{ "schema_version": "chamgap-public-criteria-1.0", "title": "Added riboflavin (vitamin B2) × Hemoglobin increase in anemic pregnant women receiving iron and folate", "criteria_version": "NGM-v3088-B2-IFB-IF-ANEMIC-PREGNANCY-HB-1.0", "criteria_date": "2026-10-05", "condition_origin": "Chamgap’s own application conditions", "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 document the question, eligibility conditions and reasons for changes, and distinguish intervention variants.", "review_level": "Reuse of the preserved methods copy and historical principles from 1585. This is neither a new review of the full methods text nor certification through an official tool." }, { "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 results are unreported.", "review_level": "Reuse of the preserved methods copy and historical principles from 1585. This is neither a new review of the full methods text nor certification through an official tool." }, { "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 when reviewing randomization, attrition, missing data, measurement and selective reporting.", "review_level": "Reuse of the preserved methods copy and historical principles from 1585. This is neither a new review of the full methods text nor certification through an official tool." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect values, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Reuse of the preserved methods copy and historical principles from 1585. This is neither a new review of the full methods text nor certification through an official tool." }, { "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 different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence.", "review_level": "Reuse of the preserved methods copy and historical principles from 1585. This is neither a new review of the full methods text nor certification through an official tool." } ], "status_dictionary": { "Met": "The identity, original attribution, and scope of this condition were verified in the retained materials. This is separate from the sufficiency of the effect or clinical certification.", "Partly verified": "Some materials have been linked, but the actual analyses, procedures, or details remain to be verified.", "Unverified": "The clinical materials or values needed for this condition remain unverified within the scope of this reading. This is distinct from an effect of 0, AE 0, or incomplete table preparation.", "Not applicable": "An obligation to extend beyond the narrow principal question does not apply. This does not substitute for an unread status or a gap in the materials.", "Not applicable (alias)": "A gray display alias for Not applicable.", "Conflicting data": "An actual discrepancy in the original sources for the same item; distinct from numerical differences between different comparisons.", "Unread": "External original materials have not been directly read in the current work; this is separate from actually reading the retained summaries.", "Review incomplete": "An individual review for preparing the table is incomplete; this is separate from unverified materials." }, "requirements": [ { "item_id": "N01", "question_type": "One question about an added treatment", "question": "Is the single question in this table IFB versus IF, with only B2 added to the same iron and folate?", "needed": "Corrections to the definition of the current claim being judged, population, IFB/IF components, endpoint, and timeframe, or new original source material.", "role": "Required", "role_reason": "The criteria for a single question about an added treatment must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.", "application_exception": "Do not fill gaps in unverified information about this single question on an added treatment with another study, allocation counts, or a different comparison in a title or abstract.", "criterion": "The question remains anchored at its original source location: a comparison adding only B2 to the same iron and folate treatment in pregnant women selected for anemia by Hb, with change in blood Hb as the outcome.", "basis": "Question-clarification principles in M03 §3.1 and §3.2.1–3.2.4; detailed rules for separating comparisons are internally designed; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed; M03 §3.2.3 and M08 §8.2.2–8.2.3; internal application — an internal adaptation for a single question about an added treatment.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "Compare the components of each arm against the question-definition table and review the selection decisions that exclude vitamin A add-on arms and the anemia-prevalence question." }, { "item_id": "N02", "question_type": "Selection of anemic pregnant women", "question": "Have the Hb eligibility criteria, stage of pregnancy, and baseline characteristics of the anemic pregnant women been verified?", "needed": "Ma’s Hb eligibility threshold, gestational age, recruitment/exclusion criteria, and baseline-characteristics table by arm.", "role": "Required", "role_reason": "The criteria for selecting anemic pregnant women must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.", "application_exception": "Do not fill gaps in unverified information on the selection of anemic pregnant women with another study, allocation counts, or a different comparison in a title or abstract.", "criterion": "The Hb eligibility threshold, stage of pregnancy, recruitment/exclusion criteria, and baseline Hb can be linked to the relevant IFB/IF population.", "basis": "M03 §3.2.1; detailed population criteria are internally designed — an internal adaptation for the selection of anemic pregnant women.