Ordinary thiamine (vitamin B1), single-ingredient oral use × Whether usual gait speed improves in older adults with objectively impaired physical function

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Met	Full text not readStored summary read	N01 · Claim identityIs the distinct boundary of the gait-speed question clear?Required	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.	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.	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.	Break the original question down into population, exposure, comparator, measure and time point, and reconsider its identity only when a new claim arises.
2	Met	Full text not readStored summary read	N02 · Retained search scopeAs of which date and within which search scope are direct results unverified?Required	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.	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.	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.	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.
3	Met	Full text not readStored summary read	N03 · Reading levelWas reading the stored summary distinguished from reading the corresponding source material?Required	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. S01 S02 S03 S04 S05 S06 S07 S08 S09 S10 S11 S12 S13 S14 S15 S16 S17 S18 S19 S20 S21	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.	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.	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.
4	Unverified	Full text not readStored summary read	N04 · Population selectionWere the criteria for older age and objective functional impairment verified?Required	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. S01 S02 S05	Without actual selection criteria from a directly eligible study, a similar age or disease label cannot substitute for verification of the population.	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.	In a comparative study of older adults with a prespecified functional-impairment instrument and cutoff, compare measurements at selection with the participants actually included.
5	Partly verified	Full text not readStored summary read	N05 · Baseline nutritional statusWas selection for deficiency distinguished from selection for functional impairment?Supplementary; required for claims of applicability by deficiency status	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. S02 S06 S14	Markers and selection boundaries in indirect materials are retained, but deficiency status in the directly eligible population cannot be established.	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.	Measure deficiency status separately in participants with functional impairment, and distinguish results for those requiring correction from those receiving additional supplementation.
6	Partly verified	Full text not readStored summary read	N06 · Molecular form and routeWere the salts and routes of ordinary thiamine accurately distinguished?Required	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. S01 S02 S10	The question and excluded forms are clear, but there is no basis for verifying the actual eligible product/salt.	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.	Fix each formulation's identity and extract results for single-active-ingredient oral exposure separately.
7	Unverified	Full text not readStored summary read	N07 · Dose and scheduleWere nominal dose, actual dose and thiamine-equivalent amount verified?Required	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. S02 S14	There is no direct administration record, and an indirect study's nominal dose cannot fill the actual-dose field for this question.	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.	Record planned doses and actual administered doses separately in a single-ingredient comparison, and examine the relationship between adherence and the analysis population.
8	Unverified	Full text not readStored summary read	N08 · Treatment and measurement timesWere treatment duration and the principal gait-speed measurement time point verified?Required	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. S02 S05	Because no eligible comparison was selected, the duration of another exposure does not establish the target regimen.	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.	Fix treatment and measurement schedules separately, distinguishing final values, changes and post-discontinuation results in advance.
9	Unverified	Full text not readStored summary read	N09 · Comparator and concomitant careHow did care other than thiamine actually differ?Required	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. S01 S02 S05	Without verification of concomitant care and changes by arm in the direct comparison, differences in other care cannot be separated from thiamine's contribution.	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.	Specify the care shared by the arms, record actual changes and adherence, and link the intervention contrast of interest to the effect analyzed.
10	Unverified	Full text not readStored summary read	N10 · Comparative designWere allocation, blinding and analysis design for the direct gait-speed comparison verified?Required	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. S01 S02	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.	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.	Select an eligible comparison first, then examine actual limitations in allocation, measurement, missing data and analysis for each gait-speed result of interest.
11	Unverified	Full text not readStored summary read	N11 · Gait measurementWas the actual testing procedure for usual gait speed verified?Required	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. S05	The measurement name alone cannot verify the actual protocol or measurement differences, and another functional scale does not substitute for target gait speed.	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.	Fix usual-speed instructions and distance/start conditions, and consistently record repeated measurements, assistive devices and assessor conditions.
12	Unverified	Full text not readStored summary read	N12 · Effect definitionWere the between-group effect, final values and changes verified?Required	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. S05	Without a selected direct result and analysis definition, the magnitude and direction of the effect of interest cannot be established.	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.	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.
13	Unverified	Full text not readStored summary read	N13 · Denominators and lossesCan the numbers allocated, completing and analyzed be distinguished from missing data?Required	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. S02 S05	There is no denominator for a direct result, and participant counts from related studies cannot be substituted as the number analyzed for that result.	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.	Trace the flow from allocation to gait measurement and analysis, and examine the effects of missingness reasons and handling for each analysis population.
14	Unverified	Full text not readStored summary read	N14 · Intervals and importanceWere the CI and a clinically important difference verified?Required	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. S05	Without a direct interval and an importance criterion applicable to this population/measure, precision and a meaningful difference cannot be judged.	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.	Report CIs linked to their original estimates and denominators/variances, explaining separately the basis for applying an importance criterion and what remains unverified.
15	Unverified	Full text not readStored summary read	N15 · Planning and registrationWere the primary gait endpoint and planned analysis compared with the actual registration?Required	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. S01 S02 S03	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.	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.	Compare planned gait endpoints, time points and analyses against initial and amended versions and actual reports, retaining the extent of discrepancies and their reasons.
16	Partly verified	Full text not readStored summary read	N16 · Study familiesWere reports from the same study distinguished from direct independent replication?Required	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. S01 S02 S03 S04	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.	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.	Link reports to unique studies first, and compare only independent results verified to match in population, preparation, measure and time point.
17	Partly verified	Full text not readStored summary read	N17 · Funding and conflicts of interestDoes funding of indirect studies establish independence of the target efficacy evidence?Supplementary; required for independence claims	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. S01 S02 S05	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.	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.	Extract study-specific funding, product provision and declared conflicts separately from results, and compare them with the scope of independence claims.
18	Partly verified	Full text not readStored summary read	N18 · HF exposure and populationDoes the single-ingredient oral trial in older HF patients match the target population?Supplementary; required for attribution of indirect materials	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. S01 S02	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.	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.	Link population, salt, route, adherence and exclusion criteria to the eligibility table, specifying differences from the target question.
19	Met	Full text not readStored summary read	N19 · HF outcome boundariesWere HF results showing no difference or unfavorable effects kept from being transferred to gait speed?Supplementary; required for boundaries on transferring results	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. S01 S02	Other endpoints in the same report were retained, with target gait_result=null kept separate from the scope of interpretation.	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.	Attribute each endpoint's results to its definition, time point and denominator, and construct a table of directness for the target question.
20	Conflicting information	Full text not readStored summary read	N20 · HF reporting discrepanciesWas the scope of discrepancies among abstracts, final reports and totals preserved?Supplementary; required for handling conflicting information	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. S02 S04	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.	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.	Compare report versions from the same cohort using the same definitions/denominators, distinguishing resolved differences from remaining conflicts.
21	Met	Full text not readStored summary read	N21 · CKD multicomponent exposureCan the CKD formula's gait results be attributed to B1 alone?Supplementary; required for attribution of combination-product results	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. S05	The actual difference between the multicomponent formula and shared diet was linked, and the failure to isolate thiamine's contribution was made explicit.	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.	If B1's contribution is the question, design a separate single-ingredient add-on contrast with other care matched, while retaining the formula results.
22	Met	Full text not readStored summary read	N22 · Attribution of CKD numerical valuesWere medians, IQRs and within-group/between-group P values distinguished?Supplementary; required for numerical attribution	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. S05	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.	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.	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.
23	Partly verified	Full text not readStored summary read	N23 · CKD testing and denominatorsWere actual CKD gait testing and the analysis population distinguished?Supplementary; required for applicability/denominators	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. S05	The retained population, allocated/analyzed n and some testing details are verified, but target functional-impairment selection and sufficient measurement/missingness information remain unresolved.	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.	Compare participant flow and measurement procedures for each outcome to limit the applicability of the formula results.
24	Conflicting information	Full text not readStored summary read	N24 · CKD registration notationWere registration-date conflicts distinguished from original tables not compared?Supplementary; required for registration/conflicts	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. S05	The record of inconsistent registration-date formatting was retained without newly establishing numerical conflicts throughout unchecked original tables, lack of registration or selective reporting.	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.	Compare the meaning and version of registration dates with the source materials, recording main-text/table access limitations alongside the scope of numerical extraction.
25	Met	Full text not readStored summary read	N25 · Nursing-home observationsWas the observed direction for deficiency and ability to walk kept from being reversed into a supplementation effect?Supplementary; required for attribution of observations	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. S06	Exposure markers, denominators, the different endpoint and confounding were linked to actual family locations, without converting the observational direction into causal supplementation efficacy.	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.	Compare the observational definitions of exposure and outcome with feeding route/care selection, distinguishing them from a separate question about assigned treatment.
26	Met	Full text not readStored summary read	N26 · Inpatient functional observationsWas Barthel recovery distinguished from a treatment effect on gait speed?Supplementary; required for attribution of observations	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. S07	The sample, nutritional marker, different functional scale, observational design and historical abstract-level scope were distinguished.	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.	Link the Barthel association to exposure, time and confounding, and assess it separately from the causal gait-speed question.
27	Met	Full text not readStored summary read	N27 · Observations on other B vitaminsDo dietary data on other B vitamins answer the B1 functional-impairment question?Supplementary; required for boundaries concerning other nutrients	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. S08	Differences from the target in nutrients, population, design and measure were verified at the actual family/bibliographic locations.	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.	Extract differences in each nutrient and functional definition, indicating relevance without pooling them as causal B1 effects.
28	Unverified	Full text not readStored summary read	N28 · Registry candidatesWere the composition, population and results of registry leads actually verified?Supplementary; required for candidate eligibility	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. S12 S13	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.	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.	Check exposure/population/outcome eligibility for each candidate first, linking it to a family only when a result is verified.
29	Met	Full text not readStored summary read	N29 · Grip-strength trial in deficiencyWas Wilkinson's deficiency/grip-strength trial kept from being transferred to gait speed?Supplementary; required for attribution of prior extractions	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. S14	The retained deficiency selection, different measure, administration and scope of extraction reuse were linked.	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.	Compare the questions and measures in the prior extraction and original report, but reconsider separate eligibility only if a gait result was actually reported.
30	Met	Full text not readStored summary read	N30 · IBD fatigue trialIs the TARIF fatigue trial a gait-speed comparison in older adults?Supplementary; required for boundaries concerning other endpoints	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. S15	The distinct fatigue/IBD population and endpoint, and reuse of prior extractions to establish boundaries, were limited to verified locations.	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.	Attribute results to their respective questions using an eligibility table that distinguishes disease-related fatigue, grip strength and gait.
31	Met	Full text not readStored summary read	N31 · Trial in healthy older adultsWas Smidt's healthy/marginal-deficiency population kept separate from the target population?Supplementary; required for population boundaries	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. S16	The difference between the shared condition of older age and actual functional impairment/gait endpoints was preserved.	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.	Distinguish health/functional-impairment and deficiency criteria, and compare direct-gait-comparison eligibility with the original results.
32	Met	Full text not readStored summary read	N32 · CMT mixed-form observationsWere uncontrolled mixed-form CMT data kept from being promoted to direct results?Supplementary; required for attribution of mixed observations	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. S17	Limitations from lack of controls, mixed preparations/ages, different endpoints and correction extractions were attributed to the relevant family.	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.	Separate form/population/route and the content before and after the original correction, examining applicability to the gait comparison.
33	Met	Full text not readStored summary read	N33 · Deficiency neuropathyWas FIM functional improvement kept from being relabeled as usual gait speed?Supplementary; required for scale boundaries	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. S18	Deficiency treatment, the separate functional scale FIM and the prior extraction level were distinguished.	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.	Attribute deficiency-treatment scales and exposures to their original reports, examining separately whether a target gait comparison is established.
34	Met	Full text not readStored summary read	N34 · Injection case reportsAre intramuscular observations in muscular dystrophy oral-comparison data?Supplementary; required for route boundaries	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. S19	The different disease, intramuscular route, absence of controls and historical extraction level were clearly linked.	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.	Separate results by route and disease, distinguishing case observations from effect estimates in controlled trials.
35	Unverified	Full text not readStored summary read	N35 · Direct harm-data gapWere adverse events/discontinuations in the same population and regimen verified?Supplementary; required for the relevant harm/safety claims	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.	Because no direct regimen/population was selected, systematic collection, events/people and discontinuations/losses for that exposure cannot be verified.	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.	Plan harm collection separately within an eligible efficacy comparison, reporting events, people, exposure periods and discontinuation reasons distinctly.
36	Partly verified	Full text not readStored summary read	N36 · HF harm signalWere diarrhea improvement after discontinuation and event totals kept from being converted into risk estimates?Supplementary; required for attribution of harm signals	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. S02	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.	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.	Compare the original event's timing, discontinuation, alternative explanations and event/person totals, distinguishing signals, comparative risk and causal statements.
37	Met	Full text not readStored summary read	N37 · Official product-information boundariesWere the absence of a UL and product wording kept from becoming a general safety guarantee?Supplementary; required for safety-interpretation boundaries	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. S09 S10	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.	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.	Compare applicability by product/route/dose, separating official wording from actually collected events and frequencies.
38	Partly verified	Full text not readStored summary read	N38 · Vulnerable groups and refeedingWere the limited HF/refeeding contexts kept from being applied to all older adults?Supplementary; required for vulnerable-group/long-term safety claims	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. S01 S02 S09 S10 S11	Selection exclusions and the refeeding context are retained, but there are no direct data for the target vulnerable population or long-term exposure.	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.	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.
39	Not applicable	Full text not readStored summary read	N39 · Extended applicabilityWere falls, optimal dose and maintained effects made mandatory parts of the gait-speed question?Supplementary; required for the relevant extended claims	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.	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.	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.	If an extension is requested, first establish the distinct question boundary, then review direct results separately from the existing gait-speed table.
40	Met	Full text not readStored summary read	N40 · Original verdict and historyWere ?/null, the calculation exception, document quality and historical deployment distinguished?Required	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.	The original current value, exception, document self-assessment and historical deployment were separated from content-verification status and current local preparation.	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.	Record verdict, document, calculation and publication events separately; if subsequent evidence is authorized, review any change to the current value through a separate process.
41	Met	Full text not readStored summary read	N41 · Historical local documentsWere S20/S21 kept from being labeled as rule files read in this review?Supplementary; required for tracing local materials	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. S20 S21	Historical records of local rules' existence were not promoted to current source-file acquisition/reading and were distinguished from the current writing instructions.	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.	If separate verification is needed, first check actual file identity, distinguishing historical application from access events in this review.

