CHAMGAP

Two-year balance training × reduced serious injurious falls in women aged 75–85 with impaired balance: an evidence checklist

Select a review item to see its details.
Required evidence, verification status and materials actually read
ItemAVerification statusBReading scopeCReview itemDCurrent findingsEWhy unverifiedFRequired materials and conditionsGFurther research
1 Partly verified Full text not readStored summary read N01 · Efficacy comparison and presentation of stored materialWhat is the selected serious-injury-only question and original grade?Required
The selected claim is reduced serious injurious falls, with subclaim grade D and a note that the HR.83 CI included 1. Combined-outcome B and parent B76 provide different context.
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. The subclaim has no score, status or axis values; parent values do not fill them. The combined effect does not establish the serious-only effect. The original content review remains incomplete.
Separate subclaim D and note, combined-outcome B and parent B76
Separate the question, assessment record and assessments of other endpoints. This is a proposal; no new investigation, calculation or trial was performed.
2 Partly verified Full text not readStored summary read N02 · Efficacy comparison and presentation of stored materialWho was studied for the serious-injury outcome and how were participants selected?Required
The original Ossébo population was 706 community-dwelling women aged 75–85 with impaired balance or gait.
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Impairment thresholds, baseline falls and illnesses, eligibility and exclusions, recruitment and the population observed for the serious-injury outcome are unverified. The finding is not extended to all older adults, men or institutional settings. The original content review remains incomplete.
Impaired balance or gait, community-dwelling women aged 75–85 and baseline risk
Retain differences between the selected population and other high-risk groups. This is a proposal; no new investigation, calculation or trial was performed.
3 Partly verified Full text not readStored summary read N03 · Efficacy comparison and presentation of stored materialWhat was the historical two-year program and actual exposure?Required
The original research program combined weekly supervised group balance training and home exercise over two years. This is not an exercise program, movement instruction or prescription.
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Detailed components, home exposure and attendance, intensity, actual adherence and discontinuation, and separate component effects are unverified. The original content review remains incomplete.
Supervised group plus home exercise, weekly sessions, adherence and discontinuation
Distinguish planned intervention from actual exposure. This is a proposal; no new investigation, calculation or trial was performed.
4 Unverified Full text not readStored summary read N04 · Efficacy comparison and presentation of stored materialWhat were the control, concomitant measures and changes?Required
The original materials compare 352 exercise participants with 354 controls.
The information currently needed is unverified in the stored summary. Control care, information and contact, group-specific concurrent exercise, treatment, environmental changes and amendments are unverified. No intervention or placebo is not filled in. The original content review remains incomplete.
Control care, shared or other exercise, medication, environment and rescue treatment
Separate the program contribution from other exposures. This is a proposal; no new investigation, calculation or trial was performed.
5 Partly verified Full text not readStored summary read N05 · Efficacy comparison and presentation of stored materialAre allocation and baseline balance in the 20-center RCT known?Required
The original text describes a 20-center, two-year RCT with 706 participants allocated 352/354.
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Allocation unit and operations, baseline balance and group correspondence within centers are unverified. Center count alone does not establish cluster randomization. The original content review remains incomplete.
Allocation unit, sequence and concealment, centers and individuals, baseline characteristics
Separate centers, participants and the actual randomized design. This is a proposal; no new investigation, calculation or trial was performed.
6 Partly verified Full text not readStored summary read N06 · Efficacy comparison and presentation of stored materialWhich criteria classified serious injury events?Required
The original text says geriatricians unaware of allocation classified events using physical-harm and healthcare-use criteria. The selected question concerns serious injuries only.
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Exact serious-injury thresholds and components, specific fracture or hospitalization rules, overlap and reclassification and adjudicator agreement are unverified. Moderate-plus-serious injuries are not treated as the same event category. The original content review remains incomplete.
Serious-injury definition, physical harm and healthcare use, adjudication and reclassification
Separate definitions of serious-only injuries, combined injuries and all falls. This is a proposal; no new investigation, calculation or trial was performed.
7 Partly verified Full text not readStored summary read N07 · Efficacy comparison and presentation of stored materialWhat is known about event collection, blinded adjudication, detection and omissions?Required
The original record of adjudicators being blinded to allocation is preserved.
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Participant, collector and analyst blinding, fall collection methods and frequency, detection and omissions and medical-record confirmation are unverified. The strength of adjudication is not treated as resolution of every measurement or missing-data issue. The original content review remains incomplete.
Reporting and verification, blinding, collection frequency and omissions over time
Separate event occurrence, reporting and adjudication stages. This is a proposal; no new investigation, calculation or trial was performed.
8 Partly verified Full text not readStored summary read N08 · Efficacy comparison and presentation of stored materialAre 68/87 events counts of unique people?Required
The original serious injurious-fall counts were 68 versus 87 events, preserved as event counts for exercise and control respectively.
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. People per event, first and repeated events, the serious-injury analysis population and observation time are unverified. Events are not converted to people or response rates, and no new total or difference is calculated. The original content review remains incomplete.
Serious events, people, repetition, denominators and duration
Distinguish repeated events in the same person from event counts. This is a proposal; no new investigation, calculation or trial was performed.
9 Partly verified Full text not readStored summary read N09 · Efficacy comparison and presentation of stored materialWhat result do the serious-only HR.83, interval and nonsignificance describe?Required
The original serious-only HR.83, CI.60~1.16 and narrative and note that the result was not significant are preserved.
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. The serious-only P value, interval construction, center and repeated-event handling, exact denominator and importance threshold are unverified. New P values, percentage reductions or CI are not calculated. The original content review remains incomplete.
Original estimate, CI, model, time and interpretation
Link the original interval to the analysis of its endpoint. This is a proposal; no new investigation, calculation or trial was performed.
10 Partly verified Full text not readStored summary read N10 · Efficacy comparison and presentation of stored materialDoes a CI including 1 establish an exactly zero effect or equivalence?Required
The original text records that the serious-only CI included benefit and no effect and the result was not statistically established. Subclaim D is the original grade.
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Important-difference and equivalence margins, prior hypotheses and additional precision data are unverified. An exactly zero effect, exclusion of every important benefit or equivalence is not newly assessed. The original content review remains incomplete.
Original uncertainty, effects compatible with the interval, important differences and hypotheses
Separate nonsignificance and uncertainty from a distinct equivalence question. This is a proposal; no new investigation, calculation or trial was performed.
11 Partly verified Full text not readStored summary read N11 · Efficacy comparison and presentation of stored materialCan the positive combined-injury finding be applied to serious injuries only?Required
Combined 305/397 events, original 0.45/0.56 events per woman-year, center-adjusted shared-frailty HR.81 (CI.67~.99) and P=.04 belong to another endpoint.
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. The combined model, denominator, P=.04 and rates do not fill serious-only values. Moderate-only effects or events are not newly calculated by subtracting serious injuries from the combined result. The original content review remains incomplete.
Moderate-plus-serious injuries, event counts, rates and HR, distinct endpoints
Preserve positive and nonsignificant results from the same trial together. This is a proposal; no new investigation, calculation or trial was performed.
12 Partly verified Full text not readStored summary read N12 · Efficacy comparison and presentation of stored materialWhat history do the original primary outcome and recruitment-stage amendment provide for the serious-injury hierarchy?Required
The original text says that the target was reduced from 1,000 per arm about eight months after recruitment began and the outcome changed from Korean first serious fall or English serious falls to moderate-plus-serious injuries.
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. The original first-event estimation definition, serious-injury hierarchy and testing after amendment, revised target and original plans are unverified. First-event or recurrent-event modeling or current serious-injury primary status is not arbitrarily established. The original content review remains incomplete.
Original and amended primary outcome, timing, sample target and reasons
Distinguish the original hierarchy, amendment and current serious-injury result. This is a proposal; no new investigation, calculation or trial was performed.
13 Partly verified Full text not readStored summary read N13 · Efficacy comparison and presentation of stored materialWere data-driven amendment, prespecification and multiplicity verified?Required
The original text records that amendment was not reported as data-driven, while prespecification had limitations.
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Decision timing, actual data access, serious-injury testing and multiplicity and original and amended plans have not been read. Neither confirmed data-driven amendment nor complete prespecified confirmation is newly certified. The original content review remains incomplete.
