{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2942-s0", "verdict_number": "2942", "title": "Two-year balance training × reduced moderate-plus-serious injurious falls in women aged 75–85 with impaired balance: an evidence checklist", "view_version": "1.0", "view_created_date": "2026-10-11", "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": "Review of the existing content is incomplete. External abstracts, full texts, registration records, protocols and SAPs have not been read, and access has not been attempted.", "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": "706 community-dwelling women aged 75–85 with impaired balance or gait; detailed selection and baseline characteristics unverified", "intervention": "Original two-year program of weekly supervised group balance training plus home exercise; actual adherence and exposure unverified", "dose": null, "comparator": "352 exercise participants versus 354 controls; detailed control care and shared treatment unverified", "endpoint": "Moderate-plus-serious injurious-fall rate; original events 305/397; shared-frailty HR.81", "duration": "Nominal two-year follow-up; primary outcome amended about eight months after recruitment began; actual observation time unverified", "excluded_extensions": [ "Repurposing the positive combined moderate-plus-serious finding as a serious-only, all-fall, individual-fracture, functional or mortality effect", "Changing the serious-only CI containing 1 or original grade D into an exactly zero effect, equivalence, exclusion of every important benefit or a new grade", "Turning 305/397 or 68/87 events into unique people or response rates, or subtracting from the combined result to calculate a new moderate-only effect", "Replacing actual endpoint-specific completion, analysis, woman-year or safety denominators with 706 participants, 352/354 allocation and nominal two years, or calculating new rates, losses or event totals", "Automatically applying the combined shared-frailty and center-adjusted model, P=.04 or .45/.56 rates to serious-only models, tests or denominators", "Calculating a simple rate ratio, new percentage reduction or absolute risk from the HR, or creating CI, P values or hypothetical numbers absent from the original", "Changing the approximate eight-month recruitment timing, original target of 1,000 per arm or Korean first serious fall versus English serious falls into a new actual sample total or established first-event model without comparing amendment plans", "Treating absence of a report of data-driven amendment as proof of no interim-data access, complete prespecification or confirmed data-driven amendment", "Using five exercise-related events as a full safety denominator, significant harm, causality or serious-injury effect, or creating movement, supervision or environmental prescriptions", "Adding Tai ji quan 1812 or Otago 1834 assessment links as new direct trials or replication of the identical program", "Adding the same trial or report, people, groups, times, severities, repeated events or related sheets into new independent-trial, participant or event totals", "Changing original public support, non-involvement, R1/I2 or unverified product support and COI into new verification of independence, absence of relationships or methodological certification", "Inheriting parent B76, original axes or historical cross-checks as selected B/D scores or axes, or as new content review or external reading", "Generalizing to other sexes, ages, settings, exercises or isolated components, beyond two years or after cessation, or providing exercise programs, movement instructions, prescriptions or treatment guidance" ] }, "requirements": [ { "item_id": "N01", "question_type": "Efficacy comparison and presentation of stored material", "question": "Which injurious-fall question and original assessment are preserved?", "needed": "Separate the selected grade B and note, parent B76 and serious-only grade D", "role": "Required", "role_reason": "This item separates Separate the selected grade B and note, parent B76 and serious-only grade D to link materials needed for the selected question with the materials currently available.", "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 materials and analysis scope for Separate the selected grade B and note, parent B76 and serious-only grade D must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal 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": "Update the question, assessment record and assessment context separately. This is a proposal; no new investigation, 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 claim is reduced moderate-plus-serious injurious falls, with subclaim grade B and a note of HR.81/P=.04. Parent B76 and its axes provide the parent context; serious-only grade D addresses a separate question.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. The subclaim has no score, status or axis values; parent values are not used to fill them. The original content review remains incomplete.", "missingness": "The subclaim has no score, status or axis values; parent values are not used to fill them.", "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": "Correction records for the selected claim and parent assessment" }, { "item_id": "N02", "question_type": "Efficacy comparison and presentation of stored material", "question": "Who was studied and how were community participants recruited?", "needed": "Women aged 75–85, impaired balance or gait, recruitment, exclusions and baseline risk", "role": "Required", "role_reason": "This item separates Women aged 75–85, impaired balance or gait, recruitment, exclusions and baseline risk to link materials needed for the selected question with the materials currently available.", "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 materials and analysis scope for Women aged 75–85, impaired balance or gait, recruitment, exclusions and baseline risk must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.", "basis": "M03 §3.2.1; detailed population conditions 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": "Retain the differences between the studied population and other groups. This is a proposal; no new investigation, 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 Ossébo population was 706 community-dwelling women aged 75–85 with impaired balance or gait.