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41 itemsWhat the statuses mean

Assessment scope

Stored-material review date: 2026-10-05
Original evidence cut-off: 2026-09-16
Scope actually checked: Stored Korean and English manuscripts and case-specific criteria and application records. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of an up-to-date clinical literature search.
Population: Older adults with objectively documented physical-function impairment; actual age, instrument and cutoff unverified
Ingredient, formulation and route: 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
Measured outcome: Usual/preferred gait speed in m/s; distance, protocol and principal time point unverified
Duration: Unverified: no directly eligible comparison selected
Questions outside this scope: 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]

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

S01 · Wong et al. 2018. Thiamine versus placebo in older heart failure patients: study protocol for a randomized controlled trial

Source

Material type: Indirect-trial protocol
Materials actually read: Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review
Findings recorded in the stored summary: 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.
Record 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.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Full protocol text in HTML Open material ↗	Only retained historical access records are available; no direct lookup in this review	Access not attempted	Not read	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.

S02 · Wong et al. 2022. High-Dose Thiamine Supplementation in Older Patients With Heart Failure: THIAMINE-HF

Source

Material type: Final report of an indirect randomized crossover trial
Materials actually read: Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review
Findings recorded in the stored summary: 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.
Record 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.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
HTML reproduction of the original article's full text Open material ↗	Only retained historical access records are available; no direct lookup in this review	Access not attempted	Not read	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.

S03 · THIAMINE-HF trial registry

Source

Material type: Registry lead for the same trial
Materials actually read: Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review
Findings recorded in the stored summary: 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.
Record 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.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Official registry app screen shell/identifier Open material ↗	Only retained historical access records are available; no direct lookup in this review	Access not attempted	Not read	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.

S04 · THIAMINE-HF 2021 conference abstract

Source

Material type: Conference report from the same cohort
Materials actually read: Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review
Findings recorded in the stored summary: 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.
Record 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.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Indexed conference-abstract excerpt Open material ↗	Only retained historical access records are available; no direct lookup in this review	Access not attempted	Not read	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.

S05 · Yang et al. 2023. Low-protein formula supplementation in older adults with chronic kidney disease

Source

Material type: Open-label randomized nutritional trial of a different exposure
Materials actually read: Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review
Findings recorded in the stored summary: 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.
Record 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.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Original article full text in HTML Open material ↗	Only retained historical access records are available; no direct lookup in this review	Access not attempted	Not read	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.

S06 · Ito et al. 2012. Thiamin status and nursing-care needs in elderly residents

Source

Material type: Cross-sectional observation of nutritional status
Materials actually read: Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review
Findings recorded in the stored summary: 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.
Record 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.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Original article full-text PDF/some page images Open material ↗	Only retained historical access records are available; no direct lookup in this review	Access not attempted	Not read	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.

S07 · Pourhassan et al. 2019. Thiamine status and functional recovery in hospitalized geriatric patients

Source

Material type: Functional/nutritional observation in older inpatients
Materials actually read: Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review
Findings recorded in the stored summary: 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.
Record 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.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Publisher abstract/references Open material ↗	Only retained historical access records are available; no direct lookup in this review	Access not attempted	Not read	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.

S08 · Struijk et al. 2018. Intake of B vitamins and impairment in physical function in older adults

Source

Material type: Dietary observational cohort concerning other nutrients
Materials actually read: Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review
Findings recorded in the stored summary: 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.
Record 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.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Officially indexed article abstract Open material ↗	Only retained historical access records are available; no direct lookup in this review	Access not attempted	Not read	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.

S09 · NIH Office of Dietary Supplements: Thiamin, Health Professional Fact Sheet

Source

Material type: Official nutritional/safety context
Materials actually read: Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review
Findings recorded in the stored summary: 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.
Record 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.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Official nutritional fact sheet full text in HTML Open material ↗	Only retained historical access records are available; no direct lookup in this review	Access not attempted	Not read	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.

S10 · Flamingo Pharma UK: Thiamine Hydrochloride 100 mg Tablets SmPC

Source

Material type: Product-specific authorization information
Materials actually read: Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review
Findings recorded in the stored summary: 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.
Record 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.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Full HTML SmPC for an oral hydrochloride 100 mg product Open material ↗	Only retained historical access records are available; no direct lookup in this review	Access not attempted	Not read	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.

S11 · NICE CG32 Nutrition support for adults

Source

Material type: Official-guideline lead for a different clinical purpose
Materials actually read: Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review
Findings recorded in the stored summary: 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.
Record 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.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Indexed official-guideline excerpt Open material ↗	Only retained historical access records are available; no direct lookup in this review	Access not attempted	Not read	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.

S12 · Nutritional support system in cerebral palsy registry

Source

Material type: Registry candidate with a different population/multicomponent exposure
Materials actually read: Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review
Findings recorded in the stored summary: 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.
Record 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.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Official registry screen shell/indexed excerpt Open material ↗	Only retained historical access records are available; no direct lookup in this review	Access not attempted	Not read	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.

S13 · GLYLOW postmenopausal obesity registry lead

Source

Material type: Registry lead with unresolved eligibility
Materials actually read: Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review
Findings recorded in the stored summary: 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.
Record 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.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Official registry app screen shell/identifier Open material ↗	Only retained historical access records are available; no direct lookup in this review	Access not attempted	Not read	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.

S14 · Wilkinson et al. 1997. The response to treatment of subclinical thiamine deficiency in the elderly

Source

Material type: Prior extraction of a trial with a different population/endpoint
Materials actually read: Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review
Findings recorded in the stored summary: 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.
Record 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.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Prior factual extraction/bibliographic summary of the original article · Original-article link (historical extraction reused) Open material ↗	Only retained historical access records are available; no direct lookup in this review	Access not attempted	Not read	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.

S15 · Bager et al. 2021. Randomised clinical trial: high-dose oral thiamine versus placebo for chronic fatigue in patients with quiescent inflammatory bowel disease

Source

Material type: Prior extraction of a trial with a different population/endpoint
Materials actually read: Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review
Findings recorded in the stored summary: 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.
Record 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.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Prior publisher-abstract/indexed grip-strength extraction · Original-article link (historical extraction reused) Open material ↗	Only retained historical access records are available; no direct lookup in this review	Access not attempted	Not read	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.

S16 · Smidt et al. 1991. Influence of Thiamin Supplementation on the Health and General Well-being of an Elderly Irish Population With Marginal Thiamin Deficiency

Source

Material type: Prior extraction of a study in a different population
Materials actually read: Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review
Findings recorded in the stored summary: 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.
Record 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.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Prior article-abstract/bibliographic extraction · Original-article link (historical extraction reused) Open material ↗	Only retained historical access records are available; no direct lookup in this review	Access not attempted	Not read	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.

S17 · 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

Source

Material type: Prior extraction of uncontrolled mixed-form observations/correction
Materials actually read: Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review
Findings recorded in the stored summary: 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.
Record 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.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Prior bibliographic/factual extraction of observations/correction · Original-article link (historical extraction reused) Open material ↗	Only retained historical access records are available; no direct lookup in this review	Access not attempted	Not read	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.

