{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "One autologous PRP injection × 24-week work limb-symmetry index — Null result, power assumption and gaps",
  "language": "en",
  "translation_date": "2026-10-13",
  "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 work limb-symmetry claim is being transferred?",
      "needed": "Selected wording, subclaim grade D and parent context",
      "role": "Required",
      "role_reason": "Needed to connect selected wording, subclaim grade D and parent context with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for selected wording, subclaim grade D and parent context together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Materials for the selected measure/estimand, timepoint/denominator, clinical threshold and existing question-boundary review. Parent scores are not used to fill the subclaim. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Which acute rupture population?",
      "needed": "Complete acute midsubstance rupture within 12 days; nonoperative care",
      "role": "Required",
      "role_reason": "Needed to connect complete acute midsubstance rupture within 12 days; nonoperative care with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for complete acute midsubstance rupture within 12 days; nonoperative care together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Eligibility/exclusion, injury/diagnosis, baseline function, comorbidities/treatment and direct materials for other populations. No PRP/tendon-management instructions. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "What was the study PRP exposure?",
      "needed": "One autologous PRP injection versus other preparations/repeated injections",
      "role": "Required",
      "role_reason": "Needed to connect one autologous PRP injection versus other preparations/repeated injections with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for one autologous PRP injection versus other preparations/repeated injections together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Original study-product/composition, manufacturing/quantities, actual-exposure and adherence/deviation materials. No blood-draw/manufacturing/injection procedures or product recommendations. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Are the comparator and common procedures preserved as research context?",
      "needed": "Imitation dry needling and common local anesthesia/blood draw",
      "role": "Required",
      "role_reason": "Needed to connect imitation dry needling and common local anesthesia/blood draw with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for imitation dry needling and common local anesthesia/blood draw together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Actual PRP/imitation procedure, concurrent-care/exposure, masking and deviation materials. No new injection/blood-draw/rehabilitation procedures are authored. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Does identical immobilization/rehabilitation imply identical actual adherence?",
      "needed": "Concurrent-care plans and actual exposure",
      "role": "Required",
      "role_reason": "Needed to connect concurrent-care plans and actual exposure with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for concurrent-care plans and actual exposure together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Group-specific actual concurrent care, exposure/adherence, deviations/crossover/rescue and baseline/recovery materials. No exercise/rehabilitation plans or treatment-replacement guidance. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Are allocation counts distinguished from functional-test/harms denominators?",
      "needed": "230 allocated, 114/116; endpoint-specific observation",
      "role": "Required",
      "role_reason": "Needed to connect 230 allocated, 114/116; endpoint-specific observation with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for 230 allocated, 114/116; endpoint-specific observation together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Original group flow, 24-week test observation/analysis, missingness/imputation/dropout and harms-exposure denominators. No new dropout counts/rates or summing of limbs/tests. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "What are the work limb-symmetry test and units?",
      "needed": "Maximal heel-rise work; injured/uninjured ×100",
      "role": "Required",
      "role_reason": "Needed to connect maximal heel-rise work; injured/uninjured ×100 with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for maximal heel-rise work; injured/uninjured ×100 together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Original test definitions/standardization, work units/measurement, limb denominators, interpretation/repetition and analysis materials. This is not equated with height, repetitions or a total score. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "Are group indices distinguished from percentage-point between-group differences?",
      "needed": "34.67% versus 38.54%; adjusted difference",
      "role": "Required",
      "role_reason": "Needed to connect 34.67% versus 38.54%; adjusted difference with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for 34.67% versus 38.54%; adjusted difference together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Original group baseline/final values, index/work variation, estimand/adjusted model and denominators/missingness. No new difference/CI calculation. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "What are the original primary effect, CI and P?",
      "needed": "−3.87%p·CI−10.45~2.71·P=.23",
      "role": "Required",
      "role_reason": "Needed to connect −3.87 percentage points; CI −10.45–2.71; P=.23 with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for −3.87 percentage points; CI −10.45–2.71; P=.23 together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Original estimation model, adjustment/variation, estimand, tests/CI and clinical-importance/denominator materials. No new effect/CI/P or invented quantities. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "How far is the relationship between +10 percentage points and the CI upper bound preserved?",
      "needed": "Sample-size/power assumption and original exclusion statement",
      "role": "Required",
      "role_reason": "Needed to connect sample-size/power assumption and original exclusion statement with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for sample-size/power assumption and original exclusion statement together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Original sample-size plans, effect assumption/source, test/CI and estimand materials. +10 percentage points is not used as an observed effect or a subgroup/other-endpoint effect. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Is +10 percentage points a validated minimum clinically important difference?",
      "needed": "Previous-trial observation versus clinical threshold",
      "role": "Required",
      "role_reason": "Needed to connect previous-trial observation versus clinical threshold with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for previous-trial observation versus clinical threshold together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Externally validated clinical thresholds/patient importance, prespecification, exact effects/CI and applicability materials. No new MCID, score or grade. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Are objective functional testing and patient reports separated?",
      "needed": "24-week work index and ATRS",
      "role": "Required",
      "role_reason": "Needed to connect 24-week work index and ATRS with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for 24-week work index and ATRS together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Original instruments/tests, scores/clinical importance, denominators/timepoints and prespecified plans. Index values are not converted to patient-symptom/daily-function values. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "Are original 24-week ATRS values preserved separately?",
