{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2942-s1", "verdict_number": "2942", "title": "Two-year balance training × reduced 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": "The same community-dwelling women aged 75–85 with impaired balance; serious-injury-specific denominators unverified", "intervention": "The same two-year supervised group plus home exercise program; no confirmation of individual component effects", "dose": null, "comparator": "The same control group; actual exposure, concomitant measures and discontinuation unverified", "endpoint": "Serious injurious falls only; original 68/87 events; HR.83/CI.60~1.16", "duration": "Two-year study; primary outcome amended during recruitment from serious injuries to the combined outcome; current serious-injury hierarchy and model 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": "What is the selected serious-injury-only question and original grade?", "needed": "Separate subclaim D and note, combined-outcome B and parent B76", "role": "Required", "role_reason": "This item separates Separate subclaim D and note, combined-outcome B and parent B76 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 subclaim D and note, combined-outcome B and parent B76 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": "Separate the question, assessment record and assessments of other endpoints. 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 serious injurious falls, with subclaim grade D and a note that the HR.83 CI included 1. Combined-outcome B and parent B76 provide different context.", "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 do not fill them. The combined effect does not establish the serious-only effect. The original content review remains incomplete.", "missingness": "The subclaim has no score, status or axis values; parent values do not fill them. The combined effect does not establish the serious-only 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": "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 for the serious-injury outcome and how were participants selected?", "needed": "Impaired balance or gait, community-dwelling women aged 75–85 and baseline risk", "role": "Required", "role_reason": "This item separates Impaired balance or gait, community-dwelling women aged 75–85 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 Impaired balance or gait, community-dwelling women aged 75–85 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 differences between the selected population and other high-risk 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. Impairment thresholds, baseline falls and illnesses, eligibility and exclusions, recruitment and the population observed for the serious-injury outcome are unverified. The finding is not extended to all older adults, men or institutional settings. The original content review remains incomplete.", "missingness": "Impairment thresholds, baseline falls and illnesses, eligibility and exclusions, recruitment and the population observed for the serious-injury outcome are unverified. The finding is not extended to all older adults, men or institutional settings.", "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, baseline and endpoint-specific population materials" }, { "item_id": "N03", "question_type": "Efficacy comparison and presentation of stored material", "question": "What was the historical two-year program and actual exposure?", "needed": "Supervised group plus home exercise, weekly sessions, adherence and discontinuation", "role": "Required", "role_reason": "This item separates Supervised group plus home exercise, weekly sessions, adherence and discontinuation 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 plus home exercise, weekly sessions, adherence and discontinuation 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 planned intervention 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 original research program combined weekly supervised group balance training and home exercise over two years. This is not 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, home exposure and attendance, intensity, actual adherence and discontinuation, and separate component effects are unverified. The original content review remains incomplete.", "missingness": "Detailed components, home exposure and attendance, intensity, actual adherence and discontinuation, and separate component effects 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": "Program, actual exposure, adherence and change records" }, { "item_id": "N04", "question_type": "Efficacy comparison and presentation of stored material", "question": "What were the control, concomitant measures and changes?", "needed": "Control care, shared or other exercise, medication, environment and rescue treatment", "role": "Required", "role_reason": "This item separates Control care, shared or other exercise, medication, environment and rescue treatment 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 care, shared or other exercise, medication, environment and rescue treatment 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": "Separate the program contribution from other exposures. 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 materials compare 352 exercise participants with 354 controls.", "condition_status": "Unverified", "status_reason": "The information currently needed is unverified in the stored summary. Control care, information and contact, group-specific concurrent exercise, treatment, environmental changes and amendments are unverified. No intervention or placebo is not filled in. The original content review remains incomplete.", "missingness": "Control care, information and contact, group-specific concurrent exercise, treatment, environmental changes and amendments are unverified. No intervention or placebo is 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": "Group-specific control, concomitant measures and change materials" }, { "item_id": "N05", "question_type": "Efficacy comparison and presentation of stored material", "question": "Are allocation and baseline balance in the 20-center RCT known?", "needed": "Allocation unit, sequence and concealment, centers and individuals, baseline characteristics", "role": "Required", "role_reason": "This item separates Allocation unit, sequence and concealment, centers and individuals, baseline characteristics 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 Allocation unit, sequence and concealment, centers and individuals, baseline characteristics 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": "Separate centers, participants and the actual randomized design. 