{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3084-main", "verdict_number": "3084", "title": "Ordinary thiamine (vitamin B1) × HbA1c reduction in type 2 diabetes with CKD stage 3", "view_version": "1.0", "view_created_date": "2026-10-29", "criteria_version": "1.0", "criteria_date": "2026-10-05", "review_date": "2026-10-05", "legacy_evidence_date": "2026-09-15", "review_scope": { "materials_read": "Stored Korean and English manuscript summaries, case-specific conditions and application records, and relevant sections of stored methods documents", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "No new reading of external clinical abstracts, full papers, registrations or analysis plans was performed. Historical access levels recorded in the manuscript are distinguished from reading the stored summaries in this work. Unverified does not mean that research or an effect is absent.", "date_meaning": "The date retained material was checked, not the date of a latest clinical-literature search." }, "claim_context": { "population": "Adults with type 2 diabetes and CKD stage 3; not all adults with diabetes", "intervention": "Ordinary thiamine (vitamin B1); single-ingredient oral thiamine capsules; salt, release formulation and manufacturer unconfirmed", "dose": "300 mg/day, 150 mg/capsule; a study regimen, not a dosing recommendation", "comparator": "Placebo; exact composition and arm-level background diabetes care unconfirmed", "endpoint": "Between-group difference in median HbA1c change at 24 weeks; a secondary trial endpoint", "duration": "24 weeks of treatment; subsequent persistence unconfirmed", "excluded_extensions": [ "Benfotiamine, injections and other renal conditions", "Substituting the primary (1st) renal outcome for HbA1c", "Reusing S20's historical arithmetic for 3-month means or post-treatment results as the 24-week median effect", "Confirmation of clinical-event prevention, an optimal dose, medication replacement or individual safety" ] }, "requirements": [ { "item_id": "N01", "question_type": "Question boundaries", "question": "What single question is defined by this table's population, thiamine, route, comparator, duration and HbA1c endpoint?", "needed": "Records identifying the current question and the direct trial's population, route, formulation, duration and comparator.", "role": "Required", "role_reason": "Changing the population or clinical endpoint would produce a different effect table.", "application_exception": "Primary (1st) renal outcomes, benfotiamine, injections and other diabetes populations are not reused as direct results for this claim.", "criterion": "Fix the question as HbA1c change with ordinary single-ingredient oral thiamine, 300 mg/day for 24 weeks versus placebo, in adults with T2D and CKD stage 3; distinguish other renal conditions, molecules and endpoints.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M03 §3.2.2–3.2.3; direction labels and test adaptations are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations are question-specific internal designs", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "When collecting new material, apply these eligibility criteria and separately record excluded molecules, renal conditions and endpoints.", "current_reports": [ "S02" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "The original assessment question and claim conditions identify HbA1c with ordinary oral thiamine, 300 mg/day for 24 weeks versus placebo, in adults with T2D and CKD stage 3.", "condition_status": "Verified", "status_reason": "The question boundaries agree across the manuscript and structured fields. Verification of question identity is distinguished from confirmation of efficacy.", "missingness": "The question's scope is verified; gaps concerning salt, background treatment and analysis values remain in the following items.", "uncertainty": "The scope verified in the current record is distinguished from the remaining uncertainty in the original clinical evidence.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Records identifying the current question and the direct trial's population, route, formulation, duration and comparator." }, { "item_id": "N02", "question_type": "Population selection", "question": "Can the direct trial's full CKD stage 3 and T2D inclusion and exclusion criteria be verified?", "needed": "The direct trial's diagnostic, eGFR, age, inclusion and exclusion criteria, and recruitment flow.", "role": "Required", "role_reason": "Microalbuminuria and CKD3 cannot be assumed to define the same population.", "application_exception": "S01's microalbuminuria criteria are not used to fill gaps in S02's CKD3 selection criteria.", "criterion": "Beyond identifying CKD3 and adult T2D, verify diagnostic criteria, renal-function ranges, age, exclusions and recruitment setting, or specify the unverified parts.", "basis": "M03 §3.2.1; detailed population conditions are internally designed; M08 §8.1–8.2.3; internal application", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "In comparative studies defining the same population, record criteria and recruitment flow in advance and separate other renal conditions.", "current_reports": [ "S02" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "S02 is a trial in adults with T2D and CKD stage 3. The stored abstract summary does not contain detailed diagnostic criteria, eGFR ranges or the full inclusion and exclusion criteria.", "condition_status": "Partly verified", "status_reason": "The population label is verified, but detailed criteria and representativeness remain unverified.", "missingness": "The direct trial's detailed eligibility criteria, recruitment setting and distribution of renal conditions.", "uncertainty": "The direct trial's detailed eligibility criteria, recruitment setting and distribution of renal conditions.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "The direct trial's diagnostic, eGFR, age, inclusion and exclusion criteria, and recruitment flow." }, { "item_id": "N03", "question_type": "Baseline B1 status", "question": "Were baseline thiamine status and the method for identifying deficiency verified in the eligible population?", "needed": "Baseline thiamine assay, concentrations, deficiency criteria and arm-level distributions.", "role": "Supplementary; required for extensions to deficient populations", "role_reason": "Results in a general study population must not be conflated with treatment effects in deficiency.", "application_exception": "Deficiency-specific effects are not mandatory for the narrow HbA1c question; unknown status is not filled in as deficient or non-deficient.", "criterion": "Verify baseline B1 measurement, units, deficiency criteria and population distribution; distinguish deficiency screening from effect-modification analysis.", "basis": "M03 §3.2.1; detailed population conditions are internally designed; M03 §3.2.1–3.2.4; detailed dose, persistence and effect-modification conditions are internally designed", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "In studies measuring deficiency status in advance, separately analyse stratum-specific effects and interactions.", "current_reports": [ "S02" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "The baseline vitamin-status and deficiency-assessment values are blank, with an unconfirmed information status.", "condition_status": "Unverified", "status_reason": "A CKD3/T2D population alone does not establish that this was a B1-deficiency treatment trial.", "missingness": "Direct information on baseline concentrations, selection by deficiency and stratum-specific effects.", "uncertainty": "Direct information on baseline concentrations, selection by deficiency and stratum-specific effects.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Baseline thiamine assay, concentrations, deficiency criteria and arm-level distributions." }, { "item_id": "N04", "question_type": "Formulation identity", "question": "To what extent are ordinary thiamine's exact salt, release formulation, manufacturer and single-ingredient status verified?", "needed": "Trial-product ingredients, salt, release formulation, manufacturer and batch specifications.", "role": "Required", "role_reason": "Trials of different molecules or formulations must not be combined as identical exposures.", "application_exception": "Benfotiamine, injections or other salts do not fill gaps in the unconfirmed product specifications.", "criterion": "Distinguish the identity of ordinary single-ingredient thiamine capsules from the exact salt, release formulation and manufacturing origin; do not fill unconfirmed details.", "basis": "M03 §3.2.2–3.2.3; direction labels and test adaptations are internally designed", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "Preserve product specifications in single-ingredient comparisons with identified formulations; screen benfotiamine and combination products separately.", "current_reports": [ "S02" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "The observed molecule is thiamine (salt unconfirmed), supplied as single-ingredient oral thiamine capsules. Salt, release formulation and manufacturer remain unconfirmed.", "condition_status": "Partly verified", "status_reason": "The molecule and capsule formulation are verified, but exact formulation details remain unresolved.", "missingness": "Exact salt, release formulation, manufacturing origin and batch specifications.", "uncertainty": "Exact salt, release formulation, manufacturing origin and batch specifications.