{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3033-main", "verdict_number": "3033", "title": "Oral Nigella sativa seed capsules × Increased complete clearance or expulsion of adult kidney stones", "view_version": "1.0", "view_created_date": "2026-10-24", "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": "The date 2026-09-08 in material items is the original evidence date, not a date of external reading in this work. The date 2026-10-06 is the original production date. Original review and verification dates are unrecorded; production timestamps are not presented as completed-content-review dates." }, "claim_context": { "population": "The population is adults with kidney stones. Age ranges, diagnostic and eligibility criteria, stone characteristics, baseline kidney function and inclusion/exclusion of obstruction or infection remain unverified. Applicability to every stone size, composition and location is not assumed.", "intervention": "The intervention is oral Nigella sativa L. ground-seed capsules containing 500 mg. Cultivar, manufacture, excipients, constituent quantification and batch quality remain unverified. Fixed oil, aqueous extracts, topical preparations, purified thymoquinone and combinations are not treated as interchangeable.", "dose": "The retained dose is 500 mg, 2 times daily. Actual use, adherence, constituent content, administration times, missed doses and adjustments remain unverified. No new daily total, cumulative dose or optimal dose is calculated or converted into personal dosing instructions.", "comparator": "The record describes comparison with matched placebo. Placebo composition and appearance, matching administration procedures, hydration and diet, concomitant drugs, standard management and additional procedures remain unverified.", "endpoint": "The endpoint selected in the retained verdict is complete disappearance of stones on ultrasound. Direct confirmation of expulsion, the correspondence of imaging disappearance with passage or dissolution, and prospective endpoint hierarchy remain unverified. It is not substituted for size reduction, symptoms, kidney function or avoidance of procedures.", "duration": "The original record describes 10 weeks of treatment and ultrasound follow-up. Interim visits, exact clearance-assessment timing, whether events were cumulative, follow-up after discontinuation and subsequent recurrence remain unverified. Long-term effects or safety are not established.", "excluded_extensions": [ "The selected question concerns complete ultrasound disappearance in a comparison of oral ground-seed capsules and matched placebo in adults with kidney stones. It is not extended to actual expulsion, size reduction, chemical dissolution, other formulations, success rates for every stone or replacement of standard care.", "The existing C·56 points·Caution and B/H/R1/I2/E+/B2/C0 are retained. Historical independent Codex cross-check wording does not establish completed content review or new certification of efficacy, safety or independent replication here.", "The original record of 60 randomized participants remains distinct from approximately 27 versus 26 in percentage-based analysis groups. Arm-specific randomized counts, original analysis and completion denominators, withdrawals and missing-data handling remain unverified. No new total, denominator reconstruction, ITT/PP set or harm denominator is created.", "The reported complete-disappearance percentages are 44.4% versus 15.3%. The historical Codex reconstruction of 12/27 versus 4/26, RD 29.1 percentage points and RR 2.89 (95% CI 1.07 to 7.82) is retained as an existing record. The accuracy of approximate denominators and counts remains unverified; they are not presented as adjusted paper estimates or new calculations in this work.", "A stone no longer visible on ultrasound remains distinct from confirmed expulsion, size reduction and chemical dissolution. Gaps in imaging equipment, assessment, masking, detection limits, analysis units, spontaneous passage and hydration conditions remain.", "The original description as a randomized, triple-blind, placebo trial is retained. It does not establish verified details of sequence generation, concealment, baseline balance, role-specific masking, registration or prospective analysis hierarchy.", "The original record of support from Mashhad University is retained. Product provision, author roles, conflicts and support roles remain unverified. General cautionary wording is not converted into actual adverse-event counts, interactions, contraindications, overall safety or new certification of independence.", "PMID30873671, DOI10.1002/ptr.6331, the 2019 bibliography, the original evidence date 2026-09-08 and the correction date 2026-09-14 for 1 English-placeholder field are retained. The date 2026-10-06 is the original production date. Unconfirmed registration identifiers are not interpreted as nonregistration, and identifiers or historical generic descriptions are not promoted to current external reading." ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which black-seed preparation and stone question are selected?", "needed": "Adult kidney stones, ground-seed capsules, placebo, 10 weeks and complete ultrasound disappearance", "role": "Required", "role_reason": "Material on Adult kidney stones, ground-seed capsules, placebo, 10 weeks and complete ultrasound disappearance is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Adult kidney stones, ground-seed capsules, placebo, 10 weeks and complete ultrasound disappearance must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original trial question, endpoint definitions and eligibility criteria This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The original effect description concerns increased complete clearance or expulsion of adult kidney stones; the selected endpoint is complete disappearance on ultrasound.", "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": "Definitions and correspondence of disappearance and expulsion, and the separate question boundary, still require existing-content review. No separate additional claims are recorded.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original trial question, endpoint definitions and eligibility criteria" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "What seed formulation is the 500 mg capsule?", "needed": "Nigella sativa L. seeds, ground-seed 500 mg capsules, composition and quality", "role": "Required", "role_reason": "Material on Nigella sativa L. seeds, ground-seed 500 mg capsules, composition and quality is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Nigella sativa L. seeds, ground-seed 500 mg capsules, composition and quality must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Product composition, raw-material/batch analyses, manufacture and quality material This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The retained intervention description specifies Nigella sativa L. seeds and ground-seed 500 mg capsules.", "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": "Cultivar and raw-material confirmation, manufacture and excipients, constituent quantification and batch quality remain unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Product composition, raw-material/batch analyses, manufacture and quality material" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Are seeds, fixed oil, extracts and thymoquinone the same intervention?", "needed": "Distinguish the original formulation from fixed oil, aqueous extracts, topical preparations, purified constituents and combinations", "role": "Required", "role_reason": "Material on Distinguish the original formulation from fixed oil, aqueous extracts, topical preparations, purified constituents and combinations is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Distinguish the original formulation from fixed oil, aqueous extracts, topical preparations, purified constituents and combinations