{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "App-based ankle exercise × Recurrence prevention — Delivery differences from balance boards and gaps in direct applicability",
  "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 existing all-app claim is being transferred?",
      "needed": "The broad wording, subclaim grade and parent B grade",
      "role": "Required",
      "role_reason": "Needed to connect the broad wording, subclaim grade and parent B grade with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.",
      "application_exception": "Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.",
      "criterion": "Show original materials for the broad wording, subclaim grade and parent B grade together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.",
      "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: Definitions of the app/training/population/comparator, recurrence endpoint and duration, plus review of the claim boundary. Parent scores/effects are not transferred to the subclaim. Only requests/material needs are recorded; no search or research is performed in this work."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Does direct evidence cover every app?",
      "needed": "Applicability of delivery, content and support",
      "role": "Required",
      "role_reason": "Needed to connect applicability of delivery, content and support with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.",
      "application_exception": "Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.",
      "criterion": "Show original materials for applicability of delivery, content and support together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.",
      "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: App identity/version, content/support, actual exposure, population/comparator/endpoint and direct comparisons/applicability. No app/device recommendations or training instructions. Only requests/material needs are recorded; no search or research is performed in this work."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Was 2BFit a trial of an app alone?",
      "needed": "The specific combined delivery program and its components",
      "role": "Required",
      "role_reason": "Needed to connect the specific combined delivery program and its components with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.",
      "application_exception": "Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.",
      "criterion": "Show original materials for the specific combined delivery program and its components together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.",
      "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/exposure, support/contact, adherence and direct comparisons with apps/other delivery methods. No certification separating the effects of individual components in the combined program. Only requests/material needs are recorded; no search or research is performed in this work."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "How much is known about the population and identity of the 2023 app trial?",
      "needed": "Primary-care trial in 165 people and an unidentified report",
      "role": "Required",
      "role_reason": "Needed to connect primary-care trial in 165 people and an unidentified report with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.",
      "application_exception": "Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.",
      "criterion": "Show original materials for primary-care trial in 165 people and an unidentified report together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.",
      "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 paper/registration, app/population/intervention/comparator/duration and endpoint/denominator materials. Unread external materials or unidentified bibliography are not changed into absence of research. Only requests/material needs are recorded; no search or research is performed in this work."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Are the app HR and balance-board RR distinguished?",
      "needed": "App HR 1.14 and CI 0.59 to 2.21",
      "role": "Required",
      "role_reason": "Needed to connect app HR 1.14 and CI 0.59 to 2.21 with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.",
      "application_exception": "Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.",
      "criterion": "Show original materials for app HR 1.14 and CI 0.59 to 2.21 together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.",
      "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: The app estimand, model/adjustment, follow-up/testing, denominators/event counts and original CI/prespecified threshold. No HR/RR conversion or new effect/CI calculation. Only requests/material needs are recorded; no search or research is performed in this work."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Have app adherence of 6.1% and balance-board adherence of 23% been certified as comparable?",
      "needed": "Adherence in different programs",
      "role": "Required",
      "role_reason": "Needed to connect adherence in different programs with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.",
      "application_exception": "Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.",
      "criterion": "Show original materials for adherence in different programs together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.",
      "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 definitions in both studies, actual exposure, aggregation/missingness, support, direct comparisons and analysis. No new adherer effects, differences or rates. Only requests/material needs are recorded; no search or research is performed in this work."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "Are the app's actual comparator and concomitant care known?",
      "needed": "The unverified app comparator and usual-care comparator",
      "role": "Required",
      "role_reason": "Needed to connect the unverified app comparator and usual-care comparator with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.",
      "application_exception": "Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.",
      "criterion": "Show original materials for the unverified app comparator and usual-care comparator together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.",
      "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: The actual app comparator, concomitant care/training, contact/expectations, contamination and recovery/sports exposure. Different comparisons are not combined. Only requests/material needs are recorded; no search or research is performed in this work."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "Are the app recurrence endpoint and prespecified hierarchy verified?",
      "needed": "Exact app events and primary/secondary plans",
      "role": "Required",
      "role_reason": "Needed to connect exact app events and primary/secondary plans with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.",
      "application_exception": "Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.",
      "criterion": "Show original materials for exact app events and primary/secondary plans together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.",
