{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3006-s0", "verdict_number": "3006", "title": "Stand-Alone Single-Leg Standing × Reduced Cumulative Falls Over Six Months · Evidence and Gaps Sheet", "view_version": "1.0", "view_created_date": "2026-10-19", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-09-07", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Existing stored summary and preserved methodology application records. External papers, errata, abstracts, registration, protocols, SAPs, original result tables and support disclosures are unread, and review of existing content remains incomplete.", "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 key trial concerned high-risk adults, mean age 81.6 years. Preserved figures are 553 randomized, 527 analyzed, 315 in exercise and 212 in control, with 26 withdrawals described in the narrative. An additional 1 recurrent faller was excluded from exercise. Exact eligibility, baseline risk, arm-specific flows and final event denominators are unverified.", "intervention": "The selection concerns a stand-alone single-leg standing program. Permission for unstable participants to use a support bar is retained as original research context. Findings from multicomponent balance-and-strength programs or broader balance and functional-exercise verdict 1557 are not transferred as direct evidence. Actual education, supervision, participation and concurrent activities are unverified. No new exercise or treatment methods are provided.", "dose": "Eyes-open standing for 1 minute per leg, 3 times daily, describes research exposure conditions preserved in the original account. Actual participation, adherence, supervision, support-bar use and exposure-specific results are unverified. Preserved conditions are not converted into individual exercise prescriptions, optimal exercise amounts or safe practice methods.", "comparator": "The research narrative records a no-exercise control, while a separate classification field records usual care. Both descriptions are retained without newly certifying equivalent conditions. Actual control activities, concurrent exercise, medication, environmental changes, contact and observation time are unlinked in current material.", "endpoint": "The selection is reduced cumulative falls over 6 months, retaining original subclaim grade C and absent separate score, status and axes. The 118 versus 121 figures after excluding 1 recurrent faller from exercise are event counts, not faller counts or individual risks. Original reported between-group significance and gaps in exact effects, P values and 95% CI are retained together. Fractures of 1 versus 1, later female-faller findings and the erratum, and null overall BMD are separate outcomes.", "duration": "The key 2006 trial observed participants for 6 months. Exact follow-up duration, female results and erratum details for the 2013 later trial, and long-term persistence data, are unlinked in current material. Research exposure and event follow-up are distinguished; the short-term signal is not extended to later persistent effects or an established prevention method.", "excluded_extensions": [ "Cumulative events after exclusion are not converted into faller counts, proportions, individual risks or incidence rates.", "Unequal analysis populations, pre-exclusion events, final denominators and person-time are not used to calculate new effects, P values or CIs.", "Later-trial female-faller findings are not combined as independent confirmation of overall cumulative events in the key trial.", "An erratum citation is not converted into a new trial, participants or verified corrected results.", "Null fracture and overall BMD findings and a small age subgroup are not combined into different efficacy conclusions for fall events.", "The same reports, participants, events and trial families are not newly summed, and unique counts or independence are not certified.", "Parent caution wording, permission to use support and efficacy falls do not establish intervention-related harms or long-term safety.", "The stand-alone research program is not converted into other multicomponent programs, individual exercise prescriptions or treatment-change instructions." ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "What are the selected falls question and original verdict?", "needed": "Separate the selected question, grade and explanation from the parent verdict", "role": "Required", "role_reason": "This condition connects Separate the selected question, grade and explanation from the parent verdict with populations, exposure, comparators, allocation, exclusions, events, observation time, denominators, prespecification, precision, report relationships or harms for the selected cumulative-falls question.", "application_exception": "Retain original subclaim C and absent separate score, status and axes without inheriting parent C50 or axes. Event counts after exclusion are not reassigned as fallers, individual risk, fracture prevention or BMD improvement. Later female findings from the same investigators and the erratum provide different context; the erratum is not a new trial. No new effects, P values, CIs, corrected values, totals, independence/safety certification or exercise methods are created.", "criterion": "Corresponding original material and analysis scope for Separate the selected question, grade and explanation from the parent verdict must distinguish cumulative events from fallers, individual risk and other outcomes, as well as currently unverified information.", "basis": "Preserved application conditions concerning questions, populations, allocation, exclusions, denominators, events versus individual outcomes, precision, reports versus trials and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed individual content review.", "proposed_research": "Material needed: The selection has no separate score, status or assessment axes. Absent fields are not filled with parent scores or axes. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content and acquisition of external originals are unverified.", "acquired_read": "Stored summary read; external papers, errata, registration, protocols, analysis plans and support disclosures unread", "observation": "The selection is 'reduced cumulative falls over 6 months', with original subclaim grade C. The original explanation concerning recurrent-faller exclusion and missing effect size and CI is retained. Parent C50 provides broader context.", "condition_status": "Partly verified", "status_reason": "Known information and remaining gaps were distinguished and transferred from the stored summary. Detailed external material is unverified and review of existing content remains incomplete. This does not establish completed current clinical review or certification.", "missingness": "The selection has no separate score, status or assessment axes. Absent fields are not filled with parent scores or axes.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Exclusion-analysis limitations and precision gaps remain, retaining original subclaim C. Gaps in currently preserved material are not extended to absence across all literature or new judgments of efficacy, safety or independence.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The selection has no separate score, status or assessment axes. Absent fields are not filled with parent scores or axes." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Which high-risk adults were studied?", "needed": "High-risk definition, age, baseline falls, recruitment and eligibility", "role": "Required", "role_reason": "This condition connects High-risk definition, age, baseline falls, recruitment and eligibility with populations, exposure, comparators, allocation, exclusions, events, observation time, denominators, prespecification, precision, report relationships or harms for the selected cumulative-falls question.", "application_exception": "Retain original subclaim C and absent separate score, status and axes without inheriting parent C50 or axes. Event counts after exclusion are not reassigned as fallers, individual risk, fracture prevention or BMD improvement. Later female findings from the same investigators and the erratum provide different context; the erratum is not a new trial. No new effects, P values, CIs, corrected values, totals, independence/safety certification or exercise methods are created.", "criterion": "Corresponding original material and analysis scope for High-risk definition, age, baseline falls, recruitment and eligibility must distinguish cumulative events from fallers, individual risk and other outcomes, as well as currently unverified information.", "basis": "Preserved application conditions concerning questions, populations, allocation, exclusions, denominators, events versus individual outcomes, precision, reports versus trials and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed individual content review.", "proposed_research": "Material needed: Exact high-risk eligibility, baseline falls, conditions, sex, living environment and exclusion criteria are unlinked in current material. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content and acquisition of external originals are unverified.", "acquired_read": "Stored summary read; external papers, errata, registration, protocols, analysis plans and support disclosures unread", "observation": "The stored account describes a trial following high-risk adults, mean age 81.6 years, for 6 months.", "condition_status": "Partly verified", "status_reason": "Known information and remaining gaps were distinguished and transferred from the stored summary. Detailed external material is unverified and review of existing content remains incomplete. This does not establish completed current clinical review or certification.", "missingness": "Exact high-risk eligibility, baseline falls, conditions, sex, living environment and exclusion criteria are unlinked in current material.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Exclusion-analysis limitations and precision gaps remain, retaining original subclaim C. Gaps in currently preserved material are not extended to absence across all literature or new judgments of efficacy, safety or independence.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact high-risk eligibility, baseline falls, conditions, sex, living environment and exclusion criteria are unlinked in current material." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What was the stand-alone single-leg program?", "needed": "Research intervention, support, participation and exposure", "role": "Required", "role_reason": "This condition connects Research intervention, support, participation and exposure with populations, exposure, comparators, allocation, exclusions, events, observation time, denominators, prespecification, precision, report relationships or harms for the selected cumulative-falls question.", "application_exception": "Retain original subclaim C and absent separate score, status and axes without inheriting parent C50 or axes. Event counts after exclusion are not reassigned as fallers, individual risk, fracture prevention or BMD improvement. Later female findings from the same investigators and the erratum provide different context; the erratum is not a new trial. No new effects, P values, CIs, corrected values, totals, independence/safety certification or exercise methods are created.", "criterion": "Corresponding original material and analysis scope for Research intervention, support, participation and exposure must distinguish cumulative events from fallers, individual risk and other outcomes, as well as currently unverified information.", "basis": "Preserved application conditions concerning questions, populations, allocation, exclusions, denominators, events versus individual outcomes, precision, reports versus trials and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed individual content review.", "proposed_research": "Material needed: Education, supervision, actual participation, adherence, the proportion using support and exposure data are unlinked in current material. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content and acquisition of external originals are unverified.", "acquired_read": "Stored summary read; external papers, errata, registration, protocols, analysis plans and support disclosures unread", "observation": "Eyes-open single-leg standing for 1 minute per leg, 3 times daily, with a support bar allowed for unstable participants, describes original research observation conditions. This sheet does not provide exercise instructions.", "condition_status": "Partly verified", "status_reason": "Known information and remaining gaps were distinguished and transferred from the stored summary. Detailed external material is unverified and review of existing content remains incomplete. This does not establish completed current clinical review or certification.", "missingness": "Education, supervision, actual participation, adherence, the proportion using support and exposure data are unlinked in current material.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Exclusion-analysis limitations and precision gaps remain, retaining original subclaim C. Gaps in currently preserved material are not extended to absence across all literature or new judgments of efficacy, safety or independence.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Education, supervision, actual participation, adherence, the proportion using support and exposure data are unlinked in current material." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "What do the no-exercise and usual-care comparator descriptions mean?", "needed": "Control activities, concurrent exercise, medication, environment and contact", "role": "Required", "role_reason": "This condition connects Control activities, concurrent exercise, medication, environment and contact with populations, exposure, comparators, allocation, exclusions, events, observation time, denominators, prespecification, precision, report relationships or harms for the selected cumulative-falls question.", "application_exception": "Retain original subclaim C and absent separate score, status and axes without inheriting parent C50 or axes. Event counts after exclusion are not reassigned as fallers, individual risk, fracture prevention or BMD improvement. Later female findings from the same investigators and the erratum provide different context; the erratum is not a new trial. No new effects, P values, CIs, corrected values, totals, independence/safety certification or exercise methods are created.", "criterion": "Corresponding original material and analysis scope for Control activities, concurrent exercise, medication, environment and contact must distinguish cumulative events from fallers, individual risk and other outcomes, as well as currently unverified information.", "basis": "Preserved application conditions concerning questions, populations, allocation, exclusions, denominators, events versus individual outcomes, precision, reports versus trials and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed individual content review.", "proposed_research": "Material needed: Actual control activities, concurrent exercise, medication, environmental changes and contact are unverified. The two descriptions are not newly certified as equivalent conditions. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content and acquisition of external originals are unverified.", "acquired_read": "Stored summary read; external papers, errata, registration, protocols, analysis plans and support disclosures unread", "observation": "The original research narrative describes a no-exercise control, while a separate classification field records usual care.", "condition_status": "Partly verified", "status_reason": "Known information and remaining gaps were distinguished and transferred from the stored summary. Detailed external material is unverified and review of existing content remains incomplete. This does not establish completed current clinical review or certification.", "missingness": "Actual control activities, concurrent exercise, medication, environmental changes and contact are unverified. The two descriptions are not newly certified as equivalent conditions.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Exclusion-analysis limitations and precision gaps remain, retaining original subclaim C. Gaps in currently preserved material are not extended to absence across all literature or new judgments of efficacy, safety or independence.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual control activities, concurrent exercise, medication, environmental changes and contact are unverified. The two descriptions are not newly certified as equivalent conditions." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Can randomization and the unequal analysis groups be explained?", "needed": "Allocation ratio, sequence, concealment and facility or group structure", "role": "Required", "role_reason": "This condition connects Allocation ratio, sequence, concealment and facility or group structure with populations, exposure, comparators, allocation, exclusions, events, observation time, denominators, prespecification, precision, report relationships or harms for the selected cumulative-falls question.", "application_exception": "Retain original subclaim C and absent separate score, status and axes without inheriting parent C50 or axes. Event counts after exclusion are not reassigned as fallers, individual risk, fracture prevention or BMD improvement. Later female findings from the same investigators and the erratum provide different context; the erratum is not a new trial. No new effects, P values, CIs, corrected values, totals, independence/safety certification or exercise methods are created.", "criterion": "Corresponding original material and analysis scope for Allocation ratio, sequence, concealment and facility or group structure must distinguish cumulative events from fallers, individual risk and other outcomes, as well as currently unverified information.", "basis": "Preserved application conditions concerning questions, populations, allocation, exclusions, denominators, events versus individual outcomes, precision, reports versus trials and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed individual content review.", "proposed_research": "Material needed: Allocation ratio, methods, concealment, facility or group structure and reasons for the imbalance are unlinked in current material. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content and acquisition of external originals are unverified.", "acquired_read": "Stored summary read; external papers, errata, registration, protocols, analysis plans and support disclosures unread", "observation": "The 2006 report is preserved as a 6-month randomized controlled trial with 553 participants randomized.", "condition_status": "Partly verified", "status_reason": "Known information and remaining gaps were distinguished and transferred from the stored summary. Detailed external material is unverified and review of existing content remains incomplete. This does not establish completed current clinical review or certification.", "missingness": "Allocation ratio, methods, concealment, facility or group structure and reasons for the imbalance are unlinked in current material.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Exclusion-analysis limitations and precision gaps remain, retaining original subclaim C. Gaps in currently preserved material are not extended to absence across all literature or new judgments of efficacy, safety or independence.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation ratio, methods, concealment, facility or group structure and reasons for the imbalance are unlinked in current material." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Are allocated, analyzed and withdrawn participants the final event denominator?", "needed": "Allocation, withdrawals, analysis and outcome-specific denominators", "role": "Required", "role_reason": "This condition connects Allocation, withdrawals, analysis and outcome-specific denominators with populations, exposure, comparators, allocation, exclusions, events, observation time, denominators, prespecification, precision, report relationships or harms for the selected cumulative-falls question.", "application_exception": "Retain original subclaim C and absent separate score, status and axes without inheriting parent C50 or axes. Event counts after exclusion are not reassigned as fallers, individual risk, fracture prevention or BMD improvement. Later female findings from the same investigators and the erratum provide different context; the erratum is not a new trial. No new effects, P values, CIs, corrected values, totals, independence/safety certification or exercise methods are created.", "criterion": "Corresponding original material and analysis scope for Allocation, withdrawals, analysis and outcome-specific denominators must distinguish cumulative events from fallers, individual risk and other outcomes, as well as currently unverified information.", "basis": "Preserved application conditions concerning questions, populations, allocation, exclusions, denominators, events versus individual outcomes, precision, reports versus trials and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed individual content review.", "proposed_research": "Material needed: Relationships between arm-specific allocation, withdrawals, analysis exclusions and the final event denominator are unverified. No new withdrawal rates or denominators are calculated. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content and acquisition of external originals are unverified.", "acquired_read": "Stored summary read; external papers, errata, registration, protocols, analysis plans and support disclosures unread", "observation": "Original figures are retained: 553 randomized, 527 analyzed, 315 in exercise and 212 in control, with 26 withdrawals described in the narrative.", "condition_status": "Partly verified", "status_reason": "Known information and remaining gaps were distinguished and transferred from the stored summary. Detailed external material is unverified and review of existing content remains incomplete. This does not establish completed current clinical review or certification.", "missingness": "Relationships between arm-specific allocation, withdrawals, analysis exclusions and the final event denominator are unverified. No new withdrawal rates or denominators are calculated.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Exclusion-analysis limitations and precision gaps remain, retaining original subclaim C. Gaps in currently preserved material are not extended to absence across all literature or new judgments of efficacy, safety or independence.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Relationships between arm-specific allocation, withdrawals, analysis exclusions and the final event denominator are unverified. No new withdrawal rates or denominators are calculated." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "How does recurrent-faller exclusion relate to the event results?", "needed": "Exclusion timing, rules, reasons and events and denominators before exclusion", "role": "Required", "role_reason": "This condition connects Exclusion timing, rules, reasons and events and denominators before exclusion with populations, exposure, comparators, allocation, exclusions, events, observation time, denominators, prespecification, precision, report relationships or harms for the selected cumulative-falls question.", "application_exception": "Retain original subclaim C and absent separate score, status and axes without inheriting parent C50 or axes. Event counts after exclusion are not reassigned as fallers, individual risk, fracture prevention or BMD improvement. Later female findings from the same investigators and the erratum provide different context; the erratum is not a new trial. No new effects, P values, CIs, corrected values, totals, independence/safety certification or exercise methods are created.", "criterion": "Corresponding original material and analysis scope for Exclusion timing, rules, reasons and events and denominators before exclusion must distinguish cumulative events from fallers, individual risk and other outcomes, as well as currently unverified information.", "basis": "Preserved application conditions concerning questions, populations, allocation, exclusions, denominators, events versus individual outcomes, precision, reports versus trials and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed individual content review.", "proposed_research": "Material needed: Prespecification of exclusion, results before exclusion, that participant's event count, final denominators and exclusion reasons are unverified. Pre-exclusion values are not inferred. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content and acquisition of external originals are unverified.", "acquired_read": "Stored summary read; external papers, errata, registration, protocols, analysis plans and support disclosures unread", "observation": "The original account of 118 versus 121 falls after excluding 1 recurrent faller from the exercise group is retained.", "condition_status": "Partly verified", "status_reason": "Known information and remaining gaps were distinguished and transferred from the stored summary. Detailed external material is unverified and review of existing content remains incomplete. This does not establish completed current clinical review or certification.", "missingness": "Prespecification of exclusion, results before exclusion, that participant's event count, final denominators and exclusion reasons are unverified. Pre-exclusion values are not inferred.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Exclusion-analysis limitations and precision gaps remain, retaining original subclaim C. Gaps in currently preserved material are not extended to absence across all literature or new judgments of efficacy, safety or independence.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Prespecification of exclusion, results before exclusion, that participant's event count, final denominators and exclusion reasons are unverified. Pre-exclusion values are not inferred." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "How do cumulative fall events differ from the number of people who fell?", "needed": "Recurrent events, fallers, individual risk and observation time", "role": "Required", "role_reason": "This condition connects Recurrent events, fallers, individual risk and observation time with populations, exposure, comparators, allocation, exclusions, events, observation time, denominators, prespecification, precision, report relationships or harms for the selected cumulative-falls question.", "application_exception": "Retain original subclaim C and absent separate score, status and axes without inheriting parent C50 or axes. Event counts after exclusion are not reassigned as fallers, individual risk, fracture prevention or BMD improvement. Later female findings from the same investigators and the erratum provide different context; the erratum is not a new trial. No new effects, P values, CIs, corrected values, totals, independence/safety certification or exercise methods are created.", "criterion": "Corresponding original material and analysis scope for Recurrent events, fallers, individual risk and observation time must distinguish cumulative events from fallers, individual risk and other outcomes, as well as currently unverified information.", "basis": "Preserved application conditions concerning questions, populations, allocation, exclusions, denominators, events versus individual outcomes, precision, reports versus trials and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed individual content review.", "proposed_research": "Material needed: Fallers, recurrent fallers, person-specific events and person-time are unverified. No new proportions, risks or incidence rates are calculated. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content and acquisition of external originals are unverified.", "acquired_read": "Stored summary read; external papers, errata, registration, protocols, analysis plans and support disclosures unread", "observation": "The 118 versus 121 figures are cumulative fall events after exclusion. They are not numbers or proportions of fallers or individual risks.", "condition_status": "Partly verified", "status_reason": "Known information and remaining gaps were distinguished and transferred from the stored summary. Detailed external material is unverified and review of existing content remains incomplete. This does not establish completed current clinical review or certification.", "missingness": "Fallers, recurrent fallers, person-specific events and person-time are unverified. No new proportions, risks or incidence rates are calculated.