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "Compare the original eligibility criteria with the flow diagram and baseline table to extract the Hb definition and stage of pregnancy, and review limitations on applicability to other maternal populations." }, { "item_id": "N03", "question_type": "Causes of anemia", "question": "Have the causes of anemia and the presence or absence of iron deficiency in IFB/IF participants been classified?", "needed": "Diagnostic methods for each cause of anemia, iron-status indicators, the composition of the IFB/IF arms by cause, and separate results by cause.", "role": "Required", "role_reason": "The criteria concerning the causes of anemia must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.", "application_exception": "Do not fill gaps in unverified information on the causes of anemia with another study, allocation counts, or a different comparison in a title or abstract.", "criterion": "The methods for determining iron deficiency and other causes, and the composition of each arm, are linked to the relevant participants.", "basis": "M03 §3.2.1; detailed population criteria are internally designed; M03 §3.2.1–3.2.4; details concerning dose, persistence, and effect modification are internally designed — an internal adaptation for the causes of anemia.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "Distinguish Hb-based selection from a diagnosis of iron deficiency, review the classification of causes, and check whether the results by cause come from planned comparisons." }, { "item_id": "N04", "question_type": "Baseline B2 status", "question": "Have baseline B2 status and the method for identifying deficiency in Ma’s participants been verified?", "needed": "Ma’s methods for measuring baseline vitamin status, deficiency thresholds, distributions by arm, and prespecified analysis plan.", "role": "Required", "role_reason": "The criteria concerning baseline B2 status must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.", "application_exception": "Do not fill gaps in unverified information on baseline B2 status with another study, allocation counts, or a different comparison in a title or abstract.", "criterion": "Verify participants’ baseline B2 indicators/thresholds and distributions, and the plan for analyzing effect modification.", "basis": "M03 §3.2.1; detailed population criteria are internally designed; M03 §3.2.1–3.2.4; details concerning dose, persistence, and effect modification are internally designed — an internal adaptation for baseline B2 status.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "Extract the assessment of B2 status separately from Hb-based selection, and review whether there is a planned between-group comparison within the deficient stratum." }, { "item_id": "N05", "question_type": "Molecule and formulation", "question": "Have the molecule, product, and detailed formulation of the B2 preparation actually used been verified?", "needed": "Information on the composition/product, detailed formulation, release profile, and manufacture of Ma’s trial preparation.", "role": "Required", "role_reason": "The criteria concerning the molecule and formulation must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.", "application_exception": "Do not fill gaps in unverified information on the molecule and formulation with another study, allocation counts, or a different comparison in a title or abstract.", "criterion": "The identity of riboflavin is linked to the product, formulation, release profile, and information on actual administration.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed — an internal adaptation for the molecule and formulation.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "Compare trial-preparation records to extract the identity of riboflavin, the product, and the release profile, and exclude results for other B-vitamin types or formulations." }, { "item_id": "N06", "question_type": "Actual route of administration", "question": "Is the actual route of administration in Ma’s IFB/IF arms explicitly stated?", "needed": "Methods material explicitly stating Ma’s actual route of administration and formulation.", "role": "Required", "role_reason": "The criteria concerning the actual route of administration must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.", "application_exception": "Do not fill gaps in unverified information on the actual route of administration with another study, allocation counts, or a different comparison in a title or abstract.", "criterion": "Verify the route of administration in the decisive study’s actual Methods section. An oral-route label in the target question alone does not meet this criterion.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed — an internal adaptation for the actual route of administration.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "Compare the oral-route token (oral) in the question being judged with the actual route in the trial methods as separate records, and update the verification status of the observed route." }, { "item_id": "N07", "question_type": "Added B2 dose", "question": "Is the nominal added B2 dose in the principal comparison 1.0 mg/day?", "needed": "Corrections to Ma’s supplementation doses by arm, or records of actual administration.", "role": "Required", "role_reason": "The criteria concerning the added B2 dose must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.", "application_exception": "Do not fill gaps in unverified information on the added B2 dose with another study, allocation counts, or a different comparison in a title or abstract.", "criterion": "The nominal B2 supplementation dose for IFB versus IF matches the original data structure. It is distinguished from actual intake and adherence.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed; M03 §3.2.3 and M08 §8.2.2–8.2.3; internal application — an internal adaptation for the added B2 dose.