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Tests and thresholds for impairment, baseline falls and function, eligibility and exclusions, illnesses, preceding treatment and recruitment procedures are unverified. The findings are not extended to all older adults, men or institutional populations. The original content review remains incomplete.", "missingness": "Tests and thresholds for impairment, baseline falls and function, eligibility and exclusions, illnesses, preceding treatment and recruitment procedures are unverified. The findings are not extended to all older adults, men or institutional populations.", "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 and eligibility records, baseline function and risk tables" }, { "item_id": "N03", "question_type": "Efficacy comparison and presentation of stored material", "question": "What was the two-year intervention and actual exposure?", "needed": "Supervised group sessions, home exercise, duration, actual adherence and changes", "role": "Required", "role_reason": "This item separates Supervised group sessions, home exercise, duration, actual adherence and changes to link materials needed for the selected question with the materials currently available.", "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 materials and analysis scope for Supervised group sessions, home exercise, duration, actual adherence and changes must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.", "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap 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": "Distinguish the planned program from actual exposure. This is a proposal; no new investigation, 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 research program combined weekly supervised group balance training and home exercise over two years. It is not presented as an exercise program, movement instruction or prescription.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Detailed components, intensity, home exposure, actual attendance and adherence, discontinuation and changes are unverified. The separate effect of each component is not established. The original content review remains incomplete.", "missingness": "Detailed components, intensity, home exposure, actual attendance and adherence, discontinuation and changes are unverified. The separate effect of each component is not established.", "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": "Intervention plans and records of actual exposure, adherence and changes" }, { "item_id": "N04", "question_type": "Efficacy comparison and presentation of stored material", "question": "What were the control, shared and concomitant measures?", "needed": "Control services, other exercise or treatment, environmental changes and rescue measures", "role": "Required", "role_reason": "This item separates Control services, other exercise or treatment, environmental changes and rescue measures to link materials needed for the selected question with the materials currently available.", "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 materials and analysis scope for Control services, other exercise or treatment, environmental changes and rescue measures must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.", "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap 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": "Distinguish the program contribution from accompanying differences. This is a proposal; no new investigation, 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 text records a comparison of 352 exercise participants and 354 controls.", "condition_status": "Unverified", "status_reason": "The information currently needed is unverified in the stored summary. Exact control care and information, shared or group-specific medication, exercise, environmental adjustments, rescue measures and changes are unverified. The control is not arbitrarily named no intervention or placebo. The original content review remains incomplete.", "missingness": "Exact control care and information, shared or group-specific medication, exercise, environmental adjustments, rescue measures and changes are unverified. The control is not arbitrarily named no intervention or placebo.", "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 control, concomitant measures and change records" }, { "item_id": "N05", "question_type": "Efficacy comparison and presentation of stored material", "question": "What was the 20-center randomized design and allocation?", "needed": "Centers, allocation unit and method, concealment and baseline balance", "role": "Required", "role_reason": "This item separates Centers, allocation unit and method, concealment and baseline balance to link materials needed for the selected question with the materials currently available.", "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 materials and analysis scope for Centers, allocation unit and method, concealment and baseline balance must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.", "basis": "M08 §8.1–8.2.3; own application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is our 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": "Record the roles of centers and people within the source scope. This is a proposal; no new investigation, 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 20-center, two-year RCT and 706 participants allocated 352/354 are preserved.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Allocation unit, sequence and concealment, center-specific allocation and baseline balance, and parallel or other operational details are unverified. Twenty centers are not automatically treated as 20 randomized clusters. The original content review remains incomplete.", "missingness": "Allocation unit, sequence and concealment, center-specific allocation and baseline balance, and parallel or other operational details are unverified. Twenty centers are not automatically treated as 20 randomized clusters.", "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": "Methods, allocation, center and baseline tables" }, { "item_id": "N06", "question_type": "Efficacy comparison and presentation of stored material", "question": "How were moderate-plus-serious injurious events defined?", "needed": "Physical harm, healthcare use, moderate and serious criteria and overlap", "role": "Required", "role_reason": "This item separates Physical harm, healthcare use, moderate and serious criteria and overlap to link materials needed for the selected question with the materials currently available.", "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 materials and analysis scope for Physical harm, healthcare use, moderate and serious criteria and overlap must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M03 §3.2.4; our own 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": "Define combined injuries, serious-only injuries and all falls separately. This is a proposal; no new investigation, 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 text states that geriatricians unaware of allocation classified events using physical-harm and healthcare-use criteria. The selected outcome combines moderate and serious injurious falls.