Home balance-board training × Same-ankle recurrence over one year — Events, exposure, adherence and gaps

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Evidence conditionWhich original one-year recurrence claim is selected?Required	The selected claim is reduced same-ankle recurrence over one year, original subclaim grade B, with the note 22% versus 33%/NNT 9. Absent subclaim score/status/axes are preserved separately from parent B with 76 points and axes. R01	Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.	Selected subclaim wording/grade versus parent context	Materials needed: Exact same-ankle recurrence definition, population/comparator, duration/denominators and user boundary review. Parent scores do not fill the subclaim score. Only material-request/research needs are recorded; no search/research was performed in this production.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionWhich previous-sprain population was studied?Required	2BFit randomized 522 athletes aged 12–70. The original intervention was home training after usual care following ankle sprain. Injury severity, recovery/start criteria, sports/comorbidities are not established in detail by the summary. R01	Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.	Athletes aged 12–70 after ankle sprain	Materials needed: Eligibility/exclusions, previous sprain/severity, usual care, training start, exposure and direct other-population data. Do not extend to all ankle disorders/app users. Only material-request/research needs are recorded; no search/research was performed in this production.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionWhat was the specific delivery approach?Required	The original was eight weeks of home neuromuscular training supplying a balance board, exercise sheets, DVD and web materials. Do not simplify into the board’s isolated-component effect, all ankle exercise or app effects. R01	Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.	Eight-week program with balance board, exercise sheets, DVD and web materials	Materials needed: Components, support/contact, training content, adherence, actual products and direct comparisons of delivery approaches. No device/app recommendations or exercise instructions. Only material-request/research needs are recorded; no search/research was performed in this production.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionWhat were usual-care comparison and concurrent treatment?Required	Original design was a multicentre randomized usual-care-controlled trial; effects concern adding an eight-week program after usual care. Actual concurrent bracing, physiotherapy, medication, return-to-sport/exposure in both arms remain unverified. R01	Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.	Additional training after usual care	Materials needed: Original usual care, additional training/other exposure, contact, contamination and recovery/return criteria in both arms. Do not repurpose effects to no treatment/other comparators. Only material-request/research needs are recorded; no search/research was performed in this production.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionAre training duration/study exposure separated from use instructions?Required	Original study facts record three sessions weekly, up to 30 minutes each, for eight weeks. Preserve study-exposure identity only; do not calculate total sessions/time or create exercise/rehabilitation/prevention instructions. R01	Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.	Original eight weeks, three times weekly, up to 30 minutes	Materials needed: Original actual training, adherence/stopping, support/contact and phase-specific exposure. No certification of identical effects for other durations/intensities. Only material-request/research needs are recorded; no search/research was performed in this production.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionAre eight-week training and one-year outcomes separated?Required	Intervention lasted eight weeks and same-ankle recurrence follow-up lasted 12 months. Maintenance training after completion, follow-up exposure/stopping and visit-specific observation remain unverified in detail. Training and event-observation periods do not become the same denominator. R01	Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.	Intervention duration versus 12-month recurrence follow-up	Materials needed: Original actual training/maintenance, follow-up schedules, observation duration/loss and sports exposure. Do not calculate new day counts/exercise amounts from one year. Only material-request/research needs are recorded; no search/research was performed in this production.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionWhat are randomization and recurrence numerators?Required	The original records 522 randomized (256/266) and 56/256 (22%) versus 89/266 (33%). Separately retain relationships among people, ankles, recurrence events, repeated reports and time; do not calculate additional event/participant totals. R01	Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.	522 participants, 256/266, original recurrence 56/89	Materials needed: Endpoint-numerator definitions, arm analysis/follow-up/observed denominators, repeated-recurrence handling and original flow tables. Do not copy numerators/denominators to all other endpoints/trials. Only material-request/research needs are recorded; no search/research was performed in this production.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionHow was same-ankle recurrence defined?Required	The original endpoint was same-ankle recurrence reported monthly and independently adjudicated under masking. Diagnostic/injury/recurrence criteria, first/all-repeated-event handling and clinical-confirmation details remain unverified. Do not extend to the opposite ankle/all injuries. R01	Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.	Original event label, first/repeated events and confirmation	Materials needed: Event definitions, original questionnaires, adjudication rules, repeated/contralateral events, severity and confirmation data. Materials clarifying aggregation of original numerators 56/89. Only material-request/research needs are recorded; no search/research was performed in this production.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionAre self-reporting and masked adjudication separated?Required	The original records monthly self-reports followed by independent adjudication by a masked physiotherapist and researcher. Initial reporting was self-reported and participant masking impossible. Do not add a declaration that all reports were confirmed through testing/clinical visits. R01	Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.	Initial monthly reporting versus independent physiotherapist/researcher adjudication	Materials needed: Original reporting/missingness, disagreement/adjudication, assessor masking, objective confirmation and participant expectations. No formal RoB assessment in this production. Only material-request/research needs are recorded; no search/research was performed in this production.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionAre recurrent people, repeated events and observations separated?Required	Preserve original 56/256, 89/266 and monthly reporting. Exact aggregation of at-least-one recurrence, first/all-repeated events and same-person bilateral-ankle/report relationships remains unverified. Monthly/repeated events are not new independent participants. R01	Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.	Original numerators and people/ankle/event units	Materials needed: Original event aggregation, person/ankle identifiers, repeat handling, analysis units and observation periods. No additional participant/event counts or new incidence-rate calculations. Only material-request/research needs are recorded; no search/research was performed in this production.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionWhich comparison do adjusted RR/CI/NNT describe?Required	Original adjusted RR 0.63 (95% CI 0.45–0.88) and NNT 9 concern 2BFit same-ankle recurrence over one year. Do not copy to app/bracing or time-loss/cost endpoints. Original adjusted-model/estimand details remain unverified. R01	Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.	2BFit one-year recurrence effects	Materials needed: Original models/adjustment variables, effects/CI, NNT definition/denominators and estimands. No new RR/RRR/NNT/CI recalculation or invented examples. Only material-request/research needs are recorded; no search/research was performed in this production.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionAre original absolute difference and arm percentages distinguished?Required	The original crux/rationale records 22% versus 33% and absolute recurrence difference −11 percentage points. Do not transfer to within-arm improvement, relative effects, other ankles/apps or calculate exact unrounded values/new absolute differences. R01	Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.	22% versus 33% and original −11 percentage points	Materials needed: Original arm denominators/rounding, effect definitions, adjusted/unadjusted results and duration/analysis data. Do not newly convert RR and absolute differences into one another. Only material-request/research needs are recorded; no search/research was performed in this production.
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionAre exposure-time incidence density and one-year risk identical?Required	Original study facts record incidence density 1.86 versus 2.90 per 1,000 ankle-exposure hours. These differ in units from 22% versus 33% with person denominators. Do not calculate actual total exposure hours, new event counts/incidence-density ratios. R01	Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.	1.86 versus 2.90 per 1,000 hours	Materials needed: Actual arm sports exposure, recording/missingness, incidence-density numerators/denominators and models/CI. Distinguish time, people and ankle units. Only material-request/research needs are recorded; no search/research was performed in this production.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionAre time-loss and cost/productivity outcomes retained separately?Required	The original rationale records time-loss recurrence RR 0.53 and medical-cost/productivity-loss recurrence RR 0.25 in the same direction. Definitions, numerators/denominators, CI/times/models remain unverified in detail. Do not copy primary RR 0.63/CI or NNT 9. R01	Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.	Other recurrence outcomes, RR 0.53 and 0.25	Materials needed: Original endpoint tables, event/cost definitions, denominators, effects/CI and hierarchy/multiplicity. No new calculations/addition beyond original numbers. Only material-request/research needs are recorded; no search/research was performed in this production.
15	Partly verified	Full text not readStored summary read	N15 · Evidence conditionAre adherence, comparator contamination and attrition retained together?Required	Preserve original full adherence 58/256 (23%), comparator contamination 5/266 (2%) and follow-up attrition 14%. Adherence definition, partial adherence and arm-specific loss/reasons remain unverified in detail. No adherer effects, new adherence differences/attrition counts/rates. R01	Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.	58/25623%·5/2662%·14%	Materials needed: Adherence measurement, actual exposure, contamination/concurrent training, arm withdrawal/missingness and sensitivity analyses. Low adherence does not newly establish delivery effects/causality. Only material-request/research needs are recorded; no search/research was performed in this production.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionDoes ITT certify resolution of completeness/missingness?Required	The original study description records all analyses following ITT principles alongside 14% attrition. ITT is not converted into universal completion/all-endpoint observation or zero missingness bias. Original B0 is parent-verdict context. R01	Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.	Analysis as randomized and actual missingness handling	Materials needed: Original arm flow, endpoint analysis/observation, missingness handling/assumptions, follow-up loss and sensitivity. No clinical calculations/formal risk assessment in this production. Only material-request/research needs are recorded; no search/research was performed in this production.
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionAre original randomization/prespecified-endpoint descriptions preserved?Required	The original records independent-researcher computer allocation, impossible participant masking/masked adjudication, ITT, and matching prespecified self-reported recurrence primary endpoint/ISRCTN34177180. Preserve original quotations/history only; no plan/procedure comparison now. R01	Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.	Independent-researcher computer allocation and recurrence primary endpoint/registration	Materials needed: Allocation concealment/implementation, plans/amendments, registration versions/public dates and original-report comparison. The unestablished first registration publication date does not newly establish prospective registration. Only material-request/research needs are recorded; no search/research was performed in this production.