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "Verify the prescribed dose in each arm, and do not add the 5 mg from another study or total dietary intake to this nominal added dose." }, { "item_id": "N08", "question_type": "Shared iron and folate", "question": "Have the shared iron and folate in IFB and IF, and the excluded combination arms, been fixed?", "needed": "Corrections to the shared treatment in IFB/IF, records of actual concomitant treatment/changes, and information on arm composition.", "role": "Required", "role_reason": "The criteria concerning shared iron and folate must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.", "application_exception": "Do not fill gaps in unverified information on shared iron and folate with another study, allocation counts, or a different comparison in a title or abstract.", "criterion": "Fix the question as a comparison differing only in B2 on top of the same iron 60 mg/day and folic acid 400 μg/day. Do not transfer results from an arm that also adds vitamin A.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed; M03 §3.2.3 and M08 §8.2.2–8.2.3; internal application — an internal adaptation for shared iron and folate.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "Compare the component tables for the four arms, and review the extent to which the shared treatment was maintained and B2 was the only difference." }, { "item_id": "N09", "question_type": "Duration of the principal comparison", "question": "Is supplementation in the principal IFB/IF question given for 2 months?", "needed": "Corrections to the duration of Ma’s principal comparison, and the measurement schedule.", "role": "Required", "role_reason": "The criteria concerning the duration of the principal comparison must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.", "application_exception": "Do not fill gaps in unverified information on the duration of the principal comparison with another study, allocation counts, or a different comparison in a title or abstract.", "criterion": "Link the 2-month duration of the principal comparison to the original data structure, and distinguish it from longer-term and postpartum follow-up.", "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; details concerning dose, persistence, and effect modification are internally designed — an internal adaptation for the duration of the principal comparison.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "Compare the start and end of administration with the timing of Hb measurements to distinguish the nominal 2 months from the actual observation period." }, { "item_id": "N10", "question_type": "Allocation and blinding", "question": "Have Ma’s random sequence, allocation concealment, and blinding procedures been verified?", "needed": "Ma’s random sequence, allocation concealment and blinding methods, and baseline table by arm.", "role": "Required", "role_reason": "The criteria concerning allocation and blinding must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.", "application_exception": "Do not fill gaps in unverified information on allocation and blinding with another study, allocation counts, or a different comparison in a title or abstract.", "criterion": "Verify random sequence generation, concealment, blinded assessment, and baseline balance for the relevant IFB/IF comparison.", "basis": "M08 §8.1–8.2.3; internal application — an internal adaptation for allocation and blinding.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "Compare the methods and baseline table of the four-arm trial to distinguish the stated design from actual procedures, and retain the areas that cannot be verified." }, { "item_id": "N11", "question_type": "Adherence and changes in concomitant treatment", "question": "Have actual adherence, rescue treatment, and total exposure in IFB/IF been verified?", "needed": "Records by arm of intake/adherence, rescue treatment, changes to iron/folate, diet, and other supplements.", "role": "Required", "role_reason": "The criteria concerning adherence and changes in concomitant treatment must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.", "application_exception": "Do not fill gaps in unverified information on adherence and changes in concomitant treatment with another study, allocation counts, or a different comparison in a title or abstract.", "criterion": "Link actual intake, deviations, changes in concomitant treatment, total dietary/supplement exposure by arm, and the methods used to handle these.", "basis": "M03 §3.2.3 and M08 §8.2.2–8.2.3; internal application; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed — an internal adaptation for adherence and changes in concomitant treatment.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "Review changes in administration and concomitant treatment over time, and compare the scope of analyses of the effect of assignment with that of analyses of the effect of actual intake." }, { "item_id": "N12", "question_type": "Hb measurement", "question": "Have the Hb measurement methods, units, time points, and assessment procedures in IFB/IF been verified?", "needed": "Ma’s Hb assay methods, units, baseline/end-of-treatment measurement table, and information on blinded assessment.", "role": "Required", "role_reason": "The criteria concerning Hb measurement must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.", "application_exception": "Do not fill gaps in unverified information on Hb measurement with another study, allocation counts, or a different comparison in a title or abstract.", "criterion": "Link the actual assay methods, time points, baseline/end-of-treatment values, and assessment procedures for changes in blood Hb to the relevant result.", "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a and M03 §3.2.4; internal application — an internal adaptation for Hb measurement.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "Compare the Hb measurement procedures with the time points and units in the results tables, and keep them separate from anemia prevalence or other laboratory values." }, { "item_id": "N13", "question_type": "Effect of interest and analysis", "question": "Have the actual analysis population, adjustment, and definition of change for IFB versus IF been verified?", "needed": "The IFB/IF analysis plan, ITT/PP populations, adjustment model, definition of change, and original results tables.", "role": "Required", "role_reason": "The conditions concerning the effect of interest and analysis must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.", "application_exception": "Do not fill gaps in unverified information on the effect of interest and analysis with another study, allocation counts, or a different comparison in a title or abstract.", "criterion": "Link the analytical definitions of the effect of assignment or adherence, ITT/PP, adjustment, and baseline/final values or change to the actual IFB/IF results.", "basis": "M08 §8.2.2, M15 §15.3.1; application for this sheet; M03 §3.2.4, M15 §15.3.1–15.3.3; adaptations of outcomes to individual questions were designed for this sheet — an adaptation for this sheet concerning the effect of interest and analysis.