Amendment decisions, data access, hypotheses, multiple comparisons and prior hierarchy
Separate the original amendment narrative from actual verification. This is a proposal; no new investigation, calculation or trial was performed.
14 Unverified Full text not readStored summary read N14 · Efficacy comparison and presentation of stored materialWhat are the two-year follow-up, event times, censoring, missing data and denominators?Required
Original allocation of 706 participants, 352/354, and two-year follow-up are preserved.
The information currently needed is unverified in the stored summary. People completing follow-up or analyzed for serious injuries, actual time, attrition, deaths, censoring and missing-data handling are unverified. Combined woman-year rates or complete two-year follow-up for everyone do not fill serious-only denominators. The original content review remains incomplete.
Allocation, observation and analysis, actual time, attrition and deaths
Distinguish nominal duration from actual serious-injury observation and analysis. This is a proposal; no new investigation, calculation or trial was performed.
15 Unverified Full text not readStored summary read N15 · Efficacy comparison and presentation of stored materialWhat are the effect of interest, ITT, adherence and repeated-event handling for serious-injury analysis?Required
The current summary provides the serious-only HR and interval but does not specify the detailed model.
The information currently needed is unverified in the stored summary. The combined center-adjusted shared-frailty model is not automatically copied to serious injuries. Serious-only ITT/PP, adherence, first and repeated events, sensitivity analyses and subgroups are unverified. The original content review remains incomplete.
Assignment effect, ITT/PP, models, deviations and sensitivity analyses
Separate endpoint-specific models, denominators and effect definitions. This is a proposal; no new investigation, calculation or trial was performed.
16 Unverified Full text not readStored summary read N16 · Efficacy comparison and presentation of stored materialDo other fall or functional outcomes answer the serious-injury-only question?Required
The original evidence concerns combined moderate-plus-serious and serious-only outcomes.
The information currently needed is unverified in the stored summary. All falls, component-specific fractures, function, quality of life, death and other secondary values are unverified. Serious-injury counts and HR are not turned into other outcomes. The original content review remains incomplete.
All falls, fractures and hospitalization, function, mortality and primary or secondary hierarchy
Distinguish serious events from other clinical and functional questions. This is a proposal; no new investigation, calculation or trial was performed.
17 Partly verified Full text not readStored summary read N17 · Efficacy comparison and presentation of stored materialWhat is the actual access status of registration, plans and amendments?Required
Original NCT00545350 and the serious-injury primary-outcome amendment narrative are linked.
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. External registration, protocols, SAP and amendment history have not been read or accessed. Registration identifiers alone do not establish serious-injury prespecified hypotheses or completed plan comparison. The original content review remains incomplete.
NCT00545350, original and amended protocols, SAP and history
If materials are supplied, distinguish testing and hierarchy amendments from current results. This is a proposal; no new investigation, calculation or trial was performed.
18 Partly verified Full text not readStored summary read N18 · Efficacy comparison and presentation of stored materialWhat is the scope of public support, non-involvement and detailed COI?Required
The original public funders and accounts of no involvement in design, collection, analysis or publication decisions are preserved.
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Contracts and amounts, actual roles, products and free equipment, employee authors and patents, COI and analysis, writing or publication support are unverified. Public funding or original I2 is not changed into independence certification. The original content review remains incomplete.
AP-HP, Ministry of Health, ANR, INPES, Ile-de-France, roles and disclosures
Separate declared support from the scope of actual relationship verification. This is a proposal; no new investigation, calculation or trial was performed.
19 Partly verified Full text not readStored summary read N19 · Harm-information gaps supplementing the efficacy tableAre the five exercise-related injurious falls the same as the serious-only outcome?Supplementary
The five exercise-related injurious falls are a separate original safety account.
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Severity of the five events, overlap with selected serious-only 68/87 events, unique people, exposure, time and adjudication methods are unverified. The five events do not fill serious-injury denominators or causes and are not used to calculate new rates or differences. The original content review remains incomplete.
Harm events, severity and time, exposure, people and event counts
Separate the prevention endpoint from program-related harm records. This is a proposal; no new investigation, calculation or trial was performed.
20 Partly verified Full text not readStored summary read N20 · Harm-information gaps supplementing the efficacy tableAre harm relatedness, alternative explanations and long-term safety known?Supplementary
The original exercise-related label and parent's Caution safety label are preserved as history.
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Relatedness adjudication, baseline illnesses, concomitant factors and environment, comparative harms, long-term or rare events and other populations are unverified. Nonsignificant serious-injury efficacy is not changed into safety or harm causality, and no new supervision or movement prescription is created. The original content review remains incomplete.
Original relatedness, baseline and concomitant factors, comparisons, rare events and vulnerable groups
Separate efficacy-related serious events from overall safety gaps. This is a proposal; no new investigation, calculation or trial was performed.
21 Partly verified Full text not readStored summary read N21 · Efficacy comparison and presentation of stored materialDo related tai ji quan and Otago assessments directly establish the serious-only effect?Required
The stored tai ji quan 1812 and Otago 1834 A86 links are historical comparisons. The current evidence and citation lists contain one Ossébo report.
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Other assessments and trials, serious events, identity and independence were not looked up. Links are not combined as additional independent confirmation of the current serious-only outcome. The original content review remains incomplete.
Other programs, populations and durations, assessment links and bibliography
Separate other exercise assessments from the current selected outcome. This is a proposal; no new investigation, calculation or trial was performed.
22 Partly verified Full text not readStored summary read N22 · Efficacy comparison and presentation of stored materialHow are the same people, event severities and related sheets shared?Required
The two selected sheets share the same Ossébo/NCT00545350 trial, 706 participants and one report. Serious injuries relate to the combined category and do not represent a separate independent trial or participants.
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. External comparison of related or follow-up reports and event duplication was not performed. Event counts, people, woman-years and original R1 are not added into new replication totals; unique clinical totals remain unrecorded. The original content review remains incomplete.
Ossébo report and registration, combined versus serious-only outcomes, repeated events and time
Distinguish report slots from unique trials, participants and replication. This is a proposal; no new investigation, calculation or trial was performed.
23 Partly verified Full text not readStored summary read N23 · Efficacy comparison and presentation of stored materialAre findings extended to other populations, programs or durations?Required
The original text limits the finding to the combined injury-rate reduction in this population and states that reduction of every serious fall was not established.
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Serious-injury effects in other populations, exercises, isolated components, after cessation or beyond two years are unverified. No exercise program, movement instruction, prescription or treatment guidance is created. The original content review remains incomplete.
High-risk women aged 75–85, combined exposure, two years and direct extension evidence
Separate the scope of the selected serious-injury question from extension questions. This is a proposal; no new investigation, calculation or trial was performed.
24 Partly verified Full text not readStored summary read N24 · Efficacy comparison and presentation of stored materialWhat history is retained in parent B76, languages, dates, empty values and corrections?Required
Parent B76, Caution safety, unrecorded precision, a true large hard-outcome RCT flag, other false flags, empty override reasons, Korean and English texts, 2026-08-26, empty correction and deliberation records, historical cross-checks and selected D and its note are preserved in full.
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Subclaim scores, status and axes are not filled with parent values. This is not a new current search, language or original-text review, correction or retraction check or independence certification. The original content review remains incomplete.
Selected D, original axes with true, false and unrecorded values, Korean and English texts and historical cross-checks
Distinguish the original record from production and amendment events. This is a proposal; no new investigation, calculation or trial was performed.
25 Partly verified Full text not readStored summary read N25 · Efficacy comparison and presentation of stored materialWhat is the reading status of the summary, external paper, registration, plans and disclosures?Required
The complete stored summary, one evidence entry and one citation were read for production and the original BMJ link was preserved. The summary is marked summary read; external materials are marked not read.
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. External abstract and full text, registration, protocols, SAP and disclosures have not been read or accessed. Original identifiers, bibliography or historical narratives do not establish new acquisition, full-text reading or review. The original content review remains incomplete.
One original evidence entry, one citation, BMJ link, acquisition and actual reading
Distinguish material-specific existence, acquisition, reading level and access. This is a proposal; no new investigation, calculation or trial was performed.
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25 itemsWhat the statuses mean