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 describes a 20-center, two-year RCT with 706 participants allocated 352/354.", "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 and operations, baseline balance and group correspondence within centers are unverified. Center count alone does not establish cluster randomization. The original content review remains incomplete.", "missingness": "Allocation unit and operations, baseline balance and group correspondence within centers are unverified. Center count alone does not establish cluster randomization.", "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": "Which criteria classified serious injury events?", "needed": "Serious-injury definition, physical harm and healthcare use, adjudication and reclassification", "role": "Required", "role_reason": "This item separates Serious-injury definition, physical harm and healthcare use, adjudication and reclassification 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 Serious-injury definition, physical harm and healthcare use, adjudication and reclassification 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": "Separate definitions of serious-only injuries, combined injuries and all falls. 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 geriatricians unaware of allocation classified events using physical-harm and healthcare-use criteria. The selected question concerns serious injuries only.", "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. Exact serious-injury thresholds and components, specific fracture or hospitalization rules, overlap and reclassification and adjudicator agreement are unverified. Moderate-plus-serious injuries are not treated as the same event category. The original content review remains incomplete.", "missingness": "Exact serious-injury thresholds and components, specific fracture or hospitalization rules, overlap and reclassification and adjudicator agreement are unverified. Moderate-plus-serious injuries are not treated as the same event category.", "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 classification, original adjudication, medical records and outcome materials" }, { "item_id": "N07", "question_type": "Efficacy comparison and presentation of stored material", "question": "What is known about event collection, blinded adjudication, detection and omissions?", "needed": "Reporting and verification, blinding, collection frequency and omissions over time", "role": "Required", "role_reason": "This item separates Reporting and verification, blinding, collection frequency and omissions over time 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 Reporting and verification, blinding, collection frequency and omissions over time 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 event occurrence, 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 record of adjudicators being blinded to 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. Participant, collector and analyst blinding, fall collection methods and frequency, detection and omissions and medical-record confirmation are unverified. The strength of adjudication is not treated as resolution of every measurement or missing-data issue. The original content review remains incomplete.", "missingness": "Participant, collector and analyst blinding, fall collection methods and frequency, detection and omissions and medical-record confirmation are unverified. The strength of adjudication is not treated as resolution of every measurement or missing-data issue.", "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": "Fall collection, adjudication, blinding and omission materials" }, { "item_id": "N08", "question_type": "Efficacy comparison and presentation of stored material", "question": "Are 68/87 events counts of unique people?", "needed": "Serious events, people, repetition, denominators and duration", "role": "Required", "role_reason": "This item separates Serious events, people, repetition, denominators and duration 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 Serious events, people, repetition, denominators and duration 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": "Distinguish repeated events in the same person from event counts. 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 injurious-fall counts were 68 versus 87 events, preserved as event counts for exercise and control respectively.", "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. People per event, first and repeated events, the serious-injury analysis population and observation time are unverified. Events are not converted to people or response rates, and no new total or difference is calculated. The original content review remains incomplete.", "missingness": "People per event, first and repeated events, the serious-injury analysis population and observation time are unverified. Events are not converted to people or response rates, and no new total or difference is 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": "Serious-injury people, event and repeated-event tables and denominators" }, { "item_id": "N09", "question_type": "Efficacy comparison and presentation of stored material", "question": "What result do the serious-only HR.83, interval and nonsignificance describe?", "needed": "Original estimate, CI, model, time and interpretation", "role": "Required", "role_reason": "This item separates Original estimate, CI, model, time and interpretation 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 estimate, CI, model, time and interpretation 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": "Link the original interval to the analysis of its endpoint. 