{ "schema_version": "chamgap-public-criteria-1.0", "title": "Stand-Alone Single-Leg Standing × Reduced Cumulative Falls Over Six Months · Evidence and Gaps Sheet", "language": "en", "translation_date": "2026-10-19", "criteria_version": "1.0", "criteria_date": "2026-10-06", "condition_origin": "Chamgap's own application conditions", "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." }, "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." } ] }