{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2970-s0", "verdict_number": "2970", "title": "One autologous PRP injection × 24-week work limb-symmetry index — Null result, power assumption and gaps", "view_version": "1.0", "view_created_date": "2026-10-13", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "230 patients, 114/116, suitable for nonoperative care of complete acute midsubstance rupture within 12 days, at 19 UK NHS hospitals; detailed 24-week observation/analysis denominators remain unverified", "intervention": "One added autologous PRP injection; detailed composition/quantities/volume remain unverified; separated from repeated injections, other preparations, chronic tendinopathy and surgical augmentation", "dose": "Original study exposure identified: one autologous PRP injection in acute rupture within 12 days; no blood-draw/manufacturing/injection/rehabilitation/exercise instructions", "comparator": "Original context of imitation dry needling, local anesthesia/blood draw in both groups and identical immobilization/rehabilitation; detailed actual exposure/adherence remain unverified", "endpoint": "Objective primary endpoint: injured/uninjured limb-symmetry index for maximal heel-rise work at 24 weeks; separated from ATRS/long-term patient reports", "duration": "24-week primary outcome and two-year ATRS follow-up of the same PATH-2 trial; detailed endpoint/timepoint-specific denominators, actual exposure and dropout remain unverified", "excluded_extensions": [ "Mixing objective index, ATRS/long-term follow-up, power assumptions/clinical thresholds or other-population results as the same effect", "Summing the same reports, people, limbs, tests, groups, events, timepoints, references or sibling sheets as new independent trials/participants", "Creating new effects/CI/invented quantities, equivalence/zero-effect claims, reassessment/grades or independence certification from original numbers", "PRP/blood-draw/injection/rehabilitation/exercise/tendon or treatment-replacement instructions" ] }, "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "The selected question is improved 24-week work limb-symmetry index. The original subclaim grade D/note says the CI upper bound excluded the +10-percentage-point power assumption, which was not a validated clinical threshold. Absent subclaim score/status/axes are separated from parent D34/axes.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Materials for the selected measure/estimand, timepoint/denominator, clinical threshold and existing question-boundary review. Parent scores are not used to fill the subclaim.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Materials for the selected measure/estimand, timepoint/denominator, clinical threshold and existing question-boundary review. Parent scores are not used to fill the subclaim." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "PATH-2 involved 230 patients suitable for nonoperative treatment of complete acute midsubstance rupture within 12 days, at 19 UK NHS hospitals. This is not extended to chronic tendinopathy, partial rupture, surgical augmentation or other populations. Existing topic-classification wording is preserved in the complete summary without replacing the population definition.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Eligibility/exclusion, injury/diagnosis, baseline function, comorbidities/treatment and direct materials for other populations. No PRP/tendon-management instructions.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Eligibility/exclusion, injury/diagnosis, baseline function, comorbidities/treatment and direct materials for other populations. No PRP/tendon-management instructions." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "The original intervention added one autologous PRP injection to acute nonoperative treatment. PRP composition, cell/platelet quantities, volume/manufacturing and actual exposure are not established in the summary. This is not extended to other preparations or repeated-injection effects.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Original study-product/composition, manufacturing/quantities, actual-exposure and adherence/deviation materials. No blood-draw/manufacturing/injection procedures or product recommendations.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original study-product/composition, manufacturing/quantities, actual-exposure and adherence/deviation materials. No blood-draw/manufacturing/injection procedures or product recommendations." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "The original study description says both groups received local anesthesia, blood draw and the same immobilization/rehabilitation, while the control had needle insertion only into the rupture gap. This is research context, not procedural guidance; the control is not changed to no treatment or another active injection.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Actual PRP/imitation procedure, concurrent-care/exposure, masking and deviation materials. No new injection/blood-draw/rehabilitation procedures are authored.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual PRP/imitation procedure, concurrent-care/exposure, masking and deviation materials. No new injection/blood-draw/rehabilitation procedures are authored." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "The original materials record identical immobilization/rehabilitation. Actual implementation/adherence, crossover/rescue/additional care and return-to-sport/exercise exposure remain unverified in detail. PRP-alone/rehabilitation-alone effects or identical actual exposure between groups are not newly certified.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Group-specific actual concurrent care, exposure/adherence, deviations/crossover/rescue and baseline/recovery materials. No exercise/rehabilitation plans or treatment-replacement guidance.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group-specific actual concurrent care, exposure/adherence, deviations/crossover/rescue and baseline/recovery materials. No exercise/rehabilitation plans or treatment-replacement guidance." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "Original allocation was 230 participants, 114/116. Detailed 24-week functional-test observation/analysis and completion/dropout remain unverified; harms denominators 84/113 and 90/116 are separate. Allocation/harms denominators are not used to fill primary-test denominators.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "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.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original group flow, 24-week test observation/analysis, missingness/imputation/dropout and harms-exposure denominators. No new dropout counts/rates or summing of limbs/tests." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "The original primary endpoint is the injured/uninjured limb-symmetry index for maximal work during the heel-rise endurance test at 24 weeks. Existing research-product information records injured/uninjured ×100, higher is better. Only the formula is preserved; no actual patient/test-value calculation or test-procedure guidance.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "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.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original test definitions/standardization, work units/measurement, limb denominators, interpretation/repetition and analysis materials. This is not equated with height, repetitions or a total score." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "At 24 weeks the index was PRP 34.67% versus imitation dry needling 38.54%, with adjusted difference −3.87 percentage points. Percentages versus percentage points and group estimates versus between-group adjustment are distinguished. No within-group recovery/absolute work, new unadjusted difference or ratio is calculated.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Original group baseline/final values, index/work variation, estimand/adjusted model and denominators/missingness. No new difference/CI calculation.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original group baseline/final values, index/work variation, estimand/adjusted model and denominators/missingness. No new difference/CI calculation." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "Original adjusted mean difference −3.87 percentage points (CI −10.45–2.71), P=.23 is a null 24-week functional result, with PRP lower. This does not newly establish harms, equivalence/noninferiority or exclusion of all benefits.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Original estimation model, adjustment/variation, estimand, tests/CI and clinical-importance/denominator materials. No new effect/CI/P or invented quantities.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original estimation model, adjustment/variation, estimand, tests/CI and clinical-importance/denominator materials. No new effect/CI/P or invented quantities." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "The existing reader answer/core summary records that the observed CI upper bound +2.71 percentage points excluded the +10-percentage-point benefit used in sample-size planning. That comparison/wording is preserved without new tests/calculations or extension to excluding benefits of every magnitude.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "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.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original 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." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "Existing research-product information/verdict reasons explicitly state that +10 percentage points was a power assumption drawn from an earlier trial, not a validated minimum clinically important difference. Parent precision C0 and the single null-trial scope are retained; no new clinical-importance threshold is set.", "condition_status": "Unverified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Externally validated clinical thresholds/patient importance, prespecification, exact effects/CI and applicability materials. No new MCID, score or grade.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Externally validated clinical thresholds/patient importance, prespecification, exact effects/CI and applicability materials. No new MCID, score or grade." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "The original primary endpoint is an objective muscle-tendon function test; ATRS is separate patient-reported-function context. The two scores/units, timepoints and hierarchy are not averaged/summed as the same effect.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Original instruments/tests, scores/clinical importance, denominators/timepoints and prespecified plans. Index values are not converted to patient-symptom/daily-function values.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original instruments/tests, scores/clinical importance, denominators/timepoints and prespecified plans. Index values are not converted to patient-symptom/daily-function values." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "Original 24-week ATRS 64.99 versus 65.53, adjusted difference −0.54 (CI −4.90–3.81), P=.81 was null. This is a different endpoint from work-index −3.87 percentage points/CI/P; denominator, exact hierarchy and model details remain unverified.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Original ATRS definitions, group values/variation, estimand/hierarchy, denominator/missingness and clinical thresholds. Percentage-point/LSI effects are not copied to ATRS.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original ATRS definitions, group values/variation, estimand/hierarchy, denominator/missingness and clinical thresholds. Percentage-point/LSI effects are not copied to ATRS." }, { "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.", "current_reports": [ "R01", "R02" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "Original two-year ATRS was 82.2 versus 83.8, adjusted difference −0.752 (CI −5.523–4.020), P=.757, a null result. This long-term report follows the same trial/registrations/participants and is not new independent replication. No new difference is calculated from original adjusted differences or rounded group values.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "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.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original 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." }, { "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.", "current_reports": [ "R02" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "The original long-term description concerns ATRS. Two-year work limb-symmetry index/other objective tests, denominators and results are not provided within the currently preserved scope. Null ATRS from the same trial is not copied as a null result for every long-term functional test.", "condition_status": "Unverified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "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.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "The original materials record ITT analysis and prespecified multiple-imputation sensitivity checks for missing 24-week data. Detailed group-specific missingness/test availability, dropout/imputation models and sensitivity values remain unverified. ITT is not changed to complete observation or zero missing-data bias.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Group flow, observed/analyzed/imputed denominators, missingness reasons, imputation assumptions/sensitivity and long-term follow-up. No new missing counts/rates or reanalysis.