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Thresholds and components for each severity category, overlap or reclassification of the same fall, number and agreement of adjudicators and medical-record confirmation are unverified. The original content review remains incomplete.", "missingness": "Thresholds and components for each severity category, overlap or reclassification of the same fall, number and agreement of adjudicators and medical-record confirmation 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": "Injury classification criteria, adjudication records and outcome tables" }, { "item_id": "N07", "question_type": "Efficacy comparison and presentation of stored material", "question": "What is known about fall collection, blinded adjudication and omissions?", "needed": "Event reporting, confirmation, blinding, detection and follow-up methods", "role": "Required", "role_reason": "This item separates Event reporting, confirmation, blinding, detection and follow-up methods to link materials needed for the selected question with the materials currently available.", "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 materials and analysis scope for Event reporting, confirmation, blinding, detection and follow-up methods must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.", "basis": "M08 Table 8.2.a, M03 §3.2.4; 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": "Separate actual verification at the reporting and adjudication stages. This is a proposal; no new investigation, 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 statement that injury adjudicators were unaware of allocation is preserved.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Fall collection frequency and methods, participant and collector blinding, missing or differential reports and the full scope of adjudication materials are unverified. Blinded adjudication is not treated as proof that all collection bias was absent. The original content review remains incomplete.", "missingness": "Fall collection frequency and methods, participant and collector blinding, missing or differential reports and the full scope of adjudication materials are unverified. Blinded adjudication is not treated as proof that all collection bias was absent.", "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": "Collection, confirmation, blinding and omission procedures" }, { "item_id": "N08", "question_type": "Efficacy comparison and presentation of stored material", "question": "Are 305/397 counts of people or fall events?", "needed": "Separate events, people, repeated events and group-specific denominators", "role": "Required", "role_reason": "This item separates Separate events, people, repeated events and group-specific denominators to link materials needed for the selected question with the materials currently available.", "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 materials and analysis scope for Separate events, people, repeated events and group-specific denominators must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap's own design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome 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": "Link randomized people, fall events and repetition separately. This is a proposal; no new investigation, 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 exercise/control event counts of 305 versus 397 moderate-plus-serious injurious falls are preserved.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Unique people who fell, repeated and first-event distributions, and observation and analysis denominators are unverified. Event counts are not converted to people or response rates, and totals or occurrence proportions are not calculated. The original content review remains incomplete.", "missingness": "Unique people who fell, repeated and first-event distributions, and observation and analysis denominators are unverified. Event counts are not converted to people or response rates, and totals or occurrence proportions are not 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": "Results and flow diagrams separating people, events and repeated events" }, { "item_id": "N09", "question_type": "Efficacy comparison and presentation of stored material", "question": "What are the woman-year rates and follow-up duration?", "needed": "Original rates, woman-years, actual observation time and censoring", "role": "Required", "role_reason": "This item separates Original rates, woman-years, actual observation time and censoring to link materials needed for the selected question with the materials currently available.", "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 materials and analysis scope for Original rates, woman-years, actual observation time and censoring must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap 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": "Distinguish nominal two-year follow-up from actual person-time. This is a proposal; no new investigation, 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 rates of 0.45 versus 0.56 events per woman-year and two-year follow-up are preserved.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Actual woman-years by group, attrition, deaths, discontinuation, censoring, missing data and denominator construction are unverified. Denominators or new rates are not calculated as 352/354 multiplied by two years. The original content review remains incomplete.", "missingness": "Actual woman-years by group, attrition, deaths, discontinuation, censoring, missing data and denominator construction are unverified. Denominators or new rates are not calculated as 352/354 multiplied by two years.", "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": "Actual observation time, censoring and attrition records and rate tables" }, { "item_id": "N10", "question_type": "Efficacy comparison and presentation of stored material", "question": "Which model produced the shared-frailty HR, interval and P value?", "needed": "Center adjustment, repeated-event and time handling, original HR, CI and P value", "role": "Required", "role_reason": "This item separates Center adjustment, repeated-event and time handling, original HR, CI and P value to link materials needed for the selected question with the materials currently available.", "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 materials and analysis scope for Center adjustment, repeated-event and time handling, original HR, CI and P value must be available so that unverified matters can be distinguished. This record links preserved wording; the original 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": "Retain event counts, rates, HR and analysis definitions separately. This is a proposal; no new investigation, 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 text records a center-adjusted shared-frailty HR.81, 95% CI.67~.99 and P=.04.