Assessment scope

Stored-material review date
Not recorded
Original evidence cut-off
2026-08-26
Scope actually checked
Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean
This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population
The same community-dwelling women aged 75–85 with impaired balance; serious-injury-specific denominators unverified
Ingredient, formulation and route
The same two-year supervised group plus home exercise program; no confirmation of individual component effects
Dose
Not recorded
Comparator
The same control group; actual exposure, concomitant measures and discontinuation unverified
Measured outcome
Serious injurious falls only; original 68/87 events; HR.83/CI.60~1.16
Duration
Two-year study; primary outcome amended during recruitment from serious injuries to the combined outcome; current serious-injury hierarchy and model unverified
Questions outside this scope
Repurposing the positive combined moderate-plus-serious finding as a serious-only, all-fall, individual-fracture, functional or mortality effect; Changing the serious-only CI containing 1 or original grade D into an exactly zero effect, equivalence, exclusion of every important benefit or a new grade; Turning 305/397 or 68/87 events into unique people or response rates, or subtracting from the combined result to calculate a new moderate-only effect; Replacing actual endpoint-specific completion, analysis, woman-year or safety denominators with 706 participants, 352/354 allocation and nominal two years, or calculating new rates, losses or event totals; Automatically applying the combined shared-frailty and center-adjusted model, P=.04 or .45/.56 rates to serious-only models, tests or denominators; Calculating a simple rate ratio, new percentage reduction or absolute risk from the HR, or creating CI, P values or hypothetical numbers absent from the original; Changing the approximate eight-month recruitment timing, original target of 1,000 per arm or Korean first serious fall versus English serious falls into a new actual sample total or established first-event model without comparing amendment plans; Treating absence of a report of data-driven amendment as proof of no interim-data access, complete prespecification or confirmed data-driven amendment; Using five exercise-related events as a full safety denominator, significant harm, causality or serious-injury effect, or creating movement, supervision or environmental prescriptions; Adding Tai ji quan 1812 or Otago 1834 assessment links as new direct trials or replication of the identical program; Adding the same trial or report, people, groups, times, severities, repeated events or related sheets into new independent-trial, participant or event totals; Changing original public support, non-involvement, R1/I2 or unverified product support and COI into new verification of independence, absence of relationships or methodological certification; Inheriting parent B76, original axes or historical cross-checks as selected B/D scores or axes, or as new content review or external reading; Generalizing to other sexes, ages, settings, exercises or isolated components, beyond two years or after cessation, or providing exercise programs, movement instructions, prescriptions or treatment guidance

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

S01 · El-Khoury F et al. 2015 Ossébo

Official source

Material type
Two-year 20-center randomized controlled trial
Materials actually read
Summary read; external material unread
Findings recorded in the stored summary
The original serious injurious-fall counts of 68 versus 87 events, HR.83, original CI.60~1.16 and nonsignificant result are preserved. No exactly zero effect, equivalence, exclusion of every important benefit, new P value or denominator is created. Combined 305/397 events, HR.81, P=.04, shared-frailty modeling and .45 versus .56 events per woman-year provide another endpoint's context and are not automatically copied to the serious-injury model.
Record level
Outcome wording in the stored summary
Study overlap and independent replication
S01, El-Khoury 2015 Ossébo/NCT00545350, is a report of the same 20-center RCT of two-year supervised group plus home exercise in 706 community-dwelling women aged 75–85 with impaired balance or gait, allocated 352/354. The two selected sheets share people, groups, times, bibliography, injury severity, repeated events and woman-year context. Combined 305/397 events, serious-only 68/87 events and original rates and HR use distinct endpoints and units. The recruitment-stage primary-outcome amendment and gaps in actual denominators, censoring, modeling, five safety events, public support and COI are retained separately; no new independent-trial, participant or event total is created. Report and material slots are not unique clinical-trial, participant or independent-replication totals; unique clinical totals remain unrecorded. Tai ji quan 1812 and Otago 1834 assessment links are not combined as new reports or direct replication.
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
Stored summaryStored fileStored summarySummary readOnly the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review.
External paperPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Registration materialPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
ProtocolPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Statistical analysis planPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Funding, product-support and COI materialPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.

