{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2975-s0", "verdict_number": "2975", "title": "Home balance-board training × Same-ankle recurrence over one year — Events, exposure, adherence and gaps", "view_version": "1.0", "view_created_date": "2026-10-14", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "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.", "intervention": "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.", "endpoint": "Same-ankle recurrence over one year; distinguish self-report/independent adjudication, people/repeated events/exposure time and other endpoints.", "duration": "2BFit eight-week intervention/12-month follow-up. App-intervention/follow-up details remain unverified. The 2014 context compared 12-month bracing with eight-week training; the 2017 recurrence context concerned 12 months.", "excluded_extensions": [ "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" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which original one-year recurrence claim is selected?", "needed": "Selected subclaim wording/grade versus parent context", "role": "Required", "role_reason": "Needed to connect selected subclaim wording/grade versus parent context with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.", "criterion": "Show original materials for selected subclaim wording/grade versus parent context together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Exact same-ankle recurrence definition, population/comparator, duration/denominators and user boundary review. Parent scores do not fill the subclaim score. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original preserved parent-summary records/context retained; identification/acquisition/reading of external detailed materials remains separately unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The selected claim is reduced same-ankle recurrence over one year, original subclaim grade B, with the note 22% versus 33%/NNT 9. Absent subclaim score/status/axes are preserved separately from parent B with 76 points and axes.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Exact same-ankle recurrence definition, population/comparator, duration/denominators and user boundary review. Parent scores do not fill the subclaim score.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact same-ankle recurrence definition, population/comparator, duration/denominators and user boundary review. Parent scores do not fill the subclaim score." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Which previous-sprain population was studied?", "needed": "Athletes aged 12–70 after ankle sprain", "role": "Required", "role_reason": "Needed to connect athletes aged 12–70 after ankle sprain with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.", "criterion": "Show original materials for athletes aged 12–70 after ankle sprain together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Eligibility/exclusions, previous sprain/severity, usual care, training start, exposure and direct other-population data. Do not extend to all ankle disorders/app users. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original preserved parent-summary records/context retained; identification/acquisition/reading of external detailed materials remains separately unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "2BFit randomized 522 athletes aged 12–70. The original intervention was home training after usual care following ankle sprain. Injury severity, recovery/start criteria, sports/comorbidities are not established in detail by the summary.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Eligibility/exclusions, previous sprain/severity, usual care, training start, exposure and direct other-population data. Do not extend to all ankle disorders/app users.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Eligibility/exclusions, previous sprain/severity, usual care, training start, exposure and direct other-population data. Do not extend to all ankle disorders/app users." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What was the specific delivery approach?", "needed": "Eight-week program with balance board, exercise sheets, DVD and web materials", "role": "Required", "role_reason": "Needed to connect eight-week program with balance board, exercise sheets, DVD and web materials with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.", "criterion": "Show original materials for eight-week program with balance board, exercise sheets, DVD and web materials together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Components, support/contact, training content, adherence, actual products and direct comparisons of delivery approaches. No device/app recommendations or exercise instructions. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original preserved parent-summary records/context retained; identification/acquisition/reading of external detailed materials remains separately unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original was eight weeks of home neuromuscular training supplying a balance board, exercise sheets, DVD and web materials. Do not simplify into the board’s isolated-component effect, all ankle exercise or app effects.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Components, support/contact, training content, adherence, actual products and direct comparisons of delivery approaches. No device/app recommendations or exercise instructions.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Components, support/contact, training content, adherence, actual products and direct comparisons of delivery approaches. No device/app recommendations or exercise instructions." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "What were usual-care comparison and concurrent treatment?", "needed": "Additional training after usual care", "role": "Required", "role_reason": "Needed to connect additional training after usual care with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.", "criterion": "Show original materials for additional training after usual care together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Original usual care, additional training/other exposure, contact, contamination and recovery/return criteria in both arms. Do not repurpose effects to no treatment/other comparators. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original preserved parent-summary records/context retained; identification/acquisition/reading of external detailed materials remains separately unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Original design was a multicentre randomized usual-care-controlled trial; effects concern adding an eight-week program after usual care. Actual concurrent bracing, physiotherapy, medication, return-to-sport/exposure in both arms remain unverified.