{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2986-s0", "verdict_number": "2986", "title": "Cranberry fruit powder × six-month IPSS reduction", "view_version": "1.0", "view_created_date": "2026-10-16", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-09-07", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "The Korean text records124 men aged45 or older with IPSS at least8; the English text says aged over45. Group allocation, completion, analysis, attrition and baseline IPSS are unverified.", "intervention": "Three groups received Flowens™ branded cranberry fruit powder250mg/day,500mg/day or placebo. Composition, PAC content, actual adherence and supply details are unverified.", "dose": "250/500mg/day and six months are research-exposure records. Recommended intake, juice or PAC conversions, and preventive or treatment doses are not created.", "comparator": "Double-blind placebo control. Placebo composition, sensory matching, exposure, concurrent care and masking-maintenance details are unverified.", "endpoint": "Distinguish six-month group IPSS changes of−3.1/−4.1/−1.5 points, the text’s approximate placebo differences of−1.6/−2.6 points, and comparison P values of approximately .05 for250mg and <.001 for500mg. Exact adjusted effects, CIs and denominators are unverified. Objective-flow/residual-urine changes from baseline in the500mg group are separate.", "duration": "Endpoint labels include three and six months; current quantitative values concern six months. Three-month values/denominators, exact objective-outcome times, post-trial persistence and long-term clinical outcomes are not linked.", "excluded_extensions": [ "Mixing group-specific changes with historical approximate placebo differences, or creating new effects, CIs or arithmetic", "Arbitrarily harmonizing the text’s MID3.1–5.2 with supporting-citation values5.2 overall/3.2 moderate, or inferring no effect for every individual", "Transferring values, units or timing across total IPSS, subscores, QoL, objective flow, residual urine, prostate size, or three/six months", "Treating the Flowens test product and250/500mg research exposure as equivalent to juice, other PAC products or recommended intake", "Adding the same124 participants, groups, times, two sheets and observational MID cohort as independent efficacy trials or participant totals", "Inheriting parent C46, axes or historical checks as subclaim scores/current review, or creating intake, urinary/prostate-treatment, preventive or replacement advice" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Selected IPSS question and original grade", "needed": "Selected wording, note, grade and parent verdict", "role": "Required", "role_reason": "This condition connects Selected wording, note, grade and parent verdict with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.", "criterion": "Material for Selected wording, note, grade and parent verdict must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Separate subclaim score, status and axes are absent from the original record. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The existing question is ‘Reduction in six-month IPSS’, graded C; the note says it was statistically favorable but small versus placebo. Subclaim score, status and axes are absent and are not filled with parent C46.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Separate subclaim score, status and axes are absent from the original record.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate subclaim score, status and axes are absent from the original record." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Participants, symptoms and age criteria", "needed": "Eligibility, baseline IPSS, age and group denominators", "role": "Required", "role_reason": "This condition connects Eligibility, baseline IPSS, age and group denominators with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.", "criterion": "Material for Eligibility, baseline IPSS, age and group denominators must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Exact age range, baseline IPSS distribution, diagnoses, history and group allocation counts are unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The Korean text records 124 men aged45 or older with IPSS at least8; the English text says aged over45. The age expressions are not arbitrarily harmonized or extended to all men or diagnosed prostate disease.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Exact age range, baseline IPSS distribution, diagnoses, history and group allocation counts are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact age range, baseline IPSS distribution, diagnoses, history and group allocation counts are unverified." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Identity of the branded cranberry powder", "needed": "Product, manufacturing, composition, form and test-product records", "role": "Required", "role_reason": "This condition connects Product, manufacturing, composition, form and test-product records with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.", "criterion": "Material for Product, manufacturing, composition, form and test-product records must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Test-product composition, PAC content, manufacturing, standardization, batches and correspondence to ordinary products are unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The test product was branded cranberry fruit powder, identified as Flowens™ in the citation. Ordinary cranberry, juice and products with different PAC content are not treated as the same intervention.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Test-product composition, PAC content, manufacturing, standardization, batches and correspondence to ordinary products are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Test-product composition, PAC content, manufacturing, standardization, batches and correspondence to ordinary products are unverified." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Research exposure at250 and500mg", "needed": "Three-group plans, actual exposure, duration and adherence", "role": "Required", "role_reason": "This condition connects Three-group plans, actual exposure, duration and adherence with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.", "criterion": "Material for Three-group plans, actual exposure, duration and adherence must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Actual adherence, discontinuation, content, intake schedule and exposure distribution are unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "This was a six-month study of250mg/day,500mg/day and placebo. These are study conditions; personal intake, recommended amounts and juice or PAC conversions are not created.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Actual adherence, discontinuation, content, intake schedule and exposure distribution are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual adherence, discontinuation, content, intake schedule and exposure distribution are unverified." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Actual placebo comparison conditions", "needed": "Placebo composition, exposure, sensory matching and concurrent care", "role": "Required", "role_reason": "This condition connects Placebo composition, exposure, sensory matching and concurrent care with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.", "criterion": "Material for Placebo composition, exposure, sensory matching and concurrent care must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Placebo specifications, exposure, appearance, taste, contact and matching of care are unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The study was double-blind and placebo-controlled. The design label alone does not verify actual placebo ingredients, frequency, sensory matching or concurrent care.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Placebo specifications, exposure, appearance, taste, contact and matching of care are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Placebo specifications, exposure, appearance, taste, contact and matching of care are unverified." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Randomization and double-blinding procedures", "needed": "Sequence, concealment, masking targets and maintenance, and analysis", "role": "Required", "role_reason": "This condition connects Sequence, concealment, masking targets and maintenance, and analysis with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.", "criterion": "Material for Sequence, concealment, masking targets and maintenance, and analysis must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Sequence generation, concealment, masking targets and maintenance, and analyst involvement are unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The original design label is a three-arm double-blind randomized placebo-controlled trial. The label does not verify allocation concealment or masking of all assessors and analysts.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Sequence generation, concealment, masking targets and maintenance, and analyst involvement are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Sequence generation, concealment, masking targets and maintenance, and analyst involvement are unverified." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "The124 participants and group/outcome denominators", "needed": "Allocation, completion, analysis and attrition", "role": "Required", "role_reason": "This condition connects Allocation, completion, analysis and attrition with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.", "criterion": "Material for Allocation, completion, analysis and attrition must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Group allocation, completion, attrition, discontinuation, outcome-analysis counts and reasons are unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The record of124 participants and three groups is preserved. Group counts, complete follow-up, completeness of IPSS analysis and equal allocation are not inferred.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Group allocation, completion, attrition, discontinuation, outcome-analysis counts and reasons are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group allocation, completion, attrition, discontinuation, outcome-analysis counts and reasons are unverified." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Definition of total IPSS assessment", "needed": "Scale, total and subscores, responses and time points", "role": "Required", "role_reason": "This condition connects Scale, total and subscores, responses and time points with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.", "criterion": "Material for Scale, total and subscores, responses and time points must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Total-score composition, assessment procedures, baseline distribution, scale language and missing responses are unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The original endpoint is International Prostate Symptom Score (IPSS) at three and six months. A subjective symptom scale is not converted into objective flow, residual urine or prostate-size outcomes.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Total-score composition, assessment procedures, baseline distribution, scale language and missing responses are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Total-score composition, assessment procedures, baseline distribution, scale language and missing responses are unverified." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Six-month changes within each group", "needed": "Changes, baseline, units and denominators for each dose and placebo", "role": "Required", "role_reason": "This condition connects Changes, baseline, units and denominators for each dose and placebo with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.", "criterion": "Material for Changes, baseline, units and denominators for each dose and placebo must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Group baseline and end values, change variance, exact analysis denominators and models are unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "Six-month changes of−3.1 points (250mg),−4.1 points (500mg) and−1.5 points (placebo) are group-specific records. Each group's change is not itself converted into an effect versus placebo.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Group baseline and end values, change variance, exact analysis denominators and models are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group baseline and end values, change variance, exact analysis denominators and models are unverified." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Original approximate differences versus placebo", "needed": "Between-group estimands, adjustment, CIs and historical calculation", "role": "Required", "role_reason": "This condition connects Between-group estimands, adjustment, CIs and historical calculation with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.", "criterion": "Material for Between-group estimands, adjustment, CIs and historical calculation must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Exact between-group models, adjustment, CIs, denominators and estimand definitions are unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The parent text's approximate differences of−1.6 and−2.6 points versus placebo are preserved. These are historical approximate statements, not newly calculated values, exact adjusted effects or CIs.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Exact between-group models, adjustment, CIs, denominators and estimand definitions are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact between-group models, adjustment, CIs, denominators and estimand definitions are unverified." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Dose-specific P values and comparison scope", "needed": "Reported P values, exact contrasts, models and multiplicity", "role": "Required", "role_reason": "This condition connects Reported P values, exact contrasts, models and multiplicity with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.", "criterion": "Material for Reported P values, exact contrasts, models and multiplicity must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Exact P values, tested contrasts, direction, multiplicity and adjusted models are unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The original comparison P values are approximately .05 for250mg and <.001 for500mg. Approximately .05 is not turned into an exact P value, within-group P value, between-dose test or prespecified success criterion.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Exact P values, tested contrasts, direction, multiplicity and adjusted models are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact P values, tested contrasts, direction, multiplicity and adjusted models are unverified." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "An apparent dose-response pattern", "needed": "Direct comparison of doses, adherence and models", "role": "Required", "role_reason": "This condition connects Direct comparison of doses, adherence and models with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.", "criterion": "Material for Direct comparison of doses, adherence and models must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Direct between-dose contrasts, exposure adherence, CIs and prespecified models are unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The parent text describes an apparent dose-response IPSS pattern as a strength. Group changes of−3.1 and−4.1 points, or each placebo comparison, are not turned into a direct between-dose difference or proof of an optimal dose.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Direct between-dose contrasts, exposure adherence, CIs and prespecified models are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct between-dose contrasts, exposure adherence, CIs and prespecified models are unverified." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Minimal important-difference numbers by source", "needed": "Textual thresholds, supporting citation estimates, populations and units", "role": "Required", "role_reason": "This condition connects Textual thresholds, supporting citation estimates, populations and units with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.", "criterion": "Material for Textual thresholds, supporting citation estimates, populations and units must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: The exact source and conditions for3.1 in the text, and correspondence to the supporting cohort's3.2, are unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The text's patient-anchored threshold of approximately3.1–5.2 points and the supporting citation's approximately5.2 overall and3.2 for moderate symptoms are preserved separately.3.1 and3.2 are not arbitrarily harmonized or recalculated.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "The exact source and conditions for3.1 in the text, and correspondence to the supporting cohort's3.2, are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The exact source and conditions for3.1 in the text, and correspondence to the supporting cohort's3.2, are unverified." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Role of the Blanker observational cohort", "needed": "MID estimation design, population, denominators and criteria", "role": "Required", "role_reason": "This condition connects MID estimation design, population, denominators and criteria with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.", "criterion": "Material for MID estimation design, population, denominators and criteria must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Supporting-cohort n, baseline severity, anchors, estimation methods, CIs and correspondence to the trial population are unverified. This records needed materials; no new research was executed.", "current_reports": [ "S02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "Blanker2019 is a Dutch primary-care observational cohort for IPSS/OABQ minimal important differences and appears only in the citations. It is not treated as cranberry efficacy, an independent RCT or a repeat of the same124 participants.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Supporting-cohort n, baseline severity, anchors, estimation methods, CIs and correspondence to the trial population are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Supporting-cohort n, baseline severity, anchors, estimation methods, CIs and correspondence to the trial population are unverified." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Mean differences and individual importance thresholds", "needed": "Estimands, individual versus group interpretation and relevance criteria", "role": "Required", "role_reason": "This condition connects Estimands, individual versus group interpretation and relevance criteria with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.", "criterion": "Material for Estimands, individual versus group interpretation and relevance criteria must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Exact correspondence between group means and individually important changes, distributions and prespecified criteria is unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The parent text states that approximately−1.6 and−2.6 points fell below estimated thresholds. This is not turned into no effect for every individual, treatment failure, a new grade or response rates.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Exact correspondence between group means and individually important changes, distributions and prespecified criteria is unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact correspondence between group means and individually important changes, distributions and prespecified criteria is unverified." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "IPSS subscores and quality of life", "needed": "Separate total, item, subscore and QoL outcomes", "role": "Required", "role_reason": "This condition connects Separate total, item, subscore and QoL outcomes with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.", "criterion": "Material for Separate total, item, subscore and QoL outcomes must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Item, subscore and QoL definitions, time points, denominators, exact effects, CIs and hierarchy are unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The stored summary's quantitative result is six-month IPSS change. Separately linked item, subscore or quality-of-life results are not assumed.