# One autologous PRP injection × 24-week work limb-symmetry index — Null result, power assumption and gaps

Verdict 2970 · Evidence Check

Stored-material review date: Not recorded  
Original evidence cut-off: 2026-08-26  
Review-criteria version: 1.0  
Public page/material preparation date: 2026-10-13

Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect.

## Assessment scope

- 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
- Ingredient, formulation and route: 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
- Measured outcome: 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
- Questions outside this scope: 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

## Checklist items

### N01 · Which existing work limb-symmetry claim is being transferred?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Materials for the selected measure/estimand, timepoint/denominator, clinical threshold and existing question-boundary review. Parent scores are not used to fill the subclaim.
- Required materials and conditions: Selected wording, subclaim grade D and parent context
- Materials to obtain first: Materials for the selected measure/estimand, timepoint/denominator, clinical threshold and existing question-boundary review. Parent scores are not used to fill the subclaim.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R01

### N02 · Which acute rupture population?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Eligibility/exclusion, injury/diagnosis, baseline function, comorbidities/treatment and direct materials for other populations. No PRP/tendon-management instructions.
- Required materials and conditions: Complete acute midsubstance rupture within 12 days; nonoperative care
- Materials to obtain first: Eligibility/exclusion, injury/diagnosis, baseline function, comorbidities/treatment and direct materials for other populations. No PRP/tendon-management instructions.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R01

### N03 · What was the study PRP exposure?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Original study-product/composition, manufacturing/quantities, actual-exposure and adherence/deviation materials. No blood-draw/manufacturing/injection procedures or product recommendations.
- Required materials and conditions: One autologous PRP injection versus other preparations/repeated injections
- Materials to obtain first: Original study-product/composition, manufacturing/quantities, actual-exposure and adherence/deviation materials. No blood-draw/manufacturing/injection procedures or product recommendations.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R01

### N04 · Are the comparator and common procedures preserved as research context?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Actual PRP/imitation procedure, concurrent-care/exposure, masking and deviation materials. No new injection/blood-draw/rehabilitation procedures are authored.
- Required materials and conditions: Imitation dry needling and common local anesthesia/blood draw
- Materials to obtain first: Actual PRP/imitation procedure, concurrent-care/exposure, masking and deviation materials. No new injection/blood-draw/rehabilitation procedures are authored.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R01

### N05 · Does identical immobilization/rehabilitation imply identical actual adherence?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Group-specific actual concurrent care, exposure/adherence, deviations/crossover/rescue and baseline/recovery materials. No exercise/rehabilitation plans or treatment-replacement guidance.
- Required materials and conditions: Concurrent-care plans and actual exposure
- Materials to obtain first: Group-specific actual concurrent care, exposure/adherence, deviations/crossover/rescue and baseline/recovery materials. No exercise/rehabilitation plans or treatment-replacement guidance.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R01

### N06 · Are allocation counts distinguished from functional-test/harms denominators?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: 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.
- Required materials and conditions: 230 allocated, 114/116; endpoint-specific observation
- Materials to obtain first: 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.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R01

### N07 · What are the work limb-symmetry test and units?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: 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.
- Required materials and conditions: Maximal heel-rise work; injured/uninjured ×100
- Materials to obtain first: 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.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R01

### N08 · Are group indices distinguished from percentage-point between-group differences?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Original group baseline/final values, index/work variation, estimand/adjusted model and denominators/missingness. No new difference/CI calculation.
- Required materials and conditions: 34.67% versus 38.54%; adjusted difference
- Materials to obtain first: Original group baseline/final values, index/work variation, estimand/adjusted model and denominators/missingness. No new difference/CI calculation.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R01

### N09 · What are the original primary effect, CI and P?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Original estimation model, adjustment/variation, estimand, tests/CI and clinical-importance/denominator materials. No new effect/CI/P or invented quantities.
- Required materials and conditions: −3.87%p·CI−10.45~2.71·P=.23
- Materials to obtain first: Original estimation model, adjustment/variation, estimand, tests/CI and clinical-importance/denominator materials. No new effect/CI/P or invented quantities.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R01

### N10 · How far is the relationship between +10 percentage points and the CI upper bound preserved?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: 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.
- Required materials and conditions: Sample-size/power assumption and original exclusion statement
- Materials to obtain first: 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.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R01

### N11 · Is +10 percentage points a validated minimum clinically important difference?

Verification status: Unverified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Externally validated clinical thresholds/patient importance, prespecification, exact effects/CI and applicability materials. No new MCID, score or grade.
- Required materials and conditions: Previous-trial observation versus clinical threshold
- Materials to obtain first: Externally validated clinical thresholds/patient importance, prespecification, exact effects/CI and applicability materials. No new MCID, score or grade.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R01

