope. External verification and clinical content review remain incomplete; this does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Current integrity of all literature is not guaranteed. Unlinked targets or original material are not newly verified or converted into a claim that everything is problem-free.", "uncertainty": "Gaps in study-specific surgical populations, oral doses, background drugs, event definitions, allocation/analysis denominators, prespecified plans, support and harms remain. Conflicting results and nonsignificance are not converted into established prevention, a precise null effect, equivalence or overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Current integrity of all literature is not guaranteed. Unlinked targets or original material are not newly verified or converted into a claim that everything is problem-free." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Are conflicting directions retained by their conditions?", "needed": "Oral positive/null findings; surgery; background care; events/baseline risk", "role": "Required", "role_reason": "Material on Oral positive/null findings; surgery; background care; events/baseline risk is needed to connect the selected oral prevention question to its surgical population, formulation, dosing, background drugs, comparison, events, surveillance window, denominator, precision and harms.", "application_exception": "Oral and intravenous or mixed routes, allocation and completer/event denominators, and placebo versus add-on prophylaxis remain separate. Other routes’ doses, rounded rates, hospital stay, commentary or registry status do not substitute for oral effects, event counts, publication retraction or overall safety; no new effects, intervals, incidence rates, cumulative doses or individual dosing guidance are created.", "criterion": "Original records on Oral positive/null findings; surgery; background care; events/baseline risk must link to the same oral route, surgical population, background drugs, comparison, event, time point and analysis population, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish questions, routes, direct comparisons, reports and trials, background prophylaxis, event definitions, denominators, precision and harms.", "condition_origin": "These evidence conditions apply to the existing question of single-ingredient oral vitamin C around cardiac surgery for postoperative atrial fibrillation prevention. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Route, prophylaxis, event and regional differences are not erased, and results are not newly pooled or established as independent replication. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "The information comes from stored oral-trial summaries, bibliography and Korean and English explanations. Original papers, registration, plans and current reading of external material remain separately unverified.", "acquired_read": "Existing Korean and English stored summary, trial records and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Older positive S02 and null S01/S03 are linked together, retaining the original description of inconsistent results.", "condition_status": "Partly verified", "status_reason": "The stored summary’s information is linked to its unverified scope. External verification and clinical content review remain incomplete; this does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Route, prophylaxis, event and regional differences are not erased, and results are not newly pooled or established as independent replication.", "uncertainty": "Gaps in study-specific surgical populations, oral doses, background drugs, event definitions, allocation/analysis denominators, prespecified plans, support and harms remain. Conflicting results and nonsignificance are not converted into established prevention, a precise null effect, equivalence or overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Route, prophylaxis, event and regional differences are not erased, and results are not newly pooled or established as independent replication." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Can findings be generalized across surgery, region, duration and dose?", "needed": "Surgery/region; dose; background drugs; long-term/prespecified subgroup hypotheses", "role": "Required", "role_reason": "Material on Surgery/region; dose; background drugs; long-term/prespecified subgroup hypotheses is needed to connect the selected oral prevention question to its surgical population, formulation, dosing, background drugs, comparison, events, surveillance window, denominator, precision and harms.", "application_exception": "Oral and intravenous or mixed routes, allocation and completer/event denominators, and placebo versus add-on prophylaxis remain separate. Other routes’ doses, rounded rates, hospital stay, commentary or registry status do not substitute for oral effects, event counts, publication retraction or overall safety; no new effects, intervals, incidence rates, cumulative doses or individual dosing guidance are created.", "criterion": "Original records on Surgery/region; dose; background drugs; long-term/prespecified subgroup hypotheses must link to the same oral route, surgical population, background drugs, comparison, event, time point and analysis population, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish questions, routes, direct comparisons, reports and trials, background prophylaxis, event definitions, denominators, precision and harms.", "condition_origin": "These evidence conditions apply to the existing question of single-ingredient oral vitamin C around cardiac surgery for postoperative atrial fibrillation prevention. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Effects across all cardiac operations, other doses, long-term/post-discharge prevention and prespecified subgroups remain unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "The information comes from stored oral-trial summaries, bibliography and Korean and English explanations. Original papers, registration, plans and current reading of external material remain separately unverified.", "acquired_read": "Existing Korean and English stored summary, trial records and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "This mainly concerns short perioperative oral add-on treatment around CABG. The original restriction against extending one region’s positive findings to all patients is retained.", "condition_status": "Unverified", "status_reason": "The stored summary’s information is linked to its unverified scope. External verification and clinical content review remain incomplete; this does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Effects across all cardiac operations, other doses, long-term/post-discharge prevention and prespecified subgroups remain unverified.", "uncertainty": "Gaps in study-specific surgical populations, oral doses, background drugs, event definitions, allocation/analysis denominators, prespecified plans, support and harms remain. Conflicting results and nonsignificance are not converted into established prevention, a precise null effect, equivalence or overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Effects across all cardiac operations, other doses, long-term/post-discharge prevention and prespecified subgroups remain unverified." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Are hospital stay and other clinical outcomes kept separate?", "needed": "POAF; hospital stay; complications; quality of life; other outcome boundaries", "role": "Required", "role_reason": "Material on POAF; hospital stay; complications; quality of life; other outcome boundaries is needed to connect the selected oral prevention question to its surgical population, formulation, dosing, background drugs, comparison, events, surveillance window, denominator, precision and harms.", "application_exception": "Oral and intravenous or mixed routes, allocation and completer/event denominators, and placebo versus add-on prophylaxis remain separate. Other routes’ doses, rounded rates, hospital stay, commentary or registry status do not substitute for oral effects, event counts, publication retraction or overall safety; no new effects, intervals, incidence rates, cumulative doses or individual dosing guidance are created.", "criterion": "Original records on POAF; hospital stay; complications; quality of life; other outcome boundaries must link to the same oral route, surgical population, background drugs, comparison, event, time point and analysis population, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish questions, routes, direct comparisons, reports and trials, background prophylaxis, event definitions, denominators, precision and harms.", "condition_origin": "These evidence conditions apply to the existing question of single-ingredient oral vitamin C around cardiac surgery for postoperative atrial fibrillation prevention. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Separate effects on stroke, death, quality of life or readmission, and treatment of existing AF, do not fill the current POAF question. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "The information comes from stored oral-trial summaries, bibliography and Korean and English explanations. Original papers, registration, plans and current reading of external material remain separately unverified.", "acquired_read": "Existing Korean and English stored summary, trial records and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The existing manuscript does not transfer shorter hospital stay into atrial-fibrillation prevention.", "condition_status": "Partly verified", "status_reason": "The stored summary’s information is linked to its unverified scope. External verification and clinical content review remain incomplete; this does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Separate effects on stroke, death, quality of life or readmission, and treatment of existing AF, do not fill the current POAF question.", "uncertainty": "Gaps in study-specific surgical populations, oral doses, background drugs, event definitions, allocation/analysis denominators, prespecified plans, support and harms remain. Conflicting results and nonsignificance are not converted into established prevention, a precise null effect, equivalence or overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate effects on stroke, death, quality of life or readmission, and treatment of existing AF, do not fill the current POAF question." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "How far are funding, products, authorship and COI verified?", "needed": "Funding; free/product support; employment; patents; original COI material", "role": "Required", "role_reason": "Material on Funding; free/product support; employment; patents; original COI material is needed to connect the selected oral prevention question to its surgical population, formulation, dosing, background drugs, comparison, events, surveillance window, denominator, precision and harms.", "application_exception": "Oral and intravenous or mixed routes, allocation and completer/event denominators, and placebo versus add-on prophylaxis remain separate. Other routes’ doses, rounded rates, hospital stay, commentary or registry status do not substitute for oral effects, event counts, publication retraction or overall safety; no new effects, intervals, incidence rates, cumulative doses or individual dosing guidance are created.", "criterion": "Original records on Funding; free/product support; employment; patents; original COI material must link to the same oral route, surgical population, background drugs, comparison, event, time point and analysis population, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish questions, routes, direct comparisons, reports and trials, background prophylaxis, event definitions, denominators, precision and harms.", "condition_origin": "These evidence conditions apply to the existing question of single-ingredient oral vitamin C around cardiac surgery for postoperative atrial fibrillation prevention. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: The existing I2 and independent cross-check are not inherited as current item-specific verification. Funding, products, employment and COI remain separately unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "The information comes from stored oral-trial summaries, bibliography and Korean and English explanations. Original papers, registration, plans and current reading of external material remain separately unverified.", "acquired_read": "Existing Korean and English stored summary, trial records and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original records retain unverified funding/products/employee authors for S01, unverified funding/manufacturer involvement for S02 and funding/COI requiring recheck for S03.", "condition_status": "Unverified", "status_reason": "The stored summary’s information is linked to its unverified scope. External verification and clinical content review remain incomplete; this does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "The existing I2 and independent cross-check are not inherited as current item-specific verification. Funding, products, employment and COI remain separately unverified.", "uncertainty": "Gaps in study-specific surgical populations, oral doses, background drugs, event definitions, allocation/analysis denominators, prespecified plans, support and harms remain. Conflicting results and nonsignificance are not converted into established prevention, a precise null effect, equivalence or overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The existing I2 and independent cross-check are not inherited as current item-specific verification. Funding, products, employment and COI remain separately unverified." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "What is the actual level of harm collection?", "needed": "Oral C events; collection; discontinuation; exposure/event/time denominators", "role": "Supplementary", "role_reason": "Material on Oral C events; collection; discontinuation; exposure/event/time denominators is needed to connect the selected oral prevention question to its surgical population, formulation, dosing, background drugs, comparison, events, surveillance window, denominator, precision and harms.", "application_exception": "Oral and intravenous or mixed routes, allocation and completer/event denominators, and placebo versus add-on prophylaxis remain separate. Other routes’ doses, rounded rates, hospital stay, commentary or registry status do not substitute for oral effects, event counts, publication retraction or overall safety; no new effects, intervals, incidence rates, cumulative doses or individual dosing guidance are created.", "criterion": "Original records on Oral C events; collection; discontinuation; exposure/event/time denominators must link to the same oral route, surgical population, background drugs, comparison, event, time point and analysis population, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish questions, routes, direct comparisons, reports and trials, background prophylaxis, event definitions, denominators, precision and harms.", "condition_origin": "These evidence conditions apply to the existing question of single-ingredient oral vitamin C around cardiac surgery for postoperative atrial fibrillation prevention. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Group harms, collection, discontinuation and denominators remain unverified. POAF prevention or null results do not determine safety. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "The information comes from stored oral-trial summaries, bibliography and Korean and English explanations. Original papers, registration, plans and current reading of external material remain separately unverified.", "acquired_read": "Existing Korean and English stored summary, trial records and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Existing safety caution, possible gastrointestinal discomfort at high oral doses and limited trial-specific event counts are retained.", "condition_status": "Unverified", "status_reason": "The stored summary’s information is linked to its unverified scope. External verification and clinical content review remain incomplete; this does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Group harms, collection, discontinuation and denominators remain unverified. POAF prevention or null results do not determine safety.", "uncertainty": "Gaps in study-specific surgical populations, oral doses, background drugs, event definitions, allocation/analysis denominators, prespecified plans, support and harms remain. Conflicting results and nonsignificance are not converted into established prevention, a precise null effect, equivalence or overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group harms, collection, discontinuation and denominators remain unverified. POAF prevention or null results do not determine safety." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "What are the surgery, concomitant-treatment, baseline-risk and harm timelines?", "needed": "Surgery/prophylaxis; kidney/stone/iron-overload risk; onset/recovery; alternatives", "role": "Supplementary", "role_reason": "Material on Surgery/prophylaxis; kidney/stone/iron-overload risk; onset/recovery; alternatives is needed to connect the selected oral prevention question to its surgical population, formulation, dosing, background drugs, comparison, events, surveillance window, denominator, precision and harms.", "application_exception": "Oral and intravenous or mixed routes, allocation and completer/event denominators, and placebo versus add-on prophylaxis remain separate. Other routes’ doses, rounded rates, hospital stay, commentary or registry status do not substitute for oral effects, event counts, publication retraction or overall safety; no new effects, intervals, incidence rates, cumulative doses or individual dosing guidance are created.", "criterion": "Original records on Surgery/prophylaxis; kidney/stone/iron-overload risk; onset/recovery; alternatives must link to the same oral route, surgical population, background drugs, comparison, event, time point and analysis population, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish questions, routes, direct comparisons, reports and trials, background prophylaxis, event definitions, denominators, precision and harms.", "condition_origin": "These evidence conditions apply to the existing question of single-ingredient oral vitamin C around cardiac surgery for postoperative atrial fibrillation prevention. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Specific interactions, harm causality, between-group risk, recovery after stopping and re-exposure remain unverified. No new event counts or incidence rates were calculated. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "The information comes from stored oral-trial summaries, bibliography and Korean and English explanations. Original papers, registration, plans and current reading of external material remain separately unverified.", "acquired_read": "Existing Korean and English stored summary, trial records and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The existing oral caution wording is linked to perioperative prophylaxis conditions.", "condition_status": "Unverified", "status_reason": "The stored summary’s information is linked to its unverified scope. External verification and clinical content review remain incomplete; this does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Specific interactions, harm causality, between-group risk, recovery after stopping and re-exposure remain unverified. No new event counts or incidence rates were calculated.", "uncertainty": "Gaps in study-specific surgical populations, oral doses, background drugs, event definitions, allocation/analysis denominators, prespecified plans, support and harms remain. Conflicting results and nonsignificance are not converted into established prevention, a precise null effect, equivalence or overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Specific interactions, harm causality, between-group risk, recovery after stopping and re-exposure remain unverified. No new event counts or incidence rates were calculated." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "What is known about long-term or rare harms and special populations?", "needed": "Long-term/rare events; direct exposure by underlying condition", "role": "Supplementary", "role_reason": "Material on Long-term/rare events; direct exposure by underlying condition is needed to connect the selected oral prevention question to its surgical population, formulation, dosing, background drugs, comparison, events, surveillance window, denominator, precision and harms.", "application_exception": "Oral and intravenous or mixed routes, allocation and completer/event denominators, and placebo versus add-on prophylaxis remain separate. Other routes’ doses, rounded rates, hospital stay, commentary or registry status do not substitute for oral effects, event counts, publication retraction or overall safety; no new effects, intervals, incidence rates, cumulative doses or individual dosing guidance are created.", "criterion": "Original records on Long-term/rare events; direct exposure by underlying condition must link to the same oral route, surgical population, background drugs, comparison, event, time point and analysis population, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish questions, routes, direct comparisons, reports and trials, background prophylaxis, event definitions, denominators, precision and harms.", "condition_origin": "These evidence conditions apply to the existing question of single-ingredient oral vitamin C around cardiac surgery for postoperative atrial fibrillation prevention. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Limited event counts do not establish the absence of long-term or rare harms or safety in every special population. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "The information comes from stored oral-trial summaries, bibliography and Korean and English explanations. Original papers, registration, plans and current reading of external material remain separately unverified.", "acquired_read": "Existing Korean and English stored summary, trial records and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The scope of short perioperative oral studies and the original safety wording is retained.", "condition_status": "Unverified", "status_reason": "The stored summary’s information is linked to its unverified scope. External verification and clinical content review remain incomplete; this does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Limited event counts do not establish the absence of long-term or rare harms or safety in every special population.", "uncertainty": "Gaps in study-specific surgical populations, oral doses, background drugs, event definitions, allocation/analysis denominators, prespecified plans, support and harms remain. Conflicting results and nonsignificance are not converted into established prevention, a precise null effect, equivalence or overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Limited event counts do not establish the absence of long-term or rare harms or safety in every special population." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "What are the original D34, assessment values, dates and empty corrections?", "needed": "Grade/score; assessment values; original evidence date; empty values; historical checks", "role": "Required", "role_reason": "Material on Grade/score; assessment values; original evidence date; empty values; historical checks is needed to connect the selected oral prevention question to its surgical population, formulation, dosing, background drugs, comparison, events, surveillance window, denominator, precision and harms.", "application_exception": "Oral and intravenous or mixed routes, allocation and completer/event denominators, and placebo versus add-on prophylaxis remain separate. Other routes’ doses, rounded rates, hospital stay, commentary or registry status do not substitute for oral effects, event counts, publication retraction or overall safety; no new effects, intervals, incidence rates, cumulative doses or individual dosing guidance are created.", "criterion": "Original records on Grade/score; assessment values; original evidence date; empty values; historical checks must link to the same oral route, surgical population, background drugs, comparison, event, time point and analysis population, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish questions, routes, direct comparisons, reports and trials, background prophylaxis, event definitions, denominators, precision and harms.", "condition_origin": "These evidence conditions apply to the existing question of single-ingredient oral vitamin C around cardiac surgery for postoperative atrial fibrillation prevention. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Historical wording about recent or verified evidence is not inherited as a new search. No new verdict or current literature-integrity certification is made. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "The information comes from stored oral-trial summaries, bibliography and Korean and English explanations. Original papers, registration, plans and current reading of external material remain separately unverified.", "acquired_read": "Existing Korean and English stored summary, trial records and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "D34, original assessment values, historical independent cross-checking, the 2026-09-07 evidence date, empty corrections, detailed claims and additional discussion and existing Korean and English explanations are retained.", "condition_status": "Partly verified", "status_reason": "The stored summary’s information is linked to its unverified scope. External verification and clinical content review remain incomplete; this does not certify fulfilled conditions, efficacy, safety, prespecification or independence.", "missingness": "Historical wording about recent or verified evidence is not inherited as a new search. No new verdict or current literature-integrity certification is made.", "uncertainty": "Gaps in study-specific surgical populations, oral doses, background drugs, event definitions, allocation/analysis denominators, prespecified plans, support and harms remain. Conflicting results and nonsignificance are not converted into established prevention, a precise null effect, equivalence or overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Historical wording about recent or verified evidence is not inherited as a new search. No new verdict or current literature-integrity certification is made." } ], "reports": [ { "report_id": "S01", "title": "Bjordahl et al. 2012 · Oral placebo report", "url": "https://pubmed.ncbi.nlm.nih.gov/23022248/", "report_type": "Triple-blind oral placebo randomized trial", "existence": "The information comes from stored oral-trial summaries, bibliography and Korean and English explanations. Original papers, registration, plans and current reading of external material remain separately unverified.", "acquired_read": "Stored summary read; external materials unread", "study_family": "TF3022-01", "independent_replication": null, "observed_result": "30.3% versus 30.2%, P=.985. Event counts are not back-calculated from rounded rates; 95%CI remains unverified.", "result_level": "185 completers(C 89/control 96). Initial randomized denominators, exact event and analysis denominators, attrition and missing-data handling 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": "PMID23022248 · DOI10.1016/j.amjsurg.2012.03.012. The historical citation’s abstract-check record is retained. Only the stored summary was read here; original papers, registration, protocols and SAPs are unread. Dates for all material slots are the original record’s historical evidence date. Unread external slots retain the same historical date, which is not presented as current external reading." }, { "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": "PMID23022248 · DOI10.1016/j.amjsurg.2012.03.012. The historical citation’s abstract-check record is retained. Only the stored summary was read here; original papers, registration, protocols and SAPs are unread. Dates for all material slots are the original record’s historical evidence date. Unread external slots retain the same historical date, which is not presented as current external