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Time and repeated events, censoring, frailty and covariates, actual denominators by group and detailed modeling are unverified. A simple ratio of the original rates or a newly calculated percentage reduction does not replace the HR. The original content review remains incomplete.", "missingness": "Time and repeated events, censoring, frailty and covariates, actual denominators by group and detailed modeling are unverified. A simple ratio of the original rates or a newly calculated percentage reduction does not replace the HR.", "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, SAP and outcome tables" }, { "item_id": "N11", "question_type": "Efficacy comparison and presentation of stored material", "question": "What are the observed interval and criteria for an important difference?", "needed": "Original interval, effect magnitude, importance and prior assumptions", "role": "Required", "role_reason": "This item separates Original interval, effect magnitude, importance and prior assumptions to link materials needed for the selected question with the materials currently available.", "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 materials and analysis scope for Original interval, effect magnitude, importance and prior assumptions must be available so that unverified matters can be distinguished. This record links preserved wording; the original 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", "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": "Separate sources for the interval and prior criteria. This is a proposal; no new investigation, 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 combined-injury HR.81/CI.67~.99/P=.04 and original grade B are preserved.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Clinically important injury-rate or HR thresholds, sample-size assumptions and the basis for interpreting the interval are unverified. Significance alone does not establish every important benefit or personal prevention effect. The original content review remains incomplete.", "missingness": "Clinically important injury-rate or HR thresholds, sample-size assumptions and the basis for interpreting the interval are unverified. Significance alone does not establish every important benefit or personal prevention effect.", "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": "Importance and sample-size rationale and original analysis" }, { "item_id": "N12", "question_type": "Efficacy comparison and presentation of stored material", "question": "What was the primary-outcome amendment during recruitment?", "needed": "Definitions before and after amendment, timing, sample target and reasons", "role": "Required", "role_reason": "This item separates Definitions before and after amendment, timing, sample target and reasons to link materials needed for the selected question with the materials currently available.", "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 materials and analysis scope for Definitions before and after amendment, timing, sample target and reasons must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; Chamgap application; M04 §4.5, §4.6.3; limits to this material conversion reflect the review scope and 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": "Distinguish the amendment event from the hierarchy of actual results. This is a proposal; no new investigation, 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 text says that logistical and recruitment delays led to a reduction from the target of 1,000 per arm and a primary-outcome change about eight months after recruitment began. Korean says first serious fall; English says serious falls. The amended outcome combined moderate and serious injuries.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. The exact first-event and repeated-event definitions, revised target, prior versions and original amendment decision are unverified. Targets and original times are not newly totaled or established. The original content review remains incomplete.", "missingness": "The exact first-event and repeated-event definitions, revised target, prior versions and original amendment decision are unverified. Targets and original times are not newly totaled or established.", "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 and amended protocols, amendment history and sample-size plans" }, { "item_id": "N13", "question_type": "Efficacy comparison and presentation of stored material", "question": "How are data-driven amendment and limits to prespecification preserved?", "needed": "Amendment reasons, decision makers and timing, data access and analysis plans", "role": "Required", "role_reason": "This item separates Amendment reasons, decision makers and timing, data access and analysis plans to link materials needed for the selected question with the materials currently available.", "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 materials and analysis scope for Amendment reasons, decision makers and timing, data access and analysis plans must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; Chamgap application; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is 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": "Separate reported amendment reasons from what was actually verified. This is a proposal; no new investigation, 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 text records that the amendment was not reported as data-driven, while prespecification had limitations.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Actual interim-data access, decisions and approval, original plans and amendment reports have not been read. Neither data-driven amendment nor complete prespecification is newly established. The original content review remains incomplete.", "missingness": "Actual interim-data access, decisions and approval, original plans and amendment reports have not been read. Neither data-driven amendment nor complete prespecification is newly established.", "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": "Amendment decisions, interim-access records, registration and plans" }, { "item_id": "N14", "question_type": "Efficacy comparison and presentation of stored material", "question": "What are the randomized, completed and endpoint-specific analysis denominators and missing data?", "needed": "706/352/354, observation, analysis, attrition and handling", "role": "Required", "role_reason": "This item separates 706/352/354, observation, analysis, attrition and handling to link materials needed for the selected question with the materials currently available.", "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 materials and analysis scope for 706/352/354, observation, analysis, attrition and handling must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap 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": "Distinguish allocation from actual observation and analysis. This is a proposal; no new investigation, 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 inclusion/allocation counts of 706 participants (352/354) and two-year follow-up wording are preserved.", "condition_status": "Unverified", "status_reason": "The information currently needed is unverified in the stored summary. Numbers completing follow-up or analyzed, missing data, attrition and deaths by group, observation time for each injury endpoint and handling are unverified. The counts are