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group flow, observed/analyzed/imputed denominators, missingness reasons, imputation assumptions/sensitivity and long-term follow-up. No new missing counts/rates or reanalysis." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "Original materials distinguish secure central web allocation, revealed only to the injector after enrollment, participant/assessor masking and inability to mask injectors. Functional-assessor masking is not extended to masking of every role.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "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.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original 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." }, { "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.", "current_reports": [ "R01", "R02" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "Original agreement of the objective 24-week primary function with NCT02302664/ISRCTN54992179 and prospective-registration wording are preserved. Shared registration in long-term reporting does not certify an independent trial; detailed two-year/secondary-endpoint plans and changes remain unread.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Registration/protocol/SAP versions/timing, 24-week/long-term endpoints, analysis/multiplicity and changes. No guessed official URLs or new certification of prespecification.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration/protocol/SAP versions/timing, 24-week/long-term endpoints, analysis/multiplicity and changes. No guessed official URLs or new certification of prespecification." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "The original evidence-list design is a blinded placebo-controlled superiority trial. Original null-result/exclusion-of-the-+10-percentage-point-power-assumption wording does not newly establish equivalence/noninferiority or absence of all clinical benefits.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Prespecified superiority/estimand, original CI/importance and externally validated clinical thresholds. No new invented values, grade or clinical certification.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Prespecified superiority/estimand, original CI/importance and externally validated clinical thresholds. No new invented values, grade or clinical certification." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "Original at-least-one-complication figures are 84/113 (74%) versus 90/116 (78%). People with at least one event are separate from total event counts/types, allocation 114/116 and functional-test denominators. No new event total, rate or risk difference is calculated.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "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.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original 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." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "Original harms wording records similar rerupture/deep-vein thrombosis and one ST-elevation myocardial infarction 2.5 hours after PRP injection, with a possible indirect relation acknowledged. Type-specific denominators/effects/CI remain unverified; temporal proximity is not changed to definite causation or no relation.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "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.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Event-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." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "Existing advertising-interpretation wording is limited to one added injection in nonoperative acute complete midsubstance rupture care. Existing counterpoint 1699 is preserved only as context for a separate chronic-tendinopathy verdict, without reading/transferring it here. This is not extended to other preparations, repeated injections or surgical augmentation.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Direct population/formulation/comparator, function/harms, periods/denominators/effects/CI for each other question. No PRP/tendon-treatment replacement or exercise/rehabilitation/injection instructions.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct population/formulation/comparator, function/harms, periods/denominators/effects/CI for each other question. No PRP/tendon-treatment replacement or exercise/rehabilitation/injection instructions." }, { "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.", "current_reports": [ "R01", "R02" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "The complete parent summary was read for production and preserved in its original form. Summary reading concerns preserved materials; external abstracts/full texts/registrations/protocols/SAP remain unread. Original citation/URL existence is not upgraded to external reading in this work.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Records of actual material acquisition/reading scope, versions and dates. No external-link/click/access testing.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Records of actual material acquisition/reading scope, versions and dates. No external-link/click/access testing." }, { "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.", "current_reports": [ "R01", "R02" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "Original NCT02302664/ISRCTN54992179, 24-week-primary agreement and prospective-registration wording are preserved; the two-year report follows the same registrations. Actual versions/plans/access remain unread here; official URLs are not guessed.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Actual registration versions/publication, recruitment/start/changes, endpoints/models/analyses and links to original reports. Only history is preserved; no current plan/prespecification certification.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual registration versions/publication, recruitment/start/changes, endpoints/models/analyses and links to original reports. Only history is preserved; no current plan/prespecification certification." }, { "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.", "current_reports": [ "R01", "R02" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "Original primary/analysis/registration descriptions and historical cross-validation are preserved. Actual protocol/SAP, versions/timing, endpoint-specific models/missingness and hierarchy/multiplicity are not read here.", "condition_status": "Unverified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Original protocol, SAP, revisions, estimands/denominators/analyses, all endpoints and publication timing. Unread documents are not declared absent.