{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3118-main", "verdict_number": "3118", "title": "Ordinary thiamine (vitamin B1), single-ingredient oral use × Whether usual gait speed improves in older adults with objectively impaired physical function", "view_version": "1.0", "view_created_date": "2026-11-06", "criteria_version": "v3118-ORAL-THIAMINE-USUAL-GAIT-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 stored summaries is distinguished from not reading external source materials or historical separate documents, while preserving the original verdict, numerical values and unverified information. No new clinical search, source reading, 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": "Older adults with objectively documented physical-function impairment; actual age, instrument and cutoff unverified", "intervention": "Single-ingredient ordinary thiamine (vitamin B1); derivatives excluded; ordinary thiamine base, hydrochloride and mononitrate distinguished individually; exact form in a directly eligible study unverified; oral", "dose": "Unverified: no directly eligible comparison selected", "comparator": "Placebo, no added thiamine, or otherwise matched usual care; actual comparator unverified", "endpoint": "Usual/preferred gait speed in m/s; distance, protocol and principal time point unverified", "duration": "Unverified: no directly eligible comparison selected", "excluded_extensions": "The closely related single-ingredient oral thiamine HF trial randomized 24 older adults with heart failure, but no functional-impairment cutoff or usual-gait-speed endpoint was verified. The CKD study that reported improved gait speed used a multicomponent nutritional product, so thiamine's effect cannot be isolated. [S01,S02,S05]" }, "requirements": [ { "item_id": "N01", "question_type": "Claim identity", "question": "Is the distinct boundary of the gait-speed question clear?", "needed": "Precisely link the original /ko/effect to the boundaries of older adults with objective functional impairment, single-ingredient oral thiamine and usual gait speed. Required source materials: The original text and identity fields of the current distinct claim, and the complete previous version if changed.", "role": "Required", "role_reason": "This identity criterion is needed to avoid combining all evidence on the ingredient or related functional studies into a single efficacy claim.", "application_exception": "Do not automatically generate additional gait-speed claims from results for grip strength, fatigue, Barthel/FIM, falls or cardiac measures.", "criterion": "Precisely link the original /ko/effect to the boundaries of older adults with objective functional impairment, single-ingredient oral thiamine and usual gait speed.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules 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 extension boundaries — this is an item-specific adaptation for claim identity, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Break the original question down into population, exposure, comparator, measure and time point, and reconsider its identity only when a new claim arises.", "current_reports": [], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "The verdict concerns whether usual gait speed improves in older adults with objectively impaired physical function. It is framed as a single comparative efficacy question about single-ingredient oral ordinary thiamine. The current stored summary has no subclaims key; neither an empty list nor a subclaim count of 0 is inferred.", "condition_status": "Met", "status_reason": "KO, question identity and facets were read directly to connect this question to the boundaries separating it from other endpoints. This does not verify an eligible study's actual regimen or population cutoff.", "missingness": "A separate subclaims field and a complete actual study identity are absent; study-specific doses and times remain unverified.", "uncertainty": "Using a single table as the production unit is a decision about the retained question boundary, not verification of direct efficacy.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "The original text and identity fields of the current distinct claim, and the complete previous version if changed." }, { "item_id": "N02", "question_type": "Retained search scope", "question": "As of which date and within which search scope are direct results unverified?", "needed": "Distinguish the evidence cutoff, actual review date, whether a search was performed and whether absence was proven. Required source materials: Historical search strategies, periods, database-specific result sets, failure records and authorized updated-search records.", "role": "Required", "role_reason": "This criterion limits the timing and scope of verification conveyed by the term unverified.", "application_exception": "Do not claim that the latest retractions, corrections or unpublished studies have been checked merely by reusing an earlier search.", "criterion": "Distinguish the evidence cutoff, actual review date, whether a search was performed and whether absence was proven.", "basis": "M04 §4.5, §4.6.3; limitations on the current material conversion follow the user-defined scope and internal design; M04 §4.5–4.6 data-collection/selection principles; separation of access from reading and the hyperlink contract are internally designed — this is an item-specific adaptation for retained search scope, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "If an update is authorized, hold the eligibility criteria for the same question fixed, compare the search/selection flow and exclusion reasons, and retain the original record of 0.", "current_reports": [], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "The evidence cutoff is 2026-09-16 and the review date is 2026-10-05. The retained manuscript records that 43 general-web queries were distinguished from unsuccessful native searches. It records 0 directly eligible comparison families within that scope at the time; this does not prove absence, and related human data exist. No new search was performed in this review.", "condition_status": "Met", "status_reason": "The search count and the scope in which direct results were unverified were limited to what the manuscript reported at the time. They were not promoted to a current exhaustive search or a finding of no studies.", "missingness": "Historical search strategies, result sets by date, original native-search failure logs and a current new search were not checked in this review.", "uncertainty": "The recorded 0 is the number of directly eligible comparisons verified within that scope, not the total number of studies worldwide.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Historical search strategies, periods, database-specific result sets, failure records and authorized updated-search records." }, { "item_id": "N03", "question_type": "Reading level", "question": "Was reading the stored summary distinguished from reading the corresponding source material?", "needed": "Reading of the local summary must be consistent with current non-reading of external/historical separate materials and their historical access levels. Required source materials: Each material's original document, version, URL identity, directly read location/date and actually acquired bytes/SHA.", "role": "Required", "role_reason": "This is a required traceability criterion to prevent false reading badges and confusion about report types.", "application_exception": "Not attempting access is not an access failure, and the SHA of the stored source summary is not the SHA of an external PDF or registry document.", "criterion": "Reading of the local summary must be consistent with current non-reading of external/historical separate materials and their historical access levels.", "basis": "M04 §4.5–4.6 data-collection/selection principles; separation of access from reading and the hyperlink contract are internally designed; M04 §4.5, §4.6.3; limitations on the current material conversion follow the user-defined scope and internal design — this is an item-specific adaptation for reading level, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "If access is separately authorized, record attempts, successes, acquisition and reading separately for each document, and compare them with the summary links used in this review.", "current_reports": [ "S01", "S02", "S03", "S04", "S05", "S06", "S07", "S08", "S09", "S10", "S11", "S12", "S13", "S14", "S15", "S16", "S17", "S18", "S19", "S20", "S21" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "The current stored manuscript's 18 KO fields, structured evidence, bibliography and citations were actually read. Historical full-text records for S01/S02/S05/S06, registry shells for S03/S12/S13 and reuse of prior extractions for S14–S19 are distinct. The 19 external materials and historical separate local documents S20/S21 were not directly read or downloaded in this review.", "condition_status": "Met", "status_reason": "The stored summary read in this review was separated, material by material, from the physical type and historical access of the source materials. The existence of a link was not labeled as full-text reading in this review.", "missingness": "The original bytes/SHA and current public availability of the original articles/PDFs, abstracts, registry records and historical separate inputs remain unverified in this review.", "uncertainty": "Historical access_level records describe access at the time; they are not evidence of successful access now, full-text verification or the SHA of an external file.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Each material's original document, version, URL identity, directly read location/date and actually acquired bytes/SHA." }, { "item_id": "N04", "question_type": "Population selection", "question": "Were the criteria for older age and objective functional impairment verified?", "needed": "Verify the definition of objective functional impairment in the question's population and its match to or differences from actual study participants. Required source materials: Eligibility criteria, baseline functional testing, participant flow and actual age/comorbidity tables.", "role": "Required", "role_reason": "This is needed to avoid applying material with an unverified population match as direct efficacy evidence.", "application_exception": "Do not automatically establish objective functional impairment from older age or a diagnosis of heart failure or CKD alone.", "criterion": "Verify the definition of objective functional impairment in the question's population and its match to or differences from actual study participants.", "basis": "M03 §3.2.1; detailed population criteria are internally designed; M08 §8.1–8.2.3; internal application — this is an item-specific adaptation for population selection, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "In a comparative study of older adults with a prespecified functional-impairment instrument and cutoff, compare measurements at selection with the participants actually included.", "current_reports": [ "S01", "S02", "S05" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "The question concerns older adults with objectively documented physical-function impairment, but the actual age range, selection instrument, cutoff and baseline gait speed are null. HF age criteria of 60 years or older and a mean age of 73.4 years, or the CKD criterion of over 65 years, do not by themselves satisfy selection for functional impairment.", "condition_status": "Unverified", "status_reason": "Without actual selection criteria from a directly eligible study, a similar age or disease label cannot substitute for verification of the population.", "missingness": "Actual eligible participants' age, setting, functional-impairment instrument/cutoff, baseline gait speed, comorbidities and cognition.", "uncertainty": "The definition of functional impairment can change applicability within the same older population.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Eligibility criteria, baseline functional testing, participant flow and actual age/comorbidity tables." }, { "item_id": "N05", "question_type": "Baseline nutritional status", "question": "Was selection for deficiency distinguished from selection for functional impairment?", "needed": "Attribute baseline deficiency, functional impairment and measurement markers to their respective populations and analyses. Required source materials: Thiamine-status testing methods, baseline diet/nutrition tables, deficiency criteria and prespecified subgroup plans.", "role": "Supplementary; required for claims of applicability by deficiency status", "role_reason": "This supplementary criterion separates the question boundaries for deficiency management and additional supplementation.", "application_exception": "Selection for deficiency using criteria for a different specimen does not by itself establish eligibility as a population with functional impairment.", "criterion": "Attribute baseline deficiency, functional impairment and measurement markers to their respective populations and analyses.", "basis": "M03 §3.2.1; detailed population criteria are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed — this is an item-specific adaptation for baseline nutritional status, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Measure deficiency status separately in participants with functional impairment, and distinguish results for those requiring correction from those receiving additional supplementation.", "current_reports": [ "S02", "S06", "S14" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "Thiamine markers, deficiency criteria and nutritional status in the directly eligible population remain unverified. HF TPP of 177.6 ± 39.0 nmol/L and exclusion of symptomatic deficiency/severe malnutrition, Ito whole-blood total thiamine <20 ng/mL, and Wilkinson erythrocyte TPP <140 nmol/L concern different populations and measurement criteria.", "condition_status": "Partly verified", "status_reason": "Markers and selection boundaries in indirect materials are retained, but deficiency status in the directly eligible population cannot be established.", "missingness": "Concurrent verification of eligible participants' specimens, assay methods, deficiency cutoffs, baseline diet/nutritional support and functional impairment.", "uncertainty": "These markers/cutoffs cannot be converted into one another, and deficiency correction cannot be combined with additional supplementation in nondeficient people as the same effect.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Thiamine-status testing methods, baseline diet/nutrition tables, deficiency criteria and prespecified subgroup plans." }, { "item_id": "N06", "question_type": "Molecular form and route", "question": "Were the salts and routes of ordinary thiamine accurately distinguished?", "needed": "Link the exact salt, number of active ingredients, formulation and route to the reasons for excluding other forms. Required source materials: Product ingredient lists, manufacturing/batch documents and records of the formulation and route administered in the study.", "role": "Required", "role_reason": "This is needed to avoid incorrectly merging exposure identities and result attribution.", "application_exception": "Retain evidence on derivatives, combinations and injections, but do not promote it to direct results for single-ingredient oral ordinary thiamine.", "criterion": "Link the exact salt, number of active ingredients, formulation and route to the reasons for excluding other forms.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and testing adaptations are internally designed; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed — this is an item-specific adaptation for molecular form and route, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Fix each formulation's identity and extract results for single-active-ingredient oral exposure separately.", "current_reports": [ "S01", "S02", "S10" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "The question concerns single-ingredient oral ordinary thiamine. Base, hydrochloride and mononitrate are distinguished; the actual salt and product in a directly eligible study are null. Do not combine results for HF mononitrate, SmPC hydrochloride, benfotiamine, TTFD, combinations or injections as though they concern a single preparation.", "condition_status": "Partly verified", "status_reason": "The question and excluded forms are clear, but there is no basis for verifying the actual eligible product/salt.", "missingness": "The salt, number of active ingredients, source/product, formulation, route and excipients of a directly eligible preparation.", "uncertainty": "The shared name B1 does not establish equivalence of preparations or routes.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Product ingredient lists, manufacturing/batch documents and records of the formulation and route administered in the study." }, { "item_id": "N07", "question_type": "Dose and schedule", "question": "Were nominal dose, actual dose and thiamine-equivalent amount verified?", "needed": "Distinguish the extent to which the eligible preparation's nominal dose for 1 time/daily dose, actual exposure, equivalent amount and administration schedule have been verified. Required source materials: Administration logs, medication/ingredient documents, count/adherence records and the basis for the stated equivalent amount.", "role": "Required", "role_reason": "This is a required criterion for exposing gaps in dose identity and actual exposure.", "application_exception": "Do not designate another study's nominal dose as the optimal dose or minimum effective dose.", "criterion": "Distinguish the extent to which the eligible preparation's nominal dose for 1 time/daily dose, actual exposure, equivalent amount and administration schedule have been verified.