must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Formulation-specific composition and original trials directly addressing the same question This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The original product description states that seed powder, fixed oil, aqueous extracts, ethanolic topical preparations, purified thymoquinone and combinations are not interchangeable.", "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 stone-clearance effects and constituent equivalence for other formulations or products remain unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Formulation-specific composition and original trials directly addressing the same question" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "What was the actual exposure to 500 mg, 2 times daily?", "needed": "Dose per 1 administration, frequency, use records, constituent quantification and adherence", "role": "Required", "role_reason": "Material on Dose per 1 administration, frequency, use records, constituent quantification and adherence is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Dose per 1 administration, frequency, use records, constituent quantification and adherence must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Administration procedures, product content and use diaries This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The original dose is 500 mg, 2 times daily.", "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": "Constituent content, actual use, adherence, timing, missed doses and excess use remain unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Administration procedures, product content and use diaries" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "What was the actual schedule for 10 weeks of treatment and ultrasound follow-up?", "needed": "Treatment start/end, ultrasound visits, discontinuation and subsequent follow-up", "role": "Required", "role_reason": "Material on Treatment start/end, ultrasound visits, discontinuation and subsequent follow-up is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Treatment start/end, ultrasound visits, discontinuation and subsequent follow-up must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Treatment/ultrasound visit schedules and discontinuation/follow-up material This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The retained duration is 10 weeks of treatment and ultrasound follow-up.", "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": "Interim visits, event dates, follow-up after discontinuation and recurrence beyond 10 weeks remain unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Treatment/ultrasound visit schedules and discontinuation/follow-up material" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Which adults and which kidney stones were studied?", "needed": "Adults, kidney-stone diagnosis, inclusion/exclusion and baseline conditions", "role": "Required", "role_reason": "Material on Adults, kidney-stone diagnosis, inclusion/exclusion and baseline conditions is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Adults, kidney-stone diagnosis, inclusion/exclusion and baseline conditions must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Participant eligibility/baseline tables and diagnostic criteria This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The retained population is limited to adults with kidney stones.", "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": "Age range, diagnostic and eligibility criteria, kidney function, obstruction/infection and inclusion/exclusion of baseline conditions remain unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Participant eligibility/baseline tables and diagnostic criteria" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "What were stone size, location, composition and number?", "needed": "Baseline size/location/composition by group, single/multiple stones and likelihood of passage", "role": "Required", "role_reason": "Material on Baseline size/location/composition by group, single/multiple stones and likelihood of passage is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Baseline size/location/composition by group, single/multiple stones and likelihood of passage must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Baseline stone characteristics, imaging tables and composition material This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The original explanation describes limited reporting of stone location and spontaneous-passage influences. It cautions against extending results to every size, composition and location.", "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": "Group-specific size distributions, location, composition, counts and disease duration remain unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline stone characteristics, imaging tables and composition material" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "What was actually compared with matched placebo?", "needed": "Placebo composition/appearance, common management and masking conditions", "role": "Required", "role_reason": "Material on Placebo composition/appearance, common management and masking conditions is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Placebo composition/appearance, common management and masking conditions must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Placebo composition and common treatment/management tables This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The retained comparison is matched placebo and the design description is a randomized, triple-blind, placebo 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": "Placebo constituents/appearance, common management and matching treatment/administration procedures remain unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Placebo composition and common treatment/management tables" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "How did hydration, diet, drugs and procedures differ?", "needed": "Hydration/diet, stone medication/standard management, additional procedures and group differences", "role": "Required", "role_reason": "Material on Hydration/diet, stone medication/standard management, additional procedures and group differences is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Hydration/diet, stone medication/standard management, additional procedures and group differences must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Hydration/diet/concomitant-treatment, procedure and change records This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The original explanation mentions limited reporting of hydration, stone location and spontaneous-passage influences.", "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": "Group-specific hydration/diet, concomitant drugs, standard treatment/procedures, changes and adherence remain unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Hydration/diet/concomitant-treatment, procedure and change records" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "How do complete ultrasound disappearance and actual expulsion differ?", "needed": "Ultrasound disappearance, confirmation of actual expulsion, operational definitions and correspondence", "role": "Required", "role_reason": "Material on Ultrasound disappearance, confirmation of actual expulsion, operational definitions and correspondence is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Ultrasound disappearance, confirmation of actual expulsion, operational definitions and correspondence must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Definitions of complete disappearance/expulsion, confirmation of expulsion and original imaging-assessment material This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The retained principal endpoint is complete disappearance of stones on ultrasound. The original effect description uses both disappearance and expulsion.", "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 capture of expulsion, correspondence