      "needed": "64.99 versus 65.53; adjusted difference −.54",
      "role": "Supplementary",
      "role_reason": "Needed to connect 64.99 versus 65.53; adjusted difference −.54 with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for 64.99 versus 65.53; adjusted difference −.54 together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Original ATRS definitions, group values/variation, estimand/hierarchy, denominator/missingness and clinical thresholds. Percentage-point/LSI effects are not copied to ATRS. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "What are the original two-year ATRS values from the same trial?",
      "needed": "82.2 versus 83.8; adjusted difference −.752",
      "role": "Supplementary",
      "role_reason": "Needed to connect 82.2 versus 83.8; adjusted difference −.752 with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for 82.2 versus 83.8; adjusted difference −.752 together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Original two-year observation/analysis denominators, follow-up loss/missingness, ATRS plans/models and exposure/harms. Long-term effects/CI are not transferred to 24-week LSI. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Is the two-year report defined as long-term repetition of the objective test?",
      "needed": "Long-term ATRS and unverified long-term work testing",
      "role": "Required",
      "role_reason": "Needed to connect long-term ATRS and unverified long-term work testing with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for long-term ATRS and unverified long-term work testing together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Complete long-term measurements/results, test-specific denominators/timepoints and plans/effects/CI. Unread materials are not declared to show that other tests were unmeasured. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "Are ITT/multiple-imputation sensitivity analyses separated from actual missingness?",
      "needed": "Allocated-group primary analysis and prespecified imputation checks",
      "role": "Required",
      "role_reason": "Needed to connect allocated-group primary analysis and prespecified imputation checks with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for allocated-group primary analysis and prespecified imputation checks together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Group flow, observed/analyzed/imputed denominators, missingness reasons, imputation assumptions/sensitivity and long-term follow-up. No new missing counts/rates or reanalysis. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Are original allocation/masking roles preserved?",
      "needed": "Central web allocation; participant/assessor masking",
      "role": "Required",
      "role_reason": "Needed to connect central web allocation; participant/assessor masking with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for central web allocation; participant/assessor masking together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Original allocation concealment/implementation, masking success/unmasking, assessment/missingness/deviation materials. Original B0/robust-design wording is parent history; no official RoB review is performed here. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Are primary plans/registration distinguished from long-term report hierarchy?",
      "needed": "NCT/ISRCTN and the same PATH-2 registrations",
      "role": "Required",
      "role_reason": "Needed to connect nCT/ISRCTN and the same PATH-2 registrations with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for nCT/ISRCTN and the same PATH-2 registrations together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Registration/protocol/SAP versions/timing, 24-week/long-term endpoints, analysis/multiplicity and changes. No guessed official URLs or new certification of prespecification. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Is a null superiority trial interpreted as equivalence/noninferiority?",
      "needed": "Original superiority design, effect and importance",
      "role": "Required",
      "role_reason": "Needed to connect original superiority design, effect and importance with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for original superiority design, effect and importance together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Prespecified superiority/estimand, original CI/importance and externally validated clinical thresholds. No new invented values, grade or clinical certification. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N20",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Are complication denominators distinguished from total event counts?",
      "needed": "At least one complication: 84/113 versus 90/116",
      "role": "Supplementary",
      "role_reason": "Needed to connect at least one complication: 84/113 versus 90/116 with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for at least one complication: 84/113 versus 90/116 together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Original group harms denominators/exposure, event/reporter definitions, collection/grading, discontinuation/relatedness and periods. This is not converted to an index effect or absence of all harms. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N21",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Are original rerupture/DVT and myocardial-infarction descriptions separated?",
      "needed": "Similarity; one STEMI 2.5 hours later; possible indirect relation",
      "role": "Supplementary",
      "role_reason": "Needed to connect similarity; one STEMI 2.5 hours later; possible indirect relation with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for similarity; one STEMI 2.5 hours later; possible indirect relation together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Event-specific collection/denominators, exposure/timing, clinical course/alternative causes, relatedness/discontinuation and long-term materials. No new harms rates/causal calculations or blood-draw/injection/treatment procedures. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Is acute rupture extended to chronic tendinopathy/other PRP?",
      "needed": "Boundaries across population, preparation, repeated injections and surgery",
      "role": "Required",
      "role_reason": "Needed to connect boundaries across population, preparation, repeated injections and surgery with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for boundaries across population, preparation, repeated injections and surgery together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Direct population/formulation/comparator, function/harms, periods/denominators/effects/CI for each other question. No PRP/tendon-treatment replacement or exercise/rehabilitation/injection instructions. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "What is the actual scope of reading/acquisition?",
      "needed": "Preserved summary and external materials",
      "role": "Required",
      "role_reason": "Needed to connect preserved summary and external materials with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for preserved summary and external materials together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Records of actual material acquisition/reading scope, versions and dates. No external-link/click/access testing. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Are historical registration/prespecification and current reading separated?",
      "needed": "Original registration identifiers, timing and plans",
      "role": "Required",