18	Partly verified	Full text not readStored summary read	N18 · Evidence conditionAre 2023 app results mixed with 2BFit?Required	The original counterview records a primary-care app trial with 165 participants, null HR 1.14 (0.59–2.21), adherence 6.1%. Preserve the original scope that delivery differed from 2BFit supplying a board/DVD and was not counted as direct conflict. Citation/design details remain unidentified. R01 R02	Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.	Different-delivery trial, 165 participants, HR 1.14	Materials needed: Exact app citations/registration, population/comparator/duration, endpoints/denominators/exposure/adherence, models and direct comparisons. Do not substitute app HR for board RR or effects of all apps. Only material-request/research needs are recorded; no search/research was performed in this production.
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionAre different bracing-trial/review results separated?Required	The original records 12-month bracing superior to eight-week training in the 2014 trial and no 12-month recurrence difference between training/bracing in a 2017 review. Populations, citations, denominators, effects and CI for both contexts remain unverified; no difference does not become equivalence. R03 R04	Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.	2014 bracing superiority and no difference in 2017	Materials needed: Each citation, original trials/review-included studies/overlap, exact comparators/durations and effects/CI/denominators. Do not count different research as new pooled effects/unique trial totals. Only material-request/research needs are recorded; no search/research was performed in this production.
20	Unverified	Full text not readStored summary read	N20 · Harm-information gaps supplementing the efficacy tableIs the separate exercise-harm reporting gap retained?Supplementary	The original safety description records that exercise-related adverse events were not collected/reported in a separate table and this trial cannot establish harmlessness. Preserve this reporting limitation; do not extend to zero AE or long-term safety. R01	Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.	Exercise-related AE collection/reporting versus harmlessness	Materials needed: Harm collection/definitions, arm actual training/exposure, events/discontinuation/relatedness/denominators and long-term data. No exercise/rehabilitation/recurrence-prevention instructions. Only material-request/research needs are recorded; no search/research was performed in this production.
21	Partly verified	Full text not readStored summary read	N21 · Evidence conditionWhat was actually read/identified?Required	The complete preserved parent summary was read for production and retained in the original archive. The single citation identifies 2BFit; three app/bracing/review entries are unidentified counterview contexts. All external abstracts/full texts/registration/plans remain unread. R01 R02 R03 R04	Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.	Preserved summary/original citation versus unidentified reference contexts	Materials needed: Exact report citations/originals, acquisition/reading scope, versions/dates. URLs/historical quotations are not upgraded to current reading; no external-link/access testing. Only material-request/research needs are recorded; no search/research was performed in this production.
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionAre registration dates/prespecification treated as current certification?Required	Original evidence/Korean text describes matching ISRCTN34177180 with the self-reported recurrence primary endpoint. Original study facts say the first registration public date was unestablished, so prospective registration was not asserted. App/bracing/review registrations are unidentified. R01 R02 R03 R04	Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.	ISRCTN34177180 and unestablished first public date	Materials needed: Actual registration versions/publication, start/amendment timing and endpoints/plans. No guessed official URLs, new registration reading or prespecification certification. Only material-request/research needs are recorded; no search/research was performed in this production.
23	Unverified	Full text not readStored summary read	N23 · Evidence conditionWere protocol/SAP and estimand/missingness plans acquired?Required	Preserve original primary/ITT/allocation/adjudication descriptions and historical cross-checking. Each trial’s protocol/SAP, versions/timing and missingness/multiplicity/analysis plans were not acquired/read now. R01 R02 R03 R04	Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.	Separate prespecified-plan/analysis/amendment materials	Materials needed: Original protocols/SAP, amendment histories, endpoints/models/people/events/exposure, missingness/sensitivity and public timing. Unread external materials do not establish document absence. Only material-request/research needs are recorded; no search/research was performed in this production.
24	Partly verified	Full text not readStored summary read	N24 · Evidence conditionAre public funding, board supply and company involvement separated?Required	2BFit had ZonMw grant 750-20-002, declarations of no financial benefit/competing interests and Avanco AB boards supplied to participants. Preserve the original limitation that manufacturer donation/funding/analysis/writing/publication support was not reported. Supply is not manufacturer donation; employee authors/roles and app/bracing/review funding remain unverified now. R01 R02 R03 R04	Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.	2BFit support versus unverified other contexts	Materials needed: Item-specific company funding, product support, employee authors, design/analysis/data control and other support for each study. I2 does not establish absence of every item or independence certification. Only material-request/research needs are recorded; no search/research was performed in this production.
25	Partly verified	Full text not readStored summary read	N25 · Evidence conditionAre specific positive effects, different-delivery null results and unverified details distinguished?Required	Positive 2BFit recurrence, null 2023 app HR, 2014 bracing superiority and no difference in the 2017 review concern different contexts. Separate original descriptions from unverified citation/effect/harm details; no new verdict on broad claims. R01 R02 R03 R04	Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.	Question/comparison-specific results and reading status	Materials needed: Report-specific direct populations/interventions/comparators, endpoints/durations, effects/CI/denominators and actual access. Unread does not mean unreported; null does not mean zero effect/equivalence. Only material-request/research needs are recorded; no search/research was performed in this production.
26	Partly verified	Full text not readStored summary read	N26 · Evidence conditionAre one original citation and three reference contexts counted as unique trials?Required	Parent 2975 and its s0/s1 claims share original 2BFit citation/trial context and counterview mentions of the 2023 app, 2014 bracing and 2017 review. The same people, ankles, arms, events, times, citations, related sheets and review-included trials are not newly added as independent trials/participants. Four links comprise one identified paper and three unidentified contexts, including a 2017 review; they are not certification of four unique clinical trials or participant totals. R01 R02 R03 R04	Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.	Document/context items versus trials/participants	Materials needed: Citations/registration, review-included reports/overlap, cohorts/analysis, endpoints/repetition relationships. Unique trial/participant totals remain unrecorded. Only material-request/research needs are recorded; no search/research was performed in this production.
27	Unverified	Full text not readStored summary read	N27 · Evidence conditionAre original single confirmation and independent replication distinguished?Supplementary	Preserve parent replication R1/independence I2 and the original single confirmatory-trial description. App/bracing/review contexts are not counted as new same-condition independent replication/conflicts or unique-trial certification. R01 R02 R03 R04	Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.	Parent R1/I2 and comparison/delivery differences	Materials needed: Separate prespecified, direct population/delivery/comparator/events, effects/CI/denominators, funding/author relationships and overlap materials for the selected question. No search/independence determination now. Only material-request/research needs are recorded; no search/research was performed in this production.
28	Partly verified	Full text not readStored summary read	N28 · Evidence conditionAre the subclaim grade and parent score/axes preserved?Required	Preserve selected subclaim B/note/bilingual claims; absent subclaim score/status/axes remain unrecorded. Parent B with 76 points, unknown safety, B/H/R1/I2/E+/B0, unrecorded precision and true large-hard-endpoint RCT are parent context and do not fill subclaim values. R01	Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.	Selected B, absent subclaim values and parent B76	Materials needed: User subclaim/parent-boundary review and actual correction materials. No new score/grade or official RoB 2/GRADE certification. Only material-request/research needs are recorded; no search/research was performed in this production.
29	Partly verified	Full text not readStored summary read	N29 · Evidence conditionAre both languages, citations and absent fields preserved?Required	Preserve original parent bilingual quotations/descriptions, evidence, citations and axes and selected-subclaim values in the complete original archive. Classification fields are absent and no new original fields are filled. No English-paper comparison now. R01	Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.	Both original languages and absent separate classification information	Materials needed: User review of languages/terminology, event/exposure units, absences and selected scope. Distinguish production descriptions from original values. Only material-request/research needs are recorded; no search/research was performed in this production.
30	Partly verified	Full text not readStored summary read	N30 · Evidence conditionAre source dates/corrections/history separated from production dates?Required	Preserve original evidence date 2026-08-26, empty corrections/deliberation and verdict-decision cross-checking. Historical quotations/registration matching differ from current production, condition freezing/application and completed content review. R01	Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.	Original 2026-08-26 and new conditions/application	Materials needed: Update materials separating originals, events, conditions/observations and verdict decisions when new evidence/corrections arise. Historical wording is not completed clinical content review here. Only material requests/research needs are recorded; no search or research was performed in that production.
31	Unverified	Full text not readStored summary read	N31 · Evidence conditionWhat direct materials would fill the selected gaps?Supplementary	Specific 2BFit event/exposure, adherence/attrition, harms/reporting details require originals; app/bracing mentions do not substitute as identical effects. R01 R02 R03 R04	Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.	Direct population/delivery/events, effects/CI and denominators	Materials needed: Question-specific tables/plans, direct comparisons/applicability, effects/CI, people/ankle/event/exposure denominators, missingness/adherence, separate confirmation and long-term harms. Need recorded only; no search/research now. Only material-request/research needs are recorded; no search/research was performed in this production.
32	Partly verified	Full text not readStored summary read	N32 · Evidence conditionAre applicability records separated from content review and instructions?Supplementary	These are summary-based applicability records. Existing content/question-boundary review remains incomplete; candidate pending/eligible markers are preserved as history. R01	Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.	Applicability records, existing candidate history and content review	Materials needed: Content review and subsequent actual evidence/correction work. Original content-production scope excludes clinical QA/testing, external-link/access/web/API research, new calculations/grades and device/app recommendations or exercise/rehabilitation/prevention/treatment-replacement instructions. Only material-request/research needs are recorded; no search/research was performed in this production.

