{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3114-main", "verdict_number": "3114", "title": "Vitamin B12 (actual chemical form unverified) × Reduction of CIS subjective-fatigue score in adults with IBD-related fatigue", "view_version": "1.0", "view_created_date": "2026-11-06", "criteria_version": "NGM-v3114-ORAL-B12-IBD-CIS8-1.0", "criteria_date": "2026-10-05", "review_date": "2026-10-05", "legacy_evidence_date": "2026-09-16", "review_scope": { "materials_read": "Stored Korean and English manuscripts and case-specific criteria and application records", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Reading the stored summaries is distinguished from not reading external original materials and earlier separate documents; the original assessment, numerical values and unverified information are preserved. No new clinical search, reading of original sources, effect calculation or reassessment was performed.", "date_meaning": "This is the date the stored materials were checked, not the date of an up-to-date clinical literature search." }, "claim_context": { "population": "Age 18–65 years, with IBD-related fatigue interfering with daily activities; the trial criterion of serum B12 ≥150 pmol/L. Not combined with IBS; detailed diagnosis, duration and functional deficiency status unverified", "intervention": "Vitamin B12 as the sole added active ingredient; actual chemical form unverified; oral B12 supplement; tablet, capsule, release form and product unverified; the tablet mentioned in a registry search lead is not confirmed as the actual formulation; oral; distinguished from sublingual, intramuscular, intravenous, intranasal and transdermal administration", "dose": "1000 µg/day; dose at 1 time, number of administrations per day and actual cumulative exposure unverified", "comparator": "Placebo; the aim is identical background management, but common treatments and placebo composition in the original abstract are unverified", "endpoint": "Between-group difference in change/adjusted estimate at 8 weeks for the CIS subjective-fatigue subscale total score (8–56 points, higher scores indicate greater severity); IBD-stratum results and prespecified subscale hierarchy unverified", "duration": "Reported 8 weeks; hierarchy of the preregistered primary time point unverified", "excluded_extensions": "The question was narrowed to subjective fatigue in IBD alone. Hb recovery in B12-deficiency anemia, vitality in healthy people, intranasal administration in ME/CFS and sublingual before-and-after observations in fibromyalgia differ from this claim. The score from the existing B12 assessment was therefore not carried over unchanged. [S01; S10; S11; S17]" }, "requirements": [ { "item_id": "N01", "question_type": "Independent claim", "question": "Has the question of CIS subjective fatigue in IBD been linked as a single unit?", "needed": "Link the original /ko/effect to oral B12 as the sole added therapy versus placebo in adults with IBD, with the reported between-group difference in CIS subjective-fatigue change at 8 weeks, and distinguish other populations and endpoints. Materials needed: the current claim, facets and identity manuscript, and the complete preceding version if the scope changes.", "role": "Required", "role_reason": "This identity criterion prevents the entire ingredient or all fatigue studies from being combined into a single effect.", "application_exception": "Preserve the empty subclaims list as the actual structure. Do not automatically create additional subclaims for the mixed cohort, anemia, vitality or motivation.", "criterion": "Link the original /ko/effect to oral B12 as the sole added therapy versus placebo in adults with IBD, with the reported between-group difference in CIS subjective-fatigue change at 8 weeks, and distinguish other populations and endpoints.", "basis": "M03 §3.1, §3.2.1–3.2.4 principles for clarifying the question; detailed separation rules are internally designed; M03 §3.2.1; detailed population criteria are internally designed; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.4; internally defined boundaries on extension — an individual internal adaptation for the independent claim, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "When a new claim is requested, separate its population, route, comparator, endpoint and time point, and first review the relationship between the original ID and the question.", "current_reports": [ "S01", "S05" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "The assessment concerns reduction of the CIS subjective-fatigue score for IBD-related fatigue. It was linked as a single question comparing oral B12 as the sole added therapy with placebo. The actual subclaims field is an empty list, and no new claim about another endpoint was created.", "condition_status": "Met", "status_reason": "The population, route, comparator and endpoint in the Korean manuscript and facets support this question boundary. This does not mean eligible IBD results have been acquired.", "missingness": "The chemical form and IBD-only results and denominators remain separately unverified.", "uncertainty": "Establishing an independent production unit differs from verifying clinical efficacy.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "The current claim, facets and identity manuscript, and the complete preceding version if the scope changes." }, { "item_id": "N02", "question_type": "Report family", "question": "Has the family relationship between the same reports and the provisional registration been confirmed?", "needed": "Group the S01·S02·S16 abstracts and S03 full-text link into the same report family, and do not count the S04 candidate registration or S05 review requotation as independent replication. Materials needed: article DOI/PMID, original registry record, review table of excluded studies and report linkage table.", "role": "Required", "role_reason": "This is needed to prevent 17 citations from being converted into 17 independent trials or a unique participant count.", "application_exception": "The S04 linkage is provisional. A candidate registration number alone does not confirm the same family or create new results.", "criterion": "Group the S01·S02·S16 abstracts and S03 full-text link into the same report family, and do not count the S04 candidate registration or S05 review requotation as independent replication.", "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is an internal application; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application — an individual internal adaptation for the report family, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "Compare authors, periods, populations and registration identities in the original reports to update the family table, retaining unconfirmed linkages as candidates.", "current_reports": [ "S01", "S02", "S03", "S04", "S05", "S16" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "S01 is the original Scholten2018 abstract, and S02·S16 record republications of the abstract. S03 is the corresponding full-text link, and S04 NL-OMON34980 is a provisional linkage. The S05 record of excluding Scholten2018 is not added as a new IBD trial.", "condition_status": "Partly verified", "status_reason": "TF01 and the level of access to abstract reproductions are preserved, but the record states that family matching through the direct S04 record failed even at that time.", "missingness": "Confirmation of the provisional registry linkage and comparison of the original identities of all related reports remain outstanding.", "uncertainty": "The number of related materials is not the same as the totals of unique studies and unique participants; the latter remain unconfirmed.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Article DOI/PMID, original registry record, review table of excluded studies and report linkage table." }, { "item_id": "N03", "question_type": "Actual reading", "question": "Has reading summaries in this run been distinguished from past access to abstracts and full texts?", "needed": "Link the locations in the source stored summaries read in this run, and separate each external material's current access not attempted, not acquired and not read states from its historical access_level. Materials needed: current input bytes, row-level pointers and records of reading/accessing each original material.", "role": "Required", "role_reason": "This is needed to prevent a current full-text-read badge from being displayed solely on the basis of a URL or a past reading record.", "application_exception": "Past failures for S03·S04·S12 are not failures of a current retry. The separate sealed audit in S17 was also not read in this run.", "criterion": "Link the locations in the source stored summaries read in this run, and separate each external material's current access not attempted, not acquired and not read states from its historical access_level.", "basis": "M04 §4.5–4.6 principles for collecting/selecting materials; separation of access and reading and the hyperlink contract are internally designed; M04 §4.5, §4.6.3; limitations on the current material conversion reflect user-defined scope and internal design — an individual internal adaptation for actual reading, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "For each subsequently permitted actual access event, separately record the material type, attempt result, sections read and date, and distinguish these from summary links.", "current_reports": [ "S01", "S02", "S03", "S04", "S05", "S06", "S07", "S08", "S09", "S10", "S11", "S12", "S13", "S14", "S15", "S16", "S17" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "The current 16 Korean fields, structured evidence and 17 citations were read as retained stored summaries. Access levels such as primary_abstract, PDF/HTML full text and registry search leads are historical records in the existing manuscript. Access to external abstracts, full texts, registrations and official documents was not attempted in this run; none were acquired or read.", "condition_status": "Met", "status_reason": "The local stored summaries actually read were separated from the external materials not read, and the source SHA is not presented as the SHA of an original article/PDF.", "missingness": "Current external original-source bytes, current public availability and reading records for this run are unavailable.", "uncertainty": "The historical access_level is the level reported by the manuscript at that time, not a result of revalidation in this run.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Current input bytes, row-level pointers and records of reading/accessing each original material." }, { "item_id": "N04", "question_type": "Search and correction scope", "question": "Has the absence of verified direct results been limited to the historical search scope?", "needed": "State the evidence cutoff date and the limits of the search and correction checks at that time, without implying that a new search was conducted in this run. Materials needed: original search/access records from that time, title/DOI-specific correction-check records and subsequent update events.", "role": "Required", "role_reason": "This is needed to prevent the lack of verified directly eligible results from being extended to worldwide absence of research or a complete current search.", "application_exception": "An empty corrections field means only that the retained list is empty; it does not prove the absence of all corrections and retractions.", "criterion": "State the evidence cutoff date and the limits of the search and correction checks at that time, without implying that a new search was conducted in this run.", "basis": "M04 §4.5, §4.6.3; limitations on the current material conversion reflect user-defined scope and internal design; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed — an individual internal adaptation for search and correction scope, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "When a new search is authorized, record search strategies, dates, registry/unpublished/correction routes and failures, and compare the existing results as well.", "current_reports": [ "S01", "S05", "S17" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "The original search/access cutoff date is 2026-09-16. evidence_status preserves both the existence of human research and the lack of verified directly eligible results, and records absence_proven=false. The record of finding nothing in a correction search by title/DOI is also not a complete integrity audit. No new search was conducted in this run.", "condition_status": "Met", "status_reason": "Statements of absence were tied to the source cutoff date and search scope, and distinguished from the current review date on which no new lookup occurred.", "missingness": "The separate audit, past search records and access_log.json were not read in this run, and not all subsequent publications/corrections were checked.", "uncertainty": "Distinguish limitations of the recorded search from absolute absence of research.