not automatically treated as complete two-year follow-up for everyone or as safety denominators. The original content review remains incomplete.", "missingness": "Numbers completing follow-up or analyzed, missing data, attrition and deaths by group, observation time for each injury endpoint and handling are unverified. The counts are not automatically treated as complete two-year follow-up for everyone or as safety denominators.", "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": "Flow diagrams, endpoint-specific denominators, follow-up and missing-data tables" }, { "item_id": "N15", "question_type": "Efficacy comparison and presentation of stored material", "question": "What is known about ITT, adherence effects and supplementary or sensitivity analyses?", "needed": "Effect of interest, ITT/PP, actual exposure, changes and sensitivity analyses", "role": "Required", "role_reason": "This item separates Effect of interest, ITT/PP, actual exposure, changes and sensitivity analyses to link materials needed for the selected question with the materials currently available.", "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 materials and analysis scope for Effect of interest, ITT/PP, actual exposure, changes and sensitivity analyses must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.", "basis": "M08 §8.2.2, M15 §15.3.1; our own application; M03 §3.2.3, M08 §8.2.2–8.2.3; our own 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": "Record the difference between assignment to the program and actual participation effects. This is a proposal; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Only the original description of a center-adjusted model is available.", "condition_status": "Unverified", "status_reason": "The information currently needed is unverified in the stored summary. ITT/PP, adherence and component-specific home-exercise effects, missing-data and model sensitivity analyses and prespecified subgroups are unverified. Unnamed analyses or independent component effects are not filled in. The original content review remains incomplete.", "missingness": "ITT/PP, adherence and component-specific home-exercise effects, missing-data and model sensitivity analyses and prespecified subgroups are unverified. Unnamed analyses or independent component effects are not filled in.", "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": "SAP, exposure, analysis populations and sensitivity materials" }, { "item_id": "N16", "question_type": "Efficacy comparison and presentation of stored material", "question": "Is the serious-injury-only result preserved alongside the combined result?", "needed": "Combined versus serious-only injuries, events, original HR and CI and hierarchy", "role": "Required", "role_reason": "This item separates Combined versus serious-only injuries, events, original HR and CI and hierarchy to link materials needed for the selected question with the materials currently available.", "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 materials and analysis scope for Combined versus serious-only injuries, events, original HR and CI and hierarchy must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.", "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap's own design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M15 §15.3.1–15.3.3; Chamgap 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": "Display other severity outcomes from the same trial together. This is a proposal; no new investigation, 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 serious-only result was 68 versus 87 events, HR.83/CI.60~1.16, and was not significant. Its subclaim grade D and note are preserved separately.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. The serious-only P value, importance threshold, denominator and analysis details are unverified. The positive combined result is not changed into serious-only confirmation or reassessed as an exactly zero effect or equivalence. The original content review remains incomplete.", "missingness": "The serious-only P value, importance threshold, denominator and analysis details are unverified. The positive combined result is not changed into serious-only confirmation or reassessed as an exactly zero effect or equivalence.", "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": "Serious-injury-only outcome and plan tables" }, { "item_id": "N17", "question_type": "Efficacy comparison and presentation of stored material", "question": "Do all falls and other secondary functional outcomes directly answer this question?", "needed": "Injuries versus all falls, fractures and function, endpoint definitions and denominators", "role": "Required", "role_reason": "This item separates Injuries versus all falls, fractures and function, endpoint definitions and denominators to link materials needed for the selected question with the materials currently available.", "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 materials and analysis scope for Injuries versus all falls, fractures and function, endpoint definitions and denominators must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M03 §3.2.4; Chamgap extension boundaries; M08 Table 8.2.a, M04 §4.6.3; Chamgap 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": "Separate fewer injuries from other events and functional outcomes. This is a proposal; no new investigation, 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 current original evidence contains values for combined moderate-plus-serious injury rates and serious-only injuries.", "condition_status": "Unverified", "status_reason": "The information currently needed is unverified in the stored summary. Values and hierarchy for all falls, individual fractures, balance or gait, quality of life and death are unverified in this summary. The same values are not repurposed for other outcomes. The original content review remains incomplete.", "missingness": "Values and hierarchy for all falls, individual fractures, balance or gait, quality of life and death are unverified in this summary. The same values are not repurposed for other outcomes.", "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 endpoint definitions and outcome tables" }, { "item_id": "N18", "question_type": "Efficacy comparison and presentation of stored material", "question": "Were registration and the original and amended plans actually read?", "needed": "NCT00545350, protocols, SAP and amendment history", "role": "Required", "role_reason": "This item separates NCT00545350, protocols, SAP and amendment history to link materials needed for the selected question with the materials currently available.", "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 materials and analysis scope for NCT00545350, protocols, SAP and amendment history must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; Chamgap application; M04 §4.5–4.6 principles for collecting and selecting materials; separation of access and reading and hyperlink rules 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": "If materials are supplied, distinguish amendments to definitions, timing and analyses. This is a proposal; no new investigation, 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 NCT00545350 and narrative of the recruitment-stage amendment are linked.