{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2965-s0", "verdict_number": "2965", "title": "Low-molecular-weight collagen peptide · WOMAC pain in early knee osteoarthritis — Evidence Check", "view_version": "1.0", "view_created_date": "2026-10-12", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "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": "Early knee osteoarthritis trial in adults with Kellgren–Lawrence grade 1–2: 80 randomized, 40/40, distinguished from primary efficacy PP60/80, exclusion of 20/80 (25%) and safety population of 80. PP KL imbalance P=.037 and detailed baseline/recruitment, group denominators, missingness/deviations remain original accounts or unverified.", "intervention": "The specific research product was low-molecular-weight collagen peptide, 3 g daily. Detailed molecular weight, source/composition, batches and actual exposure are unverified. This is not transferred to undenatured type II, ordinary hydrolyzed type I/III or all oral collagen; no new intake instructions, product recommendations or treatment methods are created.", "dose": "Original 3 g daily for 180 days is retained. PP inclusion required at least 80% adherence and no major deviation, distinct from actual individual adherence, changes and discontinuation. No conversion/implementation guidance for other doses, durations or long-term exposure is created.", "comparator": "Double-blind randomized trial versus placebo manufactured by NEWTREE. Allocation generation/concealment, role-specific masking, placebo ingredients/matching, accompanying pain management and actual implementation are unverified. Company nonparticipation is a paper declaration, not current confirmation of independence.", "endpoint": "Selected prespecified primary endpoint: baseline-to-day-180 WOMAC pain change. Original PP60 changes of -1.90±4.14 versus +0.61±3.97 with placebo and approximate between-group -2.51 points/P=.006 are retained. Group-specific PP observed denominators, meaning of ±, scale range/units, original model/CI are unverified or originally unreported. The 10-point WOMAC total sample-size assumption and post hoc SMD 0.46/external AAOS 0.39 are separate planning/interpretive context, not a prespecified pain-success threshold. VAS P=.299 is a different result.", "duration": "The 180-day study and prespecified WOMAC change timing are retained. Actual individual visit windows, repeated/intermediate results, completed follow-up/exposure and long-term outcomes are unverified. Exact VAS timing is not filled from WOMAC timing.", "excluded_extensions": [ "Mixing WOMAC pain, WOMAC total and VAS scales, timing, estimands, denominators or hierarchy", "Calculating new effects, CIs, final values or response rates from original ± values, P values or sample size, or relabeling original approximate -2.51/SMD as a current calculation", "Using the same-direction ITT account to fill quantitative effects, significance or confirmed CI", "Reusing PP60/80, exclusion of 20/80 (25%), randomized 40/40 or safety population of 80 as the same confirmed denominator for the selected outcome", "Turning the 10-point WOMAC total sample-size assumption or post hoc SMD 0.46/external AAOS 0.39 into a prespecified pain/VAS success threshold", "Extending positive WOMAC results to all pain scales/collagen, or converting nonsignificant VAS into exact zero effect, equivalence or certified exclusion of all important benefit", "Totaling the same report/KCT, participants/groups, scales, time points or sibling sheets as new independent trials/participants", "Turning product/placebo manufacture, support, company/subsidiary affiliations or nonparticipation declarations into new confirmation of independence or all detailed disclosures", "Assigning parent scores/axes or historical cross-checks to subclaim scores, current review or original-material reading", "New calculations, hypothetical values, effects/CIs, grades, independence certification or implementation guidance for collagen/product intake or pain/knee treatment" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Selected question and original subclaim values", "needed": "Selected question grade/note, parent context and presence of score/status/axes", "role": "Required", "role_reason": "Preparation item distinguishing selected question grade/note, parent context and presence of score/status/axes to link required evidence with current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Selected question grade/note, parent context and presence of score/status/axes: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed updating research linking original-question scope to additional materials; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original selected Reduced WOMAC pain subclaim, grade C and note are retained. Parent C50 and original axes concern the parent verdict.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Subclaim score, status and axes are absent; parent values are not assigned to the subclaim. Existing-content review remains incomplete.", "missingness": "Subclaim score, status and axes are absent; parent values are not assigned to the subclaim.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Materials distinguishing the selected subclaim from the parent verdict" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Early knee osteoarthritis population", "needed": "Actual disease stage, recruitment criteria and baseline characteristics", "role": "Required", "role_reason": "Preparation item distinguishing actual disease stage, recruitment criteria and baseline characteristics to link required evidence with current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Actual disease stage, recruitment criteria and baseline characteristics: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.", "basis": "M03 §3.2.1; Detailed population criteria are designed by CHAMGAP; M03 §3.2.1–3.2.4; Dose, duration and effect-modification details are designed by CHAMGAP; M03 §3.2.2–3.2.3; Reverse labels and test adaptations are designed by CHAMGAP", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research on applicability and heterogeneity within the same population scope; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original population was 80 adults with Kellgren–Lawrence grade 1–2 early knee osteoarthritis.