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original search/access records from that time, title/DOI-specific correction-check records and subsequent update events." }, { "item_id": "N05", "question_type": "Directness for the IBD stratum", "question": "Have separate fatigue results and arm-specific analysis denominators for the IBD stratum been verified?", "needed": "Actual separate results and analysis denominators for the IBD stratum are required before they can be used as the target between-group effect; retain the indirectness of mixed-cohort results. Materials needed: IBD-stratum results table, arm-specific denominators, separate analysis plan and the original S05 excluded-studies table.", "role": "Required", "role_reason": "This is needed to prevent results including IBS from being transferred to a causal effect on IBD fatigue with a specified cause.", "application_exception": "Do not delete the mixed-trial results. Unverified IBD-stratum results do not mean an effect of 0, equivalence or absence of all human research.", "criterion": "Actual separate results and analysis denominators for the IBD stratum are required before they can be used as the target between-group effect; retain the indirectness of mixed-cohort results.", "basis": "M03 §3.2.1; detailed population criteria are internally designed; M08 §8.2.2, M15 §15.3.1; internal application — an individual internal adaptation for directness for the IBD stratum, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "First compare the prespecified IBD analysis in the existing trial and the feasibility of separating the original data; in a separate study, prespecify the IBD diagnosis and causes of fatigue.", "current_reports": [ "S01", "S05" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "Scholten2018 analyzed IBS and IBD together. The manuscript records that no between-group estimate for the IBD stratum could be verified in the original abstract, and that the S05 review excluded the same trial because a separate analysis was unavailable.", "condition_status": "Unverified", "status_reason": "Mixed-cohort numerical values are available, but between-group results and analysis denominators for the selected IBD stratum are not linked.", "missingness": "The IBD-stratum difference in change, CI, P and arm-specific analysis denominators are unverified.", "uncertainty": "Exclusion from a review does not mean no effect in IBD.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "IBD-stratum results table, arm-specific denominators, separate analysis plan and the original S05 excluded-studies table." }, { "item_id": "N06", "question_type": "Population selection", "question": "Can age and fatigue criteria and IBD diagnosis/activity be verified?", "needed": "Distinguish the reported age and fatigue interfering with daily activities from actual IBD diagnosis, activity, anemia/mixed causes and duration. Materials needed: inclusion/exclusion table, IBD diagnosis/assessor, Crohn/UC, activity, anemia and fatigue-duration information.", "role": "Required", "role_reason": "This is needed to avoid assuming identical population selection and applicability solely because the same IBD label is used.", "application_exception": "Do not use the fatigue scale's 2-week recall period as the fatigue-duration threshold for entry.", "criterion": "Distinguish the reported age and fatigue interfering with daily activities from actual IBD diagnosis, activity, anemia/mixed causes and duration.", "basis": "M03 §3.2.1; detailed population criteria are internally designed — an individual internal adaptation for population selection, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "Compare the selection table defining IBD type, activity and causes of fatigue, and consider prespecified stratification and representativeness in future comparisons.", "current_reports": [ "S01", "S02", "S03", "S04" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "The related trial is recorded as enrolling IBS/IBD outpatients aged 18–65 years with fatigue interfering with daily activities. IBD diagnostic criteria, assessor, Crohn/UC, activity/remission, fatigue duration and Hb/anemia criteria are null.", "condition_status": "Partly verified", "status_reason": "Age and the fatigue description are preserved, but details of clinical selection for the target IBD population are unverified.", "missingness": "Diagnosis, activity, anemia/other causes and the fatigue-duration threshold are unverified.", "uncertainty": "Without selection details, generalization to all patients with IBD is not possible.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Inclusion/exclusion table, IBD diagnosis/assessor, Crohn/UC, activity, anemia and fatigue-duration information." }, { "item_id": "N07", "question_type": "Baseline B12 status", "question": "Can the serum B12 criterion and functional baseline status both be verified?", "needed": "Verify separately the serum eligibility criterion of ≥150 pmol/L, assay, MMA, homocysteine, holotranscobalamin, folate and anemia status. Materials needed: serum assay, baseline distribution, functional B12/folate, Hb and malabsorption/medication assessment information.", "role": "Required", "role_reason": "This is needed to prevent a single serum criterion from merging deficiency-related fatigue and additional supplementation without deficiency into the same question.", "application_exception": "Meeting the serum criterion does not mean that other functional markers are normal. Hb recovery during treatment of deficiency anemia is a separate endpoint.", "criterion": "Verify separately the serum eligibility criterion of ≥150 pmol/L, assay, MMA, homocysteine, holotranscobalamin, folate and anemia status.", "basis": "M03 §3.2.1; detailed population criteria are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed — an individual internal adaptation for baseline B12 status, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "Compare baseline status separately by test, and prespecify hypotheses about effect modification by status when a new comparison is needed.", "current_reports": [ "S01", "S13" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "The trial's serum B12 eligibility criterion is ≥150 pmol/L. assay, MMA, homocysteine, holotranscobalamin, folate, the Hb/anemia definition and metformin/PPI/malabsorption information are unverified. This criterion alone does not establish functional sufficiency.", "condition_status": "Partly verified", "status_reason": "The serum criterion is verified, but information needed to determine whether fatigue is related to deficiency and to establish functional status is unavailable.", "missingness": "The assay, functional markers and baseline information on anemia/absorption and medications remain outstanding.", "uncertainty": "A measured serum criterion and a clinically sufficient state are not the same information.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Serum assay, baseline distribution, functional B12/folate, Hb and malabsorption/medication assessment information." }, { "item_id": "N08", "question_type": "Molecule and formulation", "question": "Have the actual B12 chemical form, product and single-ingredient composition been verified?", "needed": "Verify the actual chemical form, number of active ingredients, product/manufacturer/batch, physical formulation and release form, and distinguish registry search leads from the formulation actually administered. Materials needed: trial product label/composition, batch, administration manual, protocol and original official registry record.", "role": "Required", "role_reason": "This is needed to prevent different cobalamins or combination products from being treated as the same oral single-agent therapy.", "application_exception": "The absence of named additional ingredients in the original abstract differs from confirmation of a single-ingredient composition in the full text/protocol.", "criterion": "Verify the actual chemical form, number of active ingredients, product/manufacturer/batch, physical formulation and release form, and distinguish registry search leads from the formulation actually administered.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application — an individual internal adaptation for molecule and formulation, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "Compare the product actually administered with planning documents to separate active ingredients, chemical form and formulation, and design comparisons between preparations as a separate question.", "current_reports": [ "S01", "S02", "S03", "S04" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "The manuscript names only B12 as the added active ingredient, but the actual chemical form among cyanocobalamin, methylcobalamin, hydroxocobalamin and adenosylcobalamin is unverified. Product, salt, batch, purity, tablet/capsule and release form are also null; the tablet mentioned in a registry search lead was not confirmed as the actual formulation.", "condition_status": "Unverified", "status_reason": "The selected question's single-ingredient boundary is fixed, but original materials needed to verify the identity of the product actually administered are unavailable.", "missingness": "Chemical form, physical formulation, manufacturer/batch and complete active-ingredient composition are unverified.", "uncertainty": "Efficacy or official warnings for another chemical form cannot automatically be transferred to this preparation's results or incidence.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Trial product label/composition, batch, administration manual, protocol and original official registry record." }, { "item_id": "N09", "question_type": "Route of administration", "question": "Has oral administration been distinguished from results for other routes?", "needed": "Verify the source for the trial's oral route, and preserve sublingual, intranasal, intramuscular/intravenous and transdermal routes as separate exposures. Materials needed: the original abstract's Objective, administration procedures and actual methods in reports of other routes.", "role": "Required", "role_reason": "This is needed to prevent before-and-after fatigue observations with intranasal or sublingual administration from being converted into oral single-agent comparative results.", "application_exception": "Verification of the oral route does not establish the actual product's absorption, bioavailability or equivalence.", "criterion": "Verify the source for the trial's oral route, and preserve sublingual, intranasal, intramuscular/intravenous and transdermal routes as separate exposures.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed — an individual internal adaptation for route of administration, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "Link each report's route to the exposure table, and consider a separate design holding compound, population and endpoint constant only when a comparison between routes is requested.", "current_reports": [ "S01", "S10", "S11" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "actual_trial_fields retains route=oral and cites S01 Objective as its source. The manuscript separates intranasal administration in ME/CFS and sublingual before-and-after observations in fibromyalgia from this oral IBD question.", "condition_status": "Met", "status_reason": "The boundary between the reported oral route and excluded routes was verified. The corresponding original sources were not reread in this run.", "missingness": "Details of oral product administration and absorption data remain separately unverified.", "uncertainty": "A difference in route does not itself provide evidence comparing effect sizes between routes.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "The original abstract's Objective, administration procedures and actual methods in reports of other routes." }, { "item_id": "N10", "question_type": "Dose and exposure", "question": "Have the nominal daily dose and actual intake and frequency been verified?", "needed": "Verify separately the nominal daily dose, dose at 1 time, daily frequency, adherence/cumulative exposure, dietary/additional B12 and loading/maintenance phases. Materials needed: administration/intake records, dose at 1 time/frequency, adherence, diet/fortified foods/additional B12 and loading/maintenance information.", "role": "Required", "role_reason": "This is needed to prevent a nominal dose from being converted into actual intake or an optimal individual dose.", "application_exception": "Preserve the manuscript's existing record of the conversion 1000 µg=1 mg. Do not newly calculate cumulative exposure or a dose-response relationship.", "criterion": "Verify separately the nominal daily dose, dose at 1 time, daily frequency, adherence/cumulative exposure, dietary/additional B12 and loading/maintenance phases.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application — an individual internal adaptation for dose and exposure, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "Compare the existing trial's nominal prescription with intake records, and separate a direct dose-response question into a distinct randomized comparison.", "current_reports": [ "S01", "S03", "S04" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "1000 µg/day and daily are preserved, and the manuscript records this as 1 mg/day. Dose at 1 time, daily frequency, adherence, actual cumulative exposure and diet/fortified foods/additional B12 are unverified. The record that separate loading/maintenance phases were not described in the original abstract also does not prove that there were no such phases.", "condition_status": "Partly verified", "status_reason": "The nominal daily dose is verified, but actual exposure and the intake schedule are not linked.", "missingness": "Dose at 1 time, frequency, adherence, cumulative exposure and concurrent B12 exposure remain outstanding.", "uncertainty": "Reporting a specified dose does not establish an optimal dose or provide individual dosing instructions.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Administration/intake records, dose at 1 time/frequency, adherence, diet/fortified foods/additional B12 and loading/maintenance information." }, { "item_id": "N11", "question_type": "Placebo comparison", "question": "Can placebo composition and matching be verified?", "needed": "Distinguish the report of placebo control from actual placebo ingredients, physical matching and the comparison between assigned groups. Materials needed: placebo composition/manufacturing table, matching to the active preparation, administration procedures and blinding checks.", "role": "Required", "role_reason": "The placebo label alone cannot establish complete verification of active-ingredient differences and sensory blinding.", "application_exception": "Retain the report of double blinding, and do not turn unverified placebo composition into absence of a placebo.", "criterion": "Distinguish the report of placebo control from actual placebo ingredients, physical matching and the comparison between assigned groups.