App-based ankle exercise × Recurrence prevention — Delivery differences from balance boards and gaps in direct applicability

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 existing all-app claim is being transferred?Required	The selected claim concerns recurrence prevention by any app-based ankle exercise. Its original subclaim grade is D; the note concerns the null 2023 trial with a different delivery method. Missing subclaim scores/status/axes are distinguished from the parent balance-board score of B with 76 points. There is no reassessment that every app has exactly zero effect. 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.	The broad wording, subclaim grade and parent B grade	Materials needed: Definitions of the app/training/population/comparator, recurrence endpoint and duration, plus review of the claim boundary. Parent scores/effects are not transferred to the subclaim. Only requests/material needs are recorded; no search or research is performed in this work.
2	Unverified	Full text not readStored summary read	N02 · Evidence conditionDoes direct evidence cover every app?Required	The original advertising interpretation explains that this does not mean every ankle-exercise app prevents recurrence: the result is limited to the eight-week program providing a balance board, sheets, DVD and web materials. Direct evidence accounting for differences in all apps/programs, their content, exposure and support remains 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.	Applicability of delivery, content and support	Materials needed: App identity/version, content/support, actual exposure, population/comparator/endpoint and direct comparisons/applicability. No app/device recommendations or training instructions. Only requests/material needs are recorded; no search or research is performed in this work.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionWas 2BFit a trial of an app alone?Required	2BFit used eight weeks of home neuromuscular training with a balance board, sheets, DVD and web materials after usual care. Including web materials does not newly define the trial as testing an app alone, every app or the board alone. 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.	The specific combined delivery program and its components	Materials needed: Components/exposure, support/contact, adherence and direct comparisons with apps/other delivery methods. No certification separating the effects of individual components in the combined program. Only requests/material needs are recorded; no search or research is performed in this work.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionHow much is known about the population and identity of the 2023 app trial?Required	The original counterview records a 2023 primary-care app trial in 165 people. Formal bibliography/registration, app name/version, previous sprains/age, eligibility, actual intervention/comparator and duration are not detailed. The 2BFit information on 522 athletes aged 12 to 70 is not copied to the app trial. 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.	Primary-care trial in 165 people and an unidentified report	Materials needed: Exact paper/registration, app/population/intervention/comparator/duration and endpoint/denominator materials. Unread external materials or unidentified bibliography are not changed into absence of research. Only requests/material needs are recorded; no search or research is performed in this work.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionAre the app HR and balance-board RR distinguished?Required	The original app result is described as null, HR 1.14 (0.59 to 2.21). This is a different effect measure and trial from 2BFit's adjusted RR 0.63. It is not newly judged to establish zero effect for every app, equivalence, harm or an identical comparison. 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.	App HR 1.14 and CI 0.59 to 2.21	Materials needed: The app estimand, model/adjustment, follow-up/testing, denominators/event counts and original CI/prespecified threshold. No HR/RR conversion or new effect/CI calculation. Only requests/material needs are recorded; no search or research is performed in this work.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionHave app adherence of 6.1% and balance-board adherence of 23% been certified as comparable?Required	Original app adherence of 6.1% and 2BFit full adherence of 58/256 (23%) remain in their respective contexts. Differences in adherence definitions, denominators and measurement are unverified; no causal conclusion that low adherence caused the null result or a new adherence difference is created. 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.	Adherence in different programs	Materials needed: Adherence definitions in both studies, actual exposure, aggregation/missingness, support, direct comparisons and analysis. No new adherer effects, differences or rates. Only requests/material needs are recorded; no search or research is performed in this work.
7	Unverified	Full text not readStored summary read	N07 · Evidence conditionAre the app's actual comparator and concomitant care known?Required	The app trial is described only as primary care/another delivery method in the original summary. Comparator identity, concomitant care/contamination and exposure remain unverified. 2BFit's usual-care comparator or the bracing comparison is not automatically used as the app comparator. 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.	The unverified app comparator and usual-care comparator	Materials needed: The actual app comparator, concomitant care/training, contact/expectations, contamination and recovery/sports exposure. Different comparisons are not combined. Only requests/material needs are recorded; no search or research is performed in this work.