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "Compare the reported analysis with the plan and review the scope of the estimate, without turning a within-group rise into a between-group effect of adding B2." }, { "item_id": "N14", "question_type": "Allocation and analysis denominators", "question": "Have the 366 participants assigned overall and the 91/93 assigned to the two arms been linked to the actual Hb analysis denominators?", "needed": "Ma's IFB/IF participant flow diagram, measurement and analysis counts (n), reasons for exclusion, and table of missing-data handling.", "role": "Required", "role_reason": "The conditions concerning allocation and analysis denominators must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.", "application_exception": "Do not fill gaps in unverified information on allocation and analysis denominators with another study, allocation counts, or a different comparison in a title or abstract.", "criterion": "Link recruitment → allocation to four arms → Hb measurement → analysis denominators, together with exclusions and missing-data handling, separately for IFB and IF.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations for individual study designs were designed for this sheet; M08 §8.2.2, M15 §15.3.1; application for this sheet — an adaptation for this sheet concerning allocation and analysis denominators.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "Compare the total across the four arms with the participant flow in the two comparison arms, and check that the original total of 184 participants is not used as the analysis denominator." }, { "item_id": "N15", "question_type": "Hb difference from adding B2 alone", "question": "Has the between-group Hb effect size for IFB versus IF been verified?", "needed": "Ma's Hb values by IFB/IF arm, between-group estimate, definitions, and original tables.", "role": "Required", "role_reason": "The conditions concerning the Hb difference from adding B2 alone must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.", "application_exception": "Do not fill gaps in unverified information on the Hb difference from adding B2 alone with another study, allocation counts, or a different comparison in a title or abstract.", "criterion": "Verify the original between-group Hb effect size, units, and definition of the estimate for the comparison that adds only B2 to the same iron and folate treatment.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; adaptations of outcomes to individual questions were designed for this sheet; M08 §8.2.2, M15 §15.3.1; application for this sheet; M15 §15.3.1–15.3.3; application for this sheet — an adaptation for this sheet concerning the Hb difference from adding B2 alone.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "Compare the original results tables for the four arms, extract only the estimate for the principal IFB/IF comparison, and exclude values for the combination arm or prevalence." }, { "item_id": "N16", "question_type": "Dispersion and intervals", "question": "Have the type of dispersion measure, CI, and criterion for an important difference for IFB/IF been verified?", "needed": "Original information on the type of dispersion measure, CI, analysis count (n), and a justified important Hb difference for the principal IFB/IF comparison.", "role": "Required", "role_reason": "The conditions concerning dispersion and intervals must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.", "application_exception": "Do not fill gaps in unverified information on dispersion and intervals with another study, allocation counts, or a different comparison in a title or abstract.", "criterion": "Verify the type of measure, such as SD/SE, the analysis count (n), and CI for the principal estimate, together with a justified criterion for an important Hb difference.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations for individual study designs were designed for this sheet; M15 §15.3.1–15.3.3; application for this sheet — an adaptation for this sheet concerning dispersion and intervals.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "Compare the original table footnotes, analysis model, and intervals, and review the scope of interpretation by comparing them with the defined important difference." }, { "item_id": "N17", "question_type": "Attribution of the combination-arm value", "question": "Has 5.4±1.1 g/L been excluded from the effect of adding B2 alone?", "needed": "Original tables and footnotes that correct the attribution of results to the combination or single-addition arm, or the type of measure represented by ±.", "role": "Required", "role_reason": "The conditions concerning attribution of the combination-arm value must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.", "application_exception": "Do not fill gaps in unverified information on attribution of the combination-arm value with another study, allocation counts, or a different comparison in a title or abstract.", "criterion": "Attribute 5.4±1.1 g/L to IFAB versus IF, in which A+B2 are added together; do not repurpose it as an effect of B2 alone or as an identified type of dispersion measure.", "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses was designed for this sheet; M03 §3.2.2–3.2.3; reverse-direction markers and adaptations of checks were designed for this sheet; M03 §3.2.3, M08 §8.2.2–8.2.3; application for this sheet — an adaptation for this sheet concerning attribution of the combination-arm value.