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Exclusion-analysis limitations and precision gaps remain, retaining original subclaim C. Gaps in currently preserved material are not extended to absence across all literature or new judgments of efficacy, safety or independence.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Fallers, recurrent fallers, person-specific events and person-time are unverified. No new proportions, risks or incidence rates are calculated." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "How were events compared across unequal analysis populations?", "needed": "Arm-specific participants, follow-up time and recurrent-event analysis", "role": "Required", "role_reason": "This condition connects Arm-specific participants, follow-up time and recurrent-event analysis with populations, exposure, comparators, allocation, exclusions, events, observation time, denominators, prespecification, precision, report relationships or harms for the selected cumulative-falls question.", "application_exception": "Retain original subclaim C and absent separate score, status and axes without inheriting parent C50 or axes. Event counts after exclusion are not reassigned as fallers, individual risk, fracture prevention or BMD improvement. Later female findings from the same investigators and the erratum provide different context; the erratum is not a new trial. No new effects, P values, CIs, corrected values, totals, independence/safety certification or exercise methods are created.", "criterion": "Corresponding original material and analysis scope for Arm-specific participants, follow-up time and recurrent-event analysis must distinguish cumulative events from fallers, individual risk and other outcomes, as well as currently unverified information.", "basis": "Preserved application conditions concerning questions, populations, allocation, exclusions, denominators, events versus individual outcomes, precision, reports versus trials and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed individual content review.", "proposed_research": "Material needed: The event-comparison model, person-time and arm-specific recurrence distributions are unverified. Simple event differences are not newly converted into adjusted effects. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content and acquisition of external originals are unverified.", "acquired_read": "Stored summary read; external papers, errata, registration, protocols, analysis plans and support disclosures unread", "observation": "The preserved 2006 analysis populations are 315 in exercise and 212 in control.", "condition_status": "Partly verified", "status_reason": "Known information and remaining gaps were distinguished and transferred from the stored summary. Detailed external material is unverified and review of existing content remains incomplete. This does not establish completed current clinical review or certification.", "missingness": "The event-comparison model, person-time and arm-specific recurrence distributions are unverified. Simple event differences are not newly converted into adjusted effects.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Exclusion-analysis limitations and precision gaps remain, retaining original subclaim C. Gaps in currently preserved material are not extended to absence across all literature or new judgments of efficacy, safety or independence.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The event-comparison model, person-time and arm-specific recurrence distributions are unverified. Simple event differences are not newly converted into adjusted effects." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "How were falls defined and collected?", "needed": "Fall definition, collection frequency, reporters and event confirmation", "role": "Required", "role_reason": "This condition connects Fall definition, collection frequency, reporters and event confirmation with populations, exposure, comparators, allocation, exclusions, events, observation time, denominators, prespecification, precision, report relationships or harms for the selected cumulative-falls question.", "application_exception": "Retain original subclaim C and absent separate score, status and axes without inheriting parent C50 or axes. Event counts after exclusion are not reassigned as fallers, individual risk, fracture prevention or BMD improvement. Later female findings from the same investigators and the erratum provide different context; the erratum is not a new trial. No new effects, P values, CIs, corrected values, totals, independence/safety certification or exercise methods are created.", "criterion": "Corresponding original material and analysis scope for Fall definition, collection frequency, reporters and event confirmation must distinguish cumulative events from fallers, individual risk and other outcomes, as well as currently unverified information.", "basis": "Preserved application conditions concerning questions, populations, allocation, exclusions, denominators, events versus individual outcomes, precision, reports versus trials and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed individual content review.", "proposed_research": "Material needed: Event definitions, diaries, contacts, confirmation procedures, assessor blinding and underreporting are unlinked in current material. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content and acquisition of external originals are unverified.", "acquired_read": "Stored summary read; external papers, errata, registration, protocols, analysis plans and support disclosures unread", "observation": "The selected question and key trial concern cumulative falls over 6 months.", "condition_status": "Partly verified", "status_reason": "Known information and remaining gaps were distinguished and transferred from the stored summary. Detailed external material is unverified and review of existing content remains incomplete. This does not establish completed current clinical review or certification.", "missingness": "Event definitions, diaries, contacts, confirmation procedures, assessor blinding and underreporting are unlinked in current material.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Exclusion-analysis limitations and precision gaps remain, retaining original subclaim C. Gaps in currently preserved material are not extended to absence across all literature or new judgments of efficacy, safety or independence.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Event definitions, diaries, contacts, confirmation procedures, assessor blinding and underreporting are unlinked in current material." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Were falls, fractures and exclusion analyses prespecified?", "needed": "Outcome hierarchy, registration, protocol, analysis plan and changes", "role": "Required", "role_reason": "This condition connects Outcome hierarchy, registration, protocol, analysis plan and changes with populations, exposure, comparators, allocation, exclusions, events, observation time, denominators, prespecification, precision, report relationships or harms for the selected cumulative-falls question.", "application_exception": "Retain original subclaim C and absent separate score, status and axes without inheriting parent C50 or axes. Event counts after exclusion are not reassigned as fallers, individual risk, fracture prevention or BMD improvement. Later female findings from the same investigators and the erratum provide different context; the erratum is not a new trial. No new effects, P values, CIs, corrected values, totals, independence/safety certification or exercise methods are created.", "criterion": "Corresponding original material and analysis scope for Outcome hierarchy, registration, protocol, analysis plan and changes must distinguish cumulative events from fallers, individual risk and other outcomes, as well as currently unverified information.", "basis": "Preserved application conditions concerning questions, populations, allocation, exclusions, denominators, events versus individual outcomes, precision, reports versus trials and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed individual content review.", "proposed_research": "Material needed: Prespecified primary and secondary outcomes, multiplicity, exclusions and analysis policies are unverified. Registration, protocols and statistical analysis plans were not read in this work. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content and acquisition of external originals are unverified.", "acquired_read": "Stored summary read; external papers, errata, registration, protocols, analysis plans and support disclosures unread", "observation": "The original evidence summary lists cumulative falls and hip fractures as outcomes. The original registration wording, 'could not verify', is retained.", "condition_status": "Unverified", "status_reason": "Known information and remaining gaps were distinguished and transferred from the stored summary. Detailed external material is unverified and review of existing content remains incomplete. This does not establish completed current clinical review or certification.", "missingness": "Prespecified primary and secondary outcomes, multiplicity, exclusions and analysis policies are unverified. Registration, protocols and statistical analysis plans were not read in this work.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Exclusion-analysis limitations and precision gaps remain, retaining original subclaim C. Gaps in currently preserved material are not extended to absence across all literature or new judgments of efficacy, safety or independence.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Prespecified primary and secondary outcomes, multiplicity, exclusions and analysis policies are unverified. Registration, protocols and statistical analysis plans were not read in this work." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "What is the reported between-group significance and the gap in effects, P values and CIs?", "needed": "Original estimand, exact P value, 95% CI, test and denominator", "role": "Required", "role_reason": "This condition connects Original estimand, exact P value, 95% CI, test and denominator with populations, exposure, comparators, allocation, exclusions, events, observation time, denominators, prespecification, precision, report relationships or harms for the selected cumulative-falls question.", "application_exception": "Retain original subclaim C and absent separate score, status and axes without inheriting parent C50 or axes. Event counts after exclusion are not reassigned as fallers, individual risk, fracture prevention or BMD improvement. Later female findings from the same investigators and the erratum provide different context; the erratum is not a new trial. No new effects, P values, CIs, corrected values, totals, independence/safety certification or exercise methods are created.", "criterion": "Corresponding original material and analysis scope for Original estimand, exact P value, 95% CI, test and denominator must distinguish cumulative events from fallers, individual risk and other outcomes, as well as currently unverified information.", "basis": "Preserved application conditions concerning questions, populations, allocation, exclusions, denominators, events versus individual outcomes, precision, reports versus trials and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed individual content review.", "proposed_research": "Material needed: No new P values, effects or CIs are calculated, and significance or null results are not reassessed from cumulative event counts alone. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content and acquisition of external originals are unverified.", "acquired_read": "Stored summary read; external papers, errata, registration, protocols, analysis plans and support disclosures unread", "observation": "The narrative says the paper reported between-group significance while explicitly leaving the exact effect size, P value and 95% CI unverified.", "condition_status": "Unverified", "status_reason": "Known information and remaining gaps were distinguished and transferred from the stored summary. Detailed external material is unverified and review of existing content remains incomplete. This does not establish completed current clinical review or certification.", "missingness": "No new P values, effects or CIs are calculated, and significance or null results are not reassessed from cumulative event counts alone.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Exclusion-analysis limitations and precision gaps remain, retaining original subclaim C. Gaps in currently preserved material are not extended to absence across all literature or new judgments of efficacy, safety or independence.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "No new P values, effects or CIs are calculated, and significance or null results are not reassessed from cumulative event counts alone." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Are differences between all allocated participants, completers and exclusion analyses verified?", "needed": "Analysis population, missingness, before-and-after exclusions and sensitivity analyses", "role": "Required", "role_reason": "This condition connects Analysis population, missingness, before-and-after exclusions and sensitivity analyses with populations, exposure, comparators, allocation, exclusions, events, observation time, denominators, prespecification, precision, report relationships or harms for the selected cumulative-falls question.", "application_exception": "Retain original subclaim C and absent separate score, status and axes without inheriting parent C50 or axes. Event counts after exclusion are not reassigned as fallers, individual risk, fracture prevention or BMD improvement. Later female findings from the same investigators and the erratum provide different context; the erratum is not a new trial. No new effects, P values, CIs, corrected values, totals, independence/safety certification or exercise methods are created.", "criterion": "Corresponding original material and analysis scope for Analysis population, missingness, before-and-after exclusions and sensitivity analyses must distinguish cumulative events from fallers, individual risk and other outcomes, as well as currently unverified information.", "basis": "Preserved application conditions concerning questions, populations, allocation, exclusions, denominators, events versus individual outcomes, precision, reports versus trials and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed individual content review.", "proposed_research": "Material needed: The effect of interest in all allocated participants, ITT, pre-exclusion sensitivity analyses and handling of missing events or time are unverified. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content and acquisition of external originals are unverified.", "acquired_read": "Stored summary read; external papers, errata, registration, protocols, analysis plans and support disclosures unread", "observation": "The 527 analyzed participants, additional recurrent-faller exclusion and bibliographic flags concerning completers and event exclusion are retained.", "condition_status": "Unverified", "status_reason": "Known information and remaining gaps were distinguished and transferred from the stored summary. Detailed external material is unverified and review of existing content remains incomplete. This does not establish completed current clinical review or certification.", "missingness": "The effect of interest in all allocated participants, ITT, pre-exclusion sensitivity analyses and handling of missing events or time are unverified.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Exclusion-analysis limitations and precision gaps remain, retaining original subclaim C. Gaps in currently preserved material are not extended to absence across all literature or new judgments of efficacy, safety or independence.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The effect of interest in all allocated participants, ITT, pre-exclusion sensitivity analyses and handling of missing events or time are unverified." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "What were actual adherence and exposure to support?", "needed": "Exercise participation, support bars, concurrent activities and exposure-specific events", "role": "Supplementary", "role_reason": "This condition connects Exercise participation, support bars, concurrent activities and exposure-specific events with populations, exposure, comparators, allocation, exclusions, events, observation time, denominators, prespecification, precision, report relationships or harms for the selected cumulative-falls question.", "application_exception": "Retain original subclaim C and absent separate score, status and axes without inheriting parent C50 or axes. Event counts after exclusion are not reassigned as fallers, individual risk, fracture prevention or BMD improvement. Later female findings from the same investigators and the erratum provide different context; the erratum is not a new trial. No new effects, P values, CIs, corrected values, totals, independence/safety certification or exercise methods are created.", "criterion": "Corresponding original material and analysis scope for Exercise participation, support bars, concurrent activities and exposure-specific events must distinguish cumulative events from fallers, individual risk and other outcomes, as well as currently unverified information.", "basis": "Preserved application conditions concerning questions, populations, allocation, exclusions, denominators, events versus individual outcomes, precision, reports versus trials and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed individual content review.", "proposed_research": "Material needed: Events and denominators by adherence, exercise exposure, support-bar use and concurrent activity are unverified. Preserved research conditions are not converted into individual exercise prescriptions. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content and acquisition of external originals are unverified.", "acquired_read": "Stored summary read; external papers, errata, registration, protocols, analysis plans and support disclosures unread", "observation": "The original account records that unstable participants were allowed to use a support bar.", "condition_status": "Unverified", "status_reason": "Known information and remaining gaps were distinguished and transferred from the stored summary. Detailed external material is unverified and review of existing content remains incomplete. This does not establish completed current clinical review or certification.", "missingness": "Events and denominators by adherence, exercise exposure, support-bar use and concurrent activity are unverified. Preserved research conditions are not converted into individual exercise prescriptions.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Exclusion-analysis limitations and precision gaps remain, retaining original subclaim C. Gaps in currently preserved material are not extended to absence across all literature or new judgments of efficacy, safety or independence.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Events and denominators by adherence, exercise exposure, support-bar use and concurrent activity are unverified. Preserved research conditions are not converted into individual exercise prescriptions." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "How do the later trial's population and fallers differ from the key event trial?", "needed": "Later-trial population, duration, outcomes and analysis denominators", "role": "Required", "role_reason": "This condition connects Later-trial population, duration, outcomes and analysis denominators with populations, exposure, comparators, allocation, exclusions, events, observation time, denominators, prespecification, precision, report relationships or harms for the selected cumulative-falls question.", "application_exception": "Retain original subclaim C and absent separate score, status and axes without inheriting parent C50 or axes. Event counts after exclusion are not reassigned as fallers, individual risk, fracture prevention or BMD improvement. Later female findings from the same investigators and the erratum provide different context; the erratum is not a new trial. No new effects, P values, CIs, corrected values, totals, independence/safety certification or exercise methods are created.", "criterion": "Corresponding original material and analysis scope for Later-trial population, duration, outcomes and analysis denominators must distinguish cumulative events from fallers, individual risk and other outcomes, as well as currently unverified information.", "basis": "Preserved application conditions concerning questions, populations, allocation, exclusions, denominators, events versus individual outcomes, precision, reports versus trials and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed individual content review.", "proposed_research": "Material needed: Later-trial analysis populations and faller findings are not combined with the 2006 trial's cumulative 6-month events. Exact follow-up duration and allocation and completion flows are unverified. This records needed materials; no new research was executed.", "current_reports": [ "S02" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content and acquisition of external originals are unverified.", "acquired_read": "Stored summary read; external papers, errata, registration, protocols, analysis plans and support disclosures unread", "observation": "The 2013 trial concerns fallers and fractures in balance-impaired adults aged at least 75. It analyzed 865 participants, 410 versus 455, and the citation describes single-leg standing for ≤15 seconds.", "condition_status": "Partly verified", "status_reason": "Known information and remaining gaps were distinguished and transferred from the stored summary. Detailed external material is unverified and review of existing content remains incomplete. This does not establish completed current clinical review or certification.", "missingness": "Later-trial analysis populations and faller findings are not combined with the 2006 trial's cumulative 6-month events. Exact follow-up duration and allocation and completion flows are unverified.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Exclusion-analysis limitations and precision gaps remain, retaining original subclaim C. Gaps in currently preserved material are not extended to absence across all literature or new judgments of efficacy, safety or independence.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Later-trial analysis populations and faller findings are not combined with the 2006 trial's cumulative 6-month events. Exact follow-up duration and allocation and completion flows are unverified." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Does a female-subgroup signal confirm overall cumulative events?", "needed": "Overall and female findings, prespecification, interaction and estimates", "role": "Required", "role_reason": "This condition connects Overall and female findings, prespecification, interaction and estimates with populations, exposure, comparators, allocation, exclusions, events, observation time, denominators, prespecification, precision, report relationships or harms for the selected cumulative-falls question.", "application_exception": "Retain original subclaim C and absent separate score, status and axes without inheriting parent C50 or axes. Event counts after exclusion are not reassigned as fallers, individual risk, fracture prevention or BMD improvement. Later female findings from the same investigators and the erratum provide different context; the erratum is not a new trial. No new effects, P values, CIs, corrected values, totals, independence/safety certification or exercise methods are created.", "criterion": "Corresponding original material and analysis scope for Overall and female findings, prespecification, interaction and estimates must distinguish cumulative events from fallers, individual risk and other outcomes, as well as currently unverified information.", "basis": "Preserved application conditions concerning questions, populations, allocation, exclusions, denominators, events versus individual outcomes, precision, reports versus trials and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed individual content review.", "proposed_research": "Material needed: Overall faller results, female estimates, CIs, P values, prespecification and interactions are unverified. The female signal is not converted into confirmation of reduced overall cumulative events. This records needed materials; no new research was executed.", "current_reports": [ "S02" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content and acquisition of external originals are unverified.", "acquired_read": "Stored summary read; external papers, errata, registration, protocols, analysis plans and support disclosures unread", "observation": "The 2013 report preserves both a positive female-faller subgroup analysis and null fracture findings.", "condition_status": "Partly verified", "status_reason": "Known information and remaining gaps were distinguished and transferred from the stored summary. Detailed external material is unverified and review of existing content remains incomplete. This does not establish completed current clinical review or certification.", "missingness": "Overall faller results, female estimates, CIs, P values, prespecification and interactions are unverified. The female signal is not converted into confirmation of reduced overall cumulative events.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Exclusion-analysis limitations and precision gaps remain, retaining original subclaim C. Gaps in currently preserved material are not extended to absence across all literature or new judgments of efficacy, safety or independence.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Overall faller results, female estimates, CIs, P values, prespecification and interactions are unverified. The female signal is not converted into confirmation of reduced overall cumulative events." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "How does an erratum citation differ from verified corrected content?", "needed": "Original trial, erratum bibliography, corrected items and effects on results", "role": "Required", "role_reason": "This condition connects Original trial, erratum bibliography, corrected items and effects on results with populations, exposure, comparators, allocation, exclusions, events, observation time, denominators, prespecification, precision, report relationships or harms for the selected cumulative-falls question.", "application_exception": "Retain original subclaim C and absent separate score, status and axes without inheriting parent C50 or axes. Event counts after exclusion are not reassigned as fallers, individual risk, fracture prevention or BMD improvement. Later female findings from the same investigators and the erratum provide different context; the erratum is not a new trial. No new effects, P values, CIs, corrected values, totals, independence/safety certification or exercise methods are created.", "criterion": "Corresponding original material and analysis scope for Original trial, erratum bibliography, corrected items and effects on results must distinguish cumulative events from fallers, individual risk and other outcomes, as well as currently unverified information.", "basis": "Preserved application conditions concerning questions, populations, allocation, exclusions, denominators, events versus individual outcomes, precision, reports versus trials and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed individual content review.", "proposed_research": "Material needed: Corrected items, original result tables and effects on estimates and denominators were unread in this work. No new trial, participants or verified corrected values are created. This records needed materials; no new research was executed.", "current_reports": [ "S02", "S03" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content and acquisition of external originals are unverified.", "acquired_read": "Stored summary read; external papers, errata, registration, protocols, analysis plans and support disclosures unread", "observation": "The preserved bibliography includes the 2014 erratum to the 2013 trial, PMID 30321915 and its DOI. The original bibliographic qualifier says the erratum details are unverified.", "condition_status": "Partly verified", "status_reason": "Known information and remaining gaps were distinguished and transferred from the stored summary. Detailed external material is unverified and review of existing content remains incomplete. This does not establish completed current clinical review or certification.", "missingness": "Corrected items, original result tables and effects on estimates and denominators were unread in this work. No new trial, participants or verified corrected values are created.