8	Unverified	Full text not readStored summary read	N08 · Evidence conditionAre the app recurrence endpoint and prespecified hierarchy verified?Required	The original app HR is described as null, but details of recurrence definitions, same/other ankle, first/repeated events, confirmation and prespecified endpoints are absent. 2BFit's monthly reporting, independent adjudication and primary-endpoint definition are not copied to the app trial. 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.	Exact app events and primary/secondary plans	Materials needed: Original app endpoints, registration/SAP, event counting, adjudication/measurement, prespecified hierarchy and all results. Unverified details are not all declared unmeasured. Only requests/material needs are recorded; no search or research is performed in this work.
9	Unverified	Full text not readStored summary read	N09 · Evidence conditionAre app duration and 2BFit's eight weeks/12 months kept separate?Required	2BFit used an eight-week program with 12-month follow-up; the original app reference does not provide exact intervention/follow-up duration. Those periods or three sessions weekly/up to 30 minutes are not transferred as app-trial exposure. 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.	Gaps in applying intervention and follow-up time points	Materials needed: Actual app duration/exposure/adherence, observation/attrition, time-specific results and comparability. No new day counts/total dose or exercise instructions. Only requests/material needs are recorded; no search or research is performed in this work.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionHas the positive balance-board result been transferred to every app?Required	Original 2BFit results of 56/256 versus 89/266, adjusted RR 0.63 (CI 0.45 to 0.88), NNT 9 and original −11 percentage points are limited to the specific balance-board delivery program. They are not copied as values for the app HR or prevention by every app. 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.	Limits of 2BFit's one-year 22% versus 33%, RR and NNT	Materials needed: Direct app/board comparisons, population/intervention/comparator, events/duration and effect/CI/denominator materials. No new pooled effects or product/treatment recommendations. Only requests/material needs are recorded; no search or research is performed in this work.
11	Unverified	Full text not readStored summary read	N11 · Evidence conditionAre 165 app participants kept separate from events and denominators?Required	The original app count of 165 people is recorded; group allocation/completion/analysis, recurrence events/observation and attrition are not detailed. The board trial's 256/266, 56/89 and 14% attrition are not copied to the app, and new group-specific app numbers are not divided out. 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.	App participant count and unverified events by group	Materials needed: The app flow diagram, event/observation/analysis denominators, people/ankles/repetition/exposure time and missing-data materials. No new group denominators or participant totals. Only requests/material needs are recorded; no search or research is performed in this work.
12	Unverified	Full text not readStored summary read	N12 · Evidence conditionAre the direct effects of delivery separated from content and adherence?Required	The original materials explain that supplying a balance board/DVD differs from app delivery in primary care. Direct evidence separating which content, support, population/exposure or adherence component produced the difference is absent. Causes or superiority attributable only to app delivery are not newly established. 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.	Comparison gaps between combined support and app delivery	Materials needed: Direct comparisons matching content/exposure, support/contact/adherence, population/comparator and results/denominators. No app/device selection or exercise instructions. Only requests/material needs are recorded; no search or research is performed in this work.
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionHas the 2014 bracing superiority result been transferred to app effects?Required	The original 2014 reference compares 12-month bracing, described as superior, with eight-week training. Bibliography, population/denominators, exact effects/CI and events/exposure are unverified. This is not substituted for the app comparator, app effect or the effect of all exercise. R03	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.	Twelve-month bracing versus eight-week training	Materials needed: The original 2014 report, registration, actual bracing/training, duration/adherence and event/denominator/effect/CI materials. No brace/device recommendations or treatment instructions. Only requests/material needs are recorded; no search or research is performed in this work.
14	Unverified	Full text not readStored summary read	N14 · Evidence conditionHas no difference in the 2017 review been expressed as equivalence?Required	The original 2017 review reference says no difference in 12-month recurrence rates was found between training and bracing. Included trials/overlap, effects/CI, heterogeneity and precise formulation/delivery are absent. This is not changed into equivalence, effects of every app or certification of independent trial counts. 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.	Review of 12-month recurrence rates with training/bracing	Materials needed: Review bibliography/methods, included reports/trials, overlap, direct comparisons/duration and effects/CI. No new pooled effect/CI or unique-trial-count calculation. Only requests/material needs are recorded; no search or research is performed in this work.