S18 · Ohkoshi et al. 2006. Functional Limitations in Thiamine Deficiency Neuropathy: FIM Score Improvement With Treatment

Source

Material type: Prior extraction of a treatment report using a different scale
Materials actually read: Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review
Findings recorded in the stored summary: 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.
Record 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.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Prior factual extraction from article title/abstract · Original-article link (historical extraction reused) Open material ↗	Only retained historical access records are available; no direct lookup in this review	Access not attempted	Not read	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.

S19 · Costantini et al. 2016. High-dose thiamine improves the symptoms of myotonic dystrophy type 1

Source

Material type: Prior extraction of cases involving a different route
Materials actually read: Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review
Findings recorded in the stored summary: 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.
Record 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.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Prior factual extraction of intramuscular cases · Original-article link (historical extraction reused) Open material ↗	Only retained historical access records are available; no direct lookup in this review	Access not attempted	Not read	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.

S20 · Supplied R01 governing prompt and current-value rules

Material type: Bibliographic record of a historical local operational input
Materials actually read: Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review
Findings recorded in the stored summary: 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.
Record 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.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Historical local prompt Markdown document Material URL unverified	Only retained historical access records are available; no direct lookup in this review	Access not attempted	Not read	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.

S21 · Supplied scoring rubric

Material type: Bibliographic record of historical local rules
Materials actually read: Retained stored summary read; access to the corresponding source material was not attempted, and it was not acquired or read in this review
Findings recorded in the stored summary: 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.
Record 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.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Historical local scoring-rubric Markdown document Material URL unverified	Only retained historical access records are available; no direct lookup in this review	Access not attempted	Not read	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.

Report counts versus independent study counts

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.

Review criteria

Version v3118-ORAL-THIAMINE-USUAL-GAIT-1.0 · Criteria record date 2026-10-05. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Is the distinct boundary of the gait-speed question clear?

Required materials and conditions: 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.
Conditions for verification: Precisely link the original /ko/effect to the boundaries of older adults with objective functional impairment, single-ingredient oral thiamine and usual gait speed.
Requirement and applicability: Required
Application exceptions: Do not automatically generate additional gait-speed claims from results for grip strength, fatigue, Barthel/FIM, falls or cardiac measures.
Why this condition is needed: This identity criterion is needed to avoid combining all evidence on the ingredient or related functional studies into a single efficacy claim.
Referenced methods: 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.

N02 · As of which date and within which search scope are direct results unverified?

Required materials and conditions: 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.
Conditions for verification: Distinguish the evidence cutoff, actual review date, whether a search was performed and whether absence was proven.
Requirement and applicability: Required
Application exceptions: Do not claim that the latest retractions, corrections or unpublished studies have been checked merely by reusing an earlier search.
Why this condition is needed: This criterion limits the timing and scope of verification conveyed by the term unverified.
Referenced methods: 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.

N03 · Was reading the stored summary distinguished from reading the corresponding source material?

Required materials and conditions: 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.
Conditions for verification: Reading of the local summary must be consistent with current non-reading of external/historical separate materials and their historical access levels.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: This is a required traceability criterion to prevent false reading badges and confusion about report types.
Referenced methods: 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.

N04 · Were the criteria for older age and objective functional impairment verified?

Required materials and conditions: 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.
Conditions for verification: Verify the definition of objective functional impairment in the question's population and its match to or differences from actual study participants.
Requirement and applicability: Required
Application exceptions: Do not automatically establish objective functional impairment from older age or a diagnosis of heart failure or CKD alone.
Why this condition is needed: This is needed to avoid applying material with an unverified population match as direct efficacy evidence.
Referenced methods: 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.

N05 · Was selection for deficiency distinguished from selection for functional impairment?

Required materials and conditions: 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.
Conditions for verification: Attribute baseline deficiency, functional impairment and measurement markers to their respective populations and analyses.
Requirement and applicability: Supplementary; required for claims of applicability by deficiency status
Application exceptions: Selection for deficiency using criteria for a different specimen does not by itself establish eligibility as a population with functional impairment.
Why this condition is needed: This supplementary criterion separates the question boundaries for deficiency management and additional supplementation.
Referenced methods: 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.

N06 · Were the salts and routes of ordinary thiamine accurately distinguished?

Required materials and conditions: 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.
Conditions for verification: Link the exact salt, number of active ingredients, formulation and route to the reasons for excluding other forms.
Requirement and applicability: Required
Application exceptions: Retain evidence on derivatives, combinations and injections, but do not promote it to direct results for single-ingredient oral ordinary thiamine.
Why this condition is needed: This is needed to avoid incorrectly merging exposure identities and result attribution.
Referenced methods: 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.

N07 · Were nominal dose, actual dose and thiamine-equivalent amount verified?

Required materials and conditions: 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.
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Do not designate another study's nominal dose as the optimal dose or minimum effective dose.
Why this condition is needed: This is a required criterion for exposing gaps in dose identity and actual exposure.
Referenced methods: 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.

N08 · Were treatment duration and the principal gait-speed measurement time point verified?

Required materials and conditions: 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.
Conditions for verification: State separately the actual extent of verification of treatment duration, the principal measurement time point and additional follow-up.
Requirement and applicability: Required
Application exceptions: Do not require every form of long-term follow-up for the original question; review long-term maintenance separately if that claim is added.
Why this condition is needed: This is needed to prevent automatic substitution of durations and effect-observation times.
Referenced methods: 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.

N09 · How did care other than thiamine actually differ?

Required materials and conditions: 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.
Conditions for verification: Separate between-arm intervention differences, shared care, deviations/rescue and the effect of interest.
Requirement and applicability: Required
Application exceptions: Do not require complete identity of every individual change; verify the actual effect of interest and how changes are handled.
Why this condition is needed: This criterion prevents attributing the contribution of a multicomponent formula or concomitant treatment to thiamine alone.
Referenced methods: 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.

N10 · Were allocation, blinding and analysis design for the direct gait-speed comparison verified?

Required materials and conditions: 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.
Conditions for verification: Link actual allocation, design and analysis information relevant to the selected result to verified source locations.
Requirement and applicability: Required
Application exceptions: Retain nonrandomized data as well, but label their design limitations and do not promote them to an RCT of causal efficacy.
Why this condition is needed: This is needed to distinguish the actual comparative design required for efficacy from design information in indirect studies.
Referenced methods: 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.

N11 · Was the actual testing procedure for usual gait speed verified?

Required materials and conditions: 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.
Conditions for verification: Link the actual test conditions required for usual gait speed to the reasons for excluding other functional endpoints.
Requirement and applicability: Required
Application exceptions: Do not automatically treat inability to blind as failure; verify limitations in the actual measurement procedures.
Why this condition is needed: This is needed to distinguish similar functional-scale names from actual measurement of the same outcome.
Referenced methods: 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.

N12 · Were the between-group effect, final values and changes verified?

Required materials and conditions: 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.
Conditions for verification: Attribute the original result's between-group/within-group contrast, final value/change and analysis/adjustment to the corresponding endpoint and time point.
Requirement and applicability: Required
Application exceptions: If the source does not specify the analysis, do not arbitrarily label it ITT or an adjusted effect.
Why this condition is needed: This is needed to avoid confusing values from different analyses with the intended causal contrast.
Referenced methods: 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.

N13 · Can the numbers allocated, completing and analyzed be distinguished from missing data?

Required materials and conditions: 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.
Conditions for verification: Link allocation, completion, analysis and arm-specific/outcome-specific denominators to the corresponding time points.
Requirement and applicability: Required
Application exceptions: Do not calculate unavailable dropout counts, denominators or CIs, or treat crossover observations as unique participants.
Why this condition is needed: This is needed to avoid incorrectly relabeling retained sample sizes as outcome-specific analysis denominators.
Referenced methods: 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.

N14 · Were the CI and a clinically important difference verified?

Required materials and conditions: 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.
Conditions for verification: Link the type of interval in the original report and the basis for importance only to the extent verified.
Requirement and applicability: Required
Application exceptions: Do not invent new MCIDs, CIs, variances or sample sizes without a basis, or convert IQR/SD/SE into an interval.
Why this condition is needed: This is needed to distinguish significance and sample size from precision and clinical meaning.
Referenced methods: 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.

N15 · Were the primary gait endpoint and planned analysis compared with the actual registration?

Required materials and conditions: 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.
Conditions for verification: Distinguish the level of plans/registration obtained, the parts not actually compared and the reasons for changes.
Requirement and applicability: Required
Application exceptions: Do not treat publication of a related trial's protocol as verification of preregistration for the target comparison.
Why this condition is needed: This criterion reveals the extent to which planned outcomes can be compared with selective reporting of favorable results.
Referenced methods: 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.

N16 · Were reports from the same study distinguished from direct independent replication?

Required materials and conditions: 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.
Conditions for verification: Link same/different/uncertain families to their original locations, leaving replication and unique-participant counts unresolved where unconfirmed.
Requirement and applicability: Required
Application exceptions: Do not erase unresolved candidates as not applicable, or count the same 24 HF participants as 4 studies or 48 people.
Why this condition is needed: This criterion distinguishes the number of reports from the number of direct independent comparisons.
Referenced methods: 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.

N17 · Does funding of indirect studies establish independence of the target efficacy evidence?

Required materials and conditions: 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.
Conditions for verification: Link the reported level of funding/conflict information, unverified information and applicability limitations to each study.
Requirement and applicability: Supplementary; required for independence claims
Application exceptions: Do not automatically exclude a study because of a conflict of interest, or establish the absence of conflicts from a missing declaration.
Why this condition is needed: This supplementary criterion prevents automatic inheritance of indirect studies' funding into the target efficacy axis.
Referenced methods: 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.

N18 · Does the single-ingredient oral trial in older HF patients match the target population?

Required materials and conditions: 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.
Conditions for verification: Distinguish the actual HF population, regimen and selection restrictions from the target population/exposure.
Requirement and applicability: Supplementary; required for attribution of indirect materials
Application exceptions: Do not generalize to all vulnerable older adults by omitting exclusions for dialysis/symptomatic deficiency or conditions involving caregiver assistance.
Why this condition is needed: This is needed to preserve both what is known from closely related single-ingredient oral evidence and its gaps in directness.
Referenced methods: 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.

N19 · Were HF results showing no difference or unfavorable effects kept from being transferred to gait speed?

Required materials and conditions: 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.
Conditions for verification: Preserve the direction of other HF results and the absence of target gait results without conflating them.
Requirement and applicability: Supplementary; required for boundaries on transferring results
Application exceptions: Do not create a gait effect by selecting favorable results for other outcomes or deleting unfavorable results for other outcomes.
Why this condition is needed: This boundary criterion preserves contrary results and prevents automatic substitution of endpoints.
Referenced methods: 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.

N20 · Was the scope of discrepancies among abstracts, final reports and totals preserved?

Required materials and conditions: 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.
Conditions for verification: Retain the locations of actual recorded discrepancies together with unchecked details and explanations of versions/denominators.
Requirement and applicability: Supplementary; required for handling conflicting information
Application exceptions: Do not create additional conflicts solely from numerical differences across definitions/time points, or average original values together.
Why this condition is needed: This is needed to limit the scope of conflicts, overlap and selective reporting to the relevant reports.
Referenced methods: 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.