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 HR.83, CI.60~1.16 and narrative and note that the result was not significant 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. The serious-only P value, interval construction, center and repeated-event handling, exact denominator and importance threshold are unverified. New P values, percentage reductions or CI are not calculated. The original content review remains incomplete.", "missingness": "The serious-only P value, interval construction, center and repeated-event handling, exact denominator and importance threshold are unverified. New P values, percentage reductions or CI 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": "Serious-only model, SAP and outcome tables" }, { "item_id": "N10", "question_type": "Efficacy comparison and presentation of stored material", "question": "Does a CI including 1 establish an exactly zero effect or equivalence?", "needed": "Original uncertainty, effects compatible with the interval, important differences and hypotheses", "role": "Required", "role_reason": "This item separates Original uncertainty, effects compatible with the interval, important differences and hypotheses 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 uncertainty, effects compatible with the interval, important differences and hypotheses 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; 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 nonsignificance and uncertainty from a distinct equivalence question. 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 serious-only CI included benefit and no effect and the result was not statistically established. Subclaim D is the original grade.", "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. Important-difference and equivalence margins, prior hypotheses and additional precision data are unverified. An exactly zero effect, exclusion of every important benefit or equivalence is not newly assessed. The original content review remains incomplete.", "missingness": "Important-difference and equivalence margins, prior hypotheses and additional precision data are unverified. An exactly zero effect, exclusion of every important benefit or equivalence is not newly assessed.", "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 hypothesis rationale and serious-injury analysis materials" }, { "item_id": "N11", "question_type": "Efficacy comparison and presentation of stored material", "question": "Can the positive combined-injury finding be applied to serious injuries only?", "needed": "Moderate-plus-serious injuries, event counts, rates and HR, distinct endpoints", "role": "Required", "role_reason": "This item separates Moderate-plus-serious injuries, event counts, rates and HR, distinct endpoints 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 Moderate-plus-serious injuries, event counts, rates and HR, distinct endpoints 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; M08 §8.2.2, 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": "Preserve positive and nonsignificant results 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": "Combined 305/397 events, original 0.45/0.56 events per woman-year, center-adjusted shared-frailty HR.81 (CI.67~.99) and P=.04 belong to another endpoint.", "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 combined model, denominator, P=.04 and rates do not fill serious-only values. Moderate-only effects or events are not newly calculated by subtracting serious injuries from the combined result. The original content review remains incomplete.", "missingness": "The combined model, denominator, P=.04 and rates do not fill serious-only values. Moderate-only effects or events are not newly calculated by subtracting serious injuries from the combined result.", "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": "Severity-specific outcome, model and denominator tables" }, { "item_id": "N12", "question_type": "Efficacy comparison and presentation of stored material", "question": "What history do the original primary outcome and recruitment-stage amendment provide for the serious-injury hierarchy?", "needed": "Original and amended primary outcome, timing, sample target and reasons", "role": "Required", "role_reason": "This item separates Original and amended primary outcome, 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 Original and amended primary outcome, 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; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; 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 original hierarchy, amendment and current serious-injury result. 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 the target was reduced from 1,000 per arm about eight months after recruitment began and the outcome changed from Korean first serious fall or English serious falls to moderate-plus-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 original first-event estimation definition, serious-injury hierarchy and testing after amendment, revised target and original plans are unverified. First-event or recurrent-event modeling or current serious-injury primary status is not arbitrarily established. The original content review remains incomplete.", "missingness": "The original first-event estimation definition, serious-injury hierarchy and testing after amendment, revised target and original plans are unverified. First-event or recurrent-event modeling or current serious-injury primary status is not arbitrarily 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, SAP and primary or secondary outcome amendment materials" }, { "item_id": "N13", "question_type": "Efficacy comparison and presentation of stored material", "question": "Were data-driven amendment, prespecification and multiplicity verified?", "needed": "Amendment decisions, data access, hypotheses, multiple comparisons and prior hierarchy", "role": "Required", "role_reason": "This item separates Amendment decisions, data access, hypotheses, multiple comparisons and prior 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 Amendment decisions, data access, hypotheses, multiple comparisons and prior hierarchy 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 the original amendment narrative from actual 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 text records that 