Report counts versus independent study counts

S01, El-Khoury 2015 Ossébo/NCT00545350, is a report of the same 20-center RCT of two-year supervised group plus home exercise in 706 community-dwelling women aged 75–85 with impaired balance or gait, allocated 352/354. The two selected sheets share people, groups, times, bibliography, injury severity, repeated events and woman-year context. Combined 305/397 events, serious-only 68/87 events and original rates and HR use distinct endpoints and units. The recruitment-stage primary-outcome amendment and gaps in actual denominators, censoring, modeling, five safety events, public support and COI are retained separately; no new independent-trial, participant or event total is created. Report and material slots are not unique clinical-trial, participant or independent-replication totals; unique clinical totals remain unrecorded. Tai ji quan 1812 and Otago 1834 assessment links are not combined as new reports or direct replication.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · What is the selected serious-injury-only question and original grade?
Required materials and conditions
Separate subclaim D and note, combined-outcome B and parent B76
Conditions for verification
Original materials and analysis scope for Separate subclaim D and note, combined-outcome B and parent B76 must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item separates Separate subclaim D and note, combined-outcome B and parent B76 to link materials needed for the selected question with the materials currently available.
Referenced methods
M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design
N02 · Who was studied for the serious-injury outcome and how were participants selected?
Required materials and conditions
Impaired balance or gait, community-dwelling women aged 75–85 and baseline risk
Conditions for verification
Original materials and analysis scope for Impaired balance or gait, community-dwelling women aged 75–85 and baseline risk must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item separates Impaired balance or gait, community-dwelling women aged 75–85 and baseline risk to link materials needed for the selected question with the materials currently available.
Referenced methods
M03 §3.2.1; detailed population conditions are Chamgap's own design
N03 · What was the historical two-year program and actual exposure?
Required materials and conditions
Supervised group plus home exercise, weekly sessions, adherence and discontinuation
Conditions for verification
Original materials and analysis scope for Supervised group plus home exercise, weekly sessions, adherence and discontinuation must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item separates Supervised group plus home exercise, weekly sessions, adherence and discontinuation to link materials needed for the selected question with the materials currently available.
Referenced methods
M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application
N04 · What were the control, concomitant measures and changes?
Required materials and conditions
Control care, shared or other exercise, medication, environment and rescue treatment
Conditions for verification
Original materials and analysis scope for Control care, shared or other exercise, medication, environment and rescue treatment must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item separates Control care, shared or other exercise, medication, environment and rescue treatment to link materials needed for the selected question with the materials currently available.
Referenced methods
M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application
N05 · Are allocation and baseline balance in the 20-center RCT known?
Required materials and conditions
Allocation unit, sequence and concealment, centers and individuals, baseline characteristics
Conditions for verification
Original materials and analysis scope for Allocation unit, sequence and concealment, centers and individuals, baseline characteristics must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item separates Allocation unit, sequence and concealment, centers and individuals, baseline characteristics to link materials needed for the selected question with the materials currently available.
Referenced methods
M08 §8.1–8.2.3; own application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is our own design
N06 · Which criteria classified serious injury events?
Required materials and conditions
Serious-injury definition, physical harm and healthcare use, adjudication and reclassification
Conditions for verification
Original materials and analysis scope for Serious-injury definition, physical harm and healthcare use, adjudication and reclassification must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item separates Serious-injury definition, physical harm and healthcare use, adjudication and reclassification to link materials needed for the selected question with the materials currently available.
Referenced methods
M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M03 §3.2.4; our own application
N07 · What is known about event collection, blinded adjudication, detection and omissions?
Required materials and conditions
Reporting and verification, blinding, collection frequency and omissions over time
Conditions for verification
Original materials and analysis scope for Reporting and verification, blinding, collection frequency and omissions over time must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item separates Reporting and verification, blinding, collection frequency and omissions over time to link materials needed for the selected question with the materials currently available.
Referenced methods
M08 Table 8.2.a, M03 §3.2.4; Chamgap application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap's own design
N08 · Are 68/87 events counts of unique people?
Required materials and conditions
Serious events, people, repetition, denominators and duration
Conditions for verification
Original materials and analysis scope for Serious events, people, repetition, denominators and duration must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item separates Serious events, people, repetition, denominators and duration to link materials needed for the selected question with the materials currently available.
Referenced methods
M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap's own design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design
N09 · What result do the serious-only HR.83, interval and nonsignificance describe?
Required materials and conditions
Original estimate, CI, model, time and interpretation
Conditions for verification
Original materials and analysis scope for Original estimate, CI, model, time and interpretation must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item separates Original estimate, CI, model, time and interpretation to link materials needed for the selected question with the materials currently available.
Referenced methods
M08 §8.2.2, M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap's own design
N10 · Does a CI including 1 establish an exactly zero effect or equivalence?
Required materials and conditions
Original uncertainty, effects compatible with the interval, important differences and hypotheses
Conditions for verification
Original materials and analysis scope for Original uncertainty, effects compatible with the interval, important differences and hypotheses must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item separates Original uncertainty, effects compatible with the interval, important differences and hypotheses to link materials needed for the selected question with the materials currently available.
Referenced methods
M15 §15.3.1–15.3.3; Chamgap application; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap's own design
N11 · Can the positive combined-injury finding be applied to serious injuries only?
Required materials and conditions
Moderate-plus-serious injuries, event counts, rates and HR, distinct endpoints
Conditions for verification
Original materials and analysis scope for Moderate-plus-serious injuries, event counts, rates and HR, distinct endpoints must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item separates Moderate-plus-serious injuries, event counts, rates and HR, distinct endpoints to link materials needed for the selected question with the materials currently available.
Referenced methods
M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap's own design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M08 §8.2.2, M15 §15.3.1; Chamgap application
N12 · What history do the original primary outcome and recruitment-stage amendment provide for the serious-injury hierarchy?
Required materials and conditions
Original and amended primary outcome, timing, sample target and reasons
Conditions for verification
Original materials and analysis scope for Original and amended primary outcome, timing, sample target and reasons must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item separates Original and amended primary outcome, timing, sample target and reasons to link materials needed for the selected question with the materials currently available.
Referenced methods
M08 Table 8.2.a, M04 §4.6.3; Chamgap application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M04 §4.5, §4.6.3; limits to this material conversion reflect the review scope and Chamgap's own design
N13 · Were data-driven amendment, prespecification and multiplicity verified?
Required materials and conditions
Amendment decisions, data access, hypotheses, multiple comparisons and prior hierarchy
Conditions for verification
Original materials and analysis scope for Amendment decisions, data access, hypotheses, multiple comparisons and prior hierarchy must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item separates Amendment decisions, data access, hypotheses, multiple comparisons and prior hierarchy to link materials needed for the selected question with the materials currently available.
Referenced methods
M08 Table 8.2.a, M04 §4.6.3; Chamgap application; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap's own design
N14 · What are the two-year follow-up, event times, censoring, missing data and denominators?
Required materials and conditions
Allocation, observation and analysis, actual time, attrition and deaths
Conditions for verification
Original materials and analysis scope for Allocation, observation and analysis, actual time, attrition and deaths must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item separates Allocation, observation and analysis, actual time, attrition and deaths to link materials needed for the selected question with the materials currently available.
Referenced methods
M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application
N15 · What are the effect of interest, ITT, adherence and repeated-event handling for serious-injury analysis?
Required materials and conditions
Assignment effect, ITT/PP, models, deviations and sensitivity analyses
Conditions for verification
Original materials and analysis scope for Assignment effect, ITT/PP, models, deviations and sensitivity analyses must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item separates Assignment effect, ITT/PP, models, deviations and sensitivity analyses to link materials needed for the selected question with the materials currently available.
Referenced methods
M08 §8.2.2, M15 §15.3.1; our own application; M03 §3.2.3, M08 §8.2.2–8.2.3; our own application
N16 · Do other fall or functional outcomes answer the serious-injury-only question?
Required materials and conditions
All falls, fractures and hospitalization, function, mortality and primary or secondary hierarchy
Conditions for verification
Original materials and analysis scope for All falls, fractures and hospitalization, function, mortality and primary or secondary hierarchy must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item separates All falls, fractures and hospitalization, function, mortality and primary or secondary hierarchy to link materials needed for the selected question with the materials currently available.
Referenced methods
M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M03 §3.2.4; Chamgap extension boundaries; M08 Table 8.2.a, M04 §4.6.3; Chamgap application
N17 · What is the actual access status of registration, plans and amendments?
Required materials and conditions
NCT00545350, original and amended protocols, SAP and history
Conditions for verification
Original materials and analysis scope for NCT00545350, original and amended protocols, SAP and history must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item separates NCT00545350, original and amended protocols, SAP and history to link materials needed for the selected question with the materials currently available.
Referenced methods
M08 Table 8.2.a, M04 §4.6.3; Chamgap application; M04 §4.5–4.6 principles for collecting and selecting materials; separation of access and reading and hyperlink rules are Chamgap's own design
N18 · What is the scope of public support, non-involvement and detailed COI?
Required materials and conditions
AP-HP, Ministry of Health, ANR, INPES, Ile-de-France, roles and disclosures
Conditions for verification
Original materials and analysis scope for AP-HP, Ministry of Health, ANR, INPES, Ile-de-France, roles and disclosures must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item separates AP-HP, Ministry of Health, ANR, INPES, Ile-de-France, roles and disclosures to link materials needed for the selected question with the materials currently available.
Referenced methods
Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.
N19 · Are the five exercise-related injurious falls the same as the serious-only outcome?
Required materials and conditions
Harm events, severity and time, exposure, people and event counts
Conditions for verification
Original materials and analysis scope for Harm events, severity and time, exposure, people and event counts must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Requirement and applicability
Supplementary
Application exceptions
Supplements gaps in safety materials for the selected subclaim. Fall-prevention effects, injury counts or the parent safety wording do not establish safety, and no new harm rate, exercise program, movement instruction or prescription is created.
Why this condition is needed
This item separates Harm events, severity and time, exposure, people and event counts to link materials needed for the selected question with the materials currently available.
Referenced methods
M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; detailed distinctions are Chamgap's own design; M19 §19.2 design-specific harm questions; timing details are Chamgap's own design; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4, M04 §4.6.3; Chamgap application
N20 · Are harm relatedness, alternative explanations and long-term safety known?
Required materials and conditions
Original relatedness, baseline and concomitant factors, comparisons, rare events and vulnerable groups
Conditions for verification
Original materials and analysis scope for Original relatedness, baseline and concomitant factors, comparisons, rare events and vulnerable groups must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Requirement and applicability
Supplementary
Application exceptions
Supplements gaps in safety materials for the selected subclaim. Fall-prevention effects, injury counts or the parent safety wording do not establish safety, and no new harm rate, exercise program, movement instruction or prescription is created.
Why this condition is needed
This item separates Original relatedness, baseline and concomitant factors, comparisons, rare events and vulnerable groups to link materials needed for the selected question with the materials currently available.
Referenced methods
M19 §19.1.2–19.2.4; Chamgap application; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap application; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap's own design; M19 §19.1.2–19.2.4; Chamgap application; Chamgap interpretive boundaries draw on M19 principles, without executing an official causality tool
N21 · Do related tai ji quan and Otago assessments directly establish the serious-only effect?
Required materials and conditions
Other programs, populations and durations, assessment links and bibliography
Conditions for verification
Original materials and analysis scope for Other programs, populations and durations, assessment links and bibliography must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item separates Other programs, populations and durations, assessment links and bibliography to link materials needed for the selected question with the materials currently available.
Referenced methods
M04 §4.6.1–4.6.2 distinction between studies and reports; cohort and outcome linkage is Chamgap's own application; M04 §4.6.1–4.6.2, M15 §15.3.1; Chamgap application; M04 §4.5–4.6 principles for collecting and selecting materials; separation of access and reading and hyperlink rules are Chamgap's own design
N22 · How are the same people, event severities and related sheets shared?
Required materials and conditions
Ossébo report and registration, combined versus serious-only outcomes, repeated events and time
Conditions for verification
Original materials and analysis scope for Ossébo report and registration, combined versus serious-only outcomes, repeated events and time must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item separates Ossébo report and registration, combined versus serious-only outcomes, repeated events and time to link materials needed for the selected question with the materials currently available.
Referenced methods
Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application
N23 · Are findings extended to other populations, programs or durations?
Required materials and conditions
High-risk women aged 75–85, combined exposure, two years and direct extension evidence
Conditions for verification
Original materials and analysis scope for High-risk women aged 75–85, combined exposure, two years and direct extension evidence must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item separates High-risk women aged 75–85, combined exposure, two years and direct extension evidence to link materials needed for the selected question with the materials currently available.
Referenced methods
M03 §3.2.1–3.2.4; dose, persistence and effect-modification details are Chamgap's own design; M03 §3.2.4; Chamgap extension boundaries
N24 · What history is retained in parent B76, languages, dates, empty values and corrections?
Required materials and conditions
Selected D, original axes with true, false and unrecorded values, Korean and English texts and historical cross-checks
Conditions for verification
Original materials and analysis scope for Selected D, original axes with true, false and unrecorded values, Korean and English texts and historical cross-checks must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item separates Selected D, original axes with true, false and unrecorded values, Korean and English texts and historical cross-checks to link materials needed for the selected question with the materials currently available.
Referenced methods
M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design; M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are our own design
N25 · What is the reading status of the summary, external paper, registration, plans and disclosures?
Required materials and conditions
One original evidence entry, one citation, BMJ link, acquisition and actual reading
Conditions for verification
Original materials and analysis scope for One original evidence entry, one citation, BMJ link, acquisition and actual reading must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item separates One original evidence entry, one citation, BMJ link, acquisition and actual reading to link materials needed for the selected question with the materials currently available.
Referenced methods
M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design
Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle
Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review
Preserved method HTML copies; no current method-content re-review or official tool execution