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32 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: 2BFit: 522 athletes aged 12–70 after previous ankle sprain, 256/266. The 2023 primary-care app trial had 165 participants; population details remain unidentified and concern separate context.
Ingredient, formulation and route: Eight-week home neuromuscular training with board, exercise sheets, DVD and web materials after usual care, separated from app delivery/bracing comparisons.
Dose: Original study exposure: three times weekly, up to 30 minutes, for eight weeks. 2023 app exposure details remain unverified. No new totals, device/app recommendations or exercise instructions.
Comparator: 2BFit usual care. App-comparator details remain unverified; 2014 bracing comparison/2017 review concern different contexts.
Measured outcome: Same-ankle recurrence over one year; distinguish self-report/independent adjudication, people/repeated events/exposure time and other endpoints.
Duration: 2BFit eight-week intervention/12-month follow-up. App-intervention/follow-up details remain unverified. The 2014 context compared 12-month bracing with eight-week training; the 2017 recurrence context concerned 12 months.
Questions outside this scope: Repurposing specific balance-board-program effects to all apps/ankle exercises/other populations or durations; Mixing app HR, board RR, bracing/review results, people/events/exposure units or denominators; Creating new causality/safety/equivalence/superiority/independence certification from original adherence/attrition/reporting limitations; Adding the same people, ankles, arms, events, times, citations, related sheets and review-included trials as new independent trials/participants; New calculations, invented quantities, effects/CI, grades or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions

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.

R01 · Hupperets MDW, et al. Effect of unsupervised home based proprioceptive training on recurrences of ankle sprain. BMJ. 2009;339:b2684. PMID: 19589822.

PubMed

Material type: Multicentre randomized usual-care-controlled trial
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/plans remain unread
Findings recorded in the stored summary: 56/256 (22%) versus 89/266 (33%); adjusted RR 0.63 (0.45–0.88), NNT 9
Record level: 2BFit core-endpoint summary from the original evidence list, separated from other contexts
Study overlap and independent replication: The 2BFit core one-year same-ankle recurrence trial concerns a specific eight-week program combining a board and delivery support. The app context used different delivery and was not counted as direct conflict with 2BFit. Bracing versus training is a different comparison and is not repurposed as app effects/equal-duration comparison. The review context is not an independent clinical trial; no difference does not certify equivalence. Parent 2975 and its s0/s1 claims share the original 2BFit citation/trial context and counterview mentions of the 2023 app, 2014 bracing and 2017 review. The same people, ankles, arms, events, times, citations, related sheets and review-included trials are not newly added as independent trials/participants. These are provisional reference-context items; actual cohort/independence and review-included-study relationships remain incompletely reviewed.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Local preserved copy of the complete parent summary	Stored summary read	Summary read	Only original PubMed URL/ISRCTN are preserved. Exact titles/authors/DOI/PMID/registration/URLs are not guessed for contexts without citations. No new external reading/access/verification certification.
External abstract	Original identifier/bibliography or required-material entry; public availability/access details remain unverified	Unread; access testing not performed	Not read	Only original PubMed URL/ISRCTN are preserved. Exact titles/authors/DOI/PMID/registration/URLs are not guessed for contexts without citations. No new external reading/access/verification certification.
External full text	Original identifier/bibliography or required-material entry; public availability/access details remain unverified	Unread; access testing not performed	Not read	Only original PubMed URL/ISRCTN are preserved. Exact titles/authors/DOI/PMID/registration/URLs are not guessed for contexts without citations. No new external reading/access/verification certification.
Registration material	Original identifier/bibliography or required-material entry; public availability/access details remain unverified	Unread; access testing not performed	Not read	Only original PubMed URL/ISRCTN are preserved. Exact titles/authors/DOI/PMID/registration/URLs are not guessed for contexts without citations. No new external reading/access/verification certification.
Protocol/SAP	Original identifier/bibliography or required-material entry; public availability/access details remain unverified	Unread; access testing not performed	Not read	Only original PubMed URL/ISRCTN are preserved. Exact titles/authors/DOI/PMID/registration/URLs are not guessed for contexts without citations. No new external reading/access/verification certification.

R02 · 2023 primary-care app trial — Unidentified reference context in the original counterview

Material type: Original mention of a primary-care app trial; detailed design/citation unidentified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/plans remain unread
Findings recorded in the stored summary: Original counterview: 165 participants, null HR 1.14 (0.59–2.21), adherence 6.1%. Exact citation/design/comparator/duration and denominator details remain unverified.
Record level: Separate reference-context summary in the original counterview; no separate evidence/citation-list entry or exact citation
Study overlap and independent replication: The 2BFit core one-year same-ankle recurrence trial concerns a specific eight-week program combining a board and delivery support. The app context used different delivery and was not counted as direct conflict with 2BFit. Bracing versus training is a different comparison and is not repurposed as app effects/equal-duration comparison. The review context is not an independent clinical trial; no difference does not certify equivalence. Parent 2975 and its s0/s1 claims share the original 2BFit citation/trial context and counterview mentions of the 2023 app, 2014 bracing and 2017 review. The same people, ankles, arms, events, times, citations, related sheets and review-included trials are not newly added as independent trials/participants. These are provisional reference-context items; actual cohort/independence and review-included-study relationships remain incompletely reviewed.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Local preserved copy of the complete parent summary	Stored summary read	Summary read	Only original PubMed URL/ISRCTN are preserved. Exact titles/authors/DOI/PMID/registration/URLs are not guessed for contexts without citations. No new external reading/access/verification certification.
External abstract	Unidentified/unacquired material items	Unread; access testing not performed	Not read	Only original PubMed URL/ISRCTN are preserved. Exact titles/authors/DOI/PMID/registration/URLs are not guessed for contexts without citations. No new external reading/access/verification certification.
External full text	Unidentified/unacquired material items	Unread; access testing not performed	Not read	Only original PubMed URL/ISRCTN are preserved. Exact titles/authors/DOI/PMID/registration/URLs are not guessed for contexts without citations. No new external reading/access/verification certification.
Registration material	Unidentified/unacquired material items	Unread; access testing not performed	Not read	Only original PubMed URL/ISRCTN are preserved. Exact titles/authors/DOI/PMID/registration/URLs are not guessed for contexts without citations. No new external reading/access/verification certification.
Protocol/SAP	Unidentified/unacquired material items	Unread; access testing not performed	Not read	Only original PubMed URL/ISRCTN are preserved. Exact titles/authors/DOI/PMID/registration/URLs are not guessed for contexts without citations. No new external reading/access/verification certification.

R03 · 2014 bracing comparison trial — Unidentified reference context in the original counterview

Material type: Original mention of a bracing comparison trial; detailed design/citation unidentified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/plans remain unread
Findings recorded in the stored summary: Original counterview: 12-month bracing superior to eight-week training; exact effects/CI, population/denominators and citation remain unverified.
Record level: Separate reference-context summary in the original counterview; no separate evidence/citation-list entry or exact citation
Study overlap and independent replication: The 2BFit core one-year same-ankle recurrence trial concerns a specific eight-week program combining a board and delivery support. The app context used different delivery and was not counted as direct conflict with 2BFit. Bracing versus training is a different comparison and is not repurposed as app effects/equal-duration comparison. The review context is not an independent clinical trial; no difference does not certify equivalence. Parent 2975 and its s0/s1 claims share the original 2BFit citation/trial context and counterview mentions of the 2023 app, 2014 bracing and 2017 review. The same people, ankles, arms, events, times, citations, related sheets and review-included trials are not newly added as independent trials/participants. These are provisional reference-context items; actual cohort/independence and review-included-study relationships remain incompletely reviewed.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Local preserved copy of the complete parent summary	Stored summary read	Summary read	Only original PubMed URL/ISRCTN are preserved. Exact titles/authors/DOI/PMID/registration/URLs are not guessed for contexts without citations. No new external reading/access/verification certification.
External abstract	Unidentified/unacquired material items	Unread; access testing not performed	Not read	Only original PubMed URL/ISRCTN are preserved. Exact titles/authors/DOI/PMID/registration/URLs are not guessed for contexts without citations. No new external reading/access/verification certification.
External full text	Unidentified/unacquired material items	Unread; access testing not performed	Not read	Only original PubMed URL/ISRCTN are preserved. Exact titles/authors/DOI/PMID/registration/URLs are not guessed for contexts without citations. No new external reading/access/verification certification.
Registration material	Unidentified/unacquired material items	Unread; access testing not performed	Not read	Only original PubMed URL/ISRCTN are preserved. Exact titles/authors/DOI/PMID/registration/URLs are not guessed for contexts without citations. No new external reading/access/verification certification.
Protocol/SAP	Unidentified/unacquired material items	Unread; access testing not performed	Not read	Only original PubMed URL/ISRCTN are preserved. Exact titles/authors/DOI/PMID/registration/URLs are not guessed for contexts without citations. No new external reading/access/verification certification.