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Exclusion-analysis limitations and precision gaps remain, retaining original subclaim C. Gaps in currently preserved material are not extended to absence across all literature or new judgments of efficacy, safety or independence.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Corrected items, original result tables and effects on estimates and denominators were unread in this work. No new trial, participants or verified corrected values are created." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Can a later report by the same investigators count as independent replication?", "needed": "Between-trial investigators, cohorts, support, outcomes and prespecification", "role": "Required", "role_reason": "This condition connects Between-trial investigators, cohorts, support, outcomes and prespecification with populations, exposure, comparators, allocation, exclusions, events, observation time, denominators, prespecification, precision, report relationships or harms for the selected cumulative-falls question.", "application_exception": "Retain original subclaim C and absent separate score, status and axes without inheriting parent C50 or axes. Event counts after exclusion are not reassigned as fallers, individual risk, fracture prevention or BMD improvement. Later female findings from the same investigators and the erratum provide different context; the erratum is not a new trial. No new effects, P values, CIs, corrected values, totals, independence/safety certification or exercise methods are created.", "criterion": "Corresponding original material and analysis scope for Between-trial investigators, cohorts, support, outcomes and prespecification must distinguish cumulative events from fallers, individual risk and other outcomes, as well as currently unverified information.", "basis": "Preserved application conditions concerning questions, populations, allocation, exclusions, denominators, events versus individual outcomes, precision, reports versus trials and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed individual content review.", "proposed_research": "Material needed: Cohort overlap, independence and confirmation of the same cumulative-event question are unverified. Repetition by the same investigators is not converted into confirmation with independent funding. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content and acquisition of external originals are unverified.", "acquired_read": "Stored summary read; external papers, errata, registration, protocols, analysis plans and support disclosures unread", "observation": "The original account and the 2013 support summary describe the same investigator group as the key trial.", "condition_status": "Partly verified", "status_reason": "Known information and remaining gaps were distinguished and transferred from the stored summary. Detailed external material is unverified and review of existing content remains incomplete. This does not establish completed current clinical review or certification.", "missingness": "Cohort overlap, independence and confirmation of the same cumulative-event question are unverified. Repetition by the same investigators is not converted into confirmation with independent funding.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Exclusion-analysis limitations and precision gaps remain, retaining original subclaim C. Gaps in currently preserved material are not extended to absence across all literature or new judgments of efficacy, safety or independence.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Cohort overlap, independence and confirmation of the same cumulative-event question are unverified. Repetition by the same investigators is not converted into confirmation with independent funding." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Can a BMD trial provide direct evidence for fall events?", "needed": "Separate BMD-trial population, denominators and overall and subgroup findings", "role": "Required", "role_reason": "This condition connects Separate BMD-trial population, denominators and overall and subgroup findings with populations, exposure, comparators, allocation, exclusions, events, observation time, denominators, prespecification, precision, report relationships or harms for the selected cumulative-falls question.", "application_exception": "Retain original subclaim C and absent separate score, status and axes without inheriting parent C50 or axes. Event counts after exclusion are not reassigned as fallers, individual risk, fracture prevention or BMD improvement. Later female findings from the same investigators and the erratum provide different context; the erratum is not a new trial. No new effects, P values, CIs, corrected values, totals, independence/safety certification or exercise methods are created.", "criterion": "Corresponding original material and analysis scope for Separate BMD-trial population, denominators and overall and subgroup findings must distinguish cumulative events from fallers, individual risk and other outcomes, as well as currently unverified information.", "basis": "Preserved application conditions concerning questions, populations, allocation, exclusions, denominators, events versus individual outcomes, precision, reports versus trials and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed individual content review.", "proposed_research": "Material needed: These BMD findings are not used as direct replication of reduced falls for the selected question. Separate fall data are unlinked in current material. This records needed materials; no new research was executed.", "current_reports": [ "S04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content and acquisition of external originals are unverified.", "acquired_read": "Stored summary read; external papers, errata, registration, protocols, analysis plans and support disclosures unread", "observation": "Sakai's 2010 trial randomized 94 postmenopausal women, 49 versus 45. Overall hip BMD at 6 months was null, with site-specific signals in a small subgroup aged at least 70.", "condition_status": "Partly verified", "status_reason": "Known information and remaining gaps were distinguished and transferred from the stored summary. Detailed external material is unverified and review of existing content remains incomplete. This does not establish completed current clinical review or certification.", "missingness": "These BMD findings are not used as direct replication of reduced falls for the selected question. Separate fall data are unlinked in current material.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Exclusion-analysis limitations and precision gaps remain, retaining original subclaim C. Gaps in currently preserved material are not extended to absence across all literature or new judgments of efficacy, safety or independence.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "These BMD findings are not used as direct replication of reduced falls for the selected question. Separate fall data are unlinked in current material." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Does a falls signal establish hip-fracture prevention?", "needed": "Separate clinical outcomes of falls and fractures", "role": "Required", "role_reason": "This condition connects Separate clinical outcomes of falls and fractures with populations, exposure, comparators, allocation, exclusions, events, observation time, denominators, prespecification, precision, report relationships or harms for the selected cumulative-falls question.", "application_exception": "Retain original subclaim C and absent separate score, status and axes without inheriting parent C50 or axes. Event counts after exclusion are not reassigned as fallers, individual risk, fracture prevention or BMD improvement. Later female findings from the same investigators and the erratum provide different context; the erratum is not a new trial. No new effects, P values, CIs, corrected values, totals, independence/safety certification or exercise methods are created.", "criterion": "Corresponding original material and analysis scope for Separate clinical outcomes of falls and fractures must distinguish cumulative events from fallers, individual risk and other outcomes, as well as currently unverified information.", "basis": "Preserved application conditions concerning questions, populations, allocation, exclusions, denominators, events versus individual outcomes, precision, reports versus trials and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed individual content review.", "proposed_research": "Material needed: The fall-event signal is not extended to fracture prevention or stronger bones. No new fracture effects or CIs are created. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content and acquisition of external originals are unverified.", "acquired_read": "Stored summary read; external papers, errata, registration, protocols, analysis plans and support disclosures unread", "observation": "Hip fractures of 1 versus 1 in 2006 and null fracture findings in 2013 are preserved together. Fracture prevention is a separate subclaim.", "condition_status": "Partly verified", "status_reason": "Known information and remaining gaps were distinguished and transferred from the stored summary. Detailed external material is unverified and review of existing content remains incomplete. This does not establish completed current clinical review or certification.", "missingness": "The fall-event signal is not extended to fracture prevention or stronger bones. No new fracture effects or CIs are created.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Exclusion-analysis limitations and precision gaps remain, retaining original subclaim C. Gaps in currently preserved material are not extended to absence across all literature or new judgments of efficacy, safety or independence.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The fall-event signal is not extended to fracture prevention or stronger bones. No new fracture effects or CIs are created." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Do stand-alone single-leg standing and other balance exercises share the same evidence?", "needed": "Program composition and boundaries with the existing verdict and multicomponent programs", "role": "Required", "role_reason": "This condition connects Program composition and boundaries with the existing verdict and multicomponent programs with populations, exposure, comparators, allocation, exclusions, events, observation time, denominators, prespecification, precision, report relationships or harms for the selected cumulative-falls question.", "application_exception": "Retain original subclaim C and absent separate score, status and axes without inheriting parent C50 or axes. Event counts after exclusion are not reassigned as fallers, individual risk, fracture prevention or BMD improvement. Later female findings from the same investigators and the erratum provide different context; the erratum is not a new trial. No new effects, P values, CIs, corrected values, totals, independence/safety certification or exercise methods are created.", "criterion": "Corresponding original material and analysis scope for Program composition and boundaries with the existing verdict and multicomponent programs must distinguish cumulative events from fallers, individual risk and other outcomes, as well as currently unverified information.", "basis": "Preserved application conditions concerning questions, populations, allocation, exclusions, denominators, events versus individual outcomes, precision, reports versus trials and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed individual content review.", "proposed_research": "Material needed: Other verdicts are not newly read or added as independent replication for this sheet. Other-program findings are unlinked in current material. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content and acquisition of external originals are unverified.", "acquired_read": "Stored summary read; external papers, errata, registration, protocols, analysis plans and support disclosures unread", "observation": "The original account restricts the question to stand-alone single-leg standing and records that findings from broader balance and functional-exercise verdict 1557 and multicomponent programs were not transferred.", "condition_status": "Partly verified", "status_reason": "Known information and remaining gaps were distinguished and transferred from the stored summary. Detailed external material is unverified and review of existing content remains incomplete. This does not establish completed current clinical review or certification.", "missingness": "Other verdicts are not newly read or added as independent replication for this sheet. Other-program findings are unlinked in current material.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Exclusion-analysis limitations and precision gaps remain, retaining original subclaim C. Gaps in currently preserved material are not extended to absence across all literature or new judgments of efficacy, safety or independence.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Other verdicts are not newly read or added as independent replication for this sheet. Other-program findings are unlinked in current material." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Can clinical importance and long-term persistence be verified?", "needed": "Recurrent-event effects, CIs, sample planning and long-term follow-up", "role": "Required", "role_reason": "This condition connects Recurrent-event effects, CIs, sample planning and long-term follow-up with populations, exposure, comparators, allocation, exclusions, events, observation time, denominators, prespecification, precision, report relationships or harms for the selected cumulative-falls question.", "application_exception": "Retain original subclaim C and absent separate score, status and axes without inheriting parent C50 or axes. Event counts after exclusion are not reassigned as fallers, individual risk, fracture prevention or BMD improvement. Later female findings from the same investigators and the erratum provide different context; the erratum is not a new trial. No new effects, P values, CIs, corrected values, totals, independence/safety certification or exercise methods are created.", "criterion": "Corresponding original material and analysis scope for Recurrent-event effects, CIs, sample planning and long-term follow-up must distinguish cumulative events from fallers, individual risk and other outcomes, as well as currently unverified information.", "basis": "Preserved application conditions concerning questions, populations, allocation, exclusions, denominators, events versus individual outcomes, precision, reports versus trials and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed individual content review.", "proposed_research": "Material needed: Criteria for clinical importance, sample planning, later persistence and exposure-specific effects are unverified. No new effects, optimal exercise amounts or established prevention methods are created. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content and acquisition of external originals are unverified.", "acquired_read": "Stored summary read; external papers, errata, registration, protocols, analysis plans and support disclosures unread", "observation": "The original narrative concerning a 6-month event signal, incomplete precision and insufficient confirmation is retained.", "condition_status": "Unverified", "status_reason": "Known information and remaining gaps were distinguished and transferred from the stored summary. Detailed external material is unverified and review of existing content remains incomplete. This does not establish completed current clinical review or certification.", "missingness": "Criteria for clinical importance, sample planning, later persistence and exposure-specific effects are unverified. No new effects, optimal exercise amounts or established prevention methods are created.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Exclusion-analysis limitations and precision gaps remain, retaining original subclaim C. Gaps in currently preserved material are not extended to absence across all literature or new judgments of efficacy, safety or independence.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Criteria for clinical importance, sample planning, later persistence and exposure-specific effects are unverified. No new effects, optimal exercise amounts or established prevention methods are created." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Does a government-support bibliographic label establish funding independence?", "needed": "Specific funding, support, affiliations, employee authors, COI and roles", "role": "Required", "role_reason": "This condition connects Specific funding, support, affiliations, employee authors, COI and roles with populations, exposure, comparators, allocation, exclusions, events, observation time, denominators, prespecification, precision, report relationships or harms for the selected cumulative-falls question.", "application_exception": "Retain original subclaim C and absent separate score, status and axes without inheriting parent C50 or axes. Event counts after exclusion are not reassigned as fallers, individual risk, fracture prevention or BMD improvement. Later female findings from the same investigators and the erratum provide different context; the erratum is not a new trial. No new effects, P values, CIs, corrected values, totals, independence/safety certification or exercise methods are created.", "criterion": "Corresponding original material and analysis scope for Specific funding, support, affiliations, employee authors, COI and roles must distinguish cumulative events from fallers, individual risk and other outcomes, as well as currently unverified information.", "basis": "Preserved application conditions concerning questions, populations, allocation, exclusions, denominators, events versus individual outcomes, precision, reports versus trials and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed individual content review.", "proposed_research": "Material needed: The bibliographic support label is not converted into verification of funding independence, absent support, absent employee authors or absent COI. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content and acquisition of external originals are unverified.", "acquired_read": "Stored summary read; external papers, errata, registration, protocols, analysis plans and support disclosures unread", "observation": "The 2006 summary records both indexing as non-U.S. government research support and unverified specific funding and COI.", "condition_status": "Partly verified", "status_reason": "Known information and remaining gaps were distinguished and transferred from the stored summary. Detailed external material is unverified and review of existing content remains incomplete. This does not establish completed current clinical review or certification.", "missingness": "The bibliographic support label is not converted into verification of funding independence, absent support, absent employee authors or absent COI.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Exclusion-analysis limitations and precision gaps remain, retaining original subclaim C. Gaps in currently preserved material are not extended to absence across all literature or new judgments of efficacy, safety or independence.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The bibliographic support label is not converted into verification of funding independence, absent support, absent employee authors or absent COI." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are support and author relationships for the later trial and erratum verified?", "needed": "Separate funding, support, authors and COI for the trial and erratum", "role": "Required", "role_reason": "This condition connects Separate funding, support, authors and COI for the trial and erratum with populations, exposure, comparators, allocation, exclusions, events, observation time, denominators, prespecification, precision, report relationships or harms for the selected cumulative-falls question.", "application_exception": "Retain original subclaim C and absent separate score, status and axes without inheriting parent C50 or axes. Event counts after exclusion are not reassigned as fallers, individual risk, fracture prevention or BMD improvement. Later female findings from the same investigators and the erratum provide different context; the erratum is not a new trial. No new effects, P values, CIs, corrected values, totals, independence/safety certification or exercise methods are created.", "criterion": "Corresponding original material and analysis scope for Separate funding, support, authors and COI for the trial and erratum must distinguish cumulative events from fallers, individual risk and other outcomes, as well as currently unverified information.", "basis": "Preserved application conditions concerning questions, populations, allocation, exclusions, denominators, events versus individual outcomes, precision, reports versus trials and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed individual content review.", "proposed_research": "Material needed: Support and COI for the original trial and erratum are not filled in as if each verified the other. This records needed materials; no new research was executed.", "current_reports": [ "S02", "S03" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content and acquisition of external originals are unverified.", "acquired_read": "Stored summary read; external papers, errata, registration, protocols, analysis plans and support disclosures unread", "observation": "The 2013 report retains unverified specific funding and COI and the same-investigator context. Only the erratum bibliography is preserved.", "condition_status": "Unverified", "status_reason": "Known information and remaining gaps were distinguished and transferred from the stored summary. Detailed external material is unverified and review of existing content remains incomplete. This does not establish completed current clinical review or certification.", "missingness": "Support and COI for the original trial and erratum are not filled in as if each verified the other.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Exclusion-analysis limitations and precision gaps remain, retaining original subclaim C. Gaps in currently preserved material are not extended to absence across all literature or new judgments of efficacy, safety or independence.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Support and COI for the original trial and erratum are not filled in as if each verified the other." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "What is known about support and interests in the separate BMD trial?", "needed": "BMD-trial funding, product support, employee authors, COI and roles", "role": "Required", "role_reason": "This condition connects BMD-trial funding, product support, employee authors, COI and roles with populations, exposure, comparators, allocation, exclusions, events, observation time, denominators, prespecification, precision, report relationships or harms for the selected cumulative-falls question.", "application_exception": "Retain original subclaim C and absent separate score, status and axes without inheriting parent C50 or axes. Event counts after exclusion are not reassigned as fallers, individual risk, fracture prevention or BMD improvement. Later female findings from the same investigators and the erratum provide different context; the erratum is not a new trial. No new effects, P values, CIs, corrected values, totals, independence/safety certification or exercise methods are created.", "criterion": "Corresponding original material and analysis scope for BMD-trial funding, product support, employee authors, COI and roles must distinguish cumulative events from fallers, individual risk and other outcomes, as well as currently unverified information.", "basis": "Preserved application conditions concerning questions, populations, allocation, exclusions, denominators, events versus individual outcomes, precision, reports versus trials and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed individual content review.", "proposed_research": "Material needed: The parent account's description of an independent BMD trial is not converted into verification of independent funding or support. This records needed materials; no new research was executed.", "current_reports": [ "S04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content and acquisition of external originals are unverified.", "acquired_read": "Stored summary read; external papers, errata, registration, protocols, analysis plans and support disclosures unread", "observation": "The wording that specific funding and COI in Sakai's trial are unverified is retained.", "condition_status": "Unverified", "status_reason": "Known information and remaining gaps were distinguished and transferred from the stored summary. Detailed external material is unverified and review of existing content remains incomplete. This does not establish completed current clinical review or certification.", "missingness": "The parent account's description of an independent BMD trial is not converted into verification of independent funding or support.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Exclusion-analysis limitations and precision gaps remain, retaining original subclaim C. Gaps in currently preserved material are not extended to absence across all literature or new judgments of efficacy, safety or independence.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The parent account's description of an independent BMD trial is not converted into verification of independent funding or support." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Are falls counted for efficacy the same as exercise-related harms?", "needed": "Intervention-related harms, collection, severity, arm-specific denominators and time", "role": "Supplementary", "role_reason": "This condition connects Intervention-related harms, collection, severity, arm-specific denominators and time with populations, exposure, comparators, allocation, exclusions, events, observation time, denominators, prespecification, precision, report relationships or harms for the selected cumulative-falls question.", "application_exception": "Retain original subclaim C and absent separate score, status and axes without inheriting parent C50 or axes. Event counts after exclusion are not reassigned as fallers, individual risk, fracture prevention or BMD improvement. Later female findings from the same investigators and the erratum provide different context; the erratum is not a new trial. No new effects, P values, CIs, corrected values, totals, independence/safety certification or exercise methods are created.", "criterion": "Corresponding original material and analysis scope for Intervention-related harms, collection, severity, arm-specific denominators and time must distinguish cumulative events from fallers, individual risk and other outcomes, as well as currently unverified information.", "basis": "Preserved application conditions concerning questions, populations, allocation, exclusions, denominators, events versus individual outcomes, precision, reports versus trials and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed individual content review.", "proposed_research": "Material needed: Falls during exercise, other harms, severity, arm-specific events, denominators, discontinuation and active collection are unverified. Efficacy-event counts are not reassigned as intervention-related harm events. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content and acquisition of external originals are unverified.", "acquired_read": "Stored summary read; external papers, errata, registration, protocols, analysis plans and support disclosures unread", "observation": "Parent safety 'Caution', permission to use support bars and the original safety narrative are preserved.", "condition_status": "Unverified", "status_reason": "Known information and remaining gaps were distinguished and transferred from the stored summary. Detailed external material is unverified and review of existing content remains incomplete. This does not establish completed current clinical review or certification.", "missingness": "Falls during exercise, other harms, severity, arm-specific events, denominators, discontinuation and active collection are unverified. Efficacy-event counts are not reassigned as intervention-related harm events.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Exclusion-analysis limitations and precision gaps remain, retaining original subclaim C. Gaps in currently preserved material are not extended to absence across all literature or new judgments of efficacy, safety or independence.