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and testing adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed — this is an item-specific adaptation for dose and schedule, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Record planned doses and actual administered doses separately in a single-ingredient comparison, and examine the relationship between adherence and the analysis population.", "current_reports": [ "S02", "S14" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "The dose for 1 time, daily dose, frequency, meals, adherence and thiamine-equivalent amount in a directly eligible study are all unverified. HF mononitrate at 1 time: 500 mg, per 1 day: 500 mg, and Wilkinson 10 mg/day are retained as the nominal doses in those indirect studies; they are not used as eligible gait-speed doses or personal recommendations.", "condition_status": "Unverified", "status_reason": "There is no direct administration record, and an indirect study's nominal dose cannot fill the actual-dose field for this question.", "missingness": "Exact units, administration schedule, missed doses/adherence, basis for equivalence and meal timing for the eligible exposure.", "uncertainty": "The labeled mass of a salt cannot automatically be converted into free-thiamine equivalents or actual intake.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Administration logs, medication/ingredient documents, count/adherence records and the basis for the stated equivalent amount." }, { "item_id": "N08", "question_type": "Treatment and measurement times", "question": "Were treatment duration and the principal gait-speed measurement time point verified?", "needed": "State separately the actual extent of verification of treatment duration, the principal measurement time point and additional follow-up. Required source materials: Protocol schedule, actual administration/visit dates and the analysis plan for the principal time point.", "role": "Required", "role_reason": "This is needed to prevent automatic substitution of durations and effect-observation times.", "application_exception": "Do not require every form of long-term follow-up for the original question; review long-term maintenance separately if that claim is added.", "criterion": "State separately the actual extent of verification of treatment duration, the principal measurement time point and additional follow-up.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and testing adaptations are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed — this is an item-specific adaptation for treatment and measurement times, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Fix treatment and measurement schedules separately, distinguishing final values, changes and post-discontinuation results in advance.", "current_reports": [ "S02", "S05" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "Directly eligible treatment duration and the principal gait-speed time point are null. HF used 90 days of treatment per period and a 6-week washout; the CKD multicomponent nutritional formula was given for 3 months. Do not fill the target comparison's duration with these periods or extend them to effects maintained after discontinuation.", "condition_status": "Unverified", "status_reason": "Because no eligible comparison was selected, the duration of another exposure does not establish the target regimen.", "missingness": "Eligible treatment start/end, measurement schedule, follow-up after discontinuation and continuity of exposure.", "uncertainty": "The observation time point and treatment duration may differ; a washout is not evidence of maintained effects or of the absence of carryover.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Protocol schedule, actual administration/visit dates and the analysis plan for the principal time point." }, { "item_id": "N09", "question_type": "Comparator and concomitant care", "question": "How did care other than thiamine actually differ?", "needed": "Separate between-arm intervention differences, shared care, deviations/rescue and the effect of interest. Required source materials: Arm-specific concomitant-treatment/change tables, diet and rehabilitation plans, and records of rescue treatment/dropout handling.", "role": "Required", "role_reason": "This criterion prevents attributing the contribution of a multicomponent formula or concomitant treatment to thiamine alone.", "application_exception": "Do not require complete identity of every individual change; verify the actual effect of interest and how changes are handled.", "criterion": "Separate between-arm intervention differences, shared care, deviations/rescue and the effect of interest.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and testing adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application — this is an item-specific adaptation for comparator and concomitant care, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Specify the care shared by the arms, record actual changes and adherence, and link the intervention contrast of interest to the effect analyzed.", "current_reports": [ "S01", "S02", "S05" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "The target comparator is placebo, no added thiamine, or usual care with other treatments matched, but the actual eligible comparison, diet, exercise/rehabilitation and rescue treatment are unverified. Usual heart-failure care in HF and the CKD comparison of multicomponent formula+low-protein diet versus diet alone are their respective indirect contexts.", "condition_status": "Unverified", "status_reason": "Without verification of concomitant care and changes by arm in the direct comparison, differences in other care cannot be separated from thiamine's contribution.", "missingness": "Diet, rehabilitation, medications, nutritional support, rescue treatment, changes and their analytical handling in both eligible arms.", "uncertainty": "The label usual care alone does not guarantee that actual exposures were identical in both arms.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Arm-specific concomitant-treatment/change tables, diet and rehabilitation plans, and records of rescue treatment/dropout handling." }, { "item_id": "N10", "question_type": "Comparative design", "question": "Were allocation, blinding and analysis design for the direct gait-speed comparison verified?", "needed": "Link actual allocation, design and analysis information relevant to the selected result to verified source locations. Required source materials: Original methods, protocol, allocation records, baseline tables and analysis plan.", "role": "Required", "role_reason": "This is needed to distinguish the actual comparative design required for efficacy from design information in indirect studies.", "application_exception": "Retain nonrandomized data as well, but label their design limitations and do not promote them to an RCT of causal efficacy.", "criterion": "Link actual allocation, design and analysis information relevant to the selected result to verified source locations.", "basis": "M08 §8.1–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.1; detailed population criteria are internally designed — this is an item-specific adaptation for comparative design, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Select an eligible comparison first, then examine actual limitations in allocation, measurement, missing data and analysis for each gait-speed result of interest.", "current_reports": [ "S01", "S02" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "The study identity of a directly eligible comparison is unverified; actual allocation, concealment, baseline balance and parallel/crossover design have not been verified. The closely related HF double-blind 2-period crossover trial has different endpoint/population boundaries and does not verify the target comparative design.", "condition_status": "Unverified", "status_reason": "Without the methods of a directly eligible trial, the label of a related RCT alone does not satisfy the target question's requirement for a causal comparison.", "missingness": "Eligible allocation procedures, concealment, parallel/crossover structure, baseline balance and outcome-specific analysis methods.", "uncertainty": "An unverified direct design cannot be relabeled as non-applicability of crossover/cluster criteria or as established bias.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original methods, protocol, allocation records, baseline tables and analysis plan." }, { "item_id": "N11", "question_type": "Gait measurement", "question": "Was the actual testing procedure for usual gait speed verified?", "needed": "Link the actual test conditions required for usual gait speed to the reasons for excluding other functional endpoints. Required source materials: Test SOP, original gait-measurement tables, assessor/device records, protocol and arm-specific implementation information.", "role": "Required", "role_reason": "This is needed to distinguish similar functional-scale names from actual measurement of the same outcome.", "application_exception": "Do not automatically treat inability to blind as failure; verify limitations in the actual measurement procedures.", "criterion": "Link the actual test conditions required for usual gait speed to the reasons for excluding other functional endpoints.", "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; M03 §3.2.4; internally defined extension boundaries — this is an item-specific adaptation for gait measurement, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Fix usual-speed instructions and distance/start conditions, and consistently record repeated measurements, assistive devices and assessor conditions.", "current_reports": [ "S05" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "The target endpoint is usual/preferred gait speed in m/s. Directly relevant distance, static/dynamic start, assistive devices, footwear, number of trials, mean/best rule, assessor/device and acceleration/deceleration zones are null. The 5 m CKD test belongs to a different comparison involving a multicomponent nutritional formula; grip strength, ability to walk and Barthel/FIM are not the same measure.", "condition_status": "Unverified", "status_reason": "The measurement name alone cannot verify the actual protocol or measurement differences, and another functional scale does not substitute for target gait speed.", "missingness": "Directly relevant walking distance, test procedures, measurement conditions, assessor blinding and differences in implementation by arm.", "uncertainty": "Protocol differences may affect comparisons of results, but they do not constitute an established measurement error here.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Test SOP, original gait-measurement tables, assessor/device records, protocol and arm-specific implementation information." }, { "item_id": "N12", "question_type": "Effect definition", "question": "Were the between-group effect, final values and changes verified?", "needed": "Attribute the original result's between-group/within-group contrast, final value/change and analysis/adjustment to the corresponding endpoint and time point. Required source materials: Result tables, analysis plan, model output, ITT/PP definitions and prespecified primary contrasts.", "role": "Required", "role_reason": "This is needed to avoid confusing values from different analyses with the intended causal contrast.", "application_exception": "If the source does not specify the analysis, do not arbitrarily label it ITT or an adjusted effect.", "criterion": "Attribute the original result's between-group/within-group contrast, final value/change and analysis/adjustment to the corresponding endpoint and time point.", "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; status distinctions are internally designed — this is an item-specific adaptation for effect definition, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Link the between-group gait-speed contrast at the defined principal time point to the analysis population/model, and report it separately from within-group changes.", "current_reports": [ "S05" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "The directly eligible effect estimate, P, baseline adjustment, multiplicity and final values/changes are null. The retained primary-comparison structure records that a between-group effect is sought but remains unverified. Do not replace the absence of results with a difference of 0 or convert the CKD within-group median into a between-group effect of thiamine alone.", "condition_status": "Unverified", "status_reason": "Without a selected direct result and analysis definition, the magnitude and direction of the effect of interest cannot be established.", "missingness": "Eligible arm-specific baseline/final/change values, between-group estimates, models, analysis populations and adjustment/multiplicity.", "uncertainty": "Unverified numerical information is distinct from verification of a nonsignificant result, equivalence or an unfavorable effect.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Result tables, analysis plan, model output, ITT/PP definitions and prespecified primary contrasts." }, { "item_id": "N13", "question_type": "Denominators and losses", "question": "Can the numbers allocated, completing and analyzed be distinguished from missing data?", "needed": "Link allocation, completion, analysis and arm-specific/outcome-specific denominators to the corresponding time points. Required source materials: Participant flow diagram, outcome-specific n, reasons for dropout/measurement failure and the handling plan.", "role": "Required", "role_reason": "This is needed to avoid incorrectly relabeling retained sample sizes as outcome-specific analysis denominators.", "application_exception": "Do not calculate unavailable dropout counts, denominators or CIs, or treat crossover observations as unique participants.", "criterion": "Link allocation, completion, analysis and arm-specific/outcome-specific denominators to the corresponding time points.", "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; M08 §8.1–8.2.3; internal application — this is an item-specific adaptation for denominators and losses, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Trace the flow from allocation to gait measurement and analysis, and examine the effects of missingness reasons and handling for each analysis population.", "current_reports": [ "S02", "S05" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "Direct numbers allocated, completing, analyzed and by arm, and missingness, are null. HF's 24 allocated/19 completing/12 per sequence and CKD's 66 allocated/47 analyzed/24 and 23 by arm are different denominators within their respective studies; they are not summed into a target gait-speed sample.", "condition_status": "Unverified", "status_reason": "There is no denominator for a direct result, and participant counts from related studies cannot be substituted as the number analyzed for that result.", "missingness": "Eligible participants' flow through allocation, measurement, completion and analysis, with outcome-specific and arm-specific missingness, reasons and handling.", "uncertainty": "The total study population is not guaranteed to equal the number included in an outcome analysis at a given time point.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Participant flow diagram, outcome-specific n, reasons for dropout/measurement failure and the handling plan." }, { "item_id": "N14", "question_type": "Intervals and importance", "question": "Were the CI and a clinically important difference verified?", "needed": "Link the type of interval in the original report and the basis for importance only to the extent verified. Required source materials: Eligible estimates/CIs, variance types, denominators, the basis for clinical importance and a prespecified interpretation plan.", "role": "Required", "role_reason": "This is needed to distinguish significance and sample size from precision and clinical meaning.", "application_exception": "Do not invent new MCIDs, CIs, variances or sample sizes without a basis, or convert IQR/SD/SE into an interval.", "criterion": "Link the type of interval in the original report and the basis for importance only to the extent verified.", "basis": "M15 §15.3.1–15.3.3; internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are internally designed — this is an item-specific adaptation for intervals and importance, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Report CIs linked to their original estimates and denominators/variances, explaining separately the basis for applying an importance criterion and what remains unverified.", "current_reports": [ "S05" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "The direct effect's CI, confidence level, SD, SE and an applicable important difference are unverified. The original calculation record explicitly states that no synthetic effect, variance, CI or MCID was created; the CKD IQR of −0.02~0.22 m/s is not a CI. Do not judge whether an important benefit is excluded or evidence is sufficient from sample size or P alone.", "condition_status": "Unverified", "status_reason": "Without a direct interval and an importance criterion applicable to this population/measure, precision and a meaningful difference cannot be judged.", "missingness": "Direct estimates, variances, CIs/confidence levels, effect direction and the basis for population-specific important differences.", "uncertainty": "A generic gait-speed cutoff or minimum sample size cannot be applied to this question without a basis.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Eligible estimates/CIs, variance types, denominators, the basis for clinical importance and a prespecified interpretation plan." }, { "item_id": "N15", "question_type": "Planning and registration", "question": "Were the primary gait endpoint and planned analysis compared with the actual registration?", "needed": "Distinguish the level of plans/registration obtained, the parts not actually compared and the reasons for changes. Required source materials: Eligible original registry history, protocol, SAP, endpoint/analysis change records and reported results.", "role": "Required", "role_reason": "This criterion reveals the extent to which planned outcomes can be compared with selective reporting of favorable results.", "application_exception": "Do not treat publication of a related trial's protocol as verification of preregistration for the target comparison.", "criterion": "Distinguish the level of plans/registration obtained, the parts not actually compared and the reasons for changes.", "basis": "M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.5–4.6 data-collection/selection principles; separation of access from reading and the hyperlink contract are internally designed; M04 §4.5, §4.6.3; limitations on the current material conversion follow the user-defined scope and internal design — this is an item-specific adaptation for planning and registration, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Compare planned gait endpoints, time points and analyses against initial and amended versions and actual reports, retaining the extent of discrepancies and their reasons.