R04 · 2017 training/bracing review — Unidentified reference context in the original counterview

Material type: Original mention of a review; methods/included trials/citation unidentified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/plans remain unread
Findings recorded in the stored summary: Original counterview: no 12-month recurrence difference found between training/bracing; original review/included trials/effects/CI remain unverified.
Record level: Separate reference-context summary in the original counterview; no separate evidence/citation-list entry or exact citation
Study overlap and independent replication: The 2BFit core one-year same-ankle recurrence trial concerns a specific eight-week program combining a board and delivery support. The app context used different delivery and was not counted as direct conflict with 2BFit. Bracing versus training is a different comparison and is not repurposed as app effects/equal-duration comparison. The review context is not an independent clinical trial; no difference does not certify equivalence. Parent 2975 and its s0/s1 claims share the original 2BFit citation/trial context and counterview mentions of the 2023 app, 2014 bracing and 2017 review. The same people, ankles, arms, events, times, citations, related sheets and review-included trials are not newly added as independent trials/participants. These are provisional reference-context items; actual cohort/independence and review-included-study relationships remain incompletely reviewed.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Local preserved copy of the complete parent summary	Stored summary read	Summary read	Only original PubMed URL/ISRCTN are preserved. Exact titles/authors/DOI/PMID/registration/URLs are not guessed for contexts without citations. No new external reading/access/verification certification.
External abstract	Unidentified/unacquired material items	Unread; access testing not performed	Not read	Only original PubMed URL/ISRCTN are preserved. Exact titles/authors/DOI/PMID/registration/URLs are not guessed for contexts without citations. No new external reading/access/verification certification.
External full text	Unidentified/unacquired material items	Unread; access testing not performed	Not read	Only original PubMed URL/ISRCTN are preserved. Exact titles/authors/DOI/PMID/registration/URLs are not guessed for contexts without citations. No new external reading/access/verification certification.
Registration material	Unidentified/unacquired material items	Unread; access testing not performed	Not read	Only original PubMed URL/ISRCTN are preserved. Exact titles/authors/DOI/PMID/registration/URLs are not guessed for contexts without citations. No new external reading/access/verification certification.
Protocol/SAP	Unidentified/unacquired material items	Unread; access testing not performed	Not read	Only original PubMed URL/ISRCTN are preserved. Exact titles/authors/DOI/PMID/registration/URLs are not guessed for contexts without citations. No new external reading/access/verification certification.

Report counts versus independent study counts

The 2BFit core one-year same-ankle recurrence trial concerns a specific eight-week program combining a board and delivery support. The app context used different delivery and was not counted as direct conflict with 2BFit. Bracing versus training is a different comparison and is not repurposed as app effects/equal-duration comparison. The review context is not an independent clinical trial; no difference does not certify equivalence. Parent 2975 and its s0/s1 claims share the original 2BFit citation/trial context and counterview mentions of the 2023 app, 2014 bracing and 2017 review. The same people, ankles, arms, events, times, citations, related sheets and review-included trials are not newly added as independent trials/participants. These are provisional reference-context items; actual cohort/independence and review-included-study relationships remain incompletely reviewed.

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 · Which original one-year recurrence claim is selected?

Required materials and conditions: Selected subclaim wording/grade versus parent context
Conditions for verification: Show original materials for selected subclaim wording/grade versus parent context together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect selected subclaim wording/grade versus parent context with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N02 · Which previous-sprain population was studied?

Required materials and conditions: Athletes aged 12–70 after ankle sprain
Conditions for verification: Show original materials for athletes aged 12–70 after ankle sprain together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect athletes aged 12–70 after ankle sprain with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N03 · What was the specific delivery approach?

Required materials and conditions: Eight-week program with balance board, exercise sheets, DVD and web materials
Conditions for verification: Show original materials for eight-week program with balance board, exercise sheets, DVD and web materials together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect eight-week program with balance board, exercise sheets, DVD and web materials with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N04 · What were usual-care comparison and concurrent treatment?

Required materials and conditions: Additional training after usual care
Conditions for verification: Show original materials for additional training after usual care together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect additional training after usual care with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N05 · Are training duration/study exposure separated from use instructions?

Required materials and conditions: Original eight weeks, three times weekly, up to 30 minutes
Conditions for verification: Show original materials for original eight weeks, three times weekly, up to 30 minutes together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect original eight weeks, three times weekly, up to 30 minutes with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N06 · Are eight-week training and one-year outcomes separated?

Required materials and conditions: Intervention duration versus 12-month recurrence follow-up
Conditions for verification: Show original materials for intervention duration versus 12-month recurrence follow-up together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect intervention duration versus 12-month recurrence follow-up with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N07 · What are randomization and recurrence numerators?

Required materials and conditions: 522 participants, 256/266, original recurrence 56/89
Conditions for verification: Show original materials for 522 participants, 256/266, original recurrence 56/89 together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect 522 participants, 256/266, original recurrence 56/89 with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N08 · How was same-ankle recurrence defined?

Required materials and conditions: Original event label, first/repeated events and confirmation
Conditions for verification: Show original materials for original event label, first/repeated events and confirmation together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect original event label, first/repeated events and confirmation with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N09 · Are self-reporting and masked adjudication separated?

Required materials and conditions: Initial monthly reporting versus independent physiotherapist/researcher adjudication
Conditions for verification: Show original materials for initial monthly reporting versus independent physiotherapist/researcher adjudication together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect initial monthly reporting versus independent physiotherapist/researcher adjudication with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N10 · Are recurrent people, repeated events and observations separated?

Required materials and conditions: Original numerators and people/ankle/event units
Conditions for verification: Show original materials for original numerators and people/ankle/event units together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect original numerators and people/ankle/event units with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N11 · Which comparison do adjusted RR/CI/NNT describe?

Required materials and conditions: 2BFit one-year recurrence effects
Conditions for verification: Show original materials for 2BFit one-year recurrence effects together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect 2BFit one-year recurrence effects with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N12 · Are original absolute difference and arm percentages distinguished?

Required materials and conditions: 22% versus 33% and original −11 percentage points
Conditions for verification: Show original materials for 22% versus 33% and original −11 percentage points together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect 22% versus 33% and original −11 percentage points with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N13 · Are exposure-time incidence density and one-year risk identical?

Required materials and conditions: 1.86 versus 2.90 per 1,000 hours
Conditions for verification: Show original materials for 1.86 versus 2.90 per 1,000 hours together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect 1.86 versus 2.90 per 1,000 hours with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N14 · Are time-loss and cost/productivity outcomes retained separately?

Required materials and conditions: Other recurrence outcomes, RR 0.53 and 0.25
Conditions for verification: Show original materials for other recurrence outcomes, RR 0.53 and 0.25 together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect other recurrence outcomes, RR 0.53 and 0.25 with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N15 · Are adherence, comparator contamination and attrition retained together?

Required materials and conditions: 58/25623%·5/2662%·14%
Conditions for verification: Show original materials for 58/256 (23%), 5/266 (2%) and 14% together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect 58/256 (23%), 5/266 (2%) and 14% with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N16 · Does ITT certify resolution of completeness/missingness?

Required materials and conditions: Analysis as randomized and actual missingness handling
Conditions for verification: Show original materials for analysis as randomized and actual missingness handling together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect analysis as randomized and actual missingness handling with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N17 · Are original randomization/prespecified-endpoint descriptions preserved?

Required materials and conditions: Independent-researcher computer allocation and recurrence primary endpoint/registration
Conditions for verification: Show original materials for independent-researcher computer allocation and recurrence primary endpoint/registration together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect independent-researcher computer allocation and recurrence primary endpoint/registration with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N18 · Are 2023 app results mixed with 2BFit?

Required materials and conditions: Different-delivery trial, 165 participants, HR 1.14
Conditions for verification: Show original materials for different-delivery trial, 165 participants, HR 1.14 together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect different-delivery trial, 165 participants, HR 1.14 with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N19 · Are different bracing-trial/review results separated?

Required materials and conditions: 2014 bracing superiority and no difference in 2017
Conditions for verification: Show original materials for 2014 bracing superiority and no difference in 2017 together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect 2014 bracing superiority and no difference in 2017 with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N20 · Is the separate exercise-harm reporting gap retained?

Required materials and conditions: Exercise-related AE collection/reporting versus harmlessness
Conditions for verification: Show original materials for exercise-related AE collection/reporting versus harmlessness together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Supplementary
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect exercise-related AE collection/reporting versus harmlessness with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N21 · What was actually read/identified?

