{ "schema_version": "chamgap-public-criteria-1.0", "title": "Oral Nigella sativa seed capsules × Increased complete clearance or expulsion of adult kidney stones", "language": "en", "translation_date": "2026-10-24", "criteria_version": "1.0", "criteria_date": "2026-10-06", "condition_origin": "Chamgap's own application conditions", "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly 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." }, "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." } ] }