15	Unverified	Full text not readStored summary read	N15 · Evidence conditionHave ascertainment procedures been automatically transferred to the app trial?Required	2BFit used monthly self-report followed by adjudication by a masked physiotherapist/researcher. App reporting, confirmation and masking are not detailed in the original reference. The shared word recurrence does not certify identical measurement accuracy. 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.	2BFit self-report/masked adjudication and unverified app procedures	Materials needed: App event reporting/omissions, independent adjudication, examination/clinical confirmation, masking, expectations and original materials. No formal RoB assessment or grade change. Only requests/material needs are recorded; no search or research is performed in this work.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionHave different trials been newly counted as direct conflict or independent replication?Required	The original counterview did not count the app trial as direct conflict with 2BFit because delivery differed. That original boundary remains; a single bibliography, unidentified contexts and studies included in a review are not newly certified as independent replications. 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.	Original delivery differences and applicability of comparisons	Materials needed: Same/different cohorts, population/intervention/comparator/events, independence/overlap and direct comparability for each report. No new reassessment or independence calculation. Only requests/material needs are recorded; no search or research is performed in this work.
17	Unverified	Full text not readStored summary read	N17 · Evidence conditionHas recurrence prevention by every app been extended to broader populations?Required	The parent record concerns one-year recurrence in previously injured athletes using a specific program. It is not extended to every app, the general population, another ankle, first injuries or prevention across all periods. The original app population/comparison/time are not detailed. 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 gaps by program, population and duration	Materials needed: Direct population/intervention/comparator, recurrence/first injury, duration and denominator/effect/CI materials for each applicability question. No rehabilitation/prevention/treatment-replacement instructions. Only requests/material needs are recorded; no search or research is performed in this work.
18	Partly verified	Full text not readStored summary read	N18 · Evidence conditionHas a new method to solve low adherence been created?Supplementary	Original adherence of 23% and app adherence of 6.1% are reports in their own contexts. This records material gaps without creating a specific app choice, encouragement/exercise method, device/rehabilitation/recurrence-prevention or treatment-replacement plan. 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.	Distinguishing research exposure/delivery gaps from instructions	Materials needed: Materials explaining actual exposure/support, adherence measurement, deviations/contamination and direct effects. Distinguish subsequent material work after content review from authority to provide practical instructions. Only requests/material needs are recorded; no search or research is performed in this work.
19	Unverified	Full text not readStored summary read	N19 · Harm-information gaps supplementing the efficacy tableIs the safety of apps or other delivery methods known?Supplementary	2BFit has gaps in separate collection/reporting of exercise AE tables; app/bracing/review references lack detailed harms. The board trial's reporting limits are not copied as facts from the app report, and harmlessness or harmfulness of every app is not newly asserted. 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.	Study-specific harm collection, exposure and denominators	Materials needed: Study-specific AE/discontinuation, actual exposure, events/denominators/attribution and long-term/rare-harm materials. No device/app recommendations or exercise/rehabilitation/prevention instructions. Only requests/material needs are recorded; no search or research is performed in this work.
20	Partly verified	Full text not readStored summary read	N20 · 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.
21	Partly verified	Full text not readStored summary read	N21 · 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.
22	Unverified	Full text not readStored summary read	N22 · 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.
23	Partly verified	Full text not readStored summary read	N23 · 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.
24	Partly verified	Full text not readStored summary read	N24 · 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.
25	Partly verified	Full text not readStored summary read	N25 · 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.
26	Unverified	Full text not readStored summary read	N26 · 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.
27	Partly verified	Full text not readStored summary read	N27 · Evidence conditionAre the subclaim grade and parent score/axes preserved?Required	The selected subclaim's D grade, note and bilingual question are preserved; absent subclaim scores/status/axes remain unrecorded. Parent B with 76 points, unknown safety, B/H/R1/I2/E+/B0, unrecorded precision and the true big-hard-RCT indicator remain 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 D grade, missing subclaim values and parent B with 76 points	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.
28	Partly verified	Full text not readStored summary read	N28 · 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.
29	Partly verified	Full text not readStored summary read	N29 · 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.
30	Unverified	Full text not readStored summary read	N30 · Evidence conditionWhat direct materials would fill the selected gaps?Supplementary	The all-app claim requires program-specific direct population/delivery/comparator/event/duration materials and comparability. A positive 2BFit result or one null app result does not create a general conclusion. 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.
31	Partly verified	Full text not readStored summary read	N31 · 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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31 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: Selected claim: recurrence prevention by every app-based ankle exercise; distinguish the null 2023 app HR from specific balance-board effects, bracing and review contexts
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 existing all-app claim is being transferred?