Required materials and conditions: Preserved summary/original citation versus unidentified reference contexts
Conditions for verification: Show original materials for preserved summary/original citation versus unidentified reference contexts together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect preserved summary/original citation versus unidentified reference contexts with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N22 · Are registration dates/prespecification treated as current certification?

Required materials and conditions: ISRCTN34177180 and unestablished first public date
Conditions for verification: Show original materials for iSRCTN34177180 and unestablished first public date together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect iSRCTN34177180 and unestablished first public date with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N23 · Were protocol/SAP and estimand/missingness plans acquired?

Required materials and conditions: Separate prespecified-plan/analysis/amendment materials
Conditions for verification: Show original materials for separate prespecified-plan/analysis/amendment materials together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect separate prespecified-plan/analysis/amendment materials with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N24 · Are public funding, board supply and company involvement separated?

Required materials and conditions: 2BFit support versus unverified other contexts
Conditions for verification: Show original materials for 2BFit support versus unverified other contexts together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect 2BFit support versus unverified other contexts with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N25 · Are specific positive effects, different-delivery null results and unverified details distinguished?

Required materials and conditions: Question/comparison-specific results and reading status
Conditions for verification: Show original materials for question/comparison-specific results and reading status together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect question/comparison-specific results and reading status with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N26 · Are one original citation and three reference contexts counted as unique trials?

Required materials and conditions: Document/context items versus trials/participants
Conditions for verification: Show original materials for document/context items versus trials/participants together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect document/context items versus trials/participants with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N27 · Are original single confirmation and independent replication distinguished?

Required materials and conditions: Parent R1/I2 and comparison/delivery differences
Conditions for verification: Show original materials for parent R1/I2 and comparison/delivery differences together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Supplementary
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect parent R1/I2 and comparison/delivery differences with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N28 · Are the subclaim grade and parent score/axes preserved?

Required materials and conditions: Selected B, absent subclaim values and parent B76
Conditions for verification: Show original materials for selected B, absent subclaim values and parent B76 together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect selected B, absent subclaim values and parent B76 with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N29 · Are both languages, citations and absent fields preserved?

Required materials and conditions: Both original languages and absent separate classification information
Conditions for verification: Show original materials for original bilingual text and absent classification fields together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect original bilingual text and absent classification fields with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N30 · Are source dates/corrections/history separated from production dates?

Required materials and conditions: Original 2026-08-26 and new conditions/application
Conditions for verification: Show original materials for original 2026-08-26 versus new conditions/application together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect original 2026-08-26 versus new conditions/application with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N31 · What direct materials would fill the selected gaps?

Required materials and conditions: Direct population/delivery/events, effects/CI and denominators
Conditions for verification: Show original materials for direct population/delivery/events, effects/CI and denominators together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Supplementary
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect direct population/delivery/events, effects/CI and denominators with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N32 · Are applicability records separated from content review and instructions?

Required materials and conditions: Applicability records, existing candidate history and content review
Conditions for verification: Show original materials for production request, candidate history and content review together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Supplementary
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect production request, candidate history and content review with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

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: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

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: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

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: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

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: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

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: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

What the statuses mean

Partly verified: Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.
Unverified: Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety
Review incomplete: Review of existing content incomplete
Met: Use only within the relevant conditions after existing content review; no automatic designation in this preparation
Not reported: Distinguish only within materials actually read; do not turn unread external materials into unreported findings
Inaccessible: Not applied during this preparation because actual access was not tested
Not applicable: Use with a reason for non-applicability based on an explicit question boundary
Conflicting data: Judge after actual material comparison; review was not performed during this preparation
Insufficient evidence for the conditions: Do not use as a clinical grade encompassing currently unread materials

Change history

2026-10-14 · Public page/material version 1.0

Public pages and materials were prepared from the existing 32 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 · Which original one-year recurrence claim is selected?

Current findings: The selected claim is reduced same-ankle recurrence over one year, original subclaim grade B, with the note 22% versus 33%/NNT 9. Absent subclaim score/status/axes are preserved separately from parent B with 76 points and axes.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.
Reason for missing information: Exact same-ankle recurrence definition, population/comparator, duration/denominators and user boundary review. Parent scores do not fill the subclaim score.
Required materials and conditions: Selected subclaim wording/grade versus parent context
Materials to obtain first: Exact same-ankle recurrence definition, population/comparator, duration/denominators and user boundary review. Parent scores do not fill the subclaim score.
Further research: Materials needed: Exact same-ankle recurrence definition, population/comparator, duration/denominators and user boundary review. Parent scores do not fill the subclaim score. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for selected subclaim wording/grade versus parent context together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Why this condition is needed: Needed to connect selected subclaim wording/grade versus parent context with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N02 · Which previous-sprain population was studied?

Current findings: 2BFit randomized 522 athletes aged 12–70. The original intervention was home training after usual care following ankle sprain. Injury severity, recovery/start criteria, sports/comorbidities are not established in detail by the summary.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.
Reason for missing information: Eligibility/exclusions, previous sprain/severity, usual care, training start, exposure and direct other-population data. Do not extend to all ankle disorders/app users.
Required materials and conditions: Athletes aged 12–70 after ankle sprain
Materials to obtain first: Eligibility/exclusions, previous sprain/severity, usual care, training start, exposure and direct other-population data. Do not extend to all ankle disorders/app users.
Further research: Materials needed: Eligibility/exclusions, previous sprain/severity, usual care, training start, exposure and direct other-population data. Do not extend to all ankle disorders/app users. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for athletes aged 12–70 after ankle sprain together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Why this condition is needed: Needed to connect athletes aged 12–70 after ankle sprain with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N03 · What was the specific delivery approach?

Current findings: The original was eight weeks of home neuromuscular training supplying a balance board, exercise sheets, DVD and web materials. Do not simplify into the board’s isolated-component effect, all ankle exercise or app effects.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.
Reason for missing information: Components, support/contact, training content, adherence, actual products and direct comparisons of delivery approaches. No device/app recommendations or exercise instructions.
Required materials and conditions: Eight-week program with balance board, exercise sheets, DVD and web materials
Materials to obtain first: Components, support/contact, training content, adherence, actual products and direct comparisons of delivery approaches. No device/app recommendations or exercise instructions.
Further research: Materials needed: Components, support/contact, training content, adherence, actual products and direct comparisons of delivery approaches. No device/app recommendations or exercise instructions. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for eight-week program with balance board, exercise sheets, DVD and web materials together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Why this condition is needed: Needed to connect eight-week program with balance board, exercise sheets, DVD and web materials with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N04 · What were usual-care comparison and concurrent treatment?

Current findings: Original design was a multicentre randomized usual-care-controlled trial; effects concern adding an eight-week program after usual care. Actual concurrent bracing, physiotherapy, medication, return-to-sport/exposure in both arms remain unverified.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.
Reason for missing information: Original usual care, additional training/other exposure, contact, contamination and recovery/return criteria in both arms. Do not repurpose effects to no treatment/other comparators.
Required materials and conditions: Additional training after usual care
Materials to obtain first: Original usual care, additional training/other exposure, contact, contamination and recovery/return criteria in both arms. Do not repurpose effects to no treatment/other comparators.
Further research: Materials needed: Original usual care, additional training/other exposure, contact, contamination and recovery/return criteria in both arms. Do not repurpose effects to no treatment/other comparators. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for additional training after usual care together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Why this condition is needed: Needed to connect additional training after usual care with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N05 · Are training duration/study exposure separated from use instructions?

Current findings: Original study facts record three sessions weekly, up to 30 minutes each, for eight weeks. Preserve study-exposure identity only; do not calculate total sessions/time or create exercise/rehabilitation/prevention instructions.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.
Reason for missing information: Original actual training, adherence/stopping, support/contact and phase-specific exposure. No certification of identical effects for other durations/intensities.
Required materials and conditions: Original eight weeks, three times weekly, up to 30 minutes
Materials to obtain first: Original actual training, adherence/stopping, support/contact and phase-specific exposure. No certification of identical effects for other durations/intensities.
Further research: Materials needed: Original actual training, adherence/stopping, support/contact and phase-specific exposure. No certification of identical effects for other durations/intensities. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for original eight weeks, three times weekly, up to 30 minutes together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Why this condition is needed: Needed to connect original eight weeks, three times weekly, up to 30 minutes with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N06 · Are eight-week training and one-year outcomes separated?

Current findings: Intervention lasted eight weeks and same-ankle recurrence follow-up lasted 12 months. Maintenance training after completion, follow-up exposure/stopping and visit-specific observation remain unverified in detail. Training and event-observation periods do not become the same denominator.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.
Reason for missing information: Original actual training/maintenance, follow-up schedules, observation duration/loss and sports exposure. Do not calculate new day counts/exercise amounts from one year.
Required materials and conditions: Intervention duration versus 12-month recurrence follow-up
Materials to obtain first: Original actual training/maintenance, follow-up schedules, observation duration/loss and sports exposure. Do not calculate new day counts/exercise amounts from one year.
Further research: Materials needed: Original actual training/maintenance, follow-up schedules, observation duration/loss and sports exposure. Do not calculate new day counts/exercise amounts from one year. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for intervention duration versus 12-month recurrence follow-up together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Why this condition is needed: Needed to connect intervention duration versus 12-month recurrence follow-up with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N07 · What are randomization and recurrence numerators?