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "Compare the components and results of the four arms side by side, and verify the comparison arms and definition of dispersion for each number." }, { "item_id": "N18", "question_type": "Registration and analysis plan", "question": "Are Ma's Hb endpoint, time points, and analysis consistent with the prospective registration and plan?", "needed": "Ma's registration, protocol, SAP, change history, and original Hb results.", "role": "Required", "role_reason": "The conditions concerning registration and the analysis plan must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.", "application_exception": "Do not fill gaps in unverified information on registration and the analysis plan with another study, allocation counts, or a different comparison in a title or abstract.", "criterion": "Compare the reported information with the endpoint status, time points, and analysis specified in the registration, protocol, and SAP for the principal comparison.", "basis": "M08 Table 8.2.a, M04 §4.6.3; application for this sheet — an adaptation for this sheet concerning registration and the analysis plan.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "Compare the status of Hb in the original plan with the actual IFB/IF report, leaving anything that cannot be cross-checked unverified." }, { "item_id": "N19", "question_type": "Suprapto comparison values", "question": "Have Suprapto's between-group Hb values for B2 versus iron and folate been verified?", "needed": "Suprapto's arm composition, Hb results for B2 versus iron/folate, dispersion/CI, and analysis count (n).", "role": "Required", "role_reason": "The conditions concerning Suprapto's comparison values must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.", "application_exception": "Do not fill gaps in unverified information on Suprapto's comparison values with another study, allocation counts, or a different comparison in a title or abstract.", "criterion": "Link the actual comparison values and intervals for B2 versus iron and folate, with alternating allocation and 5 mg/60 days, to the corresponding population and denominators.", "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses was designed for this sheet; M08 §8.1–8.2.3; application for this sheet; M04 §4.6.1–4.6.2, M15 §15.3.1; application for this sheet — an adaptation for this sheet concerning Suprapto's comparison values.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "Compare the original results by arm with the significant comparison in the abstract, distinguishing B2 versus vitamin A results from results versus iron and folate." }, { "item_id": "N20", "question_type": "Suprapto exclusion flow", "question": "Have the reasons by arm for excluding 19 of 103 participants and the Hb analysis denominators been verified?", "needed": "Suprapto's allocation/exclusion/analysis flow by arm, reasons for excluding 19 participants, and missing-data handling.", "role": "Required", "role_reason": "The conditions concerning Suprapto's exclusion flow must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.", "application_exception": "Do not fill gaps in unverified information on Suprapto's exclusion flow with another study, allocation counts, or a different comparison in a title or abstract.", "criterion": "Link the total assigned by alternating allocation, reasons for exclusion by arm, actual Hb analysis counts (n), and handling methods.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations for individual study designs were designed for this sheet; M08 §8.1–8.2.3; application for this sheet — an adaptation for this sheet concerning Suprapto's exclusion flow.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "Review the original flow diagram to verify the distribution by arm of the 19 excluded participants and the originally reported 18.4%; do not generate an analysis count (n) by totaling the remaining participants." }, { "item_id": "N21", "question_type": "RIBOFEM as one study family", "question": "Do the S10 protocol and the S11 results citation belong to the same RIBOFEM study family?", "needed": "Original bibliographic and registration materials that correct the identity relationship between the RIBOFEM protocol and results.", "role": "Required", "role_reason": "The conditions concerning RIBOFEM as one study family must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.", "application_exception": "Do not fill gaps in unverified information on RIBOFEM as one study family with another study, allocation counts, or a different comparison in a title or abstract.", "criterion": "Link the preserved study identifier (study_id) and relationships, so that the protocol and results reports are not counted as new independent trials.", "basis": "M04 §4.6.1–4.6.2 on distinguishing studies from reports; cohort/outcome linkage is an application for this sheet; M04 §4.6.1–4.6.2, M15 §15.3.1; application for this sheet — an adaptation for this sheet concerning RIBOFEM as one study family.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "Cross-check the protocol/results linkage using registration, authorship, and recruitment information; do not count reports from the same study family as separate trials." }, { "item_id": "N22", "question_type": "Healthy women and design assumptions", "question": "Have the healthy women with low B2 status and the Hb assumptions for sample-size planning been excluded from observed treatment effects?", "needed": "Original materials that correct the attribution of RIBOFEM's actual results, population, and design assumptions.", "role": "Required", "role_reason": "The conditions concerning healthy women and design assumptions must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.", "application_exception": "Do not fill gaps in unverified information on healthy women and design assumptions with another study, allocation counts, or a different comparison in a title or abstract.", "criterion": "Do not use RIBOFEM's selection of healthy women and sample-size planning assumptions as actual IFB/IF treatment effects in anemic pregnant women.", "basis": "M03 §3.2.1; detailed population conditions were designed for this sheet; M03 §3.2.4, M15 §15.3.1–15.3.3; adaptations of outcomes to individual questions were designed for this sheet; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses was designed for this sheet; M04 §4.6.1–4.6.2, M15 §15.3.1; application for this sheet — an adaptation for this sheet concerning healthy women and design assumptions.