      "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 app endpoints, registration/SAP, event counting, adjudication/measurement, prespecified hierarchy and all results. Unverified details are not all declared unmeasured. Only requests/material needs are recorded; no search or research is performed in this work."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "Are app duration and 2BFit's eight weeks/12 months kept separate?",
      "needed": "Gaps in applying intervention and follow-up time points",
      "role": "Required",
      "role_reason": "Needed to connect gaps in applying intervention and follow-up time points with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.",
      "application_exception": "Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.",
      "criterion": "Show original materials for gaps in applying intervention and follow-up time points together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.",
      "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 app duration/exposure/adherence, observation/attrition, time-specific results and comparability. No new day counts/total dose or exercise instructions. Only requests/material needs are recorded; no search or research is performed in this work."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "Has the positive balance-board result been transferred to every app?",
      "needed": "Limits of 2BFit's one-year 22% versus 33%, RR and NNT",
      "role": "Required",
      "role_reason": "Needed to connect limits of 2BFit's one-year 22% versus 33%, RR and NNT with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.",
      "application_exception": "Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.",
      "criterion": "Show original materials for limits of 2BFit's one-year 22% versus 33%, RR and NNT together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.",
      "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: Direct app/board comparisons, population/intervention/comparator, events/duration and effect/CI/denominator materials. No new pooled effects or product/treatment recommendations. Only requests/material needs are recorded; no search or research is performed in this work."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Are 165 app participants kept separate from events and denominators?",
      "needed": "App participant count and unverified events by group",
      "role": "Required",
      "role_reason": "Needed to connect app participant count and unverified events by group with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.",
      "application_exception": "Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.",
      "criterion": "Show original materials for app participant count and unverified events by group together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.",
      "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: The app flow diagram, event/observation/analysis denominators, people/ankles/repetition/exposure time and missing-data materials. No new group denominators or participant totals. Only requests/material needs are recorded; no search or research is performed in this work."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Are the direct effects of delivery separated from content and adherence?",
      "needed": "Comparison gaps between combined support and app delivery",
      "role": "Required",
      "role_reason": "Needed to connect comparison gaps between combined support and app delivery with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.",
      "application_exception": "Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.",
      "criterion": "Show original materials for comparison gaps between combined support and app delivery together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.",
      "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: Direct comparisons matching content/exposure, support/contact/adherence, population/comparator and results/denominators. No app/device selection or exercise instructions. Only requests/material needs are recorded; no search or research is performed in this work."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "Has the 2014 bracing superiority result been transferred to app effects?",
      "needed": "Twelve-month bracing versus eight-week training",
      "role": "Required",
      "role_reason": "Needed to connect twelve-month bracing versus eight-week training with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.",
      "application_exception": "Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.",
      "criterion": "Show original materials for twelve-month bracing versus eight-week training together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.",
      "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: The original 2014 report, registration, actual bracing/training, duration/adherence and event/denominator/effect/CI materials. No brace/device recommendations or treatment instructions. Only requests/material needs are recorded; no search or research is performed in this work."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "Has no difference in the 2017 review been expressed as equivalence?",
      "needed": "Review of 12-month recurrence rates with training/bracing",
      "role": "Required",
      "role_reason": "Needed to connect review of 12-month recurrence rates with training/bracing with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.",
      "application_exception": "Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.",
      "criterion": "Show original materials for review of 12-month recurrence rates with training/bracing together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.",
      "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: Review bibliography/methods, included reports/trials, overlap, direct comparisons/duration and effects/CI. No new pooled effect/CI or unique-trial-count calculation. Only requests/material needs are recorded; no search or research is performed in this work."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Have ascertainment procedures been automatically transferred to the app trial?",
      "needed": "2BFit self-report/masked adjudication and unverified app procedures",
      "role": "Required",
      "role_reason": "Needed to connect 2BFit self-report/masked adjudication and unverified app procedures with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.",
      "application_exception": "Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.",
      "criterion": "Show original materials for 2BFit self-report/masked adjudication and unverified app procedures together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.",
      "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: App event reporting/omissions, independent adjudication, examination/clinical confirmation, masking, expectations and original materials. No formal RoB assessment or grade change. Only requests/material needs are recorded; no search or research is performed in this work."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "Have different trials been newly counted as direct conflict or independent replication?",
      "needed": "Original delivery differences and applicability of comparisons",