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original usual care, additional training/other exposure, contact, contamination and recovery/return criteria in both arms. Do not repurpose effects to no treatment/other comparators.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original usual care, additional training/other exposure, contact, contamination and recovery/return criteria in both arms. Do not repurpose effects to no treatment/other comparators." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Are training duration/study exposure separated from use instructions?", "needed": "Original eight weeks, three times weekly, up to 30 minutes", "role": "Required", "role_reason": "Needed to connect original eight weeks, three times weekly, up to 30 minutes with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.", "criterion": "Show original materials for original eight weeks, three times weekly, up to 30 minutes together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Original actual training, adherence/stopping, support/contact and phase-specific exposure. No certification of identical effects for other durations/intensities. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original preserved parent-summary records/context retained; identification/acquisition/reading of external detailed materials remains separately unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Original study facts record three sessions weekly, up to 30 minutes each, for eight weeks. Preserve study-exposure identity only; do not calculate total sessions/time or create exercise/rehabilitation/prevention instructions.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original actual training, adherence/stopping, support/contact and phase-specific exposure. No certification of identical effects for other durations/intensities.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original actual training, adherence/stopping, support/contact and phase-specific exposure. No certification of identical effects for other durations/intensities." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Are eight-week training and one-year outcomes separated?", "needed": "Intervention duration versus 12-month recurrence follow-up", "role": "Required", "role_reason": "Needed to connect intervention duration versus 12-month recurrence follow-up with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.", "criterion": "Show original materials for intervention duration versus 12-month recurrence follow-up together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Original actual training/maintenance, follow-up schedules, observation duration/loss and sports exposure. Do not calculate new day counts/exercise amounts from one year. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original preserved parent-summary records/context retained; identification/acquisition/reading of external detailed materials remains separately unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Intervention lasted eight weeks and same-ankle recurrence follow-up lasted 12 months. Maintenance training after completion, follow-up exposure/stopping and visit-specific observation remain unverified in detail. Training and event-observation periods do not become the same denominator.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original actual training/maintenance, follow-up schedules, observation duration/loss and sports exposure. Do not calculate new day counts/exercise amounts from one year.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original actual training/maintenance, follow-up schedules, observation duration/loss and sports exposure. Do not calculate new day counts/exercise amounts from one year." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "What are randomization and recurrence numerators?", "needed": "522 participants, 256/266, original recurrence 56/89", "role": "Required", "role_reason": "Needed to connect 522 participants, 256/266, original recurrence 56/89 with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.", "criterion": "Show original materials for 522 participants, 256/266, original recurrence 56/89 together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Endpoint-numerator definitions, arm analysis/follow-up/observed denominators, repeated-recurrence handling and original flow tables. Do not copy numerators/denominators to all other endpoints/trials. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original preserved parent-summary records/context retained; identification/acquisition/reading of external detailed materials remains separately unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original records 522 randomized (256/266) and 56/256 (22%) versus 89/266 (33%). Separately retain relationships among people, ankles, recurrence events, repeated reports and time; do not calculate additional event/participant totals.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Endpoint-numerator definitions, arm analysis/follow-up/observed denominators, repeated-recurrence handling and original flow tables. Do not copy numerators/denominators to all other endpoints/trials.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Endpoint-numerator definitions, arm analysis/follow-up/observed denominators, repeated-recurrence handling and original flow tables. Do not copy numerators/denominators to all other endpoints/trials." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "How was same-ankle recurrence defined?", "needed": "Original event label, first/repeated events and confirmation", "role": "Required", "role_reason": "Needed to connect original event label, first/repeated events and confirmation with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.", "criterion": "Show original materials for original event label, first/repeated events and confirmation together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Event definitions, original questionnaires, adjudication rules, repeated/contralateral events, severity and confirmation data. Materials clarifying aggregation of original numerators 56/89. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original preserved parent-summary records/context retained; identification/acquisition/reading of external detailed materials remains separately unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original endpoint was same-ankle recurrence reported monthly and independently adjudicated under masking. Diagnostic/injury/recurrence criteria, first/all-repeated-event handling and clinical-confirmation details remain unverified. Do not extend to the opposite ankle/all injuries.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Event definitions, original questionnaires, adjudication rules, repeated/contralateral events, severity and confirmation data. Materials clarifying aggregation of original numerators 56/89.