{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3029-main", "verdict_number": "3029", "title": "Oral Nigella sativa seed oil as adjunctive therapy × Improved DAS28 disease activity and joint symptoms in rheumatoid arthritis", "view_version": "1.0", "view_created_date": "2026-10-23", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-09-08", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Existing stored summary and preserved methodology application records. External papers, abstracts, registration, protocols, SAPs, original result tables and support disclosures are unread, and review of existing content remains incomplete.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "The population is women with rheumatoid arthritis who continued stable antirheumatic medication. Detailed diagnosis, age, baseline DAS28, severity, comorbidities and inclusion/exclusion criteria remain unverified. Applicability to men, osteoarthritis or every disease stage is not assumed.", "intervention": "The question concerns oral adjunctive fixed seed-oil capsules prepared by a manufacturer. Detailed product, batch, content, active-constituent and quality information remains unverified. Seed powder, extracts, topical preparations, purified thymoquinone and combinations are not treated as interchangeable.", "dose": "The original record of 500 mg, 2 times daily, with an original total of 1 g/day is retained. Actual use, adherence, discontinuation and active-constituent exposure remain unverified. No new active-dose conversion, cumulative dose, optimal dose or individual dosing guidance is created.", "comparator": "A comparison adding starch placebo to common antirheumatic treatment is kept distinct from the fixed sequence in which everyone received placebo followed by seed oil. Details of maintained/changed medication, rescue treatment, placebo composition and masking remain unverified.", "endpoint": "The selected question concerns DAS28 disease activity and joint symptoms. Detailed scale components, version, assessor, baseline adjustment, change scores, prospective hierarchy and response or remission criteria remain unverified. Immune, inflammatory and oxidative-stress markers are not converted into independent clinical replications.", "duration": "The original 1–2-month range is retained. R01 used a fixed sequence of placebo for 1 month followed by seed oil for 1 month; the R02 result is after 2 months. Exposure periods and assessment times are not merged into the same comparison, and persistence after discontinuation or long-term effects remains unverified.", "excluded_extensions": [ "The question concerns adjunctive seed oil in women continuing stable DMARD and steroid treatment. It is not extended to established replacement/discontinuation of antirheumatic drugs, prevention of structural damage, cure or other joint diseases.", "The existing C·50 points·Caution, B/P/R1/I1/E+/B2/C0 and evidence date 2026-09-08 are retained. Historical cross-checking wording and assessment do not establish new independent clinical validation or completed review here.", "The R01 record of 40 women and DAS28 4.99±0.72 after placebo versus 4.55±0.82 after oil, P=.017 is retained. Randomized period allocation is not recorded, and these period-specific values are not used to calculate a new concurrent between-group difference, change score or CI.", "The R02 report of between-group DAS28 improvement after 2 months and the absence of an exact adjusted CI are retained within the stored-summary scope. No completion denominator is selected from 39·42·43 people, averaged or pooled, and R01 numbers are not transferred to fill gaps.", "Reports on hs-CRP, TNF, IL-10 and oxidative stress are distinguished as additional reports from the same parallel cohort. Report counts are not converted into totals of unique trials, independent teams or participants; unestablished totals remain unverified.", "Limited funding information for R01 remains separate from Tabriz University support, Barij employee authorship and product preparation for R02. University support, product provision, employment and declared conflicts do not substitute for one another, and no new independence judgment is made here.", "The English-placeholder correction date 2026-09-14 for 2 fields and the original evidence date are retained. Material-specific production-reading records for stored summaries remain distinct from unread external material and unrecorded dates; historical generic verification wording is not promoted into current verification.", "Short-term seed-oil material in women does not certify long-term, rare or vulnerable-group harms or overall safety. Original caution about product differences, pregnancy/breastfeeding, children, liver/kidney disease, surgery and concomitant medicines remains; no new harm rate, causality or contraindication is created." ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which rheumatoid arthritis question is addressed?", "needed": "Adjunctive oral seed oil and DAS28 in women continuing stable antirheumatic medication", "role": "Required", "role_reason": "Material on Adjunctive oral seed oil and DAS28 in women continuing stable antirheumatic medication is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on Adjunctive oral seed oil and DAS28 in women continuing stable antirheumatic medication must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original eligibility, common-treatment and DAS28 endpoint/timepoint tables are needed. Osteoarthritis, drug replacement, prevention of structural damage and cure are excluded. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The selected claim is improvement in DAS28 disease activity and joint symptoms. The original scope of adjunctive use with stable medication, women and 1–2 months is retained.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Detailed matching of original eligibility, background treatment and DAS28 assessment timing is not established in the stored summary. Osteoarthritis, drug replacement, prevention of structural damage and cure are outside this question.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original eligibility, common-treatment and DAS28 endpoint/timepoint tables are needed. Osteoarthritis, drug replacement, prevention of structural damage and cure are excluded." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Are manufacturer-prepared seed-oil capsules distinguished from other formulations?", "needed": "Product, content and preparation information for fixed seed-oil capsules", "role": "Required", "role_reason": "Material on Product, content and preparation information for fixed seed-oil capsules is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on Product, content and preparation information for fixed seed-oil capsules must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original manufacturing, active-constituent, standardization, lot and product-support records are needed. Equivalence to other formulations is not established. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The formulation is fixed seed-oil capsules prepared by a manufacturer. It is not interchanged with powder, extracts, topical oil, purified thymoquinone or combinations.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Detailed manufacturing, constituent, standardization, lot and product-support records are unavailable in the stored material, so product quality or equivalence to other formulations cannot be established.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original manufacturing, active-constituent, standardization, lot and product-support records are needed. Equivalence to other formulations is not established." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What dose, frequency and actual exposure are recorded?", "needed": "500 mg, 2 times daily, with the original total of 1 g/day, and adherence", "role": "Required", "role_reason": "Material on 500 mg, 2 times daily, with the original total of 1 g/day, and adherence is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on 500 mg, 2 times daily, with the original total of 1 g/day, and adherence must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original dosing, adherence, product-content, discontinuation and actual-exposure records are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original dose record is 500 mg, 2 times daily, totaling 1 g/day. It is retained without a new active-dose conversion or recommended dose.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "A nominal dosing record exists, but detailed actual use, adherence, product content and exposure after discontinuation are not established.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original dosing, adherence, product-content, discontinuation and actual-exposure records are needed." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "What is the scope of the female population and baseline disease activity?", "needed": "Rheumatoid arthritis diagnosis, baseline DAS28, treatment and severity in women", "role": "Required", "role_reason": "Material on Rheumatoid arthritis diagnosis, baseline DAS28, treatment and severity in women is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on Rheumatoid arthritis diagnosis, baseline DAS28, treatment and severity in women must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original tables on diagnosis, baseline scores, comorbidities, inclusion/exclusion, age and treatment composition are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The population is women with rheumatoid arthritis continuing stable antirheumatic medication. It is not extended to men, every severity level or other joint diseases.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Original tables on diagnosis, baseline scores, comorbidities, age, inclusion/exclusion and treatment composition are missing, limiting detailed applicability.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original tables on diagnosis, baseline scores, comorbidities, inclusion/exclusion, age and treatment composition are needed." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Are maintained DMARD/steroid treatment and drug replacement distinguished?", "needed": "Medication types, doses, changes and common management in each arm", "role": "Required", "role_reason": "Material on Medication types, doses, changes and common management in each arm is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on Medication types, doses, changes and common management in each arm must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original records of medication, maintained/changed doses, adherence, rescue medication and additional treatment are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The stored summary states that seed oil was added while existing DMARD and steroid treatment was maintained. This was not a replacement trial.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "The statement that treatment was maintained does not establish the actual medication types, doses, changes, adherence or rescue treatment in each arm.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original records of medication, maintained/changed doses, adherence, rescue medication and additional treatment are needed." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Are the 1–2-month range and the study-specific sequences distinguished?", "needed": "Report-specific placebo/oil exposure and DAS28 assessment times", "role": "Required", "role_reason": "Material on Report-specific placebo/oil exposure and DAS28 assessment times is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on Report-specific placebo/oil exposure and DAS28 assessment times must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original report-specific assessment schedules, timing, exposure and discontinuation records are needed. Long-term or persistent effects remain unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original duration is 1–2 months with no long-term follow-up. R01 gave everyone placebo for 1 month followed by oil for 1 month; the R02 result is after 2 months. These are not merged into the same time comparison.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Original exposure, discontinuation and assessment schedules are missing, so detailed timing, long-term effects and persistence after discontinuation cannot be established.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original report-specific assessment schedules, timing, exposure and discontinuation records are needed. Long-term or persistent effects remain unverified." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Are starch placebo and the fixed-sequence control the same comparison?", "needed": "The parallel placebo comparison versus the within-period placebo/oil comparison", "role": "Required", "role_reason": "Material on The parallel placebo comparison versus the within-period placebo/oil comparison is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on The parallel placebo comparison versus the within-period placebo/oil comparison must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original placebo-composition, management, period-comparison, masking and similarity records are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original facets describe adjunctive starch placebo, while R01 gave placebo followed by oil to everyone. These designs are not both presented as concurrent parallel controls.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Original placebo composition, management, period comparisons, masking and similarity records are missing, so control conditions cannot be treated as equivalent.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original placebo-composition, management, period-comparison, masking and similarity records are needed." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Is each report’s design retained separately?", "needed": "The 2012 fixed sequence and the 2016 randomized parallel trial linked to reports and families", "role": "Required", "role_reason": "Material on The 2012 fixed sequence and the 2016 randomized parallel trial linked to reports and families is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on The 2012 fixed sequence and the 2016 randomized parallel trial linked to reports and families must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Methods, registration, samples/institutions and links to additional reports are needed. Both reports do not certify a count of unique independent trials. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "R01 is the Gheita/Kenawy fixed-sequence report; R02 is the Kheirouri et al. randomized double-blind parallel placebo trial. Each is retained as an original record.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Detailed methods, registration, samples, institutions and additional-report links are missing, so report counts cannot establish a total of unique independent trials.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Methods, registration, samples/institutions and links to additional reports are needed. Both reports do not certify a count of unique independent trials." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Is randomized period allocation avoided for the fixed sequence?", "needed": "The fixed placebo→oil sequence, period allocation and time effects", "role": "Required", "role_reason": "Material on The fixed placebo→oil sequence, period allocation and time effects is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on The fixed placebo→oil sequence, period allocation and time effects must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original timing/sequence, treatment changes, stability and time-course records are needed. No effect separating time/order influences is newly calculated. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "R01 gave placebo for 1 month followed by oil for 1 month to everyone; its original qualification is “No randomized period order”. It is not changed into a randomized crossover or randomized period sequence.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Original period, sequence, treatment-change, stability and course records are missing, preventing separation of time or order effects. No new comparative effect is calculated.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original timing/sequence, treatment changes, stability and time-course records are needed. No effect separating time/order influences is newly calculated." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "What denominator does the R01 record of 40 people represent?", "needed": "Enrollment, analysis, completion and timepoint denominators for the 40 women", "role": "Required", "role_reason": "Material on Enrollment, analysis, completion and timepoint denominators for the 40 women is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on Enrollment, analysis, completion and timepoint denominators for the 40 women must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original flow, measurements in each period, attrition and analysis denominators are needed. No additional participant total is calculated. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "R01 records 40 women. This is not changed into 40 randomized people or 40 in each arm. The generic English randomized/analysis-denominator wording is retained historically.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Original flow, period-specific measurements, attrition and analysis denominators are missing, so the stage represented by the participant record is unresolved. Participants are not pooled with other reports.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original flow, measurements in each period, attrition and analysis denominators are needed. No additional participant total is calculated." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "What DAS28 values are recorded for R01?", "needed": "Original post-placebo and post-oil values, dispersion and P value", "role": "Required", "role_reason": "Material on Original post-placebo and post-oil values, dispersion and P value is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on Original post-placebo and post-oil values, dispersion and P value must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original result tables linking arms/periods, dispersion, baseline/change values, tests and denominators are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The result record is DAS28 4.99±0.72 after placebo versus 4.55±0.82 after oil, P=.017. Order and assessment timing are retained; no new difference or CI is calculated.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "The stored summary does not establish detailed arm/period matching, dispersion, baseline/change values, tests or denominators from the original result tables.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original result tables linking arms/periods, dispersion, baseline/change values, tests and denominators are needed." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Are R01 P/± notation and an exact effect interval distinguished?", "needed": "The original test, dispersion definition, effect of interest and CI", "role": "Required", "role_reason": "Material on The original test, dispersion definition, effect of interest and CI is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on The original test, dispersion definition, effect of interest and CI must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original test/variance, within-period correlation, estimand and CI records are needed. The ± notation is not arbitrarily labeled as a CI or SE. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "P=.017 and the ± notation are original records. They are not converted into an adjusted concurrent between-group comparison, a CI or an independently replicated effect.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Records establishing the test, dispersion definition, within-period correlation, estimand and interval are missing. The ± notation cannot be assigned to a CI or SE.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original test/variance, within-period correlation, estimand and CI records are needed. The ± notation is not arbitrarily labeled as a CI or SE." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "How much is known about allocation and masking in the parallel trial?", "needed": "R02 sequence generation, concealment and participant/assessor masking", "role": "Required", "role_reason": "Material on R02 sequence generation, concealment and participant/assessor masking is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on R02 sequence generation, concealment and participant/assessor masking must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original methods, masking, assessor, registration/plan and control-composition records are needed. No new official RoB2/GRADE assessment is created. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "R02 is recorded as a randomized double-blind parallel placebo trial. The original rationale also leaves masking concerns unresolved. Methodological adequacy or successful masking is not newly judged here.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Methods, masking, assessor, control-composition and registration/plan records are missing, limiting assessment of adequacy. No official RoB2/GRADE assessment was performed here.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original methods, masking, assessor, registration/plan and control-composition records are needed. No new official RoB2/GRADE assessment is created." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Are conflicting completion denominators of 39·42·43 retained?", "needed": "Report-specific allocation, completion and analysis matching within the parallel cohort", "role": "Required", "role_reason": "Material on Report-specific allocation, completion and analysis matching within the parallel cohort is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on Report-specific allocation, completion and analysis matching within the parallel cohort must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Each report’s original flow, arm counts, endpoint/measurement/exclusion/additional-analysis details and participant matching are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "R02 records inconsistent report-specific completion denominators of 39·42·43 people. No value is selected as correct, averaged or pooled.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "The stored summary does not resolve report-specific flow, arm counts, measurements, exclusions, additional analyses or matching of the same participants.