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Detailed eligibility, age/symptoms, baseline pain, comorbidities and group-specific characteristics are unverified. Existing-content review remains incomplete.", "missingness": "Detailed eligibility, age/symptoms, baseline pain, comorbidities and group-specific characteristics are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Recruitment/eligibility, baseline characteristics and group-specific population materials" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Specific low-molecular-weight peptide", "needed": "Identity, composition and exposure of the tested preparation", "role": "Required", "role_reason": "Preparation item distinguishing identity, composition and exposure of the tested preparation to link required evidence with current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Identity, composition and exposure of the tested preparation: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labels and checking adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research distinguishing formulation differences and result attribution; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The specific tested low-molecular-weight collagen peptide at 3 g daily is retained; it does not become an effect of all oral collagen or other compositions.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Molecular-weight distribution, source/manufacturing, detailed composition, batches and actual individual exposure are unverified. Existing-content review remains incomplete.", "missingness": "Molecular-weight distribution, source/manufacturing, detailed composition, batches and actual individual exposure are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original product-identity, composition, batch and exposure materials" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Placebo, manufacturing and control conditions", "needed": "Actual placebo identity, matching and accompanying conditions", "role": "Required", "role_reason": "Preparation item distinguishing actual placebo identity, matching and accompanying conditions to link required evidence with current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Actual placebo identity, matching and accompanying conditions: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; CHAMGAP-specific independence/attribution conditions. Official-method sections used in this pilot do not certify all these detailed items.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research on control conditions and measurement bias; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original double-blind placebo-controlled design and account that NEWTREE manufactured product and placebo are retained.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Placebo ingredients, sensory matching, co-exposure and equality of actual conditions between groups are unverified. Existing-content review remains incomplete.", "missingness": "Placebo ingredients, sensory matching, co-exposure and equality of actual conditions between groups are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Placebo identity, sensory matching and group-specific co-exposure materials" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Research exposure: 3 g daily for 180 days", "needed": "Original dose/duration and actual exposure/discontinuation", "role": "Required", "role_reason": "Preparation item distinguishing original dose/duration and actual exposure/discontinuation to link required evidence with current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original dose/duration and actual exposure/discontinuation: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labels and checking adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research distinguishing dose/duration-specific applicability; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original research condition was 3 g daily for 180 days; no new intake instructions, product recommendations or treatment methods are provided.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Individual exposure, adherence measurement, discontinuation/changes and results for other durations/doses are unverified. Existing-content review remains incomplete.", "missingness": "Individual exposure, adherence measurement, discontinuation/changes and results for other durations/doses are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Research exposure, adherence, discontinuation and change records" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "80 randomized; 40/40", "needed": "Allocation unit, generation/concealment and group denominators", "role": "Required", "role_reason": "Preparation item distinguishing allocation unit, generation/concealment and group denominators to link required evidence with current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Allocation unit, generation/concealment and group denominators: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.", "basis": "M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M04 §4.6.1–4.6.2 distinguish studies from reports; cohort/outcome linkage is internally applied; M04 §4.5–4.6 cover material collection/selection; separation of access/reading and hyperlink specifications are internally designed.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research on allocation procedures and actual populations; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original allocation denominators of 80 participants randomized, 40 per group, are retained.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Original allocation generation/concealment, stratification, responsible roles and implementation remain unread. The two groups are not separate trials. Existing-content review remains incomplete.", "missingness": "Original allocation generation/concealment, stratification, responsible roles and implementation remain unread. The two groups are not separate trials.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation procedures, access permissions and analysis-population flow materials" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Double blinding and measurement roles", "needed": "Masking of participants, clinical/research staff and outcome assessment/analysis", "role": "Required", "role_reason": "Preparation item distinguishing masking of participants, clinical/research staff and outcome assessment/analysis to link required evidence with current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Masking of participants, clinical/research staff and outcome assessment/analysis: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.", "basis": "M08 Table 8.2.a, M03 §3.2.4; CHAMGAP adaptation; Material collection/selection principles in M04 §4.5–4.6; Separating access from reading and defining hyperlink behavior are designed by CHAMGAP", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research on maintained masking and outcome measurement; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original double-blind design is retained.