      "role": "Required",
      "role_reason": "Needed to connect original delivery differences and applicability of comparisons with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.",
      "application_exception": "Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.",
      "criterion": "Show original materials for original delivery differences and applicability of comparisons together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.",
      "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: Same/different cohorts, population/intervention/comparator/events, independence/overlap and direct comparability for each report. No new reassessment or independence calculation. Only requests/material needs are recorded; no search or research is performed in this work."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Has recurrence prevention by every app been extended to broader populations?",
      "needed": "Applicability gaps by program, population and duration",
      "role": "Required",
      "role_reason": "Needed to connect applicability gaps by program, population and duration with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.",
      "application_exception": "Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.",
      "criterion": "Show original materials for applicability gaps by program, population and duration together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.",
      "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: Direct population/intervention/comparator, recurrence/first injury, duration and denominator/effect/CI materials for each applicability question. No rehabilitation/prevention/treatment-replacement instructions. Only requests/material needs are recorded; no search or research is performed in this work."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Has a new method to solve low adherence been created?",
      "needed": "Distinguishing research exposure/delivery gaps from instructions",
      "role": "Supplementary",
      "role_reason": "Needed to connect distinguishing research exposure/delivery gaps from instructions with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.",
      "application_exception": "Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.",
      "criterion": "Show original materials for distinguishing research exposure/delivery gaps from instructions together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.",
      "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: Materials explaining actual exposure/support, adherence measurement, deviations/contamination and direct effects. Distinguish subsequent material work after content review from authority to provide practical instructions. Only requests/material needs are recorded; no search or research is performed in this work."
    },
    {
      "item_id": "N19",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Is the safety of apps or other delivery methods known?",
      "needed": "Study-specific harm collection, exposure and denominators",
      "role": "Supplementary",
      "role_reason": "Needed to connect study-specific harm collection, exposure and denominators with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.",
      "application_exception": "Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.",
      "criterion": "Show original materials for study-specific harm collection, exposure and denominators together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.",
      "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: Study-specific AE/discontinuation, actual exposure, events/denominators/attribution and long-term/rare-harm materials. No device/app recommendations or exercise/rehabilitation/prevention instructions. Only requests/material needs are recorded; no search or research is performed in this work."
    },
    {
      "item_id": "N20",
      "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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.",
      "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": "N21",
      "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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.",
      "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": "N22",
      "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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.",
      "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": "N23",
      "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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.",
      "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": "N24",
      "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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.",
      "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": "N25",
      "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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.",
      "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": "N26",
      "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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.",
      "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": "N27",
      "question_type": "Evidence condition",
      "question": "Are the subclaim grade and parent score/axes preserved?",
      "needed": "Selected D grade, missing subclaim values and parent B with 76 points",
      "role": "Required",
      "role_reason": "Needed to connect selected D grade, missing subclaim values and parent B with 76 points with the selected question, actual population/intervention/comparator, endpoints/time points/estimands, denominators/repetition/exposure and reports/harms.",
      "application_exception": "Distinguish the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.",
      "criterion": "Show original materials for selected D grade, missing subclaim values and parent B with 76 points together with selected-subclaim/parent boundaries, direct endpoints/estimands, denominators/exposure and the scope of external reading.",
      "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": "N28",
      "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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.",
      "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": "N29",
      "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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.",
      "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": "N30",
      "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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.",
      "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": "N31",
      "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 the broad all-app claim, the unidentified 2023 primary-care app, HR/adherence and unverified population/comparator/duration/events/denominators from 2BFit’s specific delivery effects, bracing/review contexts, direct comparisons/applicability and study-specific harms. Preserve original numbers only; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or device/app recommendations/exercise/rehabilitation/recurrence-prevention/treatment-replacement instructions.",
      "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."
    }
  ]
}