      "role_reason": "Needed to connect original registration identifiers, timing and plans with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for original registration identifiers, timing and plans together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Actual registration versions/publication, recruitment/start/changes, endpoints/models/analyses and links to original reports. Only history is preserved; no current plan/prespecification certification. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "Have protocol/SAP and analysis/missing-data plans been acquired?",
      "needed": "Separate materials for prespecified plans/changes",
      "role": "Required",
      "role_reason": "Needed to connect separate materials for prespecified plans/changes with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for separate materials for prespecified plans/changes together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Original protocol, SAP, revisions, estimands/denominators/analyses, all endpoints and publication timing. Unread documents are not declared absent. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Are sponsorship/funding, products, authors and research involvement separated?",
      "needed": "Four company-involvement items and institution/foundation support",
      "role": "Required",
      "role_reason": "Needed to connect four company-involvement items and institution/foundation support with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for four company-involvement items and institution/foundation support together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Individual original materials on company cash funding, product support, employee authors/outside relationships, design/analysis/data control and other institutional support. Original I2 is not used as new certification of all items/independence. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "Are unmeasured outcomes, null endpoints and unverified details separated?",
      "needed": "Question/results and access gaps",
      "role": "Required",
      "role_reason": "Needed to connect question/results and access gaps with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for question/results and access gaps together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Original direct-measurement/endpoint tables, estimands/denominators, plans and actual-access records. Unread is not substituted for unreported, or null for exactly zero effect/equivalence. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "Are reports, trials, people, tests/timepoints and sibling sheets separated?",
      "needed": "Linked records versus unique trials/participants",
      "role": "Required",
      "role_reason": "Needed to connect linked records versus unique trials/participants with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for linked records versus unique trials/participants together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Original report/registration, cohort/test/timepoint, event/repetition/observation and overlap relationships. Unique-trial counts/participant totals remain not recorded. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "Are the original single trial and separate independent replication distinguished?",
      "needed": "Parent R1/I2, follow-up and confirmation",
      "role": "Supplementary",
      "role_reason": "Needed to connect parent R1/I2, follow-up and confirmation with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for parent R1/I2, follow-up and confirmation together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Confirmatory materials with separate prespecified plans, direct population/intervention/comparator/endpoint/period, denominators/effects/CI and disclosed funding/author relationships for the selected question. No new search/independence judgment 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": "Are the subclaim grade and parent score/axes preserved?",
      "needed": "Selected D grade, absent subclaim values and parent D34",
      "role": "Required",
      "role_reason": "Needed to connect selected D grade, absent subclaim values and parent D34 with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for selected D grade, absent subclaim values and parent D34 together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Materials for existing subclaim/parent-boundary review and actual corrections. No new grade/score or official RoB 2/GRADE certification. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "Are Korean/English manuscripts, original citations and absent fields preserved?",
      "needed": "Both original languages and absent separate classification information",
      "role": "Required",
      "role_reason": "Needed to connect both original languages and absent separate classification information with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for both original languages and absent separate classification information together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Materials needed for review of terminology, endpoints/effects/test units, selected scope and absent fields in both languages. Production explanations are distinguished from original records. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N32",
      "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 and new conditions/application with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for original 2026-08-26 and new conditions/application together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Materials for updates separating original texts, events, conditions/observations and verdict decisions when new evidence/corrections arise. Historical wording is not used as completed clinical content review in this work. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N33",
      "question_type": "Evidence condition",
      "question": "What direct materials would fill the selected gaps?",
      "needed": "Direct endpoints, estimands/CI and denominators/follow-up",
      "role": "Supplementary",
      "role_reason": "Needed to connect direct endpoints, estimands/CI and denominators/follow-up with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for direct endpoints, estimands/CI and denominators/follow-up together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Original tables/plans, direct population/comparator/endpoints, estimands/CI, observation/tests/denominators, actual exposure/adherence, separate confirmation and long-term harms. Only needs are recorded; no new search/research here. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N34",
      "question_type": "Evidence condition",
      "question": "Are applicability records distinguished from content review and treatment instructions?",
      "needed": "Applicability records, existing candidate history and content review",
      "role": "Supplementary",
      "role_reason": "Needed to connect applicability records, existing candidate history and content review with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish the acute population, autologous PRP/imitation procedure/concurrent care, 24-week objective work index/denominators/units, group values/adjusted effects/CI, +10-percentage-point power assumption/clinical threshold, ATRS/two-year follow-up of the same trial, follow-up and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions.",
      "criterion": "Show original materials for applicability records, existing candidate history and content review together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production",
      "condition_origin": "Preserved applicability conditions for the existing subclaim; not preregistration, an official tool or completed content review",
      "proposed_research": "Materials needed: Existing content review and later actual-material/correction work. The historical production did not perform clinical original-material review, external access, new calculations, grade changes or PRP/blood-draw/injection/rehabilitation/exercise/tendon/treatment-replacement instructions. Only material requests/research needs are recorded; no search or research was performed in that production."
    }
  ]
}