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Trial-product ingredients, salt, release formulation, manufacturer and batch specifications." }, { "item_id": "N05", "question_type": "Actual route", "question": "Was actual oral administration verified in the direct trial?", "needed": "Records of the trial intervention's actual administration route.", "role": "Required", "role_reason": "The planned route must be distinguished from the route actually used.", "application_exception": "Verification of an oral route does not verify effects of injections or oral bioavailability.", "criterion": "Compare the planned question route with the observed trial route and link the source location supporting actual oral administration.", "basis": "M03 §3.2.2–3.2.3; direction labels and test adaptations are internally designed", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "Manage studies using other routes in separate eligibility groups; do not combine them with oral results.", "current_reports": [ "S02" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "The direct study's actual administration route was verified as oral and attributed to S02.", "condition_status": "Verified", "status_reason": "The actual study-route field was checked, rather than reading only the planned route in the claim conditions.", "missingness": "Actual oral administration is verified; absorption and formulation differences remain separate gaps.", "uncertainty": "The scope verified in the current record is distinguished from the remaining uncertainty in the original clinical evidence.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Records of the trial intervention's actual administration route." }, { "item_id": "N06", "question_type": "Administered dose", "question": "Are the nominal doses of 300 mg/day and 150 mg/capsule, and actual exposure, verified?", "needed": "Trial dosing instructions, frequency, medication-taking records and actual intake.", "role": "Required", "role_reason": "Differences between nominal dose and actual exposure may affect the analysis.", "application_exception": "Do not convert 300 to another unit or total dietary B1; do not turn the study dose into individual dosing instructions.", "criterion": "Link the nominal daily and per-capsule doses; verify dosing frequency, actual intake and adherence separately.", "basis": "M03 §3.2.2–3.2.3; direction labels and test adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "Collect medication-taking records in same-dose comparisons; distinguish actual-exposure analysis from the effect of assignment.", "current_reports": [ "S02" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "The recorded dose value is 300, described as 300 mg/day and 150 mg/capsule. Actual intake and detailed dosing frequency remain unconfirmed.", "condition_status": "Partly verified", "status_reason": "The nominal dose is verified, but it cannot be substituted for every participant's actual intake.", "missingness": "Dosing frequency, adherence and actual cumulative exposure.", "uncertainty": "Dosing frequency, adherence and actual cumulative exposure.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Trial dosing instructions, frequency, medication-taking records and actual intake." }, { "item_id": "N07", "question_type": "24-week time point", "question": "Are the treatment duration and measurement time point of the direct HbA1c result verified?", "needed": "The 24-week treatment and measurement schedule, with time-point labels for each result.", "role": "Required", "role_reason": "S20's on-treatment and post-treatment time points must not be combined with the current 24-week question.", "application_exception": "Verification of duration does not establish persistence of the effect afterward.", "criterion": "Link 24 weeks of treatment to the corresponding HbA1c change time point; separate subsequent persistence.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations are question-specific internal designs; M03 §3.2.1–3.2.4; detailed dose, persistence and effect-modification conditions are internally designed", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "Prespecify measurement times for each outcome and report post-treatment follow-up as a separate outcome.", "current_reports": [ "S02" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "Actual treatment duration is verified as 24 weeks; this table's endpoint is the between-group difference in median HbA1c change at 24 weeks. Subsequent persistence remains unconfirmed.", "condition_status": "Verified", "status_reason": "The time point for the current 24-week question is verified. Long-term and post-treatment effects are outside that verification.", "missingness": "The 24-week time point itself has no identified gap; subsequent persistence remains in N29.", "uncertainty": "The scope verified in the current record is distinguished from the remaining uncertainty in the original clinical evidence.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "The 24-week treatment and measurement schedule, with time-point labels for each result." }, { "item_id": "N08", "question_type": "Comparator composition", "question": "To what extent are the placebo comparator's identity, exact composition and masking conditions verified?", "needed": "Placebo ingredients, appearance, allocation codes and masking procedures.", "role": "Required", "role_reason": "The comparator's own exposure and measurement differences must not be misattributed to B1.", "application_exception": "The labels RCT or placebo alone do not establish successful double masking or allocation concealment.", "criterion": "Verify the placebo comparison and distinguish its composition, appearance, presence of active ingredients and details of masking implementation.", "basis": "M03 §3.2.2–3.2.3; direction labels and test adaptations are internally designed; M08 §8.1–8.2.3; internal application; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "In comparisons using a matched placebo, record composition, masking procedures and their success.", "current_reports": [ "S02" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "S02 is a randomized placebo-controlled trial. The claim conditions mark the placebo's exact composition as unconfirmed.", "condition_status": "Partly verified", "status_reason": "A placebo comparator is verified, but its composition and successful masking were not verified.", "missingness": "Placebo ingredients, matched appearance or taste, and masking implementation.", "uncertainty": "Placebo ingredients, matched appearance or taste, and masking implementation.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Placebo ingredients, appearance, allocation codes and masking procedures." }, { "item_id": "N09", "question_type": "Background treatment", "question": "Can diabetes treatments, rescue medication and treatment changes in both arms be verified?", "needed": "Arm-level diabetes medications, renal treatments, and changes or rescue-treatment records.", "role": "Required", "role_reason": "Differences in other treatments must not be attributed to the contribution of added thiamine.", "application_exception": "Do not require all medication changes to be identical; verify the actual effect of interest and how changes were handled.", "criterion": "Verify arm-level drugs, doses, changes, rescue treatment and analytical handling, or retain these as limitations on attributing the intervention's contribution.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.2–3.2.3; direction labels and test adaptations are internally designed", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "Prespecify background care and rescue criteria, report changes by arm and link them to analysis of the assignment effect.", "current_reports": [ "S02" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "The comparator field records the exact composition and arm-level details of shared diabetes care as unconfirmed.", "condition_status": "Unverified", "status_reason": "The current summary does not verify details showing that shared treatment was maintained identically.", "missingness": "Arm-level medications, doses, treatment changes, rescue treatment and analytical implications.", "uncertainty": "Arm-level medications, doses, treatment changes, rescue treatment and analytical implications.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Arm-level diabetes medications, renal treatments, and changes or rescue-treatment records." }, { "item_id": "N10", "question_type": "Total exposure", "question": "Are total dietary B1 and concurrent-vitamin exposures verified by arm?", "needed": "Arm-level dietary B1, supplements and concurrent-vitamin intake records.", "role": "Supplementary; required to interpret exposure contributions", "role_reason": "Exposure outside the trial medication must not be assumed equal.", "application_exception": "An empty linked-source list does not mean no concurrent vitamins were used; do not arbitrarily reclassify this as a combination-product trial.", "criterion": "Distinguish the trial supplement dose from total diet, other supplements and concurrent vitamins.", "basis": "M03 §3.2.2–3.2.3; direction labels and test adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "In comparisons measuring concurrent exposures, record total intake and background vitamins to analyse the applicability of the main effect.", "current_reports": [ "S02" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "The total-dietary-intake and concurrent-vitamin values are blank and their information status is unconfirmed. Their linked-source lists are also empty.", "condition_status": "Unverified", "status_reason": "The trial dose of 300 mg/day cannot be described as total B1 including diet or the entirety of the isolated added-exposure difference.", "missingness": "Arm-level details of total dietary intake and all concurrent vitamins.", "uncertainty": "Arm-level details of total dietary intake and all concurrent vitamins.