Required materials and conditions: The broad wording, subclaim grade and parent B grade
Conditions for verification: Show original materials for the broad wording, subclaim grade and parent B grade together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 the broad wording, subclaim grade and parent B grade 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 · Does direct evidence cover every app?

Required materials and conditions: Applicability of delivery, content and support
Conditions for verification: Show original materials for applicability of delivery, content and support together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 applicability of delivery, content and support 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 · Was 2BFit a trial of an app alone?

Required materials and conditions: The specific combined delivery program and its components
Conditions for verification: Show original materials for the specific combined delivery program and its components together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 the specific combined delivery program and its components 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 · How much is known about the population and identity of the 2023 app trial?

Required materials and conditions: Primary-care trial in 165 people and an unidentified report
Conditions for verification: Show original materials for primary-care trial in 165 people and an unidentified report together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 primary-care trial in 165 people and an unidentified report 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 the app HR and balance-board RR distinguished?

Required materials and conditions: App HR 1.14 and CI 0.59 to 2.21
Conditions for verification: Show original materials for app HR 1.14 and CI 0.59 to 2.21 together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 app HR 1.14 and CI 0.59 to 2.21 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 · Have app adherence of 6.1% and balance-board adherence of 23% been certified as comparable?

Required materials and conditions: Adherence in different programs
Conditions for verification: Show original materials for adherence in different programs together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 adherence in different programs 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 · Are the app's actual comparator and concomitant care known?

Required materials and conditions: The unverified app comparator and usual-care comparator
Conditions for verification: Show original materials for the unverified app comparator and usual-care comparator together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 the unverified app comparator and usual-care comparator 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 · Are the app recurrence endpoint and prespecified hierarchy verified?

Required materials and conditions: Exact app events and primary/secondary plans
Conditions for verification: Show original materials for exact app events and primary/secondary plans together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 exact app events and primary/secondary plans 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 app duration and 2BFit's eight weeks/12 months kept separate?

Required materials and conditions: Gaps in applying intervention and follow-up time points
Conditions for verification: Show original materials for gaps in applying intervention and follow-up time 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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 gaps in applying intervention and follow-up time 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

N10 · Has the positive balance-board result been transferred to every app?

Required materials and conditions: Limits of 2BFit's one-year 22% versus 33%, RR and NNT
Conditions for verification: Show original materials for limits of 2BFit's one-year 22% versus 33%, RR and NNT together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 limits of 2BFit's one-year 22% versus 33%, RR and NNT 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 · Are 165 app participants kept separate from events and denominators?

Required materials and conditions: App participant count and unverified events by group
Conditions for verification: Show original materials for app participant count and unverified events by group together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 app participant count and unverified events by group 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 the direct effects of delivery separated from content and adherence?

Required materials and conditions: Comparison gaps between combined support and app delivery
Conditions for verification: Show original materials for comparison gaps between combined support and app delivery together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 comparison gaps between combined support and app delivery 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 · Has the 2014 bracing superiority result been transferred to app effects?

Required materials and conditions: Twelve-month bracing versus eight-week training
Conditions for verification: Show original materials for twelve-month bracing versus eight-week training together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 twelve-month bracing versus eight-week training 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 · Has no difference in the 2017 review been expressed as equivalence?

Required materials and conditions: Review of 12-month recurrence rates with training/bracing
Conditions for verification: Show original materials for review of 12-month recurrence rates with training/bracing together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 review of 12-month recurrence rates with training/bracing 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 · Have ascertainment procedures been automatically transferred to the app trial?

Required materials and conditions: 2BFit self-report/masked adjudication and unverified app procedures
Conditions for verification: Show original materials for 2BFit self-report/masked adjudication and unverified app procedures together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 self-report/masked adjudication and unverified app procedures 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 · Have different trials been newly counted as direct conflict or independent replication?

Required materials and conditions: Original delivery differences and applicability of comparisons
Conditions for verification: Show original materials for original delivery differences and applicability of comparisons together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 delivery differences and applicability of comparisons 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 · Has recurrence prevention by every app been extended to broader populations?

Required materials and conditions: Applicability gaps by program, population and duration
Conditions for verification: Show original materials for applicability gaps by program, population and duration together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 applicability gaps by program, population and duration 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 · Has a new method to solve low adherence been created?

Required materials and conditions: Distinguishing research exposure/delivery gaps from instructions
Conditions for verification: Show original materials for distinguishing research exposure/delivery gaps from instructions together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.
Requirement and applicability: Supplementary
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 distinguishing research exposure/delivery gaps from instructions 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 · Is the safety of apps or other delivery methods known?

Required materials and conditions: Study-specific harm collection, exposure and denominators
Conditions for verification: Show original materials for study-specific harm collection, exposure 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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 study-specific harm collection, exposure 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

N20 · 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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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

N21 · 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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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

N22 · 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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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

N23 · 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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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

N24 · 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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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

N25 · 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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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

N26 · 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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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

N27 · Are the subclaim grade and parent score/axes preserved?

Required materials and conditions: Selected D grade, missing subclaim values and parent B with 76 points
Conditions for verification: Show original materials for selected D grade, missing subclaim values and parent B with 76 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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 D grade, missing subclaim values and parent B with 76 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

N28 · 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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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

N29 · 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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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

N30 · 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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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

N31 · 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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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

A public view and materials were prepared from the existing31 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 existing all-app claim is being transferred?

Current findings: The selected claim concerns recurrence prevention by any app-based ankle exercise. Its original subclaim grade is D; the note concerns the null 2023 trial with a different delivery method. Missing subclaim scores/status/axes are distinguished from the parent balance-board score of B with 76 points. There is no reassessment that every app has exactly zero effect.
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: Definitions of the app/training/population/comparator, recurrence endpoint and duration, plus review of the claim boundary. Parent scores/effects are not transferred to the subclaim.
Required materials and conditions: The broad wording, subclaim grade and parent B grade
Materials to obtain first: Definitions of the app/training/population/comparator, recurrence endpoint and duration, plus review of the claim boundary. Parent scores/effects are not transferred to the subclaim.
Further research: Materials needed: Definitions of the app/training/population/comparator, recurrence endpoint and duration, plus review of the claim boundary. Parent scores/effects are not transferred to the subclaim. Only requests/material needs are recorded; no search or research is performed in this work.
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 the broad wording, subclaim grade and parent B grade 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 the broad wording, subclaim grade and parent B grade with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 · Does direct evidence cover every app?