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle
Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review
Preserved method HTML copies; no current method-content re-review or official tool execution

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle
Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review
Preserved method HTML copies; no current method-content re-review or official tool execution

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle
Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review
Preserved method HTML copies; no current method-content re-review or official tool execution

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle
Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review
Preserved method HTML copies; no current method-content re-review or official tool execution
What the statuses mean
Met
Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.
Partly verified
Some information in the stored summary is linked into the table. External comparison/content review is not complete.
Unverified
The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.
Review incomplete
Existing content review remains incomplete.
Not reported
Not reported within the stored material actually read; not extended to the entire primary paper.
Inaccessible
Means an actual access failure. Access not attempted here is not assigned this state.
Not applicable
Not used as a substitute for an evidence gap.
Conflicting data
Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.
Insufficient evidence for the conditions
Marks a gap in additional material required by the selected conditions; not a new efficacy grade.

Change history

2026-10-11 · Public page/material version 1.0

The public page and data were prepared from the existing 25 items. No new clinical search, verification-status change or scoring was performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-08-26) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · What is the selected serious-injury-only question and original grade?

Current findings
The selected claim is reduced serious injurious falls, with subclaim grade D and a note that the HR.83 CI included 1. Combined-outcome B and parent B76 provide different context.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. The subclaim has no score, status or axis values; parent values do not fill them. The combined effect does not establish the serious-only effect. The original content review remains incomplete.
Reason for missing information
The subclaim has no score, status or axis values; parent values do not fill them. The combined effect does not establish the serious-only effect.
Required materials and conditions
Separate subclaim D and note, combined-outcome B and parent B76
Materials to obtain first
Correction records for the selected claim and parent assessment
Further research
Separate the question, assessment record and assessments of other endpoints. This is a proposal; no new investigation, calculation or trial was performed.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Original materials and analysis scope for Separate subclaim D and note, combined-outcome B and parent B76 must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Why this condition is needed
This item separates Separate subclaim D and note, combined-outcome B and parent B76 to link materials needed for the selected question with the materials currently available.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

Related sources S01

N02 · Who was studied for the serious-injury outcome and how were participants selected?

Current findings
The original Ossébo population was 706 community-dwelling women aged 75–85 with impaired balance or gait.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Impairment thresholds, baseline falls and illnesses, eligibility and exclusions, recruitment and the population observed for the serious-injury outcome are unverified. The finding is not extended to all older adults, men or institutional settings. The original content review remains incomplete.
Reason for missing information
Impairment thresholds, baseline falls and illnesses, eligibility and exclusions, recruitment and the population observed for the serious-injury outcome are unverified. The finding is not extended to all older adults, men or institutional settings.
Required materials and conditions
Impaired balance or gait, community-dwelling women aged 75–85 and baseline risk
Materials to obtain first
Recruitment, baseline and endpoint-specific population materials
Further research
Retain differences between the selected population and other high-risk groups. This is a proposal; no new investigation, calculation or trial was performed.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Original materials and analysis scope for Impaired balance or gait, community-dwelling women aged 75–85 and baseline risk must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Why this condition is needed
This item separates Impaired balance or gait, community-dwelling women aged 75–85 and baseline risk to link materials needed for the selected question with the materials currently available.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M03 §3.2.1; detailed population conditions are Chamgap's own design

Related sources S01

N03 · What was the historical two-year program and actual exposure?

Current findings
The original research program combined weekly supervised group balance training and home exercise over two years. This is not an exercise program, movement instruction or prescription.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Detailed components, home exposure and attendance, intensity, actual adherence and discontinuation, and separate component effects are unverified. The original content review remains incomplete.
Reason for missing information
Detailed components, home exposure and attendance, intensity, actual adherence and discontinuation, and separate component effects are unverified.
Required materials and conditions
Supervised group plus home exercise, weekly sessions, adherence and discontinuation
Materials to obtain first
Program, actual exposure, adherence and change records
Further research
Distinguish planned intervention from actual exposure. This is a proposal; no new investigation, calculation or trial was performed.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Original materials and analysis scope for Supervised group plus home exercise, weekly sessions, adherence and discontinuation must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Why this condition is needed
This item separates Supervised group plus home exercise, weekly sessions, adherence and discontinuation to link materials needed for the selected question with the materials currently available.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application

Related sources S01

N04 · What were the control, concomitant measures and changes?

Current findings
The original materials compare 352 exercise participants with 354 controls.
Verification status
Unverified
Materials actually read
Summary read; external material unread
Why unverified
The information currently needed is unverified in the stored summary. Control care, information and contact, group-specific concurrent exercise, treatment, environmental changes and amendments are unverified. No intervention or placebo is not filled in. The original content review remains incomplete.
Reason for missing information
Control care, information and contact, group-specific concurrent exercise, treatment, environmental changes and amendments are unverified. No intervention or placebo is not filled in.
Required materials and conditions
Control care, shared or other exercise, medication, environment and rescue treatment
Materials to obtain first
Group-specific control, concomitant measures and change materials
Further research
Separate the program contribution from other exposures. This is a proposal; no new investigation, calculation or trial was performed.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Original materials and analysis scope for Control care, shared or other exercise, medication, environment and rescue treatment must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Why this condition is needed
This item separates Control care, shared or other exercise, medication, environment and rescue treatment to link materials needed for the selected question with the materials currently available.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application

Related sources S01

N05 · Are allocation and baseline balance in the 20-center RCT known?

Current findings
The original text describes a 20-center, two-year RCT with 706 participants allocated 352/354.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Allocation unit and operations, baseline balance and group correspondence within centers are unverified. Center count alone does not establish cluster randomization. The original content review remains incomplete.
Reason for missing information
Allocation unit and operations, baseline balance and group correspondence within centers are unverified. Center count alone does not establish cluster randomization.
Required materials and conditions
Allocation unit, sequence and concealment, centers and individuals, baseline characteristics
Materials to obtain first
Methods, allocation, center and baseline tables
Further research
Separate centers, participants and the actual randomized design. This is a proposal; no new investigation, calculation or trial was performed.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Original materials and analysis scope for Allocation unit, sequence and concealment, centers and individuals, baseline characteristics must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Why this condition is needed
This item separates Allocation unit, sequence and concealment, centers and individuals, baseline characteristics to link materials needed for the selected question with the materials currently available.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M08 §8.1–8.2.3; own application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is our own design

Related sources S01

N06 · Which criteria classified serious injury events?

