{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Home balance-board training × Same-ankle recurrence over one year — Events, exposure, adherence and gaps",
  "language": "en",
  "translation_date": "2026-10-14",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "condition_origin": "Chamgap's own application conditions",
  "method_sources": [
    {
      "id": "M03",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03",
      "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13",
      "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.",
      "review_level": "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"
  },
  "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    }
  ]
}