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed; M08 §8.1–8.2.3; internal application — an individual internal adaptation for placebo comparison, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "Compare the composition, appearance and administration of the actual placebo and active preparation to examine what difference the named comparison introduced.", "current_reports": [ "S01", "S02", "S03" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "Placebo control and double blinding are reported. comparator.type is placebo, ingredients is null, and the record states that physical composition was not verified.", "condition_status": "Partly verified", "status_reason": "The comparator's name is verified, but original materials on exact placebo composition and matching are unavailable.", "missingness": "Placebo ingredients, matching of appearance/taste and other properties, and maintenance of blinding after allocation are unverified.", "uncertainty": "Missing composition information alone cannot establish blinding failure or the magnitude of bias in the effect.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Placebo composition/manufacturing table, matching to the active preparation, administration procedures and blinding checks." }, { "item_id": "N12", "question_type": "Background treatment", "question": "Have arm-specific IBD management, concomitant treatments and rescue treatment been verified?", "needed": "Verify common IBD management, concomitant medications/diet, rescue treatment, arm-specific changes and their impact on the effect of interest. Materials needed: arm-specific IBD treatments, doses/changes, diet, rescue treatment, additional active ingredients and adherence records.", "role": "Required", "role_reason": "This is needed to prevent differences in IBD management from being attributed to the contribution of added B12.", "application_exception": "The aim of identical background management differs from verified balance in the actual trial. Do not require every change to be identical.", "criterion": "Verify common IBD management, concomitant medications/diet, rescue treatment, arm-specific changes and their impact on the effect of interest.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application — an individual internal adaptation for background treatment, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "Compare the existing arm-specific management table and analytical handling, and prespecify principles for common management and rescue treatment in subsequent comparisons.", "current_reports": [ "S01", "S03", "S04" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "The target comparison uses placebo with identical background management. However, names/doses of common treatments in the original abstract, background_balance, rescue and adherence are unverified.", "condition_status": "Unverified", "status_reason": "Materials needed to verify treatment differences other than the selected intervention and their analytical handling are unavailable.", "missingness": "IBD medications/diet, rescue/changes, between-arm balance and actual intake are unverified.", "uncertainty": "Missing information does not establish that concomitant treatment was absent or imbalanced.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Arm-specific IBD treatments, doses/changes, diet, rescue treatment, additional active ingredients and adherence records." }, { "item_id": "N13", "question_type": "Observation time point", "question": "Can the 8-week observation, prespecified primary time point and follow-up scope be verified?", "needed": "Separate the 8 weeks of exposure/measurement from the preregistered primary time-point hierarchy, follow-up after discontinuation and sustained effects. Materials needed: visit/exposure schedule, registration history, protocol/SAP time-point hierarchy and follow-up data.", "role": "Required", "role_reason": "This is needed to prevent a reported time point from being converted into the sole prespecified primary time point or a long-term sustained effect.", "application_exception": "Do not impose an arbitrary minimum long-term duration on this 8-week question.", "criterion": "Separate the 8 weeks of exposure/measurement from the preregistered primary time-point hierarchy, follow-up after discontinuation and sustained effects.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M04 §4.6.3; internal application — an individual internal adaptation for observation time point, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "Compare planned visits with reported results, and design separate follow-up after discontinuation only when sustained effects are requested.", "current_reports": [ "S01", "S03", "S04" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "Trial duration and measurement horizon are reported as 8 weeks. prospectively_verified_primary_time=false, and the manuscript also states that 8 weeks has not been verified through registration as the sole primary time point.", "condition_status": "Partly verified", "status_reason": "The reported 8 weeks are verified, but the prespecified primary time-point hierarchy and follow-up scope are unverified.", "missingness": "Planned time points from the registration/protocol/SAP and data on persistence after discontinuation are unavailable.", "uncertainty": "Do not generalize the existence of 8-week results to benefits or safety over a longer period.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Visit/exposure schedule, registration history, protocol/SAP time-point hierarchy and follow-up data." }, { "item_id": "N14", "question_type": "CIS definition", "question": "Have the number of subjective-fatigue items, range and direction been preserved?", "needed": "Clearly link the CIS subjective-fatigue total for 8 items, its range of 8–56 points and the direction in which higher scores indicate greater severity. Materials needed: CIS subjective-fatigue definition, trial questionnaire/scoring rules and results tables by time point.", "role": "Required", "role_reason": "This is needed to prevent changes in total CIS or motivation scores from being converted into subjective-fatigue subscale values.", "application_exception": "Verification of the scale definition does not mean that the actual trial language, version and measurement procedures have also been verified.", "criterion": "Clearly link the CIS subjective-fatigue total for 8 items, its range of 8–56 points and the direction in which higher scores indicate greater severity.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application — an individual internal adaptation for the CIS definition, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "Compare the scale definition with the actual trial questionnaire/results columns to verify that they use the same score unit.", "current_reports": [ "S01", "S06", "S07" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "The manuscript describes CIS subjective fatigue as a total of 8 items ranging from 8–56 points, with higher scores indicating greater severity. actual_trial_fields also preserves item_count=8, range=[8,56], direction=higher_worse.", "condition_status": "Met", "status_reason": "The selected measure's definition and score direction are explicit, and historical verification locations in S06/S07 were linked.", "missingness": "Verification of the language, version and actual questionnaire used in the trial remains separately outstanding.", "uncertainty": "Verification of the definition does not provide the corresponding IBD-stratum effect estimate.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "CIS subjective-fatigue definition, trial questionnaire/scoring rules and results tables by time point." }, { "item_id": "N15", "question_type": "Recall and importance", "question": "Have the 2-week recall period, trial language and important difference in IBD been distinguished?", "needed": "Separate the 2-week recall period from the symptom-duration requirement for entry, and verify the actual language/version and an MCID appropriate to the target between-group estimate. Materials needed: trial language/version, recall instructions and MCID evidence applicable to the between-group effect in IBD.", "role": "Required", "role_reason": "This is needed to prevent thresholds from another disease or scale from being imported to establish the sufficiency or clinical importance of fatigue results.", "application_exception": "Do not turn an unverified MCID into absence of a score definition, or adopt an arbitrary number.", "criterion": "Separate the 2-week recall period from the symptom-duration requirement for entry, and verify the actual language/version and an MCID appropriate to the target between-group estimate.", "basis": "M03 §3.2.1; detailed population criteria are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M15 §15.3.1–15.3.3; internal application — an individual internal adaptation for recall and importance, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "Compare the original questionnaire instructions, and separately review anchor-based evidence of importance appropriate to the population and estimate.", "current_reports": [ "S01", "S06", "S07" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "recall_weeks=2 and recall_is_symptom_duration=false are recorded. trial_language, version and MCID_applicable_to_target_estimator are null. No MCID was imported from another disease or scale.", "condition_status": "Partly verified", "status_reason": "The distinction between recall and the duration requirement for entry is verified, but the actual trial version and target MCID cannot be established.", "missingness": "Trial language/version, symptom duration for entry and the target between-group MCID are unverified.", "uncertainty": "Within-group change or an MCID from another population cannot substitute for the importance of the target between-group effect.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Trial language/version, recall instructions and MCID evidence applicable to the between-group effect in IBD." }, { "item_id": "N16", "question_type": "Endpoint hierarchy", "question": "Has the prespecified hierarchy of CIS fatigue, motivation and other subscales been verified?", "needed": "Distinguish the abstract's designation of fatigue(CIS) as primary from the exact subscale hierarchy, and do not repurpose separate motivation/depression/quality-of-life results. Materials needed: protocol/SAP, results tables by scale and multiplicity/prespecified hierarchy documents.", "role": "Required", "role_reason": "This is needed to prevent selection of a favorable subscale to replace the target subjective-fatigue result.", "application_exception": "Do not delete actual favorable reports for other endpoints because the target fatigue result was nonsignificant; retain their separate attribution.", "criterion": "Distinguish the abstract's designation of fatigue(CIS) as primary from the exact subscale hierarchy, and do not repurpose separate motivation/depression/quality-of-life results.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application — an individual internal adaptation for endpoint hierarchy, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "Compare the prespecified hierarchy with all reported subscales, and separate analyses and interpretations by outcome.", "current_reports": [ "S01", "S03", "S04" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "The original abstract names fatigue(CIS) as primary, but the exact prespecified subscale hierarchy is unverified. The manuscript preserves a favorable result for the separate motivation subscale without repurposing it as a subjective-fatigue effect. Depression, quality of life, vitality, serum B12 and Hb are also excluded endpoints.", "condition_status": "Partly verified", "status_reason": "Boundaries between endpoints are verified, but the prespecified hierarchy, multiplicity and numerical values/denominators for the separate motivation outcome cannot be verified in this retained content.", "missingness": "The prespecified subscale/multiplicity plan and detailed results tables for separate endpoints remain outstanding.", "uncertainty": "Other favorable results do not substitute for a direct effect on the target IBD fatigue.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Protocol/SAP, results tables by scale and multiplicity/prespecified hierarchy documents." }, { "item_id": "N17", "question_type": "Allocation and design", "question": "Have the actual randomized design, sequence and allocation concealment been verified?", "needed": "Verify separately the reported randomized placebo-controlled design and actual sequence generation, allocation concealment and baseline balance. Materials needed: original Methods, allocation/concealment procedures, baseline characteristics and analysis-unit table.", "role": "Required", "role_reason": "This is needed to avoid concluding from the RCT label that allocation-related bias or baseline differences have been resolved.", "application_exception": "Do not arbitrarily mark crossover/cluster considerations as inapplicable or reclassify the study as nonrandomized because design details are unavailable.", "criterion": "Verify separately the reported randomized placebo-controlled design and actual sequence generation, allocation concealment and baseline balance.", "basis": "M08 §8.1–8.2.3; internal application; M03 §3.2.1; detailed population criteria are internally designed — an individual internal adaptation for allocation and design, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "Compare existing allocation documents and the baseline table, and apply only assessment questions appropriate to the design.", "current_reports": [ "S01", "S02", "S03" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "evidence records the original abstract of a randomized placebo-controlled trial. The KO assessment retains both the reports of randomization and double blinding and the unverified sequence and allocation concealment.", "condition_status": "Partly verified", "status_reason": "The design designation is preserved, but materials on the actual sequence, concealment and baseline balance are unavailable.", "missingness": "Sequence generation, concealment, baseline balance and the exact unit of analysis are unverified.", "uncertainty": "This gap alone does not establish the presence, absence or magnitude of bias.