N21 · Can the CKD formula's gait results be attributed to B1 alone?

Required materials and conditions: 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.
Conditions for verification: Verify the actual formula, diet and comparison, and that individual component contributions have not been separated.
Requirement and applicability: Supplementary; required for attribution of combination-product results
Application exceptions: 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.
Why this condition is needed: This attribution criterion prevents a positive multicomponent-exposure result from erasing gaps in the single-ingredient B1 question.
Referenced methods: 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.

N22 · Were medians, IQRs and within-group/between-group P values distinguished?

Required materials and conditions: 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.
Conditions for verification: Preserve the median, IQR and the hypothesis tested by each P value, leaving unverified between-group estimates unverified.
Requirement and applicability: Supplementary; required for numerical attribution
Application exceptions: Do not use arithmetic in this review to create an unavailable between-group magnitude or CI, or read an IQR as a precision interval.
Why this condition is needed: This criterion prevents attributing positive numerical results to the wrong ingredient, comparison or interval.
Referenced methods: 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.

N23 · Were actual CKD gait testing and the analysis population distinguished?

Required materials and conditions: 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.
Conditions for verification: Link CKD allocation/analysis flow and test conditions to differences from the target selection criteria.
Requirement and applicability: Supplementary; required for applicability/denominators
Application exceptions: 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.
Why this condition is needed: This criterion accurately preserves the populations, tests and denominators behind the formula's numerical results.
Referenced methods: 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.

N24 · Were registration-date conflicts distinguished from original tables not compared?

Required materials and conditions: 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.
Conditions for verification: Separate the record of conflicting registration-date notation from the scope of original tables/registration not compared.
Requirement and applicability: Supplementary; required for registration/conflicts
Application exceptions: Do not label a current lack of attempt as a current access failure, or automatically fill detailed dates from other files.
Why this condition is needed: This criterion retains historical access limitations and actual reported conflicts within their precise scope.
Referenced methods: 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.

N25 · Was the observed direction for deficiency and ability to walk kept from being reversed into a supplementation effect?

Required materials and conditions: 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.
Conditions for verification: Accurately preserve the observational population, deficiency/feeding routes, walking denominators and causal limitations.
Requirement and applicability: Supplementary; required for attribution of observations
Application exceptions: Do not convert ability to walk into speed, or treat tube/intravenous feeding in the nondeficient group as an oral B1 intervention.
Why this condition is needed: This criterion prevents reversing deficiency associations into treatment directions or mixing denominators.
Referenced methods: 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.

N26 · Was Barthel recovery distinguished from a treatment effect on gait speed?

Required materials and conditions: 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.
Conditions for verification: Attribute the inpatient observation's scale, population, nutritional markers and material-access level to its own result.
Requirement and applicability: Supplementary; required for attribution of observations
Application exceptions: Do not generalize the abstract's association or 0 deficiency cases into an oral B1 treatment effect or to all nondeficient older adults.
Why this condition is needed: This criterion prevents an observed result for another form of functional recovery from substituting for target efficacy.
Referenced methods: 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.

N27 · Do dietary data on other B vitamins answer the B1 functional-impairment question?

Required materials and conditions: 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.
Conditions for verification: Identify differences in B6/B12/folate exposure, a population with unimpaired function and self-reported outcomes.
Requirement and applicability: Supplementary; required for boundaries concerning other nutrients
Application exceptions: Do not promote an indexed abstract to newly read full text or record it as a successful current PubMed search.
Why this condition is needed: This criterion keeps the presence or absence of positive findings for other ingredients/observational questions from erasing the direct B1 evidence gap.
Referenced methods: 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.

N28 · Were the composition, population and results of registry leads actually verified?

Required materials and conditions: 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.
Conditions for verification: Record each of the two candidates' verified identities and unresolved composition, eligibility and results separately.
Requirement and applicability: Supplementary; required for candidate eligibility
Application exceptions: Do not replace an unresolved candidate with confirmed exclusion from eligibility, an effect of 0 or not applicable.
Why this condition is needed: This criterion separates the existence of a candidate from acquisition of efficacy results.
Referenced methods: 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.

N29 · Was Wilkinson's deficiency/grip-strength trial kept from being transferred to gait speed?

Required materials and conditions: 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.
Conditions for verification: Limit deficiency selection, grip strength and the oral regimen to the relevant family and extraction level.
Requirement and applicability: Supplementary; required for attribution of prior extractions
Application exceptions: Do not inherit a previous verdict/score or a dose for another endpoint as fulfillment of new gait-speed criteria.
Why this condition is needed: This criterion clarifies reuse of prior extractions and attribution to a different distinct claim.
Referenced methods: 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.

N30 · Is the TARIF fatigue trial a gait-speed comparison in older adults?

Required materials and conditions: 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.
Conditions for verification: Distinguish TARIF's population/results and the original extraction level from the gait-speed question.
Requirement and applicability: Supplementary; required for boundaries concerning other endpoints
Application exceptions: Do not adopt a previous fatigue verdict or another endpoint's results as a new direct gait-speed effect.
Why this condition is needed: This criterion separates the different population and endpoint of a closely related oral trial.
Referenced methods: 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.

N31 · Was Smidt's healthy/marginal-deficiency population kept separate from the target population?

Required materials and conditions: 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.
Conditions for verification: Link the applicability limitations concerning healthy women, marginal deficiency and unverified function/gait.
Requirement and applicability: Supplementary; required for population boundaries
Application exceptions: Do not reclassify a study of healthy older adults as a study of objective functional impairment.
Why this condition is needed: This criterion prevents expanding population directness based on the label older adults.
Referenced methods: 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.

N32 · Were uncontrolled mixed-form CMT data kept from being promoted to direct results?

Required materials and conditions: 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.
Conditions for verification: Preserve boundaries concerning mixed forms/ages, lack of controls, correction extractions and unverified target results.
Requirement and applicability: Supplementary; required for attribution of mixed observations
Application exceptions: Do not label an error resolved merely because metadata indicate a correction, or combine derivative effects as ordinary-thiamine effects.
Why this condition is needed: This criterion prevents overinterpretation of mixed uncontrolled observations and original corrections.
Referenced methods: 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.

N33 · Was FIM functional improvement kept from being relabeled as usual gait speed?

Required materials and conditions: 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.
Conditions for verification: Separate FIM, deficiency neuropathy and treatment extractions from a direct gait-speed comparison.
Requirement and applicability: Supplementary; required for scale boundaries
Application exceptions: Do not generalize the need to correct deficiency or FIM improvement into a gait effect in nondeficient older adults.
Why this condition is needed: This criterion prevents automatically exchanging outcomes because functional scales use similar wording.
Referenced methods: 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.

N34 · Are intramuscular observations in muscular dystrophy oral-comparison data?

Required materials and conditions: 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.
Conditions for verification: Identify differences between intramuscular case reports and single-ingredient oral gait comparisons.
Requirement and applicability: Supplementary; required for route boundaries
Application exceptions: Do not convert a public PMC URL into a badge of current full-text reading or a result for an oral preparation.
Why this condition is needed: This criterion prevents overstepping disease/route/design boundaries and falsely promoting the existence of a link.
Referenced methods: 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.

N35 · Were adverse events/discontinuations in the same population and regimen verified?

Required materials and conditions: 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.
Conditions for verification: Separate collection methods, denominators, duration and unverified scope for direct harms/discontinuations.
Requirement and applicability: Supplementary; required for the relevant harm/safety claims
Application exceptions: Do not delete indirect efficacy sources because of a harm-data gap, or automatically assign the same status as the efficacy criteria.
Why this condition is needed: This supplementary criterion displays the efficacy gap separately from the gap in direct safety data.
Referenced methods: 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.

N36 · Were diarrhea improvement after discontinuation and event totals kept from being converted into risk estimates?

Required materials and conditions: 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.
Conditions for verification: Preserve the 1 diarrhea event, improvement after discontinuation and original discrepancies in totals at the level of the report.
Requirement and applicability: Supplementary; required for attribution of harm signals
Application exceptions: Do not automatically use all 24 randomized participants or the 19 completers as AE denominators, or correct table totals through new calculations.
Why this condition is needed: This criterion is needed to preserve harm signals while preventing their promotion to incidence or causality.
Referenced methods: 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.

N37 · Were the absence of a UL and product wording kept from becoming a general safety guarantee?

Required materials and conditions: 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.
Conditions for verification: Distinguish the absence of a UL, product-specific salts/wording, route-specific risks and current non-reading.
Requirement and applicability: Supplementary; required for safety-interpretation boundaries
Application exceptions: Do not transfer oral-product-specific pregnancy/lactation or excipient cautions to all nutritional exposures/other salts.
Why this condition is needed: This criterion prevents mistaking the existence of an official fact sheet/label for established efficacy or safety, or for identity of products.
Referenced methods: 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.

N38 · Were the limited HF/refeeding contexts kept from being applied to all older adults?

Required materials and conditions: 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.
Conditions for verification: Distinguish original exclusions/vulnerable groups and the purpose of refeeding from direct/long-term safety gaps.
Requirement and applicability: Supplementary; required for vulnerable-group/long-term safety claims
Application exceptions: Do not require every rare-harm study for the current narrow gait-speed question, or convert refeeding wording into a personal prescription.
Why this condition is needed: This supplementary criterion prevents generalizing safety from selected populations or exceeding the scope of clinically supervised contexts.
Referenced methods: 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.

N39 · Were falls, optimal dose and maintained effects made mandatory parts of the gait-speed question?

Required materials and conditions: 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.
Conditions for verification: Clarify why separate questions about events, dose and maintained effects do not apply as conditions for the gait-speed result.
Requirement and applicability: Supplementary; required for the relevant extended claims
Application exceptions: Do not require an event trial for the numerical-change question itself; keep unresolved candidate/eligible materials unverified in other rows.
Why this condition is needed: This supplementary criterion separates requirements for the narrow subject of the verdict from separate extension criteria.
Referenced methods: 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.

N40 · Were ?/null, the calculation exception, document quality and historical deployment distinguished?

Required materials and conditions: 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.
Conditions for verification: Separate the original ?/null, unscored axes, invalid suggestion, document self-assessment and historical deployment from what was produced in this review.
Requirement and applicability: Required
Application exceptions: Do not use general code-structure checks as a new clinical score, implementation of an official method or certification of study absence.
Why this condition is needed: This is a required preservation criterion to prevent automatic inheritance of scores/statuses or historical completion metadata.
Referenced methods: 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.

N41 · Were S20/S21 kept from being labeled as rule files read in this review?