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. Decision timing, actual data access, serious-injury testing and multiplicity and original and amended plans have not been read. Neither confirmed data-driven amendment nor complete prespecified confirmation is newly certified. The original content review remains incomplete.", "missingness": "Decision timing, actual data access, serious-injury testing and multiplicity and original and amended plans have not been read. Neither confirmed data-driven amendment nor complete prespecified confirmation is newly certified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Amendment decisions, access records, plans and original testing materials" }, { "item_id": "N14", "question_type": "Efficacy comparison and presentation of stored material", "question": "What are the two-year follow-up, event times, censoring, missing data and denominators?", "needed": "Allocation, observation and analysis, actual time, attrition and deaths", "role": "Required", "role_reason": "This item separates Allocation, observation and analysis, actual time, attrition and deaths 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 Allocation, observation and analysis, actual time, attrition and deaths 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 duration from actual serious-injury 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": "Original allocation of 706 participants, 352/354, and two-year follow-up are preserved.", "condition_status": "Unverified", "status_reason": "The information currently needed is unverified in the stored summary. People completing follow-up or analyzed for serious injuries, actual time, attrition, deaths, censoring and missing-data handling are unverified. Combined woman-year rates or complete two-year follow-up for everyone do not fill serious-only denominators. The original content review remains incomplete.", "missingness": "People completing follow-up or analyzed for serious injuries, actual time, attrition, deaths, censoring and missing-data handling are unverified. Combined woman-year rates or complete two-year follow-up for everyone do not fill serious-only 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 person-time and losses" }, { "item_id": "N15", "question_type": "Efficacy comparison and presentation of stored material", "question": "What are the effect of interest, ITT, adherence and repeated-event handling for serious-injury analysis?", "needed": "Assignment effect, ITT/PP, models, deviations and sensitivity analyses", "role": "Required", "role_reason": "This item separates Assignment effect, ITT/PP, models, deviations 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 Assignment effect, ITT/PP, models, deviations 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": "Separate endpoint-specific models, denominators and effect definitions. 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 summary provides the serious-only HR and interval but does not specify the detailed model.", "condition_status": "Unverified", "status_reason": "The information currently needed is unverified in the stored summary. The combined center-adjusted shared-frailty model is not automatically copied to serious injuries. Serious-only ITT/PP, adherence, first and repeated events, sensitivity analyses and subgroups are unverified. The original content review remains incomplete.", "missingness": "The combined center-adjusted shared-frailty model is not automatically copied to serious injuries. Serious-only ITT/PP, adherence, first and repeated events, sensitivity analyses and subgroups 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": "Serious-injury SAP, models, exposure and sensitivity materials" }, { "item_id": "N16", "question_type": "Efficacy comparison and presentation of stored material", "question": "Do other fall or functional outcomes answer the serious-injury-only question?", "needed": "All falls, fractures and hospitalization, function, mortality and primary or secondary hierarchy", "role": "Required", "role_reason": "This item separates All falls, fractures and hospitalization, function, mortality and primary or secondary 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 All falls, fractures and hospitalization, function, mortality and primary or secondary hierarchy 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": "Distinguish serious events from other clinical and functional 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 evidence concerns combined moderate-plus-serious and serious-only outcomes.", "condition_status": "Unverified", "status_reason": "The information currently needed is unverified in the stored summary. All falls, component-specific fractures, function, quality of life, death and other secondary values are unverified. Serious-injury counts and HR are not turned into other outcomes. The original content review remains incomplete.", "missingness": "All falls, component-specific fractures, function, quality of life, death and other secondary values are unverified. Serious-injury counts and HR are not turned into 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": "Endpoint definitions, outcomes and prior hierarchy" }, { "item_id": "N17", "question_type": "Efficacy comparison and presentation of stored material", "question": "What is the actual access status of registration, plans and amendments?", "needed": "NCT00545350, original and amended protocols, SAP and history", "role": "Required", "role_reason": "This item separates NCT00545350, original and amended protocols, SAP and 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, original and amended protocols, SAP and 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 testing and hierarchy amendments from current 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": "Original NCT00545350 and the serious-injury primary-outcome amendment narrative 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, protocols, SAP and amendment history have not been read or accessed. Registration identifiers alone do not establish serious-injury prespecified hypotheses or completed plan comparison. The original content review remains incomplete.", "missingness": "External registration, protocols, SAP