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Item, subscore and QoL definitions, time points, denominators, exact effects, CIs and hierarchy are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Item, subscore and QoL definitions, time points, denominators, exact effects, CIs and hierarchy are unverified." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Three and six months, and persistence after completion", "needed": "Time-specific results, denominators and post-discontinuation persistence", "role": "Required", "role_reason": "This condition connects Time-specific results, denominators and post-discontinuation persistence with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.", "criterion": "Material for Time-specific results, denominators and post-discontinuation persistence must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Three-month quantitative values, denominators, time-specific missingness and persistence beyond six months are not linked. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The endpoint label includes three and six months, but current quantitative values concern six months. Three months is not treated as a separate replication trial or confirmation of identical numbers.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Three-month quantitative values, denominators, time-specific missingness and persistence beyond six months are not linked.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Three-month quantitative values, denominators, time-specific missingness and persistence beyond six months are not linked." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Prespecified IPSS statements and registration", "needed": "Original prespecification statements, registration, protocol and SAP", "role": "Required", "role_reason": "This condition connects Original prespecification statements, registration, protocol and SAP with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.", "criterion": "Material for Original prespecification statements, registration, protocol and SAP must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original registration, recruitment and registration timing, protocol, SAP and amendment history are unread. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The parent text describes a prespecified IPSS endpoint, while the citation flags registration as unverified. Absence of a registration-identifier key in the evidence record is not turned into no registration or completed preregistration.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Original registration, recruitment and registration timing, protocol, SAP and amendment history are unread.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original registration, recruitment and registration timing, protocol, SAP and amendment history are unread." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Plans for multiple doses, times and outcomes", "needed": "Prespecified hierarchy, contrasts, multiplicity and analysis models", "role": "Required", "role_reason": "This condition connects Prespecified hierarchy, contrasts, multiplicity and analysis models with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.", "criterion": "Material for Prespecified hierarchy, contrasts, multiplicity and analysis models must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Exact hierarchy, dose/time contrasts, multiplicity and the complete SAP are unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The two doses,3/6 months, IPSS and objective outcomes have distinct analysis scopes. A prespecified-IPSS statement is not extended into verified prespecified primary effects for all subscores or flow outcomes.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Exact hierarchy, dose/time contrasts, multiplicity and the complete SAP are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact hierarchy, dose/time contrasts, multiplicity and the complete SAP are unverified." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Blinding and measurement of symptoms", "needed": "Participants, assessors, scale administration and expectancy", "role": "Required", "role_reason": "This condition connects Participants, assessors, scale administration and expectancy with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.", "criterion": "Material for Participants, assessors, scale administration and expectancy must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Masking maintenance, assessment procedures, missing responses, analysts and expectancy effects are unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "Double-blinding and placebo control are design strengths recorded in the original text. Actual masking maintenance and standardization of symptom responses and analyses are not thereby verified.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Masking maintenance, assessment procedures, missing responses, analysts and expectancy effects are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Masking maintenance, assessment procedures, missing responses, analysts and expectancy effects are unverified." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Concurrent care and actual exposure", "needed": "Medication, lifestyle, concurrent interventions and adherence", "role": "Required", "role_reason": "This condition connects Medication, lifestyle, concurrent interventions and adherence with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.", "criterion": "Material for Medication, lifestyle, concurrent interventions and adherence must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Concurrent treatment, lifestyle changes, adherence, discontinuation and baseline adjustment are unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "This is a comparison of three branded-powder groups. Identical or absent concurrent urinary-symptom care, medication, lifestyle changes and product adherence are not inferred.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Concurrent treatment, lifestyle changes, adherence, discontinuation and baseline adjustment are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Concurrent treatment, lifestyle changes, adherence, discontinuation and baseline adjustment are unverified." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Analysis populations and missing-data handling", "needed": "ITT, PP, group attrition/discontinuation and missing outcomes", "role": "Required", "role_reason": "This condition connects ITT, PP, group attrition/discontinuation and missing outcomes with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.", "criterion": "Material for ITT, PP, group attrition/discontinuation and missing outcomes must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Group attrition, missing IPSS, exclusions, ITT, PP, imputation and sensitivity analyses are unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The original124 describes total participants; completion counts, missingness rates, ITT and PP are not provided. Parent scores and design labels do not fill the analysis scope.