Required materials and conditions: 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.
Conditions for verification: Separate historical reading of S20/S21 from reading their bibliographic summaries and not reading the source documents in this review.
Requirement and applicability: Supplementary; required for tracing local materials
Application exceptions: Do not create current file links from original relative paths without safe actual files, or count them as external clinical results.
Why this condition is needed: This traceability criterion distinguishes current summary access from source-document access for local rule documents as well.
Referenced methods: 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.

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility criteria and reasons for changes, and distinguish variations in the intervention.
Extent of review: 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.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish and link studies and reports, and do not omit a study solely because its outcomes are not reported.
Extent of review: 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.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Hold the outcome and effect of interest fixed, then assess randomization, deviations, missing data, measurement and selective reporting.
Extent of review: 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.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: 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.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Questions about harms may require designs, populations and follow-up different from efficacy questions. Case reports do not establish incidence.
Extent of review: 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.

What the statuses mean

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.

Change history

2026-11-06 · Public page/material version 1.0

Public-facing display and data were prepared from the existing 41 items. No new clinical search, verification-status change or scoring was performed.

The stored-material review date (2026-10-05) and original evidence cut-off (2026-09-16) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · Is the distinct boundary of the gait-speed question clear?

Current findings: 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.
Verification status: Met
Materials actually 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
Why unverified: 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.
Reason for missing information: A separate subclaims field and a complete actual study identity are absent; study-specific doses and times remain unverified.
Required materials and conditions: 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.
Materials to obtain first: The original text and identity fields of the current distinct claim, and the complete previous version if changed.
Further research: Break the original question down into population, exposure, comparator, measure and time point, and reconsider its identity only when a new claim arises.
Remaining uncertainty: Using a single table as the production unit is a decision about the retained question boundary, not verification of direct efficacy.
Conditions for verification: Precisely link the original /ko/effect to the boundaries of older adults with objective functional impairment, single-ingredient oral thiamine and usual gait speed.
Why this condition is needed: This identity criterion is needed to avoid combining all evidence on the ingredient or related functional studies into a single efficacy claim.
Application exceptions: Do not automatically generate additional gait-speed claims from results for grip strength, fatigue, Barthel/FIM, falls or cardiac measures.
Referenced methods: 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.

Related sources

N02 · As of which date and within which search scope are direct results unverified?

Current findings: 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.
Verification status: Met
Materials actually 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
Why unverified: 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.
Reason for missing information: Historical search strategies, result sets by date, original native-search failure logs and a current new search were not checked in this review.
Required materials and conditions: 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.
Materials to obtain first: Historical search strategies, periods, database-specific result sets, failure records and authorized updated-search records.
Further 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.
Remaining uncertainty: The recorded 0 is the number of directly eligible comparisons verified within that scope, not the total number of studies worldwide.
Conditions for verification: Distinguish the evidence cutoff, actual review date, whether a search was performed and whether absence was proven.
Why this condition is needed: This criterion limits the timing and scope of verification conveyed by the term unverified.
Application exceptions: Do not claim that the latest retractions, corrections or unpublished studies have been checked merely by reusing an earlier search.
Referenced methods: 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.

Related sources

N03 · Was reading the stored summary distinguished from reading the corresponding source material?

Current findings: 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.
Verification status: Met
Materials actually 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
Why unverified: 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.
Reason for missing information: 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.
Required materials and conditions: 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.
Materials to obtain first: Each material's original document, version, URL identity, directly read location/date and actually acquired bytes/SHA.
Further 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.
Remaining 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.
Conditions for verification: Reading of the local summary must be consistent with current non-reading of external/historical separate materials and their historical access levels.
Why this condition is needed: This is a required traceability criterion to prevent false reading badges and confusion about report types.
Application exceptions: 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.
Referenced methods: 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.

Related sources S01 S02 S03 S04 S05 S06 S07 S08 S09 S10 S11 S12 S13 S14 S15 S16 S17 S18 S19 S20 S21

N04 · Were the criteria for older age and objective functional impairment verified?

Current findings: 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.
Verification status: Unverified
Materials actually 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
Why unverified: Without actual selection criteria from a directly eligible study, a similar age or disease label cannot substitute for verification of the population.
Reason for missing information: Actual eligible participants' age, setting, functional-impairment instrument/cutoff, baseline gait speed, comorbidities and cognition.
Required materials and conditions: 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.
Materials to obtain first: Eligibility criteria, baseline functional testing, participant flow and actual age/comorbidity tables.
Further 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.
Remaining uncertainty: The definition of functional impairment can change applicability within the same older population.
Conditions for verification: Verify the definition of objective functional impairment in the question's population and its match to or differences from actual study participants.
Why this condition is needed: This is needed to avoid applying material with an unverified population match as direct efficacy evidence.
Application exceptions: Do not automatically establish objective functional impairment from older age or a diagnosis of heart failure or CKD alone.
Referenced methods: 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.

Related sources S01 S02 S05

N05 · Was selection for deficiency distinguished from selection for functional impairment?

Current findings: 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.
Verification status: Partly verified
Materials actually 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
Why unverified: Markers and selection boundaries in indirect materials are retained, but deficiency status in the directly eligible population cannot be established.
Reason for missing information: Concurrent verification of eligible participants' specimens, assay methods, deficiency cutoffs, baseline diet/nutritional support and functional impairment.
Required materials and conditions: 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.
Materials to obtain first: Thiamine-status testing methods, baseline diet/nutrition tables, deficiency criteria and prespecified subgroup plans.
Further research: Measure deficiency status separately in participants with functional impairment, and distinguish results for those requiring correction from those receiving additional supplementation.
Remaining 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.
Conditions for verification: Attribute baseline deficiency, functional impairment and measurement markers to their respective populations and analyses.
Why this condition is needed: This supplementary criterion separates the question boundaries for deficiency management and additional supplementation.
Application exceptions: Selection for deficiency using criteria for a different specimen does not by itself establish eligibility as a population with functional impairment.
Referenced methods: 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.

Related sources S02 S06 S14

N06 · Were the salts and routes of ordinary thiamine accurately distinguished?

Current findings: 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.
Verification status: Partly verified
Materials actually 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
Why unverified: The question and excluded forms are clear, but there is no basis for verifying the actual eligible product/salt.
Reason for missing information: The salt, number of active ingredients, source/product, formulation, route and excipients of a directly eligible preparation.
Required materials and conditions: 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.
Materials to obtain first: Product ingredient lists, manufacturing/batch documents and records of the formulation and route administered in the study.
Further research: Fix each formulation's identity and extract results for single-active-ingredient oral exposure separately.
Remaining uncertainty: The shared name B1 does not establish equivalence of preparations or routes.
Conditions for verification: Link the exact salt, number of active ingredients, formulation and route to the reasons for excluding other forms.
Why this condition is needed: This is needed to avoid incorrectly merging exposure identities and result attribution.
Application exceptions: Retain evidence on derivatives, combinations and injections, but do not promote it to direct results for single-ingredient oral ordinary thiamine.
Referenced methods: 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.

Related sources S01 S02 S10

N07 · Were nominal dose, actual dose and thiamine-equivalent amount verified?

Current findings: 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.
Verification status: Unverified
Materials actually 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
Why unverified: There is no direct administration record, and an indirect study's nominal dose cannot fill the actual-dose field for this question.
Reason for missing information: Exact units, administration schedule, missed doses/adherence, basis for equivalence and meal timing for the eligible exposure.
Required materials and conditions: 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.
Materials to obtain first: Administration logs, medication/ingredient documents, count/adherence records and the basis for the stated equivalent amount.
Further research: Record planned doses and actual administered doses separately in a single-ingredient comparison, and examine the relationship between adherence and the analysis population.
Remaining uncertainty: The labeled mass of a salt cannot automatically be converted into free-thiamine equivalents or actual intake.
Conditions for verification: 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.
Why this condition is needed: This is a required criterion for exposing gaps in dose identity and actual exposure.
Application exceptions: Do not designate another study's nominal dose as the optimal dose or minimum effective dose.
Referenced methods: 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.

Related sources S02 S14

N08 · Were treatment duration and the principal gait-speed measurement time point verified?

Current findings: 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.
Verification status: Unverified
Materials actually 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
Why unverified: Because no eligible comparison was selected, the duration of another exposure does not establish the target regimen.
Reason for missing information: Eligible treatment start/end, measurement schedule, follow-up after discontinuation and continuity of exposure.
Required materials and conditions: 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.
Materials to obtain first: Protocol schedule, actual administration/visit dates and the analysis plan for the principal time point.
Further research: Fix treatment and measurement schedules separately, distinguishing final values, changes and post-discontinuation results in advance.
Remaining uncertainty: The observation time point and treatment duration may differ; a washout is not evidence of maintained effects or of the absence of carryover.
Conditions for verification: State separately the actual extent of verification of treatment duration, the principal measurement time point and additional follow-up.
Why this condition is needed: This is needed to prevent automatic substitution of durations and effect-observation times.
Application exceptions: Do not require every form of long-term follow-up for the original question; review long-term maintenance separately if that claim is added.
Referenced methods: 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.

Related sources S02 S05

N09 · How did care other than thiamine actually differ?

Current findings: 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.
Verification status: Unverified
Materials actually 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
Why unverified: Without verification of concomitant care and changes by arm in the direct comparison, differences in other care cannot be separated from thiamine's contribution.
Reason for missing information: Diet, rehabilitation, medications, nutritional support, rescue treatment, changes and their analytical handling in both eligible arms.
Required materials and conditions: 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.
Materials to obtain first: Arm-specific concomitant-treatment/change tables, diet and rehabilitation plans, and records of rescue treatment/dropout handling.
Further research: Specify the care shared by the arms, record actual changes and adherence, and link the intervention contrast of interest to the effect analyzed.
Remaining uncertainty: The label usual care alone does not guarantee that actual exposures were identical in both arms.
Conditions for verification: Separate between-arm intervention differences, shared care, deviations/rescue and the effect of interest.
Why this condition is needed: This criterion prevents attributing the contribution of a multicomponent formula or concomitant treatment to thiamine alone.
Application exceptions: Do not require complete identity of every individual change; verify the actual effect of interest and how changes are handled.
Referenced methods: 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.

Related sources S01 S02 S05

N10 · Were allocation, blinding and analysis design for the direct gait-speed comparison verified?

Current findings: 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.
Verification status: Unverified
Materials actually 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
Why unverified: 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.
Reason for missing information: Eligible allocation procedures, concealment, parallel/crossover structure, baseline balance and outcome-specific analysis methods.
Required materials and conditions: 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.
Materials to obtain first: Original methods, protocol, allocation records, baseline tables and analysis plan.
Further research: Select an eligible comparison first, then examine actual limitations in allocation, measurement, missing data and analysis for each gait-speed result of interest.
Remaining uncertainty: An unverified direct design cannot be relabeled as non-applicability of crossover/cluster criteria or as established bias.
Conditions for verification: Link actual allocation, design and analysis information relevant to the selected result to verified source locations.
Why this condition is needed: This is needed to distinguish the actual comparative design required for efficacy from design information in indirect studies.
Application exceptions: Retain nonrandomized data as well, but label their design limitations and do not promote them to an RCT of causal efficacy.
Referenced methods: 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.