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Event definitions, original questionnaires, adjudication rules, repeated/contralateral events, severity and confirmation data. Materials clarifying aggregation of original numerators 56/89." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Are self-reporting and masked adjudication separated?", "needed": "Initial monthly reporting versus independent physiotherapist/researcher adjudication", "role": "Required", "role_reason": "Needed to connect initial monthly reporting versus independent physiotherapist/researcher adjudication with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.", "criterion": "Show original materials for initial monthly reporting versus independent physiotherapist/researcher adjudication together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Original reporting/missingness, disagreement/adjudication, assessor masking, objective confirmation and participant expectations. No formal RoB assessment in this production. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original preserved parent-summary records/context retained; identification/acquisition/reading of external detailed materials remains separately unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original records monthly self-reports followed by independent adjudication by a masked physiotherapist and researcher. Initial reporting was self-reported and participant masking impossible. Do not add a declaration that all reports were confirmed through testing/clinical visits.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original reporting/missingness, disagreement/adjudication, assessor masking, objective confirmation and participant expectations. No formal RoB assessment in this production.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original reporting/missingness, disagreement/adjudication, assessor masking, objective confirmation and participant expectations. No formal RoB assessment in this production." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Are recurrent people, repeated events and observations separated?", "needed": "Original numerators and people/ankle/event units", "role": "Required", "role_reason": "Needed to connect original numerators and people/ankle/event units with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.", "criterion": "Show original materials for original numerators and people/ankle/event units together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Original event aggregation, person/ankle identifiers, repeat handling, analysis units and observation periods. No additional participant/event counts or new incidence-rate calculations. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original preserved parent-summary records/context retained; identification/acquisition/reading of external detailed materials remains separately unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Preserve original 56/256, 89/266 and monthly reporting. Exact aggregation of at-least-one recurrence, first/all-repeated events and same-person bilateral-ankle/report relationships remains unverified. Monthly/repeated events are not new independent participants.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original event aggregation, person/ankle identifiers, repeat handling, analysis units and observation periods. No additional participant/event counts or new incidence-rate calculations.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original event aggregation, person/ankle identifiers, repeat handling, analysis units and observation periods. No additional participant/event counts or new incidence-rate calculations." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Which comparison do adjusted RR/CI/NNT describe?", "needed": "2BFit one-year recurrence effects", "role": "Required", "role_reason": "Needed to connect 2BFit one-year recurrence effects with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.", "criterion": "Show original materials for 2BFit one-year recurrence effects together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Original models/adjustment variables, effects/CI, NNT definition/denominators and estimands. No new RR/RRR/NNT/CI recalculation or invented examples. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original preserved parent-summary records/context retained; identification/acquisition/reading of external detailed materials remains separately unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Original adjusted RR 0.63 (95% CI 0.45–0.88) and NNT 9 concern 2BFit same-ankle recurrence over one year. Do not copy to app/bracing or time-loss/cost endpoints. Original adjusted-model/estimand details remain unverified.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original models/adjustment variables, effects/CI, NNT definition/denominators and estimands. No new RR/RRR/NNT/CI recalculation or invented examples.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original models/adjustment variables, effects/CI, NNT definition/denominators and estimands. No new RR/RRR/NNT/CI recalculation or invented examples." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Are original absolute difference and arm percentages distinguished?", "needed": "22% versus 33% and original −11 percentage points", "role": "Required", "role_reason": "Needed to connect 22% versus 33% and original −11 percentage points with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.", "criterion": "Show original materials for 22% versus 33% and original −11 percentage points together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Original arm denominators/rounding, effect definitions, adjusted/unadjusted results and duration/analysis data. Do not newly convert RR and absolute differences into one another. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original preserved parent-summary records/context retained; identification/acquisition/reading of external detailed materials remains separately unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original crux/rationale records 22% versus 33% and absolute recurrence difference −11 percentage points. Do not transfer to within-arm improvement, relative effects, other ankles/apps or calculate exact unrounded values/new absolute differences.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original arm denominators/rounding, effect definitions, adjusted/unadjusted results and duration/analysis data. Do not newly convert RR and absolute differences into one another.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original arm denominators/rounding, effect definitions, adjusted/unadjusted results and duration/analysis data. Do not newly convert RR and absolute differences into one another." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Are exposure-time incidence density and one-year risk identical?", "needed": "1.86 versus 2.90 per 1,000 hours", "role": "Required", "role_reason": "Needed to connect 1.86 versus 2.90 per 1,000 hours with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.", "criterion": "Show original materials for 1.86 versus 2.90 per 1,000 hours together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Actual arm sports exposure, recording/missingness, incidence-density numerators/denominators and models/CI. Distinguish time, people and ankle units. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original preserved parent-summary records/context retained; identification/acquisition/reading of external detailed materials remains separately unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Original study facts record incidence density 1.86 versus 2.90 per 1,000 ankle-exposure hours. These differ in units from 22% versus 33% with person denominators. Do not calculate actual total exposure hours, new event counts/incidence-density ratios.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Actual arm sports exposure, recording/missingness, incidence-density numerators/denominators and models/CI. Distinguish time, people and ankle units.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual arm sports exposure, recording/missingness, incidence-density numerators/denominators and models/CI. Distinguish time, people and ankle units." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Are time-loss and cost/productivity outcomes retained separately?", "needed": "Other recurrence outcomes, RR 0.53 and 0.25", "role": "Required", "role_reason": "Needed to connect other recurrence outcomes, RR 0.53 and 0.25 with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.", "criterion": "Show original materials for other recurrence outcomes, RR 0.53 and 0.25 together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Original endpoint tables, event/cost definitions, denominators, effects/CI and hierarchy/multiplicity. No new calculations/addition beyond original numbers. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original preserved parent-summary records/context retained; identification/acquisition/reading of external detailed materials remains separately unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original rationale records time-loss recurrence RR 0.53 and medical-cost/productivity-loss recurrence RR 0.25 in the same direction. Definitions, numerators/denominators, CI/times/models remain unverified in detail. Do not copy primary RR 0.63/CI or NNT 9.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original endpoint tables, event/cost definitions, denominators, effects/CI and hierarchy/multiplicity. No new calculations/addition beyond original numbers.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original endpoint tables, event/cost definitions, denominators, effects/CI and hierarchy/multiplicity. No new calculations/addition beyond original numbers." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Are adherence, comparator contamination and attrition retained together?", "needed": "58/25623%·5/2662%·14%", "role": "Required", "role_reason": "Needed to connect 58/256 (23%), 5/266 (2%) and 14% with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.", "criterion": "Show original materials for 58/256 (23%), 5/266 (2%) and 14% together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Adherence measurement, actual exposure, contamination/concurrent training, arm withdrawal/missingness and sensitivity analyses. Low adherence does not newly establish delivery effects/causality. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original preserved parent-summary records/context retained; identification/acquisition/reading of external detailed materials remains separately unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Preserve original full adherence 58/256 (23%), comparator contamination 5/266 (2%) and follow-up attrition 14%. Adherence definition, partial adherence and arm-specific loss/reasons remain unverified in detail. No adherer effects, new adherence differences/attrition counts/rates.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Adherence measurement, actual exposure, contamination/concurrent training, arm withdrawal/missingness and sensitivity analyses. Low adherence does not newly establish delivery effects/causality.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Adherence measurement, actual exposure, contamination/concurrent training, arm withdrawal/missingness and sensitivity analyses. Low adherence does not newly establish delivery effects/causality." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Does ITT certify resolution of completeness/missingness?", "needed": "Analysis as randomized and actual missingness handling", "role": "Required", "role_reason": "Needed to connect analysis as randomized and actual missingness handling with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.", "criterion": "Show original materials for analysis as randomized and actual missingness handling together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Original arm flow, endpoint analysis/observation, missingness handling/assumptions, follow-up loss and sensitivity. No clinical calculations/formal risk assessment in this production. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original preserved parent-summary records/context retained; identification/acquisition/reading of external detailed materials remains separately unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original study description records all analyses following ITT principles alongside 14% attrition. ITT is not converted into universal completion/all-endpoint observation or zero missingness bias. Original B0 is parent-verdict context.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original arm flow, endpoint analysis/observation, missingness handling/assumptions, follow-up loss and sensitivity. No clinical calculations/formal risk assessment in this production.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original arm flow, endpoint analysis/observation, missingness handling/assumptions, follow-up loss and sensitivity. No clinical calculations/formal risk assessment in this production." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Are original randomization/prespecified-endpoint descriptions preserved?", "needed": "Independent-researcher computer allocation and recurrence primary endpoint/registration", "role": "Required", "role_reason": "Needed to connect independent-researcher computer allocation and recurrence primary endpoint/registration with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.", "criterion": "Show original materials for independent-researcher computer allocation and recurrence primary endpoint/registration together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Allocation concealment/implementation, plans/amendments, registration versions/public dates and original-report comparison. The unestablished first registration publication date does not newly establish prospective registration. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original preserved parent-summary records/context retained; identification/acquisition/reading of external detailed materials remains separately unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original records independent-researcher computer allocation, impossible participant masking/masked adjudication, ITT, and matching prespecified self-reported recurrence primary endpoint/ISRCTN34177180. Preserve original quotations/history only; no plan/procedure comparison now.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Allocation concealment/implementation, plans/amendments, registration versions/public dates and original-report comparison. The unestablished first registration publication date does not newly establish prospective registration.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation concealment/implementation, plans/amendments, registration versions/public dates and original-report comparison. The unestablished first registration publication date does not newly establish prospective registration." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Are 2023 app results mixed with 2BFit?", "needed": "Different-delivery trial, 165 participants, HR 1.14", "role": "Required", "role_reason": "Needed to connect different-delivery trial, 165 participants, HR 1.14 with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.", "criterion": "Show original materials for different-delivery trial, 165 participants, HR 1.14 together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Exact app citations/registration, population/comparator/duration, endpoints/denominators/exposure/adherence, models and direct comparisons. Do not substitute app HR for board RR or effects of all apps. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01", "R02" ], "existence": "Original preserved parent-summary records/context retained; identification/acquisition/reading of external detailed materials remains separately unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original counterview records a primary-care app trial with 165 participants, null HR 1.14 (0.59–2.21), adherence 6.1%. Preserve the original scope that delivery differed from 2BFit supplying a board/DVD and was not counted as direct conflict. Citation/design details remain unidentified.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Exact app citations/registration, population/comparator/duration, endpoints/denominators/exposure/adherence, models and direct comparisons. Do not substitute app HR for board RR or effects of all apps.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact app citations/registration, population/comparator/duration, endpoints/denominators/exposure/adherence, models and direct comparisons. Do not substitute app HR for board RR or effects of all apps." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Are different bracing-trial/review results separated?", "needed": "2014 bracing superiority and no difference in 2017", "role": "Required", "role_reason": "Needed to connect 2014 bracing superiority and no difference in 2017 with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.", "criterion": "Show original materials for 2014 bracing superiority and no difference in 2017 together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Each citation, original trials/review-included studies/overlap, exact comparators/durations and effects/CI/denominators. Do not count different research as new pooled effects/unique trial totals. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R03", "R04" ], "existence": "Original preserved parent-summary records/context retained; identification/acquisition/reading of external detailed materials remains separately unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original records 12-month bracing superior to eight-week training in the 2014 trial and no 12-month recurrence difference between training/bracing in a 2017 review. Populations, citations, denominators, effects and CI for both contexts remain unverified; no difference does not become equivalence.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Each citation, original trials/review-included studies/overlap, exact comparators/durations and effects/CI/denominators. Do not count different research as new pooled effects/unique trial totals.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Each citation, original trials/review-included studies/overlap, exact comparators/durations and effects/CI/denominators. Do not count different research as new pooled effects/unique trial totals." }, { "item_id": "N20", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Is the separate exercise-harm reporting gap retained?", "needed": "Exercise-related AE collection/reporting versus harmlessness", "role": "Supplementary", "role_reason": "Needed to connect exercise-related AE collection/reporting versus harmlessness with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.", "criterion": "Show original materials for exercise-related AE collection/reporting versus harmlessness together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Harm collection/definitions, arm actual training/exposure, events/discontinuation/relatedness/denominators and long-term data. No exercise/rehabilitation/recurrence-prevention instructions. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original preserved parent-summary records/context retained; identification/acquisition/reading of external detailed materials remains separately unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original safety description records that exercise-related adverse events were not collected/reported in a separate table and this trial cannot establish harmlessness. Preserve this reporting limitation; do not extend to zero AE or long-term safety.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Harm collection/definitions, arm actual training/exposure, events/discontinuation/relatedness/denominators and long-term data. No exercise/rehabilitation/recurrence-prevention instructions.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Harm collection/definitions, arm actual training/exposure, events/discontinuation/relatedness/denominators and long-term data. No exercise/rehabilitation/recurrence-prevention instructions." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "What was actually read/identified?", "needed": "Preserved summary/original citation versus unidentified reference contexts", "role": "Required", "role_reason": "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_exception": "Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.", "criterion": "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.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Original preserved parent-summary records/context retained; identification/acquisition/reading of external detailed materials remains separately unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Exact report citations/originals, acquisition/reading scope, versions/dates. URLs/historical quotations are not upgraded to current reading; no external-link/access testing.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact report citations/originals, acquisition/reading scope, versions/dates. URLs/historical quotations are not upgraded to current reading; no external-link/access testing." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Are registration dates/prespecification treated as current certification?", "needed": "ISRCTN34177180 and unestablished first public date", "role": "Required", "role_reason": "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_exception": "Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.", "criterion": "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.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Original preserved parent-summary records/context retained; identification/acquisition/reading of external detailed materials remains separately unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Actual registration versions/publication, start/amendment timing and endpoints/plans. No guessed official URLs, new registration reading or prespecification certification.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual registration versions/publication, start/amendment timing and endpoints/plans. No guessed official URLs, new registration reading or prespecification certification." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Were protocol/SAP and estimand/missingness plans acquired?", "needed": "Separate prespecified-plan/analysis/amendment materials", "role": "Required", "role_reason": "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_exception": "Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.", "criterion": "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.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Original preserved parent-summary records/context retained; identification/acquisition/reading of external detailed materials remains separately unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Original protocols/SAP, amendment histories, endpoints/models/people/events/exposure, missingness/sensitivity and public timing. Unread external materials do not establish document absence.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original protocols/SAP, amendment histories, endpoints/models/people/events/exposure, missingness/sensitivity and public timing. Unread external materials do not establish document absence." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are public funding, board supply and company involvement separated?", "needed": "2BFit support versus unverified other contexts", "role": "Required", "role_reason": "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_exception": "Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.", "criterion": "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.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Original preserved parent-summary records/context retained; identification/acquisition/reading of external detailed materials remains separately unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Are specific positive effects, different-delivery null results and unverified details distinguished?", "needed": "Question/comparison-specific results and reading status", "role": "Required", "role_reason": "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_exception": "Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.", "criterion": "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.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Original preserved parent-summary records/context retained; identification/acquisition/reading of external detailed materials remains separately unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Are one original citation and three reference contexts counted as unique trials?", "needed": "Document/context items versus trials/participants", "role": "Required", "role_reason": "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_exception": "Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.", "criterion": "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.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Original preserved parent-summary records/context retained; identification/acquisition/reading of external detailed materials remains separately unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Citations/registration, review-included reports/overlap, cohorts/analysis, endpoints/repetition relationships. Unique trial/participant totals remain unrecorded.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Citations/registration, review-included reports/overlap, cohorts/analysis, endpoints/repetition relationships. Unique trial/participant totals remain unrecorded." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Are original single confirmation and independent replication distinguished?", "needed": "Parent R1/I2 and comparison/delivery differences", "role": "Supplementary", "role_reason": "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_exception": "Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.", "criterion": "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.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Original preserved parent-summary records/context retained; identification/acquisition/reading of external detailed materials remains separately unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Are the subclaim grade and parent score/axes preserved?", "needed": "Selected B, absent subclaim values and parent B76", "role": "Required", "role_reason": "Needed to connect selected B, absent subclaim values and parent B76 with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.", "criterion": "Show original materials for selected B, absent subclaim values and parent B76 together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "Original preserved parent-summary records/context retained; identification/acquisition/reading of external detailed materials remains separately unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Preserve selected subclaim B/note/bilingual claims; absent subclaim score/status/axes remain unrecorded. Parent B with 76 points, unknown safety, B/H/R1/I2/E+/B0, unrecorded precision and true large-hard-endpoint RCT are parent context and do not fill subclaim values.