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "A directly eligible protocol, registration and analysis plan have not been verified. Recruitment feasibility is the primary endpoint in HF; the historical official registration S03 was only an app shell, with no version history acquired. Do not label the registration-date accounts in S01/S02 as direct verification of native history.", "condition_status": "Unverified", "status_reason": "There is no comparison of direct plans with actual results, and the identity of an indirect protocol/registration does not substitute for a plan for the target gait endpoint.", "missingness": "Registration versions and actual reports of the direct primary endpoint, time point, analysis and reasons for changes.", "uncertainty": "Failure to acquire registration does not mean no registration, established selective reporting or endpoint failure.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Eligible original registry history, protocol, SAP, endpoint/analysis change records and reported results." }, { "item_id": "N16", "question_type": "Study families", "question": "Were reports from the same study distinguished from direct independent replication?", "needed": "Link same/different/uncertain families to their original locations, leaving replication and unique-participant counts unresolved where unconfirmed. Required source materials: Report-registration-cohort linkage tables, directly eligible criteria/result tables and materials for identifying overlap.", "role": "Required", "role_reason": "This criterion distinguishes the number of reports from the number of direct independent comparisons.", "application_exception": "Do not erase unresolved candidates as not applicable, or count the same 24 HF participants as 4 studies or 48 people.", "criterion": "Link same/different/uncertain families to their original locations, leaving replication and unique-participant counts unresolved where unconfirmed.", "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 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are internally designed — this is an item-specific adaptation for study families, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Link reports to unique studies first, and compare only independent results verified to match in population, preparation, measure and time point.", "current_reports": [ "S01", "S02", "S03", "S04" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "S01–S04 are the protocol, final report, registration and conference abstract of the single THIAMINE-HF family F01. The original materials contain related/candidate families F01–F13 and reports S01–S21, but no directly eligible family was verified within the retained scope. Each family's replication count for the target question is recorded as 0; the 13 families are not counted as direct replications.", "condition_status": "Partly verified", "status_reason": "Retained family links and the shared HF cohort were verified, but directly eligible independent replication and the total number of unique participants have not been established.", "missingness": "Directly eligible unique families, outcome-specific links and the actual independent identities of unresolved candidates.", "uncertainty": "The existence of multiple indirect materials does not establish replication for the same population, exposure and gait-speed outcome.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Report-registration-cohort linkage tables, directly eligible criteria/result tables and materials for identifying overlap." }, { "item_id": "N17", "question_type": "Funding and conflicts of interest", "question": "Does funding of indirect studies establish independence of the target efficacy evidence?", "needed": "Link the reported level of funding/conflict information, unverified information and applicability limitations to each study. Required source materials: Each study's original Funding/COI sections, provision/institution/employment documents and relationships among reports in the family.", "role": "Supplementary; required for independence claims", "role_reason": "This supplementary criterion prevents automatic inheritance of indirect studies' funding into the target efficacy axis.", "application_exception": "Do not automatically exclude a study because of a conflict of interest, or establish the absence of conflicts from a missing declaration.", "criterion": "Link the reported level of funding/conflict information, unverified information and applicability limitations to each study.", "basis": "Chamgap's own independence/attribution criteria. The official methodological sections used in this pilot do not guarantee all of these detailed items; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is an internal application — this is an item-specific adaptation for funding and conflicts of interest, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Extract study-specific funding, product provision and declared conflicts separately from results, and compare them with the scope of independence claims.", "current_reports": [ "S01", "S02", "S05" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "HF records both public/institutional funding and donated active/placebo products. For the CKD report's funding and conflicts, the current source contains only a statement that they were retained in a separate package audit table. Without a decisive directly eligible study, neither that funding nor document quality A is borrowed as evidence of independence for target efficacy.", "condition_status": "Partly verified", "status_reason": "HF funding information is available at the report level, but the original CKD audit file and the scope of funding/declarations for an eligible study were not verified in this review.", "missingness": "Eligible-study funding, product provision, author employment/patents/declarations and details in the separate CKD audit table.", "uncertainty": "The presence or absence of public funding or donated products does not automatically establish unbiased results or independent replication.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Each study's original Funding/COI sections, provision/institution/employment documents and relationships among reports in the family." }, { "item_id": "N18", "question_type": "HF exposure and population", "question": "Does the single-ingredient oral trial in older HF patients match the target population?", "needed": "Distinguish the actual HF population, regimen and selection restrictions from the target population/exposure. Required source materials: Original HF methods, selection/baseline tables, formulation/administration records, adherence and original supplements.", "role": "Supplementary; required for attribution of indirect materials", "role_reason": "This is needed to preserve both what is known from closely related single-ingredient oral evidence and its gaps in directness.", "application_exception": "Do not generalize to all vulnerable older adults by omitting exclusions for dialysis/symptomatic deficiency or conditions involving caregiver assistance.", "criterion": "Distinguish the actual HF population, regimen and selection restrictions from the target population/exposure.", "basis": "M03 §3.2.1; detailed population criteria are internally designed; M03 §3.2.2–3.2.3; reverse-direction labeling and testing adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application — this is an item-specific adaptation for HF exposure and population, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Link population, salt, route, adherence and exclusion criteria to the eligibility table, specifying differences from the target question.", "current_reports": [ "S01", "S02" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "F01 comprises adults with symptomatic heart failure, NYHA II–IV and LVEF ≤45%, aged 60 years or older, totaling 24 participants. Mean age is 73.4 ± 7.4 years, with 7 women; the functional-impairment cutoff and baseline gait speed are null. The regimen is mononitrate Accurex capsules, 500 mg, per 1 day: 1 time, for 90 days per period with a 6-week washout, inert placebo and usual HF care; reported adherence is 92.5%. Exclusions including dialysis and symptomatic deficiency/severe malnutrition are also retained.", "condition_status": "Partly verified", "status_reason": "The closely related single-ingredient oral regimen and some details of the actual population are verified, but the objective-functional-impairment/gait-endpoint boundaries do not match, so it is not directly eligible.", "missingness": "Functional-impairment cutoff, baseline gait speed, renal function, meals/rehabilitation, thiamine equivalents and the actual effect of adherence on each outcome.", "uncertainty": "Older age in HF and NYHA class do not guarantee fulfillment of this question's functional-impairment selection criteria or representativeness of all older adults.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original HF methods, selection/baseline tables, formulation/administration records, adherence and original supplements." }, { "item_id": "N19", "question_type": "HF outcome boundaries", "question": "Were HF results showing no difference or unfavorable effects kept from being transferred to gait speed?", "needed": "Preserve the direction of other HF results and the absence of target gait results without conflating them. Required source materials: Original HF result tables, endpoint definitions, each analysis/denominator and the relevant location if a gait endpoint has been newly reported.", "role": "Supplementary; required for boundaries on transferring results", "role_reason": "This boundary criterion preserves contrary results and prevents automatic substitution of endpoints.", "application_exception": "Do not create a gait effect by selecting favorable results for other outcomes or deleting unfavorable results for other outcomes.", "criterion": "Preserve the direction of other HF results and the absence of target gait results without conflating them.", "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; status distinctions are internally designed; M03 §3.2.4; internally defined extension boundaries — this is an item-specific adaptation for HF outcome boundaries, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Attribute each endpoint's results to its definition, time point and denominator, and construct a table of directness for the target question.", "current_reports": [ "S01", "S02" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "The record states that recruitment feasibility was the primary endpoint in HF and usual gait speed was not measured. Echocardiography, NT-proBNP, NYHA, KCCQ and clinical events are other outcomes. Retain the recorded cardiac results showing no difference and the unfavorable KCCQ signal, but do not transfer them into a 0 effect, worsening or positive result for gait speed.", "condition_status": "Met", "status_reason": "Other endpoints in the same report were retained, with target gait_result=null kept separate from the scope of interpretation.", "missingness": "No HF gait-speed result is retained, and detailed values/denominators for other endpoints were not available in the current source.", "uncertainty": "Null or unfavorable results for other cardiac/quality-of-life outcomes do not verify the direction of the target gait effect.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original HF result tables, endpoint definitions, each analysis/denominator and the relevant location if a gait endpoint has been newly reported." }, { "item_id": "N20", "question_type": "HF reporting discrepancies", "question": "Was the scope of discrepancies among abstracts, final reports and totals preserved?", "needed": "Retain the locations of actual recorded discrepancies together with unchecked details and explanations of versions/denominators. Required source materials: Original conference abstract, final original tables, adherence definitions, supplements/corrections and registry history.", "role": "Supplementary; required for handling conflicting information", "role_reason": "This is needed to limit the scope of conflicts, overlap and selective reporting to the relevant reports.", "application_exception": "Do not create additional conflicts solely from numerical differences across definitions/time points, or average original values together.", "criterion": "Retain the locations of actual recorded discrepancies together with unchecked details and explanations of versions/denominators.", "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are internally designed; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is an internal application; M04 §4.5–4.6 data-collection/selection principles; separation of access from reading and the hyperlink contract are internally designed; M08 Table 8.2.a, M04 §4.6.3; internal application — this is an item-specific adaptation for HF reporting discrepancies, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Compare report versions from the same cohort using the same definitions/denominators, distinguishing resolved differences from remaining conflicts.", "current_reports": [ "S02", "S04" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "Retain the record that adherence in S04's abstract for the same 24 participants was 95.0%, differing from the final report S02's 92.5%. Table/text discrepancies in S02 and inconsistent totals in the serious-event table are also recorded, but the detailed original tables were not compared in this review. The adherence figures do not represent separate trials, and differences at those reporting levels are not expanded into conflicting target gait effects.", "condition_status": "Conflicting information", "status_reason": "The retained manuscript explicitly records adherence differences and table/text and event-total discrepancies in the same HF reports. Reasons for differences in definitions, denominators or versions have not yet been verified.", "missingness": "Each adherence definition, denominator/version, original table/text values, people/events counted and explanations of corrections.", "uncertainty": "Neither extraction can be chosen as the correction to the other, and the cause of the difference cannot be established.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original conference abstract, final original tables, adherence definitions, supplements/corrections and registry history." }, { "item_id": "N21", "question_type": "CKD multicomponent exposure", "question": "Can the CKD formula's gait results be attributed to B1 alone?", "needed": "Verify the actual formula, diet and comparison, and that individual component contributions have not been separated. Required source materials: Product ingredient lists, original administration/diet plans, actual intake and component-specific contrast data.", "role": "Supplementary; required for attribution of combination-product results", "role_reason": "This attribution criterion prevents a positive multicomponent-exposure result from erasing gaps in the single-ingredient B1 question.", "application_exception": "Preserving the combined effect does not mean deleting it or declaring it invalid, and it is not promoted to direct evidence for the target single ingredient.", "criterion": "Verify the actual formula, diet and comparison, and that individual component contributions have not been separated.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and testing adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are internally designed — this is an item-specific adaptation for CKD multicomponent exposure, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "If B1's contribution is the question, design a separate single-ingredient add-on contrast with other care matched, while retaining the formula results.", "current_reports": [ "S05" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "F02 is an open-label trial comparing Fresubin Renal multicomponent nutritional formula providing 400 kcal, 6 g protein, EPA/DHA and multiple micronutrients alongside a low-protein diet for 3 months with diet alone. It is not the target single-ingredient thiamine regimen; the thiamine amount is null. Reported adherence of 91.6% and dietary targets of 0.6–0.8 g/kg/day and 30 kcal/kg/day belong to this multicomponent comparison.", "condition_status": "Met", "status_reason": "The actual difference between the multicomponent formula and shared diet was linked, and the failure to isolate thiamine's contribution was made explicit.", "missingness": "The formula's exact B1 form/amount, amounts of all components, actual intake and contrasts isolating individual components.", "uncertainty": "The formula's effect cannot be attributed solely to thiamine or to a single component such as energy or protein.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Product ingredient lists, original administration/diet plans, actual intake and component-specific contrast data." }, { "item_id": "N22", "question_type": "Attribution of CKD numerical values", "question": "Were medians, IQRs and within-group/between-group P values distinguished?", "needed": "Preserve the median, IQR and the hypothesis tested by each P value, leaving unverified between-group estimates unverified. Required source materials: Original result Table 3, models/tests, arm-specific change distributions and between-group estimates/CIs.", "role": "Supplementary; required for numerical attribution", "role_reason": "This criterion prevents attributing positive numerical results to the wrong ingredient, comparison or interval.", "application_exception": "Do not use arithmetic in this review to create an unavailable between-group magnitude or CI, or read an IQR as a precision interval.", "criterion": "Preserve the median, IQR and the hypothesis tested by each P value, leaving unverified between-group estimates unverified.", "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; M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application — this is an item-specific adaptation for attribution of CKD numerical values, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Compare the arm-specific medians/distributions and the analysis definition of the between-group change test against the original table, explaining component attribution separately from the statistical contrast.", "current_reports": [ "S05" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "In S05, the intervention arm's median gait-speed change at 3 months is +0.07 m/s, with an IQR of −0.02~0.22 m/s. The structure separately contains within-group P=0.048 and between-group change-test P=0.009. The between-group effect estimate and CI are null. Do not convert +0.07 into a between-group effect of B1 alone, or the IQR into a CI.", "condition_status": "Met", "status_reason": "The original numbers, statistical types and tested contrasts were linked to the respective verified structural/KO locations. The retained between-group P does not provide an effect magnitude for an isolated ingredient.", "missingness": "Control-arm change distribution, between-group estimate/CI, exact test/model, denominator and original Table 3.", "uncertainty": "Different within-group/between-group P values do not automatically conflict; significance alone cannot establish B1 efficacy or an important difference.