{ "schema_version": "chamgap-public-criteria-1.0", "title": "Oral dispersible methylcobalamin (vitamin B12) × Reduction in reported painDETECT score in metformin-treated diabetic neuropathy with low B12", "criteria_version": "NGM-v3111-METHYL-B12-METFORMIN-PAINDETECT12M-1.0", "criteria_date": "2026-10-05", "condition_origin": "Chamgap application criteria", "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility criteria and reasons for changes, and distinguish variations in the intervention.", "review_level": "Reuse of actual bytes/SHA and historical principles from the retained methods HTML copy for case 1585. No new reading of the full methods text, official application or certification was performed in this exercise." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish and link studies and reports, and do not omit a study solely because its outcomes are not reported.", "review_level": "Reuse of actual bytes/SHA and historical principles from the retained methods HTML copy for case 1585. No new reading of the full methods text, official application or certification was performed in this exercise." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Hold the outcome and effect of interest fixed, then assess randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Reuse of actual bytes/SHA and historical principles from the retained methods HTML copy for case 1585. No new reading of the full methods text, official application or certification was performed in this exercise." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Reuse of actual bytes/SHA and historical principles from the retained methods HTML copy for case 1585. No new reading of the full methods text, official application or certification was performed in this exercise." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Questions about harms may require designs, populations and follow-up different from efficacy questions. Case reports do not establish incidence.", "review_level": "Reuse of actual bytes/SHA and historical principles from the retained methods HTML copy for case 1585. No new reading of the full methods text, official application or certification was performed in this exercise." } ], "status_dictionary": { "Met": "The criterion's identity, attribution within retained materials and interpretive boundaries were verified. This is not confirmation of clinical efficacy/safety or official certification.", "Partly verified": "Some facts were linked within the currently retained material, but further dimensions of evidence or comparisons remain outstanding.", "Unverified": "The material read lacks necessary values, criteria or source materials. This does not mean a count or value of 0 for studies, effects or events, or incomplete review in preparing the table.", "Conflicting information": "The current retained manuscript explicitly states a discrepancy for the same item. The exact scope is preserved without selecting or correcting an original value.", "Not applicable": "A requirement to impose other extension studies as mandatory for the current narrow score question does not apply. This does not verify other effects or replace an unread status.", "Does not apply": "A display alias for Not applicable. The original criterion/status is preserved as Not applicable.", "Not read": "The relevant external or older separate source material was not directly read in this exercise. This is separate from actual reading of the retained summary.", "Review incomplete": "Actual review of individual criteria/observations for preparation of the table remains outstanding. This is distinct from unverified source information." }, "requirements": [ { "item_id": "N01", "question_type": "Separate question", "question": "Which population and which 12-month score are being compared?", "needed": "The original question and specifications of the population, ingredient, route, dose, comparator, time point and endpoint", "role": "Required", "role_reason": "The B12 effects discussed across the page must be distinguished from the selected score comparison.", "application_exception": "The actual subclaims list is empty. Mean pain NRS, all diabetic neuropathy and replacement of analgesics are not added as new subclaims.", "criterion": "Link the population, methylcobalamin, placebo and 12-month painDETECT comparison in the original /ko/effect and fixed question.", "basis": "M03 §3.1, §3.2.1–3.2.4 principles for clarifying the question; detailed separation rules are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations for each question are internally designed — An internally developed, item-specific adaptation for Separate question. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Fix the original question and eligibility criteria, then separately examine only comparisons involving the same population, formulation and score." }, { "item_id": "N02", "question_type": "Active ingredient", "question": "Was methylcobalamin the trial's single active ingredient?", "needed": "The original trial's active ingredient, chemical form and whether it was a combination product", "role": "Required", "role_reason": "Needed to avoid combining effects of different chemical forms or combination products solely on the basis of the name B12.", "application_exception": "Cyanocobalamin, hydroxocobalamin and B-vitamin combinations are not direct evidence for this single-ingredient methylcobalamin comparison.", "criterion": "Identify methylcobalamin/mecobalamin as the actual added ingredient and distinguish it from other cobalamins.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are internally designed — An internally developed, item-specific adaptation for Active ingredient. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare the active-ingredient specifications with each original trial's composition to distinguish comparisons of a single added ingredient in the same chemical form." }, { "item_id": "N03", "question_type": "Trial product", "question": "Do the supply identity and historical batch of B12 fix match?", "needed": "Trial-product supply records, batch/purity documentation and the current product description", "role": "Required", "role_reason": "Needed to avoid treating the current product page as verification of the historical trial batch.", "application_exception": "Linking the UNI-PHARMA name and B12 fix page does not independently confirm the historical batch, purity or efficacy.", "criterion": "Record the trial product name and supplier, the current manufacturer description, and historical batch and purity separately.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are internally designed — An internally developed, item-specific adaptation for Trial product. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Obtain the trial supply records and contemporaneous batch documentation, and compare them with the current product description while distinguishing their dates." }, { "item_id": "N04", "question_type": "Route of administration", "question": "Has the oral dispersible formulation been reinterpreted as sublingual or injectable?", "needed": "Trial administration method and oral dispersible formulation specifications", "role": "Required", "role_reason": "A formulation that disperses in the mouth cannot be assumed to have the same administration route as sublingual holding or injection.", "application_exception": "Do not add a sublingual holding time, injection route or absorption mechanism absent from the source material.", "criterion": "Preserve the actual oral dispersible formulation and route without filling in an unreported sublingual holding time.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are internally designed — An internally developed, item-specific adaptation for Route of administration. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare the contemporaneous administration instructions to distinguish the dosing procedure from the actual route." }, { "item_id": "N05", "question_type": "Nominal dose", "question": "Has the trial dose been distinguished from total exposure?", "needed": "Trial dose and frequency, dietary/additional supplementation exposure and adherence records", "role": "Required", "role_reason": "Needed to avoid turning the trial's nominal dose into an individual dosing instruction or actual total intake.", "application_exception": "1000 µg/day is a trial condition, not an instruction for personal use or a change in diabetes medication.", "criterion": "Distinguish the trial dose of 1000 µg 1 time daily from total exposure including diet and additional supplementation.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application — An internally developed, item-specific adaptation for Nominal dose. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare administration, additional supplementation and dietary records by group to assess differences between nominal dose and actual exposure." }, { "item_id": "N06", "question_type": "Conflicting product units", "question": "Has the manufacturer's 1000 µg versus 1000 mg labeling been resolved?", "needed": "Locations of the manufacturer's labels, corrections and contemporaneous trial-dose documentation", "role": "Required", "role_reason": "Needed to avoid silently harmonizing conflicting product units or substituting them for the trial dose.", "application_exception": "The conflict on the current product page does not justify changing the original trial's 1000 µg/day to 1000 mg/day.", "criterion": "Preserve both printed units on the current product page and handle them separately from the trial dose.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; the separation of statuses is internally designed — An internally developed, item-specific adaptation for Conflicting product units. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare labeling and correction history on the same product page with their original locations to verify the conflict, while maintaining the trial specifications separately." }, { "item_id": "N07", "question_type": "Observation period", "question": "Has 12-month administration been separated from results over other durations?", "needed": "Trial administration and assessment times, and the duration of each adjacent study", "role": "Required", "role_reason": "Studies cannot be counted as direct replications when durations and measurements differ, even if they use the same neuropathy label.", "application_exception": "The 4-month nerve-conduction result in S05 is a different outcome from this 12-month painDETECT comparison.", "criterion": "Link the selected score's 12-month time point and administration period without combining the adjacent 4-month result with it.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations for each question are internally designed — An internally developed, item-specific adaptation for Observation period. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare the original time-specific tables and trial schedule to separate administration duration, observation duration and the time point of the selected outcome." }, { "item_id": "N08", "question_type": "Population selection", "question": "Which adults with diabetic neuropathy were selected?", "needed": "Population diagnoses, duration of metformin use and B12 eligibility criterion", "role": "Required", "role_reason": "Needed to avoid automatically applying the results to all patients with diabetic neuropathy.", "application_exception": "Do not extend the selected population with low B12 and long-term metformin use to diabetes generally or to populations with normal B12.", "criterion": "Link the actual selection criteria: type 2 diabetes, confirmed peripheral and autonomic neuropathy, metformin for ≥4 years and low B12.", "basis": "M03 §3.2.1; detailed population criteria are internally designed — An internally developed, item-specific adaptation for Population selection. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare inclusion/exclusion documentation and baseline characteristics to assess the applicability boundaries of the narrowly selected population." }, { "item_id": "N09", "question_type": "Low-B12 boundary", "question": "Is B12 <400 pmol/L being interpreted as absolute deficiency in everyone?", "needed": "Baseline B12 criterion, diagnosis of deficiency and population-specific results", "role": "Required", "role_reason": "A low eligibility value and correction of confirmed deficiency are different questions of applicability.", "application_exception": "Do not classify every participant as having confirmed absolute deficiency solely on the basis of B12 <400 pmol/L.", "criterion": "Distinguish the trial's low-B12 criterion from confirmed absolute deficiency and the effects of supplementation in people with normal B12.", "basis": "M03 §3.2.1; detailed population criteria are internally designed; M03 §3.2.1–3.2.4; details on dose, duration and effect modification are internally designed — An internally developed, item-specific adaptation for Low-B12 boundary. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare diagnostic evidence of deficiency with the eligibility value, and assess extension to a normal-B12 population through a separate comparison." }, { "item_id": "N10", "question_type": "Pain entry criteria", "question": "Were the pain NRS entry threshold and minimum duration verified?", "needed": "Pain diagnosis, entry NRS criterion and minimum duration in the eligibility documentation", "role": "Required", "role_reason": "The description 'painful' alone does not establish a population with a particular pain intensity or duration of chronic pain.", "application_exception": "Do not reinterpret unverified entry criteria as a population without pain or absence of analgesic efficacy.", "criterion": "Distinguish the description of painful neuropathy from the verification status of the exact pain threshold and duration for entry.", "basis": "M03 §3.2.1; detailed population criteria are internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application — An internally developed, item-specific adaptation for Pain entry criteria. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare the eligibility documentation and diagnostic procedures to verify actual pain-intensity and duration entry criteria." }, { "item_id": "N11", "question_type": "Glycemic-status selection", "question": "Was selection for stable HbA1c of 6.5–7.5% preserved?", "needed": "Baseline glycemic status, stability criteria and glycemic-medication records by group", "role": "Required", "role_reason": "Needed to avoid applying the result of adjunctive treatment on stable glycemic management to all glycemic states.", "application_exception": "A nonsignificant result for HbA1c change is not a direct substitute for this stable-range selection criterion or the painDETECT result.", "criterion": "Link the stable HbA1c range with the population receiving common glycemic management.", "basis": "M03 §3.2.1; detailed population criteria are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application — An internally developed, item-specific adaptation for Glycemic-status selection. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare baseline glycemic selection criteria and management/medication records by group to assess applicability and concomitant-treatment boundaries." }, { "item_id": "N12", "question_type": "Placebo specifications", "question": "Was the full composition of the similar-looking placebo verified?", "needed": "Placebo appearance, composition and batch, and common management in each group", "role": "Required", "role_reason": "Needed to avoid confusing similar appearance with complete placebo identity or biological inactivity.", "application_exception": "Do not conclude that the placebo was an active treatment or that blinding was broken because its full composition is unverified.", "criterion": "Record the similar-looking placebo comparison separately from the unverified full excipient composition.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application — An internally developed, item-specific adaptation for Placebo specifications. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare contemporaneous placebo specifications and manufacturing records to assess comparator composition and implementation of blinding." }, { "item_id": "N13", "question_type": "Common treatment", "question": "Were common glycemic management and adjustment variables distinguished?", "needed": "Glycemic medications and management changes by group, and ANCOVA adjustment specifications", "role": "Required", "role_reason": "Needed to avoid using a common policy as proof that all actual treatments were identical.", "application_exception": "Do not indicate that all differences in concomitant treatment, confounding and adherence were resolved merely because adjustment variables were used.", "criterion": "Record the common management policy, actual treatment changes by group, and adjustment for HbA1c/glycemic medications separately.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application — An internally developed, item-specific adaptation for Common treatment. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare concomitant-treatment changes by group and analysis specifications to assess the selected intervention's contribution and the effect of interest." }, { "item_id": "N14", "question_type": "Rescue analgesics", "question": "Is the policy permitting paracetamol the same as actual use?", "needed": "Rescue-analgesic policy, amount used and changes by group, and handling in the analysis", "role": "Required", "role_reason": "A permission rule alone cannot establish that actual analgesic exposure was identical between groups.", "application_exception": "Do not interpret the policy restricting analgesics as an effect replacing analgesics, or fill in actual use as 0.", "criterion": "Distinguish restrictions on other analgesics and occasional paracetamol permitted for 2–3 days from the actual amounts used by group.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; internal application — An internally developed, item-specific adaptation for Rescue analgesics. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare rescue-medication use records by group to assess the relationship between the score comparison and concurrent treatment." }, { "item_id": "N15", "question_type": "Adherence and diet", "question": "Were numerical adherence and additional B12 exposure verified?", "needed": "Dosing records and numerical adherence by group, and records of diet, fortified foods and additional supplementation", "role": "Required", "role_reason": "Needed because reported completion by everyone differs from actual adherence.", "application_exception": "Do not substitute 90 fully adherent participants or identical total intake for the 90 reported completers.", "criterion": "Distinguish nominal administration from actual dosing, diet, fortified foods and other supplementation exposure.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application — An internally developed, item-specific adaptation for Adherence and diet. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare dosing, diet and additional-exposure records, and assess their handling in relation to the effect of interest." }, { "item_id": "N16", "question_type": "Scale definition", "question": "Is the painDETECT total score a mean pain-intensity NRS?", "needed": "Original scale definition, total-score components, range and direction", "role": "Required", "role_reason": "Needed to avoid elevating a screening total score to a reduction in mean pain NRS/VAS.", "application_exception": "Preserve the scale's original screening purpose while retaining the comparison of the patient-reported score itself selected for this page.", "criterion": "Distinguish the screening composite of sensory qualities, pain course and radiation from items recording pain intensity.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations for each question are internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M03 §3.2.4; internally defined boundaries for extending the claim — An internally developed, item-specific adaptation for Scale definition. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare the original scale definition with the items actually used in the trial to assess how the total score relates to the intensity items." }, { "item_id": "N17", "question_type": "Questionnaire implementation", "question": "Were the trial questionnaire's language, version and recall period verified?", "needed": "Trial questionnaire, language/translation, version, recall period and scoring procedure", "role": "Required", "role_reason": "The original scale definition does not verify all aspects of how measurement was actually implemented in the trial.", "application_exception": "Do not infer the trial questionnaire version or recall period from the original scale's total-score range.", "criterion": "Distinguish the original scale description from the verification status of the language, version and recall period actually used in the trial.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations for each question are internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application — An internally developed, item-specific adaptation for Questionnaire implementation. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare the contemporaneous questionnaire and scoring procedure with the original scale definition to assess how the actual measurement corresponds to it." }, { "item_id": "N18", "question_type": "Selected time point", "question": "Was the page's primary endpoint at 12 months distinguished from a registered primary (1st) endpoint?", "needed": "Outcome time points, original registration hierarchy, initial posting and amendment history", "role": "Required", "role_reason": "Needed to avoid automatically turning the page's primary endpoint into a preregistered primary (1st) outcome.", "application_exception": "Do not reinterpret an unverified registration hierarchy as confirmed absence of registration or confirmed selective reporting.", "criterion": "Record the reported score at 12 months selected for this page separately from the verification status of the preregistered primary endpoint.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations for each question are internally designed; M08 Table 8.2.a, M04 §4.6.3; internal application — An internally developed, item-specific adaptation for Selected time point. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare the initial registration and timing of outcome reporting to assess how selection occurred and why changes were made." }, { "item_id": "N19", "question_type": "Allocation and blinding", "question": "Was the RCT designation distinguished from implementation of allocation concealment?", "needed": "Original trial design, allocation/concealment, implementation of blinding and baseline data", "role": "Required", "role_reason": "Needed because a design designation alone cannot establish absence of allocation or measurement bias.", "application_exception": "Do not present unreported implementation of allocation concealment as actual concealment failure or an established magnitude of bias.", "criterion": "Link the randomized, placebo-controlled, double-blind design and the unreported implementation of allocation concealment to each outcome.", "basis": "M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application — An internally developed, item-specific adaptation for Allocation and blinding. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare allocation procedures, placebo specifications and assessment-blinding documentation to assess potential bias in the selected score." }, { "item_id": "N20", "question_type": "Allocation and completion", "question": "Are allocation of 90 participants, 44/46 by group, and completion being read as analysis denominators?", "needed": "Flow diagram and denominators for allocation, completion, measurement and analysis by group", "role": "Required", "role_reason": "Needed to avoid automatically using a statement that everyone completed the trial as the analysis denominator for each outcome.", "application_exception": "Do not treat the 90 reported completers as a verified painDETECT analysis n=90 or group-specific n=44/46.", "criterion": "Preserve allocation and reported completion of 44/46 separately from endpoint-specific analysis denominators.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations for each study design are internally designed; M08 §8.2.2, M15 §15.3.1; internal application — An internally developed, item-specific adaptation for Allocation and completion. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare the flow diagram and endpoint-specific analysis tables to link participant counts for allocation → completion → measurement → analysis." }, { "item_id": "N21", "question_type": "Analysis population and missing data", "question": "Were the painDETECT analysis population and missing-data handling verified?", "needed": "PainDETECT analysis denominators by group, analysis population, reasons for missing data/exclusions and their handling", "role": "Required", "role_reason": "Needed to avoid filling in absent analysis populations and denominators as ITT or all completers.", "application_exception": "Do not arbitrarily label an unreported analysis population as ITT/PP or fill in dropouts and missing data as 0.", "criterion": "Distinguish endpoint-specific analysis populations, ITT/PP and missing-data handling from reported completion.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations for each study design are internally designed; M08 §8.2.2, M15 §15.3.1; internal application — An internally developed, item-specific adaptation for Analysis population and missing data. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare outcome-specific analysis specifications and missing-data/exclusion records to assess the effect of interest and the actual analysis population." }, { "item_id": "N22", "question_type": "Original scores and descriptive differences", "question": "Are the original scores, existing change contrast and endpoint difference being read as the same estimate?", "needed": "Scores and time points in the original results table, definitions of existing descriptive differences and adjusted results", "role": "Required", "role_reason": "Needed to avoid confusing within-group change, between-group difference in change, endpoint difference and an adjusted coefficient.", "application_exception": "Do not present the existing −2.9 and −3.8 as new calculations or unreported adjusted estimates.", "criterion": "Preserve 18.4→17.1 versus 19.3→20.9 and the manuscript's descriptive values of −2.9/−3.8 separately.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations for each question are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; the separation of statuses is internally designed; M08 §8.2.2, M15 §15.3.1; internal application — An internally developed, item-specific adaptation for Original scores and descriptive differences. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare the original table and analysis definitions to assess the correspondence among original scores, descriptive differences and the formal adjusted effect." }, { "item_id": "N23", "question_type": "Adjusted effect and interval", "question": "Has P<0.001 been turned into an adjusted coefficient, SE or CI?", "needed": "ANCOVA specifications, adjusted coefficient, SE, CI, denominators and results table", "role": "Required", "role_reason": "Needed to avoid establishing effect magnitude or precision from statistical significance alone.", "application_exception": "P<0.001 is not an exact P value; no adjusted CI or standardized effect is newly back-calculated.", "criterion": "Link the formal ANCOVA comparison of change, adjustment variables and reported P separately from the unreported coefficient/SE/CI.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations for each question are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations for each study design are internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application — An internally developed, item-specific adaptation for Adjusted effect and interval. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare formal model output and the results table to verify the formal effect of interest, interval and denominators." }, { "item_id": "N24", "question_type": "Conflicting baseline SD", "question": "Have the baseline SD values of 9.2 and 9.7 been silently harmonized?", "needed": "Locations of baseline SD in the original Table 4 and text, corrections, and group/time-point specifications", "role": "Required", "role_reason": "Needed to avoid arbitrarily selecting or correcting conflicting variability values, or using them as established inputs for a CI calculation.", "application_exception": "Preserve only the recorded conflict of 9.2 versus 9.7 without filling in table cells or group attribution absent from the current stored summary.", "criterion": "Retain the conflict between the two baseline SD values reported in the retained manuscript and their unresolved attribution.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations for each study design are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; the separation of statuses is internally designed — An internally developed, item-specific adaptation for Conflicting baseline SD. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare the original table, relevant text and correction history for the same group/time point to verify the location and attribution of the SD conflict." }, { "item_id": "N25", "question_type": "Clinical importance", "question": "Is there an applicable MCID for painDETECT change in this population?", "needed": "Evidence for an MCID applicable to this population, scale version and change estimate", "role": "Required (for interpreting clinical importance)", "role_reason": "Needed to avoid elevating a statistically significant score difference to a clinically important mean analgesic effect.", "application_exception": "Do not turn a screening total-score threshold into an MCID or substitute thresholds from another disease or language. Do not reassess the original EX solely because an MCID is absent.", "criterion": "Distinguish a criterion for an important difference applicable to the selected score, population and time point from a diagnostic screening threshold.", "basis": "M15 §15.3.1–15.3.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application — An internally developed, item-specific adaptation for Clinical importance. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare evidence on important change in the same population and scale version with the score definition, and interpret it alongside the reported interval." }, { "item_id": "N26", "question_type": "Registration history", "question": "Was the identity of NCT04706377 distinguished from reading its content?", "needed": "Original registration record, initial posting, amendment history and outcome hierarchy", "role": "Required", "role_reason": "Needed to avoid turning the existence of a registration number into verification of a prespecified primary (1st) endpoint or registration timing.", "application_exception": "Do not present historical access classified as registration_shell_only as reading the full registration or as confirmation that the trial was unregistered.", "criterion": "Distinguish linking a registration number from obtaining the initial posting, amendment history and readable endpoint hierarchy.", "basis": "M04 §4.5–4.6 principles for collecting/selecting material; the separation of access from reading and the hyperlink contract are internally designed; M08 Table 8.2.a, M04 §4.6.3; internal application — An internally developed, item-specific adaptation for Registration history. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare the initial registration and amendment history with outcome reporting to assess temporal order, the selected endpoint and reasons for changes." }, { "item_id": "N27", "question_type": "Plans and multiple endpoints", "question": "Were the protocol and SAP compared with the selection of actual results?", "needed": "Protocol, SAP, prespecified endpoints/analyses/time points, handling of multiple endpoints and reporting", "role": "Required", "role_reason": "Needed to expose the lack of materials for assessing whether only favorable scores were selected.", "application_exception": "Do not treat unavailable materials as confirmation of selective reporting or arbitrarily fill in primary_failed_secondary_positive as true/false.", "criterion": "Distinguish unavailable plans and unverified multiple-endpoint handling and prespecified hierarchy from confirmed selective reporting.", "basis": "M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.6.3, M15 §15.3.1–15.3.3; the separation of statuses is internally designed — An internally developed, item-specific adaptation for Plans and multiple endpoints. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare the registration, protocol and SAP with all reported endpoints, analyses and time points to assess changes to the plan and reasons for selection." }, { "item_id": "N28", "question_type": "Results without a significant difference", "question": "Were nonsignificant results for MNSIE and HbA1c preserved?", "needed": "All reported endpoints, denominators, time points and analyses, including favorable results and results without a significant difference", "role": "Required", "role_reason": "Other endpoints without a significant difference must be preserved alongside favorable scores, rather than retaining only favorable scores.", "application_exception": "Do not reinterpret nonsignificance as an effect of 0, equivalence or direct refutation of the painDETECT result.", "criterion": "Attribute P=0.607 and P=0.876 to their other endpoints separately from the selected painDETECT outcome.", "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; the separation of statuses is internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations for each question are internally designed — An internally developed, item-specific adaptation for Results without a significant difference. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare each endpoint, denominator and analysis in the complete results table to assess how favorable results and those without a significant difference relate to the selected score." }, { "item_id": "N29", "question_type": "Same-trial family", "question": "Are S01, S02 and S03 being counted as three replications?", "needed": "DOI, PMID, PMCID, registration number and report-family linkage", "role": "Required", "role_reason": "Needed to avoid converting the number of article, bibliographic and registration reports into a count of unique trials.", "application_exception": "Do not delete bibliographic/registration records because they lack separate results, or add linked records as new independent trials.", "criterion": "Link the original trial, NLM bibliographic record and registration number within F01, distinguishing them from independent replication.", "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is an internal application; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application — An internally developed, item-specific adaptation for Same-trial family. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare identifiers, trial numbers and original-report identities to link reports belonging to the same trial family." }, { "item_id": "N30", "question_type": "Adjacent 1992 trial", "question": "Are improvement and the absence of a significant nerve-conduction difference in S05 being read as replication of the same question?", "needed": "S05 original abstract, population/dose/scale, denominators, duration and results", "role": "Supplementary; required for a claim of exact replication", "role_reason": "Needed to avoid creating an exact painDETECT replication from favorable related symptom results alone.", "application_exception": "Do not substitute nonsignificant nerve-conduction results at 4 months for no effect on the selected 12-month painDETECT outcome.", "criterion": "Record F02's symptom improvement and nonsignificant nerve-conduction result at 4 months alongside the unverified selected score, population and dose.", "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is an internal application; M04 §4.6.3, M15 §15.3.1–15.3.3; the separation of statuses is internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application — An internally developed, item-specific adaptation for Adjacent 1992 trial. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare population, dose, measurements and denominators in the original abstract and full text to distinguish direct replication from adjacent symptom results." }, { "item_id": "N31", "question_type": "2026 active-dose comparison", "question": "Is a comparison of 1000 versus 2000 µg a placebo-controlled replication?", "needed": "S06 population, chemical form, active doses, endpoints, denominators and full results", "role": "Supplementary; required for dose or replication claims", "role_reason": "A comparison of two active doses differs from the efficacy question of added B12 versus no supplementation.", "application_exception": "Do not automatically establish that oral B12 in the title means the exact methylcobalamin form, the same painDETECT endpoint or the same population.", "criterion": "Distinguish F03's comparison of two active doses from a placebo comparison without supplementation, without filling in unverified pain values.", "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is an internal application; M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application; M03 §3.2.1–3.2.4; details on dose, duration and effect modification are internally designed — An internally developed, item-specific adaptation for 2026 active-dose comparison. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare the original trial's population, chemical form, doses, comparator and endpoints, and assess dose comparison as a separate question." }, { "item_id": "N32", "question_type": "Reviews and discovery leads", "question": "Are S11 and S12 being counted as new independent replications?", "needed": "Reviews' included-study tables, original-trial identities, chemical forms/routes/endpoints and duplicate-report linkage", "role": "Supplementary; required for claims about overall replication", "role_reason": "Needed to avoid adding discovery citations to the number of independent trials addressing the same question.", "application_exception": "Do not use reviews of mixed B-vitamin types, routes and formulations as direct results for a single-ingredient methylcobalamin painDETECT comparison.", "criterion": "Distinguish review identities used for discovery from comparison of the actual inclusion and results of independent original trials.", "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is an internal application; M04 §4.5, §4.6.3; limits on the present conversion of material reflect the user-defined scope and internal design; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application — An internally developed, item-specific adaptation for Reviews and discovery leads. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Link the trials included in reviews to original reports, then individually compare family overlap, differences in conditions and unverified results." }, { "item_id": "N33", "question_type": "Funding and independence", "question": "Were product supply and no external funding reinterpreted as independent funding?", "needed": "Research funding, product/placebo supply, company role, COI and institutional/author declarations", "role": "Supplementary; required for independence claims", "role_reason": "Needed to avoid confusing in-kind product supply with funding and independent replication.", "application_exception": "Do not use company supply as an automatic reason for exclusion or infer public independent funding I2 or manufacturer-only I0 from no external funding.", "criterion": "Preserve separately the scope of declarations of no external research funding, company product/placebo supply, no involvement and no COI.", "basis": "Chamgap's own criteria for independence and attribution. The official methods sections used in this pilot do not endorse all of these detailed items — An internally developed, item-specific adaptation for Funding and independence. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare funding, supply, company roles and author declarations report by report, recording the scope of verification and omissions." }, { "item_id": "N34", "question_type": "Trial reporting of harms", "question": "Is nonreporting of suspected B12-related AEs being read as 0 AEs of any kind?", "needed": "All AEs, SAEs, relatedness, discontinuations, collection methods, events/people and denominators/duration by group", "role": "Supplementary; required for safety interpretation", "role_reason": "Needed to avoid turning limited reporting of relatedness into absence of all events or verified safety.", "application_exception": "Do not substitute 0 AEs, SAEs or discontinuations for the report that everyone completed the trial, or newly calculate event rates.", "criterion": "Distinguish the report that no suspected B12-related adverse reactions were observed from all AEs/SAEs, discontinuations, denominators and the scope of collection.", "basis": "M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; detailed differentiation is internally designed; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application — An internally developed, item-specific adaptation for Trial reporting of harms. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare original safety tables and collection, relatedness and discontinuation records by group to distinguish people, events, duration and unreported information." }, { "item_id": "N35", "question_type": "Official metformin document", "question": "Is the safety context of metformin and low B12 an analgesic effect?", "needed": "Population, scope of recommendations and original location in official document S07", "role": "Supplementary; required for safety and population interpretation", "role_reason": "Needed to avoid reversing an association between medication and B12 status into an analgesic effect of supplementation.", "application_exception": "Do not use the official monitoring document to justify a methylcobalamin painDETECT effect or an individual change in metformin.", "criterion": "Distinguish the MHRA risk-monitoring context from efficacy of the selected methylcobalamin intervention and individual medication changes.", "basis": "M03 §3.2.1; detailed population criteria are internally designed; M19 §19.1.2–19.2.4; internal application; Chamgap's own interpretive boundaries. M19 principles are referenced; no official causality assessment tool was applied — An internally developed, item-specific adaptation for Official metformin document. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare the official document's exposure, population and recommendations with the original trial question to distinguish safety context from efficacy claims." }, { "item_id": "N36", "question_type": "Warnings for other chemical forms", "question": "Has the cobalt warning been repurposed as a methylcobalamin event rate?", "needed": "Specified products, chemical forms and scope of sensitivity reactions in official notice S08", "role": "Supplementary; required for extending harms claims", "role_reason": "Needed to avoid transferring warnings for other cobalamins to harm incidence in this trial or individual safety.", "application_exception": "Do not turn a cobalt-sensitivity warning into confirmation that methylcobalamin is risk-free, or that causality or frequency of harm is established.", "criterion": "Preserve the chemical-form and event scope of the warning explicitly naming hydroxocobalamin and cyanocobalamin.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for testing are internally designed; M19 §19.1.2–19.2.4; internal application; Chamgap's own interpretive boundaries. M19 principles are referenced; no official causality assessment tool was applied — An internally developed, item-specific adaptation for Warnings for other chemical forms. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare the notice's specified chemical forms and reactions with the trial formulation and population to assess the scope of the warning's applicability." }, { "item_id": "N37", "question_type": "UL and reused source", "question": "Does the ODS statement that no UL is established mean unlimited safety?", "needed": "Original S09 ODS text, actual content/review history of the excerpt from prior record 110, and long-term/special-population safety data", "role": "Supplementary; required for generalizing safety", "role_reason": "Needed because absence of a UL differs from a guarantee of safety at high doses, over the long term or in all populations.", "application_exception": "Do not present the review date 2026-07-07 from prior record 110 as the actual access date of S09 or the date of reading ODS in this exercise.", "criterion": "Distinguish the inherited UL description and source-material review date from prior record 110 from actual reading in the current exercise.", "basis": "M04 §4.5–4.6 principles for collecting/selecting material; the separation of access from reading and the hyperlink contract are internally designed; M19 §19.1.2–19.2.4; internal application; Chamgap's own interpretive boundaries. M19 principles are referenced; no official causality assessment tool was applied — An internally developed, item-specific adaptation for UL and reused source. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Separately compare the original location of the ODS description, the prior excerpt and long-term/special-population harms data to assess how absence of an upper limit can be interpreted." }, { "item_id": "N38", "question_type": "Dose, persistence and subgroups", "question": "Does this also answer optimal dose, persistence after stopping and effects in people with normal B12?", "needed": "Direct dose comparisons, follow-up after discontinuation and prespecified interaction results for normal-B12 populations/subgroups", "role": "Supplementary; required for the corresponding extended claims", "role_reason": "Needed to avoid extending the main effect to an optimal dose, permanent effect or effects at all B12 levels.", "application_exception": "Do not make every dose, discontinuation or normal-B12 study mandatory for the narrow original question. Do not determine an optimal dose solely from S06's active-dose title.", "criterion": "Distinguish 1000 µg/day for 12 months in the selected low-B12 population from extensions concerning dose, post-discontinuation follow-up and normal B12.", "basis": "M03 §3.2.1–3.2.4; details on dose, duration and effect modification are internally designed; M03 §3.2.1; detailed population criteria are internally designed — An internally developed, item-specific adaptation for Dose, persistence and subgroups. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Define dose, post-discontinuation follow-up and subgroup questions separately, then assess the corresponding direct comparisons and interaction results." }, { "item_id": "N39", "question_type": "Other clinical questions", "question": "Are NRS, replacement of analgesics and clinical events being required for this score question?", "needed": "Interpretive boundaries of the selected question and corresponding direct clinical results if the claim is extended", "role": "Does not apply to the current score question; required for extended claims", "role_reason": "Needed to avoid unconditionally requiring studies of other clinical questions for the narrow score question.", "application_exception": "Does not apply does not mean that other clinical outcomes were verified. Mean pain intensity and replacement of analgesics remain unverified.", "criterion": "Distinguish the selected painDETECT score itself from separate questions about mean pain NRS, replacement of analgesics and clinical events.", "basis": "M03 §3.1, §3.2.1–3.2.4 principles for clarifying the question; detailed separation rules are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations for each question are internally designed; M03 §3.2.4; internally defined boundaries for extending the claim — An internally developed, item-specific adaptation for Other clinical questions. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "When extending the question to mean pain, medication replacement or clinical events, define and assess separate populations, endpoints, comparators and direct results." }, { "item_id": "N40", "question_type": "Actual reading", "question": "Were the stored summary, historical full-text reading and current unread status distinguished?", "needed": "Exact locations in retained summaries, physical material types, historical access, current acquisition/reading and dates", "role": "Required", "role_reason": "Needed to avoid upgrading full-text access recorded in an original citation to full-text reading in this exercise.", "application_exception": "Leave missing report-specific access dates null. Do not infer access dates from the global verified_date.", "criterion": "Separate actual reading of the current stored summary from each material's historical access, lack of original bytes and unattempted access in this exercise.", "basis": "M04 §4.5–4.6 principles for collecting/selecting material; the separation of access from reading and the hyperlink contract are internally designed; M04 §4.5, §4.6.3; limits on the present conversion of material reflect the user-defined scope and internal design — An internally developed, item-specific adaptation for Actual reading. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Record each material's identity, original location, access events and acquisition/reading separately, and distinguish summary links from external links when comparing them." }, { "item_id": "N41", "question_type": "Scope of searches and corrections", "question": "Is the review of 2026-09-16 being read as a current exhaustive search?", "needed": "Historical search scope, list of unverified matters, correction/retraction records and reasons for updates", "role": "Required", "role_reason": "Needed to avoid exaggerating a check of stored materials into a current search of all literature or a guarantee of completeness.", "application_exception": "Do not present the absence of a new search as proof of 0 studies, an effect of 0 or no new corrections.", "criterion": "Distinguish the evidence reference date, the review date for this conversion, the historical search scope and the absence of a new search.", "basis": "M04 §4.5, §4.6.3; limits on the present conversion of material reflect the user-defined scope and internal design; M04 §4.6.3, M15 §15.3.1–15.3.3; the separation of statuses is internally designed — An internally developed, item-specific adaptation for Scope of searches and corrections. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "During an authorized update, compare the historical search scope with the scope of new materials, and link corrections, retractions and unpublished/registered records to original reports." }, { "item_id": "N42", "question_type": "Original verdict and historical calculations", "question": "Have C, 46 and the existing EX/CX been turned into verdicts produced by this new table?", "needed": "Original grade, score, axes, null values, sources of existing calculations and reasons for unverified information", "role": "Required (to preserve the original verdict)", "role_reason": "Needed to avoid automatically carrying the existing assessment over as new table scores, efficacy probabilities or fulfillment of criteria.", "application_exception": "Do not rerun the original calculator or precedents in this exercise. Link the original C, 46, EX, CX and null values only as historical source values.", "criterion": "Preserve the original grade/score, 7 axes, null values and references to existing calculations, distinguishing them from statuses in the unscored evidence-gap table.", "basis": "M03 §3.1, §3.2.1–3.2.4 principles for clarifying the question; detailed separation rules are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations for each question are internally designed; M04 §4.5, §4.6.3; limits on the present conversion of material reflect the user-defined scope and internal design — An internally developed, item-specific adaptation for Original verdict and historical calculations. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Preserve the original assessment inputs, historical calculations and correction records to distinguish original values from new evidence events, and compare before and after an authorized revision." }, { "item_id": "N43", "question_type": "Publication metadata and updates", "question": "Is historical deployment metadata being read as completed publication of this table?", "needed": "Original ID, canonical URL, initial-publication/server metadata and revision policy/history", "role": "Required (for tracking events)", "role_reason": "Needed to avoid using historical metadata statements as evidence of public release in this exercise.", "application_exception": "Do not arbitrarily correct original values such as server_deployed=true, server_write_performed=false and first_published_at=null. For this creation, published is false.", "criterion": "Distinguish events in the existing ID/URL and publication/server metadata from this creation and future website posting.", "basis": "M03 §3.1, §3.2.1–3.2.4 principles for clarifying the question; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits on the present conversion of material reflect the user-defined scope and internal design — An internally developed, item-specific adaptation for Publication metadata and updates. No official methodological tool was applied or certification performed.", "condition_origin": "An individually developed criterion designed after actually reading the current retained content for case 3111. This is neither a blinded exercise nor a new clinical preregistration.", "proposed_research": "Compare receipts for each publication event and actual public-release times with original metadata and revision history, preserving the full before-and-after content under the same ID/URL." } ] }