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "User subclaim/parent-boundary review and actual correction materials. No new score/grade or official RoB 2/GRADE certification.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "User subclaim/parent-boundary review and actual correction materials. No new score/grade or official RoB 2/GRADE certification." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Are both languages, citations and absent fields preserved?", "needed": "Both original languages and absent separate classification information", "role": "Required", "role_reason": "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_exception": "Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.", "criterion": "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.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "Original preserved parent-summary records/context retained; identification/acquisition/reading of external detailed materials remains separately unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "User review of languages/terminology, event/exposure units, absences and selected scope. Distinguish production descriptions from original values.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "User review of languages/terminology, event/exposure units, absences and selected scope. Distinguish production descriptions from original values." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Are source dates/corrections/history separated from production dates?", "needed": "Original 2026-08-26 and new conditions/application", "role": "Required", "role_reason": "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_exception": "Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.", "criterion": "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.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "Original preserved parent-summary records/context retained; identification/acquisition/reading of external detailed materials remains separately unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Update materials separating originals, events, conditions/observations and verdict decisions when new evidence/corrections arise. Historical wording is not completed clinical content review here.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Update materials separating originals, events, conditions/observations and verdict decisions when new evidence/corrections arise. Historical wording is not completed clinical content review here." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "What direct materials would fill the selected gaps?", "needed": "Direct population/delivery/events, effects/CI and denominators", "role": "Supplementary", "role_reason": "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_exception": "Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.", "criterion": "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.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Original preserved parent-summary records/context retained; identification/acquisition/reading of external detailed materials remains separately unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Specific 2BFit event/exposure, adherence/attrition, harms/reporting details require originals; app/bracing mentions do not substitute as identical effects.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "Are applicability records separated from content review and instructions?", "needed": "Applicability records, existing candidate history and content review", "role": "Supplementary", "role_reason": "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_exception": "Distinguish 2BFit’s actual post-sprain population, board/sheets/DVD/web support, usual care, eight weeks/one year, self-report/adjudication, people/ankles/events/exposure time, RR/CI/NNT, adherence/contamination/attrition, app/bracing/review contexts, harms and unread materials. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.", "criterion": "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.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "Original preserved parent-summary records/context retained; identification/acquisition/reading of external detailed materials remains separately unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "These are summary-based applicability records. Existing content/question-boundary review remains incomplete; candidate pending/eligible markers are preserved as history.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." } ], "reports": [ { "report_id": "R01", "title": "Hupperets MDW, et al. Effect of unsupervised home based proprioceptive training on recurrences of ankle sprain. BMJ. 2009;339:b2684. PMID: 19589822.", "url": "https://pubmed.ncbi.nlm.nih.gov/19589822/", "report_type": "Multicentre randomized usual-care-controlled trial", "existence": "Report bibliography exists in original citations; external availability/access remain unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/plans remain unread", "study_family": "F01", "independent_replication": "Provisional document/reference-context links, not certification of unique trials/independent replication", "observed_result": "56/256 (22%) versus 89/266 (33%); adjusted RR 0.63 (0.45–0.88), NNT 9", "result_level": "2BFit core-endpoint summary from the original evidence list, separated from other contexts", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Local preserved copy of the complete parent summary", "access_status": "Stored summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "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." }, { "material_type": "External abstract", "public_status": "Original identifier/bibliography or required-material entry; public availability/access details remain unverified", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "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." }, { "material_type": "External full text", "public_status": "Original identifier/bibliography or required-material entry; public availability/access details remain unverified", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "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." }, { "material_type": "Registration material", "public_status": "Original identifier/bibliography or required-material entry; public availability/access details remain unverified", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "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." }, { "material_type": "Protocol/SAP", "public_status": "Original identifier/bibliography or required-material entry; public availability/access details remain unverified", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "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." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/19589822/" } ] }, { "report_id": "R02", "title": "2023 primary-care app trial — Unidentified reference context in the original counterview", "url": null, "report_type": "Original mention of a primary-care app trial; detailed design/citation unidentified", "existence": "Year/comparison context occurs in the original counterview; exact citations/original-report acquisition remain unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/plans remain unread", "study_family": "F02", "independent_replication": "Provisional document/reference-context links, not certification of unique trials/independent replication", "observed_result": "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.", "result_level": "Separate reference-context summary in the original counterview; no separate evidence/citation-list entry or exact citation", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Local preserved copy of the complete parent summary", "access_status": "Stored summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "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." }, { "material_type": "External abstract", "public_status": "Unidentified/unacquired material items", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "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." }, { "material_type": "External full text", "public_status": "Unidentified/unacquired material items", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "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." }, { "material_type": "Registration material", "public_status": "Unidentified/unacquired material items", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "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." }, { "material_type": "Protocol/SAP", "public_status": "Unidentified/unacquired material items", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "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." } ], "links": [] }, { "report_id": "R03", "title": "2014 bracing comparison trial — Unidentified reference context in the original counterview", "url": null, "report_type": "Original mention of a bracing comparison trial; detailed design/citation unidentified", "existence": "Year/comparison context occurs in the original counterview; exact citations/original-report acquisition remain unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/plans remain unread", "study_family": "F03", "independent_replication": "Provisional document/reference-context links, not certification of unique trials/independent replication", "observed_result": "Original counterview: 12-month bracing superior to eight-week training; exact effects/CI, population/denominators and citation remain unverified.", "result_level": "Separate reference-context summary in the original counterview; no separate evidence/citation-list entry or exact citation", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Local preserved copy of the complete parent summary", "access_status": "Stored summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "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." }, { "material_type": "External abstract", "public_status": "Unidentified/unacquired material items", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "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." }, { "material_type": "External full text", "public_status": "Unidentified/unacquired material items", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "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." }, { "material_type": "Registration material", "public_status": "Unidentified/unacquired material items", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "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." }, { "material_type": "Protocol/SAP", "public_status": "Unidentified/unacquired material items", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "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." } ], "links": [] }, { "report_id": "R04", "title": "2017 training/bracing review — Unidentified reference context in the original counterview", "url": null, "report_type": "Original mention of a review; methods/included trials/citation unidentified", "existence": "Year/comparison context occurs in the original counterview; exact citations/original-report acquisition remain unverified.", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/plans remain unread", "study_family": "F04", "independent_replication": "Provisional document/reference-context links, not certification of unique trials/independent replication", "observed_result": "Original counterview: no 12-month recurrence difference found between training/bracing; original review/included trials/effects/CI remain unverified.", "result_level": "Separate reference-context summary in the original counterview; no separate evidence/citation-list entry or exact citation", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Local preserved copy of the complete parent summary", "access_status": "Stored summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "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." }, { "material_type": "External abstract", "public_status": "Unidentified/unacquired material items", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "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." }, { "material_type": "External full text", "public_status": "Unidentified/unacquired material items", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "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." }, { "material_type": "Registration material", "public_status": "Unidentified/unacquired material items", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "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." }, { "material_type": "Protocol/SAP", "public_status": "Unidentified/unacquired material items", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "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." } ], "links": [] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." } ], "status_dictionary": { "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" }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "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." }, "history": [ { "date": "2026-10-14", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public pages and materials were prepared from the existing 32 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-14" }