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Role-specific masking, maintenance/unmasking, sensory matching and measurement/analysis procedures are unverified. The design label does not certify absence of actual bias. Existing-content review remains incomplete.", "missingness": "Role-specific masking, maintenance/unmasking, sensory matching and measurement/analysis procedures are unverified. The design label does not certify absence of actual bias.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Role-specific masking and measurement/analysis records" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "WOMAC pain scale", "needed": "Definition, units, range and measurement conditions of the selected pain scale", "role": "Required", "role_reason": "Preparation item distinguishing definition, units, range and measurement conditions of the selected pain scale to link required evidence with current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Definition, units, range and measurement conditions of the selected pain scale: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.", "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a and M03 §3.2.4; Chamgap application; M03 §3.2.4; Chamgap interpretation boundary", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research using the same pain scale and measurement scope; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The selected existing question is reduced WOMAC pain, distinguished from WOMAC total, other subscales and VAS.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. WOMAC version, pain range/score units, assessment procedures, observer/self-report and measurement conditions are unverified. Existing-content review remains incomplete.", "missingness": "WOMAC version, pain range/score units, assessment procedures, observer/self-report and measurement conditions are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original scale, measurement procedures and outcome-specific materials" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Change from baseline to day 180", "needed": "Distinctions between change, final values, timing and analysis population", "role": "Required", "role_reason": "Preparation item distinguishing distinctions between change, final values, timing and analysis population to link required evidence with current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Distinctions between change, final values, timing and analysis population: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M08 Table 8.2.a, M04 §4.6.3; internal application.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research distinguishing change, final values and time points; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The prespecified primary endpoint was WOMAC pain change from baseline to day 180; it is not recast as final absolute values or another visit’s results.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Group-specific baseline/final values, actual visit windows, repeated/intermediate results and time-specific observed denominators are unverified. Existing-content review remains incomplete.", "missingness": "Group-specific baseline/final values, actual visit windows, repeated/intermediate results and time-specific observed denominators are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline, final/visit-specific values and observed materials" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Group-specific PP pain change", "needed": "Selected group-specific changes, dispersion and group correspondence", "role": "Required", "role_reason": "Preparation item distinguishing selected group-specific changes, dispersion and group correspondence to link required evidence with current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Selected group-specific changes, dispersion and group correspondence: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.", "basis": "M08 §8.2.2, M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap's own design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research using the same estimand/population scope; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original WOMAC changes in the PP population of 60 were -1.90±4.14 versus +0.61±3.97 with placebo; values, signs and groups are retained.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Group-specific PP/observed denominators, meaning of ±, scale range, adjusted/change calculations and individual data are unverified. No new final values, dispersion or response rates are calculated. Existing-content review remains incomplete.", "missingness": "Group-specific PP/observed denominators, meaning of ±, scale range, adjusted/change calculations and individual data are unverified. No new final values, dispersion or response rates are calculated.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group-specific analysis/observed denominators, change calculations and dispersion materials" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Original approximate -2.51 and P=.006", "needed": "Original between-group estimate, P value, model and precision", "role": "Required", "role_reason": "Preparation item distinguishing original between-group estimate, P value, model and precision to link required evidence with current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original between-group estimate, P value, model and precision: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.", "basis": "M15 §15.3.1–15.3.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research on precision and uncertainty of the same estimand; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The approximate between-group -2.51 points and P=.006 are retained as existing reported/explanatory values, without new calculation or confirmation.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Original between-group model, exact estimand, adjustment variables, test and 95% CI are unverified or originally unreported. Existing-content review remains incomplete.", "missingness": "Original between-group model, exact estimand, adjustment variables, test and 95% CI are unverified or originally unreported.