between imaging disappearance and expulsion, and adjudication rules remain unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Definitions of complete disappearance/expulsion, confirmation of expulsion and original imaging-assessment material" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "What does dissolution in the study title establish?", "needed": "Distinguish imaging disappearance, expulsion and chemical dissolution/mechanisms", "role": "Supplementary; required if extending to dissolution mechanisms", "role_reason": "Material on Distinguish imaging disappearance, expulsion and chemical dissolution/mechanisms is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Distinguish imaging disappearance, expulsion and chemical dissolution/mechanisms must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original trial endpoints/measurements and stone-composition/expulsion material This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The article title includes kidney stone dissolution, but the retained verdict selects complete ultrasound disappearance.", "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": "Changes in stone composition, dissolution mechanisms, routes of expulsion and correspondence between actual dissolution and disappearance remain unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original trial endpoints/measurements and stone-composition/expulsion material" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Are complete-disappearance events and size reduction the same outcome?", "needed": "Size units, measurement/timing, between-group change and separation from complete disappearance", "role": "Required", "role_reason": "Material on Size units, measurement/timing, between-group change and separation from complete disappearance is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Size units, measurement/timing, between-group change and separation from complete disappearance must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Separate size-reduction result tables, imaging measurements and denominators This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The retained endpoint is complete ultrasound disappearance; size reduction is separate, and the original explanation also states that these outcomes should not be mixed.", "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": "Numerical size changes, denominators, between-group effects, confidence intervals and measurement timing remain unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate size-reduction result tables, imaging measurements and denominators" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Which assessment procedures determined ultrasound disappearance?", "needed": "Imaging equipment, sensitivity, assessors/masking, agreement and confirmation of disappearance", "role": "Required", "role_reason": "Material on Imaging equipment, sensitivity, assessors/masking, agreement and confirmation of disappearance is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Imaging equipment, sensitivity, assessors/masking, agreement and confirmation of disappearance must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Ultrasound SOPs, masking/assessment procedures and original images This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The original text describes ultrasound assessment of stone status and limited reporting of imaging-assessment procedures.", "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": "Equipment/acquisition, detection limits, assessors, agreement, confirmation and misclassification remain unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Ultrasound SOPs, masking/assessment procedures and original images" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "How do 60 randomized participants differ from analysis groups?", "needed": "Randomization and arm-specific allocation, analysis, completion and endpoint denominators", "role": "Required", "role_reason": "Material on Randomization and arm-specific allocation, analysis, completion and endpoint denominators is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Randomization and arm-specific allocation, analysis, completion and endpoint denominators must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: CONSORT flow and arm-specific allocation/analysis tables This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The retained participant record states 60 randomized; percentage-based analysis approximately 27 versus 26.", "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": "Arm-specific allocation, originally reported analysis/completion counts, withdrawals and analysis-population definitions remain unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "CONSORT flow and arm-specific allocation/analysis tables" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "How were the approximately 27 and 26 analysis participants recorded?", "needed": "Reported percentages, historical reconstruction, original denominators, rounding and units", "role": "Required", "role_reason": "Material on Reported percentages, historical reconstruction, original denominators, rounding and units is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Reported percentages, historical reconstruction, original denominators, rounding and units must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original event/denominator tables, flow and original rounding/calculation records This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The original explanation states that 44.4% and 15.3% came from small analysis groups of approximately 27 and 26. The original participant record also states percentage-based analysis approximately 27 versus 26.", "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 paper denominators/exclusion rules, original rounding material and analysis units remain unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original event/denominator tables, flow and original rounding/calculation records" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Are 12/27 versus 4/26 original counts or reconstructions?", "needed": "Original event counts, reconstructed counts, approximation labels, denominators and group correspondence", "role": "Required", "role_reason": "Material on Original event counts, reconstructed counts, approximation labels, denominators and group correspondence is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Original event counts, reconstructed counts, approximation labels, denominators and group correspondence must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original frequency tables and historical reconstruction records This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The result labels 12/27 versus 4/26 as reconstructed, while the reader answer presents approximately 12/27 versus 4/26.", "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 paper event counts, denominators, group correspondence and assumptions/accuracy of reconstruction remain unverified because external material was unread.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original frequency tables and historical reconstruction records" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Which endpoint do the reported 44.4% versus 15.3% describe?", "needed": "Complete-disappearance percentages, group correspondence, timing, units and denominators", "role": "Required", "role_reason": "Material on Complete-disappearance percentages, group correspondence, timing, units and denominators is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Complete-disappearance percentages, group correspondence, timing, units and denominators must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Complete-disappearance result tables, group denominators and definitions This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The original result and reader answer report complete disappearance of 44.4% versus 15.3%.", "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 values/rounding in the original table, units/denominators and timing definitions remain unverified because external material was unread.