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original protocol, SAP, revisions, estimands/denominators/analyses, all endpoints and publication timing. Unread documents are not declared absent." }, { "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.", "current_reports": [ "R01", "R02" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "MRC/NIHR EME, NIHR Oxford BRC/Fellowship/CLAHRC Oxford support and the University of Oxford sponsor are preserved. The declaration of no manufacturer product/analysis/writing/publication support is distinguished from SEL’s outside-trial Pleuristem consulting and KW’s Zimmer Biomet royalties. Detailed company cash funding, employee authors and individual roles are not newly certified.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "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.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01", "R02" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "The null 24-week work result, original CI exclusion of the power-assumption magnitude, absence of a clinical threshold, ATRS/long-term results and unread details are distinguished.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "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.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original direct-measurement/endpoint tables, estimands/denominators, plans and actual-access records. Unread is not substituted for unreported, or null for exactly zero effect/equivalence." }, { "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.", "current_reports": [ "R01", "R02" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "Parent 2970 and both existing subclaims share the same PATH-2 cohort/registrations, 2019 core report and 2022 long-term report. The two-year report is not a separate replication trial; the same people, limbs, tests, groups, timepoints, references and sibling sheets are not summed as new independent trials/participants. Linked-report counts do not certify unique-trial/participant totals.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Original report/registration, cohort/test/timepoint, event/repetition/observation and overlap relationships. Unique-trial counts/participant totals remain not recorded.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original report/registration, cohort/test/timepoint, event/repetition/observation and overlap relationships. Unique-trial counts/participant totals remain not recorded." }, { "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.", "current_reports": [ "R01", "R02" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "Parent R1/I2 and the single-trial scope are preserved. Timepoints/endpoints in the same participants, sibling sheets and long-term PRP reports are not certified as new independent replication.", "condition_status": "Unverified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "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.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "Selected grade/note and Korean/English question are preserved; absent subclaim score/status/axes remain not recorded. Parent D34, safety and axes are parent context, not transferred to a selected-subclaim score.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Materials for existing subclaim/parent-boundary review and actual corrections. No new grade/score or official RoB 2/GRADE certification.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Materials for existing subclaim/parent-boundary review and actual corrections. No new grade/score or official RoB 2/GRADE certification." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "Original citations/descriptions, evidence, citation lists, axes and selected subclaim records in both parent languages are preserved in the complete summary. Separate Korean/English classification information is absent; new fields are not filled in the original. No comparison with external English full texts.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "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.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "Original 2026-08-26, empty corrections/deliberation and verdict-decision cross-validation are preserved. Original citation/registration descriptions differ from current production/condition freezing/application or completed content review.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "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.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01", "R02" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "Gaps in 24-week work testing, estimands/denominators, power assumptions/clinical thresholds, missingness and harms require corresponding original materials; ATRS/two-year reports or chronic tendinopathy are not substituted.", "condition_status": "Unverified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "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.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original 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." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; acquisition/reading of detailed external materials remains separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread", "observation": "These are applicability records based on the preserved summary. Existing content/question-boundary review remains incomplete; candidate review-pending/production-eligible markers are preserved as history.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "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.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." } ], "reports": [ { "report_id": "R01", "title": "Keene DJ, et al. Platelet rich plasma injection for acute Achilles tendon rupture: PATH-2 randomised, placebo controlled, superiority trial. BMJ. 2019;367:l6132. PMID: 31748208.", "url": "https://pubmed.ncbi.nlm.nih.gov/31748208/", "report_type": "Multicenter participant- and assessor-blinded randomized placebo-controlled superiority trial", "existence": "Report references exist in original citations; external publication/access status remains unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/plans unread", "study_family": "F01", "independent_replication": "The same reports/endpoints/timepoints, long-term follow-up and sibling sheets are not certified as new independent replication", "observed_result": "34.67% vs 38.54%; adjusted difference −3.87 percentage points (95% CI −10.45–2.71), P=0.23", "result_level": "Parent-endpoint summary in the original evidence list; directness/scope for selected and other endpoints are distinguished in condition rows/roles", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Local preserved copy of the complete parent summary", "access_status": "Stored summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only original PubMed URLs/references and wording on shared original registrations are preserved; full-text/registration/plan URLs are not guessed. No new external reading/access or