and amendment history have not been read or accessed. Registration identifiers alone do not establish serious-injury prespecified hypotheses or 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": "N18", "question_type": "Efficacy comparison and presentation of stored material", "question": "What is the scope of public support, non-involvement and detailed COI?", "needed": "AP-HP, Ministry of Health, ANR, INPES, Ile-de-France, roles and disclosures", "role": "Required", "role_reason": "This item separates AP-HP, Ministry of Health, ANR, INPES, Ile-de-France, roles 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 AP-HP, Ministry of Health, ANR, INPES, Ile-de-France, roles and disclosures 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 declared support from the scope of actual relationship 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 public funders and accounts of no involvement in design, collection, analysis or publication decisions 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. Contracts and amounts, actual roles, products and free equipment, employee authors and patents, COI and analysis, writing or publication support are unverified. Public funding or original I2 is not changed into independence certification. The original content review remains incomplete.", "missingness": "Contracts and amounts, actual roles, products and free equipment, employee authors and patents, COI and analysis, writing or publication support are unverified. Public funding or original I2 is not changed into independence 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": "Original funding, product, author, COI and role disclosures" }, { "item_id": "N19", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Are the five exercise-related injurious falls the same as the serious-only outcome?", "needed": "Harm events, severity and time, exposure, people and event counts", "role": "Supplementary", "role_reason": "This item separates Harm events, severity and time, exposure, people and event counts 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 Harm events, severity and time, exposure, people and event counts 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": "Separate the prevention endpoint from program-related harm records. 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 five exercise-related injurious falls are a separate original safety account.", "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. Severity of the five events, overlap with selected serious-only 68/87 events, unique people, exposure, time and adjudication methods are unverified. The five events do not fill serious-injury denominators or causes and are not used to calculate new rates or differences. The original content review remains incomplete.", "missingness": "Severity of the five events, overlap with selected serious-only 68/87 events, unique people, exposure, time and adjudication methods are unverified. The five events do not fill serious-injury denominators or causes and are not used to calculate new rates or differences.", "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": "Harm-event details and links to severity, denominators and exposure" }, { "item_id": "N20", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Are harm relatedness, alternative explanations and long-term safety known?", "needed": "Original relatedness, baseline and concomitant factors, comparisons, rare events and vulnerable groups", "role": "Supplementary", "role_reason": "This item separates Original relatedness, baseline and concomitant factors, comparisons, rare events and 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 Original relatedness, baseline and concomitant factors, comparisons, rare events and 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 efficacy-related serious events from overall safety gaps. 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 label and parent's Caution safety label are preserved as history.", "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 adjudication, baseline illnesses, concomitant factors and environment, comparative harms, long-term or rare events and other populations are unverified. Nonsignificant serious-injury efficacy is not changed into safety or harm causality, and no new supervision or movement prescription is created. The original content review remains incomplete.", "missingness": "Relatedness adjudication, baseline illnesses, concomitant factors and environment, comparative harms, long-term or rare events and other populations are unverified. Nonsignificant serious-injury efficacy is not changed into safety or harm causality, and no new supervision or movement 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": "Adjudication, alternative explanations, exposure and long-term harm materials" }, { "item_id": "N21", "question_type": "Efficacy comparison and presentation of stored material", "question": "Do related tai ji quan and Otago assessments directly establish the serious-only effect?", "needed": "Other programs, populations and durations, assessment links and bibliography", "role": "Required", "role_reason": "This item separates Other programs, populations and durations, assessment links and bibliography 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 Other programs, populations and durations, assessment links and bibliography 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 other exercise assessments from the current selected outcome. 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 tai ji quan 1812 and Otago 1834 A86 links are historical comparisons. 