Current findings
The original text says geriatricians unaware of allocation classified events using physical-harm and healthcare-use criteria. The selected question concerns serious injuries only.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Exact serious-injury thresholds and components, specific fracture or hospitalization rules, overlap and reclassification and adjudicator agreement are unverified. Moderate-plus-serious injuries are not treated as the same event category. The original content review remains incomplete.
Reason for missing information
Exact serious-injury thresholds and components, specific fracture or hospitalization rules, overlap and reclassification and adjudicator agreement are unverified. Moderate-plus-serious injuries are not treated as the same event category.
Required materials and conditions
Serious-injury definition, physical harm and healthcare use, adjudication and reclassification
Materials to obtain first
Serious-injury classification, original adjudication, medical records and outcome materials
Further research
Separate definitions of serious-only injuries, combined injuries and all falls. This is a proposal; no new investigation, calculation or trial was performed.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Original materials and analysis scope for Serious-injury definition, physical harm and healthcare use, adjudication and reclassification must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Why this condition is needed
This item separates Serious-injury definition, physical harm and healthcare use, adjudication and reclassification to link materials needed for the selected question with the materials currently available.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M03 §3.2.4; our own application

Related sources S01

N07 · What is known about event collection, blinded adjudication, detection and omissions?

Current findings
The original record of adjudicators being blinded to allocation is preserved.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Participant, collector and analyst blinding, fall collection methods and frequency, detection and omissions and medical-record confirmation are unverified. The strength of adjudication is not treated as resolution of every measurement or missing-data issue. The original content review remains incomplete.
Reason for missing information
Participant, collector and analyst blinding, fall collection methods and frequency, detection and omissions and medical-record confirmation are unverified. The strength of adjudication is not treated as resolution of every measurement or missing-data issue.
Required materials and conditions
Reporting and verification, blinding, collection frequency and omissions over time
Materials to obtain first
Fall collection, adjudication, blinding and omission materials
Further research
Separate event occurrence, reporting and adjudication stages. This is a proposal; no new investigation, calculation or trial was performed.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Original materials and analysis scope for Reporting and verification, blinding, collection frequency and omissions over time must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Why this condition is needed
This item separates Reporting and verification, blinding, collection frequency and omissions over time to link materials needed for the selected question with the materials currently available.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M08 Table 8.2.a, M03 §3.2.4; Chamgap application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap's own design

Related sources S01

N08 · Are 68/87 events counts of unique people?

Current findings
The original serious injurious-fall counts were 68 versus 87 events, preserved as event counts for exercise and control respectively.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. People per event, first and repeated events, the serious-injury analysis population and observation time are unverified. Events are not converted to people or response rates, and no new total or difference is calculated. The original content review remains incomplete.
Reason for missing information
People per event, first and repeated events, the serious-injury analysis population and observation time are unverified. Events are not converted to people or response rates, and no new total or difference is calculated.
Required materials and conditions
Serious events, people, repetition, denominators and duration
Materials to obtain first
Serious-injury people, event and repeated-event tables and denominators
Further research
Distinguish repeated events in the same person from event counts. This is a proposal; no new investigation, calculation or trial was performed.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Original materials and analysis scope for Serious events, people, repetition, denominators and duration must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Why this condition is needed
This item separates Serious events, people, repetition, denominators and duration to link materials needed for the selected question with the materials currently available.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap's own design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design

Related sources S01

N09 · What result do the serious-only HR.83, interval and nonsignificance describe?

Current findings
The original serious-only HR.83, CI.60~1.16 and narrative and note that the result was not significant are preserved.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. The serious-only P value, interval construction, center and repeated-event handling, exact denominator and importance threshold are unverified. New P values, percentage reductions or CI are not calculated. The original content review remains incomplete.
Reason for missing information
The serious-only P value, interval construction, center and repeated-event handling, exact denominator and importance threshold are unverified. New P values, percentage reductions or CI are not calculated.
Required materials and conditions
Original estimate, CI, model, time and interpretation
Materials to obtain first
Serious-only model, SAP and outcome tables
Further research
Link the original interval to the analysis of its endpoint. This is a proposal; no new investigation, calculation or trial was performed.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Original materials and analysis scope for Original estimate, CI, model, time and interpretation must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Why this condition is needed
This item separates Original estimate, CI, model, time and interpretation to link materials needed for the selected question with the materials currently available.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M08 §8.2.2, M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap's own design

Related sources S01

N10 · Does a CI including 1 establish an exactly zero effect or equivalence?

Current findings
The original text records that the serious-only CI included benefit and no effect and the result was not statistically established. Subclaim D is the original grade.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Important-difference and equivalence margins, prior hypotheses and additional precision data are unverified. An exactly zero effect, exclusion of every important benefit or equivalence is not newly assessed. The original content review remains incomplete.
Reason for missing information
Important-difference and equivalence margins, prior hypotheses and additional precision data are unverified. An exactly zero effect, exclusion of every important benefit or equivalence is not newly assessed.
Required materials and conditions
Original uncertainty, effects compatible with the interval, important differences and hypotheses
Materials to obtain first
Importance and hypothesis rationale and serious-injury analysis materials
Further research
Separate nonsignificance and uncertainty from a distinct equivalence question. This is a proposal; no new investigation, calculation or trial was performed.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Original materials and analysis scope for Original uncertainty, effects compatible with the interval, important differences and hypotheses must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Why this condition is needed
This item separates Original uncertainty, effects compatible with the interval, important differences and hypotheses to link materials needed for the selected question with the materials currently available.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M15 §15.3.1–15.3.3; Chamgap application; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap's own design

Related sources S01

N11 · Can the positive combined-injury finding be applied to serious injuries only?

Current findings
Combined 305/397 events, original 0.45/0.56 events per woman-year, center-adjusted shared-frailty HR.81 (CI.67~.99) and P=.04 belong to another endpoint.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. The combined model, denominator, P=.04 and rates do not fill serious-only values. Moderate-only effects or events are not newly calculated by subtracting serious injuries from the combined result. The original content review remains incomplete.
Reason for missing information
The combined model, denominator, P=.04 and rates do not fill serious-only values. Moderate-only effects or events are not newly calculated by subtracting serious injuries from the combined result.
Required materials and conditions
Moderate-plus-serious injuries, event counts, rates and HR, distinct endpoints
Materials to obtain first
Severity-specific outcome, model and denominator tables
Further research
Preserve positive and nonsignificant results from the same trial together. This is a proposal; no new investigation, calculation or trial was performed.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Original materials and analysis scope for Moderate-plus-serious injuries, event counts, rates and HR, distinct endpoints must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Why this condition is needed
This item separates Moderate-plus-serious injuries, event counts, rates and HR, distinct endpoints to link materials needed for the selected question with the materials currently available.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap's own design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M08 §8.2.2, M15 §15.3.1; Chamgap application

Related sources S01

N12 · What history do the original primary outcome and recruitment-stage amendment provide for the serious-injury hierarchy?

Current findings
The original text says that the target was reduced from 1,000 per arm about eight months after recruitment began and the outcome changed from Korean first serious fall or English serious falls to moderate-plus-serious injuries.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. The original first-event estimation definition, serious-injury hierarchy and testing after amendment, revised target and original plans are unverified. First-event or recurrent-event modeling or current serious-injury primary status is not arbitrarily established. The original content review remains incomplete.
Reason for missing information
The original first-event estimation definition, serious-injury hierarchy and testing after amendment, revised target and original plans are unverified. First-event or recurrent-event modeling or current serious-injury primary status is not arbitrarily established.
Required materials and conditions
Original and amended primary outcome, timing, sample target and reasons
Materials to obtain first
Original and amended protocols, SAP and primary or secondary outcome amendment materials
Further research
Distinguish the original hierarchy, amendment and current serious-injury result. This is a proposal; no new investigation, calculation or trial was performed.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Original materials and analysis scope for Original and amended primary outcome, timing, sample target and reasons must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Why this condition is needed
This item separates Original and amended primary outcome, timing, sample target and reasons to link materials needed for the selected question with the materials currently available.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M08 Table 8.2.a, M04 §4.6.3; Chamgap application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M04 §4.5, §4.6.3; limits to this material conversion reflect the review scope and Chamgap's own design

Related sources S01

N13 · Were data-driven amendment, prespecification and multiplicity verified?