Related sources S01 S02

N11 · Was the actual testing procedure for usual gait speed verified?

Current findings: 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.
Verification status: Unverified
Materials actually 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
Why unverified: The measurement name alone cannot verify the actual protocol or measurement differences, and another functional scale does not substitute for target gait speed.
Reason for missing information: Directly relevant walking distance, test procedures, measurement conditions, assessor blinding and differences in implementation by arm.
Required materials and conditions: 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.
Materials to obtain first: Test SOP, original gait-measurement tables, assessor/device records, protocol and arm-specific implementation information.
Further research: Fix usual-speed instructions and distance/start conditions, and consistently record repeated measurements, assistive devices and assessor conditions.
Remaining uncertainty: Protocol differences may affect comparisons of results, but they do not constitute an established measurement error here.
Conditions for verification: Link the actual test conditions required for usual gait speed to the reasons for excluding other functional endpoints.
Why this condition is needed: This is needed to distinguish similar functional-scale names from actual measurement of the same outcome.
Application exceptions: Do not automatically treat inability to blind as failure; verify limitations in the actual measurement procedures.
Referenced methods: 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.

Related sources S05

N12 · Were the between-group effect, final values and changes verified?

Current findings: 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.
Verification status: Unverified
Materials actually 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
Why unverified: Without a selected direct result and analysis definition, the magnitude and direction of the effect of interest cannot be established.
Reason for missing information: Eligible arm-specific baseline/final/change values, between-group estimates, models, analysis populations and adjustment/multiplicity.
Required materials and conditions: 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.
Materials to obtain first: Result tables, analysis plan, model output, ITT/PP definitions and prespecified primary contrasts.
Further 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.
Remaining uncertainty: Unverified numerical information is distinct from verification of a nonsignificant result, equivalence or an unfavorable effect.
Conditions for verification: Attribute the original result's between-group/within-group contrast, final value/change and analysis/adjustment to the corresponding endpoint and time point.
Why this condition is needed: This is needed to avoid confusing values from different analyses with the intended causal contrast.
Application exceptions: If the source does not specify the analysis, do not arbitrarily label it ITT or an adjusted effect.
Referenced methods: 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.

Related sources S05

N13 · Can the numbers allocated, completing and analyzed be distinguished from missing data?

Current findings: 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.
Verification status: Unverified
Materials actually 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
Why unverified: There is no denominator for a direct result, and participant counts from related studies cannot be substituted as the number analyzed for that result.
Reason for missing information: Eligible participants' flow through allocation, measurement, completion and analysis, with outcome-specific and arm-specific missingness, reasons and handling.
Required materials and conditions: 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.
Materials to obtain first: Participant flow diagram, outcome-specific n, reasons for dropout/measurement failure and the handling plan.
Further research: Trace the flow from allocation to gait measurement and analysis, and examine the effects of missingness reasons and handling for each analysis population.
Remaining uncertainty: The total study population is not guaranteed to equal the number included in an outcome analysis at a given time point.
Conditions for verification: Link allocation, completion, analysis and arm-specific/outcome-specific denominators to the corresponding time points.
Why this condition is needed: This is needed to avoid incorrectly relabeling retained sample sizes as outcome-specific analysis denominators.
Application exceptions: Do not calculate unavailable dropout counts, denominators or CIs, or treat crossover observations as unique participants.
Referenced methods: 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.

Related sources S02 S05

N14 · Were the CI and a clinically important difference verified?

Current findings: 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.
Verification status: Unverified
Materials actually 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
Why unverified: Without a direct interval and an importance criterion applicable to this population/measure, precision and a meaningful difference cannot be judged.
Reason for missing information: Direct estimates, variances, CIs/confidence levels, effect direction and the basis for population-specific important differences.
Required materials and conditions: 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.
Materials to obtain first: Eligible estimates/CIs, variance types, denominators, the basis for clinical importance and a prespecified interpretation plan.
Further research: Report CIs linked to their original estimates and denominators/variances, explaining separately the basis for applying an importance criterion and what remains unverified.
Remaining uncertainty: A generic gait-speed cutoff or minimum sample size cannot be applied to this question without a basis.
Conditions for verification: Link the type of interval in the original report and the basis for importance only to the extent verified.
Why this condition is needed: This is needed to distinguish significance and sample size from precision and clinical meaning.
Application exceptions: Do not invent new MCIDs, CIs, variances or sample sizes without a basis, or convert IQR/SD/SE into an interval.
Referenced methods: 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.

Related sources S05

N15 · Were the primary gait endpoint and planned analysis compared with the actual registration?

Current findings: 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.
Verification status: Unverified
Materials actually 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
Why unverified: 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.
Reason for missing information: Registration versions and actual reports of the direct primary endpoint, time point, analysis and reasons for changes.
Required materials and conditions: 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.
Materials to obtain first: Eligible original registry history, protocol, SAP, endpoint/analysis change records and reported results.
Further 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.
Remaining uncertainty: Failure to acquire registration does not mean no registration, established selective reporting or endpoint failure.
Conditions for verification: Distinguish the level of plans/registration obtained, the parts not actually compared and the reasons for changes.
Why this condition is needed: This criterion reveals the extent to which planned outcomes can be compared with selective reporting of favorable results.
Application exceptions: Do not treat publication of a related trial's protocol as verification of preregistration for the target comparison.
Referenced methods: 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.

Related sources S01 S02 S03

N16 · Were reports from the same study distinguished from direct independent replication?

Current findings: 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.
Verification status: Partly verified
Materials actually 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
Why unverified: 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.
Reason for missing information: Directly eligible unique families, outcome-specific links and the actual independent identities of unresolved candidates.
Required materials and conditions: 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.
Materials to obtain first: Report-registration-cohort linkage tables, directly eligible criteria/result tables and materials for identifying overlap.
Further research: Link reports to unique studies first, and compare only independent results verified to match in population, preparation, measure and time point.
Remaining uncertainty: The existence of multiple indirect materials does not establish replication for the same population, exposure and gait-speed outcome.
Conditions for verification: Link same/different/uncertain families to their original locations, leaving replication and unique-participant counts unresolved where unconfirmed.
Why this condition is needed: This criterion distinguishes the number of reports from the number of direct independent comparisons.
Application exceptions: Do not erase unresolved candidates as not applicable, or count the same 24 HF participants as 4 studies or 48 people.
Referenced methods: 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.

Related sources S01 S02 S03 S04

N17 · Does funding of indirect studies establish independence of the target efficacy evidence?

Current findings: 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.
Verification status: Partly verified
Materials actually 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
Why unverified: 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.
Reason for missing information: Eligible-study funding, product provision, author employment/patents/declarations and details in the separate CKD audit table.
Required materials and conditions: 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.
Materials to obtain first: Each study's original Funding/COI sections, provision/institution/employment documents and relationships among reports in the family.
Further research: Extract study-specific funding, product provision and declared conflicts separately from results, and compare them with the scope of independence claims.
Remaining uncertainty: The presence or absence of public funding or donated products does not automatically establish unbiased results or independent replication.
Conditions for verification: Link the reported level of funding/conflict information, unverified information and applicability limitations to each study.
Why this condition is needed: This supplementary criterion prevents automatic inheritance of indirect studies' funding into the target efficacy axis.
Application exceptions: Do not automatically exclude a study because of a conflict of interest, or establish the absence of conflicts from a missing declaration.
Referenced methods: 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.

Related sources S01 S02 S05

N18 · Does the single-ingredient oral trial in older HF patients match the target population?

Current findings: 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.
Verification status: Partly verified
Materials actually 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
Why unverified: 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.
Reason for missing information: Functional-impairment cutoff, baseline gait speed, renal function, meals/rehabilitation, thiamine equivalents and the actual effect of adherence on each outcome.
Required materials and conditions: 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.
Materials to obtain first: Original HF methods, selection/baseline tables, formulation/administration records, adherence and original supplements.
Further research: Link population, salt, route, adherence and exclusion criteria to the eligibility table, specifying differences from the target question.
Remaining 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.
Conditions for verification: Distinguish the actual HF population, regimen and selection restrictions from the target population/exposure.
Why this condition is needed: This is needed to preserve both what is known from closely related single-ingredient oral evidence and its gaps in directness.
Application exceptions: Do not generalize to all vulnerable older adults by omitting exclusions for dialysis/symptomatic deficiency or conditions involving caregiver assistance.
Referenced methods: 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.

Related sources S01 S02

N19 · Were HF results showing no difference or unfavorable effects kept from being transferred to gait speed?

Current findings: 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.
Verification status: Met
Materials actually 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
Why unverified: Other endpoints in the same report were retained, with target gait_result=null kept separate from the scope of interpretation.
Reason for missing information: No HF gait-speed result is retained, and detailed values/denominators for other endpoints were not available in the current source.
Required materials and conditions: 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.
Materials to obtain first: Original HF result tables, endpoint definitions, each analysis/denominator and the relevant location if a gait endpoint has been newly reported.
Further research: Attribute each endpoint's results to its definition, time point and denominator, and construct a table of directness for the target question.
Remaining uncertainty: Null or unfavorable results for other cardiac/quality-of-life outcomes do not verify the direction of the target gait effect.
Conditions for verification: Preserve the direction of other HF results and the absence of target gait results without conflating them.
Why this condition is needed: This boundary criterion preserves contrary results and prevents automatic substitution of endpoints.
Application exceptions: Do not create a gait effect by selecting favorable results for other outcomes or deleting unfavorable results for other outcomes.
Referenced methods: 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.

Related sources S01 S02

N20 · Was the scope of discrepancies among abstracts, final reports and totals preserved?

Current findings: 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.
Verification status: Conflicting information
Materials actually 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
Why unverified: 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.
Reason for missing information: Each adherence definition, denominator/version, original table/text values, people/events counted and explanations of corrections.
Required materials and conditions: 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.
Materials to obtain first: Original conference abstract, final original tables, adherence definitions, supplements/corrections and registry history.
Further research: Compare report versions from the same cohort using the same definitions/denominators, distinguishing resolved differences from remaining conflicts.
Remaining uncertainty: Neither extraction can be chosen as the correction to the other, and the cause of the difference cannot be established.
Conditions for verification: Retain the locations of actual recorded discrepancies together with unchecked details and explanations of versions/denominators.
Why this condition is needed: This is needed to limit the scope of conflicts, overlap and selective reporting to the relevant reports.
Application exceptions: Do not create additional conflicts solely from numerical differences across definitions/time points, or average original values together.
Referenced methods: 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.

Related sources S02 S04

N21 · Can the CKD formula's gait results be attributed to B1 alone?