reading." }, { "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": "PMID23022248 · DOI10.1016/j.amjsurg.2012.03.012. The historical citation’s abstract-check record is retained. Only the stored summary was read here; original papers, registration, protocols and SAPs are unread. Dates for all material slots are the original record’s historical evidence date. Unread external slots retain the same historical date, which is not presented as current external reading." }, { "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": "PMID23022248 · DOI10.1016/j.amjsurg.2012.03.012. The historical citation’s abstract-check record is retained. Only the stored summary was read here; original papers, registration, protocols and SAPs are unread. Dates for all material slots are the original record’s historical evidence date. Unread external slots retain the same historical date, which is not presented as current external reading." }, { "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": "PMID23022248 · DOI10.1016/j.amjsurg.2012.03.012. The historical citation’s abstract-check record is retained. Only the stored summary was read here; original papers, registration, protocols and SAPs are unread. Dates for all material slots are the original record’s historical evidence date. Unread external slots retain the same historical date, which is not presented as current external reading." }, { "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": "PMID23022248 · DOI10.1016/j.amjsurg.2012.03.012. The historical citation’s abstract-check record is retained. Only the stored summary was read here; original papers, registration, protocols and SAPs are unread. Dates for all material slots are the original record’s historical evidence date. Unread external slots retain the same historical date, which is not presented as current external reading." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/23022248/" } ] }, { "report_id": "S02", "title": "Eslami et al. 2007 · Oral add-on report", "url": "https://pubmed.ncbi.nlm.nih.gov/17948074/", "report_type": "Randomized oral vitamin C plus beta-blocker versus beta-blocker add-on trial", "existence": "The information comes from stored oral-trial summaries, bibliography and Korean and English explanations. Original papers, registration, plans and current reading of external material remain separately unverified.", "acquired_read": "Stored summary read; external materials unread", "study_family": "TF3022-02", "independent_replication": null, "observed_result": "This is an older positive oral add-on result. Modern background-care and registration boundaries remain unverified.", "result_level": "The original record of 100 participants is retained. Group event counts, denominators, effects, intervals and oral dose/duration remain unverified and are not filled with other reports or IV schedules.", "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": "PMID17948074 · PMCIDPMC1995047. Historical citation wording about an independent cross-check does not establish current reading of original material or new independent replication. Oral add-on treatment remains separate from IV-dose labels; exact events, intervals and support remain unverified. Dates for all material slots are the original record’s historical evidence date. Unread external slots retain the same historical date, which is not presented as current external reading." }, { "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": "PMID17948074 · PMCIDPMC1995047. Historical citation wording about an independent cross-check does not establish current reading of original material or new independent replication. Oral add-on treatment remains separate from IV-dose labels; exact events, intervals and support remain unverified. Dates for all material slots are the original record’s historical evidence date. Unread external slots retain the same historical date, which is not presented as current external reading." }, { "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": "PMID17948074 · PMCIDPMC1995047. Historical citation wording about an independent cross-check does not establish current reading of original material or new independent replication. Oral add-on treatment remains separate from IV-dose labels; exact events, intervals and support remain unverified. Dates for all material slots are the original record’s historical evidence date. Unread external slots retain the same historical date, which is not presented as current external reading." }, { "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": "PMID17948074 · PMCIDPMC1995047. Historical citation wording about an independent cross-check does not establish current reading of original material or new independent replication. Oral add-on treatment remains separate from IV-dose labels; exact events, intervals and support remain unverified. Dates for all material slots are the original record’s historical evidence date. Unread external slots retain the same historical date, which is not presented as current external reading." }, { "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": "PMID17948074 · PMCIDPMC1995047. Historical citation wording about an independent cross-check does not establish current reading of original material or new independent replication. Oral add-on treatment remains separate from IV-dose labels; exact events, intervals and support remain unverified. Dates for all material slots are the original record’s historical evidence date. Unread external slots retain the same historical date, which is not presented as current external reading." }, { "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": "PMID17948074 · PMCIDPMC1995047. Historical citation wording about an independent cross-check does not establish current reading of original material or new independent replication. Oral add-on treatment remains separate from IV-dose labels; exact events, intervals and support remain unverified. Dates for all material slots are the original record’s historical evidence date. Unread external slots retain the same historical date, which is not presented as current external reading." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/17948074/" } ] }, { "report_id": "S03", "title": "2023 registered oral trial · Generic title in the stored citation", "url": "https://pubmed.ncbi.nlm.nih.gov/37039967/", "report_type": "Registered randomized controlled oral trial; registry contents and prespecification unverified", "existence": "The information comes from stored oral-trial summaries, bibliography and Korean and English explanations. Original papers, registration, plans and current reading of external material remain separately unverified.", "acquired_read": "Stored summary read; external materials unread", "study_family": "TF3022-03", "independent_replication": null, "observed_result": "Oral 1 g 2 times daily from 5 days before through 10 days after surgery did not confirm a POAF difference.", "result_level": "The original record states 253 participants. Initial allocation, group event counts, denominators, effects, intervals and exact full bibliography remain unverified; registration, plans and funding/COI are currently unread.", "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": "PMID37039967 · Citation registry identifier NCT03592680. The stored citation’s generic title is not converted into full original-report identity verification. The original registration-identity field is empty; the identifier does not establish prespecification, registry/change-history reading or agreement with plans. Historical cross-checking is not current reading. Dates for all material slots are the original record’s historical evidence date. Unread external slots retain the same historical date, which is not presented as current external reading." }, { "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": "PMID37039967 · Citation registry identifier NCT03592680. The stored citation’s generic title is not converted into full original-report identity verification. The original registration-identity field is empty; the identifier does not establish prespecification, registry/change-history reading or agreement with plans. Historical cross-checking is not current reading. Dates for all material slots are the original record’s historical evidence date. Unread external slots retain the same historical date, which is not presented as current external reading." }, { "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": "PMID37039967 · Citation registry identifier NCT03592680. The stored citation’s generic title is not converted into full original-report identity verification. The original registration-identity field is empty; the identifier does not establish prespecification, registry/change-history reading or agreement with plans. Historical cross-checking is not current reading. Dates for all material slots are the original record’s historical evidence date. Unread external slots retain the same historical date, which is not presented as current external reading." }, { "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": "PMID37039967 · Citation registry identifier NCT03592680. The stored citation’s generic title is not converted into full original-report identity verification. The original registration-identity field is empty; the identifier does not establish prespecification, registry/change-history reading or agreement with plans. Historical cross-checking is not current reading. Dates for all material slots are the original record’s historical evidence date. Unread external slots retain the same historical date, which is not presented as current external reading." }, { "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": "PMID37039967 · Citation registry identifier NCT03592680. The stored citation’s generic title is not converted into full original-report identity verification. The original registration-identity field is empty; the identifier does not establish prespecification, registry/change-history reading or agreement with plans. Historical cross-checking is not current reading. Dates for all material slots are the original record’s historical evidence date. Unread external slots retain the same historical date, which is not presented as current external reading." }, { "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": "PMID37039967 · Citation registry identifier NCT03592680. The stored citation’s generic title is not converted into full original-report identity verification. The original registration-identity field is empty; the identifier does not establish prespecification, registry/change-history reading or agreement with plans. Historical cross-checking is not current reading. Dates for all material slots are the original record’s historical evidence date. Unread external slots retain the same historical date, which is not presented as current external reading." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/37039967/" } ] } ], "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": "S01’s 185 completers, S02’s 100 participants and S03’s 253 participants remain separate original records. Allocation, analysis and event denominators, background drugs, schedules and surveillance windows differ or remain unverified; no new participant total, unique trial count or independent-replication total is established." }, "history": [ { "date": "2026-10-22", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 30 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-22" }