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Complete-disappearance result tables, group denominators and definitions" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "What are the sources of RD 29.1 percentage points, RR 2.89 and the CI?", "needed": "Original estimates versus reconstructed risk differences/RRs/CIs, effect of interest and adjustment", "role": "Required", "role_reason": "Material on Original estimates versus reconstructed risk differences/RRs/CIs, effect of interest and adjustment is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Original estimates versus reconstructed risk differences/RRs/CIs, effect of interest and adjustment must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original effect tables and historical calculation-event records This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The original result reports RD 29.1 percentage points and RR 2.89 (95% CI 1.07 to 7.82) with reconstructed counts. Its note explicitly identifies a Codex reconstruction rather than adjusted paper estimates.", "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 correspondence with adjusted/unadjusted paper estimates, calculation methods and original denominators remains unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original effect tables and historical calculation-event records" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "What uncertainty remains with few events and a wide interval?", "needed": "Intervals for the effect of interest, direct events/denominators and clinical importance", "role": "Required", "role_reason": "Material on Intervals for the effect of interest, direct events/denominators and clinical importance is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Intervals for the effect of interest, direct events/denominators and clinical importance must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original counts/effects and sample-size/clinical-importance plans This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The original reader answer describes small absolute event counts and the need to reproduce imaging/spontaneous-passage conditions. The historical RR CI is 1.07 to 7.82.", "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 denominators/CIs, prespecified important differences, planned sample size and population-specific precision remain unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original counts/effects and sample-size/clinical-importance plans" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "What was the 1st endpoint in the prospective trial plan?", "needed": "Registration, protocol, SAP and original endpoint/timing/analysis hierarchy", "role": "Required", "role_reason": "Material on Registration, protocol, SAP and original endpoint/timing/analysis hierarchy is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Registration, protocol, SAP and original endpoint/timing/analysis hierarchy must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Registration/protocol/SAP and change histories This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The retained intervention record labels complete ultrasound disappearance as the primary endpoint; the registration identifier is unconfirmed.", "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": "External registration/plans, the 1st endpoint hierarchy, changes and analysis selection remain unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration/protocol/SAP and change histories" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "How were sequence generation, concealment and baseline balance handled?", "needed": "Random sequence/concealment, allocation and baseline stone/participant balance", "role": "Required", "role_reason": "Material on Random sequence/concealment, allocation and baseline stone/participant balance is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Random sequence/concealment, allocation and baseline stone/participant balance must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Allocation procedures and baseline tables This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The original design is described as a randomized, triple-blind, placebo trial, with 60 randomized participants.", "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": "Allocation sequence, concealment and group-specific baseline stone, hydration and participant balance remain unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation procedures and baseline tables" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Which roles remained masked?", "needed": "Participants, personnel and assessors, product distinguishability and maintenance of masking", "role": "Required", "role_reason": "Material on Participants, personnel and assessors, product distinguishability and maintenance of masking is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Participants, personnel and assessors, product distinguishability and maintenance of masking must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Placebo/preparations, role-specific masking and assessment procedures This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The original design description states triple blinding.", "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": "Who was masked, product distinguishability, imaging-assessment masking and maintenance/unmasking remain unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Placebo/preparations, role-specific masking and assessment procedures" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "How were actual use, discontinuation and additional treatment handled?", "needed": "Use diaries, nonadherence/discontinuation, additional treatment and the effect targeted in analysis", "role": "Required", "role_reason": "Material on Use diaries, nonadherence/discontinuation, additional treatment and the effect targeted in analysis is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Use diaries, nonadherence/discontinuation, additional treatment and the effect targeted in analysis must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Use diaries, deviation/procedure records and analysis plans This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The original record specifies 500 mg, 2 times daily, 10 weeks of treatment and comparison with placebo.", "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": "Adherence, discontinuation/crossover, additional treatment/procedures and handling of deviations remain unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Use diaries, deviation/procedure records and analysis plans" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Who among the 60 randomized participants was omitted from analysis?", "needed": "Group-specific flow, withdrawal/missingness, ITT/PP, original denominators and handling", "role": "Required", "role_reason": "Material on Group-specific flow, withdrawal/missingness, ITT/PP, original denominators and handling is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Group-specific flow, withdrawal/missingness, ITT/PP, original denominators and handling must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Group-specific flow, analysis definitions and missing-data handling This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The original participant record combines 60 randomized with percentage-based analysis of approximately 27/26.", "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": "Missing counts/reasons, group-specific withdrawals, ITT/PP, missing measurements and sensitivity analyses remain unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group-specific flow, analysis definitions and missing-data handling" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "When and for whom was complete disappearance assessed?", "needed": "Clearance-assessment timing, interim/end