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original Methods, allocation/concealment procedures, baseline characteristics and analysis-unit table." }, { "item_id": "N18", "question_type": "Subjective measurement", "question": "Have blinding, the scale and collection conditions for fatigue measurement been verified?", "needed": "Verify participant/assessor blinding, questionnaire collection and between-arm measurement differences as appropriate to the subjective-fatigue endpoint. Materials needed: questionnaire collection procedures, participant/assessor blinding and placebo matching/blinding checks.", "role": "Required", "role_reason": "This is needed to distinguish differences in measurement of subjective outcomes from actual outcome differences.", "application_exception": "Do not treat the double-blind designation as confirmation of fully maintained blinding, or conclude failure solely because details are unverified.", "criterion": "Verify participant/assessor blinding, questionnaire collection and between-arm measurement differences as appropriate to the subjective-fatigue endpoint.", "basis": "M08 Table 8.2.a, M03 §3.2.4; internal application; M08 §8.1–8.2.3; internal application — an individual internal adaptation for subjective measurement, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "Compare questionnaire/visit conditions and actual blinding to review measurement limitations by endpoint.", "current_reports": [ "S01", "S03", "S06", "S07" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "Randomization, double blinding and use of the CIS fatigue subscale are reported. Physical placebo composition, trial language/version and actual assessment procedures are unverified.", "condition_status": "Partly verified", "status_reason": "A design and measure are named, but verification of identical measurement across arms and maintained blinding remains outstanding.", "missingness": "Participant/assessor-specific blinding, questionnaire collection conditions and missing measurements by arm are unverified.", "uncertainty": "The fact that an endpoint is subjective does not itself mean the results are invalid or bias is established.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Questionnaire collection procedures, participant/assessor blinding and placebo matching/blinding checks." }, { "item_id": "N19", "question_type": "Allocation and analysis denominators", "question": "Can arm-specific and IBD-stratum analysis denominators also be verified beyond the total of 95 participants?", "needed": "Link the total included separately from arm-specific randomized/completed/analyzed counts and IBD-stratum denominators. Materials needed: CONSORT flow diagram and tables of arm-specific randomized/completed/analyzed counts and IBS/IBD composition.", "role": "Required", "role_reason": "This is needed to avoid dividing the mixed-cohort total in half or assuming that all were analyzed participants with IBD.", "application_exception": "When denominators are unavailable, do not estimate arm-specific counts; preserve only the descriptive total.", "criterion": "Link the total included separately from arm-specific randomized/completed/analyzed counts and IBD-stratum denominators.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; internal application — an individual internal adaptation for allocation and analysis denominators, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "Link participant flow to denominators in each results table to review differences among randomized, completed and analyzed populations.", "current_reports": [ "S01", "S02", "S03" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "reported_included_total is 95 participants. randomized_by_arm, analysed_by_arm, completed_by_arm, dropout_by_arm and IBD_only are all preserved as [null,null].", "condition_status": "Partly verified", "status_reason": "The mixed-cohort total included is verified, but the target arm-specific analysis denominators are unknown.", "missingness": "Arm-specific randomized, completed, analyzed and dropout counts and IBD-stratum denominators remain outstanding.", "uncertainty": "Do not use the total of 95 participants to create an effect SE, CI, event rate or unique IBD participant count.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "CONSORT flow diagram and tables of arm-specific randomized/completed/analyzed counts and IBS/IBD composition." }, { "item_id": "N20", "question_type": "Missing data and analysis population", "question": "Can ITT/PP, imputation and handling of attrition be verified?", "needed": "Compare reasons for missing data/dropout, ITT/PP, imputation and rescue treatment with the effect of interest in the analysis results. Materials needed: arm-specific dropout reasons, missing-data table, ITT/PP definitions, imputation/SAP and handling of rescue treatment.", "role": "Required", "role_reason": "This is needed to prevent missing denominators from being converted into complete follow-up or an ITT analysis.", "application_exception": "Unverified baseline/analysis details do not mean that there was no attrition in either arm or that bias is established.", "criterion": "Compare reasons for missing data/dropout, ITT/PP, imputation and rescue treatment with the effect of interest in the analysis results.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application — an individual internal adaptation for missing data and analysis population, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "Compare the original participant flow and analysis definitions, and plan a missing-data sensitivity review within the scope of acquired materials.", "current_reports": [ "S01", "S03", "S04" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "ITT_PP, imputation, rescue, adjustment_covariates and model are null. The KO assessment also retains arm-specific denominators, ITT/PP and imputation as unverified.", "condition_status": "Unverified", "status_reason": "The actual analysis population cannot be linked to information on handling missing data/attrition.", "missingness": "Dropout reasons, analysis inclusion principles, imputation, adjustment/rescue handling and baseline fatigue values remain outstanding.", "uncertainty": "Without this information, no new between-group analysis or effect of assignment is reconstructed.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Arm-specific dropout reasons, missing-data table, ITT/PP definitions, imputation/SAP and handling of rescue treatment." }, { "item_id": "N21", "question_type": "Original mixed-cohort values", "question": "Can mixed-cohort change values, the definition of ± and the type of values be verified?", "needed": "Preserve the mixed IBS/IBD change values of −8.1 ±9.5 and −8.3 ±10.6 in their original units, without inferring mean/median or SD/SE. Materials needed: original results table, definition of ±, mean/median, baseline/end/change values and arm-specific denominators.", "role": "Required", "role_reason": "This is needed to prevent the displayed ± from being assumed to be SD and used to create precision or a target IBD effect.", "application_exception": "Retain the original values as the corresponding mixed-cohort changes without deleting them. Do not convert them into absolute baseline/end values or a between-group estimate.", "criterion": "Preserve the mixed IBS/IBD change values of −8.1 ±9.5 and −8.3 ±10.6 in their original units, without inferring mean/median or SD/SE.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application — an individual internal adaptation for original mixed-cohort values, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "Compare numerical column headings, dispersion notation and denominators in the table to verify the type of values. Do not newly calculate statistics without authorization.", "current_reports": [ "S01", "S02", "S16" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "Mixed-cohort changes are recorded as B12 −8.1 ±9.5 and placebo −8.3 ±10.6. plus_minus_type and mean_or_median_label are null. These values were not used as the IBD-stratum effect.", "condition_status": "Partly verified", "status_reason": "The reported original values are preserved, but the statistical definitions of the values and ± are unverified.", "missingness": "Mean/median, whether ± denotes SD/SE, baseline/end values and denominators are unverified.", "uncertainty": "Similar directions do not provide grounds for calculating an effect of 0 or equivalence.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original results table, definition of ±, mean/median, baseline/end/change values and arm-specific denominators." }, { "item_id": "N22", "question_type": "Historical descriptive difference", "question": "Has the existing +0.2-point value been kept from being converted into the target IBD effect?", "needed": "Preserve the manuscript's simple mixed-cohort difference of +0.2 as existing descriptive arithmetic, and distinguish it from the actual adjusted between-group effect and CI. Materials needed: original results table, existing arithmetic record and analysis document specifying the estimand/population/denominators.", "role": "Required", "role_reason": "This is needed to prevent earlier descriptive calculations from being presented as a new calculation in this run or a directly eligible estimate.", "application_exception": "The calculation audit/tools are not executed or separately read in this run. Preserving the original arithmetic value alone does not constitute a claim of reproducibility verification.", "criterion": "Preserve the manuscript's simple mixed-cohort difference of +0.2 as existing descriptive arithmetic, and distinguish it from the actual adjusted between-group effect and CI.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed — an individual internal adaptation for the historical descriptive difference, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "In an authorized subsequent review, compare original values with calculation definitions, and keep the descriptive difference and target estimand in separate columns.", "current_reports": [ "S01", "S17" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "The manuscript and assessment_profile.calculation preserve +0.2 CIS points as a simple mixed-cohort difference. status is descriptive_mixed_cohort_arithmetic_only; n, SD, SE, df and the interval are null, and it is explicitly not a target-population estimator. The calculation was not executed in this run.", "condition_status": "Met", "status_reason": "The population and limitations of the existing descriptive arithmetic were stated, without elevating it to an IBD effect or a new statistical result.", "missingness": "The target IBD estimand is unavailable, and the original arithmetic tools/audit were not checked for reproducibility in this run.", "uncertainty": "The descriptive difference and the authors' estimated adjusted between-group effect cannot be assumed to be the same value.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original results table, existing arithmetic record and analysis document specifying the estimand/population/denominators." }, { "item_id": "N23", "question_type": "CI attribution", "question": "Has the estimate corresponding to the 95% CI −11.65~6.71 been verified?", "needed": "Attach a reported CI to an effect only after verifying its population, estimate, denominators and analysis. Materials needed: CI headings in the original Results/tables, corresponding estimate, group/stratum, model and denominators.", "role": "Required", "role_reason": "This is needed to prevent an unattributed CI from being attached as the interval for the existing +0.2 or the IBD-stratum effect.", "application_exception": "Preserve both the original notation and the unverified attribution, without deleting the CI or calculating a new interval.", "criterion": "Attach a reported CI to an effect only after verifying its population, estimate, denominators and analysis.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M15 §15.3.1–15.3.3; internal application; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed — an individual internal adaptation for CI attribution, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "Compare the original CI sentence and table to verify which estimand the interval concerns, then interpret it in the same units and at the same time point.", "current_reports": [ "S01", "S02", "S03", "S16" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "The manuscript records 95% CI −11.65~6.71, but unassigned_CI_estimand is null. target_CI is also null, and this CI was not attached to the simple mixed-cohort difference of +0.2.", "condition_status": "Unverified", "status_reason": "CI values are present, but the corresponding estimand/analysis/population is unverified, so they cannot be used to judge target precision.", "missingness": "The corresponding estimate, target stratum, denominators, dispersion/model and exact original context of the CI remain outstanding.", "uncertainty": "The presence of numbers differs from having acquired the target CI; a mismatch with the simple difference is not immediately designated as Conflicting information.