Current findings
The original text records that amendment was not reported as data-driven, while prespecification had limitations.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Decision timing, actual data access, serious-injury testing and multiplicity and original and amended plans have not been read. Neither confirmed data-driven amendment nor complete prespecified confirmation is newly certified. The original content review remains incomplete.
Reason for missing information
Decision timing, actual data access, serious-injury testing and multiplicity and original and amended plans have not been read. Neither confirmed data-driven amendment nor complete prespecified confirmation is newly certified.
Required materials and conditions
Amendment decisions, data access, hypotheses, multiple comparisons and prior hierarchy
Materials to obtain first
Amendment decisions, access records, plans and original testing materials
Further research
Separate the original amendment narrative from actual verification. This is a proposal; no new investigation, calculation or trial was performed.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Original materials and analysis scope for Amendment decisions, data access, hypotheses, multiple comparisons and prior hierarchy must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Why this condition is needed
This item separates Amendment decisions, data access, hypotheses, multiple comparisons and prior hierarchy to link materials needed for the selected question with the materials currently available.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M08 Table 8.2.a, M04 §4.6.3; Chamgap application; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap's own design

Related sources S01

N14 · What are the two-year follow-up, event times, censoring, missing data and denominators?

Current findings
Original allocation of 706 participants, 352/354, and two-year follow-up are preserved.
Verification status
Unverified
Materials actually read
Summary read; external material unread
Why unverified
The information currently needed is unverified in the stored summary. People completing follow-up or analyzed for serious injuries, actual time, attrition, deaths, censoring and missing-data handling are unverified. Combined woman-year rates or complete two-year follow-up for everyone do not fill serious-only denominators. The original content review remains incomplete.
Reason for missing information
People completing follow-up or analyzed for serious injuries, actual time, attrition, deaths, censoring and missing-data handling are unverified. Combined woman-year rates or complete two-year follow-up for everyone do not fill serious-only denominators.
Required materials and conditions
Allocation, observation and analysis, actual time, attrition and deaths
Materials to obtain first
Flow diagrams, endpoint-specific person-time and losses
Further research
Distinguish nominal duration from actual serious-injury observation and analysis. This is a proposal; no new investigation, calculation or trial was performed.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Original materials and analysis scope for Allocation, observation and analysis, actual time, attrition and deaths must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Why this condition is needed
This item separates Allocation, observation and analysis, actual time, attrition and deaths to link materials needed for the selected question with the materials currently available.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application

Related sources S01

N15 · What are the effect of interest, ITT, adherence and repeated-event handling for serious-injury analysis?

Current findings
The current summary provides the serious-only HR and interval but does not specify the detailed model.
Verification status
Unverified
Materials actually read
Summary read; external material unread
Why unverified
The information currently needed is unverified in the stored summary. The combined center-adjusted shared-frailty model is not automatically copied to serious injuries. Serious-only ITT/PP, adherence, first and repeated events, sensitivity analyses and subgroups are unverified. The original content review remains incomplete.
Reason for missing information
The combined center-adjusted shared-frailty model is not automatically copied to serious injuries. Serious-only ITT/PP, adherence, first and repeated events, sensitivity analyses and subgroups are unverified.
Required materials and conditions
Assignment effect, ITT/PP, models, deviations and sensitivity analyses
Materials to obtain first
Serious-injury SAP, models, exposure and sensitivity materials
Further research
Separate endpoint-specific models, denominators and effect definitions. This is a proposal; no new investigation, calculation or trial was performed.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Original materials and analysis scope for Assignment effect, ITT/PP, models, deviations and sensitivity analyses must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Why this condition is needed
This item separates Assignment effect, ITT/PP, models, deviations and sensitivity analyses to link materials needed for the selected question with the materials currently available.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M08 §8.2.2, M15 §15.3.1; our own application; M03 §3.2.3, M08 §8.2.2–8.2.3; our own application

Related sources S01

N16 · Do other fall or functional outcomes answer the serious-injury-only question?

Current findings
The original evidence concerns combined moderate-plus-serious and serious-only outcomes.
Verification status
Unverified
Materials actually read
Summary read; external material unread
Why unverified
The information currently needed is unverified in the stored summary. All falls, component-specific fractures, function, quality of life, death and other secondary values are unverified. Serious-injury counts and HR are not turned into other outcomes. The original content review remains incomplete.
Reason for missing information
All falls, component-specific fractures, function, quality of life, death and other secondary values are unverified. Serious-injury counts and HR are not turned into other outcomes.
Required materials and conditions
All falls, fractures and hospitalization, function, mortality and primary or secondary hierarchy
Materials to obtain first
Endpoint definitions, outcomes and prior hierarchy
Further research
Distinguish serious events from other clinical and functional questions. This is a proposal; no new investigation, calculation or trial was performed.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Original materials and analysis scope for All falls, fractures and hospitalization, function, mortality and primary or secondary hierarchy must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Why this condition is needed
This item separates All falls, fractures and hospitalization, function, mortality and primary or secondary hierarchy to link materials needed for the selected question with the materials currently available.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M03 §3.2.4; Chamgap extension boundaries; M08 Table 8.2.a, M04 §4.6.3; Chamgap application

Related sources S01

N17 · What is the actual access status of registration, plans and amendments?

Current findings
Original NCT00545350 and the serious-injury primary-outcome amendment narrative are linked.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. External registration, protocols, SAP and amendment history have not been read or accessed. Registration identifiers alone do not establish serious-injury prespecified hypotheses or completed plan comparison. The original content review remains incomplete.
Reason for missing information
External registration, protocols, SAP and amendment history have not been read or accessed. Registration identifiers alone do not establish serious-injury prespecified hypotheses or completed plan comparison.
Required materials and conditions
NCT00545350, original and amended protocols, SAP and history
Materials to obtain first
Registration history, original and amended plans and SAP
Further research
If materials are supplied, distinguish testing and hierarchy amendments from current results. This is a proposal; no new investigation, calculation or trial was performed.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Original materials and analysis scope for NCT00545350, original and amended protocols, SAP and history must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Why this condition is needed
This item separates NCT00545350, original and amended protocols, SAP and history to link materials needed for the selected question with the materials currently available.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M08 Table 8.2.a, M04 §4.6.3; Chamgap application; M04 §4.5–4.6 principles for collecting and selecting materials; separation of access and reading and hyperlink rules are Chamgap's own design

Related sources S01

N18 · What is the scope of public support, non-involvement and detailed COI?

Current findings
The original public funders and accounts of no involvement in design, collection, analysis or publication decisions are preserved.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Contracts and amounts, actual roles, products and free equipment, employee authors and patents, COI and analysis, writing or publication support are unverified. Public funding or original I2 is not changed into independence certification. The original content review remains incomplete.
Reason for missing information
Contracts and amounts, actual roles, products and free equipment, employee authors and patents, COI and analysis, writing or publication support are unverified. Public funding or original I2 is not changed into independence certification.
Required materials and conditions
AP-HP, Ministry of Health, ANR, INPES, Ile-de-France, roles and disclosures
Materials to obtain first
Original funding, product, author, COI and role disclosures
Further research
Separate declared support from the scope of actual relationship verification. This is a proposal; no new investigation, calculation or trial was performed.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Original materials and analysis scope for AP-HP, Ministry of Health, ANR, INPES, Ile-de-France, roles and disclosures must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Why this condition is needed
This item separates AP-HP, Ministry of Health, ANR, INPES, Ile-de-France, roles and disclosures to link materials needed for the selected question with the materials currently available.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

Related sources S01

N19 · Are the five exercise-related injurious falls the same as the serious-only outcome?

Current findings
The five exercise-related injurious falls are a separate original safety account.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Severity of the five events, overlap with selected serious-only 68/87 events, unique people, exposure, time and adjudication methods are unverified. The five events do not fill serious-injury denominators or causes and are not used to calculate new rates or differences. The original content review remains incomplete.
Reason for missing information
Severity of the five events, overlap with selected serious-only 68/87 events, unique people, exposure, time and adjudication methods are unverified. The five events do not fill serious-injury denominators or causes and are not used to calculate new rates or differences.
Required materials and conditions
Harm events, severity and time, exposure, people and event counts
Materials to obtain first
Harm-event details and links to severity, denominators and exposure
Further research
Separate the prevention endpoint from program-related harm records. This is a proposal; no new investigation, calculation or trial was performed.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Original materials and analysis scope for Harm events, severity and time, exposure, people and event counts must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Why this condition is needed
This item separates Harm events, severity and time, exposure, people and event counts to link materials needed for the selected question with the materials currently available.
Application exceptions
Supplements gaps in safety materials for the selected subclaim. Fall-prevention effects, injury counts or the parent safety wording do not establish safety, and no new harm rate, exercise program, movement instruction or prescription is created.
Referenced methods
M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; detailed distinctions are Chamgap's own design; M19 §19.2 design-specific harm questions; timing details are Chamgap's own design; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4, M04 §4.6.3; Chamgap application

Related sources S01

N20 · Are harm relatedness, alternative explanations and long-term safety known?