visits, cumulative/single-visit events and denominators", "role": "Required", "role_reason": "Material on Clearance-assessment timing, interim/end visits, cumulative/single-visit events and denominators is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Clearance-assessment timing, interim/end visits, cumulative/single-visit events and denominators must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Visit-specific clearance tables, event timing and follow-up/denominators This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The recorded duration is 10 weeks of treatment and ultrasound follow-up.", "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": "The exact assessment visit for reported percentages, cumulative events versus final visit, recurrence after interim clearance and endpoint denominators remain unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Visit-specific clearance tables, event timing and follow-up/denominators" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "How were event units for people and stones defined?", "needed": "People/stones, multiple stones, complete-clearance criteria and group denominators", "role": "Required", "role_reason": "Material on People/stones, multiple stones, complete-clearance criteria and group denominators is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on People/stones, multiple stones, complete-clearance criteria and group denominators must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Person/stone definitions and multiple-stone/denominator tables This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The original reader answer explains 12/27 and 4/26 in the context of participant denominators.", "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": "Complete-clearance criteria for multiple stones, stone-level versus person-level analysis and unit handling remain unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Person/stone definitions and multiple-stone/denominator tables" }, { "item_id": "N27", "question_type": "Evidence condition", "question": "How were spontaneous passage and intervention effects distinguished?", "needed": "Hydration/location/size, spontaneous passage, comparison conditions and assessment/timing", "role": "Required", "role_reason": "Material on Hydration/location/size, spontaneous passage, comparison conditions and assessment/timing is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Hydration/location/size, spontaneous passage, comparison conditions and assessment/timing must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Baseline stones, hydration/common management and expulsion/adjustment material This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The original explanation describes limited reporting of hydration, stone location and spontaneous-passage influences.", "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": "Spontaneous-passage conditions in the groups, follow-up time, direct expulsion and differences/adjustments for other interventions remain unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline stones, hydration/common management and expulsion/adjustment material" }, { "item_id": "N28", "question_type": "Evidence condition", "question": "How were analyses of clearance, size and expulsion specified in advance?", "needed": "Planned endpoints, analyses/timing, multiple comparisons and reporting changes", "role": "Required", "role_reason": "Material on Planned endpoints, analyses/timing, multiple comparisons and reporting changes is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Planned endpoints, analyses/timing, multiple comparisons and reporting changes must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Plans/registration and result tables for all analyses/times This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The original endpoint description separates complete disappearance from size reduction; the registration identifier is unconfirmed.", "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": "Planned comparisons, multiplicity, correspondence between registration and reporting, and analysis changes remain unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Plans/registration and result tables for all analyses/times" }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Does a clearance signal establish replacement of standard care or effects on symptoms/kidney function?", "needed": "Standard treatment/procedures, pain/infection/obstruction, kidney function and patient-important outcomes", "role": "Supplementary; required if extending to treatment replacement or additional effects", "role_reason": "Material on Standard treatment/procedures, pain/infection/obstruction, kidney function and patient-important outcomes is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Standard treatment/procedures, pain/infection/obstruction, kidney function and patient-important outcomes must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Patient-important outcomes and standard-care coadministration/procedure material This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The original advertising-boundary text states that replacement of surgery/standard care cannot be claimed for stones of every size, composition and location.", "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": "Direct results for symptoms, kidney function, infection/obstruction, avoidance of procedures and treatment replacement remain unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Patient-important outcomes and standard-care coadministration/procedure material" }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Which original report do the current summary and citation identify?", "needed": "Evidence/citation, PMID/DOI and study-report families", "role": "Required", "role_reason": "Material on Evidence/citation, PMID/DOI and study-report families is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Evidence/citation, PMID/DOI and study-report families must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Article/registration and lists of reports from the same trial This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The original citation is Ardakani Movaghati MR et al., Phytother Res.2019, PMID30873671, DOI10.1002/ptr.6331.", "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 identity, original article/registration, subsequent reports of the same trial and unique counts remain unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Article/registration and lists of reports from the same trial" }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Has the small-sample signal been repeated in other independent material?", "needed": "Teams/trial families, the same formulation/conditions and independent replication", "role": "Required", "role_reason": "Material on Teams/trial families, the same formulation/conditions and independent replication is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Teams/trial families, the same formulation/conditions and independent replication must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original trials addressing the same formulation/question and imaging/expulsion conditions This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The original rationale lists independent research as a strength while noting a single small sample, denominator reconstruction and imaging limitations. The original R1/I2 axes are 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": "Independent replication under the same formulation, spontaneous-passage/imaging conditions, and unique trial/team/participant counts remain unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original trials addressing the same formulation/question and imaging/expulsion conditions" }, { "item_id": "N32", "question_type": "Evidence condition", "question": "What was the actual role of Mashhad University support?", "needed": "Funding/product support, affiliations, COI and support