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. External registration, original and amended protocols and SAP have not been read or accessed. An identifier or the original narrative is not treated as completed plan comparison. The original content review remains incomplete.", "missingness": "External registration, original and amended protocols and SAP have not been read or accessed. An identifier or the original narrative is not treated as completed plan comparison.", "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": "Registration history, original and amended plans and SAP" }, { "item_id": "N19", "question_type": "Efficacy comparison and presentation of stored material", "question": "What is the scope of public support and declared non-involvement?", "needed": "AP-HP, French Ministry of Health, ANR, INPES, Ile-de-France and roles", "role": "Required", "role_reason": "This item separates AP-HP, French Ministry of Health, ANR, INPES, Ile-de-France and roles to link materials needed for the selected question with the materials currently available.", "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 materials and analysis scope for AP-HP, French Ministry of Health, ANR, INPES, Ile-de-France and roles must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.", "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these 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": "Separate funders, declared and actual roles and the scope of verification. This is a proposal; no new investigation, 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 support from five public bodies and no funder involvement in design, collection, analysis or publication decisions is preserved.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Items and amounts, contracts, actual roles and comparison of individual agencies' roles are unverified. Public support or declarations are not treated as verification of every aspect of independence. The original content review remains incomplete.", "missingness": "Items and amounts, contracts, actual roles and comparison of individual agencies' roles are unverified. Public support or declarations are not treated as verification of every aspect of independence.", "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 funding and role disclosures" }, { "item_id": "N20", "question_type": "Efficacy comparison and presentation of stored material", "question": "Are product support, employee authors, COI and analysis or writing support known?", "needed": "Product and equipment provision, employment, patents, disclosures and external services", "role": "Required", "role_reason": "This item separates Product and equipment provision, employment, patents, disclosures and external services to link materials needed for the selected question with the materials currently available.", "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 materials and analysis scope for Product and equipment provision, employment, patents, disclosures and external services must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.", "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these 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": "Update each relationship separately from the support already recorded. This is a proposal; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Only accounts of public support and non-involvement are preserved.", "condition_status": "Unverified", "status_reason": "The information currently needed is unverified in the stored summary. Free product or equipment provision, author employment and patents, individual COI and analysis, writing or publication support are unverified. These relationships are not filled in as absent. The original content review remains incomplete.", "missingness": "Free product or equipment provision, author employment and patents, individual COI and analysis, writing or publication support are unverified. These relationships are not filled in as absent.", "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": "Product, author, COI, analysis and writing disclosures" }, { "item_id": "N21", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "What do the five exercise-related injurious falls record?", "needed": "Event definition, people versus events, exposure, duration, severity and collection", "role": "Supplementary", "role_reason": "This item separates Event definition, people versus events, exposure, duration, severity and collection to link materials needed for the selected question with the materials currently available.", "application_exception": "Supplements gaps in safety materials for the selected subclaim. Fall-prevention effects, injury counts or the parent safety wording do not establish safety, and no new harm rate, exercise program, movement instruction or prescription is created.", "criterion": "Original materials and analysis scope for Event definition, people versus events, exposure, duration, severity and collection must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.", "basis": "M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; detailed distinctions are Chamgap's own design; M19 §19.2 design-specific harm questions; timing details are Chamgap's own design; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4, M04 §4.6.3; Chamgap 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": "Distinguish prevention-related injury endpoints from program-related harms. This is a proposal; no new investigation, 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 text records five exercise-related injurious falls. This is a reported event count.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Unique people, event timing, supervised and home exposure, severity, denominators, collection and discontinuation are unverified. New rates or between-group harms are not calculated from 352 participants or two years. The original content review remains incomplete.", "missingness": "Unique people, event timing, supervised and home exposure, severity, denominators, collection and discontinuation are unverified. New rates or between-group harms are not calculated from 352 participants or two years.", "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": "Related-event details, exposure, denominators and collection materials" }, { "item_id": "N22", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "What can be said about relatedness and overall safety?", "needed": "Relatedness, other causes, comparative harms and long-term or vulnerable groups", "role": "Supplementary", "role_reason": "This item separates Relatedness, other causes, comparative harms and long-term or vulnerable groups to link materials