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original model, exact output and CI for the selected comparison" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Between-group CI and clinical-meaning gaps", "needed": "CI and prespecified important difference for the selected comparison", "role": "Required", "role_reason": "Preparation item distinguishing cI and prespecified important difference for the selected comparison to link required evidence with current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "CI and prespecified important difference for the selected comparison: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.", "basis": "M15 §15.3.1–15.3.3; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.5–4.6 cover material collection/selection; separation of access/reading and hyperlink specifications are internally designed.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research separating uncertainty from important differences; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The historical account that a between-group WOMAC pain CI was absent from the preserved summary is retained. No CI is calculated from ± values, sample size or P value.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Direct materials for a prespecified pain-success threshold, CI, measurement scope and clinical importance are unverified; post hoc SMD/external criteria do not fill gaps. Existing-content review remains incomplete.", "missingness": "Direct materials for a prespecified pain-success threshold, CI, measurement scope and clinical importance are unverified; post hoc SMD/external criteria do not fill gaps.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original analysis output, prespecified important difference and scale correspondence" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Null VAS; separate result", "needed": "Relationship between another pain result in the same trial and the selected question", "role": "Required", "role_reason": "Preparation item distinguishing relationship between another pain result in the same trial and the selected question to link required evidence with current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relationship between another pain result in the same trial and the selected question: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.", "basis": "M04 §4.6.3 and M15 §§15.3.1–15.3.3; status separation is Chamgap-designed; M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M15 §§15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a and M04 §4.6.3; Chamgap adaptation", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research distinguishing scale-specific results and disagreement; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Concurrent VAS pain had an original null result, P=.299. Positive WOMAC results are not generalized to all pain scales.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Group-specific VAS values, denominators, exact timing, prespecified hierarchy, CI and between-scale correspondence are unverified. Existing-content review remains incomplete.", "missingness": "Group-specific VAS values, denominators, exact timing, prespecified hierarchy, CI and between-scale correspondence are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original VAS outcome-specific data, analysis/hierarchy and WOMAC correspondence" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "PP 60: selection criteria", "needed": "Inclusion criteria and group-specific denominators for the primary PP efficacy population", "role": "Required", "role_reason": "Preparation item distinguishing inclusion criteria and group-specific denominators for the primary PP efficacy population to link required evidence with current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Inclusion criteria and group-specific denominators for the primary PP efficacy population: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research on differences between PP-selected and randomized populations; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original primary efficacy population was 60/80 PP participants with at least 80% adherence and no major deviation, distinct from the safety population of 80 and randomized 40/40.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Group-specific PP denominators, time-specific observations, deviation/attrition reasons and the selected question’s actual analysis population are not verified in detail. Existing-content review remains incomplete.", "missingness": "Group-specific PP denominators, time-specific observations, deviation/attrition reasons and the selected question’s actual analysis population are not verified in detail.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group-specific PP inclusion/exclusion, observation and deviation materials" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "20/80 (25%) excluded", "needed": "Reasons, group distribution and outcome implications of efficacy exclusions", "role": "Required", "role_reason": "Preparation item distinguishing reasons, group distribution and outcome implications of efficacy exclusions to link required evidence with current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Reasons, group distribution and outcome implications of efficacy exclusions: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research on uncertainty under exclusion/missingness assumptions; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original exclusion of 20/80 (25%) is retained; exclusions are not all relabeled as follow-up losses or a single reason.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Group-specific adherence/deviation versus missingness/discontinuation, missingness assumptions and sensitivity results are unverified. Existing-content review remains incomplete.", "missingness": "Group-specific adherence/deviation versus missingness/discontinuation, missingness assumptions and sensitivity results are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group-specific exclusion reasons, observation/missingness and analysis handling" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "ITT described as the same direction", "needed": "ITT population, estimand, precision and relationship to PP", "role": "Required", "role_reason": "Preparation item distinguishing iTT population, estimand, precision and relationship to PP to link required evidence with current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "ITT population, estimand, precision and relationship to PP: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.", "basis": "M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research distinguishing different ITT/PP analysis scopes; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original account describes ITT only as the same direction; this does not fill equal effect sizes, significance, CI or confirmation of PP results.