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original result Table 3, models/tests, arm-specific change distributions and between-group estimates/CIs." }, { "item_id": "N23", "question_type": "CKD testing and denominators", "question": "Were actual CKD gait testing and the analysis population distinguished?", "needed": "Link CKD allocation/analysis flow and test conditions to differences from the target selection criteria. Required source materials: Baseline/selection tables, participant flow, gait SOP and outcome-specific analysis/missingness tables.", "role": "Supplementary; required for applicability/denominators", "role_reason": "This criterion accurately preserves the populations, tests and denominators behind the formula's numerical results.", "application_exception": "Do not establish functional impairment from a CKD diagnosis or age alone, or guarantee that the overall analysis n is the n for every test.", "criterion": "Link CKD allocation/analysis flow and test conditions to differences from the target selection criteria.", "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, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application — this is an item-specific adaptation for CKD testing and denominators, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Compare participant flow and measurement procedures for each outcome to limit the applicability of the formula results.", "current_reports": [ "S05" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "F02 concerns nondialysis participants aged over 65 years with CKD stages 3–5: 66 randomized, 47 analyzed (24 intervention, 23 control). The original structured values of median age 73 years and median eGFR 36 are retained; the required functional-impairment cutoff and baseline gait speed are null. Usual 5 m gait speed in m/s, footwear and assistive devices if needed are recorded, but start/acceleration/deceleration conditions, repetition/averaging rules and assessors remain unverified.", "condition_status": "Partly verified", "status_reason": "The retained population, allocated/analyzed n and some testing details are verified, but target functional-impairment selection and sufficient measurement/missingness information remain unresolved.", "missingness": "Selection for functional impairment, baseline speed, exact gait SOP, dropout reasons/handling and outcome-specific n.", "uncertainty": "The difference between 66 randomized and 47 analyzed cannot be newly interpreted as the original reason for missingness or as a direct B1 denominator.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Baseline/selection tables, participant flow, gait SOP and outcome-specific analysis/missingness tables." }, { "item_id": "N24", "question_type": "CKD registration notation", "question": "Were registration-date conflicts distinguished from original tables not compared?", "needed": "Separate the record of conflicting registration-date notation from the scope of original tables/registration not compared. Required source materials: Initial/amended registry history, original registration-date sections, Table 2/3 and explanations of corrections.", "role": "Supplementary; required for registration/conflicts", "role_reason": "This criterion retains historical access limitations and actual reported conflicts within their precise scope.", "application_exception": "Do not label a current lack of attempt as a current access failure, or automatically fill detailed dates from other files.", "criterion": "Separate the record of conflicting registration-date notation from the scope of original tables/registration not compared.", "basis": "M04 §4.5–4.6 data-collection/selection principles; separation of access from reading and the hyperlink contract are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are internally designed; M08 Table 8.2.a, M04 §4.6.3; internal application — this is an item-specific adaptation for CKD registration notation, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Compare the meaning and version of registration dates with the source materials, recording main-text/table access limitations alongside the scope of numerical extraction.", "current_reports": [ "S05" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "The retained manuscript explicitly records S05's NCT05318014 and conflicting registration-date notation. It records that the main HTML text was read previously, separate Table 2/Table 3 views failed, and only values in readable narrative were used. The original registration and tables were not opened in this review, so exact date strings, causes of the conflict and whether it was resolved remain unverified.", "condition_status": "Conflicting information", "status_reason": "The record of inconsistent registration-date formatting was retained without newly establishing numerical conflicts throughout unchecked original tables, lack of registration or selective reporting.", "missingness": "Original strings for each registration date, their meanings/versions, initial registry history and separate original tables.", "uncertainty": "Formatting/registration-date differences are separate from conflicts in treatment duration or results. The record alone cannot determine which date is authoritative.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Initial/amended registry history, original registration-date sections, Table 2/3 and explanations of corrections." }, { "item_id": "N25", "question_type": "Nursing-home observations", "question": "Was the observed direction for deficiency and ability to walk kept from being reversed into a supplementation effect?", "needed": "Accurately preserve the observational population, deficiency/feeding routes, walking denominators and causal limitations. Required source materials: Original Table 2/3, feeding route/care level/walking denominators, design and adjustment data.", "role": "Supplementary; required for attribution of observations", "role_reason": "This criterion prevents reversing deficiency associations into treatment directions or mixing denominators.", "application_exception": "Do not convert ability to walk into speed, or treat tube/intravenous feeding in the nondeficient group as an oral B1 intervention.", "criterion": "Accurately preserve the observational population, deficiency/feeding routes, walking denominators and causal limitations.", "basis": "M03 §3.2.1; detailed population criteria are internally designed; M03 §3.2.2–3.2.3; reverse-direction labeling and testing adaptations are internally designed; 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; status distinctions are internally designed; M08 §8.1–8.2.3; internal application; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application — this is an item-specific adaptation for nursing-home observations, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Compare the observational definitions of exposure and outcome with feeding route/care selection, distinguishing them from a separate question about assigned treatment.", "current_reports": [ "S06" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "F03 Ito is a cross-sectional observation of 74 nursing-home residents (42 deficient, 32 nondeficient). It uses whole-blood total thiamine by HPLC and a <20 ng/mL criterion, recording unaided walking in 21/42 versus 6/32. All deficient participants received oral nutrition, while 12/32 nondeficient participants received tube/intravenous nutrition, creating confounding by feeding route and care level. This is neither gait speed in m/s nor a contrast of assigned supplementation; the inverse descriptive pattern is not interpreted as a benefit of deficiency.", "condition_status": "Met", "status_reason": "Exposure markers, denominators, the different endpoint and confounding were linked to actual family locations, without converting the observational direction into causal supplementation efficacy.", "missingness": "Supplement allocation, speed in m/s, temporal sequence, confounding adjustment and an eligible treatment comparison.", "uncertainty": "Feeding-route/care selection in the cross-sectional population does not support a simple causal explanation of deficiency→poor function.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original Table 2/3, feeding route/care level/walking denominators, design and adjustment data." }, { "item_id": "N26", "question_type": "Inpatient functional observations", "question": "Was Barthel recovery distinguished from a treatment effect on gait speed?", "needed": "Attribute the inpatient observation's scale, population, nutritional markers and material-access level to its own result. Required source materials: Original methods/results, marker criteria, adjustment, functional-recovery tables and an eligible comparison.", "role": "Supplementary; required for attribution of observations", "role_reason": "This criterion prevents an observed result for another form of functional recovery from substituting for target efficacy.", "application_exception": "Do not generalize the abstract's association or 0 deficiency cases into an oral B1 treatment effect or to all nondeficient older adults.", "criterion": "Attribute the inpatient observation's scale, population, nutritional markers and material-access level to its own result.", "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 §8.1–8.2.3; internal application; M03 §3.2.4; internally defined extension boundaries — this is an item-specific adaptation for inpatient functional observations, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Link the Barthel association to exposure, time and confounding, and assess it separately from the causal gait-speed question.", "current_reports": [ "S07" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "F04 is an observation of 233 older inpatients with a mean age of 82.1 ± 7.1 years; the recorded number with thiamine <20 ng/mL is 0. The association between thiamine and Barthel Index improvement is not an assigned oral-treatment or usual-gait-speed result. Historical S07 access was also limited to publisher abstract/references, with full text recorded as inaccessible.", "condition_status": "Met", "status_reason": "The sample, nutritional marker, different functional scale, observational design and historical abstract-level scope were distinguished.", "missingness": "Full methods, adjustment/temporal sequence, detailed functional/nutritional denominators and an eligible oral comparison.", "uncertainty": "The observation of 0 deficient participants under that criterion does not establish nutritional adequacy by every criterion, an effect of additional supplementation or that supplementation is unnecessary.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original methods/results, marker criteria, adjustment, functional-recovery tables and an eligible comparison." }, { "item_id": "N27", "question_type": "Observations on other B vitamins", "question": "Do dietary data on other B vitamins answer the B1 functional-impairment question?", "needed": "Identify differences in B6/B12/folate exposure, a population with unimpaired function and self-reported outcomes. Required source materials: Original exposure, selection/baseline function, measure definitions and an eligible B1 comparison.", "role": "Supplementary; required for boundaries concerning other nutrients", "role_reason": "This criterion keeps the presence or absence of positive findings for other ingredients/observational questions from erasing the direct B1 evidence gap.", "application_exception": "Do not promote an indexed abstract to newly read full text or record it as a successful current PubMed search.", "criterion": "Identify differences in B6/B12/folate exposure, a population with unimpaired function and self-reported outcomes.", "basis": "M03 §3.2.1; detailed population criteria are internally designed; M03 §3.2.2–3.2.3; reverse-direction labeling and testing adaptations are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 §8.1–8.2.3; internal application — this is an item-specific adaptation for observations on other B vitamins, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Extract differences in each nutrient and functional definition, indicating relevance without pooling them as causal B1 effects.", "current_reports": [ "S08" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "F05 Seniors-ENRICA is an observational cohort of people aged 60 years or older, numbering 1,630. It concerns B6/B12/folate intake and self-reported functional outcomes in a population without functional impairment at baseline. These all differ from single-ingredient oral B1 supplementation, selection for objective functional impairment and usual gait speed. A blank direct PubMed page and access to the official indexed abstract through the general web are historical records.", "condition_status": "Met", "status_reason": "Differences from the target in nutrients, population, design and measure were verified at the actual family/bibliographic locations.", "missingness": "B1 administration, an eligible population with functional impairment and a direct gait-speed comparison/result.", "uncertainty": "The shared label B vitamins alone cannot establish equivalence of effects or exposures.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original exposure, selection/baseline function, measure definitions and an eligible B1 comparison." }, { "item_id": "N28", "question_type": "Registry candidates", "question": "Were the composition, population and results of registry leads actually verified?", "needed": "Record each of the two candidates' verified identities and unresolved composition, eligibility and results separately. Required source materials: Original structured registry content, amendment history, protocol and linked result reports.", "role": "Supplementary; required for candidate eligibility", "role_reason": "This criterion separates the existence of a candidate from acquisition of efficacy results.", "application_exception": "Do not replace an unresolved candidate with confirmed exclusion from eligibility, an effect of 0 or not applicable.", "criterion": "Record each of the two candidates' verified identities and unresolved composition, eligibility and results separately.", "basis": "M04 §4.5–4.6 data-collection/selection principles; separation of access from 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; M03 §3.2.1; detailed population criteria are internally designed; M03 §3.2.2–3.2.3; reverse-direction labeling and testing adaptations are internally designed; M08 Table 8.2.a, M04 §4.6.3; internal application — this is an item-specific adaptation for registry candidates, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Check exposure/population/outcome eligibility for each candidate first, linking it to a family only when a result is verified.", "current_reports": [ "S12", "S13" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "S12 NCT05648422 is a registry-shell/indexed lead for a multicomponent nutritional intervention in cerebral palsy; an isolated ordinary-thiamine gait effect is unverified. S13 NCT06242535 GLYLOW is a postmenopausal-obesity candidate whose detailed official fields/history, exact composition and eligible results remain unverified. Do not combine these leads as direct results or independent replication.", "condition_status": "Unverified", "status_reason": "Candidate identities are available, but the composition, populations and results in the original official registrations and their eligibility for the target have not been verified.", "missingness": "Original registration versions, ingredients/routes, objective-functional-impairment eligibility criteria, denominators and gait results/time points.", "uncertainty": "A 3rd-party lead or registry title does not establish actual result publication/completion or a valid single-ingredient B1 regimen.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original structured registry content, amendment history, protocol and linked result reports." }, { "item_id": "N29", "question_type": "Grip-strength trial in deficiency", "question": "Was Wilkinson's deficiency/grip-strength trial kept from being transferred to gait speed?", "needed": "Limit deficiency selection, grip strength and the oral regimen to the relevant family and extraction level. Required source materials: Original eligibility/administration, grip and gait measurements/results, and exact-salt data.", "role": "Supplementary; required for attribution of prior extractions", "role_reason": "This criterion clarifies reuse of prior extractions and attribution to a different distinct claim.", "application_exception": "Do not inherit a previous verdict/score or a dose for another endpoint as fulfillment of new gait-speed criteria.", "criterion": "Limit deficiency selection, grip strength and the oral regimen to the relevant family and extraction level.", "basis": "M03 §3.2.1; detailed population criteria are internally designed; M03 §3.2.2–3.2.3; reverse-direction labeling and testing adaptations 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 data-collection/selection principles; separation of access from reading and the hyperlink contract are internally designed — this is an item-specific adaptation for grip-strength trial in deficiency, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Compare the questions and measures in the prior extraction and original report, but reconsider separate eligibility only if a gait result was actually reported.", "current_reports": [ "S14" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "F08 Wilkinson is a trial described in a prior extraction: 76 randomized, selection by erythrocyte TPP <140 nmol/L, oral 10 mg/day for 3 months. The exact salt is null; the endpoint is dominant-hand grip measured with a Preston dynamometer, and no usual-gait result was verified. S14 records reuse only of the earlier 3117 extraction; the historical file/external source was not reopened in this review.", "condition_status": "Met", "status_reason": "The retained deficiency selection, different measure, administration and scope of extraction reuse were linked.", "missingness": "Selection for objective functional impairment, an eligible usual-gait result, the exact salt and comparison with original tables/full text in this review.", "uncertainty": "Results/samples for the deficiency grip-strength question are not direct effects on gait speed in older adults with functional impairment.