needed for the selected question with the materials currently available.", "application_exception": "Supplements gaps in safety materials for the selected subclaim. Fall-prevention effects, injury counts or the parent safety wording do not establish safety, and no new harm rate, exercise program, movement instruction or prescription is created.", "criterion": "Original materials and analysis scope for Relatedness, other causes, comparative harms and long-term or vulnerable groups must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.", "basis": "M19 §19.1.2–19.2.4; Chamgap application; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap application; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap's own design; M19 §19.1.2–19.2.4; Chamgap application; Chamgap interpretive boundaries draw on M19 principles, without executing an official causality tool", "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": "Separate original events from gaps in causality and safety scope. This is a proposal; no new investigation, 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 exercise-related wording and five events are preserved; the parent's Caution safety label is historical.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Relatedness assessment, baseline and concomitant factors, alternatives and comparative, long-term or rare events are unverified. No safety certification or new movement, supervision or environmental prescription is created. The original content review remains incomplete.", "missingness": "Relatedness assessment, baseline and concomitant factors, alternatives and comparative, long-term or rare events are unverified. No safety certification or new movement, supervision or environmental prescription is 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": "Relatedness, alternative explanations and long-term harm materials" }, { "item_id": "N23", "question_type": "Efficacy comparison and presentation of stored material", "question": "Are links to other exercise assessments new independent replication?", "needed": "Tai ji quan 1812, Otago 1834 and relationships between assessments, populations and programs", "role": "Required", "role_reason": "This item separates Tai ji quan 1812, Otago 1834 and relationships between assessments, populations and programs to link materials needed for the selected question with the materials currently available.", "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 materials and analysis scope for Tai ji quan 1812, Otago 1834 and relationships between assessments, populations and programs must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.", "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort and outcome linkage is Chamgap's own application; M04 §4.6.1–4.6.2, M15 §15.3.1; Chamgap application; M04 §4.5–4.6 principles for collecting and selecting materials; separation of access and reading and hyperlink rules 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": "Separate comparison links from the evidence status of the current trial. This is a proposal; no new investigation, 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 stored 1812 and Otago 1834 A86 links are historical comparisons in the same direction. The current evidence and citation lists contain one Ossébo report.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Related assessments, trials, populations, durations and independence were not looked up. Links are not combined as new reports or direct replication of the same program. The original content review remains incomplete.", "missingness": "Related assessments, trials, populations, durations and independence were not looked up. Links are not combined as new reports or direct replication of the same program.", "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": "Other exercise, population and related-report materials" }, { "item_id": "N24", "question_type": "Efficacy comparison and presentation of stored material", "question": "How are the same people, severities, events and times shared?", "needed": "Report, Ossébo trial, injury categories, repeated events and other sheets from the same trial", "role": "Required", "role_reason": "This item separates Report, Ossébo trial, injury categories, repeated events and other sheets from the same trial to link materials needed for the selected question with the materials currently available.", "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 materials and analysis scope for Report, Ossébo trial, injury categories, repeated events and other sheets from the same trial must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.", "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap 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": "Distinguish unrecorded unique clinical totals from report and material slots. This is a proposal; no new investigation, 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 two selected sheets share the same Ossébo/NCT00545350 trial, 706 participants and one report. Combined and serious-only events, people and woman-years are different outcomes or units.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. External comparison of related or follow-up reports and event duplication was not performed. The original single pivotal trial and R1/I2 are not backdated as new independence certification; participants or events are not added together. The original content review remains incomplete.", "missingness": "External comparison of related or follow-up reports and event duplication was not performed. The original single pivotal trial and R1/I2 are not backdated as new independence certification; participants or events are not added together.", "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": "Registration, related reports and event-denominator links" }, { "item_id": "N25", "question_type": "Efficacy comparison and presentation of stored material", "question": "Are findings extended to other populations, exercises, durations or outcomes?", "needed": "High-risk women, the specific combined program, two years and direct extension evidence", "role": "Required", "role_reason": "This item separates High-risk women, the specific combined program, two years and direct extension evidence to link materials needed for the selected question with the materials currently available.", "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 materials and analysis scope for High-risk women, the specific combined program, two years and direct extension evidence must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.", "basis": "M03 §3.2.1–3.2.4; dose, persistence and effect-modification details are Chamgap's own design; M03 §3.2.4; Chamgap extension boundaries", "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": "Separate the narrow selected effect from extension questions. This is a proposal; no new investigation, 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 text limits the finding to reduced moderate-plus-serious combined rates in this high-risk group of women, without claiming reduction in every serious fall.