Current findings: 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.
Verification status: Met
Materials actually 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
Why unverified: The actual difference between the multicomponent formula and shared diet was linked, and the failure to isolate thiamine's contribution was made explicit.
Reason for missing information: The formula's exact B1 form/amount, amounts of all components, actual intake and contrasts isolating individual components.
Required materials and conditions: 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.
Materials to obtain first: Product ingredient lists, original administration/diet plans, actual intake and component-specific contrast data.
Further 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.
Remaining uncertainty: The formula's effect cannot be attributed solely to thiamine or to a single component such as energy or protein.
Conditions for verification: Verify the actual formula, diet and comparison, and that individual component contributions have not been separated.
Why this condition is needed: This attribution criterion prevents a positive multicomponent-exposure result from erasing gaps in the single-ingredient B1 question.
Application exceptions: 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.
Referenced methods: 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.

Related sources S05

N22 · Were medians, IQRs and within-group/between-group P values distinguished?

Current findings: 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.
Verification status: Met
Materials actually 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
Why unverified: 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.
Reason for missing information: Control-arm change distribution, between-group estimate/CI, exact test/model, denominator and original Table 3.
Required materials and conditions: 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.
Materials to obtain first: Original result Table 3, models/tests, arm-specific change distributions and between-group estimates/CIs.
Further 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.
Remaining uncertainty: Different within-group/between-group P values do not automatically conflict; significance alone cannot establish B1 efficacy or an important difference.
Conditions for verification: Preserve the median, IQR and the hypothesis tested by each P value, leaving unverified between-group estimates unverified.
Why this condition is needed: This criterion prevents attributing positive numerical results to the wrong ingredient, comparison or interval.
Application exceptions: Do not use arithmetic in this review to create an unavailable between-group magnitude or CI, or read an IQR as a precision interval.
Referenced methods: 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.

Related sources S05

N23 · Were actual CKD gait testing and the analysis population distinguished?

Current findings: 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.
Verification status: Partly verified
Materials actually 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
Why unverified: The retained population, allocated/analyzed n and some testing details are verified, but target functional-impairment selection and sufficient measurement/missingness information remain unresolved.
Reason for missing information: Selection for functional impairment, baseline speed, exact gait SOP, dropout reasons/handling and outcome-specific n.
Required materials and conditions: 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.
Materials to obtain first: Baseline/selection tables, participant flow, gait SOP and outcome-specific analysis/missingness tables.
Further research: Compare participant flow and measurement procedures for each outcome to limit the applicability of the formula results.
Remaining 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.
Conditions for verification: Link CKD allocation/analysis flow and test conditions to differences from the target selection criteria.
Why this condition is needed: This criterion accurately preserves the populations, tests and denominators behind the formula's numerical results.
Application exceptions: 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.
Referenced methods: 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.

Related sources S05

N24 · Were registration-date conflicts distinguished from original tables not compared?

Current findings: 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.
Verification status: Conflicting information
Materials actually 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
Why unverified: The record of inconsistent registration-date formatting was retained without newly establishing numerical conflicts throughout unchecked original tables, lack of registration or selective reporting.
Reason for missing information: Original strings for each registration date, their meanings/versions, initial registry history and separate original tables.
Required materials and conditions: 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.
Materials to obtain first: Initial/amended registry history, original registration-date sections, Table 2/3 and explanations of corrections.
Further 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.
Remaining uncertainty: Formatting/registration-date differences are separate from conflicts in treatment duration or results. The record alone cannot determine which date is authoritative.
Conditions for verification: Separate the record of conflicting registration-date notation from the scope of original tables/registration not compared.
Why this condition is needed: This criterion retains historical access limitations and actual reported conflicts within their precise scope.
Application exceptions: Do not label a current lack of attempt as a current access failure, or automatically fill detailed dates from other files.
Referenced methods: 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.

Related sources S05

N25 · Was the observed direction for deficiency and ability to walk kept from being reversed into a supplementation effect?

Current findings: 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.
Verification status: Met
Materials actually 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
Why unverified: Exposure markers, denominators, the different endpoint and confounding were linked to actual family locations, without converting the observational direction into causal supplementation efficacy.
Reason for missing information: Supplement allocation, speed in m/s, temporal sequence, confounding adjustment and an eligible treatment comparison.
Required materials and conditions: 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.
Materials to obtain first: Original Table 2/3, feeding route/care level/walking denominators, design and adjustment data.
Further research: Compare the observational definitions of exposure and outcome with feeding route/care selection, distinguishing them from a separate question about assigned treatment.
Remaining uncertainty: Feeding-route/care selection in the cross-sectional population does not support a simple causal explanation of deficiency→poor function.
Conditions for verification: Accurately preserve the observational population, deficiency/feeding routes, walking denominators and causal limitations.
Why this condition is needed: This criterion prevents reversing deficiency associations into treatment directions or mixing denominators.
Application exceptions: Do not convert ability to walk into speed, or treat tube/intravenous feeding in the nondeficient group as an oral B1 intervention.
Referenced methods: 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.

Related sources S06

N26 · Was Barthel recovery distinguished from a treatment effect on gait speed?

Current findings: 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.
Verification status: Met
Materials actually 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
Why unverified: The sample, nutritional marker, different functional scale, observational design and historical abstract-level scope were distinguished.
Reason for missing information: Full methods, adjustment/temporal sequence, detailed functional/nutritional denominators and an eligible oral comparison.
Required materials and conditions: 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.
Materials to obtain first: Original methods/results, marker criteria, adjustment, functional-recovery tables and an eligible comparison.
Further research: Link the Barthel association to exposure, time and confounding, and assess it separately from the causal gait-speed question.
Remaining 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.
Conditions for verification: Attribute the inpatient observation's scale, population, nutritional markers and material-access level to its own result.
Why this condition is needed: This criterion prevents an observed result for another form of functional recovery from substituting for target efficacy.
Application exceptions: Do not generalize the abstract's association or 0 deficiency cases into an oral B1 treatment effect or to all nondeficient older adults.
Referenced methods: 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.

Related sources S07

N27 · Do dietary data on other B vitamins answer the B1 functional-impairment question?

Current findings: 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.
Verification status: Met
Materials actually 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
Why unverified: Differences from the target in nutrients, population, design and measure were verified at the actual family/bibliographic locations.
Reason for missing information: B1 administration, an eligible population with functional impairment and a direct gait-speed comparison/result.
Required materials and conditions: 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.
Materials to obtain first: Original exposure, selection/baseline function, measure definitions and an eligible B1 comparison.
Further research: Extract differences in each nutrient and functional definition, indicating relevance without pooling them as causal B1 effects.
Remaining uncertainty: The shared label B vitamins alone cannot establish equivalence of effects or exposures.
Conditions for verification: Identify differences in B6/B12/folate exposure, a population with unimpaired function and self-reported outcomes.
Why this condition is needed: This criterion keeps the presence or absence of positive findings for other ingredients/observational questions from erasing the direct B1 evidence gap.
Application exceptions: Do not promote an indexed abstract to newly read full text or record it as a successful current PubMed search.
Referenced methods: 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.

Related sources S08

N28 · Were the composition, population and results of registry leads actually verified?

Current findings: 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.
Verification status: Unverified
Materials actually 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
Why unverified: 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.
Reason for missing information: Original registration versions, ingredients/routes, objective-functional-impairment eligibility criteria, denominators and gait results/time points.
Required materials and conditions: 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.
Materials to obtain first: Original structured registry content, amendment history, protocol and linked result reports.
Further research: Check exposure/population/outcome eligibility for each candidate first, linking it to a family only when a result is verified.
Remaining uncertainty: A 3rd-party lead or registry title does not establish actual result publication/completion or a valid single-ingredient B1 regimen.
Conditions for verification: Record each of the two candidates' verified identities and unresolved composition, eligibility and results separately.
Why this condition is needed: This criterion separates the existence of a candidate from acquisition of efficacy results.
Application exceptions: Do not replace an unresolved candidate with confirmed exclusion from eligibility, an effect of 0 or not applicable.
Referenced methods: 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.

Related sources S12 S13

N29 · Was Wilkinson's deficiency/grip-strength trial kept from being transferred to gait speed?

Current findings: 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.
Verification status: Met
Materials actually 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
Why unverified: The retained deficiency selection, different measure, administration and scope of extraction reuse were linked.
Reason for missing information: Selection for objective functional impairment, an eligible usual-gait result, the exact salt and comparison with original tables/full text in this review.
Required materials and conditions: 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.
Materials to obtain first: Original eligibility/administration, grip and gait measurements/results, and exact-salt data.
Further 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.
Remaining uncertainty: Results/samples for the deficiency grip-strength question are not direct effects on gait speed in older adults with functional impairment.
Conditions for verification: Limit deficiency selection, grip strength and the oral regimen to the relevant family and extraction level.
Why this condition is needed: This criterion clarifies reuse of prior extractions and attribution to a different distinct claim.
Application exceptions: Do not inherit a previous verdict/score or a dose for another endpoint as fulfillment of new gait-speed criteria.
Referenced methods: 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.

Related sources S14

N30 · Is the TARIF fatigue trial a gait-speed comparison in older adults?

Current findings: 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.
Verification status: Met
Materials actually 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
Why unverified: The distinct fatigue/IBD population and endpoint, and reuse of prior extractions to establish boundaries, were limited to verified locations.
Reason for missing information: Eligible selection of older adults with functional impairment, a gait-speed contrast and original methods/relevant results.
Required materials and conditions: 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.
Materials to obtain first: Original population, endpoint/analysis tables, exposure form and eligible gait results.
Further research: Attribute results to their respective questions using an eligibility table that distinguishes disease-related fatigue, grip strength and gait.
Remaining uncertainty: Even if thiamine appears in the title and the study is placebo-controlled, the population and outcome do not automatically match.
Conditions for verification: Distinguish TARIF's population/results and the original extraction level from the gait-speed question.
Why this condition is needed: This criterion separates the different population and endpoint of a closely related oral trial.
Application exceptions: Do not adopt a previous fatigue verdict or another endpoint's results as a new direct gait-speed effect.
Referenced methods: 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.

Related sources S15

N31 · Was Smidt's healthy/marginal-deficiency population kept separate from the target population?

Current findings: 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.
Verification status: Met
Materials actually 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
Why unverified: The difference between the shared condition of older age and actual functional impairment/gait endpoints was preserved.
Reason for missing information: Functional-impairment eligibility criteria, usual-gait protocol/results and complete administration/denominator information.
Required materials and conditions: 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.
Materials to obtain first: Original selection, sex/baseline status, administration and actual functional-measurement/analysis tables.
Further research: Distinguish health/functional-impairment and deficiency criteria, and compare direct-gait-comparison eligibility with the original results.
Remaining uncertainty: Well-being/deficiency boundaries in healthy older women do not represent effects in all older adults with functional impairment.
Conditions for verification: Link the applicability limitations concerning healthy women, marginal deficiency and unverified function/gait.
Why this condition is needed: This criterion prevents expanding population directness based on the label older adults.
Application exceptions: Do not reclassify a study of healthy older adults as a study of objective functional impairment.
Referenced methods: 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.