Current findings: The original advertising interpretation explains that this does not mean every ankle-exercise app prevents recurrence: the result is limited to the eight-week program providing a balance board, sheets, DVD and web materials. Direct evidence accounting for differences in all apps/programs, their content, exposure and support remains unverified.
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: App identity/version, content/support, actual exposure, population/comparator/endpoint and direct comparisons/applicability. No app/device recommendations or training instructions.
Required materials and conditions: Applicability of delivery, content and support
Materials to obtain first: App identity/version, content/support, actual exposure, population/comparator/endpoint and direct comparisons/applicability. No app/device recommendations or training instructions.
Further research: Materials needed: App identity/version, content/support, actual exposure, population/comparator/endpoint and direct comparisons/applicability. No app/device recommendations or training instructions. Only requests/material needs are recorded; no search or research is performed in this work.
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 applicability of delivery, content and support 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 applicability of delivery, content and support with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 · Was 2BFit a trial of an app alone?

Current findings: 2BFit used eight weeks of home neuromuscular training with a balance board, sheets, DVD and web materials after usual care. Including web materials does not newly define the trial as testing an app alone, every app or the board alone.
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/exposure, support/contact, adherence and direct comparisons with apps/other delivery methods. No certification separating the effects of individual components in the combined program.
Required materials and conditions: The specific combined delivery program and its components
Materials to obtain first: Components/exposure, support/contact, adherence and direct comparisons with apps/other delivery methods. No certification separating the effects of individual components in the combined program.
Further research: Materials needed: Components/exposure, support/contact, adherence and direct comparisons with apps/other delivery methods. No certification separating the effects of individual components in the combined program. Only requests/material needs are recorded; no search or research is performed in this work.
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 the specific combined delivery program and its components 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 the specific combined delivery program and its components with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 · How much is known about the population and identity of the 2023 app trial?

Current findings: The original counterview records a 2023 primary-care app trial in 165 people. Formal bibliography/registration, app name/version, previous sprains/age, eligibility, actual intervention/comparator and duration are not detailed. The 2BFit information on 522 athletes aged 12 to 70 is not copied to the app trial.
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 paper/registration, app/population/intervention/comparator/duration and endpoint/denominator materials. Unread external materials or unidentified bibliography are not changed into absence of research.
Required materials and conditions: Primary-care trial in 165 people and an unidentified report
Materials to obtain first: Exact paper/registration, app/population/intervention/comparator/duration and endpoint/denominator materials. Unread external materials or unidentified bibliography are not changed into absence of research.
Further research: Materials needed: Exact paper/registration, app/population/intervention/comparator/duration and endpoint/denominator materials. Unread external materials or unidentified bibliography are not changed into absence of research. Only requests/material needs are recorded; no search or research is performed in this work.
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 primary-care trial in 165 people and an unidentified report 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 primary-care trial in 165 people and an unidentified report with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 R02

N05 · Are the app HR and balance-board RR distinguished?

Current findings: The original app result is described as null, HR 1.14 (0.59 to 2.21). This is a different effect measure and trial from 2BFit's adjusted RR 0.63. It is not newly judged to establish zero effect for every app, equivalence, harm or an identical comparison.
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: The app estimand, model/adjustment, follow-up/testing, denominators/event counts and original CI/prespecified threshold. No HR/RR conversion or new effect/CI calculation.
Required materials and conditions: App HR 1.14 and CI 0.59 to 2.21
Materials to obtain first: The app estimand, model/adjustment, follow-up/testing, denominators/event counts and original CI/prespecified threshold. No HR/RR conversion or new effect/CI calculation.
Further research: Materials needed: The app estimand, model/adjustment, follow-up/testing, denominators/event counts and original CI/prespecified threshold. No HR/RR conversion or new effect/CI calculation. Only requests/material needs are recorded; no search or research is performed in this work.
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 app HR 1.14 and CI 0.59 to 2.21 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 app HR 1.14 and CI 0.59 to 2.21 with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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

N06 · Have app adherence of 6.1% and balance-board adherence of 23% been certified as comparable?