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Arm-level dietary B1, supplements and concurrent-vitamin intake records." }, { "item_id": "N11", "question_type": "Allocation implementation", "question": "Are randomization sequence, concealment and baseline balance verified?", "needed": "Trial methods describing sequence generation, concealment, separation of responsibilities and the baseline table.", "role": "Required", "role_reason": "An RCT label does not replace review of bias in its implementation.", "application_exception": "Do not judge small samples or unread full texts as evidence of actual randomization failure.", "criterion": "Distinguish the randomized placebo-controlled design from actual sequence generation, concealment responsibilities and baseline balance.", "basis": "M08 §8.1–8.2.3; internal application", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "Report implementation methods and arm-level baseline data in randomized comparisons, with planning before analysis.", "current_reports": [ "S02" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "S02 is recorded as a randomized placebo-controlled trial. Sequence generation, allocation concealment, separation of responsibilities and the full baseline table remain unverified in the current abstract summary.", "condition_status": "Partly verified", "status_reason": "The design label is verified, but the available material does not establish the adequacy of implementation.", "missingness": "Original information on the allocation sequence, concealment implementation and baseline balance.", "uncertainty": "Original information on the allocation sequence, concealment implementation and baseline balance.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Trial methods describing sequence generation, concealment, separation of responsibilities and the baseline table." }, { "item_id": "N12", "question_type": "Baseline glycaemia", "question": "Can baseline HbA1c, renal function and balance of relevant prognostic factors be verified in both arms?", "needed": "S02 arm-level baseline HbA1c, eGFR, medications, prognostic factors and adjustment plan.", "role": "Required", "role_reason": "Baseline differences and values from another trial family must not be conflated with the direct trial's effect.", "application_exception": "Do not assume a simple between-group median-change contrast necessarily uses a baseline-adjusted model.", "criterion": "Verify the direct trial's arm-level baseline outcomes, renal status and analytical adjustment variables.", "basis": "M03 §3.2.1; detailed population conditions are internally designed; M08 §8.1–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "Report outcome tables including baseline values and prespecified adjustment models to assess the implications of imbalance.", "current_reports": [ "S02", "S20" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "Historical access was at abstract level; arm-level baseline HbA1c values and adjustment models are not verified in the currently stored material.", "condition_status": "Unverified", "status_reason": "S20's baseline values of 9.2%/8.8% belong to another trial family and cannot fill S02's baseline gaps.", "missingness": "The direct trial's baseline HbA1c, renal function, prognostic factors and adjustment model.", "uncertainty": "The direct trial's baseline HbA1c, renal function, prognostic factors and adjustment model.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "S02 arm-level baseline HbA1c, eGFR, medications, prognostic factors and adjustment plan." }, { "item_id": "N13", "question_type": "Adherence and treatment deviations", "question": "Are medication adherence, intervention deviations, rescue treatment and their handling verified?", "needed": "Medication-taking records, arm changes, intervention discontinuation, rescue treatment and analytical handling.", "role": "Required", "role_reason": "The contribution of the chosen intervention must be distinguished from actual deviations.", "application_exception": "Treatment discontinuation and missing follow-up are separate; do not use the same denominator without support.", "criterion": "Verify actual medication-taking, arm changes, rescue drugs and how assignment effects and adherence effects were handled.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "In comparisons collecting post-allocation deviation data, plan assignment-effect and adherence-effect analyses separately.", "current_reports": [ "S02" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "The nominal dose is verified, but the current summary lacks arm-level details on adherence, intervention changes and rescue treatment.", "condition_status": "Unverified", "status_reason": "Nominal 24-week treatment cannot be read as complete medication-taking by every participant.", "missingness": "Actual adherence, arm changes, discontinuation, rescue treatment and handling details.", "uncertainty": "Actual adherence, arm changes, discontinuation, rescue treatment and handling details.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Medication-taking records, arm changes, intervention discontinuation, rescue treatment and analytical handling." }, { "item_id": "N14", "question_type": "HbA1c measurement", "question": "Are the HbA1c assay, units, quality control and arm-level measurement conditions verified?", "needed": "HbA1c assay, units, blood-sampling schedule, quality control and assay-interference information.", "role": "Required", "role_reason": "Differences in measurement conditions must not be mistaken for differences in effects.", "application_exception": "An objective blood test alone does not establish absence of measurement bias or interference.", "criterion": "Specify the HbA1c assay, units, collection schedule, assessment conditions and scope of interference verification.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations are question-specific internal designs; M08 Table 8.2.a, M03 §3.2.4; internal application", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "Use matching assays and measurement schedules, assess interference and report criteria before analysis.", "current_reports": [ "S02" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "The HbA1c endpoint and 24-week time point are recorded, but assay and assessment details remain unconfirmed. No separate systematic search for assay interference was performed.", "condition_status": "Partly verified", "status_reason": "The endpoint is verified; equivalent measurement conditions and absence of interference were not verified.", "missingness": "Assay, measurement units, quality control, arm-level conditions and interference status.", "uncertainty": "Assay, measurement units, quality control, arm-level conditions and interference status.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "HbA1c assay, units, blood-sampling schedule, quality control and assay-interference information." }, { "item_id": "N15", "question_type": "Endpoint hierarchy", "question": "Is the reported hierarchy of the primary (1st) renal outcome and secondary (2nd) HbA1c outcome verified?", "needed": "The trial's description of primary and secondary endpoints and their results.", "role": "Required", "role_reason": "A favourable secondary (2nd) result must not be recast as a successful primary (1st) result.", "application_exception": "A nonsignificant primary renal outcome does not prove an HbA1c effect of 0 and is not used for new clinical regrading.", "criterion": "Distinguish the paper's primary endpoint from this page's endpoint; preserve the original primary (1st) nonsignificant and secondary (2nd) positive findings.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations are question-specific internal designs; M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "Report analyses and multiplicity plans with primary and secondary (2nd) endpoints distinguished in advance.", "current_reports": [ "S02" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "Renal function is the trial's primary endpoint and HbA1c is secondary. The original primary-nonsignificant/secondary-positive flag is recorded as true. Its observation value remains blank while its information status remains verified.", "condition_status": "Verified", "status_reason": "The hierarchy reported in the original summary is verified. This does not mean a complete comparison against preregistration was performed.", "missingness": "The reported hierarchy is verified; registered prespecification and multiplicity plans remain gaps in N16.", "uncertainty": "The scope verified in the current record is distinguished from the remaining uncertainty in the original clinical evidence.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "The trial's description of primary and secondary endpoints and their results." }, { "item_id": "N16", "question_type": "Prespecified plan", "question": "Can HbA1c timing, analysis and multiplicity be compared against registration, protocol and SAP?", "needed": "S02's original registration, time history, protocol, SAP and complete results.", "role": "Required", "role_reason": "Gaps in the material needed to assess selection of favourable findings must be made explicit.", "application_exception": "Do not turn unverified registration into confirmed nonregistration, selective reporting or absence of research.", "criterion": "Distinguish the registrations or plans actually compared from material not acquired; verify HbA1c prespecification and analysis changes.", "basis": "M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.5, §4.6.3; the limits of this material conversion follow the user's scope and internal design", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "Prespecify HbA1c analyses, time points and multiplicity handling; compare them with results and reasons for changes.", "current_reports": [ "S02" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "The registered-primary-endpoint value is blank/unconfirmed, and S02's registration field is blank. The paper describes a primary (1st) renal endpoint, but independent comparison against the registry remains unverified.", "condition_status": "Unverified", "status_reason": "No acquired registration or plan is recorded, so HbA1c analysis prespecification and agreement with the results cannot be verified.", "missingness": "Registration identity and timing, the HbA1c plan, SAP, changes and multiplicity methods.", "uncertainty": "Registration identity and timing, the HbA1c plan, SAP, changes and multiplicity methods.