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "Compare the protocol assumptions with the results tables to separate the Hb difference used for planning from observed values, and reassess the direct relevance of the population." }, { "item_id": "N23", "question_type": "Direct replication", "question": "Has the same IFB/IF question been replicated in a separate independent study family?", "needed": "Population, product, dose, duration, IFB/IF Hb results, and study-family linkage information for an independent trial.", "role": "Required", "role_reason": "The conditions concerning direct replication must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.", "application_exception": "Do not fill gaps in unverified information on direct replication with another study, allocation counts, or a different comparison in a title or abstract.", "criterion": "Link actual results from an independent study family that is eligible in terms of the same population, addition of B2 alone, duration/dose, and Hb analysis.", "basis": "M04 §4.6.1–4.6.2 on distinguishing studies from reports; cohort/outcome linkage is an application for this sheet; M04 §4.6.1–4.6.2, M15 §15.3.1; application for this sheet — an adaptation for this sheet concerning direct replication.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "Compare distinct study families and comparison conditions to assess whether reports with other doses/designs or healthy women are exact replications." }, { "item_id": "N24", "question_type": "Funding and interests", "question": "Have funding, product provision, and author interests been verified for each relevant report?", "needed": "Original declarations of funding, product provision, and conflicts of interest (COI) for each Ma/Suprapto/RIBOFEM report.", "role": "Supplementary; required for independence claims", "role_reason": "The conditions concerning funding and interests must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.", "application_exception": "Do not fill gaps in unverified information on funding and interests with another study, allocation counts, or a different comparison in a title or abstract.", "criterion": "Verify the actual funding, provision, and author declarations for each report and its study-family relationships at the recorded source locations.", "basis": "Chamgap's own conditions for independence and attribution. The official methods sections used in this pilot do not endorse all of these detailed items — an adaptation for this sheet concerning funding and interests.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "Compare each report's declarations with institutional support and product provision, without concluding that unverified funding is independent funding or evidence of bias." }, { "item_id": "N25", "question_type": "Extension to the optimal dose", "question": "Does this Hb question require a judgment on the optimal dose of 1 mg versus 5 mg?", "needed": "If a separate dose comparison is reviewed: a direct randomized comparison of doses in the same population, with its plan and results.", "role": "Conditional; required when extending the question to dose comparisons", "role_reason": "The conditions concerning an extension to the optimal dose must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.", "application_exception": "Proof of the optimal dose is not imposed as a requirement for the narrow question of adding 1 mg.", "criterion": "Preserve the current question of adding 1 mg, and do not remove that narrow question because a separate dose comparison is unavailable.", "basis": "M03 §3.2.1–3.2.4; details concerning dose, persistence, and effect modification were designed for this sheet — an adaptation for this sheet concerning an extension to the optimal dose.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "If the extended question is approved, review a randomized comparison of doses in the same population with Hb and harms predefined for each dose." }, { "item_id": "N26", "question_type": "Extension to postpartum effects and persistence", "question": "Does this question require a judgment on persistence beyond 2 months or on postpartum effects?", "needed": "If the question is extended to persistence: denominators and time points for Hb after treatment discontinuation, postpartum, and over the long term, together with separate plans and results.", "role": "Conditional; required for an extension to persistence", "role_reason": "The conditions for an extension to postpartum effects and persistence must be checked separately for this IFB versus IF question so that results from different populations, combination products, or denominators are not mixed.", "application_exception": "Do not impose evidence of long-term maintenance as a requirement for the 2-month effect question.", "criterion": "Distinguish the principal 2-month comparison from separate questions about the long term, discontinuation, or the postpartum period.", "basis": "M03 §3.2.1–3.2.4; the details concerning dose, persistence, and effect modification were developed for this assessment — an adaptation for the extension to postpartum effects and persistence.