roles", "role": "Required", "role_reason": "Material on Funding/product support, affiliations, COI and support roles is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Funding/product support, affiliations, COI and support roles must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original funding/COI, author-affiliation and product-support disclosures This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The original funding record states support from Mashhad University.", "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": "Support amounts/preparations, employee authorship/COI and funding/product roles remain unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original funding/COI, author-affiliation and product-support disclosures" }, { "item_id": "N33", "question_type": "Evidence condition", "question": "Were the PubMed link, original article and registration read?", "needed": "Stored JSON, external abstracts/full text, registration/plans and acquisition/reading", "role": "Required", "role_reason": "Material on Stored JSON, external abstracts/full text, registration/plans and acquisition/reading is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Stored JSON, external abstracts/full text, registration/plans and acquisition/reading must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original text, registration/plans and supplementary material corresponding to the citation This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The clinical material read was the entire stored JSON summary. The PubMed URL is recorded as in the original citation.", "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 abstracts/full text/registration, plans and additional material were unread, with no access attempt; public availability is not inferred.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original text, registration/plans and supplementary material corresponding to the citation" }, { "item_id": "N34", "question_type": "Evidence condition", "question": "What dates are 2026-09-08 and the correction date?", "needed": "Roles of the original evidence date, correction/bibliography and current preparation date", "role": "Required", "role_reason": "Material on Roles of the original evidence date, correction/bibliography and current preparation date is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Roles of the original evidence date, correction/bibliography and current preparation date must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original search, receipt, publication and correction records This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The original evidence date is 2026-09-08, the correction date is 2026-09-14 and the bibliography is from 2019.", "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": "Actual external-reading dates, original trial-search cutoff and completion of a current literature search are absent or unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original search, receipt, publication and correction records" }, { "item_id": "N35", "question_type": "Evidence condition", "question": "Are generic English wording and the 1-field correction retained?", "needed": "Korean/English numbers, generic explanations and before/after correction events", "role": "Required", "role_reason": "Material on Korean/English numbers, generic explanations and before/after correction events is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Korean/English numbers, generic explanations and before/after correction events must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Complete before/after correction originals and English result/denominator correspondence This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The English reader answer gives approximately 12/27 and 4/26 and historical RR/CI. Generic explanations remain for English funding, endpoint and result fields, while the English participant explanation describes preservation without actual denominators. The correction records replacement of 1 field.", "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 specific field and its before/after originals, and review of current detailed English correspondence, remain unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Complete before/after correction originals and English result/denominator correspondence" }, { "item_id": "N36", "question_type": "Evidence condition", "question": "What roles do C56 and historical Codex reconstruction/cross-checks have here?", "needed": "Separate grade, score, caution label, axes, verdict decisions, historical calculation and current preparation", "role": "Required", "role_reason": "Material on Separate grade, score, caution label, axes, verdict decisions, historical calculation and current preparation is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Separate grade, score, caution label, axes, verdict decisions, historical calculation and current preparation must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original verdict/reconstruction events and separately authorized subsequent corrections This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The original C56, Caution, B/H/R1/I2/E+/B2/C0 axes and historical independent Codex cross-check/reconstruction wording are preserved in the original copy.", "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": "Current content review, external clinical validation and official assessment certification remain incomplete.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original verdict/reconstruction events and separately authorized subsequent corrections" }, { "item_id": "N37", "question_type": "Evidence condition", "question": "From which denominators were actual adverse events for this formulation collected?", "needed": "Event definitions/collection, group event/person counts, harm denominators and discontinuation/missingness", "role": "Required", "role_reason": "Material on Event definitions/collection, group event/person counts, harm denominators and discontinuation/missingness is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Event definitions/collection, group event/person counts, harm denominators and discontinuation/missingness must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original adverse-event/discontinuation tables and group-specific collection/denominators This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The original safety text states that small trials do not exclude rare adverse events or long-term safety concerns.", "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": "Trial-formulation event counts, collection/discontinuation, group denominators, durations and omissions remain unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original adverse-event/discontinuation tables and group-specific collection/denominators" }, { "item_id": "N38", "question_type": "Evidence condition", "question": "What are the onset/recovery and concomitant-condition/treatment limits for harms?", "needed": "Event timing, discontinuation/re-exposure, baseline conditions/concomitant drugs and alternative causes", "role": "Required", "role_reason": "Material on Event timing, discontinuation/re-exposure, baseline conditions/concomitant drugs and alternative causes is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Event timing, discontinuation/re-exposure, baseline conditions/concomitant drugs and alternative causes must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Individual event timing, concomitant treatment/baseline conditions and causal material This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The original text records the oral 10-week exposure and general cautionary wording.", "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": "Individual harm onset/recovery, improvement after discontinuation/re-exposure and alternative explanations involving kidney disease/concomitant drugs remain unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Individual event timing, concomitant