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Selected-outcome ITT values, group denominators, model, missingness handling and CI/P are unverified. Existing-content review remains incomplete.", "missingness": "Selected-outcome ITT values, group denominators, model, missingness handling and CI/P are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Outcome-specific ITT estimates, denominators, missingness model and PP correspondence" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "PP Kellgren–Lawrence imbalance", "needed": "Baseline disease-stage distribution and adjustment in the PP population", "role": "Required", "role_reason": "Preparation item distinguishing baseline disease-stage distribution and adjustment in the PP population to link required evidence with current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Baseline disease-stage distribution and adjustment in the PP population: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.", "basis": "M03 §3.2.1; detailed population conditions are internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research on baseline imbalance and population selection; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original account of PP Kellgren–Lawrence grade-distribution imbalance, P=.037, is retained.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Group-specific stage distributions, pain/other baseline differences, adjustment and sensitivity materials are unverified. No adjusted effect is newly calculated. Existing-content review remains incomplete.", "missingness": "Group-specific stage distributions, pain/other baseline differences, adjustment and sensitivity materials are unverified. No adjusted effect is newly calculated.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "PP baseline characteristics and adjustment/sensitivity materials" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Co-exposure and adherence", "needed": "Pain-related co-exposure and adherence/change records", "role": "Required", "role_reason": "Preparation item distinguishing pain-related co-exposure and adherence/change records to link required evidence with current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Pain-related co-exposure and adherence/change records: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; custom application; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are custom design; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research on co-exposure and attribution of product results; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The PP inclusion criterion of at least 80% adherence is distinguished from actual participant-specific adherence.", "condition_status": "Unverified", "status_reason": "The currently required information is unverified in the preserved summary. Concurrent analgesics, rehabilitation/activity, other supplements, rescue medication and actual adherence measurement/discontinuation are unverified. No new treatment/exercise methods are created. Existing-content review remains incomplete.", "missingness": "Concurrent analgesics, rehabilitation/activity, other supplements, rescue medication and actual adherence measurement/discontinuation are unverified. No new treatment/exercise methods are created.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group-specific co-exposure, adherence, change and rescue-medication records" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "KCT and prospective registration", "needed": "Original registration identity, prespecified endpoints/analyses and changes", "role": "Required", "role_reason": "Preparation item distinguishing original registration identity, prespecified endpoints/analyses and changes to link required evidence with current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original registration identity, prespecified endpoints/analyses and changes: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; custom application; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research linking prespecified plans with reported results; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original registration identifier KCT0005507 and prospective-registration account are retained; identifier format is not changed and no new registration status is certified.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Registration full text, change history, protocol/SAP and comparison with actual recruitment/analysis timing remain unread. Existing-content review remains incomplete.", "missingness": "Registration full text, change history, protocol/SAP and comparison with actual recruitment/analysis timing remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original registration history, protocol and SAP" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Two pain scales and prespecified hierarchy", "needed": "Prespecified endpoint, timing and multiplicity scope for WOMAC pain and VAS", "role": "Required", "role_reason": "Preparation item distinguishing prespecified endpoint, timing and multiplicity scope for WOMAC pain and VAS to link required evidence with current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Prespecified endpoint, timing and multiplicity scope for WOMAC pain and VAS: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; internal application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research distinguishing endpoint estimates and prespecified hierarchy; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The prespecified primary endpoint was baseline-to-day-180 WOMAC pain change; concurrent VAS was a separate pain outcome. The original false marker for split coprimary results is not converted into a new coprimary declaration.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. VAS prespecified hierarchy, actual assessment windows, multiple outcome/time-point tests, multiplicity handling and SAP are unverified. Existing-content review remains incomplete.", "missingness": "VAS prespecified hierarchy, actual assessment windows, multiple outcome/time-point tests, multiplicity handling and SAP are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original endpoint hierarchy, timing and multiplicity plans" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Sample size: 10-point WOMAC total difference", "needed": "Sample-size planning endpoint/assumptions and selected result", "role": "Required", "role_reason": "Preparation item distinguishing sample-size planning endpoint/assumptions and selected result to link required evidence with current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Sample-size planning endpoint/assumptions and selected result: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; internal application; M15 §15.3.1–15.3.3; internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research on planning assumptions and actual endpoints; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original sample-size calculation assumed a 10-point WOMAC total difference rather than WOMAC pain; those 10 points do not become a prespecified pain-success threshold.