Related sources S16

N32 · Were uncontrolled mixed-form CMT data kept from being promoted to direct results?

Current findings: 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.
Verification status: Met
Materials actually 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
Why unverified: Limitations from lack of controls, mixed preparations/ages, different endpoints and correction extractions were attributed to the relevant family.
Reason for missing information: Exact form-specific populations/results, original correction content, assigned comparisons and eligible gait-speed analyses.
Required materials and conditions: 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.
Materials to obtain first: Original observations/corrections, individual forms/routes/ages, gait results and comparative data.
Further research: Separate form/population/route and the content before and after the original correction, examining applicability to the gait comparison.
Remaining uncertainty: Neuropathy improvement or mixed observational results are not evidence of a causal effect in the target comparison or of resolution through correction.
Conditions for verification: Preserve boundaries concerning mixed forms/ages, lack of controls, correction extractions and unverified target results.
Why this condition is needed: This criterion prevents overinterpretation of mixed uncontrolled observations and original corrections.
Application exceptions: Do not label an error resolved merely because metadata indicate a correction, or combine derivative effects as ordinary-thiamine effects.
Referenced methods: 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.

Related sources S17

N33 · Was FIM functional improvement kept from being relabeled as usual gait speed?

Current findings: 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.
Verification status: Met
Materials actually 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
Why unverified: Deficiency treatment, the separate functional scale FIM and the prior extraction level were distinguished.
Reason for missing information: Eligible population, exact preparation/route, actual comparator and usual-gait-speed results in m/s.
Required materials and conditions: 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.
Materials to obtain first: Original population, administration/route, FIM/gait measurement, comparator and results by time point.
Further research: Attribute deficiency-treatment scales and exposures to their original reports, examining separately whether a target gait comparison is established.
Remaining uncertainty: Functional recovery and numerical gait speed have different meanings; observation after treatment alone cannot establish a causal comparison.
Conditions for verification: Separate FIM, deficiency neuropathy and treatment extractions from a direct gait-speed comparison.
Why this condition is needed: This criterion prevents automatically exchanging outcomes because functional scales use similar wording.
Application exceptions: Do not generalize the need to correct deficiency or FIM improvement into a gait effect in nondeficient older adults.
Referenced methods: 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.

Related sources S18

N34 · Are intramuscular observations in muscular dystrophy oral-comparison data?

Current findings: 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.
Verification status: Met
Materials actually 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
Why unverified: The different disease, intramuscular route, absence of controls and historical extraction level were clearly linked.
Reason for missing information: A comparator for the target oral exposure, older adults with objective functional impairment and gait-speed results.
Required materials and conditions: 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.
Materials to obtain first: Original case diseases, routes/preparations, time points/function definitions and an eligible oral comparison.
Further research: Separate results by route and disease, distinguishing case observations from effect estimates in controlled trials.
Remaining uncertainty: Symptom improvement in cases with different routes/diseases does not establish the magnitude or replication of the target oral effect.
Conditions for verification: Identify differences between intramuscular case reports and single-ingredient oral gait comparisons.
Why this condition is needed: This criterion prevents overstepping disease/route/design boundaries and falsely promoting the existence of a link.
Application exceptions: Do not convert a public PMC URL into a badge of current full-text reading or a result for an oral preparation.
Referenced methods: 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.

Related sources S19

N35 · Were adverse events/discontinuations in the same population and regimen verified?

Current findings: 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.
Verification status: Unverified
Materials actually 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
Why unverified: Because no direct regimen/population was selected, systematic collection, events/people and discontinuations/losses for that exposure cannot be verified.
Reason for missing information: Direct AE definitions, systematic/spontaneous collection, severity, people/event counts, exposure/denominators and discontinuation reasons/losses.
Required materials and conditions: 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.
Materials to obtain first: AE/discontinuation tables for the same population/preparation, exposure/follow-up flow, collection methods and original event records.
Further research: Plan harm collection separately within an eligible efficacy comparison, reporting events, people, exposure periods and discontinuation reasons distinctly.
Remaining uncertainty: Indirect signals and product wording do not substitute for incidence, overall safety or a causal judgment for the target exposure.
Conditions for verification: Separate collection methods, denominators, duration and unverified scope for direct harms/discontinuations.
Why this condition is needed: This supplementary criterion displays the efficacy gap separately from the gap in direct safety data.
Application exceptions: Do not delete indirect efficacy sources because of a harm-data gap, or automatically assign the same status as the efficacy criteria.
Referenced methods: 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.

Related sources

N36 · Were diarrhea improvement after discontinuation and event totals kept from being converted into risk estimates?

Current findings: 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.
Verification status: Partly verified
Materials actually 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
Why unverified: 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.
Reason for missing information: Diarrhea onset/recovery timing, event collection, exposure denominators, concomitant treatment/underlying disease and original SAE tables/corrections.
Required materials and conditions: 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.
Materials to obtain first: Original HF AE/SAE tables, original discontinuation records, exposure by arm/period, alternative causes and correction materials.
Further research: Compare the original event's timing, discontinuation, alternative explanations and event/person totals, distinguishing signals, comparative risk and causal statements.
Remaining uncertainty: Improvement after discontinuation is important temporal information, but alone does not establish causality, frequency or risk for all oral forms.
Conditions for verification: Preserve the 1 diarrhea event, improvement after discontinuation and original discrepancies in totals at the level of the report.
Why this condition is needed: This criterion is needed to preserve harm signals while preventing their promotion to incidence or causality.
Application exceptions: Do not automatically use all 24 randomized participants or the 19 completers as AE denominators, or correct table totals through new calculations.
Referenced methods: 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.

Related sources S02

N37 · Were the absence of a UL and product wording kept from becoming a general safety guarantee?

Current findings: 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.
Verification status: Met
Materials actually 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
Why unverified: 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.
Reason for missing information: The exact SmPC/excipients for the target eligible product, the current official version and actual incidence denominators.
Required materials and conditions: 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.
Materials to obtain first: Exact ingredients/excipients of the relevant study product, product-information versions and original harm data for the same route/population.
Further research: Compare applicability by product/route/dose, separating official wording from actually collected events and frequencies.
Remaining 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.
Conditions for verification: Distinguish the absence of a UL, product-specific salts/wording, route-specific risks and current non-reading.
Why this condition is needed: This criterion prevents mistaking the existence of an official fact sheet/label for established efficacy or safety, or for identity of products.
Application exceptions: Do not transfer oral-product-specific pregnancy/lactation or excipient cautions to all nutritional exposures/other salts.
Referenced methods: 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.

Related sources S09 S10

N38 · Were the limited HF/refeeding contexts kept from being applied to all older adults?

Current findings: 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.
Verification status: Partly verified
Materials actually 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
Why unverified: Selection exclusions and the refeeding context are retained, but there are no direct data for the target vulnerable population or long-term exposure.
Reason for missing information: Actual preparations/exposures, long-term/rare harms and concomitant medications by population, including dialysis and malnutrition/cognitive impairment.
Required materials and conditions: 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.
Materials to obtain first: Vulnerable-group selection/exposure, concomitant medications, long-term follow-up/harm data and the exact refeeding-guideline version.
Further 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.
Remaining uncertainty: Short-term observations in selected populations and separate clinically supervised contexts do not represent safety in all older adults with functional impairment.
Conditions for verification: Distinguish original exclusions/vulnerable groups and the purpose of refeeding from direct/long-term safety gaps.
Why this condition is needed: This supplementary criterion prevents generalizing safety from selected populations or exceeding the scope of clinically supervised contexts.
Application exceptions: Do not require every rare-harm study for the current narrow gait-speed question, or convert refeeding wording into a personal prescription.
Referenced methods: 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.

Related sources S01 S02 S09 S10 S11

N39 · Were falls, optimal dose and maintained effects made mandatory parts of the gait-speed question?

Current findings: 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.
Verification status: Not applicable
Materials actually 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
Why unverified: 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.
Reason for missing information: If the extension is actually claimed, direct comparisons, time points, denominators and separate results for that question are needed.
Required materials and conditions: 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.
Materials to obtain first: The exact original wording of the extended claim, relevant event/dose/follow-up comparisons and results.
Further research: If an extension is requested, first establish the distinct question boundary, then review direct results separately from the existing gait-speed table.
Remaining uncertainty: The concept of gait speed as mobility function is not causal evidence of preventing falls/death or improving every aspect of function.
Conditions for verification: Clarify why separate questions about events, dose and maintained effects do not apply as conditions for the gait-speed result.
Why this condition is needed: This supplementary criterion separates requirements for the narrow subject of the verdict from separate extension criteria.
Application exceptions: Do not require an event trial for the numerical-change question itself; keep unresolved candidate/eligible materials unverified in other rows.
Referenced methods: 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.

Related sources

N40 · Were ?/null, the calculation exception, document quality and historical deployment distinguished?

Current findings: 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.
Verification status: Met
Materials actually 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
Why unverified: The original current value, exception, document self-assessment and historical deployment were separated from content-verification status and current local preparation.
Reason for missing information: Directly eligible effect/CI, support in an up-to-date calculation system, public publication in this review and independent clinical certification remain incomplete.
Required materials and conditions: 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.
Materials to obtain first: Original verdict/calculation-exception records, identity/deployment history, authorized change decisions and complete versions before and after changes.
Further 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.
Remaining 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.
Conditions for verification: Separate the original ?/null, unscored axes, invalid suggestion, document self-assessment and historical deployment from what was produced in this review.
Why this condition is needed: This is a required preservation criterion to prevent automatic inheritance of scores/statuses or historical completion metadata.
Application exceptions: Do not use general code-structure checks as a new clinical score, implementation of an official method or certification of study absence.
Referenced methods: 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.

Related sources

N41 · Were S20/S21 kept from being labeled as rule files read in this review?

Current findings: 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.
Verification status: Met
Materials actually 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
Why unverified: Historical records of local rules' existence were not promoted to current source-file acquisition/reading and were distinguished from the current writing instructions.
Reason for missing information: The current existence/identity of the two historical source files and their original bytes/SHA remain unverified in this review.
Required materials and conditions: 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.
Materials to obtain first: Historical local source documents, versions, bytes/SHA and application/access records from the time.
Further research: If separate verification is needed, first check actual file identity, distinguishing historical application from access events in this review.
Remaining uncertainty: A URL string being a local relative path does not itself make it a currently valid clickable link or an acquired file.
Conditions for verification: Separate historical reading of S20/S21 from reading their bibliographic summaries and not reading the source documents in this review.
Why this condition is needed: This traceability criterion distinguishes current summary access from source-document access for local rule documents as well.
Application exceptions: Do not create current file links from original relative paths without safe actual files, or count them as external clinical results.
Referenced methods: 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.

Related sources S20 S21