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Each report’s original flow, arm counts, endpoint/measurement/exclusion/additional-analysis details and participant matching are needed." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "What is the scope of the R02 DAS28 result after 2 months?", "needed": "Parallel between-group estimates, adjusted CI, P value and denominators", "role": "Required", "role_reason": "Material on Parallel between-group estimates, adjusted CI, P value and denominators is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on Parallel between-group estimates, adjusted CI, P value and denominators must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original DAS28 overall/adjusted analyses, baseline/change values, models, P/CI and denominators are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The record reports between-group DAS28 improvement after 2 months, with no exact adjusted CI in the summary. No specific effect or P value is invented, and R01 numbers are not copied into it.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Original DAS28 tables, baseline/change values, adjustment model, tests, intervals and denominators are missing, limiting the exact comparative effect and its precision.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original DAS28 overall/adjusted analyses, baseline/change values, models, P/CI and denominators are needed." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "What remains unknown about completion, analysis sets and missing data?", "needed": "Report/timepoint-specific missingness, attrition, analysis exclusions and handling", "role": "Required", "role_reason": "Material on Report/timepoint-specific missingness, attrition, analysis exclusions and handling is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on Report/timepoint-specific missingness, attrition, analysis exclusions and handling must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original arm-specific flow, missingness/exclusion reasons, analysis plans and sensitivity analyses are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "R02 completion-denominator inconsistencies and the scope of the R01 participant record remain unresolved. Detailed missingness, attrition and ITT/completer analysis definitions are unverified here.", "condition_status": "Unverified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Arm-specific flow, reasons for missing data/exclusions, analysis plans and sensitivity analyses are missing, preventing separation of their effects on analysis sets.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original arm-specific flow, missingness/exclusion reasons, analysis plans and sensitivity analyses are needed." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Are inflammatory-marker papers excluded from independent clinical replication counts?", "needed": "Clinical DAS28 reports versus hs-CRP/TNF/IL-10/oxidative-stress papers from the same cohort", "role": "Required", "role_reason": "Material on Clinical DAS28 reports versus hs-CRP/TNF/IL-10/oxidative-stress papers from the same cohort is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on Clinical DAS28 reports versus hs-CRP/TNF/IL-10/oxidative-stress papers from the same cohort must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Report-specific participant, institution/period, endpoint and denominator links are needed. Values, citations or trial counts for unidentified papers are not invented. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original summary and rationale state that inflammatory-marker papers from the same people are not independent DAS28 replications. Biomarker reports are not added as new original trials.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Report-specific matching of participants, institutions, periods, endpoints and denominators is missing, so additional-paper identity and independence remain unestablished. Unidentified citations, values or trial counts are not invented.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report-specific participant, institution/period, endpoint and denominator links are needed. Values, citations or trial counts for unidentified papers are not invented." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Are the immune-marker title and the selected DAS28 endpoint distinguished?", "needed": "R02 T-lymphocyte/immune-marker reporting and the hierarchy of DAS28 outcomes", "role": "Required", "role_reason": "Material on R02 T-lymphocyte/immune-marker reporting and the hierarchy of DAS28 outcomes is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on R02 T-lymphocyte/immune-marker reporting and the hierarchy of DAS28 outcomes must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original protocols, registration, complete results and endpoint/timepoint/denominator links are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The R02 title concerns immunomodulation/T lymphocytes; the recorded endpoint is DAS28, with immune markers in the 2nd tier. The title does not establish prospective endpoint hierarchy or change the clinical effect.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Protocol, registration, complete result tables and endpoint/timepoint/denominator matching are missing; the title cannot establish prospective hierarchy or the role of the selected result.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original protocols, registration, complete results and endpoint/timepoint/denominator links are needed." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Are unique-trial, independent-team and participant totals established?", "needed": "Trial families, shared cohorts, institutions, teams and additional-report links", "role": "Required", "role_reason": "Material on Trial families, shared cohorts, institutions, teams and additional-report links is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on Trial families, shared cohorts, institutions, teams and additional-report links must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original trial/report maps, samples, registration, authors and funding records are needed. Final unique-trial and participant totals remain null. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Both structured reports remain distinct from additional papers from the parallel cohort. Original R1/I1 axes are retained without certifying independent replication or a participant total here.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Links among original trials, additional reports, samples, registration, authors and funding are missing, so established totals of unique studies and participants cannot be produced.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original trial/report maps, samples, registration, authors and funding records are needed. Final unique-trial and participant totals remain null." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "What DAS28 measurement, components and analysis timing were used?", "needed": "Original DAS28 definition, assessors, measurement components and baseline/change values", "role": "Required", "role_reason": "Material on Original DAS28 definition, assessors, measurement components and baseline/change values is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on Original DAS28 definition, assessors, measurement components and baseline/change values must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original scale versions, assessment/examination details, assessor masking, timing and analysis models are needed. No new component results are created. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original principal endpoint is DAS28 and the claim concerns improved joint symptoms. Detailed measurement/components, baseline adjustment and denominators are absent from the stored summary.", "condition_status": "Unverified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Detailed scale version, examinations, assessor masking, timing and models are missing, limiting the definition of measurement and analysis.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original scale versions, assessment/examination details, assessor masking, timing and analysis models are needed. No new component results are created." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Are joint symptoms distinguished from DAS28 and mechanistic endpoints?", "needed": "Symptom-specific results, denominators and times versus the selected DAS28 endpoint", "role": "Supplementary", "role_reason": "Material on Symptom-specific results, denominators and times versus the selected DAS28 endpoint is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on Symptom-specific results, denominators and times versus the selected DAS28 endpoint must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original joint/symptom-scale results, prospective hierarchy and denominators are needed. DAS28 values are not copied into every pain or functional outcome. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original claim concerns DAS28 disease activity and joint symptoms. Structured numerical results concern R01 DAS28; separate joint-symptom values are not detailed.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Joint-specific and symptom-specific results, hierarchy and denominators are not detailed, so DAS28 cannot substitute for every pain or functional outcome.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original joint/symptom-scale results, prospective hierarchy and denominators are needed. DAS28 values are not copied into every pain or functional outcome." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Were registration and prospective endpoint/timepoint plans verified?", "needed": "Original registration, protocol/SAP and amendment history", "role": "Required", "role_reason": "Material on Original registration, protocol/SAP and amendment history is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on Original registration, protocol/SAP and amendment history must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original registration, plans, all endpoints/timepoints and multiplicity information are needed. No new external registration search is performed here. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Both original registration fields state that confirmation was not obtained. A design label or favorable direction is not converted into verified registration or prospective hierarchy.", "condition_status": "Unverified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Original registration, plans, complete endpoints/timepoints and multiplicity material were not read, so registration status or agreement with prospective plans cannot be established.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original registration, plans, all endpoints/timepoints and multiplicity information are needed. No new external registration search is performed here." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Are favorable directions kept separate from an identical comparative effect?", "needed": "The differing estimands of the fixed-sequence and parallel designs", "role": "Supplementary", "role_reason": "Material on The differing estimands of the fixed-sequence and parallel designs is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on The differing estimands of the fixed-sequence and parallel designs must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Direct matching of original designs, models, CI, denominators and samples is needed. No pooled effect or replication total is newly calculated. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original counterview records favorable DAS28 directions in both designs. R01 period comparisons and R02 concurrent between-group comparisons are not pooled as the same values or estimand.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Original designs, models, intervals, denominators and samples are not directly matched, so differing comparisons cannot be interpreted as the same pooled effect or replication count.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct matching of original designs, models, CI, denominators and samples is needed. No pooled effect or replication total is newly calculated." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are importance thresholds, responder rates and remission rates known?", "needed": "Prospective importance thresholds, response/remission definitions, arm denominators and CI", "role": "Supplementary", "role_reason": "Material on Prospective importance thresholds, response/remission definitions, arm denominators and CI is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on Prospective importance thresholds, response/remission definitions, arm denominators and CI must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original criteria, response/remission results, denominators and intervals are needed. A DAS28 mean is not converted into a treatment-success rate. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original rationale records a favorable clinical-scale signal. Response/remission rates and prospective importance thresholds are absent from the structured summary.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Prospective criteria, response/remission results, denominators and intervals are missing, so a DAS28 mean cannot be interpreted as a treatment-success rate.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original criteria, response/remission results, denominators and intervals are needed. A DAS28 mean is not converted into a treatment-success rate." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Are long-term effects, structural damage, drug replacement and cure separate questions?", "needed": "Direct evidence on long follow-up, structural damage, drug replacement/discontinuation and cure", "role": "Supplementary", "role_reason": "Material on Direct evidence on long follow-up, structural damage, drug replacement/discontinuation and cure is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on Direct evidence on long follow-up, structural damage, drug replacement/discontinuation and cure must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Direct long-follow-up, structural/clinical-event and drug-replacement material is needed. Short-term DAS28 is not extended to these effects. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original duration record states that there was no long-term follow-up. The excluded claims of antirheumatic-drug replacement, prevention of structural damage and cure were not tested.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Direct long-term, structural/clinical-event and drug-replacement material is missing, so short-term DAS28 results cannot establish those effects.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct long-follow-up, structural/clinical-event and drug-replacement material is needed. Short-term DAS28 is not extended to these effects." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Are the four company-involvement routes distinguished for each report?", "needed": "Report-specific funding, product support, employee authorship and conflict disclosures", "role": "Required", "role_reason": "Material on Report-specific funding, product support, employee authorship and conflict disclosures is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on Report-specific funding, product support, employee authorship and conflict disclosures must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original support, product provision/preparation, affiliations and conflict disclosures are needed. University support, manufacturing and employment do not substitute for one another, and unrecorded involvement is not added. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "R01 funding information is limited. R02 records Tabriz University support, Barij employee authorship and product preparation. The original rationale states that employee authorship and product support limit independence.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Original funding, provision/preparation, affiliation and conflict disclosures are missing, limiting verification of each involvement route. One route does not substitute for another.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original support, product provision/preparation, affiliations and conflict disclosures are needed. University support, manufacturing and employment do not substitute for one another, and unrecorded involvement is not added." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Are historical independence assessments distinguished from current uncertainty?", "needed": "The original I1/rationale and the present preserved-material scope", "role": "Supplementary", "role_reason": "Material on The original I1/rationale and the present preserved-material scope is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on The original I1/rationale and the present preserved-material scope must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original funding, author, product-contract and trial-family links are needed. No new score or count of independent teams is created here. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original I1 axis and company-involvement rationale are retained. Generic historical English funding wording does not verify every disclosure route or create a new independence judgment.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Original funding, author, product-contract and trial-family links are missing, so historical independence wording cannot establish current verification or an independent-team count.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original funding, author, product-contract and trial-family links are needed. No new score or count of independent teams is created here." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Are harm-collection methods, events and discontinuations known?", "needed": "Adverse-event definitions, active/passive collection, discontinuations and severity", "role": "Supplementary", "role_reason": "Material on Adverse-event definitions, active/passive collection, discontinuations and severity is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on Adverse-event definitions, active/passive collection, discontinuations and severity must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original harm methods, events/discontinuations, missingness and arm-specific records are needed. Unread material is not converted into no harm. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "General safety cautions and limits of small trials for rare/long-term harms are retained. Specific event tables and collection methods are absent from the summary.", "condition_status": "Unverified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Arm-specific harm-collection, event, discontinuation and missing-data details are unavailable, so the type and extent of observed events remain unverified. Unread material does not establish absence of harm.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original harm methods, events/discontinuations, missingness and arm-specific records are needed. Unread material is not converted into no harm." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "What harm denominators, exposure and controls were used?", "needed": "Report/period-specific safety sets, actual dosing, events and controls", "role": "Supplementary", "role_reason": "Material on Report/period-specific safety sets, actual dosing, events and controls is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on Report/period-specific safety sets, actual dosing, events and controls must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original safety denominators, event counts, exposure/discontinuation, control groups/periods and participant matching are needed. No incidence rate is calculated. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The R01 record of 40 women and the R02 denominators of 39·42·43 do not establish safety denominators. The designs also differ in timing and controls.", "condition_status": "Unverified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Safety sets, event counts, exposure/discontinuation, control periods and participant matching are missing, so harm denominators and incidence rates cannot be established.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original safety denominators, event counts, exposure/discontinuation, control groups/periods and participant matching are needed. No incidence rate is calculated." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Are DMARDs, steroids and alternative causes distinguished?", "needed": "Concomitant medicines, underlying disease, event timing, changes and course", "role": "Supplementary", "role_reason": "Material on Concomitant medicines, underlying disease, event timing, changes and course is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on Concomitant medicines, underlying disease, event timing, changes and course must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Medication, dose, changes, underlying disease, timing/controls, course after discontinuation and alternative-cause records are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Background treatment maintained DMARDs/steroids, and the original caution includes consultation about concomitant immune-modifying medicines. This does not establish event-specific interaction or causality.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Medication, dose, changes, underlying disease, timing, controls and course after discontinuation are not detailed, so alternative causes or concomitant contributions remain unestablished.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Medication, dose, changes, underlying disease, timing/controls, course after discontinuation and alternative-cause records are needed." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Were long-term, rare and vulnerable-population harms verified?", "needed": "Independent harm reports, long exposure, vulnerable populations and denominators", "role": "Supplementary", "role_reason": "Material on Independent harm reports, long exposure, vulnerable populations and denominators is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on Independent harm reports, long exposure, vulnerable populations and denominators must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Long follow-up, vulnerable-population material, independent reports and exposure/denominators are needed. No new harm search or assessment is performed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Original cautions concern pregnancy/breastfeeding, children, liver/kidney disease, surgery and concomitant medicines, alongside the harm limits of small trials. Safety is not certified from 1–2 months.