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "S02's original registration, time history, protocol, SAP and complete results." }, { "item_id": "N17", "question_type": "Analysis population", "question": "Are the allocated, completing and actually analysed populations and analysis-set definition verified for 24-week HbA1c?", "needed": "Outcome-specific analysis n for 24-week HbA1c, allocation/completion flow and analysis-set definitions.", "role": "Required", "role_reason": "Allocated participants cannot fill gaps in the outcome denominator or precision.", "application_exception": "Do not automatically use 18/17 as the HbA1c analysis n, completion n or safety n.", "criterion": "Distinguish allocation of 18/17 from actual HbA1c analysis n; verify ITT/PP and the outcome contributors.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; internal application", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "Report outcome-specific flow and analysis denominators; specify assignment-effect and available-outcome analyses.", "current_reports": [ "S02" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "The 35 participants were allocated as 18 to thiamine and 17 to placebo. The HbA1c analysis denominator is blank/unconfirmed, with an empty linked-source list.", "condition_status": "Partly verified", "status_reason": "Allocation denominators are verified, but the analysis denominator for this outcome was not verified.", "missingness": "24-week HbA1c analysis n, ITT/PP definitions and the number providing outcome data.", "uncertainty": "24-week HbA1c analysis n, ITT/PP definitions and the number providing outcome data.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Outcome-specific analysis n for 24-week HbA1c, allocation/completion flow and analysis-set definitions." }, { "item_id": "N18", "question_type": "Missing-data handling", "question": "Can the extent and handling of missing HbA1c data, losses and discontinuations be verified?", "needed": "HbA1c measurement losses, discontinuation and dropout reasons, missing-data handling and sensitivity analyses.", "role": "Required", "role_reason": "The limitations that losses and analysis impose on interpretation must be identified.", "application_exception": "Do not newly calculate missing counts or dropout rates from allocation and completion counts belonging to another trial family.", "criterion": "Distinguish outcome-specific loss reasons and timing, intervention discontinuation and missing follow-up; verify handling and sensitivity analyses.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; internal application", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "Report outcome-specific missingness reasons and prespecify suitable missing-data assumptions and sensitivity analyses.", "current_reports": [ "S02" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "The outcome's analysis denominator and between-group interval remain unconfirmed; missing-data and dropout flow and handling are also unverified in the current abstract summary.", "condition_status": "Unverified", "status_reason": "Enrollment of 35 participants does not establish complete 24-week outcome data or a complete-case analysis.", "missingness": "Outcome-specific losses, reasons, handling models and sensitivity analyses.", "uncertainty": "Outcome-specific losses, reasons, handling models and sensitivity analyses.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "HbA1c measurement losses, discontinuation and dropout reasons, missing-data handling and sensitivity analyses." }, { "item_id": "N19", "question_type": "Effect measure", "question": "Which between-group median-change comparison and analysis does the estimate −1.35 represent?", "needed": "Arm-level HbA1c change distributions, the between-group estimand definition and analysis model.", "role": "Required", "role_reason": "Medians must not be conflated with means, or between-group comparisons with within-group changes.", "application_exception": "S20's arithmetic on mean changes does not establish the model for this between-group median-change contrast.", "criterion": "Distinguish the reported between-group median-change contrast from within-group changes, final values and adjusted mean differences; verify the analysis model.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations are question-specific internal designs; M08 §8.2.2, M15 §15.3.1; internal application", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "Prespecify the HbA1c effect of interest and method for estimating the median-change contrast; report the model and denominator.", "current_reports": [ "S02" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "S02 records a between-group difference in median HbA1c change of −1.35. Adjustment, testing models and ITT/PP details remain unconfirmed in the direct trial.", "condition_status": "Partly verified", "status_reason": "The reported between-group measure is known, but it cannot be converted into an adjusted mean difference or an individual's probability of improvement.", "missingness": "Arm-level median changes, models, adjustment and analysis-population details.", "uncertainty": "Arm-level median changes, models, adjustment and analysis-population details.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Arm-level HbA1c change distributions, the between-group estimand definition and analysis model." }, { "item_id": "N20", "question_type": "Reported-value units", "question": "To what extent are the HbA1c contrast of −1.35 and its units verified?", "needed": "An original results table, full paper or correction explicitly identifying the units of −1.35.", "role": "Required", "role_reason": "Without units, clinical magnitude and direct comparison with other trials cannot be established.", "application_exception": "Do not retroactively assign customary HbA1c units or S20's % units to this value.", "criterion": "Both the reported value and units must be verified to interpret magnitude; do not assume unreported units such as percentage points (%p).", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations are question-specific internal designs; M15 §15.3.1–15.3.3; internal application", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "State HbA1c units and changes in outcome reports; provide the between-group estimate and dispersion together.", "current_reports": [ "S02" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "The reported value −1.35 is retained. The manuscript explicitly states that the value's units were not given in the abstract accessed historically.", "condition_status": "Partly verified", "status_reason": "The value is verified, but its units are not; units such as %p or mmol/mol were not filled in.", "missingness": "Explicit units and the results table for this contrast.", "uncertainty": "Explicit units and the results table for this contrast.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "An original results table, full paper or correction explicitly identifying the units of −1.35." }, { "item_id": "N21", "question_type": "Significance reporting", "question": "To what extent are the P value and model for this HbA1c test verified?", "needed": "S02's test type, exact P value and analysis results table.", "role": "Required", "role_reason": "A record of statistical significance alone must not establish sufficiency or clinical importance.", "application_exception": "Do not reverse-convert a P threshold into SE/SD/CI or a user's probability of success.", "criterion": "Distinguish verification of the reported P threshold, exact P value and testing model; do not convert these into effect dispersion, CI or importance.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations are question-specific internal designs; M15 §15.3.1–15.3.3; internal application", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "Report estimates, intervals and testing models together; do not determine clinical importance from significance alone.", "current_reports": [ "S02" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "The HbA1c result is reported as P<0.01. The exact P value and testing details remain unverified, so no effect estimate was derived from P.", "condition_status": "Partly verified", "status_reason": "The significance threshold is verified; the exact P value, model and precision remain unconfirmed.", "missingness": "Exact P value, testing model and dispersion or interval for the effect.", "uncertainty": "Exact P value, testing model and dispersion or interval for the effect.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "S02's test type, exact P value and analysis results table." }, { "item_id": "N22", "question_type": "Dispersion and intervals", "question": "Can the CI, dispersion and denominator of the direct HbA1c contrast be verified?", "needed": "S02's between-group HbA1c CI, dispersion, analysis n and model.", "role": "Required", "role_reason": "Significance or allocation n must not fill gaps in intervals and dispersion.", "application_exception": "Do not substitute renal-outcome CIs or another trial's means/SD for the current HbA1c contrast.", "criterion": "Link the CI, dispersion and actual analysis n for the same endpoint, time point and analysis; do not generalize material not acquired to nonreporting throughout the full paper.