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original eligibility/administration, grip and gait measurements/results, and exact-salt data." }, { "item_id": "N30", "question_type": "IBD fatigue trial", "question": "Is the TARIF fatigue trial a gait-speed comparison in older adults?", "needed": "Distinguish TARIF's population/results and the original extraction level from the gait-speed question. Required source materials: Original population, endpoint/analysis tables, exposure form and eligible gait results.", "role": "Supplementary; required for boundaries concerning other endpoints", "role_reason": "This criterion separates the different population and endpoint of a closely related oral trial.", "application_exception": "Do not adopt a previous fatigue verdict or another endpoint's results as a new direct gait-speed effect.", "criterion": "Distinguish TARIF's population/results and the original extraction level from the gait-speed question.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; 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; M04 §4.5–4.6 data-collection/selection principles; separation of access from reading and the hyperlink contract are internally designed — this is an item-specific adaptation for IBD fatigue trial, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Attribute results to their respective questions using an eligibility table that distinguishes disease-related fatigue, grip strength and gait.", "current_reports": [ "S15" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "F09 TARIF is a prior extraction concerning a placebo-controlled crossover trial of oral thiamine for chronic fatigue in quiescent IBD. S15's historical access level was publisher abstract and indexed grip-strength excerpts; it was not reread in this review. It was not verified as a direct usual-gait-speed result in older adults with functional impairment.", "condition_status": "Met", "status_reason": "The distinct fatigue/IBD population and endpoint, and reuse of prior extractions to establish boundaries, were limited to verified locations.", "missingness": "Eligible selection of older adults with functional impairment, a gait-speed contrast and original methods/relevant results.", "uncertainty": "Even if thiamine appears in the title and the study is placebo-controlled, the population and outcome do not automatically match.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original population, endpoint/analysis tables, exposure form and eligible gait results." }, { "item_id": "N31", "question_type": "Trial in healthy older adults", "question": "Was Smidt's healthy/marginal-deficiency population kept separate from the target population?", "needed": "Link the applicability limitations concerning healthy women, marginal deficiency and unverified function/gait. Required source materials: Original selection, sex/baseline status, administration and actual functional-measurement/analysis tables.", "role": "Supplementary; required for population boundaries", "role_reason": "This criterion prevents expanding population directness based on the label older adults.", "application_exception": "Do not reclassify a study of healthy older adults as a study of objective functional impairment.", "criterion": "Link the applicability limitations concerning healthy women, marginal deficiency and unverified function/gait.", "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; M04 §4.5–4.6 data-collection/selection principles; separation of access from reading and the hyperlink contract are internally designed — this is an item-specific adaptation for trial in healthy older adults, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Distinguish health/functional-impairment and deficiency criteria, and compare direct-gait-comparison eligibility with the original results.", "current_reports": [ "S16" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "F10 Smidt is a prior historical extraction concerning healthy older women/marginal thiamine deficiency; it records that no objective-functional-impairment cutoff or usual-gait result was verified. S16 reuses a prior extraction and retains only title/abstract locations; this is not a full-text review in the current review.", "condition_status": "Met", "status_reason": "The difference between the shared condition of older age and actual functional impairment/gait endpoints was preserved.", "missingness": "Functional-impairment eligibility criteria, usual-gait protocol/results and complete administration/denominator information.", "uncertainty": "Well-being/deficiency boundaries in healthy older women do not represent effects in all older adults with functional impairment.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original selection, sex/baseline status, administration and actual functional-measurement/analysis tables." }, { "item_id": "N32", "question_type": "CMT mixed-form observations", "question": "Were uncontrolled mixed-form CMT data kept from being promoted to direct results?", "needed": "Preserve boundaries concerning mixed forms/ages, lack of controls, correction extractions and unverified target results. Required source materials: Original observations/corrections, individual forms/routes/ages, gait results and comparative data.", "role": "Supplementary; required for attribution of mixed observations", "role_reason": "This criterion prevents overinterpretation of mixed uncontrolled observations and original corrections.", "application_exception": "Do not label an error resolved merely because metadata indicate a correction, or combine derivative effects as ordinary-thiamine effects.", "criterion": "Preserve boundaries concerning mixed forms/ages, lack of controls, correction extractions and unverified target results.", "basis": "M03 §3.2.1; detailed population criteria are internally designed; M03 §3.2.2–3.2.3; reverse-direction labeling and testing adaptations are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 §8.1–8.2.3; internal application; M04 §4.5–4.6 data-collection/selection principles; separation of access from reading and the hyperlink contract are internally designed — this is an item-specific adaptation for CMT mixed-form observations, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Separate form/population/route and the content before and after the original correction, examining applicability to the gait comparison.", "current_reports": [ "S17" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "F11 CMT is a family of prior extractions of uncontrolled observations and a correction involving mixed ages and thiamine forms/derivatives. No eligible comparison of usual gait speed for single-ingredient oral ordinary thiamine was verified. S17 was reused to check boundaries; the original report/correction and historical extraction file were not opened in this review.", "condition_status": "Met", "status_reason": "Limitations from lack of controls, mixed preparations/ages, different endpoints and correction extractions were attributed to the relevant family.", "missingness": "Exact form-specific populations/results, original correction content, assigned comparisons and eligible gait-speed analyses.", "uncertainty": "Neuropathy improvement or mixed observational results are not evidence of a causal effect in the target comparison or of resolution through correction.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original observations/corrections, individual forms/routes/ages, gait results and comparative data." }, { "item_id": "N33", "question_type": "Deficiency neuropathy", "question": "Was FIM functional improvement kept from being relabeled as usual gait speed?", "needed": "Separate FIM, deficiency neuropathy and treatment extractions from a direct gait-speed comparison. Required source materials: Original population, administration/route, FIM/gait measurement, comparator and results by time point.", "role": "Supplementary; required for scale boundaries", "role_reason": "This criterion prevents automatically exchanging outcomes because functional scales use similar wording.", "application_exception": "Do not generalize the need to correct deficiency or FIM improvement into a gait effect in nondeficient older adults.", "criterion": "Separate FIM, deficiency neuropathy and treatment extractions from a direct gait-speed comparison.", "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 §8.1–8.2.3; internal application; M03 §3.2.4; internally defined extension boundaries; M04 §4.5–4.6 data-collection/selection principles; separation of access from reading and the hyperlink contract are internally designed — this is an item-specific adaptation for deficiency neuropathy, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Attribute deficiency-treatment scales and exposures to their original reports, examining separately whether a target gait comparison is established.", "current_reports": [ "S18" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "F12 Ohkoshi is a prior title/abstract extraction concerning functional limitations in deficiency neuropathy and FIM improvement after treatment. It was not verified as an eligible controlled gait-speed result for single-ingredient oral use in older adults, and the source was not reread in this review.", "condition_status": "Met", "status_reason": "Deficiency treatment, the separate functional scale FIM and the prior extraction level were distinguished.", "missingness": "Eligible population, exact preparation/route, actual comparator and usual-gait-speed results in m/s.", "uncertainty": "Functional recovery and numerical gait speed have different meanings; observation after treatment alone cannot establish a causal comparison.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original population, administration/route, FIM/gait measurement, comparator and results by time point." }, { "item_id": "N34", "question_type": "Injection case reports", "question": "Are intramuscular observations in muscular dystrophy oral-comparison data?", "needed": "Identify differences between intramuscular case reports and single-ingredient oral gait comparisons. Required source materials: Original case diseases, routes/preparations, time points/function definitions and an eligible oral comparison.", "role": "Supplementary; required for route boundaries", "role_reason": "This criterion prevents overstepping disease/route/design boundaries and falsely promoting the existence of a link.", "application_exception": "Do not convert a public PMC URL into a badge of current full-text reading or a result for an oral preparation.", "criterion": "Identify differences between intramuscular case reports and single-ingredient oral gait comparisons.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and testing adaptations are internally designed; 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 §8.1–8.2.3; internal application; M04 §4.5–4.6 data-collection/selection principles; separation of access from reading and the hyperlink contract are internally designed — this is an item-specific adaptation for injection case reports, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Separate results by route and disease, distinguishing case observations from effect estimates in controlled trials.", "current_reports": [ "S19" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "F13 Costantini is a prior extraction of uncontrolled intramuscular case observations in myotonic dystrophy. It is not an eligible gait comparison for single-ingredient oral ordinary thiamine; S19's PMC link likewise does not mean the original full text was read in this review.", "condition_status": "Met", "status_reason": "The different disease, intramuscular route, absence of controls and historical extraction level were clearly linked.", "missingness": "A comparator for the target oral exposure, older adults with objective functional impairment and gait-speed results.", "uncertainty": "Symptom improvement in cases with different routes/diseases does not establish the magnitude or replication of the target oral effect.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original case diseases, routes/preparations, time points/function definitions and an eligible oral comparison." }, { "item_id": "N35", "question_type": "Direct harm-data gap", "question": "Were adverse events/discontinuations in the same population and regimen verified?", "needed": "Separate collection methods, denominators, duration and unverified scope for direct harms/discontinuations. Required source materials: AE/discontinuation tables for the same population/preparation, exposure/follow-up flow, collection methods and original event records.", "role": "Supplementary; required for the relevant harm/safety claims", "role_reason": "This supplementary criterion displays the efficacy gap separately from the gap in direct safety data.", "application_exception": "Do not delete indirect efficacy sources because of a harm-data gap, or automatically assign the same status as the efficacy criteria.", "criterion": "Separate collection methods, denominators, duration and unverified scope for direct harms/discontinuations.", "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 — this is an item-specific adaptation for direct harm-data gap, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Plan harm collection separately within an eligible efficacy comparison, reporting events, people, exposure periods and discontinuation reasons distinctly.", "current_reports": [], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "The original safety label is Caution. Adverse-event/discontinuation data and exposure denominators/durations in directly eligible trials have not been verified. Do not replace unverified directly eligible harm denominators in the source with 0 events or an assertion of safety. Unverified efficacy and unverified harms are separate.", "condition_status": "Unverified", "status_reason": "Because no direct regimen/population was selected, systematic collection, events/people and discontinuations/losses for that exposure cannot be verified.", "missingness": "Direct AE definitions, systematic/spontaneous collection, severity, people/event counts, exposure/denominators and discontinuation reasons/losses.", "uncertainty": "Indirect signals and product wording do not substitute for incidence, overall safety or a causal judgment for the target exposure.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "AE/discontinuation tables for the same population/preparation, exposure/follow-up flow, collection methods and original event records." }, { "item_id": "N36", "question_type": "HF harm signal", "question": "Were diarrhea improvement after discontinuation and event totals kept from being converted into risk estimates?", "needed": "Preserve the 1 diarrhea event, improvement after discontinuation and original discrepancies in totals at the level of the report. Required source materials: Original HF AE/SAE tables, original discontinuation records, exposure by arm/period, alternative causes and correction materials.", "role": "Supplementary; required for attribution of harm signals", "role_reason": "This criterion is needed to preserve harm signals while preventing their promotion to incidence or causality.", "application_exception": "Do not automatically use all 24 randomized participants or the 19 completers as AE denominators, or correct table totals through new calculations.", "criterion": "Preserve the 1 diarrhea event, improvement after discontinuation and original discrepancies in totals at the level of the report.", "basis": "M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; detailed distinctions are internally designed; M19 §19.2 design-specific harm questions; temporal-relationship details are internally designed; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are internally designed; Chamgap's own interpretation boundaries. M19 principles are referenced; no official causality tool is implemented; M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are internally designed — this is an item-specific adaptation for HF harm signal, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Compare the original event's timing, discontinuation, alternative explanations and event/person totals, distinguishing signals, comparative risk and causal statements.", "current_reports": [ "S02" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "Retain, as originally recorded, the 1 diarrhea event in indirect HF evidence that improved after oral mononitrate discontinuation. The discrepancy in serious-event table totals also remains. Actual AE denominators, people/event counts, timing, comparisons and alternative causes for the target population/salt were not verified; do not newly turn the 1 diarrhea event into an incidence of 1/24 or an established causal risk.", "condition_status": "Partly verified", "status_reason": "There is a signal of improvement after discontinuation and a conflict in original totals, but event definitions, periods, denominators and comparison/alternative-explanation details remain unverified.", "missingness": "Diarrhea onset/recovery timing, event collection, exposure denominators, concomitant treatment/underlying disease and original SAE tables/corrections.", "uncertainty": "Improvement after discontinuation is important temporal information, but alone does not establish causality, frequency or risk for all oral forms.