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "For an extended question, review designs that distinguish the end of treatment, discontinuation, and postpartum time points while tracking Hb and changes in the shared treatment." }, { "item_id": "N27", "question_type": "Hb and clinical events", "question": "Does the Hb question require evidence of benefit for maternal and fetal clinical events?", "needed": "If the question is extended to clinical events: definitions of maternal/fetal events, denominators, follow-up, and results of the planned comparisons.", "role": "Conditional; required for an extension to clinical events", "role_reason": "The conditions concerning Hb and clinical events must be checked separately for this IFB versus IF question so that results from different populations, combination products, or denominators are not mixed.", "application_exception": "Do not impose a clinical-event trial as a requirement for a question about the Hb value itself.", "criterion": "Separate the question about change in Hb values from questions about clinical events, quality of life, mortality, or birth outcomes.", "basis": "M03 §3.2.4; limits on extensions were developed for this assessment; M03 §3.2.4, M15 §15.3.1–15.3.3; adaptations of outcomes to each question were developed for this assessment — an adaptation for Hb and clinical events.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "For an extended question, define maternal/fetal events as endpoints separate from Hb and review the relevant direct comparison and follow-up." }, { "item_id": "N28", "question_type": "Collection of harms by arm", "question": "Have the definitions of adverse events and discontinuation, and the denominators for each IFB/IF arm, been verified?", "needed": "Ma IFB/IF harm-collection methods; tables of adverse events (AE), serious adverse events (SAE), and discontinuations; participant/event counts; and denominators and follow-up by arm.", "role": "Supplementary; required for comparative safety claims", "role_reason": "The conditions for collection of harms by arm must be checked separately for this IFB versus IF question so that results from different populations, combination products, or denominators are not mixed.", "application_exception": "Do not fill gaps in unverified data on collection of harms by arm using another study, allocation counts, or a different comparison in a title or abstract.", "criterion": "Verify event/participant counts, systematic collection, severity, discontinuations, exposure and analysis denominators by arm, and duration.", "basis": "M19 §19.1.2–19.2.4; application developed for this assessment; M19 §19.1.2–19.2.4; detailed distinctions were developed for this assessment; M19 §19.2.2–19.2.4, M03 §3.2.3; application developed for this assessment; M19 §19.1.2–19.2.4, M04 §4.6.3; application developed for this assessment — an adaptation for collection of harms by arm.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "Distinguish events from participants in the original harm tables, compare follow-up and discontinuations by arm, and do not convert unreported or unobtained data into 0 events." }, { "item_id": "N29", "question_type": "Pregnancy and long-term safety", "question": "Have long-term maternal/fetal harms and their timing in relation to exposure been verified?", "needed": "Exposure by stage of pregnancy; timing of maternal/fetal event onset and discontinuation; and long-term follow-up results.", "role": "Supplementary; required for an extension to pregnancy safety", "role_reason": "The conditions for pregnancy and long-term safety must be checked separately for this IFB versus IF question so that results from different populations, combination products, or denominators are not mixed.", "application_exception": "Do not fill gaps in unverified pregnancy and long-term safety data using another study, allocation counts, or a different comparison in a title or abstract.", "criterion": "Verify the stage of pregnancy, exposure/event onset, long-term maternal/fetal follow-up, and the actual scope of event reporting.", "basis": "M19 §19.1.2–19.2.4; application developed for this assessment; harm questions by study design in M19 §19.2; details of temporal relationships were developed for this assessment; Chamgap's own limits on interpretation. This draws on M19 principles and is not an application of an official causality tool — an adaptation for pregnancy and long-term safety.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "Compare the stage of pregnancy with the exposure timeline, and review rare events and fetal outcomes separately with appropriate long-term follow-up." }, { "item_id": "N30", "question_type": "Assay interference", "question": "Has Hb assay interference for this question been checked separately?", "needed": "The actual Hb assay method, data on testing for B2 interference, and search records for that scope.", "role": "Supplementary; needed to interpret measurements", "role_reason": "The conditions for assay interference must be checked separately for this IFB versus IF question so that results from different populations, combination products, or denominators are not mixed.", "application_exception": "Do not fill gaps in unverified assay-interference data using another study, allocation counts, or a different comparison in a title or abstract.", "criterion": "Distinguish the scope in which interference between the Hb assay method and B2 exposure was directly checked from areas that were not searched.", "basis": "M08 Table 8.2.a, M03 §3.2.4; application developed for this assessment; design considerations in M19 §19.2.2–19.2.4; detailed records of confounding were developed for this assessment — an adaptation for assay interference.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "Compare the original assay with interference experiments, and review clinical Hb change and the possibility of analytical interference separately." }, { "item_id": "N31", "question_type": "Limits concerning drugs and concomitant use", "question": "Have drug interactions beyond the shared treatment been comprehensively verified?", "needed": "Participants' complete lists of concomitant treatments; interaction/exposure data; and the original search scope.", "role": "Supplementary; required for an extension to safety of concomitant use", "role_reason": "The conditions concerning limits on drugs and concomitant use must be checked separately for this IFB versus IF question so that results from different populations, combination products, or denominators are not mixed.", "application_exception": "Do not fill gaps in unverified data on the limits concerning drugs and concomitant use using another study, allocation counts, or a different comparison in a title or abstract.", "criterion": "Link the scope of verification and searches concerning concomitant drug/supplement use and interactions to the actual records.