Current findings: The original records 522 randomized (256/266) and 56/256 (22%) versus 89/266 (33%). Separately retain relationships among people, ankles, recurrence events, repeated reports and time; do not calculate additional event/participant totals.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.
Reason for missing information: Endpoint-numerator definitions, arm analysis/follow-up/observed denominators, repeated-recurrence handling and original flow tables. Do not copy numerators/denominators to all other endpoints/trials.
Required materials and conditions: 522 participants, 256/266, original recurrence 56/89
Materials to obtain first: Endpoint-numerator definitions, arm analysis/follow-up/observed denominators, repeated-recurrence handling and original flow tables. Do not copy numerators/denominators to all other endpoints/trials.
Further research: Materials needed: Endpoint-numerator definitions, arm analysis/follow-up/observed denominators, repeated-recurrence handling and original flow tables. Do not copy numerators/denominators to all other endpoints/trials. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for 522 participants, 256/266, original recurrence 56/89 together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Why this condition is needed: Needed to connect 522 participants, 256/266, original recurrence 56/89 with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N08 · How was same-ankle recurrence defined?

Current findings: The original endpoint was same-ankle recurrence reported monthly and independently adjudicated under masking. Diagnostic/injury/recurrence criteria, first/all-repeated-event handling and clinical-confirmation details remain unverified. Do not extend to the opposite ankle/all injuries.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.
Reason for missing information: Event definitions, original questionnaires, adjudication rules, repeated/contralateral events, severity and confirmation data. Materials clarifying aggregation of original numerators 56/89.
Required materials and conditions: Original event label, first/repeated events and confirmation
Materials to obtain first: Event definitions, original questionnaires, adjudication rules, repeated/contralateral events, severity and confirmation data. Materials clarifying aggregation of original numerators 56/89.
Further research: Materials needed: Event definitions, original questionnaires, adjudication rules, repeated/contralateral events, severity and confirmation data. Materials clarifying aggregation of original numerators 56/89. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for original event label, first/repeated events and confirmation together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Why this condition is needed: Needed to connect original event label, first/repeated events and confirmation with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N09 · Are self-reporting and masked adjudication separated?

Current findings: The original records monthly self-reports followed by independent adjudication by a masked physiotherapist and researcher. Initial reporting was self-reported and participant masking impossible. Do not add a declaration that all reports were confirmed through testing/clinical visits.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.
Reason for missing information: Original reporting/missingness, disagreement/adjudication, assessor masking, objective confirmation and participant expectations. No formal RoB assessment in this production.
Required materials and conditions: Initial monthly reporting versus independent physiotherapist/researcher adjudication
Materials to obtain first: Original reporting/missingness, disagreement/adjudication, assessor masking, objective confirmation and participant expectations. No formal RoB assessment in this production.
Further research: Materials needed: Original reporting/missingness, disagreement/adjudication, assessor masking, objective confirmation and participant expectations. No formal RoB assessment in this production. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for initial monthly reporting versus independent physiotherapist/researcher adjudication together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Why this condition is needed: Needed to connect initial monthly reporting versus independent physiotherapist/researcher adjudication with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N10 · Are recurrent people, repeated events and observations separated?

Current findings: Preserve original 56/256, 89/266 and monthly reporting. Exact aggregation of at-least-one recurrence, first/all-repeated events and same-person bilateral-ankle/report relationships remains unverified. Monthly/repeated events are not new independent participants.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.
Reason for missing information: Original event aggregation, person/ankle identifiers, repeat handling, analysis units and observation periods. No additional participant/event counts or new incidence-rate calculations.
Required materials and conditions: Original numerators and people/ankle/event units
Materials to obtain first: Original event aggregation, person/ankle identifiers, repeat handling, analysis units and observation periods. No additional participant/event counts or new incidence-rate calculations.
Further research: Materials needed: Original event aggregation, person/ankle identifiers, repeat handling, analysis units and observation periods. No additional participant/event counts or new incidence-rate calculations. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for original numerators and people/ankle/event units together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Why this condition is needed: Needed to connect original numerators and people/ankle/event units with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N11 · Which comparison do adjusted RR/CI/NNT describe?

Current findings: Original adjusted RR 0.63 (95% CI 0.45–0.88) and NNT 9 concern 2BFit same-ankle recurrence over one year. Do not copy to app/bracing or time-loss/cost endpoints. Original adjusted-model/estimand details remain unverified.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.
Reason for missing information: Original models/adjustment variables, effects/CI, NNT definition/denominators and estimands. No new RR/RRR/NNT/CI recalculation or invented examples.
Required materials and conditions: 2BFit one-year recurrence effects
Materials to obtain first: Original models/adjustment variables, effects/CI, NNT definition/denominators and estimands. No new RR/RRR/NNT/CI recalculation or invented examples.
Further research: Materials needed: Original models/adjustment variables, effects/CI, NNT definition/denominators and estimands. No new RR/RRR/NNT/CI recalculation or invented examples. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for 2BFit one-year recurrence effects together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Why this condition is needed: Needed to connect 2BFit one-year recurrence effects with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N12 · Are original absolute difference and arm percentages distinguished?

Current findings: The original crux/rationale records 22% versus 33% and absolute recurrence difference −11 percentage points. Do not transfer to within-arm improvement, relative effects, other ankles/apps or calculate exact unrounded values/new absolute differences.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.
Reason for missing information: Original arm denominators/rounding, effect definitions, adjusted/unadjusted results and duration/analysis data. Do not newly convert RR and absolute differences into one another.
Required materials and conditions: 22% versus 33% and original −11 percentage points
Materials to obtain first: Original arm denominators/rounding, effect definitions, adjusted/unadjusted results and duration/analysis data. Do not newly convert RR and absolute differences into one another.
Further research: Materials needed: Original arm denominators/rounding, effect definitions, adjusted/unadjusted results and duration/analysis data. Do not newly convert RR and absolute differences into one another. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for 22% versus 33% and original −11 percentage points together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Why this condition is needed: Needed to connect 22% versus 33% and original −11 percentage points with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N13 · Are exposure-time incidence density and one-year risk identical?

Current findings: Original study facts record incidence density 1.86 versus 2.90 per 1,000 ankle-exposure hours. These differ in units from 22% versus 33% with person denominators. Do not calculate actual total exposure hours, new event counts/incidence-density ratios.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.
Reason for missing information: Actual arm sports exposure, recording/missingness, incidence-density numerators/denominators and models/CI. Distinguish time, people and ankle units.
Required materials and conditions: 1.86 versus 2.90 per 1,000 hours
Materials to obtain first: Actual arm sports exposure, recording/missingness, incidence-density numerators/denominators and models/CI. Distinguish time, people and ankle units.
Further research: Materials needed: Actual arm sports exposure, recording/missingness, incidence-density numerators/denominators and models/CI. Distinguish time, people and ankle units. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for 1.86 versus 2.90 per 1,000 hours together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Why this condition is needed: Needed to connect 1.86 versus 2.90 per 1,000 hours with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N14 · Are time-loss and cost/productivity outcomes retained separately?

Current findings: The original rationale records time-loss recurrence RR 0.53 and medical-cost/productivity-loss recurrence RR 0.25 in the same direction. Definitions, numerators/denominators, CI/times/models remain unverified in detail. Do not copy primary RR 0.63/CI or NNT 9.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.
Reason for missing information: Original endpoint tables, event/cost definitions, denominators, effects/CI and hierarchy/multiplicity. No new calculations/addition beyond original numbers.
Required materials and conditions: Other recurrence outcomes, RR 0.53 and 0.25
Materials to obtain first: Original endpoint tables, event/cost definitions, denominators, effects/CI and hierarchy/multiplicity. No new calculations/addition beyond original numbers.
Further research: Materials needed: Original endpoint tables, event/cost definitions, denominators, effects/CI and hierarchy/multiplicity. No new calculations/addition beyond original numbers. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for other recurrence outcomes, RR 0.53 and 0.25 together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Why this condition is needed: Needed to connect other recurrence outcomes, RR 0.53 and 0.25 with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N15 · Are adherence, comparator contamination and attrition retained together?