Current findings: Original app adherence of 6.1% and 2BFit full adherence of 58/256 (23%) remain in their respective contexts. Differences in adherence definitions, denominators and measurement are unverified; no causal conclusion that low adherence caused the null result or a new adherence difference is created.
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 definitions in both studies, actual exposure, aggregation/missingness, support, direct comparisons and analysis. No new adherer effects, differences or rates.
Required materials and conditions: Adherence in different programs
Materials to obtain first: Adherence definitions in both studies, actual exposure, aggregation/missingness, support, direct comparisons and analysis. No new adherer effects, differences or rates.
Further research: Materials needed: Adherence definitions in both studies, actual exposure, aggregation/missingness, support, direct comparisons and analysis. No new adherer effects, differences or rates. Only requests/material needs are recorded; no search or research is performed in this work.
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 adherence in different programs 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 adherence in different programs with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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

N07 · Are the app's actual comparator and concomitant care known?

Current findings: The app trial is described only as primary care/another delivery method in the original summary. Comparator identity, concomitant care/contamination and exposure remain unverified. 2BFit's usual-care comparator or the bracing comparison is not automatically used as the app comparator.
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: The actual app comparator, concomitant care/training, contact/expectations, contamination and recovery/sports exposure. Different comparisons are not combined.
Required materials and conditions: The unverified app comparator and usual-care comparator
Materials to obtain first: The actual app comparator, concomitant care/training, contact/expectations, contamination and recovery/sports exposure. Different comparisons are not combined.
Further research: Materials needed: The actual app comparator, concomitant care/training, contact/expectations, contamination and recovery/sports exposure. Different comparisons are not combined. Only requests/material needs are recorded; no search or research is performed in this work.
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 the unverified app comparator and usual-care comparator 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 the unverified app comparator and usual-care comparator with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 R02

N08 · Are the app recurrence endpoint and prespecified hierarchy verified?

Current findings: The original app HR is described as null, but details of recurrence definitions, same/other ankle, first/repeated events, confirmation and prespecified endpoints are absent. 2BFit's monthly reporting, independent adjudication and primary-endpoint definition are not copied to the app trial.
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 app endpoints, registration/SAP, event counting, adjudication/measurement, prespecified hierarchy and all results. Unverified details are not all declared unmeasured.
Required materials and conditions: Exact app events and primary/secondary plans
Materials to obtain first: Original app endpoints, registration/SAP, event counting, adjudication/measurement, prespecified hierarchy and all results. Unverified details are not all declared unmeasured.
Further research: Materials needed: Original app endpoints, registration/SAP, event counting, adjudication/measurement, prespecified hierarchy and all results. Unverified details are not all declared unmeasured. Only requests/material needs are recorded; no search or research is performed in this work.
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 exact app events and primary/secondary plans 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 exact app events and primary/secondary plans with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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

N09 · Are app duration and 2BFit's eight weeks/12 months kept separate?

Current findings: 2BFit used an eight-week program with 12-month follow-up; the original app reference does not provide exact intervention/follow-up duration. Those periods or three sessions weekly/up to 30 minutes are not transferred as app-trial exposure.
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: Actual app duration/exposure/adherence, observation/attrition, time-specific results and comparability. No new day counts/total dose or exercise instructions.
Required materials and conditions: Gaps in applying intervention and follow-up time points
Materials to obtain first: Actual app duration/exposure/adherence, observation/attrition, time-specific results and comparability. No new day counts/total dose or exercise instructions.
Further research: Materials needed: Actual app duration/exposure/adherence, observation/attrition, time-specific results and comparability. No new day counts/total dose or exercise instructions. Only requests/material needs are recorded; no search or research is performed in this work.
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 gaps in applying intervention and follow-up time 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 gaps in applying intervention and follow-up time points with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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

N10 · Has the positive balance-board result been transferred to every app?

Current findings: Original 2BFit results of 56/256 versus 89/266, adjusted RR 0.63 (CI 0.45 to 0.88), NNT 9 and original −11 percentage points are limited to the specific balance-board delivery program. They are not copied as values for the app HR or prevention by every app.
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: Direct app/board comparisons, population/intervention/comparator, events/duration and effect/CI/denominator materials. No new pooled effects or product/treatment recommendations.
Required materials and conditions: Limits of 2BFit's one-year 22% versus 33%, RR and NNT
Materials to obtain first: Direct app/board comparisons, population/intervention/comparator, events/duration and effect/CI/denominator materials. No new pooled effects or product/treatment recommendations.
Further research: Materials needed: Direct app/board comparisons, population/intervention/comparator, events/duration and effect/CI/denominator materials. No new pooled effects or product/treatment recommendations. Only requests/material needs are recorded; no search or research is performed in this work.
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 limits of 2BFit's one-year 22% versus 33%, RR and NNT 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 limits of 2BFit's one-year 22% versus 33%, RR and NNT with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 · Are 165 app participants kept separate from events and denominators?