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M15 §15.3.1–15.3.3; internal application", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "Report estimates and confidence intervals for the same effect of interest; specify missing-data and adjustment assumptions.", "current_reports": [ "S02" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "The between-group interval and analysis denominator remain unconfirmed. Complete mean/SD/n or adjusted-contrast inputs were unavailable, so no new CI or SMD was created.", "condition_status": "Unverified", "status_reason": "The original CX and EX descriptions concern verification limits in the accessed material; they do not mean the unread full paper has no data.", "missingness": "CI, dispersion, denominator and model for the same 24-week HbA1c contrast.", "uncertainty": "CI, dispersion, denominator and model for the same 24-week HbA1c contrast.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "S02's between-group HbA1c CI, dispersion, analysis n and model." }, { "item_id": "N23", "question_type": "Important difference", "question": "Can an applicable clinically important HbA1c difference and its relationship to the interval be verified for this population?", "needed": "Evidence supporting an applicable important difference for CKD3/T2D HbA1c, and units/CI for the direct contrast.", "role": "Supplementary; required for claims of clinical importance", "role_reason": "A laboratory signal must be distinguished from improvement meaningful to patients.", "application_exception": "Do not substitute an unverified criterion with no clinical effect or failure to meet an MCID; do not require an event trial for the narrow laboratory-value question.", "criterion": "Units, an interval and a justified important difference are needed to interpret their relationship; retain the unverified criterion.", "basis": "M15 §15.3.1–15.3.3; internal application; M03 §3.2.4; internally designed extension boundaries", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "Assess the interval against a previously justified important difference without inventing minimum sample sizes, durations or efficacy grades.", "current_reports": [ "S02" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "The manuscript limits its conclusion: clinically meaningful glycaemic improvement cannot be established. Units/CI for −1.35 and an important-difference criterion remain unverified.", "condition_status": "Unverified", "status_reason": "The value and significance alone cannot establish clinical importance or failure to meet an important difference.", "missingness": "An applicable important-difference criterion and units/interval for the same measure.", "uncertainty": "An applicable important-difference criterion and units/interval for the same measure.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Evidence supporting an applicable important difference for CKD3/T2D HbA1c, and units/CI for the direct contrast." }, { "item_id": "N24", "question_type": "Unfavourable context", "question": "How should S01's lack of glycaemic benefit be read alongside the direct CKD3 result?", "needed": "S01's glycaemic results, population, duration and analysis details, compared with S02.", "role": "Required", "role_reason": "Earlier no-difference reports must not be deleted while retaining only the positive direct finding.", "application_exception": "Do not extend the abstract's no-effect wording to proof of an effect of 0 for all B1, all T2D or CKD3.", "criterion": "Retain unfavourable context; distinguish whether findings address the same question using actual differences in population, duration and endpoints.", "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application; M03 §3.2.1; detailed population conditions are internally designed", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "Directly compare only studies addressing the same question; analyse other renal populations as stratified context.", "current_reports": [ "S01", "S02" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "The earlier S01 microalbuminuria-trial abstract states that glycaemic control was not improved. It was not pooled as identical to CKD3/24-week S02.", "condition_status": "Verified", "status_reason": "The manuscript's unfavourable context and question differences are retained. Differences in duration and renal status were not declared conflicting solely from significance.", "missingness": "The context and its differences are verified; S01's detailed glycaemic analysis n and model are outside the current material.", "uncertainty": "The scope verified in the current record is distinguished from the remaining uncertainty in the original clinical evidence.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "S01's glycaemic results, population, duration and analysis details, compared with S02." }, { "item_id": "N25", "question_type": "Same trial family", "question": "Were S01 and S20's shared registration number distinguished from independent replication?", "needed": "S01/S20 registration numbers, cohort linkage and outcome-specific participant flow.", "role": "Required", "role_reason": "Report counts must not be converted into independent replications or unique participant counts.", "application_exception": "Retain different outcomes under the same registration number, distinguishing their time points and analyses.", "criterion": "Link report identities, study identifiers and same/different family relationships as recorded; do not sum unverified total participant counts.", "basis": "M04 §4.6.1–4.6.2 on distinguishing studies and reports; cohort/outcome linkage is an internal application; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "Maintain a family map linking reports to unique trials and identify overlapping participants and analyses separately.", "current_reports": [ "S01", "S20" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "S01 and S20 both use study identifier CTRI-2008-091-000112. S20 is recorded as context from the same trial.", "condition_status": "Verified", "status_reason": "The retained shared registration number and original roles distinguish the re-reported trial family. No new reading of the original registry was performed here.", "missingness": "The stored family relationship is verified; a cross-tabulation of actual outcome-specific participants in both reports remains unconfirmed.", "uncertainty": "The scope verified in the current record is distinguished from the remaining uncertainty in the original clinical evidence.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "S01/S20 registration numbers, cohort linkage and outcome-specific participant flow." }, { "item_id": "N26", "question_type": "Historical time-point values", "question": "Which time points do S20's on-treatment and post-treatment HbA1c values and historical arithmetic represent?", "needed": "S20 Table2's time-specific values, analysis denominators and original arithmetic records.", "role": "Required", "role_reason": "Improvement after discontinuation must not be reclassified as an on-treatment effect.", "application_exception": "Do not reuse arithmetic on rounded means in the original source as the current trial's adjusted mean difference, median difference or a new calculation.", "criterion": "Separate baseline, 3-month treatment-end and 2-month off-treatment means and historical calculations; do not reuse them as the current 24-week median effect.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations are question-specific internal designs; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.1–3.2.4; detailed dose, persistence and effect-modification conditions are internally designed", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "Prespecify on-treatment and post-treatment results as separate effects of interest; provide values and intervals for the same analysis.", "current_reports": [ "S20" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "S20 records thiamine 9.2→9.0→7.8% and placebo 8.8→8.5→8.4% at baseline, 3-month treatment end and 2-month off-treatment follow-up. Original C001's +0.1%p and C002's −1.0%p are historical arithmetic at different times.", "condition_status": "Verified", "status_reason": "The values, time points and original context-only/off-treatment arithmetic labels are verified. No new arithmetic was performed here.", "missingness": "Preservation of original values and time points is verified; these do not replace S20 analysis n/precision or S02's direct effect.", "uncertainty": "The scope verified in the current record is distinguished from the remaining uncertainty in the original clinical evidence.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "S20 Table2's time-specific values, analysis denominators and original arithmetic records." }, { "item_id": "N27", "question_type": "Direct replication", "question": "Are independent replication and study counts verified for the same CKD3/24-week question?", "needed": "Eligible-study identities, families, funding and results for the same question.", "role": "Supplementary; required for replication extensions", "role_reason": "Adjacent material or reports under the same registration must not be counted as independent replications.", "application_exception": "Do not discard a result merely because it belongs to a single direct family. Without an exhaustive search, do not claim that only 1 direct study exists worldwide.", "criterion": "Distinguish direct and adjacent trial families; limit unique-study and participant counts to what the stored material verifies.", "basis": "M04 §4.6.1–4.6.2 on distinguishing studies and reports; cohort/outcome linkage is an internal application; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application; Chamgap's own independence/attribution conditions. The referenced official sections do not certify every detail of these conditions", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "Screen independent comparisons addressing the same question; compare condition differences and unfavourable findings by trial family.", "current_reports": [ "S02", "S01", "S20" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "In the stored material, S02 is the decisive direct family, while S01/S20 share a registration in another population. Original R1 records this restricted direct-evidence scope.", "condition_status": "Partly verified", "status_reason": "The direct family is verified, but independent replication for the same question and worldwide study totals were not verified.", "missingness": "Independent replication, funding and exact unique participant counts for the same CKD3/24-week question.", "uncertainty": "Independent replication, funding and exact unique participant counts for the same CKD3/24-week question.