{ "schema_version": "chamgap-public-criteria-1.0", "title": "Ordinary thiamine (vitamin B1) × Handgrip improvement in objectively weak adults", "criteria_version": "3117-ORAL-THIAMINE-HANDGRIP-1.0", "criteria_date": "2026-10-05", "condition_origin": "Chamgap application criteria", "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility criteria and reasons for changes, and distinguish variations in the intervention.", "review_level": "Records reuse of retained methodological principles/versions and the 5 actual HTML copies from 1585. This is not new reading of methodological full texts or an official execution/certification in the current work." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish and link studies and reports, and do not omit a study solely because its outcomes are not reported.", "review_level": "Records reuse of retained methodological principles/versions and the 5 actual HTML copies from 1585. This is not new reading of methodological full texts or an official execution/certification in the current work." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Hold the outcome and effect of interest fixed, then assess randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Records reuse of retained methodological principles/versions and the 5 actual HTML copies from 1585. This is not new reading of methodological full texts or an official execution/certification in the current work." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Records reuse of retained methodological principles/versions and the 5 actual HTML copies from 1585. This is not new reading of methodological full texts or an official execution/certification in the current work." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Questions about harms may require designs, populations and follow-up different from efficacy questions. Case reports do not establish incidence.", "review_level": "Records reuse of retained methodological principles/versions and the 5 actual HTML copies from 1585. This is not new reading of methodological full texts or an official execution/certification in the current work." } ], "status_dictionary": { "Partly verified": "Some retained information exists, but gaps remain in eligible populations/exposures, measurements/denominators/estimates, original-source access, and related details.", "Unverified": "The necessary information/conditions cannot be established within the current verification scope.", "Review incomplete": "Original-material comparison/search was not performed within the permitted scope.", "Not reported": "A scope-limited status indicating that the item was not stated in the particular material/section read.", "Inaccessible": "Used only for materials for which access was actually attempted and failed. Not assigned to clinical materials in the current work.", "Insufficient eligible evidence": "Used only when, after reviewing related studies within a defined scope, evidence is insufficient to answer the specified question. Not applied across all entries in this work.", "Not applicable": "Specific non-applicability: separate extension studies are not imposed on the current narrow handgrip question. Not a substitute for unverified actual exposure/population/outcomes.", "Conflicting information": "Used when incompatible information has been compared for the same question, time point, and analysis. Not assigned merely because numbers differ between reviews.", "Met": "Verification of the stated preservation, boundary/distinction, or linkage conditions. Not certification of clinical efficacy, external full-text reading, or individual safety." }, "requirements": [ { "item_id": "N01", "question_type": "Independent claim", "question": "Which population, route, and strength outcome does this table address?", "needed": "Current independent claim, adults with objectively reduced muscle strength, oral ordinary thiamine, comparator, and handgrip boundary", "role": "Required (selected handgrip question)", "role_reason": "This is needed to avoid combining fatigue, muscle mass, walking, and deficiency treatment with comparative handgrip efficacy.", "application_exception": "Do not arbitrarily fill in the salt, dose, test, or time point from adjacent studies to resolve the absence of a verified selected trial.", "criterion": "Maintain the same unit of inquiry as the original question and distinguish question-level boundaries from actual trial identity.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "Verify comparative handgrip data that meet this boundary, and assess other endpoints and formulations as separate questions." }, { "item_id": "N02", "question_type": "Ingredient, salt, and product", "question": "Have the ordinary-thiamine salt and single-ingredient product in the target trial been verified?", "needed": "Base/hydrochloride/nitrate, manufacturer, ingredients/excipients, and free-thiamine-equivalent amount of the product in an eligible original report", "role": "Required (selected handgrip question)", "role_reason": "This is needed to avoid identifying the actual trial product from derivatives, a separate licensed product, or mixed CMT treatments.", "application_exception": "Specifying single-ingredient ordinary thiamine in the question is different from verifying the actual product.", "criterion": "Retain null values for the actual salt/product and the exclusion of derivatives and combination products separately.