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "CI headings in the original Results/tables, corresponding estimate, group/stratum, model and denominators." }, { "item_id": "N24", "question_type": "Target effect and precision", "question": "Have the IBD-stratum difference in change, CI and P and their relationship to importance been verified?", "needed": "Link the target IBD stratum's between-group estimate, denominators, CI, P and model, and compare them with applicable evidence of importance. Materials needed: adjusted/unadjusted IBD-stratum difference in change, CI/P, model, denominators and target MCID evidence.", "role": "Required", "role_reason": "This is needed to prevent effect size or sufficiency from being inferred solely from total sample size, nonsignificance or an unattributed CI.", "application_exception": "Do not adopt sample-size/duration thresholds or a new grade while the MCID, model and target values remain unverified.", "criterion": "Link the target IBD stratum's between-group estimate, denominators, CI, P and model, and compare them with applicable evidence of importance.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application — an individual internal adaptation for target effect and precision, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "First fix the target estimand and compare the results table with the analysis plan; review importance/precision only against verified criteria.", "current_reports": [ "S01", "S03", "S04", "S05" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "target_between_group_estimate, target_CI and target_P are null. pooled_exact_P, the model and adjustment covariates are also unverified, and the IBD between-group MCID is null as well. Preserve the original target_estimate=null and 0 directly eligible results unchanged.", "condition_status": "Unverified", "status_reason": "Without the target result and interval, importance and precision cannot be compared.", "missingness": "The IBD-stratum effect/CI/P, denominators, dispersion, analysis definition and target MCID remain outstanding.", "uncertainty": "Unverified data do not constitute a judgment of efficacy/inefficacy, equivalence or the probability of an effect.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Adjusted/unadjusted IBD-stratum difference in change, CI/P, model, denominators and target MCID evidence." }, { "item_id": "N25", "question_type": "Registration and plan", "question": "Have the candidate registration's actual identity and comparison of the plan with results been verified?", "needed": "Record whether the NL-OMON34980 linkage is confirmed and the actual scope of comparison of the protocol/SAP, subscales/time points and analysis plan. Materials needed: original official registry record/version, protocol/SAP and reported results/reasons for changes.", "role": "Required", "role_reason": "This is needed to avoid claiming that a prior plan is verified solely from a registry search lead, or establishing nonregistration from an access failure.", "application_exception": "Do not repurpose the S04 tablet lead or past access failure as the actual formulation or a current access failure.", "criterion": "Record whether the NL-OMON34980 linkage is confirmed and the actual scope of comparison of the protocol/SAP, subscales/time points and analysis plan.", "basis": "M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.5–4.6 principles for collecting/selecting materials; separation of access and reading and the hyperlink contract are internally designed; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is an internal application — an individual internal adaptation for registration and plan, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "Verify dates/versions of existing registration and plans, and compare the original report's subscales, time points and analyses individually.", "current_reports": [ "S01", "S03", "S04" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "S04 is a provisional linkage to NL-OMON34980, and the citation records registry_search_snippet_only. Direct record/PDF access failed at that time. The original trial full text, protocol, SAP and prespecified subscale and time-point hierarchy are unverified in the current input.", "condition_status": "Unverified", "status_reason": "A candidate registration exists, but there is no evidence that the actual plan was read and compared with the report.", "missingness": "Confirmed registry linkage, version history and comparison of planning documents with results remain outstanding.", "uncertainty": "Failure to acquire materials does not establish nonregistration or selective reporting, and access was not retried in this run.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original official registry record/version, protocol/SAP and reported results/reasons for changes." }, { "item_id": "N26", "question_type": "Nonsignificant results", "question": "Has mixed-cohort nonsignificance been kept from being converted into an IBD effect of 0 or equivalence?", "needed": "Retain the report of nonsignificant subjective fatigue in the mixed cohort, while linking limitations concerning the population, exact P/interval and equivalence design. Materials needed: original Results, exact P, interval, test/equivalence margins and IBD-stratum analysis.", "role": "Required", "role_reason": "This is needed to avoid hiding contrary results or establishing no effect solely from nonsignificance.", "application_exception": "Do not convert nonsignificant subjective fatigue into absence of a separate motivation result.", "criterion": "Retain the report of nonsignificant subjective fatigue in the mixed cohort, while linking limitations concerning the population, exact P/interval and equivalence design.", "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application — an individual internal adaptation for nonsignificant results, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "Compare the direction, population and estimand across all relevant results, and examine equivalence questions using a separate design with prespecified margins.", "current_reports": [ "S01", "S02", "S16" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "The original authors reported no significant between-group difference in subjective fatigue in the mixed cohort. This contrary, nonsignificant result is preserved, but the exact pooled P and IBD-stratum results are unverified. Nonsignificance was not interpreted as an IBD effect of 0 or equivalence.", "condition_status": "Met", "status_reason": "The verified contrary report and interpretive limitations were retained together, without newly assessing the target effect.", "missingness": "The exact test, target interval, equivalence margins and target-stratum estimate are unavailable.", "uncertainty": "Statistical nonsignificance and absence of effect/equivalence are different claims.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original Results, exact P, interval, test/equivalence margins and IBD-stratum analysis." }, { "item_id": "N27", "question_type": "Eligible replication", "question": "Can independent replication results for the target IBD fatigue be verified?", "needed": "Distinguish the verified scope of directly eligible results, related families and requotations, without estimating replication or unique participants. Materials needed: eligible IBD comparative results, unique trial/registration family table and distribution of results by time point/analysis.", "role": "Required", "role_reason": "This is needed to prevent 17 materials or multiple reports of a single trial from being converted into independent replication.", "application_exception": "Do not convert the absence of verified eligible results into absence of heterogeneity across all studies or Not applicable for applicability across conditions.", "criterion": "Distinguish the verified scope of directly eligible results, related families and requotations, without estimating replication or unique participants.", "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is an internal application; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application; M04 §4.5, §4.6.3; limitations on the current material conversion reflect user-defined scope and internal design — an individual internal adaptation for eligible replication, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "First compare direct eligibility and family identity, and compare differences in conditions/contrary results only when a new independent result is available.", "current_reports": [ "S01", "S02", "S04", "S05", "S08", "S16" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "The original count of directly eligible results is 0, and existence of human research is true. The KO assessment records replication as unevaluated because eligible results are unavailable. Articles, registration leads and reviews are not independent replications, and the replication axis is null.", "condition_status": "Unverified", "status_reason": "The retained scope lacks a target result set, so independent replication/heterogeneity cannot be compared.", "missingness": "The distribution of directly eligible IBD results by family, confirmed independent identities and the total of unique participants remain outstanding.", "uncertainty": "Here, 0 is the count of verified eligible results, not a worldwide trial count of 0.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Eligible IBD comparative results, unique trial/registration family table and distribution of results by time point/analysis." }, { "item_id": "N28", "question_type": "Combination-product boundary", "question": "Have the favorable combination-product results in S09 been separated from the effect of B12 alone?", "needed": "Retain the favorable fatigue results for the B-vitamin and magnesium combination in their original report context, without repurposing them as the contribution of B12 alone. Materials needed: S09 actual composition, route, population, fatigue scale, arm-specific results/denominators and design documents.", "role": "Required", "role_reason": "This is needed to prevent results from a trial containing other active ingredients from being attributed to single-ingredient efficacy.", "application_exception": "Do not delete favorable indirect results either. Do not fill in doses, denominators or effect estimates absent from the current stored summary by estimation.", "criterion": "Retain the favorable fatigue results for the B-vitamin and magnesium combination in their original report context, without repurposing them as the contribution of B12 alone.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application — an individual internal adaptation for the combination-product boundary, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "Compare original combination-product reports by ingredient/population/scale, and consider comparisons separating ingredients when an individual contribution is the question.", "current_reports": [ "S09" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "The manuscript preserves favorable results from another trial of a B-vitamin and magnesium combination, but does not repurpose them as a fatigue effect of B12 alone. The S09 citation contains only historical verification locations for Abstract, Methods and fatigue results; detailed result values/denominators are absent from this stored summary.", "condition_status": "Met", "status_reason": "Favorable results were retained while explicitly marking the boundary between the combination product and the target single-ingredient question.", "missingness": "S09 composition, population, scale, effect estimates, denominators and the contribution of B12 alone were not retained in detail.", "uncertainty": "Favorable results for a different composition/question do not automatically constitute Conflicting information with the contrary report for the target question.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "S09 actual composition, route, population, fatigue scale, arm-specific results/denominators and design documents." }, { "item_id": "N29", "question_type": "Reviews and requotations", "question": "Can the original-trial linkages and target IBD results in S05/S08 be verified?", "needed": "Link review inclusion/exclusion and requotation identities to the actual original trials, and distinguish the scope of results retained in the current stored summary. Materials needed: review inclusion/exclusion tables, original-trial linkages and each study's population/intervention/endpoint/results.", "role": "Required", "role_reason": "This is needed to prevent the number of review documents from being converted into a count of new independent effect replications.", "application_exception": "Do not create new results or a unique trial count solely from the S08 location record of Section3.6, Table1 Schlichtiger1996 and reference81.", "criterion": "Link review inclusion/exclusion and requotation identities to the actual original trials, and distinguish the scope of results retained in the current stored summary.", "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is an internal application; M04 §4.5–4.6 principles for collecting/selecting materials; separation of access and reading and the hyperlink contract are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application — an individual internal adaptation for reviews and requotations, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "Compare the linkage table between reviews and original reports to group the same trials/requotations, and separately verify only eligible comparisons.", "current_reports": [ "S05", "S08" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "S05 records the exclusion of Scholten2018 because IBS/IBD results were not separated. S08 is a citation containing a historical verification location in a transcription of a systematic review of cognition, depression and fatigue; detailed results/included-trial materials were not separately retained in this stored summary.", "condition_status": "Partly verified", "status_reason": "The S05 exclusion reason is linked to the manuscript, but S08 target eligibility and study-specific results cannot be judged from location records alone.", "missingness": "Actual details of the S08 original review/included trials and whether they address the target oral single-agent IBD comparison remain outstanding.", "uncertainty": "Do not add reviews to their included studies, or describe details not retained as unreported throughout the article.