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Eligible-study identities, families, funding and results for the same question." }, { "item_id": "N28", "question_type": "Funding and COI", "question": "Are S02's funding, product provision, author employment/patents and declared interests verified?", "needed": "The direct paper's funding, COI, product provision and author/patent information.", "role": "Supplementary; required for independence claims", "role_reason": "Unverified funding must not be described as independent research or manufacturer-only research.", "application_exception": "Unconfirmed funding or company product provision alone does not automatically exclude a result or establish the magnitude of bias.", "criterion": "Identify declarations, resources, product provision and unknowns by location; do not treat I1 as proof of actual mixed funding.", "basis": "Chamgap's own independence/attribution conditions. The referenced official sections do not certify every detail of these conditions", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "In independent comparisons disclosing funding and product provision, record each party's role and analytical involvement.", "current_reports": [ "S02" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "The decisive trial's funding source is unconfirmed. Original I1 follows rubric precedent29; it does not establish actual mixed or independent funding.", "condition_status": "Unverified", "status_reason": "The full-text funding section and declarations were not acquired, so actual sources of funding and independence cannot be verified.", "missingness": "S02 funding, products, employment, patents, analytical involvement and declarations.", "uncertainty": "S02 funding, products, employment, patents, analytical involvement and declarations.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "The direct paper's funding, COI, product provision and author/patent information." }, { "item_id": "N29", "question_type": "Persistence and dose extensions", "question": "Can persistence beyond 24 weeks, an optimal dose or effects in particular subgroups be directly verified?", "needed": "Post-treatment CKD3 follow-up, direct dose comparisons and prespecified subgroup/interaction results.", "role": "Supplementary; required for extension claims", "role_reason": "The chosen main effect must not be extended to maintenance effects or an optimal dose.", "application_exception": "Do not make all extension studies mandatory for verifying the current narrow 24-week question.", "criterion": "Verify post-treatment/long-term, direct dose-comparison and prespecified stratum/interaction information separately; do not infer these from the main effect.", "basis": "M03 §3.2.1–3.2.4; detailed dose, persistence and effect-modification conditions are internally designed; M03 §3.2.1; detailed population conditions are internally designed", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "Design post-treatment follow-up, dose comparisons and prespecified stratum analyses separately from the current question; report estimates for each.", "current_reports": [ "S02", "S20" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "S02 addresses 300 mg/day for 24 weeks; subsequent persistence remains unconfirmed. S20's post-treatment values in another population cannot replace this information.", "condition_status": "Unverified", "status_reason": "The current summary has no persistence, optimal-dose or stratum-specific evidence under the same direct conditions.", "missingness": "Long-term, post-treatment, dose and subgroup information under the direct CKD3 conditions.", "uncertainty": "Long-term, post-treatment, dose and subgroup information under the direct CKD3 conditions.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Post-treatment CKD3 follow-up, direct dose comparisons and prespecified subgroup/interaction results." }, { "item_id": "N30", "question_type": "Extension to clinical events", "question": "Does HbA1c change also answer questions about preventing complications or death, or improving quality of life?", "needed": "Direct comparative evidence on clinical events and quality of life under the same population and exposure conditions.", "role": "Supplementary; required for clinical-event extensions", "role_reason": "A laboratory signal must not be converted into event prevention or replacement of existing medication.", "application_exception": "Unverified event trials are not a reason to delete the reported HbA1c value or assert no effect.", "criterion": "Separate the glycaemic laboratory surrogate from clinical-event questions; do not extend the claim without direct event outcomes.", "basis": "M03 §3.2.4; internally designed extension boundaries; M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations are question-specific internal designs", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "Evaluate clinical-event questions in studies with separately prespecified outcome definitions, durations and denominators.", "current_reports": [ "S02" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "The record distinguishing laboratory markers from clinical events has a blank value and verified information status. Its warning against extending laboratory surrogates to clinical-event prevention is retained.", "condition_status": "Not applicable", "status_reason": "The current claim concerns HbA1c change; fewer clinical events are not the chosen question's endpoint.", "missingness": "Event prevention is not applicable to the current laboratory-value question; separate direct evidence supporting event benefits was not verified.", "uncertainty": "The scope verified in the current record is distinguished from the remaining uncertainty in the original clinical evidence.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Direct comparative evidence on clinical events and quality of life under the same population and exposure conditions." }, { "item_id": "N31", "question_type": "Adverse-event accounting", "question": "Can event definitions, collection and denominators underlying the statement that no serious adverse events were reported be verified?", "needed": "S02 adverse-event and serious-event definitions, arm-level counts, exposure denominators, collection and discontinuation tables.", "role": "Supplementary; required for safety claims", "role_reason": "Efficacy summaries and harm information have different verification levels.", "application_exception": "Do not delete the HbA1c value because of safety-data gaps or automatically use allocation of 18/17 as the safety-analysis denominator.", "criterion": "Distinguish a nonreporting statement from actual event counts, people, collection methods and duration; do not promote it to 0 events or a safety guarantee.", "basis": "M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; detailed distinctions are internally designed; M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; Chamgap's own interpretive boundaries. M19 principles are referenced; no official causality tool was applied", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "For the same exposure and population, report systematic harm collection, exposure time, event/person counts and discontinuation reasons.", "current_reports": [ "S02" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "The original abstract states that no serious adverse events were reported; specific event counts, denominators and long-term exposure remain unconfirmed.", "condition_status": "Partly verified", "status_reason": "The presence of a harm statement is verified; actual counts of 0 people or event rates were not verified.", "missingness": "Event definitions, systematic collection, arm-level person/event counts, duration and safety denominators.", "uncertainty": "Event definitions, systematic collection, arm-level person/event counts, duration and safety denominators.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "S02 adverse-event and serious-event definitions, arm-level counts, exposure denominators, collection and discontinuation tables." }, { "item_id": "N32", "question_type": "Interactions", "question": "Are interactions and assay effects of concurrent exposures, including diabetes medications, verified?", "needed": "Arm-level concomitant exposures and relevant interaction or assay-effect information.", "role": "Supplementary; required for concomitant-use safety extensions", "role_reason": "Effects of concurrent medication and underlying disease must not be attributed to a single exposure.", "application_exception": "Do not turn a search not performed into confirmed interaction or absence of risk.", "criterion": "Specify separate interaction searches, actual concomitant exposure and review scope; do not interpret an unperformed search as no risk.", "basis": "M19 §19.1.2–19.2.4; internal application; M19 §19.2.2–19.2.4 on design considerations; detailed confounding records are internally designed; M19 §19.1.2–19.2.4; internal application", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "In safety studies collecting concomitant exposures, distinguish underlying disease and assay effects in the assessment.", "current_reports": [ "S02" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "The drug-interaction information value is blank and recorded as not separately searched. No separate comprehensive search covering all drug interactions was performed.", "condition_status": "Unverified", "status_reason": "The current summary and historical search scope do not establish absence of interactions or individual safety.", "missingness": "Actual concomitant exposures, interactions, assay effects and collection scope.", "uncertainty": "Actual concomitant exposures, interactions, assay effects and collection scope.