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "Compare product and ingredient records from an eligible trial, and extract derivative/combination exposures separately." }, { "item_id": "N03", "question_type": "Route and physical dosage form", "question": "Have the question's oral route and the actual tablet/capsule form been distinguished?", "needed": "Oral route, physical dosage form, and manufacturing/batch data for an eligible comparison", "role": "Required (selected handgrip question)", "role_reason": "This is needed to avoid transferring responses from injection cases or a specific tablet's product information to the target trial exposure.", "application_exception": "Preserve the oral-route boundary of the question without automatically assigning an unverified tablet/capsule form.", "criterion": "Explain the oral question, exclusion of injections, and the gap concerning the actual physical dosage form.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "Verify administration and physical dosage form in the original trial, and link injection and derivative evidence separately." }, { "item_id": "N04", "question_type": "Nominal and actual dose", "question": "Have the dose and adherence in the target handgrip trial been verified?", "needed": "Nominal dose, dosing schedule, active amount, actual adherence/exposure, and concomitant supplementation by eligible group", "role": "Required (selected handgrip question)", "role_reason": "This is needed to avoid turning 10 mg, 600–1800 mg, or high-dose case reports into effective doses for this population.", "application_exception": "Doses in adjacent studies are historical records, not individual dosing recommendations or dose-response evidence.", "criterion": "Distinguish the null value for the actual target dose from historical doses in individual sources.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "Link dosing/adherence records for an eligible product to outcome denominators, and assess direct dose comparisons separately." }, { "item_id": "N05", "question_type": "Duration and principal time point", "question": "Have the eligible treatment duration and handgrip measurement time point been verified?", "needed": "Eligible treatment duration, principal handgrip time point, follow-up after discontinuation, and measurements by visit", "role": "Required (selected handgrip question)", "role_reason": "This is needed to avoid filling in 3 months, 4 weeks, 5 days, or long-term cases as verified timing for the target question.", "application_exception": "Do not replace the question's unverified duration with the duration of an adjacent trial.", "criterion": "Preserve null actual_duration/actual_timepoint values separately from durations in individual sources.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "Verify visit, treatment, and discontinuation times in an eligible comparison, and assess maintenance effects using separate data." }, { "item_id": "N06", "question_type": "Population and reduced strength", "question": "Is there an actual enrollment cutoff for objectively reduced muscle strength?", "needed": "Adult inclusion/exclusion, definition of objectively reduced handgrip, cutoff, baseline distribution, and verified subgroup", "role": "Required (selected handgrip question)", "role_reason": "This is needed to avoid turning low TPP, older age, fatigue, or a low group mean into reduced muscle strength in every participant.", "application_exception": "Distinguish the question's population definition from verification of an actually eligible population.", "criterion": "Leave the cutoff unverified and explain mismatches in adjacent populations with reference to the original source locations.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "Obtain enrollment criteria, individual/subgroup baseline handgrip, and prespecified definitions before comparing population eligibility." }, { "item_id": "N07", "question_type": "Nutritional status and deficiency", "question": "Can deficiency correction be separated from the effect of general additional supplementation?", "needed": "Thiamine status, deficiency definition, handgrip outcomes by status, and deficiency-treatment context in an eligible population", "role": "Required (selected handgrip question)", "role_reason": "This is needed to avoid transferring low TPP, deficiency neuropathy, or altered nutritional requirements to the efficacy of general strength supplementation.", "application_exception": "This undetermined assessment is not an instruction to stop necessary deficiency treatment.", "criterion": "Keep actual_thiamine_status null and identify deficiency correction as a separate question.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "Compare status definitions, treatment context, and direct handgrip comparisons by status separately." }, { "item_id": "N08", "question_type": "Comparison and background care", "question": "Have the actual comparator and balance of concomitant treatments been verified?", "needed": "Eligible placebo/no added thiamine/matched usual care, concomitant treatments, changes/rescue treatment, and adherence", "role": "Required (selected handgrip question)", "role_reason": "This is needed to avoid turning other CMT treatments or healthy-participant biomarker comparisons into handgrip comparators.", "application_exception": "Distinguish the intended comparator from the null actual_comparator value, without requiring every change in every group to be identical.", "criterion": "Record the question's comparison separately from the actual unverified comparator and effects of concomitant interventions.