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Review inclusion/exclusion tables, original-trial linkages and each study's population/intervention/endpoint/results." }, { "item_id": "N30", "question_type": "Other fatigue studies", "question": "Have intranasal ME/CFS, sublingual fibromyalgia and protocol materials been separated?", "needed": "Distinguish the different populations, routes and before-and-after observations in S10/S11 and the S12 protocol search identity from the target comparative results. Materials needed: S10/S11 actual populations, administration/analysis and results, and the S12 original protocol and subsequent completed report.", "role": "Required", "role_reason": "This is needed to prevent response observations in other diseases and routes or planning documents from being converted into completed oral IBD RCT results.", "application_exception": "Do not establish the population, product or completed results solely from the S12 search citation. Do not fill in responder counts absent from the current stored summary.", "criterion": "Distinguish the different populations, routes and before-and-after observations in S10/S11 and the S12 protocol search identity from the target comparative results.", "basis": "M03 §3.2.1; detailed population criteria are internally designed; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; internal application — an individual internal adaptation for other fatigue studies, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "Distinguish population, route, controlled/before-and-after comparison and plan/results for each report in an identity table, and review the eligible IBD question separately.", "current_reports": [ "S10", "S11", "S12" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "The manuscript explicitly distinguishes intranasal administration in ME/CFS and sublingual before-and-after observations in fibromyalgia from this claim. S12 is a protocol search citation, and direct full-text access failed at that time. Detailed response values from original materials and S12 completed results were not newly filled in during this run.", "condition_status": "Met", "status_reason": "The scope of documents concerning other populations, routes, before-and-after observations and plans was separated from the target oral IBD between-group results.", "missingness": "Detailed S10/S11 results and the actual S12 plan/completion status were not directly compared in this run.", "uncertainty": "This boundary record is not a new assessment of effects in other diseases.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "S10/S11 actual populations, administration/analysis and results, and the S12 original protocol and subsequent completed report." }, { "item_id": "N31", "question_type": "Mechanisms and clinical extension", "question": "Have serum increases, anemia recovery and vitality been kept from replacing CIS fatigue?", "needed": "Distinguish mechanisms, serum B12, Hb/anemia and vitality/other clinical events from the target patient-reported fatigue score. Materials needed: endpoint-specific definitions/original results and direct comparative materials for the proposed extended clinical question.", "role": "Supplementary; required for extended claims", "role_reason": "This is needed to prevent a metabolic role or correction of anemia from being converted into direct benefit for the target fatigue versus placebo.", "application_exception": "Do not require all event trials for the selected symptom-score question; review them separately when a claim is extended.", "criterion": "Distinguish mechanisms, serum B12, Hb/anemia and vitality/other clinical events from the target patient-reported fatigue score.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.4; internally defined boundaries on extension; M03 §3.1, §3.2.1–3.2.4 principles for clarifying the question; detailed separation rules are internally designed — an individual internal adaptation for mechanisms and clinical extension, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "Separate current fatigue results from other endpoints, and first define a distinct population, comparator and time frame if an event/anemia/vitality question is requested.", "current_reports": [ "S01", "S10", "S11", "S17" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "The manuscript does not use a role in energy metabolism, increased serum B12, correction of anemia or experiences of vitality as substitute evidence for a CIS fatigue effect versus placebo. The patient-reported symptom score in this table is not extended to hospitalization, complications, death or Hb recovery.", "condition_status": "Met", "status_reason": "The boundary between the selected endpoint and other questions was preserved, without creating unverified results for other events.", "missingness": "Direct comparative evidence for extended questions is outside the scope of this review.", "uncertainty": "The symptom score is a patient-reported outcome and is not automatically converted into a biochemical surrogate or hard clinical event.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Endpoint-specific definitions/original results and direct comparative materials for the proposed extended clinical question." }, { "item_id": "N32", "question_type": "Funding and interests", "question": "Has the actual scope of disclosures for funding, product supply and COI been verified?", "needed": "State the actual scope of disclosures and unverified information on funding, product supply, employment/patents and COI. Materials needed: original Funding/COI, product supply, author employment/patents and institutional/trial-family disclosures.", "role": "Supplementary; required for claims of independence", "role_reason": "This is needed to prevent unverified funding from being converted into independent funding or proof of independent replication.", "application_exception": "Do not automatically exclude results because a COI lead exists, or conclude absence of bias because none is available.", "criterion": "State the actual scope of disclosures and unverified information on funding, product supply, employment/patents and COI.", "basis": "Chamgap's internal independence and attribution criteria. The official methods sections used in this pilot do not endorse every detail of this item; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is an internal application — an individual internal adaptation for funding and interests, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "Compare original disclosures with product supply and institutional relationships, record only the verified level, and separate this from replication-family identity.", "current_reports": [ "S01", "S03", "S16" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "Funding sources and product supply are unverified in the manuscript. funding, product_supply, employee_authors and patents are null, and the record states that a publisher-index lead was not treated as a complete COI disclosure.", "condition_status": "Unverified", "status_reason": "Without the actual original disclosures, independence or the level of funding cannot be established.", "missingness": "Complete Funding/COI, product supply, employment/patents and institutional relationships remain outstanding.", "uncertainty": "Unverified information is neither proof of absent funding or independence nor grounds for invalidating results.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original Funding/COI, product supply, author employment/patents and institutional/trial-family disclosures." }, { "item_id": "N33", "question_type": "Trial harms and denominators", "question": "Have arm-specific adverse events, serious adverse events, discontinuations and denominators in the oral trial been verified?", "needed": "Verify separately the oral trial's arm-specific AE/SAE/discontinuations due to adverse events, denominators and collection/follow-up. Materials needed: arm-specific AE/SAE/discontinuation tables, person/event counts, exposure denominators, collection methods and losses to follow-up.", "role": "Supplementary; required for safety questions", "role_reason": "This is needed to avoid establishing absence of events or safety simply because safety events are absent from an efficacy summary.", "application_exception": "Do not extend what could not be verified in the original abstract to nonreporting throughout the full article. Do not delete original efficacy values because of gaps in harms information.", "criterion": "Verify separately the oral trial's arm-specific AE/SAE/discontinuations due to adverse events, denominators and collection/follow-up.", "basis": "M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; detailed distinctions are internally designed; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed — an individual internal adaptation for trial harms and denominators, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "Compare original safety collection with events/persons and denominators, and prespecify systematic collection, discontinuation reasons and losses to follow-up in future comparisons.", "current_reports": [ "S01", "S03" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "actual_trial_fields.safety records 8 weeks and leaves events_by_arm, SAE_by_arm and AE_discontinuations_by_arm all as [null,null]. status explicitly states that these were not reported/unverified in the original abstract, not 0.", "condition_status": "Unverified", "status_reason": "Within the retained original-abstract content read, arm-specific harm and discontinuation counts and denominators cannot be verified.", "missingness": "Event/person counts, AE/SAE, discontinuations, exposure denominators, collection methods and losses to follow-up are unverified.", "uncertainty": "Do not newly calculate or assert 0 events, risk ratios, incidence or long-term safety.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Arm-specific AE/SAE/discontinuation tables, person/event counts, exposure denominators, collection methods and losses to follow-up." }, { "item_id": "N34", "question_type": "UL and general safety", "question": "Has the absence of an established UL for B12 been kept from being converted into an unlimited safety guarantee?", "needed": "Distinguish the scope of official B12 safety/status and medication documents from direct trial harms data. Materials needed: the relevant S13 safety/status/medication sections and direct harms data by exposure and population.", "role": "Supplementary; required for extensions of safety claims", "role_reason": "This is needed to prevent water solubility or the absence of a UL from being converted into safety evidence for a particular high oral dose, population or duration.", "application_exception": "An official-document link or historical reading record does not constitute access to the official original in this run or verification of the trial's event rate.", "criterion": "Distinguish the scope of official B12 safety/status and medication documents from direct trial harms data.", "basis": "M19 §19.1.2–19.2.4; internal application; Chamgap's internal interpretive boundaries. M19 principles are referenced; no official causality tool is implemented — an individual internal adaptation for UL and general safety, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "Compare the scope of judgments in official documents with the direct trial's population, duration and collection methods; consider suitable separate designs for rare and long-term harms.", "current_reports": [ "S13" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "The original safety statement explicitly says that the absence of an established UL is not an unlimited safety guarantee. S13 retains historical full-text HTML verification locations for Health Risks, Medication interactions and B12 status assessment, but was not directly read in this run.", "condition_status": "Met", "status_reason": "The interpretive scope of the absent UL and official documents/trial results were separated. Gaps in direct harms evidence were not erased.", "missingness": "There was no direct comparison of current official-document content, interaction-specific details or target-trial harms data.", "uncertainty": "Official information is not treated as providing incidence for the trial preparation whose chemical form is unverified.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "The relevant S13 safety/status/medication sections and direct harms data by exposure and population." }, { "item_id": "N35", "question_type": "Cobalt and chemical form", "question": "Have the chemical forms covered by the cobalt-sensitivity notice been preserved?", "needed": "Distinguish the official notice concerning hydroxocobalamin and cyanocobalamin from the oral trial whose actual chemical form is unverified. Materials needed: preparations/exposures covered by the S14 official notice, the actual trial chemical form and allergy eligibility/event data.", "role": "Supplementary; required for the relevant scope of harms", "role_reason": "This is needed to prevent a warning for a particular chemical form from being converted into confirmed events or incidence in this trial.", "application_exception": "Do not interpret an unverified chemical form as meaning there is no cobalt sensitivity.", "criterion": "Distinguish the official notice concerning hydroxocobalamin and cyanocobalamin from the oral trial whose actual chemical form is unverified.", "basis": "M19 §19.1.2–19.2.4; internal application; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are internally designed; Chamgap's internal interpretive boundaries. M19 principles are referenced; no official causality tool is implemented; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed — an individual internal adaptation for cobalt and chemical form, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "Compare preparations and exposures in the notice with the trial product to review applicability, and separate allergy/alternative explanations in the harms record.", "current_reports": [ "S14" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "The manuscript links the cobalt-sensitivity notice to hydroxocobalamin and cyanocobalamin. S14 cites the corresponding official drug-safety-update HTML and was not repurposed as incidence in this oral trial with an unverified chemical form.", "condition_status": "Met", "status_reason": "The official notice's chemical-form boundary and the unverified target preparation were preserved together.", "missingness": "The actual trial chemical form and cobalt-allergy eligibility/events were not compared with the current full notice.", "uncertainty": "The existence of a warning is not a judgment of risk magnitude for the target exposure or of individual safety.