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Direct evidence for other ages, sexes, institutions, other exercises, isolated components, persistence after cessation or beyond two years is unverified. Exercise prescriptions or movement instructions are not created. The original content review remains incomplete.", "missingness": "Direct evidence for other ages, sexes, institutions, other exercises, isolated components, persistence after cessation or beyond two years is unverified. Exercise prescriptions or movement instructions are not 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": "Other populations and programs, long-term and post-cessation outcomes" }, { "item_id": "N26", "question_type": "Efficacy comparison and presentation of stored material", "question": "What history is preserved in parent values, Korean and English wording, dates and empty correction records?", "needed": "B76, original axes with true, false, unrecorded and empty values, and language-specific amendment wording", "role": "Required", "role_reason": "This item separates B76, original axes with true, false, unrecorded and empty values, and language-specific amendment wording to link materials needed for the selected question with the materials currently available.", "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 materials and analysis scope for B76, original axes with true, false, unrecorded and empty values, and language-specific amendment wording must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.", "basis": "M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design; M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are our 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": "Distinguish the original record from production and amendment events. This is a proposal; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "B76, Caution safety, unrecorded precision, a true large hard-outcome RCT flag, other false flags, empty override reasons, Korean and English texts, 2026-08-26, empty correction and deliberation records and historical cross-check wording are preserved in the complete stored summary.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Parent values do not fill subclaim scores or axes. This is not a new current search, original-text or language review, correction or retraction check or clinical certification. The original content review remains incomplete.", "missingness": "Parent values do not fill subclaim scores or axes. This is not a new current search, original-text or language review, correction or retraction check or clinical certification.", "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": "Corrections, user comments and supplied original materials" }, { "item_id": "N27", "question_type": "Efficacy comparison and presentation of stored material", "question": "What summary and external materials were actually read?", "needed": "One evidence entry, one citation, original URL and reading status of the paper, registration, plans and disclosures", "role": "Required", "role_reason": "This item separates One evidence entry, one citation, original URL and reading status of the paper, registration, plans and disclosures to link materials needed for the selected question with the materials currently available.", "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 materials and analysis scope for One evidence entry, one citation, original URL and reading status of the paper, registration, plans and disclosures must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal 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": "Distinguish existence, acquisition, reading level and access history. This is a proposal; no new investigation, 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 complete stored summary, one evidence entry and one citation were read for production, and the original BMJ link was retained. The summary is marked summary read; external materials are marked not read.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. External abstract and full text, registration, protocols, SAP and disclosures have not been read or accessed. Identifiers, bibliography or historical accounts are not treated as full-text reading or completed review. The original content review remains incomplete.", "missingness": "External abstract and full text, registration, protocols, SAP and disclosures have not been read or accessed. Identifiers, bibliography or historical accounts are not treated as full-text reading or completed review.", "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": "Each original material and actual reading history" } ], "reports": [ { "report_id": "S01", "title": "El-Khoury F et al. 2015 Ossébo", "url": "https://www.bmj.com/content/351/bmj.h3830", "report_type": "Two-year 20-center randomized controlled trial", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2942-OSSEBO", "independent_replication": null, "observed_result": "The original combined result of 305 versus 397 events, HR.81 (95% CI.67~.99), P=.04, rates of .45 versus .56 per woman-year and center-adjusted shared-frailty wording are preserved. Events are not converted to people, nor rates to a simple ratio or new percentage reduction. Serious-only 68/87 events and HR.83/CI.60~1.16 provide separate context; no new denominator, difference or interval is calculated.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review." }, { "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": "2026-08-26", "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": "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": "Official source", "url": "https://www.bmj.com/content/351/bmj.h3830" } ] } ], "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, El-Khoury 2015 Ossébo/NCT00545350, is a report of the same 20-center RCT of two-year supervised group plus home exercise in 706 community-dwelling women aged 75–85 with impaired balance or gait, allocated 352/354. The two selected sheets share people, groups, times, bibliography, injury severity, repeated events and woman-year context. Combined 305/397 events, serious-only 68/87 events and original rates and HR use distinct endpoints and units. The recruitment-stage primary-outcome amendment and gaps in actual denominators, censoring, modeling, five safety events, public support and COI are retained separately; no new independent-trial, participant or event total is created. Report and material slots are not unique clinical-trial, participant or independent-replication totals; unique clinical totals remain unrecorded. Tai ji quan 1812 and Otago 1834 assessment links are not combined as new reports or direct replication." }, "history": [ { "date": "2026-10-11", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public pages and materials were prepared from the existing 27 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-11" }