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "Link background care and changes by group to the analysis of the actual effect of interest." }, { "item_id": "N09", "question_type": "Handgrip measurement", "question": "Is there an actual target measurement specifying hand, device, units, and repeated-measurement rules?", "needed": "Eligible handgrip device/calibration, hand, posture, repetition/aggregation rules, units, assessor masking, and principal time point", "role": "Required (selected handgrip question)", "role_reason": "This is needed to avoid filling in dominant-hand measurement with a Preston device as the protocol of an unselected target trial.", "application_exception": "The name of an objective measurement alone does not resolve measurement bias or its importance for daily function.", "criterion": "Distinguish null actual device/hand/unit values from test information in adjacent studies.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "Extract eligible testing procedures and implementation/assessment by group together with the original handgrip results." }, { "item_id": "N10", "question_type": "Endpoint hierarchy", "question": "Have the page's handgrip question and the original trial's primary endpoint been distinguished?", "needed": "Handgrip endpoint, principal time point/analysis hierarchy in eligible registration/planning records, and actual reporting", "role": "Required (selected handgrip question)", "role_reason": "This is needed to avoid turning a primary fatigue endpoint and a secondary handgrip excerpt into the same prespecified primary handgrip effect.", "application_exception": "The fact that handgrip is the page's target does not itself mean that it was the trial's primary endpoint or was preregistered.", "criterion": "Distinguish handgrip being fixed at the question level from the unverified actual trial hierarchy and plan.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "Compare registration, protocol, and analysis plan with actual handgrip reporting." }, { "item_id": "N11", "question_type": "TF01 enrollment", "question": "Are the 76 older adults with low TPP an objectively weak population?", "needed": "Wilkinson enrollment criteria, TPP strata, baseline low-handgrip cutoff/prespecified subgroup", "role": "Required (selected handgrip question)", "role_reason": "This is needed to avoid promoting the closest controlled trial to a direct trial matching the target population.", "application_exception": "Low TPP and a low group mean alone do not establish reduced strength in every person or subgroup.", "criterion": "Retain the trial of 76 participants together with the reasons for the population mismatch.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "Verify original enrollment, baseline handgrip, and prespecified comparisons by stratum to prepare material for reassessing eligibility." }, { "item_id": "N12", "question_type": "TF01 testing and timing", "question": "Has the scope of dominant-hand Preston grip measurement and 3 months of exposure been preserved?", "needed": "S01 testing, units/repetitions, time points, original results tables, and quantitative handgrip contrast", "role": "Required (selected handgrip question)", "role_reason": "This is needed to avoid assigning the device/time to another trial or claiming new verification of the complete testing section.", "application_exception": "Historical access to a full-text reproduction on a 3rd-party host differs from reading the local summary in this work.", "criterion": "Attribute dominant-hand Preston measurement/10 mg/3 months to TF01 and retain the additional measurement gaps.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "Verify testing procedures and analysis values in the original Methods/Results/tables, and link them to the same outcome." }, { "item_id": "N13", "question_type": "TF01 allocation and masking", "question": "Does a randomized/double-blind label establish actual implementation?", "needed": "S01 allocation/concealment, who was masked/masking success, baseline balance, actual adherence, and analysis handling", "role": "Required (selected handgrip question)", "role_reason": "This is needed to avoid erasing concealment, deviation, measurement, or selective-reporting problems on the basis of the design's name.", "application_exception": "Do not borrow methods from an indirect trial to assign the bias axis of an eligible trial.", "criterion": "Distinguish the reported parallel design/TPP stratification from unverified implementation details.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "Compare the original methods with baseline, implementation, and analysis information for the handgrip outcome of interest." }, { "item_id": "N14", "question_type": "TF01 denominators", "question": "Are 38 versus 38 and completion by all being turned into a handgrip analysis denominator?", "needed": "Allocation/completion, handgrip measurement and analysis denominators, missingness, and variance/intervals", "role": "Required (selected handgrip question)", "role_reason": "This is needed to avoid assuming from participation/completion counts alone that all handgrip observations and analyses involve the same numbers.", "application_exception": "Retain the existing record of 76, 38/38, and completion by all without creating new sums.", "criterion": "Distinguish original participation/completion records from unverified handgrip analyses and effect intervals.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "Link measurement/analysis counts at each time point in the original handgrip tables with missing-data handling and variance definitions." }, { "item_id": "N15", "question_type": "TF01 nonsignificance and estimation", "question": "Is handgrip nonsignificance being read as an effect of 0 or equivalence?", "needed": "Original handgrip treatment contrast, variance, CI, exact P, and analysis population/model", "role": "Required (selected handgrip question)", "role_reason": "This is needed to avoid turning a statement about significance into a quantitative effect magnitude or exclusion of benefit.", "application_exception": "The statement that a quantitative contrast was not reported is limited to the retained extraction currently read.", "criterion": "Preserve the nonsignificant report together with unverified numerical values/intervals, and do not make new calculations.