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Arm-level concomitant exposures and relevant interaction or assay-effect information." }, { "item_id": "N33", "question_type": "Long-term and rare harm", "question": "Can long-term or rare harms beyond 24 weeks and safety in vulnerable groups be directly verified?", "needed": "Long-term and rare-event data, vulnerable-group exposure/collection data and suitable comparisons.", "role": "Supplementary; required for broader safety claims", "role_reason": "Limited observations must not be extended to overall safety.", "application_exception": "Do not require every rare-harm study as an additional prerequisite for reporting the HbA1c value.", "criterion": "Distinguish harm duration and extensions for the direct exposure/population; do not rule out rare risks because the sample is limited.", "basis": "M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; internal application", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "Collect rare events and vulnerable-group events through long-term follow-up or suitable observational designs; report denominators and concomitant exposures.", "current_reports": [ "S02" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "The manuscript retains unconfirmed event denominators and long-term exposure; it does not instruct treatment changes or self-medication at the study dose.", "condition_status": "Unverified", "status_reason": "A harm statement in a small, short-term trial abstract cannot establish safety across all durations and vulnerable groups.", "missingness": "Direct safety information on long-term or rare harms and separate vulnerable groups.", "uncertainty": "Direct safety information on long-term or rare harms and separate vulnerable groups.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Long-term and rare-event data, vulnerable-group exposure/collection data and suitable comparisons." }, { "item_id": "N34", "question_type": "Current versus historical reading", "question": "Was reading the stored summary in this work distinguished from each paper's historical access level?", "needed": "Stored manuscript summary, bibliography, historical access levels, source locations and individual access-date records.", "role": "Required", "role_reason": "Links, summaries and historical access records must not be recast as current full-text reading.", "application_exception": "Do not copy S20's historical HTML access to S01/S02 full papers or current successful HTML access.", "criterion": "Distinguish the stored manuscript actually read here from historical abstract/HTML access by material and date; retain current external full-text unread status.", "basis": "M04 §4.5–4.6 on collecting/selecting material; access/reading separation and the hyperlink contract are internally designed; M04 §4.5, §4.6.3; the limits of this material conversion follow the user's scope and internal design", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "Maintain collection records identifying attempts, acquisition and reading levels by material, linked to original locations and versions.", "current_reports": [ "S01", "S02", "S20" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "The whole stored manuscript summary was read here. Historical records identify publisher abstracts for S01/S02 and HTML full text for S20; external readings/attempts in this work were 0.", "condition_status": "Verified", "status_reason": "Reading levels distinguish current actions from historical records. External links are not treated as current full-text reading.", "missingness": "The current reading scope is verified; separate historical access dates are absent from the manuscript and remain blank for each document.", "uncertainty": "The scope verified in the current record is distinguished from the remaining uncertainty in the original clinical evidence.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Stored manuscript summary, bibliography, historical access levels, source locations and individual access-date records." }, { "item_id": "N35", "question_type": "Search and update scope", "question": "What are the stored evidence date, current review date and search/correction scope?", "needed": "Historical search records, correction/retraction/registration-check scope, and dates and identities of new material.", "role": "Required", "role_reason": "Absence of studies outside the search scope must not be claimed.", "application_exception": "Historical search and numeric records and the original reused162 material were not opened here; only their reference strings are retained.", "criterion": "Distinguish the 2026-09-15 evidence date from the 2026-10-05 conversion review; qualify non-exhaustive searches and update triggers by scope.", "basis": "M04 §4.5, §4.6.3; the limits of this material conversion follow the user's scope and internal design; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "For separately authorized updates, record eligible searches and registration/correction tracking; preserve previous values and reasons for changes.", "current_reports": [ "S01", "S02", "S20" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "The original evidence/search date is 2026-09-15 and the conversion review date is 2026-10-05. The historical search was not exhaustive across worldwide databases; no new search was performed here.", "condition_status": "Verified", "status_reason": "The current review scope, original uncertainty and update conditions are verified. This is not completion of a current comprehensive literature verification.", "missingness": "Search and date boundaries are verified; new eligible literature, registrations and corrections were not checked here.", "uncertainty": "The scope verified in the current record is distinguished from the remaining uncertainty in the original clinical evidence.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Historical search records, correction/retraction/registration-check scope, and dates and identities of new material." }, { "item_id": "N36", "question_type": "Original assessment preservation", "question": "Were original C46, axes, blank values/empty lists and corrections distinguished from new condition-status judgments?", "needed": "The current manuscript's grade/score/axes, original observed-evidence/nutrition fields, corrections and existing calculation records.", "role": "Required", "role_reason": "The original grade and model statuses must not be merged into a single quality or efficacy score.", "application_exception": "A structural PASS and model review do not constitute official method execution, independent clinical certification or completed publication.", "criterion": "Link original values, historical assessments and calculations unchanged; do not automatically inherit them as condition statuses, new scores or probabilities.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; the limits of this material conversion follow the user's scope and internal design", "condition_origin": "Individually designed for the known development case in the stored 3084 records; family definitions are model-review inputs, not a fixed row-count form", "proposed_research": "When a change is needed, separately preserve the entire original text, version, reason and date; distinguish clinical regrading from display conversion.", "current_reports": [ "S01", "S02", "S20" ], "existence": "The relevant record exists in the stored manuscript; acquisition of the detailed material needed is shown separately in each status and column F", "acquired_read": "Stored prior-review summary read / external materials not read", "observation": "Original grade C/score46 and B-S-R1-I1-EX-B1-CX, the primary-endpoint failure flag, blank values, empty linked-source lists and historical arithmetic are retained unchanged. No new efficacy grade, score or calculation is created.", "condition_status": "Verified", "status_reason": "Verified refers to preservation of the original assessment and the conversion scope, not to a newly clinically confirmed grade.", "missingness": "There is no gap in the preservation contract; original clinical and material gaps remain in the corresponding rows.", "uncertainty": "The scope verified in the current record is distinguished from the remaining uncertainty in the original clinical evidence.