certification of fulfillment." }, { "material_type": "External abstract", "public_status": "Original identifiers/references or required-material entries; detailed publication/access status remains unverified", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Only original PubMed URLs/references and wording on shared original registrations are preserved; full-text/registration/plan URLs are not guessed. No new external reading/access or certification of fulfillment." }, { "material_type": "External full text", "public_status": "Original identifiers/references or required-material entries; detailed publication/access status remains unverified", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Only original PubMed URLs/references and wording on shared original registrations are preserved; full-text/registration/plan URLs are not guessed. No new external reading/access or certification of fulfillment." }, { "material_type": "Registration material", "public_status": "Original identifiers/references or required-material entries; detailed publication/access status remains unverified", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Only original PubMed URLs/references and wording on shared original registrations are preserved; full-text/registration/plan URLs are not guessed. No new external reading/access or certification of fulfillment." }, { "material_type": "Protocol/SAP", "public_status": "Original identifiers/references or required-material entries; detailed publication/access status remains unverified", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Only original PubMed URLs/references and wording on shared original registrations are preserved; full-text/registration/plan URLs are not guessed. No new external reading/access or certification of fulfillment." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/31748208/" } ] }, { "report_id": "R02", "title": "Alsousou J, et al. Platelet-rich plasma injection for acute Achilles tendon rupture: two-year follow-up of the PATH-2 trial. Bone Joint J. 2022. PMID: 36317349.", "url": "https://pubmed.ncbi.nlm.nih.gov/36317349/", "report_type": "Two-year follow-up report of the same PATH-2 participants; not a separate clinical trial", "existence": "Report references exist in original citations; external publication/access status remains unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/plans unread", "study_family": "F01", "independent_replication": "The same reports/endpoints/timepoints, long-term follow-up and sibling sheets are not certified as new independent replication", "observed_result": "Two-year ATRS 82.2 vs 83.8; adjusted difference −0.752 (CI −5.523–4.020), P=.757; follow-up of the same trial", "result_level": "Two-year ATRS context is separated from the existing counterview; the same passage’s 24-week ATRS wording and instrument-specific scopes are distinguished", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Local preserved copy of the complete parent summary", "access_status": "Stored summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only original PubMed URLs/references and wording on shared original registrations are preserved; full-text/registration/plan URLs are not guessed. No new external reading/access or certification of fulfillment." }, { "material_type": "External abstract", "public_status": "Original identifiers/references or required-material entries; detailed publication/access status remains unverified", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Only original PubMed URLs/references and wording on shared original registrations are preserved; full-text/registration/plan URLs are not guessed. No new external reading/access or certification of fulfillment." }, { "material_type": "External full text", "public_status": "Original identifiers/references or required-material entries; detailed publication/access status remains unverified", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Only original PubMed URLs/references and wording on shared original registrations are preserved; full-text/registration/plan URLs are not guessed. No new external reading/access or certification of fulfillment." }, { "material_type": "Registration material", "public_status": "Original identifiers/references or required-material entries; detailed publication/access status remains unverified", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Only original PubMed URLs/references and wording on shared original registrations are preserved; full-text/registration/plan URLs are not guessed. No new external reading/access or certification of fulfillment." }, { "material_type": "Protocol/SAP", "public_status": "Original identifiers/references or required-material entries; detailed publication/access status remains unverified", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Only original PubMed URLs/references and wording on shared original registrations are preserved; full-text/registration/plan URLs are not guessed. No new external reading/access or certification of fulfillment." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/36317349/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." } ], "status_dictionary": { "Partly verified": "Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.", "Unverified": "Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety", "Review incomplete": "Review of existing content incomplete", "Met": "Use only within the relevant conditions after existing content review; no automatic designation in this preparation", "Not reported": "Distinguish only within materials actually read; do not turn unread external materials into unreported findings", "Inaccessible": "Not applied during this preparation because actual access was not tested", "Not applicable": "Use with a reason for non-applicability based on an explicit question boundary", "Conflicting data": "Judge after actual material comparison; review was not performed during this preparation", "Insufficient evidence for the conditions": "Do not use as a clinical grade encompassing currently unread materials" }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "Parent 2970 and both existing subclaims share the same PATH-2 cohort/registrations, 2019 core report and 2022 long-term report. The two-year report is not a separate replication trial; the same people, limbs, tests, groups, timepoints, references and sibling sheets are not summed as new independent trials/participants. Only report/registration/follow-up relationships are linked; unique trials/participants or independence are not certified." }, "history": [ { "date": "2026-10-13", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public views and materials were prepared from the existing 34 items. No new clinical search, verification-status changes or scoring were performed." } ], "language": "en", "translation_date": "2026-10-13" }