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "If the original between-group handgrip estimate/interval and analysis definition are acquired, compare them separately from clinical importance." }, { "item_id": "N16", "question_type": "Funding and provision", "question": "Is funding from indirect trials being borrowed as independent efficacy replication?", "needed": "TF01/TF02/TF03 funding, product provision, author declarations/patents, and family relationships", "role": "Required (selected handgrip question)", "role_reason": "This is needed to avoid turning the names of public/private funders into absence of product provision or conflicts of interest, or into independent replication.", "application_exception": "Do not automatically exclude a study because funding exists or establish bias because it is unknown.", "criterion": "Distinguish retained funding and not-reported/unverified provision information from the currently unscored independence axis.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "Compare original Funding/COI, product provision, and family relationships by outcome." }, { "item_id": "N17", "question_type": "TF02 population and endpoint", "question": "Is a handgrip excerpt from an IBD-fatigue crossover trial the target result?", "needed": "TARIF baseline reduced-strength enrollment/strata, handgrip analysis results, and fatigue/handgrip hierarchy", "role": "Required (selected handgrip question)", "role_reason": "This is needed to avoid turning severe chronic fatigue and a secondary handgrip excerpt into a direct effect in an objectively weak population.", "application_exception": "Do not modify existing fatigue verdict 3086 or borrow it to score handgrip efficacy.", "criterion": "Separate the existence of the 40-participant fatigue trial from gaps concerning the target population and quantitative handgrip results.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "Compare original handgrip subgroups, results, and denominators with the prespecified plan to reassess eligibility." }, { "item_id": "N18", "question_type": "TF02 crossover and analysis", "question": "Are the 40 participants across two periods being counted as independent participants or a between-group handgrip effect?", "needed": "4-week treatment, 4-week washout, sequence/period, paired data, handgrip analysis counts, and carryover/model", "role": "Required (selected handgrip question)", "role_reason": "This is needed to avoid summing crossover participants as new people in each period or borrowing fatigue analysis as handgrip analysis.", "application_exception": "Do not create an eligible crossover estimand while population/endpoint mismatches remain unresolved.", "criterion": "Distinguish the retained schedule and nominal dose from unverified handgrip-specific analysis.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "Verify sequence, period, paired variance, handling of carryover, and actual denominators in the original crossover handgrip analysis." }, { "item_id": "N19", "question_type": "TF02 registration", "question": "Have the NCT identifier and actual reading of the plan/amendment history been distinguished?", "needed": "Structured content of NCT03634735, original registration timing, handgrip hierarchy/analysis, and amendment history", "role": "Required (selected handgrip question)", "role_reason": "This is needed to avoid turning a registration number into prospective registration or completion of selective-reporting assessment.", "application_exception": "Distinguish historical shell/API/DNS failures from external access not attempted in this work.", "criterion": "Preserve verification of the identifier and unverified content/history, without newly assigning a current Inaccessible status.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "In an authorized update, compare the official registration/history with the handgrip plan in the original report." }, { "item_id": "N20", "question_type": "TF02 subsequent reports", "question": "Is the supplied 3086 extraction being read as new full-text reading or independent replication?", "needed": "Original identities of subsequent metabolic/maintenance reports, common family/population, and handgrip endpoint/access", "role": "Required (selected handgrip question)", "role_reason": "This is needed to avoid counting the hydrochloride lead in previously supplied material and subsequent fatigue analyses as new handgrip trials.", "application_exception": "Do not record that older protected_input files or external subsequent full texts were opened in this work.", "criterion": "Distinguish the historical supplied-material/multiple-report role of S19 from unverified handgrip results.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "Verify the original identity, cohort, and handgrip data in each subsequent report, and link it to the same family." }, { "item_id": "N21", "question_type": "TF03 composition and denominators", "question": "Are the 15, 14, 5, and 2 participants counted as the same trial of a pure oral preparation in adults?", "needed": "Age, formulation, other treatments, and participants/denominators for handgrip follow-up in each row of the CMT supplementary material", "role": "Required (selected handgrip question)", "role_reason": "Needed to avoid combining mixed formulations, a participant aged 16, other treatments, and different denominators into a single oral-treatment result in adults.", "application_exception": "The existing denominators are historical extractions; no additional totals or effect calculations are generated in this work.", "criterion": "Preserve the supplementary material's 15 participants/14 adults, 5 adult HCl rows, and 2 participants with long-term HCl handgrip observations according to their respective roles.