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; application developed for this assessment; M19 §19.1.2–19.2.4; application developed for this assessment; design considerations in M19 §19.2.2–19.2.4; detailed records of confounding were developed for this assessment — an adaptation for limits concerning drugs and concomitant use.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "Compare concomitant use and actual exposure by arm, and review drug-interaction data and areas not searched separately." }, { "item_id": "N32", "question_type": "Current and historical reading", "question": "Has reading the summaries in this work been distinguished from each report's historical access and from the fact that external materials have not been read in this work?", "needed": "Corrections to each report's original access record/access date, link, and material type, or an actual material-acquisition event.", "role": "Required", "role_reason": "The conditions for current and historical reading must be checked separately for this IFB versus IF question so that results from different populations, combination products, or denominators are not mixed.", "application_exception": "Do not fill gaps in unverified data on current and historical reading using another study, allocation counts, or a different comparison in a title or abstract.", "criterion": "Record the actual reading of the currently retained summaries and, for each external material, that access was not attempted and the material was neither obtained nor read in this work; preserve historical access levels and original locations separately.", "basis": "Material-collection and selection principles in M04 §4.5–4.6; the distinction between access and reading and the rules governing hyperlinks were developed for this assessment; M04 §4.5, §4.6.3; limits on the current conversion of materials follow the user's scope and were developed for this assessment — an adaptation for current and historical reading.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "Compare each report's citation record (citation) with its access history, link the summary viewer (reader) to the original location, and record any actual reading of external materials only as a separate event." }, { "item_id": "N33", "question_type": "Scope of searches and corrections", "question": "Have the original search cutoff, corrections, and the scope of activities not performed in this work been stated explicitly?", "needed": "Original search and selection/correction logs, or a new official correction or full-text acquisition event.", "role": "Required", "role_reason": "The conditions for the scope of searches and corrections must be checked separately for this IFB versus IF question so that results from different populations, combination products, or denominators are not mixed.", "application_exception": "Do not fill gaps in unverified data on the scope of searches and corrections using another study, allocation counts, or a different comparison in a title or abstract.", "criterion": "Link the preserved search cutoff, revisions, and unverified items to the scope of new searches, full-text reading, and calculations not performed in this work.", "basis": "M04 §4.5, §4.6.3; limits on the current conversion of materials follow the user's scope and were developed for this assessment; M04 §4.6.3, M15 §15.3.1–15.3.3; distinctions between statuses were developed for this assessment — an adaptation for the scope of searches and corrections.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "Compare the original records of existing searches and corrections, and, if a new evidence review is separately approved, update them while recording dates, inclusion/exclusion decisions, and material levels." }, { "item_id": "N34", "question_type": "Original judgment and historical values", "question": "Have the original C·46, all assessment axes, empty values, and historical arithmetic been preserved unchanged?", "needed": "An official correction concerning the original judgment, assessment axes, empty values, arithmetic, or sources/identity.", "role": "Required", "role_reason": "The conditions for the original judgment and historical values must be checked separately for this IFB versus IF question so that results from different populations, combination products, or denominators are not mixed.", "application_exception": "Do not fill gaps in unverified data on the original judgment and historical values using another study, allocation counts, or a different comparison in a title or abstract.", "criterion": "Preserve the current original grade and score (grade/score), assessment axes, statuses, all values in their original form, and historical arithmetic separately from any new assessment of conditions.", "basis": "Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules were developed for this assessment; M04 §4.5, §4.6.3; limits on the current conversion of materials follow the user's scope and were developed for this assessment — an adaptation for the original judgment and historical values.", "condition_origin": "Criteria developed for this case with knowledge of the original content. This is not a blinded or preregistered process or an officially certified assessment.", "proposed_research": "Compare the complete original text before and after a correction, link only the changed identities/values to their supporting evidence and dates, and distinguish revision of the conditions version from a new judgment." } ], "language": "en", "translation_date": "2026-11-01" }