treatment/baseline conditions and causal material" }, { "item_id": "N39", "question_type": "Evidence condition", "question": "Are drugs mentioned in cautions actual interaction events?", "needed": "Glucose-lowering, blood-pressure, anticoagulant, antiseizure and immunomodulatory drugs, exposures/events and alternatives", "role": "Supplementary; required for concomitant-use harms", "role_reason": "Material on Glucose-lowering, blood-pressure, anticoagulant, antiseizure and immunomodulatory drugs, exposures/events and alternatives is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Glucose-lowering, blood-pressure, anticoagulant, antiseizure and immunomodulatory drugs, exposures/events and alternatives must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Drug-specific exposure/formulation and original interaction material This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The retained safety explanation preserves cautionary wording to consult a clinician while taking relevant drugs.", "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": "Trial concomitant-use/exclusion, specific interaction events/denominators and drug-specific causal material remain unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Drug-specific exposure/formulation and original interaction material" }, { "item_id": "N40", "question_type": "Evidence condition", "question": "What remains unknown about rare/long-term safety and vulnerable groups?", "needed": "Duration/formulation, pregnancy/breastfeeding, children, liver/kidney disease, perioperative use and rare harms", "role": "Supplementary; required for long-term or vulnerable-population safety", "role_reason": "Material on Duration/formulation, pregnancy/breastfeeding, children, liver/kidney disease, perioperative use and rare harms is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Duration/formulation, pregnancy/breastfeeding, children, liver/kidney disease, perioperative use and rare harms must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Long-term/rare, formulation-specific and population-specific harm material This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The original text describes constituent differences between products/extraction methods, cautions for vulnerable groups/perioperative use and the inability of small trials to exclude rare/long-term harms.", "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 material for this formulation on long-term/rare events, vulnerable groups, perioperative use and kidney function remains unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Long-term/rare, formulation-specific and population-specific harm material" }, { "item_id": "N41", "question_type": "Evidence condition", "question": "Is the same formulation/event recorded in independent material?", "needed": "Unique harm cases, report families and matching formulation/exposure/event", "role": "Supplementary; required for repeated-harm claims", "role_reason": "Material on Unique harm cases, report families and matching formulation/exposure/event is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Unique harm cases, report families and matching formulation/exposure/event must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Unique cases/report families and actual formulation/exposure material This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The retained text preserves general cautionary wording and does not present an actual unique-case list.", "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": "Independent harm cases versus recitations, repeated matching exposures/events and case denominators remain unverified.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Unique cases/report families and actual formulation/exposure material" }, { "item_id": "N42", "question_type": "Evidence condition", "question": "How are unread material and subsequent changes connected?", "needed": "Stored summary, external articles/registration/denominators/imaging, complete pre-change originals and condition/evidence events", "role": "Required", "role_reason": "Material on Stored summary, external articles/registration/denominators/imaging, complete pre-change originals and condition/evidence events is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.", "application_exception": "Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.", "criterion": "Original records on Stored summary, external articles/registration/denominators/imaging, complete pre-change originals and condition/evidence events must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.", "condition_origin": "These existing conditions are linked to the stored adult kidney-stone record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: User-provided or separately authorized original material and corrections This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.", "observation": "The stored JSON summary is used for preparation and only the original PubMed link is connected. External material was unread, with no access attempt.", "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 denominators/imaging, registration/plans/product/concomitant-use/harm material and existing-content review remain outstanding.", "uncertainty": "Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "User-provided or separately authorized original material and corrections" } ], "reports": [ { "report_id": "R01", "title": "Ardakani Movaghati et al. 2019 · Report of black-seed capsules and kidney-stone disappearance", "url": "https://pubmed.ncbi.nlm.nih.gov/30873671/", "report_type": "Retained description as a randomized, triple-blind, placebo trial; detailed procedures not externally verified", "existence": "The information is recorded in a stored trial summary and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "Summary read; external abstracts/full text, registration and plans unread, with no access attempt", "study_family": "SF01-ArdakaniMovaghati-2019-seed-kidneystone-native", "independent_replication": "Original independent-research description retained; direct replication for the same formulation and unique-trial counts are not certified here", "observed_result": "Reported complete disappearance 44.4% versus 15.3%; historical reconstruction 12/27 versus 4/26, RD 29.1 percentage points, RR 2.89 (95% CI 1.07 to 7.82)", "result_level": "Reported percentages remain distinct from historical Codex reconstructions. Direct correspondence with original counts, denominators, timing and adjusted estimates remains unverified. Imaging disappearance is not substituted for direct expulsion, size change or chemical dissolution.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Existing stored summary acquired", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-08 (original evidence date; not external reading in this work)", "qualification": "The stored summary was read for preparation. This does not establish acquisition or content reading of the original trial full text. Existing bibliography is linked; external articles, registration, protocols, analysis plans and additional material are unread. A retained URL or identifier alone does not establish full-text acquisition, content reading or absence of material. The date 2026-09-08 in material items is the original evidence date, not a date of external reading in this work. The date 2026-10-06 is the original production date. Original review and verification dates are unrecorded; production timestamps are not presented as completed-content-review dates." }, { "material_type": "External article identity link", "public_status": "Original bibliography link only; external content unread", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08 (original evidence date; not external reading in this work)", "qualification": "Only the existing PubMed citation URL is linked. External content reading and access or click testing were not performed. Existing bibliography is linked; external