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "Link age, formulation, and follow-up results from the original Table S1/figures to individual rows." }, { "item_id": "N22", "question_type": "TF03 handgrip figure", "question": "Were HCl in patients 1 and 3 distinguished from sulbutiamine in patient 2?", "needed": "Patient-specific formulations, durations, handgrip follow-up, concomitant treatments/controls, and original measurements in Figure 1", "role": "Required (selected handgrip question)", "role_reason": "Needed to avoid converting favorable before-and-after observations into a causal between-group effect of ordinary thiamine.", "application_exception": "The Russian/English reports concern the same cohort/translation and are not independent replications.", "criterion": "Preserve individual formulations and uncontrolled follow-up without repurposing them as comparative efficacy evidence.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "Compare each patient's handgrip follow-up with actual exposure/concomitant treatment, and obtain comparison data under the same conditions separately." }, { "item_id": "N23", "question_type": "TF03 biomarkers and controls", "question": "Is a healthy-person biomarker comparison an untreated handgrip control?", "needed": "Actual comparators, tests, and time points for the biomarker comparison/Figure S2 and long-term handgrip observations", "role": "Required (selected handgrip question)", "role_reason": "Needed to avoid importing healthy controls for different outcomes/time points into the same handgrip efficacy comparison.", "application_exception": "Distinguish the historical record of visual review of 3 supplementary PDF pages from the current reading of the summary.", "criterion": "Record the comparative meaning of biomarkers and handgrip, and the unverified control, separately.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "Check the original materials for an actual control with the same handgrip measurement, time point, and exposure." }, { "item_id": "N24", "question_type": "TF03 correction", "question": "Were the existence of a correction and verification of its actual full text distinguished?", "needed": "Original/corrected versions, page changes, scope of text/table corrections, and effects on attribution of handgrip observations", "role": "Required (selected handgrip question)", "role_reason": "Needed to avoid treating a bibliographic correction, inaccessible full text, or search excerpt as a fully verified clinical correction.", "application_exception": "Do not count a correction within the same family as a new trial or use the gray-shading excerpt as a verified fact.", "criterion": "Preserve the historical correction notice, page correction, unacquired full text, and excerpt limitations.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "During a permitted update, compare the complete correction with the original table and review linked observations/statuses." }, { "item_id": "N25", "question_type": "TF04 injection cases", "question": "Are the two DM1 cases being read as an oral-treatment handgrip comparison?", "needed": "Actual route, 100 mg 2 times per week, symptoms/measurements, and presence or absence of a control in the DM1 cases", "role": "Required (selected handgrip question)", "role_reason": "Needed to avoid transferring uncontrolled improvement with intramuscular injections to an effect of single-ingredient oral treatment on handgrip.", "application_exception": "Preserve the existence of the cases rather than recasting it as an absence of human research; distinguish only their eligibility for the target question.", "criterion": "Indicate the 2 cases, injection route, uncontrolled design, and current non-reading of the external full text.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "Preserve the exposures/measurements in the original cases and review the target oral-treatment handgrip comparison using separate materials." }, { "item_id": "N26", "question_type": "TF05 general health", "question": "Is well-being in healthy older women being transferred to a handgrip effect in people with low muscle strength?", "needed": "Smidt's baseline definition of low muscle strength, handgrip results, health/well-being endpoints, and denominators", "role": "Required (selected handgrip question)", "role_reason": "Needed to avoid treating older age, marginal thiamine status, and improved well-being as the same handgrip outcome in objectively weak participants.", "application_exception": "Preserve the existence of the original trial in healthy participants without newly importing an effect size.", "criterion": "Distinguish the context of 80 participants/10 mg/6 weeks and a 4-week baseline from gaps in the target population/endpoint.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "If original eligibility criteria/handgrip measurements are available, compare them with the conditions of the same question." }, { "item_id": "N27", "question_type": "TF06 TTFD", "question": "Are the TTFD title and landing page being read as numerical evidence for ordinary thiamine?", "needed": "Original molecular identity, title/material type, and level of access to actual population/measurement results", "role": "Required (selected handgrip question)", "role_reason": "Needed to avoid pooling a derivative and an original article verified only at title level with handgrip effects of ordinary thiamine.", "application_exception": "Do not turn 'double blind' in a title into a complete extraction of methods/numbers.", "criterion": "Preserve both the molecular exclusion of TTFD and the lack of extraction of original numerical results.