Current findings: Preserve original full adherence 58/256 (23%), comparator contamination 5/266 (2%) and follow-up attrition 14%. Adherence definition, partial adherence and arm-specific loss/reasons remain unverified in detail. No adherer effects, new adherence differences/attrition counts/rates.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.
Reason for missing information: Adherence measurement, actual exposure, contamination/concurrent training, arm withdrawal/missingness and sensitivity analyses. Low adherence does not newly establish delivery effects/causality.
Required materials and conditions: 58/25623%·5/2662%·14%
Materials to obtain first: Adherence measurement, actual exposure, contamination/concurrent training, arm withdrawal/missingness and sensitivity analyses. Low adherence does not newly establish delivery effects/causality.
Further research: Materials needed: Adherence measurement, actual exposure, contamination/concurrent training, arm withdrawal/missingness and sensitivity analyses. Low adherence does not newly establish delivery effects/causality. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for 58/256 (23%), 5/266 (2%) and 14% together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Why this condition is needed: Needed to connect 58/256 (23%), 5/266 (2%) and 14% with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N16 · Does ITT certify resolution of completeness/missingness?

Current findings: The original study description records all analyses following ITT principles alongside 14% attrition. ITT is not converted into universal completion/all-endpoint observation or zero missingness bias. Original B0 is parent-verdict context.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.
Reason for missing information: Original arm flow, endpoint analysis/observation, missingness handling/assumptions, follow-up loss and sensitivity. No clinical calculations/formal risk assessment in this production.
Required materials and conditions: Analysis as randomized and actual missingness handling
Materials to obtain first: Original arm flow, endpoint analysis/observation, missingness handling/assumptions, follow-up loss and sensitivity. No clinical calculations/formal risk assessment in this production.
Further research: Materials needed: Original arm flow, endpoint analysis/observation, missingness handling/assumptions, follow-up loss and sensitivity. No clinical calculations/formal risk assessment in this production. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for analysis as randomized and actual missingness handling together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Why this condition is needed: Needed to connect analysis as randomized and actual missingness handling with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N17 · Are original randomization/prespecified-endpoint descriptions preserved?

Current findings: The original records independent-researcher computer allocation, impossible participant masking/masked adjudication, ITT, and matching prespecified self-reported recurrence primary endpoint/ISRCTN34177180. Preserve original quotations/history only; no plan/procedure comparison now.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.
Reason for missing information: Allocation concealment/implementation, plans/amendments, registration versions/public dates and original-report comparison. The unestablished first registration publication date does not newly establish prospective registration.
Required materials and conditions: Independent-researcher computer allocation and recurrence primary endpoint/registration
Materials to obtain first: Allocation concealment/implementation, plans/amendments, registration versions/public dates and original-report comparison. The unestablished first registration publication date does not newly establish prospective registration.
Further research: Materials needed: Allocation concealment/implementation, plans/amendments, registration versions/public dates and original-report comparison. The unestablished first registration publication date does not newly establish prospective registration. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for independent-researcher computer allocation and recurrence primary endpoint/registration together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Why this condition is needed: Needed to connect independent-researcher computer allocation and recurrence primary endpoint/registration with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N18 · Are 2023 app results mixed with 2BFit?

Current findings: The original counterview records a primary-care app trial with 165 participants, null HR 1.14 (0.59–2.21), adherence 6.1%. Preserve the original scope that delivery differed from 2BFit supplying a board/DVD and was not counted as direct conflict. Citation/design details remain unidentified.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.
Reason for missing information: Exact app citations/registration, population/comparator/duration, endpoints/denominators/exposure/adherence, models and direct comparisons. Do not substitute app HR for board RR or effects of all apps.
Required materials and conditions: Different-delivery trial, 165 participants, HR 1.14
Materials to obtain first: Exact app citations/registration, population/comparator/duration, endpoints/denominators/exposure/adherence, models and direct comparisons. Do not substitute app HR for board RR or effects of all apps.
Further research: Materials needed: Exact app citations/registration, population/comparator/duration, endpoints/denominators/exposure/adherence, models and direct comparisons. Do not substitute app HR for board RR or effects of all apps. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for different-delivery trial, 165 participants, HR 1.14 together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Why this condition is needed: Needed to connect different-delivery trial, 165 participants, HR 1.14 with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01 R02

N19 · Are different bracing-trial/review results separated?

Current findings: The original records 12-month bracing superior to eight-week training in the 2014 trial and no 12-month recurrence difference between training/bracing in a 2017 review. Populations, citations, denominators, effects and CI for both contexts remain unverified; no difference does not become equivalence.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.
Reason for missing information: Each citation, original trials/review-included studies/overlap, exact comparators/durations and effects/CI/denominators. Do not count different research as new pooled effects/unique trial totals.
Required materials and conditions: 2014 bracing superiority and no difference in 2017
Materials to obtain first: Each citation, original trials/review-included studies/overlap, exact comparators/durations and effects/CI/denominators. Do not count different research as new pooled effects/unique trial totals.
Further research: Materials needed: Each citation, original trials/review-included studies/overlap, exact comparators/durations and effects/CI/denominators. Do not count different research as new pooled effects/unique trial totals. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for 2014 bracing superiority and no difference in 2017 together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Why this condition is needed: Needed to connect 2014 bracing superiority and no difference in 2017 with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R03 R04

N20 · Is the separate exercise-harm reporting gap retained?

Current findings: The original safety description records that exercise-related adverse events were not collected/reported in a separate table and this trial cannot establish harmlessness. Preserve this reporting limitation; do not extend to zero AE or long-term safety.
Verification status: Unverified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.
Reason for missing information: Harm collection/definitions, arm actual training/exposure, events/discontinuation/relatedness/denominators and long-term data. No exercise/rehabilitation/recurrence-prevention instructions.
Required materials and conditions: Exercise-related AE collection/reporting versus harmlessness
Materials to obtain first: Harm collection/definitions, arm actual training/exposure, events/discontinuation/relatedness/denominators and long-term data. No exercise/rehabilitation/recurrence-prevention instructions.
Further research: Materials needed: Harm collection/definitions, arm actual training/exposure, events/discontinuation/relatedness/denominators and long-term data. No exercise/rehabilitation/recurrence-prevention instructions. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for exercise-related AE collection/reporting versus harmlessness together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Why this condition is needed: Needed to connect exercise-related AE collection/reporting versus harmlessness with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N21 · What was actually read/identified?

Current findings: The complete preserved parent summary was read for production and retained in the original archive. The single citation identifies 2BFit; three app/bracing/review entries are unidentified counterview contexts. All external abstracts/full texts/registration/plans remain unread.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.
Reason for missing information: Exact report citations/originals, acquisition/reading scope, versions/dates. URLs/historical quotations are not upgraded to current reading; no external-link/access testing.
Required materials and conditions: Preserved summary/original citation versus unidentified reference contexts
Materials to obtain first: Exact report citations/originals, acquisition/reading scope, versions/dates. URLs/historical quotations are not upgraded to current reading; no external-link/access testing.
Further research: Materials needed: Exact report citations/originals, acquisition/reading scope, versions/dates. URLs/historical quotations are not upgraded to current reading; no external-link/access testing. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for preserved summary/original citation versus unidentified reference contexts together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Why this condition is needed: Needed to connect preserved summary/original citation versus unidentified reference contexts with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01 R02 R03 R04

N22 · Are registration dates/prespecification treated as current certification?

Current findings: Original evidence/Korean text describes matching ISRCTN34177180 with the self-reported recurrence primary endpoint. Original study facts say the first registration public date was unestablished, so prospective registration was not asserted. App/bracing/review registrations are unidentified.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.
Reason for missing information: Actual registration versions/publication, start/amendment timing and endpoints/plans. No guessed official URLs, new registration reading or prespecification certification.
Required materials and conditions: ISRCTN34177180 and unestablished first public date
Materials to obtain first: Actual registration versions/publication, start/amendment timing and endpoints/plans. No guessed official URLs, new registration reading or prespecification certification.
Further research: Materials needed: Actual registration versions/publication, start/amendment timing and endpoints/plans. No guessed official URLs, new registration reading or prespecification certification. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for iSRCTN34177180 and unestablished first public date together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Why this condition is needed: Needed to connect iSRCTN34177180 and unestablished first public date with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01 R02 R03 R04

N23 · Were protocol/SAP and estimand/missingness plans acquired?

Current findings: Preserve original primary/ITT/allocation/adjudication descriptions and historical cross-checking. Each trial’s protocol/SAP, versions/timing and missingness/multiplicity/analysis plans were not acquired/read now.
Verification status: Unverified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.
Reason for missing information: Original protocols/SAP, amendment histories, endpoints/models/people/events/exposure, missingness/sensitivity and public timing. Unread external materials do not establish document absence.
Required materials and conditions: Separate prespecified-plan/analysis/amendment materials
Materials to obtain first: Original protocols/SAP, amendment histories, endpoints/models/people/events/exposure, missingness/sensitivity and public timing. Unread external materials do not establish document absence.
Further research: Materials needed: Original protocols/SAP, amendment histories, endpoints/models/people/events/exposure, missingness/sensitivity and public timing. Unread external materials do not establish document absence. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for separate prespecified-plan/analysis/amendment materials together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Why this condition is needed: Needed to connect separate prespecified-plan/analysis/amendment materials with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01 R02 R03 R04

N24 · Are public funding, board supply and company involvement separated?