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original HF AE/SAE tables, original discontinuation records, exposure by arm/period, alternative causes and correction materials." }, { "item_id": "N37", "question_type": "Official product-information boundaries", "question": "Were the absence of a UL and product wording kept from becoming a general safety guarantee?", "needed": "Distinguish the absence of a UL, product-specific salts/wording, route-specific risks and current non-reading. Required source materials: Exact ingredients/excipients of the relevant study product, product-information versions and original harm data for the same route/population.", "role": "Supplementary; required for safety-interpretation boundaries", "role_reason": "This criterion prevents mistaking the existence of an official fact sheet/label for established efficacy or safety, or for identity of products.", "application_exception": "Do not transfer oral-product-specific pregnancy/lactation or excipient cautions to all nutritional exposures/other salts.", "criterion": "Distinguish the absence of a UL, product-specific salts/wording, route-specific risks and current non-reading.", "basis": "M19 §19.1.2–19.2.4; internal application; M03 §3.2.2–3.2.3; reverse-direction labeling and testing adaptations are internally designed; M04 §4.5–4.6 data-collection/selection principles; separation of access from reading and the hyperlink contract are internally designed; Chamgap's own interpretation boundaries. M19 principles are referenced; no official causality tool is implemented — this is an item-specific adaptation for official product-information boundaries, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Compare applicability by product/route/dose, separating official wording from actually collected events and frequencies.", "current_reports": [ "S09", "S10" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "The lack of an established UL in S09 NIH ODS does not mean unlimited safety. S10 is the product-specific SmPC for Flamingo oral hydrochloride 100 mg tablets, with a historical locator recording an update on 2025-09-08. Do not generalize gastrointestinal, hypersensitivity, pregnancy/lactation or excipient wording to all thiamine products, or transfer predominantly injection-related anaphylaxis cautions into a target oral incidence.", "condition_status": "Met", "status_reason": "The report type, product/route and original applicability limitations of the official information were linked, without labeling the corresponding official full text as reread in this review.", "missingness": "The exact SmPC/excipients for the target eligible product, the current official version and actual incidence denominators.", "uncertainty": "Do not add a new causal explanation for the absence of a UL that this source did not verify. Wording is not the magnitude of actual clinical risk.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Exact ingredients/excipients of the relevant study product, product-information versions and original harm data for the same route/population." }, { "item_id": "N38", "question_type": "Vulnerable groups and refeeding", "question": "Were the limited HF/refeeding contexts kept from being applied to all older adults?", "needed": "Distinguish original exclusions/vulnerable groups and the purpose of refeeding from direct/long-term safety gaps. Required source materials: Vulnerable-group selection/exposure, concomitant medications, long-term follow-up/harm data and the exact refeeding-guideline version.", "role": "Supplementary; required for vulnerable-group/long-term safety claims", "role_reason": "This supplementary criterion prevents generalizing safety from selected populations or exceeding the scope of clinically supervised contexts.", "application_exception": "Do not require every rare-harm study for the current narrow gait-speed question, or convert refeeding wording into a personal prescription.", "criterion": "Distinguish original exclusions/vulnerable groups and the purpose of refeeding from direct/long-term safety gaps.", "basis": "M03 §3.2.1; detailed population criteria are internally designed; M19 §19.1.2–19.2.4; internal application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed — this is an item-specific adaptation for vulnerable groups and refeeding, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Link population-specific exclusions and clinical-supervision purposes to the eligibility table; if long-term/vulnerable-group claims are needed, review materials within those scopes separately.", "current_reports": [ "S01", "S02", "S09", "S10", "S11" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "HF records exclusions including dialysis, symptomatic thiamine deficiency and severe malnutrition/refeeding risk. S11 NICE CG32 1.4.8 is an official indexed excerpt on clinically supervised refeeding; direct access failed previously. This context is not the target gait-speed regimen or a personal-dose recommendation; long-term/rare harms and safety in vulnerable groups remain unverified.", "condition_status": "Partly verified", "status_reason": "Selection exclusions and the refeeding context are retained, but there are no direct data for the target vulnerable population or long-term exposure.", "missingness": "Actual preparations/exposures, long-term/rare harms and concomitant medications by population, including dialysis and malnutrition/cognitive impairment.", "uncertainty": "Short-term observations in selected populations and separate clinically supervised contexts do not represent safety in all older adults with functional impairment.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Vulnerable-group selection/exposure, concomitant medications, long-term follow-up/harm data and the exact refeeding-guideline version." }, { "item_id": "N39", "question_type": "Extended applicability", "question": "Were falls, optimal dose and maintained effects made mandatory parts of the gait-speed question?", "needed": "Clarify why separate questions about events, dose and maintained effects do not apply as conditions for the gait-speed result. Required source materials: The exact original wording of the extended claim, relevant event/dose/follow-up comparisons and results.", "role": "Supplementary; required for the relevant extended claims", "role_reason": "This supplementary criterion separates requirements for the narrow subject of the verdict from separate extension criteria.", "application_exception": "Do not require an event trial for the numerical-change question itself; keep unresolved candidate/eligible materials unverified in other rows.", "criterion": "Clarify why separate questions about events, dose and maintained effects do not apply as conditions for the gait-speed result.", "basis": "M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed; M03 §3.2.4; internally defined extension boundaries; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed — this is an item-specific adaptation for extended applicability, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "If an extension is requested, first establish the distinct question boundary, then review direct results separately from the existing gait-speed table.", "current_reports": [], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "This unit is limited to a comparison of usual-gait-speed improvement. Grip strength, fatigue, falls, death/cardiac events, optimal dose and effects maintained after discontinuation are not imposed as requirements for this narrow outcome. Extended claims are not automatically answered by the current materials.", "condition_status": "Not applicable", "status_reason": "Non-applicability in this row concerns separate requirements for events, optimal dose or maintained effects. It does not erase an unverified direct gait result as not applicable.", "missingness": "If the extension is actually claimed, direct comparisons, time points, denominators and separate results for that question are needed.", "uncertainty": "The concept of gait speed as mobility function is not causal evidence of preventing falls/death or improving every aspect of function.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "The exact original wording of the extended claim, relevant event/dose/follow-up comparisons and results." }, { "item_id": "N40", "question_type": "Original verdict and history", "question": "Were ?/null, the calculation exception, document quality and historical deployment distinguished?", "needed": "Separate the original ?/null, unscored axes, invalid suggestion, document self-assessment and historical deployment from what was produced in this review. Required source materials: Original verdict/calculation-exception records, identity/deployment history, authorized change decisions and complete versions before and after changes.", "role": "Required", "role_reason": "This is a required preservation criterion to prevent automatic inheritance of scores/statuses or historical completion metadata.", "application_exception": "Do not use general code-structure checks as a new clinical score, implementation of an official method or certification of study absence.", "criterion": "Separate the original ?/null, unscored axes, invalid suggestion, document self-assessment and historical deployment from what was produced in this review.", "basis": "M04 §4.5, §4.6.3; limitations on the current material conversion follow the user-defined scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are internally designed — this is an item-specific adaptation for original verdict and history, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "Record verdict, document, calculation and publication events separately; if subsequent evidence is authorized, review any change to the current value through a separate process.", "current_reports": [], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "Preserve the original grade ?, score null and safety label Caution. Related human data exist, so no label of no human research is applied; downstream evidence axes remain null. The original calculator's rejection of the null schema, non-adoption of its invalid raw B suggestion, document self-assessment A and historical deployment on 2026-09-16 are separate events. Do not aggregate the current criterion statuses into a new score/grade or label public completion.", "condition_status": "Met", "status_reason": "The original current value, exception, document self-assessment and historical deployment were separated from content-verification status and current local preparation.", "missingness": "Directly eligible effect/CI, support in an up-to-date calculation system, public publication in this review and independent clinical certification remain incomplete.", "uncertainty": "The original ? expresses unverified information; the raw B suggestion is not an adopted efficacy grade. Document quality A is not certainty of the evidence.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original verdict/calculation-exception records, identity/deployment history, authorized change decisions and complete versions before and after changes." }, { "item_id": "N41", "question_type": "Historical local documents", "question": "Were S20/S21 kept from being labeled as rule files read in this review?", "needed": "Separate historical reading of S20/S21 from reading their bibliographic summaries and not reading the source documents in this review. Required source materials: Historical local source documents, versions, bytes/SHA and application/access records from the time.", "role": "Supplementary; required for tracing local materials", "role_reason": "This traceability criterion distinguishes current summary access from source-document access for local rule documents as well.", "application_exception": "Do not create current file links from original relative paths without safe actual files, or count them as external clinical results.", "criterion": "Separate historical reading of S20/S21 from reading their bibliographic summaries and not reading the source documents in this review.", "basis": "M04 §4.5–4.6 data-collection/selection principles; separation of access from reading and the hyperlink contract are internally designed; M04 §4.5, §4.6.3; limitations on the current material conversion follow the user-defined scope and internal design — this is an item-specific adaptation for historical local documents, not implementation/certification of an official method.", "condition_origin": "Development criteria individually designed with knowledge of the current retained content for 3118. Neither blinded nor preregistered.", "proposed_research": "If separate verification is needed, first check actual file identity, distinguishing historical application from access events in this review.", "current_reports": [ "S20", "S21" ], "existence": "Location and source identity of the currently retained stored summary verified; the current existence and public availability of all original external/historical separate documents remain unverified", "acquired_read": "Retained stored summary read; external full texts, abstracts, registry records and historical separate documents were not accessed, acquired or read in this review, and access was not attempted", "observation": "S20 governing prompt and S21 scoring rubric are local documents recorded as having been read previously as complete supplied files. In this review, only bibliography/locations/metadata at /sources/19·20 were read; the full text, bytes and SHA of those historical separate files were not directly verified. They are also distinct from the current quality contract, family copies and retained materials for the 5 methods chapters.", "condition_status": "Met", "status_reason": "Historical records of local rules' existence were not promoted to current source-file acquisition/reading and were distinguished from the current writing instructions.", "missingness": "The current existence/identity of the two historical source files and their original bytes/SHA remain unverified in this review.", "uncertainty": "A URL string being a local relative path does not itself make it a currently valid clickable link or an acquired file.", "review_date": "2026-10-05", "reading_status": "Original source not read · Stored summary read", "additional_material": "Historical local source documents, versions, bytes/SHA and application/access records from the time." } ], "reports": [ { "report_id": "S01", "title": "Wong et al. 2018. Thiamine versus placebo in older heart failure patients: study protocol for a randomized controlled trial", "url": "https://link.springer.com/article/10.1186/s40814-018-0342-0", "report_type": "Indirect-trial protocol", "existence": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified", "acquired_read": "Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review", "study_family": "F01", "independent_replication": false, "observed_result": "The 2018 HF protocol concerns ordinary thiamine mononitrate in heart failure at age 60 years or older: 500 mg/day, 90 days per period, a 6-week washout and a placebo-controlled crossover. It lacks an objective-functional-impairment cutoff and usual-gait-speed endpoint, and belongs to the same family as S02–S04. The historical record concerns the main HTML text; the corresponding source was not read in this review.", "result_level": "The retained extraction, bibliographic and access records as of 2026-09-16 were read and attributed through the local summary in this review. This is not rereading/verification of the corresponding source document.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Full protocol text in HTML", "public_status": "Only retained historical access records are available; no direct lookup in this review", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified. Access to the source material was not attempted, and it was not acquired or read in this review.", "material_id": "S01-M1", "url": "https://link.springer.com/article/10.1186/s40814-018-0342-0", "parent_url": "https://link.springer.com/article/10.1186/s40814-018-0342-0" } ], "links": [ { "label": "Source", "url": "https://link.springer.com/article/10.1186/s40814-018-0342-0" } ] }, { "report_id": "S02", "title": "Wong et al. 2022. High-Dose Thiamine Supplementation in Older Patients With Heart Failure: THIAMINE-HF", "url": "https://www.researchgate.net/publication/358711461_High-Dose_Thiamine_Supplementation_in_Older_Patients_With_Heart_Failure_A_Pilot_Randomized_Controlled_Crossover_Trial_THIAMINE-HF", "report_type": "Final report of an indirect randomized crossover trial", "existence": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified", "acquired_read": "Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review", "study_family": "F01", "independent_replication": false, "observed_result": "HF: 24 randomized, 12 per sequence, 19 completed; mean age 73.4 ± 7.4 years, 7 women. Mononitrate 500 mg/day, 90 days per period, a 6-week washout and reported adherence of 92.5%, but usual gait speed was not measured. Records of other cardiac results showing no difference/an unfavorable KCCQ signal, improvement after discontinuation for 1 diarrhea event and inconsistent SAE totals are retained. Only the reproduction of the relevant original article's main text on ResearchGate was used at the time; publisher 403, PMC challenge and lack of supplement access are separate. No rereading or new incidence estimate in this review.", "result_level": "The retained extraction, bibliographic and access records as of 2026-09-16 were read and attributed through the local summary in this review. This is not rereading/verification of the corresponding source document.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "HTML reproduction of the original article's full text", "public_status": "Only retained historical access records are available; no direct lookup in this review", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified. Access to the source material was not attempted, and it was not acquired or read in this review.", "material_id": "S02-M1", "url": "https://www.researchgate.net/publication/358711461_High-Dose_Thiamine_Supplementation_in_Older_Patients_With_Heart_Failure_A_Pilot_Randomized_Controlled_Crossover_Trial_THIAMINE-HF", "parent_url": "https://www.researchgate.net/publication/358711461_High-Dose_Thiamine_Supplementation_in_Older_Patients_With_Heart_Failure_A_Pilot_Randomized_Controlled_Crossover_Trial_THIAMINE-HF" } ], "links": [ { "label": "Source", "url": "https://www.researchgate.net/publication/358711461_High-Dose_Thiamine_Supplementation_in_Older_Patients_With_Heart_Failure_A_Pilot_Randomized_Controlled_Crossover_Trial_THIAMINE-HF" } ] }, { "report_id": "S03", "title": "THIAMINE-HF trial registry", "url": "https://clinicaltrials.gov/study/NCT03228030", "report_type": "Registry lead for the same trial", "existence": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified", "acquired_read": "Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review", "study_family": "F01", "independent_replication": false, "observed_result": "NCT03228030 identifies the same HF registration as S01/S02. Previously, only the official shell was readable; detailed fields/version history were not acquired. The registration-date account relies on S01/S02 and is neither verification of native history nor independent replication.", "result_level": "The retained extraction, bibliographic and access records as of 2026-09-16 were read and attributed through the local summary in this review. This is not rereading/verification of the corresponding source document.