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "Link the derivative to a separate question and verify direct results for ordinary thiamine separately." }, { "item_id": "N28", "question_type": "TF07 allithiamine", "question": "Is an isokinetic P>0.05 in healthy participants being read as no handgrip effect?", "needed": "Allithiamine, 15 healthy students, 5 days/1 g, Biodex isokinetic results, and original intervals", "role": "Required (selected handgrip question)", "role_reason": "Needed to avoid converting nonsignificance for a derivative, a different population, and a different muscle-strength endpoint into a target effect of 0.", "application_exception": "The existing P>0.05 is a historical report; no exact P value or equivalence interval is generated.", "criterion": "Indicate differences in molecule/population/endpoint together with the limitations of nonsignificance.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "Attribute the original result to its derivative/isokinetic question and review the handgrip comparison separately." }, { "item_id": "N29", "question_type": "TF08 functional recovery", "question": "Were FIM recovery, actual handgrip, and an oral-treatment comparison distinguished?", "needed": "FIM results, actual route/comparator, separate handgrip testing, and access to original methods", "role": "Required (selected handgrip question)", "role_reason": "Needed to avoid transferring overall function in deficiency neuropathy to an isolated handgrip outcome.", "application_exception": "Do not infer an oral preparation/comparator from inaccessible methods.", "criterion": "Retain the general functional endpoint and unverified route/methods.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "If original methods/handgrip data are acquired, compare the actual route, control, and endpoint for correspondence." }, { "item_id": "N30", "question_type": "Other diseases and combinations", "question": "Do PBC fatigue and B-vitamin/magnesium results replicate a single-ingredient handgrip effect?", "needed": "The disease/endpoint in S20 and the combined ingredients/fatigue question and original access in S21", "role": "Required (selected handgrip question)", "role_reason": "Needed to avoid attributing results for fatigue in another disease or for a combined intervention to ordinary thiamine alone for handgrip.", "application_exception": "Do not borrow effect sizes or rescore the existing fatigue assessment.", "criterion": "Preserve differences in disease/endpoint/ingredient eligibility for each source.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "Separate actual results by question and review the single-ingredient handgrip comparison using separate materials." }, { "item_id": "N31", "question_type": "Dietary association", "question": "Is a micronutrient association in Korean adults being recast as supplementation efficacy?", "needed": "Dietary observational design, direction of the exposure/handgrip association, and presence or absence of an actual randomized supplementation comparison", "role": "Required (selected handgrip question)", "role_reason": "Needed to avoid converting a dietary-intake association into a single-ingredient treatment or a supplementation dose/need.", "application_exception": "Do not calculate a supplementation dose from dietary intake in this work or import the original observational effect.", "criterion": "Indicate the difference between questions about observational associations and intervention comparisons.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "Link the dietary association to its original direction and verify a single-ingredient supplementation handgrip comparison separately." }, { "item_id": "N32", "question_type": "Reports and families", "question": "How should 23 sources, 11 families, and 0 directly eligible comparisons be interpreted?", "needed": "Links from report to study/case family to endpoint/time point; provisionally related reports; duplication/unique counts", "role": "Required (selected handgrip question)", "role_reason": "Needed to avoid counting bibliographic records, registrations, safety sources, reviews, and access attempts as 23 trials, or converting 0 directly eligible comparisons into 0 human studies.", "application_exception": "Do not treat the TF01 lead for potentially shared recruitment of 222 people as a verified independent trial or an additional denominator.", "criterion": "Distinguish the current structural family/report relationships from unverified overall unique study/participant counts.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "Verify recruitment/registration/population/result links for each report and preserve relationships identified as the same or unknown." }, { "item_id": "N33", "question_type": "Target effect and analysis", "question": "Is an unverified effect being filled in using within-group changes or baseline handgrip?", "needed": "Eligible between-group handgrip estimand; ITT/PP/adjustment; original effect/CI/exact P; denominators", "role": "Required (selected handgrip question)", "role_reason": "Needed to avoid constructing a target causal effect from baseline values, nonsignificance, or favorable before-and-after observations in adjacent studies.", "application_exception": "Do not fill invalid raw calculation suggestions or an eligibility-schema gap with an effect of 0.", "criterion": "Keep primary_effect/CI/P null and no_effect_claim=false.