Current findings: 2BFit had ZonMw grant 750-20-002, declarations of no financial benefit/competing interests and Avanco AB boards supplied to participants. Preserve the original limitation that manufacturer donation/funding/analysis/writing/publication support was not reported. Supply is not manufacturer donation; employee authors/roles and app/bracing/review funding remain unverified now.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.
Reason for missing information: Item-specific company funding, product support, employee authors, design/analysis/data control and other support for each study. I2 does not establish absence of every item or independence certification.
Required materials and conditions: 2BFit support versus unverified other contexts
Materials to obtain first: Item-specific company funding, product support, employee authors, design/analysis/data control and other support for each study. I2 does not establish absence of every item or independence certification.
Further research: Materials needed: Item-specific company funding, product support, employee authors, design/analysis/data control and other support for each study. I2 does not establish absence of every item or independence certification. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for 2BFit support versus unverified other contexts together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Why this condition is needed: Needed to connect 2BFit support versus unverified other contexts with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01 R02 R03 R04

N25 · Are specific positive effects, different-delivery null results and unverified details distinguished?

Current findings: Positive 2BFit recurrence, null 2023 app HR, 2014 bracing superiority and no difference in the 2017 review concern different contexts. Separate original descriptions from unverified citation/effect/harm details; no new verdict on broad claims.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.
Reason for missing information: Report-specific direct populations/interventions/comparators, endpoints/durations, effects/CI/denominators and actual access. Unread does not mean unreported; null does not mean zero effect/equivalence.
Required materials and conditions: Question/comparison-specific results and reading status
Materials to obtain first: Report-specific direct populations/interventions/comparators, endpoints/durations, effects/CI/denominators and actual access. Unread does not mean unreported; null does not mean zero effect/equivalence.
Further research: Materials needed: Report-specific direct populations/interventions/comparators, endpoints/durations, effects/CI/denominators and actual access. Unread does not mean unreported; null does not mean zero effect/equivalence. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for question/comparison-specific results and reading status together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Why this condition is needed: Needed to connect question/comparison-specific results and reading status with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01 R02 R03 R04

N26 · Are one original citation and three reference contexts counted as unique trials?

Current findings: Parent 2975 and its s0/s1 claims share original 2BFit citation/trial context and counterview mentions of the 2023 app, 2014 bracing and 2017 review. The same people, ankles, arms, events, times, citations, related sheets and review-included trials are not newly added as independent trials/participants. Four links comprise one identified paper and three unidentified contexts, including a 2017 review; they are not certification of four unique clinical trials or participant totals.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.
Reason for missing information: Citations/registration, review-included reports/overlap, cohorts/analysis, endpoints/repetition relationships. Unique trial/participant totals remain unrecorded.
Required materials and conditions: Document/context items versus trials/participants
Materials to obtain first: Citations/registration, review-included reports/overlap, cohorts/analysis, endpoints/repetition relationships. Unique trial/participant totals remain unrecorded.
Further research: Materials needed: Citations/registration, review-included reports/overlap, cohorts/analysis, endpoints/repetition relationships. Unique trial/participant totals remain unrecorded. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for document/context items versus trials/participants together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Why this condition is needed: Needed to connect document/context items versus trials/participants with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01 R02 R03 R04

N27 · Are original single confirmation and independent replication distinguished?

Current findings: Preserve parent replication R1/independence I2 and the original single confirmatory-trial description. App/bracing/review contexts are not counted as new same-condition independent replication/conflicts or unique-trial certification.
Verification status: Unverified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.
Reason for missing information: Separate prespecified, direct population/delivery/comparator/events, effects/CI/denominators, funding/author relationships and overlap materials for the selected question. No search/independence determination now.
Required materials and conditions: Parent R1/I2 and comparison/delivery differences
Materials to obtain first: Separate prespecified, direct population/delivery/comparator/events, effects/CI/denominators, funding/author relationships and overlap materials for the selected question. No search/independence determination now.
Further research: Materials needed: Separate prespecified, direct population/delivery/comparator/events, effects/CI/denominators, funding/author relationships and overlap materials for the selected question. No search/independence determination now. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for parent R1/I2 and comparison/delivery differences together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Why this condition is needed: Needed to connect parent R1/I2 and comparison/delivery differences with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01 R02 R03 R04

N28 · Are the subclaim grade and parent score/axes preserved?

Current findings: Preserve selected subclaim B/note/bilingual claims; absent subclaim score/status/axes remain unrecorded. Parent B with 76 points, unknown safety, B/H/R1/I2/E+/B0, unrecorded precision and true large-hard-endpoint RCT are parent context and do not fill subclaim values.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.
Reason for missing information: User subclaim/parent-boundary review and actual correction materials. No new score/grade or official RoB 2/GRADE certification.
Required materials and conditions: Selected B, absent subclaim values and parent B76
Materials to obtain first: User subclaim/parent-boundary review and actual correction materials. No new score/grade or official RoB 2/GRADE certification.
Further research: Materials needed: User subclaim/parent-boundary review and actual correction materials. No new score/grade or official RoB 2/GRADE certification. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for selected B, absent subclaim values and parent B76 together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Why this condition is needed: Needed to connect selected B, absent subclaim values and parent B76 with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N29 · Are both languages, citations and absent fields preserved?

Current findings: Preserve original parent bilingual quotations/descriptions, evidence, citations and axes and selected-subclaim values in the complete original archive. Classification fields are absent and no new original fields are filled. No English-paper comparison now.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.
Reason for missing information: User review of languages/terminology, event/exposure units, absences and selected scope. Distinguish production descriptions from original values.
Required materials and conditions: Both original languages and absent separate classification information
Materials to obtain first: User review of languages/terminology, event/exposure units, absences and selected scope. Distinguish production descriptions from original values.
Further research: Materials needed: User review of languages/terminology, event/exposure units, absences and selected scope. Distinguish production descriptions from original values. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for original bilingual text and absent classification fields together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Why this condition is needed: Needed to connect original bilingual text and absent classification fields with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N30 · Are source dates/corrections/history separated from production dates?

Current findings: Preserve original evidence date 2026-08-26, empty corrections/deliberation and verdict-decision cross-checking. Historical quotations/registration matching differ from current production, condition freezing/application and completed content review.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.
Reason for missing information: Update materials separating originals, events, conditions/observations and verdict decisions when new evidence/corrections arise. Historical wording is not completed clinical content review here.
Required materials and conditions: Original 2026-08-26 and new conditions/application
Materials to obtain first: Update materials separating originals, events, conditions/observations and verdict decisions when new evidence/corrections arise. Historical wording is not completed clinical content review here.
Further research: Materials needed: Update materials separating originals, events, conditions/observations and verdict decisions when new evidence/corrections arise. Historical wording is not completed clinical content review here. Only material requests/research needs are recorded; no search or research was performed in that production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for original 2026-08-26 versus new conditions/application together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Why this condition is needed: Needed to connect original 2026-08-26 versus new conditions/application with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N31 · What direct materials would fill the selected gaps?

Current findings: Specific 2BFit event/exposure, adherence/attrition, harms/reporting details require originals; app/bracing mentions do not substitute as identical effects.
Verification status: Unverified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.
Reason for missing information: Question-specific tables/plans, direct comparisons/applicability, effects/CI, people/ankle/event/exposure denominators, missingness/adherence, separate confirmation and long-term harms. Need recorded only; no search/research now.
Required materials and conditions: Direct population/delivery/events, effects/CI and denominators
Materials to obtain first: Question-specific tables/plans, direct comparisons/applicability, effects/CI, people/ankle/event/exposure denominators, missingness/adherence, separate confirmation and long-term harms. Need recorded only; no search/research now.
Further research: Materials needed: Question-specific tables/plans, direct comparisons/applicability, effects/CI, people/ankle/event/exposure denominators, missingness/adherence, separate confirmation and long-term harms. Need recorded only; no search/research now. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for direct population/delivery/events, effects/CI and denominators together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Why this condition is needed: Needed to connect direct population/delivery/events, effects/CI and denominators with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01 R02 R03 R04

N32 · Are applicability records separated from content review and instructions?

Current findings: These are summary-based applicability records. Existing content/question-boundary review remains incomplete; candidate pending/eligible markers are preserved as history.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, identified reports/reference contexts and comparison/endpoint materials in the preserved summary. Detailed originals remain unverified and existing content review incomplete; this does not establish passed review/clinical certification.
Reason for missing information: Content review and subsequent actual evidence/correction work. Original content-production scope excludes clinical QA/testing, external-link/access/web/API research, new calculations/grades and device/app recommendations or exercise/rehabilitation/prevention/treatment-replacement instructions.
Required materials and conditions: Applicability records, existing candidate history and content review
Materials to obtain first: Content review and subsequent actual evidence/correction work. Original content-production scope excludes clinical QA/testing, external-link/access/web/API research, new calculations/grades and device/app recommendations or exercise/rehabilitation/prevention/treatment-replacement instructions.
Further research: Materials needed: Content review and subsequent actual evidence/correction work. Original content-production scope excludes clinical QA/testing, external-link/access/web/API research, new calculations/grades and device/app recommendations or exercise/rehabilitation/prevention/treatment-replacement instructions. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for production request, candidate history and content review together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Why this condition is needed: Needed to connect production request, candidate history and content review with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01