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Official registry app screen shell/identifier", "public_status": "Only retained historical access records are available; no direct lookup in this review", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified. Access to the source material was not attempted, and it was not acquired or read in this review.", "material_id": "S03-M1", "url": "https://clinicaltrials.gov/study/NCT03228030", "parent_url": "https://clinicaltrials.gov/study/NCT03228030" } ], "links": [ { "label": "Source", "url": "https://clinicaltrials.gov/study/NCT03228030" } ] }, { "report_id": "S04", "title": "THIAMINE-HF 2021 conference abstract", "url": "https://www.sciencedirect.com/science/article/pii/S0828282X21005365", "report_type": "Conference report from the same cohort", "existence": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified", "acquired_read": "Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review", "study_family": "F01", "independent_replication": false, "observed_result": "The 2021 conference abstract is a recruitment/adherence excerpt from the same 24-participant family. The difference between the abstract's 95.0% and the final report's 92.5% is retained as originally recorded; reasons involving definitions/denominators remain unverified. It is not a separate trial or a target gait-speed result.", "result_level": "The retained extraction, bibliographic and access records as of 2026-09-16 were read and attributed through the local summary in this review. This is not rereading/verification of the corresponding source document.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Indexed conference-abstract excerpt", "public_status": "Only retained historical access records are available; no direct lookup in this review", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified. Access to the source material was not attempted, and it was not acquired or read in this review.", "material_id": "S04-M1", "url": "https://www.sciencedirect.com/science/article/pii/S0828282X21005365", "parent_url": "https://www.sciencedirect.com/science/article/pii/S0828282X21005365" } ], "links": [ { "label": "Source", "url": "https://www.sciencedirect.com/science/article/pii/S0828282X21005365" } ] }, { "report_id": "S05", "title": "Yang et al. 2023. Low-protein formula supplementation in older adults with chronic kidney disease", "url": "https://link.springer.com/article/10.1186/s12882-023-03423-8", "report_type": "Open-label randomized nutritional trial of a different exposure", "existence": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified", "acquired_read": "Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review", "study_family": "F02", "independent_replication": false, "observed_result": "Nondialysis older adults with CKD stages 3–5: 66 randomized, 47 analyzed (24/23), with multicomponent formula+low-protein diet versus diet alone for 3 months. For 5 m gait change, the intervention-arm median is +0.07 m/s (IQR −0.02~0.22), with within-group P=0.048 and between-group change-test P=0.009; the between-group magnitude/CI is null. This is not an effect of B1 alone, and the objective-functional-impairment cutoff is unverified. Retain historical records of main-text-only access, failure to access separate Table 2/3 and conflicting registration-date formatting.", "result_level": "The retained extraction, bibliographic and access records as of 2026-09-16 were read and attributed through the local summary in this review. This is not rereading/verification of the corresponding source document.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Original article full text in HTML", "public_status": "Only retained historical access records are available; no direct lookup in this review", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified. Access to the source material was not attempted, and it was not acquired or read in this review.", "material_id": "S05-M1", "url": "https://link.springer.com/article/10.1186/s12882-023-03423-8", "parent_url": "https://link.springer.com/article/10.1186/s12882-023-03423-8" } ], "links": [ { "label": "Source", "url": "https://link.springer.com/article/10.1186/s12882-023-03423-8" } ] }, { "report_id": "S06", "title": "Ito et al. 2012. Thiamin status and nursing-care needs in elderly residents", "url": "https://www.jstage.jst.go.jp/article/jnsv/58/3/58_210/_pdf", "report_type": "Cross-sectional observation of nutritional status", "existence": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified", "acquired_read": "Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review", "study_family": "F03", "independent_replication": false, "observed_result": "Nursing-home residents: 74 (42 deficient, 32 nondeficient), whole-blood thiamine by HPLC <20 ng/mL. Unaided walking in 21/42 versus 6/32 is not m/s. Confounding includes oral nutrition in all deficient participants and tube/intravenous nutrition in 12/32 nondeficient participants, so this is not interpreted as a benefit of deficiency or a causal supplementation effect. Historical checking of text from all 7 pages of the PDF/some screenshots is recorded; the original PDF was not read in this review.", "result_level": "The retained extraction, bibliographic and access records as of 2026-09-16 were read and attributed through the local summary in this review. This is not rereading/verification of the corresponding source document.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Original article full-text PDF/some page images", "public_status": "Only retained historical access records are available; no direct lookup in this review", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified. Access to the source material was not attempted, and it was not acquired or read in this review.", "material_id": "S06-M1", "url": "https://www.jstage.jst.go.jp/article/jnsv/58/3/58_210/_pdf", "parent_url": "https://www.jstage.jst.go.jp/article/jnsv/58/3/58_210/_pdf" } ], "links": [ { "label": "Source", "url": "https://www.jstage.jst.go.jp/article/jnsv/58/3/58_210/_pdf" } ] }, { "report_id": "S07", "title": "Pourhassan et al. 2019. Thiamine status and functional recovery in hospitalized geriatric patients", "url": "https://journals.sagepub.com/doi/10.1177/0891988718819862", "report_type": "Functional/nutritional observation in older inpatients", "existence": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified", "acquired_read": "Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review", "study_family": "F04", "independent_replication": false, "observed_result": "The record describes 233 inpatients, mean age 82.1 ± 7.1 years; the number with thiamine <20 ng/mL is 0. The observed association between blood thiamine and Barthel improvement is not an oral-treatment or usual-gait-speed effect. Historical access was to the publisher abstract; full text was not acquired.", "result_level": "The retained extraction, bibliographic and access records as of 2026-09-16 were read and attributed through the local summary in this review. This is not rereading/verification of the corresponding source document.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Publisher abstract/references", "public_status": "Only retained historical access records are available; no direct lookup in this review", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified. Access to the source material was not attempted, and it was not acquired or read in this review.", "material_id": "S07-M1", "url": "https://journals.sagepub.com/doi/10.1177/0891988718819862", "parent_url": "https://journals.sagepub.com/doi/10.1177/0891988718819862" } ], "links": [ { "label": "Source", "url": "https://journals.sagepub.com/doi/10.1177/0891988718819862" } ] }, { "report_id": "S08", "title": "Struijk et al. 2018. Intake of B vitamins and impairment in physical function in older adults", "url": "https://pubmed.ncbi.nlm.nih.gov/28602467/", "report_type": "Dietary observational cohort concerning other nutrients", "existence": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified", "acquired_read": "Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review", "study_family": "F05", "independent_replication": false, "observed_result": "Self-reported functional data from people aged 60 years or older, numbering 1,630, concerning B6/B12/folate intake in a population without functional impairment at baseline. This is not single-ingredient oral B1 supplementation or an eligible gait comparison. Historical indexed-abstract reading through the general web is distinguished from a blank direct PubMed page and unsuccessful native search.", "result_level": "The retained extraction, bibliographic and access records as of 2026-09-16 were read and attributed through the local summary in this review. This is not rereading/verification of the corresponding source document.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Officially indexed article abstract", "public_status": "Only retained historical access records are available; no direct lookup in this review", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified. Access to the source material was not attempted, and it was not acquired or read in this review.", "material_id": "S08-M1", "url": "https://pubmed.ncbi.nlm.nih.gov/28602467/", "parent_url": "https://pubmed.ncbi.nlm.nih.gov/28602467/" } ], "links": [ { "label": "Source", "url": "https://pubmed.ncbi.nlm.nih.gov/28602467/" } ] }, { "report_id": "S09", "title": "NIH Office of Dietary Supplements: Thiamin, Health Professional Fact Sheet", "url": "https://ods.od.nih.gov/factsheets/Thiamin-HealthProfessional/", "report_type": "Official nutritional/safety context", "existence": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified", "acquired_read": "Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review", "study_family": null, "independent_replication": false, "observed_result": "Official context on at-risk groups, risks of excessive intake and medication interactions. No established UL does not mean unlimited safety, and this is not a gait-speed efficacy or actual oral-exposure incidence result. Historical official full-text HTML access is recorded; the source was not read in this review.", "result_level": "The retained extraction, bibliographic and access records as of 2026-09-16 were read and attributed through the local summary in this review. This is not rereading/verification of the corresponding source document.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Official nutritional fact sheet full text in HTML", "public_status": "Only retained historical access records are available; no direct lookup in this review", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified. Access to the source material was not attempted, and it was not acquired or read in this review.", "material_id": "S09-M1", "url": "https://ods.od.nih.gov/factsheets/Thiamin-HealthProfessional/", "parent_url": "https://ods.od.nih.gov/factsheets/Thiamin-HealthProfessional/" } ], "links": [ { "label": "Source", "url": "https://ods.od.nih.gov/factsheets/Thiamin-HealthProfessional/" } ] }, { "report_id": "S10", "title": "Flamingo Pharma UK: Thiamine Hydrochloride 100 mg Tablets SmPC", "url": "https://www.medicines.org.uk/emc/product/13528/smpc", "report_type": "Product-specific authorization information", "existence": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified", "acquired_read": "Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review", "study_family": null, "independent_replication": false, "observed_result": "Flamingo hydrochloride 100 mg tablet SmPC, with a locator recording the 2025-09-08 update and §2/4.1–4.9. Gastrointestinal/hypersensitivity, pregnancy/lactation and excipient warnings are limited to that product; predominantly injection-related hypersensitivity wording is not transferred into an oral risk rate. It is not the same product as the target eligible study product or HF mononitrate.", "result_level": "The retained extraction, bibliographic and access records as of 2026-09-16 were read and attributed through the local summary in this review. This is not rereading/verification of the corresponding source document.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Full HTML SmPC for an oral hydrochloride 100 mg product", "public_status": "Only retained historical access records are available; no direct lookup in this review", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified. Access to the source material was not attempted, and it was not acquired or read in this review.", "material_id": "S10-M1", "url": "https://www.medicines.org.uk/emc/product/13528/smpc", "parent_url": "https://www.medicines.org.uk/emc/product/13528/smpc" } ], "links": [ { "label": "Source", "url": "https://www.medicines.org.uk/emc/product/13528/smpc" } ] }, { "report_id": "S11", "title": "NICE CG32 Nutrition support for adults", "url": "https://www.nice.org.uk/guidance/cg32/chapter/recommendations", "report_type": "Official-guideline lead for a different clinical purpose", "existence": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified", "acquired_read": "Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review", "study_family": null, "independent_replication": false, "observed_result": "Only the context of high risk of refeeding problems in NICE CG32 1.4.8 is retained. Historical indexed excerpts and failed direct access are recorded; the original guideline was not read in this review. Do not convert this into a gait-speed dose/efficacy claim or personal supplementation recommendation.", "result_level": "The retained extraction, bibliographic and access records as of 2026-09-16 were read and attributed through the local summary in this review. This is not rereading/verification of the corresponding source document.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Indexed official-guideline excerpt", "public_status": "Only retained historical access records are available; no direct lookup in this review", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified. Access to the source material was not attempted, and it was not acquired or read in this review.", "material_id": "S11-M1", "url": "https://www.nice.org.uk/guidance/cg32/chapter/recommendations", "parent_url": "https://www.nice.org.uk/guidance/cg32/chapter/recommendations" } ], "links": [ { "label": "Source", "url": "https://www.nice.org.uk/guidance/cg32/chapter/recommendations" } ] }, { "report_id": "S12", "title": "Nutritional support system in cerebral palsy registry", "url": "https://clinicaltrials.gov/study/NCT05648422", "report_type": "Registry candidate with a different population/multicomponent exposure", "existence": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified", "acquired_read": "Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review", "study_family": "F06", "independent_replication": false, "observed_result": "A lead for the multicomponent intervention in NCT05648422 (multiple amino acids/vitamins). No isolated ordinary-thiamine usual-gait effect or result in the target population of older adults with objective functional impairment was verified. Historical shell/indexed access is recorded; the original registration was not read in this review.", "result_level": "The retained extraction, bibliographic and access records as of 2026-09-16 were read and attributed through the local summary in this review. This is not rereading/verification of the corresponding source document.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Official registry screen shell/indexed excerpt", "public_status": "Only retained historical access records are available; no direct lookup in this review", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified. Access to the source material was not attempted, and it was not acquired or read in this review.", "material_id": "S12-M1", "url": "https://clinicaltrials.gov/study/NCT05648422", "parent_url": "https://clinicaltrials.gov/study/NCT05648422" } ], "links": [ { "label": "Source", "url": "https://clinicaltrials.gov/study/NCT05648422" } ] }, { "report_id": "S13", "title": "GLYLOW postmenopausal obesity registry lead", "url": "https://clinicaltrials.gov/study/NCT06242535", "report_type": "Registry lead with unresolved eligibility", "existence": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified", "acquired_read": "Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review", "study_family": "F07", "independent_replication": false, "observed_result": "A title/identifier lead for NCT06242535 GLYLOW in postmenopausal obesity. Detailed official fields/history were inaccessible previously; 3rd-party leads alone did not establish exact composition or an eligible gait result. Access to the original registration was not attempted in this review, and it is not counted as direct replication.", "result_level": "The retained extraction, bibliographic and access records as of 2026-09-16 were read and attributed through the local summary in this review. This is not rereading/verification of the corresponding source document.