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "Verify the effect of interest, population, and between-group estimate/interval together in an eligible original analysis." }, { "item_id": "N34", "question_type": "Precision and meaning", "question": "Does objective handgrip guarantee a benefit in daily function or clinical events?", "needed": "Eligible handgrip interval, justified important difference, meaning of the test, and separate daily-function outcomes", "role": "Required (selected handgrip question)", "role_reason": "Needed to avoid arbitrarily establishing patient-important benefit, H/P, or equivalence from objectivity, significance, or sample size.", "application_exception": "Do not assign an unsupported MCID, required participant count/duration, or P/S as new numbers/axes.", "criterion": "Distinguish unverified importance/intervals and test meaning from separate function/event questions.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "Verify the original interval and a valid criterion for handgrip importance; review function/events separately using direct data." }, { "item_id": "N35", "question_type": "Plans and selective reporting", "question": "Is selective reporting being established merely because an eligible registration/plan is unavailable?", "needed": "Eligible original registration/protocol/analysis plan, endpoints/time points, reasons for changes, and corrected versions", "role": "Required (selected handgrip question)", "role_reason": "Needed to avoid converting unacquired plans into confirmed non-registration, selective reporting, or absence of original results.", "application_exception": "Do not use unverified TF01/TF03 registrations or the TARIF identifier as verification of an eligible plan.", "criterion": "Indicate the actual eligible plan that could not be compared and access limitations for adjacent materials.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "After comparing an actual eligible plan with the handgrip report, record the scope of changes/selection." }, { "item_id": "N36", "question_type": "Harms of an oral product", "question": "Does a separate 100 mg SmPC provide the safety denominator for the target exposure?", "needed": "Product-specific adverse reactions/frequencies in S15; eligible actual exposure/duration and population; collection, discontinuations, and denominators", "role": "Required (selected handgrip question)", "role_reason": "Needed to avoid transferring precautions for an authorized product to individual safety or incidence in the target handgrip trial.", "application_exception": "Preserve existing cautions without deleting the efficacy manuscript because of gaps in harm information.", "criterion": "Distinguish product-specific reactions from unverified target frequencies/denominators and doses safe for long-term use.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "Link adverse-event collection, group-specific denominators/durations, and discontinuations for an eligible exposure to the product identity." }, { "item_id": "N37", "question_type": "Safety by route and special population", "question": "Are injection-related hypersensitivity and product-specific pregnancy/pediatric restrictions being generalized?", "needed": "Route of hypersensitivity reactions, product-specific pregnancy/lactation and age recommendations, and applicability to populations", "role": "Required (selected handgrip question)", "role_reason": "Needed to avoid turning an injection-related anaphylaxis risk rate or product restrictions into contraindications to all oral nutritional intake.", "application_exception": "Do not extend the adult handgrip question to children or pregnancy.", "criterion": "Indicate historical cautions limited to the route/product/population without claiming established safety.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "Link safety materials for the relevant product/route/population separately from the efficacy question." }, { "item_id": "N38", "question_type": "Interactions and medical management", "question": "Do dialysis, malabsorption, and refeeding management establish the benefit of general handgrip supplementation?", "needed": "Drug interactions, requirements in dialysis/malabsorption, and actual medical management of alcohol-related deficiency/refeeding", "role": "Required (selected handgrip question)", "role_reason": "Needed to avoid converting different requirements or combined medical management into high-dose oral handgrip efficacy or a safety upper limit.", "application_exception": "Do not assert an absence of interactions or interpret this as an instruction to stop necessary deficiency treatment.", "criterion": "Distinguish the original medical/drug context from separate gaps in efficacy/safety.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "Review relevant drugs/medical situations by product/population, separately from direct target handgrip data." }, { "item_id": "N39", "question_type": "UL and safety limits", "question": "Are the absence of an established UL and water solubility being read as unlimited safety?", "needed": "Reason no UL was established, actual toxicity data, safety by population/dose/duration, and harm denominators", "role": "Required (selected handgrip question)", "role_reason": "Needed to avoid turning insufficient data, water solubility, or excretion into a guarantee of high-dose safety for an individual.", "application_exception": "Do not propose unsupported numerical safety limits or doses.", "criterion": "Record both the reason no limit was established and the unverified therapeutic dose/long-term safety.