Current findings: The original app count of 165 people is recorded; group allocation/completion/analysis, recurrence events/observation and attrition are not detailed. The board trial's 256/266, 56/89 and 14% attrition are not copied to the app, and new group-specific app numbers are not divided out.
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: The app flow diagram, event/observation/analysis denominators, people/ankles/repetition/exposure time and missing-data materials. No new group denominators or participant totals.
Required materials and conditions: App participant count and unverified events by group
Materials to obtain first: The app flow diagram, event/observation/analysis denominators, people/ankles/repetition/exposure time and missing-data materials. No new group denominators or participant totals.
Further research: Materials needed: The app flow diagram, event/observation/analysis denominators, people/ankles/repetition/exposure time and missing-data materials. No new group denominators or participant totals. Only requests/material needs are recorded; no search or research is performed in this work.
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 app participant count and unverified events by group 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 app participant count and unverified events by group with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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

N12 · Are the direct effects of delivery separated from content and adherence?

Current findings: The original materials explain that supplying a balance board/DVD differs from app delivery in primary care. Direct evidence separating which content, support, population/exposure or adherence component produced the difference is absent. Causes or superiority attributable only to app delivery are not newly established.
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: Direct comparisons matching content/exposure, support/contact/adherence, population/comparator and results/denominators. No app/device selection or exercise instructions.
Required materials and conditions: Comparison gaps between combined support and app delivery
Materials to obtain first: Direct comparisons matching content/exposure, support/contact/adherence, population/comparator and results/denominators. No app/device selection or exercise instructions.
Further research: Materials needed: Direct comparisons matching content/exposure, support/contact/adherence, population/comparator and results/denominators. No app/device selection or exercise instructions. Only requests/material needs are recorded; no search or research is performed in this work.
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 comparison gaps between combined support and app delivery 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 comparison gaps between combined support and app delivery with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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

N13 · Has the 2014 bracing superiority result been transferred to app effects?

Current findings: The original 2014 reference compares 12-month bracing, described as superior, with eight-week training. Bibliography, population/denominators, exact effects/CI and events/exposure are unverified. This is not substituted for the app comparator, app effect or the effect of all exercise.
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: The original 2014 report, registration, actual bracing/training, duration/adherence and event/denominator/effect/CI materials. No brace/device recommendations or treatment instructions.
Required materials and conditions: Twelve-month bracing versus eight-week training
Materials to obtain first: The original 2014 report, registration, actual bracing/training, duration/adherence and event/denominator/effect/CI materials. No brace/device recommendations or treatment instructions.
Further research: Materials needed: The original 2014 report, registration, actual bracing/training, duration/adherence and event/denominator/effect/CI materials. No brace/device recommendations or treatment instructions. Only requests/material needs are recorded; no search or research is performed in this work.
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 twelve-month bracing versus eight-week training 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 twelve-month bracing versus eight-week training with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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

N14 · Has no difference in the 2017 review been expressed as equivalence?

Current findings: The original 2017 review reference says no difference in 12-month recurrence rates was found between training and bracing. Included trials/overlap, effects/CI, heterogeneity and precise formulation/delivery are absent. This is not changed into equivalence, effects of every app or certification of independent trial counts.
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: Review bibliography/methods, included reports/trials, overlap, direct comparisons/duration and effects/CI. No new pooled effect/CI or unique-trial-count calculation.
Required materials and conditions: Review of 12-month recurrence rates with training/bracing
Materials to obtain first: Review bibliography/methods, included reports/trials, overlap, direct comparisons/duration and effects/CI. No new pooled effect/CI or unique-trial-count calculation.
Further research: Materials needed: Review bibliography/methods, included reports/trials, overlap, direct comparisons/duration and effects/CI. No new pooled effect/CI or unique-trial-count calculation. Only requests/material needs are recorded; no search or research is performed in this work.
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 review of 12-month recurrence rates with training/bracing 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 review of 12-month recurrence rates with training/bracing with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 R04

N15 · Have ascertainment procedures been automatically transferred to the app trial?

Current findings: 2BFit used monthly self-report followed by adjudication by a masked physiotherapist/researcher. App reporting, confirmation and masking are not detailed in the original reference. The shared word recurrence does not certify identical measurement accuracy.
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: App event reporting/omissions, independent adjudication, examination/clinical confirmation, masking, expectations and original materials. No formal RoB assessment or grade change.
Required materials and conditions: 2BFit self-report/masked adjudication and unverified app procedures
Materials to obtain first: App event reporting/omissions, independent adjudication, examination/clinical confirmation, masking, expectations and original materials. No formal RoB assessment or grade change.
Further research: Materials needed: App event reporting/omissions, independent adjudication, examination/clinical confirmation, masking, expectations and original materials. No formal RoB assessment or grade change. Only requests/material needs are recorded; no search or research is performed in this work.
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 self-report/masked adjudication and unverified app procedures 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 self-report/masked adjudication and unverified app procedures with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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

N16 · Have different trials been newly counted as direct conflict or independent replication?