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Long follow-up, vulnerable-population material, independent reports and exposure denominators are missing, limiting rare/delayed harms and population-specific safety.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Long follow-up, vulnerable-population material, independent reports and exposure/denominators are needed. No new harm search or assessment is performed." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "Are stored-summary reading and external original-paper links distinguished?", "needed": "Access records for both stored reports, abstracts, full text, registration and protocols/SAPs", "role": "Required", "role_reason": "Material on Access records for both stored reports, abstracts, full text, registration and protocols/SAPs is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on Access records for both stored reports, abstracts, full text, registration and protocols/SAPs must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: External material remains unread pending material provision and content review. URL existence does not establish reading, accessibility or fulfilled conditions. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The complete stored JSON was read for preparation. Both PubMed URLs are original citation links. External abstracts, full text, registration and protocols/SAPs were not read in this work.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Detailed external material was not read and successful access was not verified. A link cannot establish full-text reading, accessibility or fulfilled conditions.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "External material remains unread pending material provision and content review. URL existence does not establish reading, accessibility or fulfilled conditions." }, { "item_id": "N33", "question_type": "Evidence condition", "question": "Are generic English wording, actual design and the correction history retained?", "needed": "Original Korean/English records, generic evidence-table wording and limits of the 2026-09-14 correction", "role": "Supplementary", "role_reason": "Material on Original Korean/English records, generic evidence-table wording and limits of the 2026-09-14 correction is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on Original Korean/English records, generic evidence-table wording and limits of the 2026-09-14 correction must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: External English text and historical correction targets remain uncompared here. Past verification wording is not presented as new content verification. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The R01 design is fixed-sequence, while the original English participant field contains generic randomized/denominator wording. Both original forms and the correction record for 2 English placeholder fields are retained. Generic wording does not alter the actual design.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "External English text and the historical correction targets were not directly compared here. Historical generic verification wording does not establish completed current content verification.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "External English text and historical correction targets remain uncompared here. Past verification wording is not presented as new content verification." }, { "item_id": "N34", "question_type": "Evidence condition", "question": "Are original grade, axes, evidence date and preparation kept separate?", "needed": "Preservation of C50, Caution, axes, evidence date and correction history", "role": "Required", "role_reason": "Material on Preservation of C50, Caution, axes, evidence date and correction history is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.", "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.", "criterion": "Original records on Preservation of C50, Caution, axes, evidence date and correction history must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.", "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: New evidence, condition revisions and verdict changes are separate events following content review. The original evidence date is not changed into a current search or external-reading date. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and citations for both reports read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original C/50/Caution, axes and evidence date 2026-09-08 are retained. Preparation does not establish a new efficacy grade, independent certification or official-method certification.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Reader-material preparation does not replace review of new evidence, condition revisions or verdict changes. The original evidence date cannot be converted into a current search or external-reading date.", "uncertainty": "Gaps in product details, background treatment, period order, scale, report-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable directions are not converted into the same comparative effect, independent replication, cure or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "New evidence, condition revisions and verdict changes are separate events following content review. The original evidence date is not changed into a current search or external-reading date." } ], "reports": [ { "report_id": "R01", "title": "Gheita and Kenawy 2012 · Fixed-sequence seed-oil report", "url": "https://pubmed.ncbi.nlm.nih.gov/22162258/", "report_type": "Fixed sequence: placebo for 1 month followed by seed oil for 1 month in everyone", "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Stored existing review summary read; external material unread", "study_family": "Distinguishes the fixed-sequence report, the parallel-cohort report and mechanistic papers from the same cohort; the 39·42·43 discrepancy remains unresolved, without certifying trial/participant totals or independent replication.", "independent_replication": "Reports remain distinct from unique trials, independent teams and participant totals; these are not certified here", "observed_result": "DAS28 4.99±0.72 after placebo versus 4.55±0.82 after oil, P=.017", "result_level": "The original record is 40 women. Period-specific measurement, completion, analysis and harm denominators and the meaning of ± remain unverified. This is not converted into randomized period order or a concurrent parallel control.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete existing review summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-06T12:39:42.858088+09:00", "qualification": "PMID22162258; DOI10.1002/ptr.3679 are retained. External abstracts, full text, registration, protocols and analysis plans are unread. Registration identifiers and PMCID are unrecorded in the preserved material, and funding information remains limited. Material dates for stored summaries are historical production-reading records, not current external-reading dates. Unrecorded dates for external material remain unrecorded." }, { "material_type": "External abstract", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "PMID22162258; DOI10.1002/ptr.3679 are retained. External abstracts, full text, registration, protocols and analysis plans are unread. Registration identifiers and PMCID are unrecorded in the preserved material, and funding information remains limited. Material dates for stored summaries are historical production-reading records, not current external-reading dates. Unrecorded dates for external material remain unrecorded." }, { "material_type": "External full text", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "PMID22162258; DOI10.1002/ptr.3679 are retained. External abstracts, full text, registration, protocols and analysis plans are unread. Registration identifiers and PMCID are unrecorded in the preserved material, and funding information remains limited. Material dates for stored summaries are historical production-reading records, not current external-reading dates. Unrecorded dates for external material remain unrecorded." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "PMID22162258; DOI10.1002/ptr.3679 are retained. External abstracts, full text, registration, protocols and analysis plans are unread. Registration identifiers and PMCID are unrecorded in the preserved material, and funding information remains limited. Material dates for stored summaries are historical production-reading records, not current external-reading dates. Unrecorded dates for external material remain unrecorded." }, { "material_type": "Protocol and analysis plan", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "PMID22162258; DOI10.1002/ptr.3679 are retained. External abstracts, full text, registration, protocols and analysis plans are unread. Registration identifiers and PMCID are unrecorded in the preserved material, and funding information remains limited. Material dates for stored summaries are historical production-reading records, not current external-reading dates. Unrecorded dates for external material remain unrecorded." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/22162258/" } ] }, { "report_id": "R02", "title": "Kheirouri et al. 2016 · DAS28 and immune-marker report from the parallel cohort", "url": "https://pubmed.ncbi.nlm.nih.gov/27100726/", "report_type": "Original record of a randomized double-blind parallel placebo-controlled trial", "existence": "The information is recorded in stored seed-oil reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Stored existing review summary read; external material unread", "study_family": "Distinguishes the fixed-sequence report, the parallel-cohort report and mechanistic papers from the same cohort; the 39·42·43 discrepancy remains unresolved, without certifying trial/participant totals or independent replication.", "independent_replication": "Reports remain distinct from unique trials, independent teams and participant totals; these are not certified here", "observed_result": "Between-group DAS28 improvement reported after 2 months; exact adjusted CI not reported in the stored summary", "result_level": "Conflicting report-specific completion denominators of 39·42·43 people are retained. Detailed matching of enrollment, allocation, arm-specific analysis, missing data and safety denominators remains unverified.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete existing review summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-06T12:39:42.858088+09:00", "qualification": "PMID27100726; DOI10.3109/08820139.2016.1153649 are retained. External abstracts, full text, registration, protocols and analysis plans are unread. Tabriz University support remains separate from Barij employee authorship and product preparation. Material dates for stored summaries are historical production-reading records, not current external-reading dates. Unrecorded dates for external material remain unrecorded." }, { "material_type": "External abstract", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "PMID27100726; DOI10.3109/08820139.2016.1153649 are retained. External abstracts, full text, registration, protocols and analysis plans are unread. Tabriz University support remains separate from Barij employee authorship and product preparation. Material dates for stored summaries are historical production-reading records, not current external-reading dates. Unrecorded dates for external material remain unrecorded." }, { "material_type": "External full text", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "PMID27100726; DOI10.3109/08820139.2016.1153649 are retained. External abstracts, full text, registration, protocols and analysis plans are unread. Tabriz University support remains separate from Barij employee authorship and product preparation. Material dates for stored summaries are historical production-reading records, not current external-reading dates. Unrecorded dates for external material remain unrecorded." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "PMID27100726; DOI10.3109/08820139.2016.1153649 are retained. External abstracts, full text, registration, protocols and analysis plans are unread. Tabriz University support remains separate from Barij employee authorship and product preparation. Material dates for stored summaries are historical production-reading records, not current external-reading dates. Unrecorded dates for external material remain unrecorded." }, { "material_type": "Protocol and analysis plan", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "PMID27100726; DOI10.3109/08820139.2016.1153649 are retained. External abstracts, full text, registration, protocols and analysis plans are unread. Tabriz University support remains separate from Barij employee authorship and product preparation. Material dates for stored summaries are historical production-reading records, not current external-reading dates. Unrecorded dates for external material remain unrecorded." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/27100726/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "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 studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "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": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "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": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "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 rates.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." } ], "status_dictionary": { "Partly verified": "Partial information from the stored summary is linked; detailed originals and content review remain incomplete.", "Unverified": "Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety.", "Review incomplete": "Review of existing content remains incomplete.", "Met": "This state is used only within the relevant conditions after material verification and content review. It was not automatically assigned in this work.", "Not reported": "Unreported within material actually read. Unread external material is not relabeled as unreported.", "Inaccessible": "This means actual access failure. External access was not attempted in this work, so this state was not assigned.", "Not applicable": "Used only with an application exception and reason based on the question scope.", "Conflicting data": "This requires actual comparison of materials; no new conflict judgment was made in this work.", "Insufficient evidence for the conditions": "This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "The existing linkage distinguishes the fixed-sequence report, the parallel-cohort report and additional mechanistic papers from the same cohort. Detailed family identity and established totals of unique trials, participants or independent replications remain unverified. Report counts and differing completion denominators are not pooled." }, "history": [ { "date": "2026-10-23", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 34 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-23" }