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "If toxicity/harm data for a population/exposure are added, compare them with the original product and denominator/duration." }, { "item_id": "N40", "question_type": "Separate expanded questions", "question": "Are data on optimal dose, maintenance, subgroups, and falls/mortality being imposed as mandatory for this table?", "needed": "Identity and direct evidence for the original handgrip question and separate dose, maintenance, function, and event extensions", "role": "Supplementary (required if a separate expanded claim is made)", "role_reason": "Needed to avoid requiring every extension study for a narrow, unresolved handgrip question or expanding an adjacent main effect.", "application_exception": "Do not turn unverified exposure/duration essential to the original comparative handgrip question into NA.", "criterion": "Do not impose the extensions themselves as requirements for the current question; distinguish them from actual exposure/denominator gaps.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "If an expanded question is raised separately, review direct dose, follow-up, subgroup, function, and event results separately." }, { "item_id": "N41", "question_type": "Scope of searches and absence claims", "question": "Is unverified eligibility in the recorded search being declared an absence of human research?", "needed": "The 2026-09-16 search/cutoff date, actual inputs/failures, and scope for unpublished studies, registrations, corrections, and retractions", "role": "Required (selected handgrip question)", "role_reason": "Needed to avoid overstating the scope of an old search and the current table conversion as an up-to-date comprehensive search.", "application_exception": "Do not label the absence of external searching in this work or unacquired full texts as 0 studies or no recent corrections.", "criterion": "Distinguish the scope of the historical search/literature map and current local reading from incomplete external verification.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "In a separately permitted update, record actual search/registration/correction results and the scope of failures/unverified information." }, { "item_id": "N42", "question_type": "Original assessment and document quality", "question": "Are the original ?/null, document A, and calculator exception being read as new evidence?", "needed": "Original grade/score, unscored axes, eligibility exception, document evaluation, and reviewer identity", "role": "Required (selected handgrip question)", "role_reason": "Needed to avoid changing the original current values into a score of 0, no effect, no human research, or independent clinical certification.", "application_exception": "The invalid raw suggestion and calculator-schema problem are historical records, not a calculator run/reassessment in this work.", "criterion": "Preserve the original ?/null/Caution, document A/self-review, and human_study_exists=true.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "Link new direct evidence or a schema change to a separate event/version and judgment." }, { "item_id": "N43", "question_type": "Reading and original bytes", "question": "Are summary reading and historical full-text access being shown as the same verification?", "needed": "Physical type, historical access level/location, current non-reading, and retained-summary pointer/literal/SHA for each material", "role": "Required (selected handgrip question)", "role_reason": "Needed to avoid turning local-summary reading or historical 3rd-party full-text/abstract access or registration-access failures into current reading of original clinical sources.", "application_exception": "The stored-manuscript SHA is not a hash of the original bytes of an external PDF/original article.", "criterion": "Link summaries to exact retained locations and indicate current non-attempted/non-read external access and the absence of preserved original bytes.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "If new materials are permitted, link actual acquisition/reading and original bytes/versions to the relevant rows/materials." }, { "item_id": "N44", "question_type": "Identity, dates, and updates", "question": "Is historical deployment metadata being read as publication in this work?", "needed": "Current ID/URL, evidence/review dates, original revision/deployment metadata, and links between update events/criteria versions", "role": "Required (selected handgrip question)", "role_reason": "Needed to avoid presenting historical site deployment and current local-sheet creation as the same completion.", "application_exception": "Preserve original materials, unfavorable results, unverified information, and assessments; record changed conditions and new evidence separately.", "criterion": "Distinguish current identity/original dates from this review/unpublished status and establish update rules for linked rows.", "basis": "Internal case-specific adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/analysis/uncertainty, and harms. This is not formal application of a methodology or clinical certification.", "condition_origin": "Development criteria created with knowledge of the current retained 3117 material after actually reading it. These are not blinded, prospectively preregistered, or independently clinically validated criteria.", "proposed_research": "If new materials/corrections are permitted, preserve the full original text and review it with links to events, versions, and change decisions." } ] }