### N12 · Are objective functional testing and patient reports separated?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Original instruments/tests, scores/clinical importance, denominators/timepoints and prespecified plans. Index values are not converted to patient-symptom/daily-function values.
- Required materials and conditions: 24-week work index and ATRS
- Materials to obtain first: Original instruments/tests, scores/clinical importance, denominators/timepoints and prespecified plans. Index values are not converted to patient-symptom/daily-function values.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R01

### N13 · Are original 24-week ATRS values preserved separately?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Original ATRS definitions, group values/variation, estimand/hierarchy, denominator/missingness and clinical thresholds. Percentage-point/LSI effects are not copied to ATRS.
- Required materials and conditions: 64.99 versus 65.53; adjusted difference −.54
- Materials to obtain first: Original ATRS definitions, group values/variation, estimand/hierarchy, denominator/missingness and clinical thresholds. Percentage-point/LSI effects are not copied to ATRS.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R01

### N14 · What are the original two-year ATRS values from the same trial?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: 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.
- Required materials and conditions: 82.2 versus 83.8; adjusted difference −.752
- Materials to obtain first: 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.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R01, R02

### N15 · Is the two-year report defined as long-term repetition of the objective test?

Verification status: Unverified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: 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.
- Required materials and conditions: Long-term ATRS and unverified long-term work testing
- Materials to obtain first: 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.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R02

### N16 · Are ITT/multiple-imputation sensitivity analyses separated from actual missingness?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Group flow, observed/analyzed/imputed denominators, missingness reasons, imputation assumptions/sensitivity and long-term follow-up. No new missing counts/rates or reanalysis.
- Required materials and conditions: Allocated-group primary analysis and prespecified imputation checks
- Materials to obtain first: Group flow, observed/analyzed/imputed denominators, missingness reasons, imputation assumptions/sensitivity and long-term follow-up. No new missing counts/rates or reanalysis.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R01

### N17 · Are original allocation/masking roles preserved?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: 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.
- Required materials and conditions: Central web allocation; participant/assessor masking
- Materials to obtain first: 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.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R01

### N18 · Are primary plans/registration distinguished from long-term report hierarchy?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Registration/protocol/SAP versions/timing, 24-week/long-term endpoints, analysis/multiplicity and changes. No guessed official URLs or new certification of prespecification.
- Required materials and conditions: NCT/ISRCTN and the same PATH-2 registrations
- Materials to obtain first: Registration/protocol/SAP versions/timing, 24-week/long-term endpoints, analysis/multiplicity and changes. No guessed official URLs or new certification of prespecification.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R01, R02

### N19 · Is a null superiority trial interpreted as equivalence/noninferiority?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Prespecified superiority/estimand, original CI/importance and externally validated clinical thresholds. No new invented values, grade or clinical certification.
- Required materials and conditions: Original superiority design, effect and importance
- Materials to obtain first: Prespecified superiority/estimand, original CI/importance and externally validated clinical thresholds. No new invented values, grade or clinical certification.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R01

### N20 · Are complication denominators distinguished from total event counts?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: 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.
- Required materials and conditions: At least one complication: 84/113 versus 90/116
- Materials to obtain first: 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.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R01

### N21 · Are original rerupture/DVT and myocardial-infarction descriptions separated?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: 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.
- Required materials and conditions: Similarity; one STEMI 2.5 hours later; possible indirect relation
- Materials to obtain first: 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.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R01

### N22 · Is acute rupture extended to chronic tendinopathy/other PRP?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Direct population/formulation/comparator, function/harms, periods/denominators/effects/CI for each other question. No PRP/tendon-treatment replacement or exercise/rehabilitation/injection instructions.
- Required materials and conditions: Boundaries across population, preparation, repeated injections and surgery
- Materials to obtain first: Direct population/formulation/comparator, function/harms, periods/denominators/effects/CI for each other question. No PRP/tendon-treatment replacement or exercise/rehabilitation/injection instructions.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R01

### N23 · What is the actual scope of reading/acquisition?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Records of actual material acquisition/reading scope, versions and dates. No external-link/click/access testing.
- Required materials and conditions: Preserved summary and external materials
- Materials to obtain first: Records of actual material acquisition/reading scope, versions and dates. No external-link/click/access testing.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R01, R02

### N24 · Are historical registration/prespecification and current reading separated?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Actual registration versions/publication, recruitment/start/changes, endpoints/models/analyses and links to original reports. Only history is preserved; no current plan/prespecification certification.
- Required materials and conditions: Original registration identifiers, timing and plans
- Materials to obtain first: Actual registration versions/publication, recruitment/start/changes, endpoints/models/analyses and links to original reports. Only history is preserved; no current plan/prespecification certification.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R01, R02

### N25 · Have protocol/SAP and analysis/missing-data plans been acquired?

Verification status: Unverified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Original protocol, SAP, revisions, estimands/denominators/analyses, all endpoints and publication timing. Unread documents are not declared absent.
- Required materials and conditions: Separate materials for prespecified plans/changes
- Materials to obtain first: Original protocol, SAP, revisions, estimands/denominators/analyses, all endpoints and publication timing. Unread documents are not declared absent.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R01, R02