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Official registry app screen shell/identifier", "public_status": "Only retained historical access records are available; no direct lookup in this review", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified. Access to the source material was not attempted, and it was not acquired or read in this review.", "material_id": "S13-M1", "url": "https://clinicaltrials.gov/study/NCT06242535", "parent_url": "https://clinicaltrials.gov/study/NCT06242535" } ], "links": [ { "label": "Source", "url": "https://clinicaltrials.gov/study/NCT06242535" } ] }, { "report_id": "S14", "title": "Wilkinson et al. 1997. The response to treatment of subclinical thiamine deficiency in the elderly", "url": "https://www.academia.edu/18660919/The_response_to_treatment_of_subclinical_thiamine_deficiency_in_the_elderly", "report_type": "Prior extraction of a trial with a different population/endpoint", "existence": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified", "acquired_read": "Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review", "study_family": "F08", "independent_replication": false, "observed_result": "A prior extraction concerning dominant-hand grip measured with a Preston dynamometer: 76 randomized, erythrocyte TPP <140 nmol/L, oral 10 mg/day, 3 months, exact salt null. Selection for objective functional impairment/usual-gait results remains unverified. A previously supplied extraction was reused; access preceding that extraction was recorded as an HTML reproduction of the source. Neither the source nor the historical 3117 file was opened directly in this review.", "result_level": "The retained extraction, bibliographic and access records as of 2026-09-16 were read and attributed through the local summary in this review. This is not rereading/verification of the corresponding source document.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Prior factual extraction/bibliographic summary of the original article · Original-article link (historical extraction reused)", "public_status": "Only retained historical access records are available; no direct lookup in this review", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified. Access to the source material was not attempted, and it was not acquired or read in this review.", "material_id": "S14-M1", "url": "https://www.academia.edu/18660919/The_response_to_treatment_of_subclinical_thiamine_deficiency_in_the_elderly", "parent_url": "https://www.academia.edu/18660919/The_response_to_treatment_of_subclinical_thiamine_deficiency_in_the_elderly" } ], "links": [ { "label": "Source", "url": "https://www.academia.edu/18660919/The_response_to_treatment_of_subclinical_thiamine_deficiency_in_the_elderly" } ] }, { "report_id": "S15", "title": "Bager et al. 2021. Randomised clinical trial: high-dose oral thiamine versus placebo for chronic fatigue in patients with quiescent inflammatory bowel disease", "url": "https://onlinelibrary.wiley.com/doi/10.1111/apt.16166", "report_type": "Prior extraction of a trial with a different population/endpoint", "existence": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified", "acquired_read": "Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review", "study_family": "F09", "independent_replication": false, "observed_result": "A prior extraction of a placebo-controlled crossover trial for chronic fatigue in quiescent IBD. Historical source access is recorded as publisher abstract/indexed grip-strength excerpt; it is not a gait-speed comparison in older adults with functional impairment. No new research, regrading or current full-text reading was performed.", "result_level": "The retained extraction, bibliographic and access records as of 2026-09-16 were read and attributed through the local summary in this review. This is not rereading/verification of the corresponding source document.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Prior publisher-abstract/indexed grip-strength extraction · Original-article link (historical extraction reused)", "public_status": "Only retained historical access records are available; no direct lookup in this review", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified. Access to the source material was not attempted, and it was not acquired or read in this review.", "material_id": "S15-M1", "url": "https://onlinelibrary.wiley.com/doi/10.1111/apt.16166", "parent_url": "https://onlinelibrary.wiley.com/doi/10.1111/apt.16166" } ], "links": [ { "label": "Source", "url": "https://onlinelibrary.wiley.com/doi/10.1111/apt.16166" } ] }, { "report_id": "S16", "title": "Smidt et al. 1991. Influence of Thiamin Supplementation on the Health and General Well-being of an Elderly Irish Population With Marginal Thiamin Deficiency", "url": "https://academic.oup.com/geronj/article-abstract/46/1/M16/638741", "report_type": "Prior extraction of a study in a different population", "existence": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified", "acquired_read": "Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review", "study_family": "F10", "independent_replication": false, "observed_result": "A prior extraction concerning healthy older women with marginal thiamine deficiency; an objective-functional-impairment cutoff and usual-gait results remain unverified. It was reused for question boundaries; the corresponding source/historical separate file was not opened in this review.", "result_level": "The retained extraction, bibliographic and access records as of 2026-09-16 were read and attributed through the local summary in this review. This is not rereading/verification of the corresponding source document.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Prior article-abstract/bibliographic extraction · Original-article link (historical extraction reused)", "public_status": "Only retained historical access records are available; no direct lookup in this review", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified. Access to the source material was not attempted, and it was not acquired or read in this review.", "material_id": "S16-M1", "url": "https://academic.oup.com/geronj/article-abstract/46/1/M16/638741", "parent_url": "https://academic.oup.com/geronj/article-abstract/46/1/M16/638741" } ], "links": [ { "label": "Source", "url": "https://academic.oup.com/geronj/article-abstract/46/1/M16/638741" } ] }, { "report_id": "S17", "title": "Artiukhov et al. 2024. Pharmacological Doses of Thiamine Benefit Patients with the Charcot–Marie–Tooth Neuropathy by Changing Thiamine Diphosphate Levels and Affecting Regulation of Thiamine-Dependent Enzymes", "url": "https://link.springer.com/article/10.1134/S0006297924070010", "report_type": "Prior extraction of uncontrolled mixed-form observations/correction", "existence": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified", "acquired_read": "Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review", "study_family": "F11", "independent_replication": false, "observed_result": "A prior extraction of uncontrolled CMT observations and a correction involving mixed ages and thiamine forms/derivatives. This is not an eligible gait comparison for single-ingredient oral ordinary thiamine; no claim is made that the original observations/correction or historical extraction were directly read in this review or that the matter was thereby certified as resolved.", "result_level": "The retained extraction, bibliographic and access records as of 2026-09-16 were read and attributed through the local summary in this review. This is not rereading/verification of the corresponding source document.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Prior bibliographic/factual extraction of observations/correction · Original-article link (historical extraction reused)", "public_status": "Only retained historical access records are available; no direct lookup in this review", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified. Access to the source material was not attempted, and it was not acquired or read in this review.", "material_id": "S17-M1", "url": "https://link.springer.com/article/10.1134/S0006297924070010", "parent_url": "https://link.springer.com/article/10.1134/S0006297924070010" } ], "links": [ { "label": "Source", "url": "https://link.springer.com/article/10.1134/S0006297924070010" } ] }, { "report_id": "S18", "title": "Ohkoshi et al. 2006. Functional Limitations in Thiamine Deficiency Neuropathy: FIM Score Improvement With Treatment", "url": "https://www.ovid.com/jnls/jcnmd/fulltext/10.1097/01.cnd.0000203643.84628.a1~functional-limitations-in-thiamine-deficiency-neuropathy-fim", "report_type": "Prior extraction of a treatment report using a different scale", "existence": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified", "acquired_read": "Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review", "study_family": "F12", "independent_replication": false, "observed_result": "Title/abstract extraction of a report on FIM improvement in deficiency neuropathy. It does not verify a controlled ordinary-oral-thiamine gait-speed result in eligible older adults; neither full text nor the historical extraction was reread in this review.", "result_level": "The retained extraction, bibliographic and access records as of 2026-09-16 were read and attributed through the local summary in this review. This is not rereading/verification of the corresponding source document.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Prior factual extraction from article title/abstract · Original-article link (historical extraction reused)", "public_status": "Only retained historical access records are available; no direct lookup in this review", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified. Access to the source material was not attempted, and it was not acquired or read in this review.", "material_id": "S18-M1", "url": "https://www.ovid.com/jnls/jcnmd/fulltext/10.1097/01.cnd.0000203643.84628.a1~functional-limitations-in-thiamine-deficiency-neuropathy-fim", "parent_url": "https://www.ovid.com/jnls/jcnmd/fulltext/10.1097/01.cnd.0000203643.84628.a1~functional-limitations-in-thiamine-deficiency-neuropathy-fim" } ], "links": [ { "label": "Source", "url": "https://www.ovid.com/jnls/jcnmd/fulltext/10.1097/01.cnd.0000203643.84628.a1~functional-limitations-in-thiamine-deficiency-neuropathy-fim" } ] }, { "report_id": "S19", "title": "Costantini et al. 2016. High-dose thiamine improves the symptoms of myotonic dystrophy type 1", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC5090854/", "report_type": "Prior extraction of cases involving a different route", "existence": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified", "acquired_read": "Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review", "study_family": "F13", "independent_replication": false, "observed_result": "Extraction of uncontrolled intramuscular observations in myotonic dystrophy. It is not the target gait comparison for single-ingredient oral ordinary thiamine; the existence of a PMC URL is not labeled as reading of the original full text in this review.", "result_level": "The retained extraction, bibliographic and access records as of 2026-09-16 were read and attributed through the local summary in this review. This is not rereading/verification of the corresponding source document.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Prior factual extraction of intramuscular cases · Original-article link (historical extraction reused)", "public_status": "Only retained historical access records are available; no direct lookup in this review", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified. Access to the source material was not attempted, and it was not acquired or read in this review.", "material_id": "S19-M1", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC5090854/", "parent_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC5090854/" } ], "links": [ { "label": "Source", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC5090854/" } ] }, { "report_id": "S20", "title": "Supplied R01 governing prompt and current-value rules", "url": null, "report_type": "Bibliographic record of a historical local operational input", "existence": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified", "acquired_read": "Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review", "study_family": null, "independent_replication": false, "observed_result": "A record that historical operational prompt §1–6 and current-value/document-quality rules were previously read as complete supplied files. Only bibliography/locations in the source were read in this review; the separate original file and SHA were not verified.", "result_level": "The retained extraction, bibliographic and access records as of 2026-09-16 were read and attributed through the local summary in this review. This is not rereading/verification of the corresponding source document.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Historical local prompt Markdown document", "public_status": "Only retained historical access records are available; no direct lookup in this review", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified. The historical separate documents were not read in this review.", "material_id": "S20-M1", "url": null, "parent_url": null } ], "links": [] }, { "report_id": "S21", "title": "Supplied scoring rubric", "url": null, "report_type": "Bibliographic record of historical local rules", "existence": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified", "acquired_read": "Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review", "study_family": null, "independent_replication": false, "observed_result": "The historical original scoring rubric is recorded as supplied_complete_file with its original SHA retained. The historical original file and actual SHA were not verified in this review; they differ from the current template/copies of the 5 methods chapters. No new axis/grade calculation was performed.", "result_level": "The retained extraction, bibliographic and access records as of 2026-09-16 were read and attributed through the local summary in this review. This is not rereading/verification of the corresponding source document.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Historical local scoring-rubric Markdown document", "public_status": "Only retained historical access records are available; no direct lookup in this review", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current stored bibliographic identity verified; the full current existence/public availability of the source material remains unverified. The historical separate documents were not read in this review.", "material_id": "S21-M1", "url": null, "parent_url": null } ], "links": [] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility criteria and reasons for changes, and distinguish variations in the intervention.", "review_level": "Historical reuse of the retained HTML copies/SHA for 1585 and the methodological principles from that time. This is not new reading of the full methodological sources, official implementation or clinical certification in this review." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish and link studies and reports, and do not omit a study solely because its outcomes are not reported.", "review_level": "Historical reuse of the retained HTML copies/SHA for 1585 and the methodological principles from that time. This is not new reading of the full methodological sources, official implementation or clinical certification in this review." }, { "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": "Historical reuse of the retained HTML copies/SHA for 1585 and the methodological principles from that time. This is not new reading of the full methodological sources, official implementation or clinical certification in this review." }, { "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": "Historical reuse of the retained HTML copies/SHA for 1585 and the methodological principles from that time. This is not new reading of the full methodological sources, official implementation or clinical certification in this review." }, { "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": "Historical reuse of the retained HTML copies/SHA for 1585 and the methodological principles from that time. This is not new reading of the full methodological sources, official implementation or clinical certification in this review." } ], "status_dictionary": { "Met": "The relevant identity, material attribution, retained scope or boundary has been verified. This is not confirmation of clinical benefit/safety or official certification.", "Partly verified": "Some populations, values or methods in the record are retained, but verification dimensions needed for the question remain unresolved.", "Unverified": "Required materials/values cannot be established within the retained scope read. This does not mean no studies, an effect of 0 or 0 events.", "Conflicting information": "Retain the record of notation/aggregation discrepancies in the relevant indirect original report. Do not create conflicts through new calculations or solely from numerical differences between different analyses.", "Not applicable": "An extension requirement that does not apply to the outcome conditions of the current narrow question; it does not replace unverified materials.", "Does not apply": "An extension requirement that does not apply to the outcome conditions of the current narrow question; it does not replace unverified materials.", "Not reported": "An information gap at the retained location actually read; not a declaration that the information is unreported throughout the external article.", "Inaccessible": "Requires an actual failed access attempt in the current review; lack of an attempt in this review must be distinguished from a historical failure.", "Review incomplete": "Individual review pending during table preparation, separate from unverified materials or unread source materials." }, "study_overlap": { "state": "The 13 original families are retained identities of related/indirect studies or candidates, not a count of directly eligible replications. Do not count F01 S01–S04, the same 24-participant crossover family, as 4 trials or 48 participants. No new total of unique participants is calculated. The total number of unique trials and the overall participant total are unverified. Reading the retained summary is distinguished from not reading the source materials in this review.", "unique_trial_count": null, "unique_participant_count": null, "reason": "The 13 original families are retained identities of related/indirect studies or candidates, not a count of directly eligible replications. Do not count F01 S01–S04, the same 24-participant crossover family, as 4 trials or 48 participants. No new total of unique participants is calculated. The total number of unique trials and the overall participant total are unverified. Reading the stored summary is distinguished from not reading the source materials in this review." }, "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 41 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-11-06" }