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Group attrition, missing IPSS, exclusions, ITT, PP, imputation and sensitivity analyses are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group attrition, missing IPSS, exclusions, ITT, PP, imputation and sensitivity analyses are unverified." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Within-group objective-flow and residual-urine comparisons", "needed": "IPSS versus Qmax, Qavg and residual urine; within/between-group distinctions", "role": "Required", "role_reason": "This condition connects IPSS versus Qmax, Qavg and residual urine; within/between-group distinctions with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.", "criterion": "Material for IPSS versus Qmax, Qavg and residual urine; within/between-group distinctions must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Exact objective values, units, time points, denominators, between-group effects and CIs are unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The original text says Qmax, Qavg and residual urine changed from baseline in the500mg group, without presenting a confirmed effect versus placebo. The placebo-controlled IPSS signal is not transferred into flow or residual-urine success.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Exact objective values, units, time points, denominators, between-group effects and CIs are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact objective values, units, time points, denominators, between-group effects and CIs are unverified." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Scope of other clinical and product questions", "needed": "Direct measurement, comparisons and generalization", "role": "Required", "role_reason": "This condition connects Direct measurement, comparisons and generalization with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.", "criterion": "Material for Direct measurement, comparisons and generalization must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Direct evidence for other clinical outcomes, products, populations and treatment replacement is not linked. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The parent text records that definitive prostate-size and urinary-flow claims exceed scope. The IPSS signal is not turned into prostate treatment, infection prevention, treatment replacement or efficacy of ordinary juice or other PAC products.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Direct evidence for other clinical outcomes, products, populations and treatment replacement is not linked.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct evidence for other clinical outcomes, products, populations and treatment replacement is not linked." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "One shared trial, supporting thresholds and independent replication", "needed": "Efficacy reports, cohort roles and duplicate times/sheets", "role": "Required", "role_reason": "This condition connects Efficacy reports, cohort roles and duplicate times/sheets with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.", "criterion": "Material for Efficacy reports, cohort roles and duplicate times/sheets must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Separate efficacy replication with the same product, population and comparison, and actual independent-study relationships, are not linked. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The Vidlar2016 trial of124 participants, three groups and3/6 months is shared by two sheets. The Blanker MID cohort is not efficacy replication. Groups, times, supporting citations and the two sheets are not counted as unique trials or participant totals.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Separate efficacy replication with the same product, population and comparison, and actual independent-study relationships, are not linked.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate efficacy replication with the same product, population and comparison, and actual independent-study relationships, are not linked." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Naturex employee authors, support and conflicts", "needed": "Employment, product, funding, support and conflict disclosures", "role": "Required", "role_reason": "This condition connects Employment, product, funding, support and conflict disclosures with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.", "criterion": "Material for Employment, product, funding, support and conflict disclosures must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Funding roles, product supply and free support, employee-author roles, conflicts and supporting-cohort support are unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The original funding field records two Naturex-employed authors and a branded test product. Employment information is not turned into complete verification of funding, free product support or conflicts. Support for the Blanker cohort is separate.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Funding roles, product supply and free support, employee-author roles, conflicts and supporting-cohort support are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Funding roles, product supply and free support, employee-author roles, conflicts and supporting-cohort support are unverified." }, { "item_id": "N27", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Laboratory changes and clinical safety", "needed": "Adverse events, hematology/clinical chemistry, exposure and denominators", "role": "Supplementary", "role_reason": "This condition connects Adverse events, hematology/clinical chemistry, exposure and denominators with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.", "criterion": "Material for Adverse events, hematology/clinical chemistry, exposure and denominators must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Event definitions, collection, group denominators, discontinuation, rare and long-term harms, and direct interaction evidence are unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "Parent safety is unknown; no clinical-chemistry or hematology change over six months is an original statement. It is not turned into zero adverse events, exclusion of rare harms or long-term safety. Interactions such as warfarin remain a possibility statement in the original text.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Event definitions, collection, group denominators, discontinuation, rare and long-term harms, and direct interaction evidence are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Event definitions, collection, group denominators, discontinuation, rare and long-term harms, and direct interaction evidence are unverified." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Parent/subclaim values, languages and dates", "needed": "Parent C46, subclaim C, axes, corrections and history", "role": "Required", "role_reason": "This condition connects Parent C46, subclaim C, axes, corrections and history with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.", "criterion": "Material for Parent C46, subclaim C, axes, corrections and history must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Subclaim score, status and axes, new corrections and external details behind historical checks are unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "Parent C46, B/P/R1/I0/E~/B1, unrecorded precision, four false flags, empty override reasons, and subclaim C/note are preserved. Original languages,2026-09-07, empty corrections array/deliberation string, and historical PubMed/effect/scoring checks are not inherited as current review or subclaim scores.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Subclaim score, status and axes, new corrections and external details behind historical checks are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Subclaim score, status and axes, new corrections and external details behind historical checks are unverified." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Summary reading, source links and updates", "needed": "Efficacy/MID summaries versus unread external material", "role": "Required", "role_reason": "This condition connects Efficacy/MID summaries versus unread external material with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.", "criterion": "Material for Efficacy/MID summaries versus unread external material must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: External original acquisition, reading, source-link verification and review of existing content remain incomplete. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The efficacy summary and supporting citation's MID wording were used, retaining original paper links. External abstracts, full texts, registration, protocols, SAPs and conflict disclosures are unread and access was not attempted. External source links were not tested.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "External original acquisition, reading, source-link verification and review of existing content remain incomplete.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "External original acquisition, reading, source-link verification and review of existing content remain incomplete." } ], "reports": [ { "report_id": "S01", "title": "Vidlar A et al. 2016", "url": "https://pubmed.ncbi.nlm.nih.gov/26049866/", "report_type": "Three-arm double-blind randomized placebo-controlled trial", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2986-VIDLAR-2016", "independent_replication": "Review of existing content remains incomplete. Report identifiers or a separate supporting cohort alone do not certify independent efficacy replication or unique-trial counts.", "observed_result": "Six-month changes−3.1 points (250mg),−4.1 points (500mg),−1.5 points (placebo)", "result_level": "Original efficacy summary; group changes distinguished from placebo differences", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07", "qualification": "Only stored-summary and bibliographic content was used for production. External material verification/review is not complete." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/26049866/" } ] }, { "report_id": "S02", "title": "Blanker MH, et al. Determining the minimal important differences in the International Prostate Symptom Score and Overactive Bladder Questionnaire: results from an observational cohort study in Dutch primary care. BMJ Open. 2019;9:e032795. PMID: 31874883. PMCID: PMC7008409. DOI: 10.1136/bmjopen-2019-032795.", "url": "https://pubmed.ncbi.nlm.nih.gov/31874883/", "report_type": "Observational-cohort minimal important-difference estimate; supporting citation", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2986-BLANKER-2019-MID", "independent_replication": "Review of existing content remains incomplete. Report identifiers or a separate supporting cohort alone do not certify independent efficacy replication or unique-trial counts.", "observed_result": "Patient-anchored IPSS minimal important differences were estimated at approximately5.2 points overall and3.2 for moderate symptoms.", "result_level": "Observational-cohort MID citation summary; not an efficacy result", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07", "qualification": "Only stored-summary and bibliographic content was used for production. External material verification/review is not complete." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/31874883/" } ] } ], "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": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "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": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "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": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "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": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "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": "Preserved method HTML copies; no current method-content re-review or official tool execution" } ], "status_dictionary": { "Met": "Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.", "Partly verified": "Some information in the stored summary is linked into the table. External comparison/content review is not complete.", "Unverified": "The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.", "Review incomplete": "Existing content review remains incomplete.", "Not reported": "Not reported within the stored material actually read; not extended to the entire primary paper.", "Inaccessible": "Means an actual access failure. Access not attempted here is not assigned this state.", "Not applicable": "Not used as a substitute for an evidence gap.", "Conflicting data": "Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.", "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "The Vidlar2016 Flowens trial of124 participants, three groups and3/6 months is shared by two sheets. Group IPSS changes, historical approximate placebo contrasts and objective-flow/residual-urine changes from baseline in the500mg group are distinguished. Blanker2019 is a supporting observational MID cohort, not cranberry efficacy replication. Textual3.1–5.2 and citation values5.2 overall/3.2 moderate are preserved separately. The same participants, groups, times, sheets and supporting citations are not newly added as unique trials or participant totals. Confirmed unique-trial, participant and independent-replication totals remain unrecorded." }, "history": [ { "date": "2026-10-16", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public pages and materials were created from the existing 29 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-16" }