### N26 · Are sponsorship/funding, products, authors and research involvement separated?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: 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.
- Required materials and conditions: Four company-involvement items and institution/foundation support
- Materials to obtain first: 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.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R01, R02

### N27 · Are unmeasured outcomes, null endpoints and unverified details separated?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: 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.
- Required materials and conditions: Question/results and access gaps
- Materials to obtain first: 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.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R01, R02

### N28 · Are reports, trials, people, tests/timepoints and sibling sheets separated?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Original report/registration, cohort/test/timepoint, event/repetition/observation and overlap relationships. Unique-trial counts/participant totals remain not recorded.
- Required materials and conditions: Linked records versus unique trials/participants
- Materials to obtain first: Original report/registration, cohort/test/timepoint, event/repetition/observation and overlap relationships. Unique-trial counts/participant totals remain not recorded.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R01, R02

### N29 · Are the original single trial and separate independent replication distinguished?

Verification status: Unverified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: 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.
- Required materials and conditions: Parent R1/I2, follow-up and confirmation
- Materials to obtain first: 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.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R01, R02

### N30 · Are the subclaim grade and parent score/axes preserved?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Materials for existing subclaim/parent-boundary review and actual corrections. No new grade/score or official RoB 2/GRADE certification.
- Required materials and conditions: Selected D grade, absent subclaim values and parent D34
- Materials to obtain first: Materials for existing subclaim/parent-boundary review and actual corrections. No new grade/score or official RoB 2/GRADE certification.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R01

### N31 · Are Korean/English manuscripts, original citations and absent fields preserved?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: 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.
- Required materials and conditions: Both original languages and absent separate classification information
- Materials to obtain first: 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.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R01

### N32 · Are source dates/corrections/history separated from production dates?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: 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.
- Required materials and conditions: Original 2026-08-26 and new conditions/application
- Materials to obtain first: 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.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R01

### N33 · What direct materials would fill the selected gaps?

Verification status: Unverified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: 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.
- Required materials and conditions: Direct endpoints, estimands/CI and denominators/follow-up
- Materials to obtain first: 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.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R01, R02

### N34 · Are applicability records distinguished from content review and treatment instructions?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: 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.
- Required materials and conditions: Applicability records, existing candidate history and content review
- Materials to obtain first: 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.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production
- Related sources: R01

## Evidence and sources

### R01

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.

[PubMed](https://pubmed.ncbi.nlm.nih.gov/31748208/)

Materials actually read: Preserved summary read; external abstracts/full texts/registrations/plans unread  
Findings recorded in the summary: 34.67% vs 38.54%; adjusted difference −3.87 percentage points (95% CI −10.45–2.71), P=0.23  
Record level: Parent-endpoint summary in the original evidence list; directness/scope for selected and other endpoints are distinguished in condition rows/roles  
Independent replication: 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.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored summary | Local preserved copy of the complete parent summary | Stored summary read | Summary read | 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. |
| External abstract | Original identifiers/references or required-material entries; detailed publication/access status remains unverified | Unread; access testing not performed | Not read | 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. |
| External full text | Original identifiers/references or required-material entries; detailed publication/access status remains unverified | Unread; access testing not performed | Not read | 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. |
| Registration material | Original identifiers/references or required-material entries; detailed publication/access status remains unverified | Unread; access testing not performed | Not read | 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. |
| Protocol/SAP | Original identifiers/references or required-material entries; detailed publication/access status remains unverified | Unread; access testing not performed | Not read | 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. |

### R02

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.

[PubMed](https://pubmed.ncbi.nlm.nih.gov/36317349/)

Materials actually read: Preserved summary read; external abstracts/full texts/registrations/plans unread  
Findings recorded in the summary: 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  
Record 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  
Independent replication: 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.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored summary | Local preserved copy of the complete parent summary | Stored summary read | Summary read | 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. |
| External abstract | Original identifiers/references or required-material entries; detailed publication/access status remains unverified | Unread; access testing not performed | Not read | 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. |
| External full text | Original identifiers/references or required-material entries; detailed publication/access status remains unverified | Unread; access testing not performed | Not read | 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. |
| Registration material | Original identifiers/references or required-material entries; detailed publication/access status remains unverified | Unread; access testing not performed | Not read | 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. |
| Protocol/SAP | Original identifiers/references or required-material entries; detailed publication/access status remains unverified | Unread; access testing not performed | Not read | 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. |

## Review criteria and methods

These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score.

- M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.
- M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.
- M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.
- M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.
- M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

## What the statuses mean

- 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

## Change history

2026-10-13 · Public page/materials 1.0. Public views and materials were prepared from the existing 34 items. No new clinical search, verification-status changes or scoring were performed.