Current findings: The original counterview did not count the app trial as direct conflict with 2BFit because delivery differed. That original boundary remains; a single bibliography, unidentified contexts and studies included in a review are not newly certified as independent replications.
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: Same/different cohorts, population/intervention/comparator/events, independence/overlap and direct comparability for each report. No new reassessment or independence calculation.
Required materials and conditions: Original delivery differences and applicability of comparisons
Materials to obtain first: Same/different cohorts, population/intervention/comparator/events, independence/overlap and direct comparability for each report. No new reassessment or independence calculation.
Further research: Materials needed: Same/different cohorts, population/intervention/comparator/events, independence/overlap and direct comparability for each report. No new reassessment or independence calculation. Only requests/material needs are recorded; no search or research is performed in this work.
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 delivery differences and applicability of comparisons 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 delivery differences and applicability of comparisons with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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

N17 · Has recurrence prevention by every app been extended to broader populations?

Current findings: The parent record concerns one-year recurrence in previously injured athletes using a specific program. It is not extended to every app, the general population, another ankle, first injuries or prevention across all periods. The original app population/comparison/time are not detailed.
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: Direct population/intervention/comparator, recurrence/first injury, duration and denominator/effect/CI materials for each applicability question. No rehabilitation/prevention/treatment-replacement instructions.
Required materials and conditions: Applicability gaps by program, population and duration
Materials to obtain first: Direct population/intervention/comparator, recurrence/first injury, duration and denominator/effect/CI materials for each applicability question. No rehabilitation/prevention/treatment-replacement instructions.
Further research: Materials needed: Direct population/intervention/comparator, recurrence/first injury, duration and denominator/effect/CI materials for each applicability question. No rehabilitation/prevention/treatment-replacement instructions. Only requests/material needs are recorded; no search or research is performed in this work.
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 applicability gaps by program, population and duration 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 applicability gaps by program, population and duration with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 · Has a new method to solve low adherence been created?

Current findings: Original adherence of 23% and app adherence of 6.1% are reports in their own contexts. This records material gaps without creating a specific app choice, encouragement/exercise method, device/rehabilitation/recurrence-prevention or treatment-replacement plan.
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: Materials explaining actual exposure/support, adherence measurement, deviations/contamination and direct effects. Distinguish subsequent material work after content review from authority to provide practical instructions.
Required materials and conditions: Distinguishing research exposure/delivery gaps from instructions
Materials to obtain first: Materials explaining actual exposure/support, adherence measurement, deviations/contamination and direct effects. Distinguish subsequent material work after content review from authority to provide practical instructions.
Further research: Materials needed: Materials explaining actual exposure/support, adherence measurement, deviations/contamination and direct effects. Distinguish subsequent material work after content review from authority to provide practical instructions. Only requests/material needs are recorded; no search or research is performed in this work.
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 distinguishing research exposure/delivery gaps from instructions 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 distinguishing research exposure/delivery gaps from instructions with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 · Is the safety of apps or other delivery methods known?

Current findings: 2BFit has gaps in separate collection/reporting of exercise AE tables; app/bracing/review references lack detailed harms. The board trial's reporting limits are not copied as facts from the app report, and harmlessness or harmfulness of every app is not newly asserted.
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: Study-specific AE/discontinuation, actual exposure, events/denominators/attribution and long-term/rare-harm materials. No device/app recommendations or exercise/rehabilitation/prevention instructions.
Required materials and conditions: Study-specific harm collection, exposure and denominators
Materials to obtain first: Study-specific AE/discontinuation, actual exposure, events/denominators/attribution and long-term/rare-harm materials. No device/app recommendations or exercise/rehabilitation/prevention instructions.
Further research: Materials needed: Study-specific AE/discontinuation, actual exposure, events/denominators/attribution and long-term/rare-harm materials. No device/app recommendations or exercise/rehabilitation/prevention instructions. Only requests/material needs are recorded; no search or research is performed in this work.
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 study-specific harm collection, exposure 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 study-specific harm collection, exposure and denominators with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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

N20 · 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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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

N21 · 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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 · 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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 · 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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 the subclaim grade and parent score/axes preserved?

Current findings: The selected subclaim's D grade, note and bilingual question are preserved; absent subclaim scores/status/axes remain unrecorded. Parent B with 76 points, unknown safety, B/H/R1/I2/E+/B0, unrecorded precision and the true big-hard-RCT indicator remain 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 D grade, missing subclaim values and parent B with 76 points
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 D grade, missing subclaim values and parent B with 76 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 selected D grade, missing subclaim values and parent B with 76 points with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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

N28 · 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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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 · What direct materials would fill the selected gaps?

Current findings: The all-app claim requires program-specific direct population/delivery/comparator/event/duration materials and comparability. A positive 2BFit result or one null app result does not create a general conclusion.
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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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

N31 · 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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. 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