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Falls during exercise, other harms, severity, arm-specific events, denominators, discontinuation and active collection are unverified. Efficacy-event counts are not reassigned as intervention-related harm events." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Are long-term harms and vulnerable high-risk populations verified?", "needed": "Harms by activity, support and control conditions and alternative causes", "role": "Supplementary", "role_reason": "This condition connects Harms by activity, support and control conditions and alternative causes with populations, exposure, comparators, allocation, exclusions, events, observation time, denominators, prespecification, precision, report relationships or harms for the selected cumulative-falls question.", "application_exception": "Retain original subclaim C and absent separate score, status and axes without inheriting parent C50 or axes. Event counts after exclusion are not reassigned as fallers, individual risk, fracture prevention or BMD improvement. Later female findings from the same investigators and the erratum provide different context; the erratum is not a new trial. No new effects, P values, CIs, corrected values, totals, independence/safety certification or exercise methods are created.", "criterion": "Corresponding original material and analysis scope for Harms by activity, support and control conditions and alternative causes must distinguish cumulative events from fallers, individual risk and other outcomes, as well as currently unverified information.", "basis": "Preserved application conditions concerning questions, populations, allocation, exclusions, denominators, events versus individual outcomes, precision, reports versus trials and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed individual content review.", "proposed_research": "Material needed: Harms by comparator, concurrent activities, conditions and long-term or vulnerable-population materials are unverified. No new safety certification is provided. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content and acquisition of external originals are unverified.", "acquired_read": "Stored summary read; external papers, errata, registration, protocols, analysis plans and support disclosures unread", "observation": "Support for high-risk or unstable participants and the parent caution wording provide preserved context. No new exercise or treatment methods are provided.", "condition_status": "Unverified", "status_reason": "Known information and remaining gaps were distinguished and transferred from the stored summary. Detailed external material is unverified and review of existing content remains incomplete. This does not establish completed current clinical review or certification.", "missingness": "Harms by comparator, concurrent activities, conditions and long-term or vulnerable-population materials are unverified. No new safety certification is provided.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Exclusion-analysis limitations and precision gaps remain, retaining original subclaim C. Gaps in currently preserved material are not extended to absence across all literature or new judgments of efficacy, safety or independence.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Harms by comparator, concurrent activities, conditions and long-term or vulnerable-population materials are unverified. No new safety certification is provided." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "How are errata, reports and trial families distinguished?", "needed": "Reports, bibliography, errata, trials and cohort relationships", "role": "Required", "role_reason": "This condition connects Reports, bibliography, errata, trials and cohort relationships with populations, exposure, comparators, allocation, exclusions, events, observation time, denominators, prespecification, precision, report relationships or harms for the selected cumulative-falls question.", "application_exception": "Retain original subclaim C and absent separate score, status and axes without inheriting parent C50 or axes. Event counts after exclusion are not reassigned as fallers, individual risk, fracture prevention or BMD improvement. Later female findings from the same investigators and the erratum provide different context; the erratum is not a new trial. No new effects, P values, CIs, corrected values, totals, independence/safety certification or exercise methods are created.", "criterion": "Corresponding original material and analysis scope for Reports, bibliography, errata, trials and cohort relationships must distinguish cumulative events from fallers, individual risk and other outcomes, as well as currently unverified information.", "basis": "Preserved application conditions concerning questions, populations, allocation, exclusions, denominators, events versus individual outcomes, precision, reports versus trials and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed individual content review.", "proposed_research": "Material needed: Unique trial, participant, event and independent-replication totals are not established or added together. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03", "S04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content and acquisition of external originals are unverified.", "acquired_read": "Stored summary read; external papers, errata, registration, protocols, analysis plans and support disclosures unread", "observation": "S01 is the 2006 report, S02 the 2013 report, S03 the 2014 erratum and S04 Sakai's 2010 report. S03 is an erratum in the S02 trial family, not a new clinical trial.", "condition_status": "Partly verified", "status_reason": "Known information and remaining gaps were distinguished and transferred from the stored summary. Detailed external material is unverified and review of existing content remains incomplete. This does not establish completed current clinical review or certification.", "missingness": "Unique trial, participant, event and independent-replication totals are not established or added together.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Exclusion-analysis limitations and precision gaps remain, retaining original subclaim C. Gaps in currently preserved material are not extended to absence across all literature or new judgments of efficacy, safety or independence.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Unique trial, participant, event and independent-replication totals are not established or added together." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "How are original empty fields, languages, dates and corrections retained?", "needed": "Parent and subclaim grades, axes, empty fields and change history", "role": "Required", "role_reason": "This condition connects Parent and subclaim grades, axes, empty fields and change history with populations, exposure, comparators, allocation, exclusions, events, observation time, denominators, prespecification, precision, report relationships or harms for the selected cumulative-falls question.", "application_exception": "Retain original subclaim C and absent separate score, status and axes without inheriting parent C50 or axes. Event counts after exclusion are not reassigned as fallers, individual risk, fracture prevention or BMD improvement. Later female findings from the same investigators and the erratum provide different context; the erratum is not a new trial. No new effects, P values, CIs, corrected values, totals, independence/safety certification or exercise methods are created.", "criterion": "Corresponding original material and analysis scope for Parent and subclaim grades, axes, empty fields and change history must distinguish cumulative events from fallers, individual risk and other outcomes, as well as currently unverified information.", "basis": "Preserved application conditions concerning questions, populations, allocation, exclusions, denominators, events versus individual outcomes, precision, reports versus trials and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed individual content review.", "proposed_research": "Material needed: Null precision is not filled with a new code, and parent scores or historical cross-checks are not inherited as a subclaim verdict or current content review. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03", "S04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content and acquisition of external originals are unverified.", "acquired_read": "Stored summary read; external papers, errata, registration, protocols, analysis plans and support disclosures unread", "observation": "Parent C50, null precision, Korean and English originals, 2026-09-07, the empty correction list and deliberation string, and subclaim C and its explanation are preserved. The literature erratum and the account's correction history are distinct.", "condition_status": "Partly verified", "status_reason": "Known information and remaining gaps were distinguished and transferred from the stored summary. Detailed external material is unverified and review of existing content remains incomplete. This does not establish completed current clinical review or certification.", "missingness": "Null precision is not filled with a new code, and parent scores or historical cross-checks are not inherited as a subclaim verdict or current content review.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Exclusion-analysis limitations and precision gaps remain, retaining original subclaim C. Gaps in currently preserved material are not extended to absence across all literature or new judgments of efficacy, safety or independence.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Null precision is not filled with a new code, and parent scores or historical cross-checks are not inherited as a subclaim verdict or current content review." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "What materials were actually read?", "needed": "Reading scope for stored summaries, papers, errata, registration, plans and support", "role": "Required", "role_reason": "This condition connects Reading scope for stored summaries, papers, errata, registration, plans and support with populations, exposure, comparators, allocation, exclusions, events, observation time, denominators, prespecification, precision, report relationships or harms for the selected cumulative-falls question.", "application_exception": "Retain original subclaim C and absent separate score, status and axes without inheriting parent C50 or axes. Event counts after exclusion are not reassigned as fallers, individual risk, fracture prevention or BMD improvement. Later female findings from the same investigators and the erratum provide different context; the erratum is not a new trial. No new effects, P values, CIs, corrected values, totals, independence/safety certification or exercise methods are created.", "criterion": "Corresponding original material and analysis scope for Reading scope for stored summaries, papers, errata, registration, plans and support must distinguish cumulative events from fallers, individual risk and other outcomes, as well as currently unverified information.", "basis": "Preserved application conditions concerning questions, populations, allocation, exclusions, denominators, events versus individual outcomes, precision, reports versus trials and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed individual content review.", "proposed_research": "Material needed: External papers, errata, registration, protocols, statistical analysis plans and support originals were unread and access was not attempted in this work. Historical verification or URLs are not labeled as current original-material reading or external-link testing. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02", "S03", "S04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content and acquisition of external originals are unverified.", "acquired_read": "Stored summary read; external papers, errata, registration, protocols, analysis plans and support disclosures unread", "observation": "The complete preserved JSON was read for this sheet. Report-level paper and erratum citations, stored-summary reading and unread external materials are distinguished.", "condition_status": "Partly verified", "status_reason": "Known information and remaining gaps were distinguished and transferred from the stored summary. Detailed external material is unverified and review of existing content remains incomplete. This does not establish completed current clinical review or certification.", "missingness": "External papers, errata, registration, protocols, statistical analysis plans and support originals were unread and access was not attempted in this work. Historical verification or URLs are not labeled as current original-material reading or external-link testing.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Exclusion-analysis limitations and precision gaps remain, retaining original subclaim C. Gaps in currently preserved material are not extended to absence across all literature or new judgments of efficacy, safety or independence.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "External papers, errata, registration, protocols, statistical analysis plans and support originals were unread and access was not attempted in this work. Historical verification or URLs are not labeled as current original-material reading or external-link testing." } ], "reports": [ { "report_id": "S01", "title": "Sakamoto K, et al. Effects of unipedal standing balance exercise on the prevention of falls and hip fracture among clinically defined high-risk elderly individuals: a randomized controlled trial. J Orthop Sci. 2006;11:467-472. PMID: 17013734. DOI: 10.1007/s00776-006-1057-2.", "url": "https://pubmed.ncbi.nlm.nih.gov/17013734/", "report_type": "Six-month randomized controlled trial", "existence": "The stored summary contains a bibliography; acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external materials unread", "study_family": "Linked groups of preserved reports and errata; unique counts and independence unverified", "independent_replication": "These report groups link preserved evidence entries and citations. The key cumulative-event report is distinguished from the same investigators' later faller report, with the erratum linked to the later trial family. The separate BMD trial is not direct replication of the selected fall-event question. Unique trial, participant, event and independent-replication totals are unverified and are not summed.", "observed_result": "Falls 118 versus 121 after excluding 1 recurrent faller from exercise; fractures 1 versus 1", "result_level": "The key 6-month cumulative-event report retains 553 randomized, 527 analyzed, 315 versus 212, 26 withdrawals and 118 versus 121 events after an additional 1 recurrent-faller exclusion. Final event denominators, pre-exclusion results, exact effects and CIs are unverified.", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete parent-verdict stored summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07", "qualification": "Preserve original PMID 17013734, DOI 10.1007/s00776-006-1057-2 and unverified registration. Indexing as non-U.S. government support does not verify specific funding, support, COI, roles or independence. External originals and plans were unread in this work." }, { "material_type": "External paper", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PMID 17013734, DOI 10.1007/s00776-006-1057-2 and unverified registration. Indexing as non-U.S. government support does not verify specific funding, support, COI, roles or independence. External originals and plans were unread in this work." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PMID 17013734, DOI 10.1007/s00776-006-1057-2 and unverified registration. Indexing as non-U.S. government support does not verify specific funding, support, COI, roles or independence. External originals and plans were unread in this work." }, { "material_type": "Protocol", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PMID 17013734, DOI 10.1007/s00776-006-1057-2 and unverified registration. Indexing as non-U.S. government support does not verify specific funding, support, COI, roles or independence. External originals and plans were unread in this work." }, { "material_type": "Statistical analysis plan", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PMID 17013734, DOI 10.1007/s00776-006-1057-2 and unverified registration. Indexing as non-U.S. government support does not verify specific funding, support, COI, roles or independence. External originals and plans were unread in this work." }, { "material_type": "Funding, product-support and COI material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PMID 17013734, DOI 10.1007/s00776-006-1057-2 and unverified registration. Indexing as non-U.S. government support does not verify specific funding, support, COI, roles or independence. External originals and plans were unread in this work." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/17013734/" } ] }, { "report_id": "S02", "title": "Sakamoto K, et al. Why not use your own body weight to prevent falls? A randomized, controlled trial of balance therapy to prevent falls and fractures for elderly people who can stand on one leg for <=15 s. J Orthop Sci. 2013;18:110-120. PMID: 23138409. DOI: 10.1007/s00776-012-0328-3.", "url": "https://pubmed.ncbi.nlm.nih.gov/23138409/", "report_type": "Randomized trial in balance-impaired adults aged at least 75", "existence": "The stored summary contains a bibliography; acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external materials unread", "study_family": "Linked groups of preserved reports and errata; unique counts and independence unverified", "independent_replication": "These report groups link preserved evidence entries and citations. The key cumulative-event report is distinguished from the same investigators' later faller report, with the erratum linked to the later trial family. The separate BMD trial is not direct replication of the selected fall-event question. Unique trial, participant, event and independent-replication totals are unverified and are not summed.", "observed_result": "Positive female faller subgroup; fractures null", "result_level": "The 2013 later trial by the same investigators retains 865 analyzed balance-impaired adults aged at least 75, 410 versus 455, a positive female-faller subgroup and null fractures. These are not converted into direct independent replication of the key cumulative events or verified overall findings.", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete parent-verdict stored summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07", "qualification": "Preserve original PMID 23138409, DOI 10.1007/s00776-012-0328-3 and unverified registration. The female subgroup, same investigator group and existence of an erratum are separate limitations; specific funding and COI are unverified." }, { "material_type": "External paper", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PMID 23138409, DOI 10.1007/s00776-012-0328-3 and unverified registration. The female subgroup, same investigator group and existence of an erratum are separate limitations; specific funding and COI are unverified." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PMID 23138409, DOI 10.1007/s00776-012-0328-3 and unverified registration. The female subgroup, same investigator group and existence of an erratum are separate limitations; specific funding and COI are unverified." }, { "material_type": "Protocol", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PMID 23138409, DOI 10.1007/s00776-012-0328-3 and unverified registration. The female subgroup, same investigator group and existence of an erratum are separate limitations; specific funding and COI are unverified." }, { "material_type": "Statistical analysis plan", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PMID 23138409, DOI 10.1007/s00776-012-0328-3 and unverified registration. The female subgroup, same investigator group and existence of an erratum are separate limitations; specific funding and COI are unverified." }, { "material_type": "Funding, product-support and COI material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PMID 23138409, DOI 10.1007/s00776-012-0328-3 and unverified registration. The female subgroup, same investigator group and existence of an erratum are separate limitations; specific funding and COI are unverified." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/23138409/" } ] }, { "report_id": "S03", "title": "Sakamoto K, et al. Erratum to: Why not use your own body weight to prevent falls? J Orthop Sci. 2014;19:373-374. PMID: 30321915. DOI: 10.1007/s00776-014-0531-5.", "url": "https://pubmed.ncbi.nlm.nih.gov/30321915/", "report_type": "Bibliographic erratum to the later trial; no separate original evidence entry", "existence": "The stored summary contains a bibliography; acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external materials unread", "study_family": "Linked groups of preserved reports and errata; unique counts and independence unverified", "independent_replication": "These report groups link preserved evidence entries and citations. The key cumulative-event report is distinguished from the same investigators' later faller report, with the erratum linked to the later trial family. The separate BMD trial is not direct replication of the selected fall-event question. Unique trial, participant, event and independent-replication totals are unverified and are not summed.", "observed_result": "The preserved bibliography discloses an erratum to the 2013 trial.", "result_level": "Only the bibliography of the 2014 erratum to the 2013 trial is preserved. No separate original evidence entry exists; corrected items and effects on results and denominators are unread. It is linked to the later trial family and is not counted as a new trial, participants or verified corrected values.", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete parent-verdict stored summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07", "qualification": "Preserve original PMID 30321915 and DOI 10.1007/s00776-014-0531-5. Only the erratum bibliography exists, without a separate original evidence entry or registration wording. Correction details, effects on results and denominators, support and COI are unverified and are not newly filled in." }, { "material_type": "External erratum", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PMID 30321915 and DOI 10.1007/s00776-014-0531-5. Only the erratum bibliography exists, without a separate original evidence entry or registration wording. Correction details, effects on results and denominators, support and COI are unverified and are not newly filled in." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PMID 30321915 and DOI 10.1007/s00776-014-0531-5. Only the erratum bibliography exists, without a separate original evidence entry or registration wording. Correction details, effects on results and denominators, support and COI are unverified and are not newly filled in." }, { "material_type": "Protocol", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PMID 30321915 and DOI 10.1007/s00776-014-0531-5. Only the erratum bibliography exists, without a separate original evidence entry or registration wording. Correction details, effects on results and denominators, support and COI are unverified and are not newly filled in." }, { "material_type": "Statistical analysis plan", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PMID 30321915 and DOI 10.1007/s00776-014-0531-5. Only the erratum bibliography exists, without a separate original evidence entry or registration wording. Correction details, effects on results and denominators, support and COI are unverified and are not newly filled in." }, { "material_type": "Funding, product-support and COI material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PMID 30321915 and DOI 10.1007/s00776-014-0531-5. Only the erratum bibliography exists, without a separate original evidence entry or registration wording. Correction details, effects on results and denominators, support and COI are unverified and are not newly filled in." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/30321915/" } ] }, { "report_id": "S04", "title": "Sakai A, et al. Unipedal standing exercise and hip bone mineral density in postmenopausal women: a randomized controlled trial. J Bone Miner Metab. 2010;28:42-48. PMID: 19521657. DOI: 10.1007/s00774-009-0100-8.", "url": "https://pubmed.ncbi.nlm.nih.gov/19521657/", "report_type": "Randomized controlled trial in postmenopausal women", "existence": "The stored summary contains a bibliography; acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external materials unread", "study_family": "Linked groups of preserved reports and errata; unique counts and independence unverified", "independent_replication": "These report groups link preserved evidence entries and citations. The key cumulative-event report is distinguished from the same investigators' later faller report, with the erratum linked to the later trial family. The separate BMD trial is not direct replication of the selected fall-event question. Unique trial, participant, event and independent-replication totals are unverified and are not summed.", "observed_result": "Overall hip BMD null; site-specific signals in a small aged 70 or older subgroup", "result_level": "The 2010 trial examined 6-month hip BMD in postmenopausal women. It retains 94 randomized, 49 versus 45, null overall findings and site-specific signals in a small subgroup aged at least 70. These are not reassigned as direct effects or independent replication of the selected cumulative fall events.", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete parent-verdict stored summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07", "qualification": "Preserve original PMID 19521657, DOI 10.1007/s00774-009-0100-8 and unverified registration. Null overall BMD findings and the small age subgroup are distinguished. Specific funding, support and COI are unverified; the parent description of an independent trial is not converted into funding independence." }, { "material_type": "External paper", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PMID 19521657, DOI 10.1007/s00774-009-0100-8 and unverified registration. Null overall BMD findings and the small age subgroup are distinguished. Specific funding, support and COI are unverified; the parent description of an independent trial is not converted into funding independence." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PMID 19521657, DOI 10.1007/s00774-009-0100-8 and unverified registration. Null overall BMD findings and the small age subgroup are distinguished. Specific funding, support and COI are unverified; the parent description of an independent trial is not converted into funding independence." }, { "material_type": "Protocol", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PMID 19521657, DOI 10.1007/s00774-009-0100-8 and unverified registration. Null overall BMD findings and the small age subgroup are distinguished. Specific funding, support and COI are unverified; the parent description of an independent trial is not converted into funding independence." }, { "material_type": "Statistical analysis plan", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PMID 19521657, DOI 10.1007/s00774-009-0100-8 and unverified registration. Null overall BMD findings and the small age subgroup are distinguished. Specific funding, support and COI are unverified; the parent description of an independent trial is not converted into funding independence." }, { "material_type": "Funding, product-support and COI material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PMID 19521657, DOI 10.1007/s00774-009-0100-8 and unverified registration. Null overall BMD findings and the small age subgroup are distinguished. Specific funding, support and COI are unverified; the parent description of an independent trial is not converted into funding independence." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/19521657/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." } ], "status_dictionary": { "Met": "A state used when required evidence is confirmed after user review. This production does not declare that review complete.", "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": "User review pending.", "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": "These report groups link preserved evidence entries and citations. The key cumulative-event report is distinguished from the same investigators' later faller report, with the erratum linked to the later trial family. The separate BMD trial is not direct replication of the selected fall-event question. Unique trial, participant, event and independent-replication totals are unverified and are not summed." }, "history": [ { "date": "2026-10-19", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public-facing views and materials were prepared from the existing 30 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-19" }