articles, registration, protocols, analysis plans and additional material are unread. A retained URL or identifier alone does not establish full-text acquisition, content reading or absence of material. The date 2026-09-08 in material items is the original evidence date, not a date of external reading in this work. The date 2026-10-06 is the original production date. Original review and verification dates are unrecorded; production timestamps are not presented as completed-content-review dates." }, { "material_type": "External full text", "public_status": "Original bibliography link only; external content unread", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08 (original evidence date; not external reading in this work)", "qualification": "A bibliographic identity URL does not establish full-text acquisition, download or reading. Existing bibliography is linked; external articles, registration, protocols, analysis plans and additional material are unread. A retained URL or identifier alone does not establish full-text acquisition, content reading or absence of material. The date 2026-09-08 in material items is the original evidence date, not a date of external reading in this work. The date 2026-10-06 is the original production date. Original review and verification dates are unrecorded; production timestamps are not presented as completed-content-review dates." }, { "material_type": "Additional material needed", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08 (original evidence date; not external reading in this work)", "qualification": "The original registration identity is unconfirmed. Registration identifiers, public availability and protocol or analysis-plan contents are not inferred. Existing bibliography is linked; external articles, registration, protocols, analysis plans and additional material are unread. A retained URL or identifier alone does not establish full-text acquisition, content reading or absence of material. The date 2026-09-08 in material items is the original evidence date, not a date of external reading in this work. The date 2026-10-06 is the original production date. Original review and verification dates are unrecorded; production timestamps are not presented as completed-content-review dates." }, { "material_type": "Additional material needed", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08 (original evidence date; not external reading in this work)", "qualification": "The 60 randomized participants remain distinct from historical approximate 27/26 denominators and reconstructed counts. No additional reconstruction or pooling was performed. Existing bibliography is linked; external articles, registration, protocols, analysis plans and additional material are unread. A retained URL or identifier alone does not establish full-text acquisition, content reading or absence of material. The date 2026-09-08 in material items is the original evidence date, not a date of external reading in this work. The date 2026-10-06 is the original production date. Original review and verification dates are unrecorded; production timestamps are not presented as completed-content-review dates." }, { "material_type": "Additional material needed", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08 (original evidence date; not external reading in this work)", "qualification": "The correspondence of imaging disappearance with direct expulsion, size change and dissolution remains unverified. Existing bibliography is linked; external articles, registration, protocols, analysis plans and additional material are unread. A retained URL or identifier alone does not establish full-text acquisition, content reading or absence of material. The date 2026-09-08 in material items is the original evidence date, not a date of external reading in this work. The date 2026-10-06 is the original production date. Original review and verification dates are unrecorded; production timestamps are not presented as completed-content-review dates." }, { "material_type": "Additional material needed", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08 (original evidence date; not external reading in this work)", "qualification": "Direct material on product specifications, constituent quantification, placebo, actual use and adherence remains unverified. Existing bibliography is linked; external articles, registration, protocols, analysis plans and additional material are unread. A retained URL or identifier alone does not establish full-text acquisition, content reading or absence of material. The date 2026-09-08 in material items is the original evidence date, not a date of external reading in this work. The date 2026-10-06 is the original production date. Original review and verification dates are unrecorded; production timestamps are not presented as completed-content-review dates." }, { "material_type": "Additional material needed", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08 (original evidence date; not external reading in this work)", "qualification": "Details of baseline stones, hydration and diet, concomitant treatment, spontaneous passage and alternative explanations in the groups remain unverified. Existing bibliography is linked; external articles, registration, protocols, analysis plans and additional material are unread. A retained URL or identifier alone does not establish full-text acquisition, content reading or absence of material. The date 2026-09-08 in material items is the original evidence date, not a date of external reading in this work. The date 2026-10-06 is the original production date. Original review and verification dates are unrecorded; production timestamps are not presented as completed-content-review dates." }, { "material_type": "Additional material needed", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08 (original evidence date; not external reading in this work)", "qualification": "General cautionary wording is not converted into actual event counts, harm denominators or confirmation of causality. Existing bibliography is linked; external articles, registration, protocols, analysis plans and additional material are unread. A retained URL or identifier alone does not establish full-text acquisition, content reading or absence of material. The date 2026-09-08 in material items is the original evidence date, not a date of external reading in this work. The date 2026-10-06 is the original production date. Original review and verification dates are unrecorded; production timestamps are not presented as completed-content-review dates." }, { "material_type": "Additional material needed", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08 (original evidence date; not external reading in this work)", "qualification": "Support roles beyond the record of Mashhad University support, product provision, author roles and conflicts remain unverified. Existing bibliography is linked; external articles, registration, protocols, analysis plans and additional material are unread. A retained URL or identifier alone does not establish full-text acquisition, content reading or absence of material. The date 2026-09-08 in material items is the original evidence date, not a date of external reading in this work. The date 2026-10-06 is the original production date. Original review and verification dates are unrecorded; production timestamps are not presented as completed-content-review dates." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/30873671/" } ] } ], "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": "Only the retained connection between the trial summary and citation is maintained. Other reports or recitations of the same trial remain distinct from independent replication; no new unique-trial, participant or event totals or independent-replication count are established." }, "history": [ { "date": "2026-10-24", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 42 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-24" }