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "The current manuscript's grade/score/axes, original observed-evidence/nutrition fields, corrections and existing calculation records." } ], "reports": [ { "report_id": "S01", "title": "Rabbani et al. — thiamine and early diabetic nephropathy (2009)", "url": "https://link.springer.com/article/10.1007/s00125-008-1224-4", "report_type": "Original trial abstract in another population", "existence": "The stored bibliography, linked URLs and result summaries were checked. Current public availability of external originals was not newly queried.", "acquired_read": "Stored manuscript summaries and condition-application records were read. External abstracts, full papers, registrations and analysis plans were not attempted, acquired or read in this work.", "study_family": "CTRI-2008-091-000112", "independent_replication": false, "observed_result": "The earlier microalbuminuria-trial abstract describes no effect on glycaemic control. It was not pooled as an equivalent question to the CKD stage 3/24-week trial.", "result_level": "The original review's summary and attribution are retained. This is not new reading or regrading of external clinical originals.", "source_evidence_date": "2026-09-15", "materials": [ { "material_type": "Paper abstract", "public_status": "Material URL identified in the stored bibliography; current public availability not rechecked", "access_status": "Not attempted", "acquired": false, "actually_read": "Unread", "as_of": "2026-10-05", "qualification": "What was actually read here is the report summary in the stored manuscript. The paper-page URL and historical access level do not establish current full-text reading or acquisition of this material.", "material_id": "S01-M1", "url": "https://link.springer.com/article/10.1007/s00125-008-1224-4" }, { "material_type": "Full paper", "public_status": "Material identity and separate direct URL unconfirmed", "access_status": "Not attempted", "acquired": false, "actually_read": "Unread", "as_of": "2026-10-05", "qualification": "What was actually read here is the report summary in the stored manuscript. The paper-page URL and historical access level do not establish current full-text reading or acquisition of this material.", "material_id": "S01-M2", "url": null } ], "links": [ { "label": "Official source", "url": "https://link.springer.com/article/10.1007/s00125-008-1224-4" } ], "independent_replication_note": "S01/S20 are an adjacent family under the same registration, not direct CKD3/24-week replications" }, { "report_id": "S02", "title": "Phrawong et al. — thiamine in T2D with CKD stage 3 (online 2025; issue 2026)", "url": "https://www.benthamscience.com/article/148808", "report_type": "Publisher abstract of the direct CKD3 RCT", "existence": "The stored bibliography, linked URLs and result summaries were checked. Current public availability of external originals was not newly queried.", "acquired_read": "Stored manuscript summaries and condition-application records were read. External abstracts, full papers, registrations and analysis plans were not attempted, acquired or read in this work.", "study_family": "Phrawong-CKD3", "independent_replication": false, "observed_result": "Between-group difference in median HbA1c change −1.35, P<0.01; units and interval not stated in the abstract", "result_level": "The original review's summary and attribution are retained. This is not new reading or regrading of external clinical originals.", "source_evidence_date": "2026-09-15", "materials": [ { "material_type": "Paper abstract", "public_status": "Material URL identified in the stored bibliography; current public availability not rechecked", "access_status": "Not attempted", "acquired": false, "actually_read": "Unread", "as_of": "2026-10-05", "qualification": "What was actually read here is the report summary in the stored manuscript. The paper-page URL and historical access level do not establish current full-text reading or acquisition of this material.", "material_id": "S02-M1", "url": "https://www.benthamscience.com/article/148808" }, { "material_type": "Full paper", "public_status": "Material identity and separate direct URL unconfirmed", "access_status": "Not attempted", "acquired": false, "actually_read": "Unread", "as_of": "2026-10-05", "qualification": "What was actually read here is the report summary in the stored manuscript. The paper-page URL and historical access level do not establish current full-text reading or acquisition of this material.", "material_id": "S02-M2", "url": null }, { "material_type": "Original trial registration", "public_status": "Material identity and separate direct URL unconfirmed", "access_status": "Not attempted", "acquired": false, "actually_read": "Unread", "as_of": "2026-10-05", "qualification": "What was actually read here is the report summary in the stored manuscript. The paper-page URL and historical access level do not establish current full-text reading or acquisition of this material.", "material_id": "S02-M3", "url": null }, { "material_type": "Full protocol/statistical analysis plan", "public_status": "Material identity and separate direct URL unconfirmed", "access_status": "Not attempted", "acquired": false, "actually_read": "Unread", "as_of": "2026-10-05", "qualification": "What was actually read here is the report summary in the stored manuscript. The paper-page URL and historical access level do not establish current full-text reading or acquisition of this material.", "material_id": "S02-M4", "url": null } ], "links": [ { "label": "Official source", "url": "https://www.benthamscience.com/article/148808" } ], "independent_replication_note": "Decisive report from a single direct family; independent replication remains unconfirmed" }, { "report_id": "S20", "title": "Alam et al. — high-dose thiamine and T2D risk factors (2012)", "url": "https://www.iomcworld.com/open-access/effect-of-high-dose-thiamine-therapy-on-risk-factors-in-type-2-diabetics-26626.html", "report_type": "Subsequent original-paper HTML from the same registered trial family", "existence": "The stored bibliography, linked URLs and result summaries were checked. Current public availability of external originals was not newly queried.", "acquired_read": "Stored manuscript summaries and condition-application records were read. External abstracts, full papers, registrations and analysis plans were not attempted, acquired or read in this work.", "study_family": "CTRI-2008-091-000112", "independent_replication": false, "observed_result": "Table 2 reports mean HbA1c of 9.2→9.0→7.8% with thiamine and 8.8→8.5→8.4% with placebo, at baseline, 3-month treatment end and 2-month off-treatment follow-up.", "result_level": "The original review's summary and attribution are retained. This is not new reading or regrading of external clinical originals.", "source_evidence_date": "2026-09-15", "materials": [ { "material_type": "Web full text of the paper (HTML)", "public_status": "Material URL identified in the stored bibliography; current public availability not rechecked", "access_status": "Not attempted", "acquired": false, "actually_read": "Unread", "as_of": "2026-10-05", "qualification": "What was actually read here is the report summary in the stored manuscript. The paper-page URL and historical access level do not establish current full-text reading or acquisition of this material.", "material_id": "S20-M1", "url": "https://www.iomcworld.com/open-access/effect-of-high-dose-thiamine-therapy-on-risk-factors-in-type-2-diabetics-26626.html" } ], "links": [ { "label": "Official source", "url": "https://www.iomcworld.com/open-access/effect-of-high-dose-thiamine-therapy-on-risk-factors-in-type-2-diabetics-26626.html" } ], "independent_replication_note": "S01/S20 are an adjacent family under the same registration, not direct CKD3/24-week replications" } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes; distinguish intervention variants.", "review_level": "Stored method principles, application records and copy hashes were checked. No new retrieval of external methods documents or execution of an entire official assessment tool was performed." }, { "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; do not omit studies solely because outcomes are unreported.", "review_level": "Stored method principles, application records and copy hashes were checked. No new retrieval of external methods documents or execution of an entire official assessment tool was performed." }, { "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": "Fix the outcome and effect of interest, then review randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Stored method principles, application records and copy hashes were checked. No new retrieval of external methods documents or execution of an entire official assessment tool was performed." }, { "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 effects, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Stored method principles, application records and copy hashes were checked. No new retrieval of external methods documents or execution of an entire official assessment tool was performed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require designs, populations and follow-up different from efficacy questions. Case reports do not establish incidence.", "review_level": "Stored method principles, application records and copy hashes were checked. No new retrieval of external methods documents or execution of an entire official assessment tool was performed. Sections 19.1.2 and 19.2.1–19.2.4 of the stored harms chapter were additionally read." } ], "status_dictionary": { "Verified": "The specified record or boundary is verified in the stored material; this differs from confirmed efficacy or a new grade", "Partly verified": "Some parts of the condition are known while specific gaps remain", "Unverified": "The actual data or methods needed for the condition could not be verified within the currently stored material", "Unread": "External material was not read in this work; this differs from no research or an effect of 0", "Not applicable": "An extension condition outside this independent question; not a substitute for unread-material status" }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "Among the 3 stored reports, S02 is the direct trial family for the CKD stage 3/24-week question, while S01 and S20 belong to the adjacent family registered as CTRI-2008-091-000112. Report counts are not summed as independent trial or unique participant counts. Independent replication for the same question, unique participant counts and worldwide study totals remain unconfirmed." }, "history": [ { "date": "2026-10-29", "kind": "Public reader/material separation", "view_version": "1.0", "change": "Public pages and materials were prepared from the existing 36 items. No new clinical search, condition-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-29" }