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Preparations/exposures covered by the S14 official notice, the actual trial chemical form and allergy eligibility/event data." }, { "item_id": "N36", "question_type": "Injection-label boundary", "question": "Have the injectable product's Leber and hypokalemia warnings been separated from oral incidence?", "needed": "Preserve the disease, treatment phase and route in the cyanocobalamin injection label as in the manuscript, without repurposing them as oral-trial harms. Materials needed: S15 label Contraindications/Warnings, the context of testing early in treatment and actual oral-preparation/harms data.", "role": "Supplementary; required for extensions of safety claims", "role_reason": "This is needed to prevent warnings in the context of injections and intensive anemia treatment from being converted into causality/frequency for another oral exposure.", "application_exception": "Do not delete the warnings or add incidence or individual dosing instructions.", "criterion": "Preserve the disease, treatment phase and route in the cyanocobalamin injection label as in the manuscript, without repurposing them as oral-trial harms.", "basis": "M19 §19.1.2–19.2.4; internal application; Chamgap's internal interpretive boundaries. M19 principles are referenced; no official causality tool is implemented; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed — an individual internal adaptation for the injection-label boundary, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "Compare the official label's route, disease and treatment phase with the target exposure to distinguish the scope of harms warnings.", "current_reports": [ "S15" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "Leber optic neuropathy and hypokalemia early in intensive treatment of severe megaloblastic anemia are recorded in the context of the cyanocobalamin injection label accessed for the manuscript. They were not transferred to event rates in the oral trial whose chemical form is unverified.", "condition_status": "Met", "status_reason": "The warnings' route and treatment context were retained and separated from direct harms observations in the target trial.", "missingness": "A current recomparison of the full label and direct event data for the relevant oral exposure are unavailable.", "uncertainty": "The limitation arising from a different route does not discard injection warnings or establish that oral administration is risk-free.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "S15 label Contraindications/Warnings, the context of testing early in treatment and actual oral-preparation/harms data." }, { "item_id": "N37", "question_type": "Extension to longer durations and vulnerable groups", "question": "Are long-term, vulnerable-group and optimal-dose data required for this 8-week fatigue question?", "needed": "Distinguish questions about long-term/rare harms, pregnancy/lactation/children, liver/kidney disease, optimal dose and individual management from the current scope. Materials needed: data on the population/duration/direct dose/follow-up after discontinuation proposed for extension, systematic harms data and separate clinical-question materials.", "role": "Supplementary; required for extended claims", "role_reason": "This is a supplementary boundary to prevent short-term reports in a restricted population from being converted into overall safety and dosing recommendations.", "application_exception": "Do not require every long-term/vulnerable-group/dose study for the reported 8-week fatigue question.", "criterion": "Distinguish questions about long-term/rare harms, pregnancy/lactation/children, liver/kidney disease, optimal dose and individual management from the current scope.", "basis": "M03 §3.2.1–3.2.4; details of dose, persistence and effect modification are internally designed; M19 §19.1.2–19.2.4; internal application; Chamgap's internal interpretive boundaries. M19 principles are referenced; no official causality tool is implemented — an individual internal adaptation for extension to longer durations and vulnerable groups, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "Define a separate population, exposure and follow-up/comparison only when an extended question is requested, and consider suitable observational/comparative designs for rare/long-term harms.", "current_reports": [ "S01", "S13", "S14", "S15" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "The current unit is the reported 8-week CIS fatigue comparison in a restricted adult population. The manuscript does not generalize 8 weeks to the safety of long-term high doses or use in pregnancy/lactation, children or liver/kidney disease, and does not use the study dose as an instruction for individual dosing or treatment changes.", "condition_status": "Does not apply", "status_reason": "This is an applicability exception: long-term/special-population/optimal-dose trials are not imposed as required conditions for the narrow symptom question. It does not indicate that evidence for those extensions has been verified.", "missingness": "Direct materials for extended questions outside the current assessment target are unverified.", "uncertainty": "Does not apply is not a substitute label for external materials not read. The direct safety gap remains in N33.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Data on the population/duration/direct dose/follow-up after discontinuation proposed for extension, systematic harms data and separate clinical-question materials." }, { "item_id": "N38", "question_type": "Original assessment and calculation history", "question": "Have 0 directly eligible results, the existence of human research, ?/null and the legacy gate been separated?", "needed": "Preserve unchanged the original grade/score, factual profile, null downstream axes and record of the legacy nonempirical gate projection, without generating a new status or score. Materials needed: the current original assessment, original scoring inputs/diagnostics, separate gate projection and existing calculation record.", "role": "Required", "role_reason": "This is needed to prevent unverified direct eligibility from being converted into no_human_study=true, or document quality/historical calculations from being inherited as an efficacy score.", "application_exception": "The S17 sealed audit and calculator are not read or executed in this run. Do not fill a null scoring axis with the conceptual symptom P.", "criterion": "Preserve unchanged the original grade/score, factual profile, null downstream axes and record of the legacy nonempirical gate projection, without generating a new status or score.", "basis": "M03 §3.1, §3.2.1–3.2.4 principles for clarifying the question; detailed separation rules are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M04 §4.5, §4.6.3; limitations on the current material conversion reflect user-defined scope and internal design — an individual internal adaptation for original assessment and calculation history, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "When an authorized correction is needed, separate the factual profile, compatibility mapping and calculation event, and preserve before/after values and reasons. No reassessment is performed in this run.", "current_reports": [ "S17" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "The original grade is ? and score is null. no_human_study=false, existence of human research=true, directly eligible results are 0, and downstream axes are null. The manuscript records disclosure of the legacy calculator's diagnostics for the original factual profile and a separate nonempirical gate projection. Neither the history nor the conceptual symptom P was transferred into a score/grade for the new table.", "condition_status": "Met", "status_reason": "The separation of the original assessment from factual/compatibility records was preserved. The calculator/audit was not rerun and the grade was not validated in this run.", "missingness": "The sealed audit's original diagnostics and execution bytes were not directly checked in this run.", "uncertainty": "The original ? is the original assessment symbol, not a material-verification status in the table or a probability of effect.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "The current original assessment, original scoring inputs/diagnostics, separate gate projection and existing calculation record." }, { "item_id": "N39", "question_type": "Operational metadata and updates", "question": "Have original ID/URL, document quality and deployment metadata been distinguished from completion of the current table?", "needed": "Preserve the current canonical/ID and historical operational metadata, and separately record actual completion of content/format/UI/publication and update events. Materials needed: original identity/operational metadata, actual publication records and revision triggers/original-version preservation records.", "role": "Required", "role_reason": "This is needed to prevent document A, past self-review and deployment labels from being converted into clinical certification or completed publication of the current table.", "application_exception": "Do not silently reconcile semantic_code_status and assigned labels, or server_deployed and initial unpublished/null time records, even when they coexist.", "criterion": "Preserve the current canonical/ID and historical operational metadata, and separately record actual completion of content/format/UI/publication and update events.", "basis": "M03 §3.1, §3.2.1–3.2.4 principles for clarifying the question; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limitations on the current material conversion reflect user-defined scope and internal design; M04 §4.5–4.6 principles for collecting/selecting materials; separation of access and reading and the hyperlink contract are internally designed — an individual internal adaptation for operational metadata and updates, not implementation of or certification by an official assessment tool.", "condition_origin": "An individually developed criterion designed with knowledge of the currently retained 3114 content. It is neither blinded nor a new clinical preregistration.", "proposed_research": "When operational facts are updated, compare actual records with original metadata, and distinguish criterion revisions, evidence additions and output/publication events.", "current_reports": [ "S17" ], "existence": "The location of the currently retained stored summary and citation identity are verified; current public availability of the original external/separate document is unverified", "acquired_read": "The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run", "observation": "Link the 3114 ID and current canonical. Original document A and single-assistant self-review are separate from efficacy ?. The original stored summary retains needs_id_assignment alongside assigned, and initial unpublished/first_published_at=null alongside server_deployed=true and deployed_at=2026-09-16. These were not elevated to actual publication of the current table, and original values were not corrected.", "condition_status": "Met", "status_reason": "Different labels in the original metadata were preserved, and current stored-summary production, QA by another author, derived formats, UI and publication were marked as separate stages.", "missingness": "Actual publication/identity records for each event in the original metadata were not directly compared in this run.", "uncertainty": "Original operational labels are not evidence of a clinical conclusion or completed website deployment in this run.