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Planned variance, power, attrition assumptions and precision scope for pain/VAS are unverified. Existing-content review remains incomplete.", "missingness": "Planned variance, power, attrition assumptions and precision scope for pain/VAS are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Sample-size calculation plan/assumptions and endpoint-specific precision" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Post hoc SMD and external important difference", "needed": "Prespecified success threshold versus post hoc interpretation/external criteria", "role": "Required", "role_reason": "Preparation item distinguishing prespecified success threshold versus post hoc interpretation/external criteria to link required evidence with current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Prespecified success threshold versus post hoc interpretation/external criteria: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.", "basis": "M15 §15.3.1–15.3.3; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application; M03 §3.2.4; internal extension boundaries; M04 §4.5–4.6 cover material collection/selection; separation of access/reading and hyperlink specifications are internally designed.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research distinguishing important differences from post hoc interpretation; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The authors’ post hoc interpretation that observed SMD 0.46 exceeded external AAOS minimum difference 0.39 is retained as original history; the original account states no clinical-success threshold was prespecified.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. SMD definition, corresponding endpoint, denominator, CI and population/scale/applicability scope of the external criterion are unverified. No new standardized effect or success certification is made. Existing-content review remains incomplete.", "missingness": "SMD definition, corresponding endpoint, denominator, CI and population/scale/applicability scope of the external criterion are unverified. No new standardized effect or success certification is made.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Prespecified important difference, original analysis and external-criterion correspondence" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "One trial, sibling sheets and independence", "needed": "Report–trial–population–outcome relationships and independent replication materials", "role": "Required", "role_reason": "Preparation item distinguishing report–trial–population–outcome relationships and independent replication materials to link required evidence with current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Report–trial–population–outcome relationships and independent replication materials: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.", "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application; M04 §4.6.1–4.6.2, M15 §15.3.1; custom application; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research distinguishing separate evidence for the same formulation/question; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The same Kim DU 2025 report, KCT0005507, 80 participants/PP60, two scales, time points and sibling sheets are not totaled as new independent trials/participants. Original R1/I0 are historical parent-verdict context.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. External comparison of actual unique trial/participant correspondence and independent replication is unverified. Existing-content review remains incomplete.", "missingness": "External comparison of actual unique trial/participant correspondence and independent replication is unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report/registration/population/outcome relationships and separate replication materials" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Research and publication support", "needed": "Separate funding and research/publication support roles", "role": "Required", "role_reason": "Preparation item distinguishing separate funding and research/publication support roles to link required evidence with current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Separate funding and research/publication support roles: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.", "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research on support roles and outcome reporting; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original account that NEWTREE Co., Ltd. supported research and publication is retained.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Original support contracts, amounts, individual costs/roles and disclosures remain unread; publication support does not establish every cost item was verified. Existing-content review remains incomplete.", "missingness": "Original support contracts, amounts, individual costs/roles and disclosures remain unread; publication support does not establish every cost item was verified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original research/publication support contracts, roles and disclosures" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Product and placebo manufacturing", "needed": "Individual records of manufacturing and free-product support/batches", "role": "Required", "role_reason": "Preparation item distinguishing individual records of manufacturing and free-product support/batches to link required evidence with current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Individual records of manufacturing and free-product support/batches: the corresponding original materials/analysis scope must be available and unverified matters distinguishable. Existing wording is linked here; content review remains incomplete.", "basis": "Chamgap independence/attribution conditions. 