Current findings
The original exercise-related label and parent's Caution safety label are preserved as history.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Relatedness adjudication, baseline illnesses, concomitant factors and environment, comparative harms, long-term or rare events and other populations are unverified. Nonsignificant serious-injury efficacy is not changed into safety or harm causality, and no new supervision or movement prescription is created. The original content review remains incomplete.
Reason for missing information
Relatedness adjudication, baseline illnesses, concomitant factors and environment, comparative harms, long-term or rare events and other populations are unverified. Nonsignificant serious-injury efficacy is not changed into safety or harm causality, and no new supervision or movement prescription is created.
Required materials and conditions
Original relatedness, baseline and concomitant factors, comparisons, rare events and vulnerable groups
Materials to obtain first
Adjudication, alternative explanations, exposure and long-term harm materials
Further research
Separate efficacy-related serious events from overall safety gaps. This is a proposal; no new investigation, calculation or trial was performed.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Original materials and analysis scope for Original relatedness, baseline and concomitant factors, comparisons, rare events and vulnerable groups must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Why this condition is needed
This item separates Original relatedness, baseline and concomitant factors, comparisons, rare events and vulnerable groups to link materials needed for the selected question with the materials currently available.
Application exceptions
Supplements gaps in safety materials for the selected subclaim. Fall-prevention effects, injury counts or the parent safety wording do not establish safety, and no new harm rate, exercise program, movement instruction or prescription is created.
Referenced methods
M19 §19.1.2–19.2.4; Chamgap application; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap application; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap's own design; M19 §19.1.2–19.2.4; Chamgap application; Chamgap interpretive boundaries draw on M19 principles, without executing an official causality tool

Related sources S01

N21 · Do related tai ji quan and Otago assessments directly establish the serious-only effect?

Current findings
The stored tai ji quan 1812 and Otago 1834 A86 links are historical comparisons. The current evidence and citation lists contain one Ossébo report.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Other assessments and trials, serious events, identity and independence were not looked up. Links are not combined as additional independent confirmation of the current serious-only outcome. The original content review remains incomplete.
Reason for missing information
Other assessments and trials, serious events, identity and independence were not looked up. Links are not combined as additional independent confirmation of the current serious-only outcome.
Required materials and conditions
Other programs, populations and durations, assessment links and bibliography
Materials to obtain first
Other program, population and related-report materials
Further research
Separate other exercise assessments from the current selected outcome. This is a proposal; no new investigation, calculation or trial was performed.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Original materials and analysis scope for Other programs, populations and durations, assessment links and bibliography must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Why this condition is needed
This item separates Other programs, populations and durations, assessment links and bibliography to link materials needed for the selected question with the materials currently available.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M04 §4.6.1–4.6.2 distinction between studies and reports; cohort and outcome linkage is Chamgap's own application; M04 §4.6.1–4.6.2, M15 §15.3.1; Chamgap application; M04 §4.5–4.6 principles for collecting and selecting materials; separation of access and reading and hyperlink rules are Chamgap's own design

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N22 · How are the same people, event severities and related sheets shared?

Current findings
The two selected sheets share the same Ossébo/NCT00545350 trial, 706 participants and one report. Serious injuries relate to the combined category and do not represent a separate independent trial or participants.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. External comparison of related or follow-up reports and event duplication was not performed. Event counts, people, woman-years and original R1 are not added into new replication totals; unique clinical totals remain unrecorded. The original content review remains incomplete.
Reason for missing information
External comparison of related or follow-up reports and event duplication was not performed. Event counts, people, woman-years and original R1 are not added into new replication totals; unique clinical totals remain unrecorded.
Required materials and conditions
Ossébo report and registration, combined versus serious-only outcomes, repeated events and time
Materials to obtain first
Related reports and registration, people, events and denominator links
Further research
Distinguish report slots from unique trials, participants and replication. This is a proposal; no new investigation, calculation or trial was performed.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Original materials and analysis scope for Ossébo report and registration, combined versus serious-only outcomes, repeated events and time must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Why this condition is needed
This item separates Ossébo report and registration, combined versus serious-only outcomes, repeated events and time to link materials needed for the selected question with the materials currently available.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

Related sources S01

N23 · Are findings extended to other populations, programs or durations?

Current findings
The original text limits the finding to the combined injury-rate reduction in this population and states that reduction of every serious fall was not established.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Serious-injury effects in other populations, exercises, isolated components, after cessation or beyond two years are unverified. No exercise program, movement instruction, prescription or treatment guidance is created. The original content review remains incomplete.
Reason for missing information
Serious-injury effects in other populations, exercises, isolated components, after cessation or beyond two years are unverified. No exercise program, movement instruction, prescription or treatment guidance is created.
Required materials and conditions
High-risk women aged 75–85, combined exposure, two years and direct extension evidence
Materials to obtain first
Other populations and programs, long-term and post-cessation outcomes
Further research
Separate the scope of the selected serious-injury question from extension questions. This is a proposal; no new investigation, calculation or trial was performed.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Original materials and analysis scope for High-risk women aged 75–85, combined exposure, two years and direct extension evidence must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Why this condition is needed
This item separates High-risk women aged 75–85, combined exposure, two years and direct extension evidence to link materials needed for the selected question with the materials currently available.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M03 §3.2.1–3.2.4; dose, persistence and effect-modification details are Chamgap's own design; M03 §3.2.4; Chamgap extension boundaries

Related sources S01

N24 · What history is retained in parent B76, languages, dates, empty values and corrections?

Current findings
Parent B76, Caution safety, unrecorded precision, a true large hard-outcome RCT flag, other false flags, empty override reasons, Korean and English texts, 2026-08-26, empty correction and deliberation records, historical cross-checks and selected D and its note are preserved in full.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. Subclaim scores, status and axes are not filled with parent values. This is not a new current search, language or original-text review, correction or retraction check or independence certification. The original content review remains incomplete.
Reason for missing information
Subclaim scores, status and axes are not filled with parent values. This is not a new current search, language or original-text review, correction or retraction check or independence certification.
Required materials and conditions
Selected D, original axes with true, false and unrecorded values, Korean and English texts and historical cross-checks
Materials to obtain first
Corrections, user comments and supplied materials
Further research
Distinguish the original record from production and amendment events. This is a proposal; no new investigation, calculation or trial was performed.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Original materials and analysis scope for Selected D, original axes with true, false and unrecorded values, Korean and English texts and historical cross-checks must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Why this condition is needed
This item separates Selected D, original axes with true, false and unrecorded values, Korean and English texts and historical cross-checks to link materials needed for the selected question with the materials currently available.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design; M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are our own design

Related sources S01

N25 · What is the reading status of the summary, external paper, registration, plans and disclosures?

Current findings
The complete stored summary, one evidence entry and one citation were read for production and the original BMJ link was preserved. The summary is marked summary read; external materials are marked not read.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the relevant information from the stored summary is recorded. Detailed original materials have not been read, and the original content review remains incomplete. External abstract and full text, registration, protocols, SAP and disclosures have not been read or accessed. Original identifiers, bibliography or historical narratives do not establish new acquisition, full-text reading or review. The original content review remains incomplete.
Reason for missing information
External abstract and full text, registration, protocols, SAP and disclosures have not been read or accessed. Original identifiers, bibliography or historical narratives do not establish new acquisition, full-text reading or review.
Required materials and conditions
One original evidence entry, one citation, BMJ link, acquisition and actual reading
Materials to obtain first
Each original material and actual reading history
Further research
Distinguish material-specific existence, acquisition, reading level and access. This is a proposal; no new investigation, calculation or trial was performed.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Original materials and analysis scope for One original evidence entry, one citation, BMJ link, acquisition and actual reading must be available so that unverified matters can be distinguished. This record links preserved wording; the original content review remains incomplete.
Why this condition is needed
This item separates One original evidence entry, one citation, BMJ link, acquisition and actual reading to link materials needed for the selected question with the materials currently available.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

Related sources S01