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original identity/operational metadata, actual publication records and revision triggers/original-version preservation records." } ], "reports": [ { "report_id": "S01", "title": "Scholten2018 mixed-trial original abstract", "url": "https://pubmed.ncbi.nlm.nih.gov/29460813/", "report_type": "Original trial abstract", "acquired_read": "The retained stored summary was read; access to the corresponding original material was not attempted, and it was not acquired or read in this run", "study_family": "TF01", "independent_replication": false, "observed_result": "Mixed cohort of 95 participants; oral B12 1000 µg/day; CIS fatigue at 8 weeks. Changes of −8.1 ±9.5 and −8.3 ±10.6 and the report of nonsignificance are preserved. The existing +0.2 descriptive difference is not an IBD effect, and the estimate corresponding to the 95% CI −11.65~6.71 is also unverified.", "result_level": "The results/attribution retained in the current source stored summary, or the scope of details not retained, were actually read. This is not current reading of the corresponding original document's full text/abstract.", "materials": [ { "material_type": "Article abstract", "public_status": "Only the manuscript's historical access-level record is preserved; no lookup in this run", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "The retained citation identity is currently verified; the corresponding original material's current public availability/access status is not fully verified. The existing manuscript's verification cutoff date is recorded separately. Actual access dates for individual materials were not retained and are unverified. Access to original materials was not attempted in this run, and they were not acquired or read.", "material_id": "S01-M1", "url": "https://pubmed.ncbi.nlm.nih.gov/29460813/", "parent_url": "https://pubmed.ncbi.nlm.nih.gov/29460813/" }, { "material_type": "Full-text article PDF", "public_status": "Only the manuscript's historical access-level record is preserved; no lookup in this run", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "The retained citation identity is currently verified; the corresponding original material's current public availability/access status is not fully verified. The existing manuscript's verification cutoff date is recorded separately. Actual access dates for individual materials were not retained and are unverified. Access to original materials was not attempted in this run, and they were not acquired or read.", "material_id": "S01-M2", "url": "https://clinicalnutritionespen.com/article/S2405-4577(16)30318-7/pdf", "parent_url": "https://pubmed.ncbi.nlm.nih.gov/29460813/" } ], "links": [ { "label": "Source", "url": "https://pubmed.ncbi.nlm.nih.gov/29460813/" } ] }, { "report_id": "S02", "title": "Scholten2018 institutional republication of the abstract", "url": "https://research.wur.nl/en/publications/surplus-vitamin-bsub12sub-use-does-not-reduce-fatigue-in-patients/", "report_type": "Institutional abstract web page", "acquired_read": "The retained stored summary was read; access to the corresponding original material was not attempted, and it was not acquired or read in this run", "study_family": "TF01", "independent_replication": false, "observed_result": "The citation records the institution's reproduction of the original abstract and verification locations for abstract/journal and DOI metadata. The manuscript summary of the same mixed trial is preserved, but this stored summary contains no separate detailed S02 results text.", "result_level": "The results/attribution retained in the current source stored summary, or the scope of details not retained, were actually read. This is not current reading of the corresponding original document's full text/abstract.", "materials": [ { "material_type": "Institutional article-abstract web page", "public_status": "Only the manuscript's historical access-level record is preserved; no lookup in this run", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "The retained citation identity is currently verified; the corresponding original material's current public availability/access status is not fully verified. The existing manuscript's verification cutoff date is recorded separately. Actual access dates for individual materials were not retained and are unverified. Access to original materials was not attempted in this run, and they were not acquired or read.", "material_id": "S02-M1", "url": "https://research.wur.nl/en/publications/surplus-vitamin-bsub12sub-use-does-not-reduce-fatigue-in-patients/", "parent_url": "https://research.wur.nl/en/publications/surplus-vitamin-bsub12sub-use-does-not-reduce-fatigue-in-patients/" }, { "material_type": "Full-text article PDF", "public_status": "Only the manuscript's historical access-level record is preserved; no lookup in this run", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "The retained citation identity is currently verified; the corresponding original material's current public availability/access status is not fully verified. The existing manuscript's verification cutoff date is recorded separately. Actual access dates for individual materials were not retained and are unverified. Access to original materials was not attempted in this run, and they were not acquired or read.", "material_id": "S02-M2", "url": "https://clinicalnutritionespen.com/article/S2405-4577(16)30318-7/pdf", "parent_url": "https://research.wur.nl/en/publications/surplus-vitamin-bsub12sub-use-does-not-reduce-fatigue-in-patients/" } ], "links": [ { "label": "Source", "url": "https://research.wur.nl/en/publications/surplus-vitamin-bsub12sub-use-does-not-reduce-fatigue-in-patients/" } ] }, { "report_id": "S03", "title": "Scholten2018 publisher full-text link", "url": "https://clinicalnutritionespen.com/article/S2405-4577(16)30318-7/pdf", "report_type": "Publisher PDF link", "acquired_read": "The retained stored summary was read; access to the corresponding original material was not attempted, and it was not acquired or read in this run", "study_family": "TF01", "independent_replication": false, "observed_result": "The publisher PDF/HTML endpoint and inaccessible_full_text remain in the historical citation. This input does not mark original full-text results as separately acquired, and access was not attempted in this run.", "result_level": "The results/attribution retained in the current source stored summary, or the scope of details not retained, were actually read. This is not current reading of the corresponding original document's full text/abstract.", "materials": [ { "material_type": "Full-text article PDF", "public_status": "Only the manuscript's historical access-level record is preserved; no lookup in this run", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "The retained citation identity is currently verified; the corresponding original material's current public availability/access status is not fully verified. The existing manuscript's verification cutoff date is recorded separately. Actual access dates for individual materials were not retained and are unverified. Access to original materials was not attempted in this run, and they were not acquired or read.", "material_id": "S03-M1", "url": "https://clinicalnutritionespen.com/article/S2405-4577(16)30318-7/pdf", "parent_url": "https://clinicalnutritionespen.com/article/S2405-4577(16)30318-7/pdf" } ], "links": [ { "label": "Source", "url": "https://clinicalnutritionespen.com/article/S2405-4577(16)30318-7/pdf" } ] }, { "report_id": "S04", "title": "NL-OMON34980 provisional registration", "url": "https://onderzoekmetmensen.nl/en/trial/34980", "report_type": "Official registration candidate", "acquired_read": "The retained stored summary was read; access to the corresponding original material was not attempted, and it was not acquired or read in this run", "study_family": "TF01_CANDIDATE", "independent_replication": false, "observed_result": "NL-OMON34980 is a candidate linkage, with failure of direct record access recorded at that time. Only search-title/summary leads are available; the tablet lead is not elevated to verification of the actual formulation or a prespecified primary time point.", "result_level": "The results/attribution retained in the current source stored summary, or the scope of details not retained, were actually read. This is not current reading of the corresponding original document's full text/abstract.", "materials": [ { "material_type": "Full original web registry record", "public_status": "Only the manuscript's historical access-level record is preserved; no lookup in this run", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "The retained citation identity is currently verified; the corresponding original material's current public availability/access status is not fully verified. The existing manuscript's verification cutoff date is recorded separately. Actual access dates for individual materials were not retained and are unverified. Access to original materials was not attempted in this run, and they were not acquired or read.", "material_id": "S04-M1", "url": "https://onderzoekmetmensen.nl/en/trial/34980", "parent_url": "https://onderzoekmetmensen.nl/en/trial/34980" } ], "links": [ { "label": "Source", "url": "https://onderzoekmetmensen.nl/en/trial/34980" } ] }, { "report_id": "S05", "title": "Record of Scholten2018 exclusion in the IBD fatigue review", "url": "https://cora.ucc.ie/bitstreams/273f0951-3ac5-4e77-a6e9-5ccaef4b5be1/download", "report_type": "Systematic review PDF", "acquired_read": "The retained stored summary was read; access to the corresponding original material was not attempted, and it was not acquired or read in this run", "study_family": "REVIEW_IBD_FATIGUE", "independent_replication": false, "observed_result": "The manuscript records that the Cochrane review excluded Scholten2018 because IBS/IBD results were not separated. Historical verification locations are the excluded-studies table at printed p67/physical page72(0-index71) and printed p20. This is not a no-effect result for IBD.", "result_level": "The results/attribution retained in the current source stored summary, or the scope of details not retained, were actually read. This is not current reading of the corresponding original document's full text/abstract.", "materials": [ { "material_type": "Full-text systematic review PDF", "public_status": "Only the manuscript's historical access-level record is preserved; no lookup in this run", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "The retained citation identity is currently verified; the corresponding original material's current public availability/access status is not fully verified. The existing manuscript's verification cutoff date is recorded separately. Actual access dates for individual materials were not retained and are unverified. Access to original materials was not attempted in this run, and they were not acquired or read.", "material_id": "S05-M1", "url": "https://cora.ucc.ie/bitstreams/273f0951-3ac5-4e77-a6e9-5ccaef4b5be1/download", "parent_url": "https://cora.ucc.ie/bitstreams/273f0951-3ac5-4e77-a6e9-5ccaef4b5be1/download" } ], "links": [ { "label": "Source", "url": "https://cora.ucc.ie/bitstreams/273f0951-3ac5-4e77-a6e9-5ccaef4b5be1/download" } ] }, { "report_id": "S06", "title": "Article defining CIS fatigue measurement", "url": "https://www.medicaljournals.se/jrm/content/html/10.2340/16501977-1838", "report_type": "Scale-definition article HTML", "acquired_read": "The retained stored summary was read; access to the corresponding original material was not attempted, and it was not acquired or read in this run", "study_family": "MEASUREMENT_CIS", "independent_replication": false, "observed_result": "Linked to S06/S07, the manuscript preserves CIS subjective fatigue as 8 items, 8–56 points, higher scores indicating greater severity, and a 2-week recall period. 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This is not new full-text reading of methods, official implementation or certification in this run." }, { "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": "Hold the outcome and effect of interest fixed, then assess randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Reuse of the actual bytes/SHA of the methods HTML copies retained for 1585 and of historical principles. This is not new full-text reading of methods, official implementation or certification in this run." }, { "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": "Reuse of the actual bytes/SHA of the methods HTML copies retained for 1585 and of historical principles. This is not new full-text reading of methods, official implementation or certification in this run." }, { "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": "Questions about harms may require designs, populations and follow-up different from efficacy questions. Case reports do not establish incidence.", "review_level": "Reuse of the actual bytes/SHA of the methods HTML copies retained for 1585 and of historical principles. This is not new full-text reading of methods, official implementation or certification in this run." } ], "status_dictionary": { "Met": "The criterion's identity, retained attribution and interpretive boundaries have been verified. This does not establish clinical efficacy, safety or official certification.", "Partly verified": "Some facts concerning the criterion are retained, but comparison of required axes/original materials remains outstanding.", "Unverified": "The required values/materials cannot be established within the retained content read. This does not mean 0 studies/effect/events.", "Does not apply": "An extension requirement that does not apply to the required conditions of the current narrow question. It does not mean the materials are verified or substitute for Not read.", "Not applicable": "An extension requirement that does not apply to the required conditions of the current narrow question.", "Not read": "The corresponding original material was not directly read in this run. This is distinguished from actual reading of the local stored summary.", "Not reported": "An information gap limited to the material/section read. This is not a conclusion that the information is absent throughout the original article.", "Inaccessible": "Used only when an actual current failure is recorded; current access not attempted and historical failures are distinguished.", "Conflicting information": "Marked only when an actual discrepancy is linked to the same question/analysis.", "Review incomplete": "Individual review for table production remains outstanding; this is distinguished from Unverified/Not read material statuses." }, "study_overlap": { "state": "TF01 report linkages in the stored record are distinguished. Candidate registry linkages and review requotations were not counted as independent trials. The total unique trial count and total participant count are unverified.", "unique_trial_count": null, "unique_participant_count": null, "reason": "TF01 report linkages in the stored record are distinguished. Candidate registry linkages and review requotations were not counted as independent trials. The total unique trial count and total participant count are unverified." }, "history": [ { "date": "2026-11-06", "kind": "Separation of public-facing display and data", "view_version": "1.0", "change": "Public-facing display and data were prepared from the existing 39 items. No new clinical search, change to verification statuses or scoring was performed." } ], "language": "en", "translation_date": "2026-11-06" }