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. Other assessments and trials, serious events, identity and independence were not looked up. Links are not combined as additional independent confirmation of the current serious-only outcome. The original content review remains incomplete.", "missingness": "Other assessments and trials, serious events, identity and independence were not looked up. Links are not combined as additional independent confirmation of the current serious-only outcome.", "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 program, population and related-report materials" }, { "item_id": "N22", "question_type": "Efficacy comparison and presentation of stored material", "question": "How are the same people, event severities and related sheets shared?", "needed": "Ossébo report and registration, combined versus serious-only outcomes, repeated events and time", "role": "Required", "role_reason": "This item separates Ossébo report and registration, combined versus serious-only outcomes, repeated events and time 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 Ossébo report and registration, combined versus serious-only outcomes, repeated events and time 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 report slots from unique trials, participants and replication. 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. Serious injuries relate to the combined category and do not represent a separate independent trial or participants.", "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. Event counts, people, woman-years and original R1 are not added into new replication totals; unique clinical totals remain unrecorded. The original content review remains incomplete.", "missingness": "External comparison of related or follow-up reports and event duplication was not performed. Event counts, people, woman-years and original R1 are not added into new replication totals; unique clinical totals remain unrecorded.", "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 reports and registration, people, events and denominator links" }, { "item_id": "N23", "question_type": "Efficacy comparison and presentation of stored material", "question": "Are findings extended to other populations, programs or durations?", "needed": "High-risk women aged 75–85, combined exposure, two years and direct extension evidence", "role": "Required", "role_reason": "This item separates High-risk women aged 75–85, combined exposure, 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 aged 75–85, combined exposure, 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 scope of the selected serious-injury question 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 the combined injury-rate reduction in this population and states that reduction of every serious fall was not established.", "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. Serious-injury effects in other populations, exercises, isolated components, after cessation or beyond two years are unverified. No exercise program, movement instruction, prescription or treatment guidance is created. The original content review remains incomplete.", "missingness": "Serious-injury effects in other populations, exercises, isolated components, after cessation or beyond two years are unverified. No exercise program, movement instruction, prescription or treatment guidance 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": "Other populations and programs, long-term and post-cessation outcomes" }, { "item_id": "N24", "question_type": "Efficacy comparison and presentation of stored material", "question": "What history is retained in parent B76, languages, dates, empty values and corrections?", "needed": "Selected D, original axes with true, false and unrecorded values, Korean and English texts and historical cross-checks", "role": "Required", "role_reason": "This item separates Selected D, original axes with true, false and unrecorded values, Korean and English texts and historical cross-checks 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 Selected D, original axes with true, false and unrecorded values, Korean and English texts and historical cross-checks 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": "Parent 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, historical cross-checks and selected D and its note are preserved in full.", "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. Subclaim scores, status and axes are not filled with parent values. This is not a new current search, language or original-text review, correction or retraction check or independence certification. The original content review remains incomplete.", "missingness": "Subclaim scores, status and axes are not filled with parent values. This is not a new current search, language or original-text review, correction or retraction check or independence 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 materials" }, { "item_id": "N25", "question_type": "Efficacy comparison and presentation of stored material", "question": "What is the reading status of the summary, external paper, registration, plans and disclosures?", "needed": "One original evidence entry, one citation, BMJ link, acquisition and actual reading", "role": "Required", "role_reason": "This item separates One original evidence entry, one citation, BMJ link, acquisition and actual reading 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 original evidence entry, one citation, BMJ link, acquisition and actual reading 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 material-specific existence, acquisition, reading level and access. 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 preserved. 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. Original identifiers, bibliography or historical narratives do not establish new acquisition, full-text reading or review. The original content review remains incomplete.", "missingness": "External abstract and full text, registration, protocols, SAP and disclosures have not been read or accessed. Original identifiers, bibliography or historical narratives do not establish new acquisition, full-text reading or 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 serious injurious-fall counts of 68 versus 87 events, HR.83, original CI.60~1.16 and nonsignificant result are preserved. No exactly zero effect, equivalence, exclusion of every important benefit, new P value or denominator is created. Combined 305/397 events, HR.81, P=.04, shared-frailty modeling and .45 versus .56 events per woman-year provide another endpoint's context and are not automatically copied to the serious-injury model.", "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": "The public page and data were prepared from the existing 25 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-11" }