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Manufacturing/batches, supply contracts, whether provision was free and role details are unverified. Manufacturing alone does not fill free-support details. Existing-content review remains incomplete.", "missingness": "Manufacturing/batches, supply contracts, whether provision was free and role details are unverified. Manufacturing alone does not fill free-support details.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Manufacturing, product/placebo supply, batches and cost materials" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Company and subsidiary authors", "needed": "Author-specific affiliations/employment versus contributions/COI", "role": "Required", "role_reason": "Preparation item distinguishing author-specific affiliations/employment versus contributions/COI to link required evidence with current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. 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Existing wording is linked here; content review remains incomplete.", "basis": "Chamgap’s own independence/attribution conditions; official methodology sections in this pilot do not certify all these detailed items; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research distinguishing author relationships and reporting roles; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original Korean account states Do-Un Kim was a NEWTREE employee and Seung Un Kim was affiliated with subsidiary EVERSPRING; the complete original summary also retains the English employment/affiliation account.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Original author-specific employment, contributions, equity/other relationships, timing and disclosures remain unread; no current affiliations/relationships are certified. Existing-content review remains incomplete.", "missingness": "Original author-specific employment, contributions, equity/other relationships, timing and disclosures remain unread; no current affiliations/relationships are certified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Author-specific affiliation, contribution, employment and COI disclosures" }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Declaration of company nonparticipation", "needed": "Declared and actual roles in design, recruitment, collection, analysis and interpretation", "role": "Required", "role_reason": "Preparation item distinguishing declared and actual roles in design, recruitment, collection, analysis and interpretation to link required evidence with current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. 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The original account records one urticaria event judged unrelated to product, recovery without sequelae and no serious adverse event.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Group-specific safety denominators, observation windows, collection criteria, discontinuation, judgment procedures and long-term/vulnerable-population harms are unverified. No new rates, causal judgments or all-safety certification are made. Existing-content review remains incomplete.", "missingness": "Group-specific safety denominators, observation windows, collection criteria, discontinuation, judgment procedures and long-term/vulnerable-population harms are unverified. No new rates, causal judgments or all-safety certification are made.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Harms collection, group-specific denominators, events/discontinuation and judgment materials" }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Other collagen and opposing materials", "needed": "Other-composition trial identity and correspondence to the same formulation/question", "role": "Required", "role_reason": "Preparation item distinguishing other-composition trial identity and correspondence to the same formulation/question to link required evidence with current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. 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They do not become the selected product’s direct comparison or new reports.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Individual bibliographies, compositions, populations, timing and estimands of mentioned other trials are not linked in the current preserved summary and remain unverified. 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External papers, registration, protocols, SAP and original funding/COI disclosures remain unread without attempted access.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed original materials are unread and content review is incomplete. Bibliography links or KCT identifiers do not upgrade external acquisition, reading or review. No separate external-link/click check is performed. Existing-content review remains incomplete.", "missingness": "Bibliography links or KCT identifiers do not upgrade external acquisition, reading or review. 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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": "2026-08-26", "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": "2026-08-26", "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": "2026-08-26", "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": "2026-08-26", "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/40977985/" } ] } ], "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": "S01 Kim DU2025/KCT0005507 concerns a double-blind placebo-controlled 180-day trial in 80 adults with Kellgren–Lawrence grade 1–2, randomized 40/40. Primary PP60/80 with exclusion of 20/80 (25%) for the specific 3-g-daily low-molecular-weight peptide is distinct from safety population of 80. Prespecified primary day-180 WOMAC pain change of -1.90±4.14 versus +0.61±3.97, approximate between-group -2.51 points/P=.006, and concurrent VAS P=.299 are different scales/results. Exact VAS timing, observed/analysis denominators, group values/CI/hierarchy are unverified in the current summary. Same-direction ITT accounts, PP KL imbalance P=.037, the 10-point WOMAC total sample-size assumption, post hoc SMD 0.46/external AAOS 0.39 and manufacturer support/author-relationship gaps are distinguished. The same report, registration, 80 participants/PP60, groups, scales, time points and sibling sheets are not totaled as new independent trials/participants. Report/material slots do not establish unique clinical-trial, participant or independent-replication totals; no new totals or independence certification are made." }, "history": [ { "date": "2026-10-12", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public pages and materials were prepared from the existing 32 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-12" }