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

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Evidence conditionWhich existing work limb-symmetry claim is being transferred?Required	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. R01	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.	Selected wording, subclaim grade D and parent context	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.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionWhich acute rupture population?Required	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. R01	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.	Complete acute midsubstance rupture within 12 days; nonoperative care	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.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionWhat was the study PRP exposure?Required	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. R01	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.	One autologous PRP injection versus other preparations/repeated injections	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.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionAre the comparator and common procedures preserved as research context?Required	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. R01	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.	Imitation dry needling and common local anesthesia/blood draw	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.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionDoes identical immobilization/rehabilitation imply identical actual adherence?Required	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. R01	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.	Concurrent-care plans and actual exposure	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.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionAre allocation counts distinguished from functional-test/harms denominators?Required	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. R01	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.	230 allocated, 114/116; endpoint-specific observation	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.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionWhat are the work limb-symmetry test and units?Required	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. R01	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.	Maximal heel-rise work; injured/uninjured ×100	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.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionAre group indices distinguished from percentage-point between-group differences?Required	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. R01	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.	34.67% versus 38.54%; adjusted difference	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.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionWhat are the original primary effect, CI and P?Required	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. R01	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.	−3.87%p·CI−10.45~2.71·P=.23	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.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionHow far is the relationship between +10 percentage points and the CI upper bound preserved?Required	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. R01	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.	Sample-size/power assumption and original exclusion statement	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.
11	Unverified	Full text not readStored summary read	N11 · Evidence conditionIs +10 percentage points a validated minimum clinically important difference?Required	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. R01	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.	Previous-trial observation versus clinical threshold	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.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionAre objective functional testing and patient reports separated?Required	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. R01	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.	24-week work index and ATRS	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.
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionAre original 24-week ATRS values preserved separately?Supplementary	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. R01	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.	64.99 versus 65.53; adjusted difference −.54	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.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionWhat are the original two-year ATRS values from the same trial?Supplementary	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. R01 R02	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.	82.2 versus 83.8; adjusted difference −.752	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.
15	Unverified	Full text not readStored summary read	N15 · Evidence conditionIs the two-year report defined as long-term repetition of the objective test?Required	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. R02	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.	Long-term ATRS and unverified long-term work testing	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.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionAre ITT/multiple-imputation sensitivity analyses separated from actual missingness?Required	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. R01	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.	Allocated-group primary analysis and prespecified imputation checks	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.
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionAre original allocation/masking roles preserved?Required	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. R01	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.	Central web allocation; participant/assessor masking	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.
18	Partly verified	Full text not readStored summary read	N18 · Evidence conditionAre primary plans/registration distinguished from long-term report hierarchy?Required	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. R01 R02	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.	NCT/ISRCTN and the same PATH-2 registrations	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.
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionIs a null superiority trial interpreted as equivalence/noninferiority?Required	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. R01	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.	Original superiority design, effect and importance	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.
20	Partly verified	Full text not readStored summary read	N20 · Harm-information gaps supplementing the efficacy tableAre complication denominators distinguished from total event counts?Supplementary	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. R01	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.	At least one complication: 84/113 versus 90/116	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.
21	Partly verified	Full text not readStored summary read	N21 · Harm-information gaps supplementing the efficacy tableAre original rerupture/DVT and myocardial-infarction descriptions separated?Supplementary	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. R01	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.	Similarity; one STEMI 2.5 hours later; possible indirect relation	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.
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionIs acute rupture extended to chronic tendinopathy/other PRP?Required	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. R01	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.	Boundaries across population, preparation, repeated injections and surgery	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.
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionWhat is the actual scope of reading/acquisition?Required	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. R01 R02	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.	Preserved summary and external materials	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.
24	Partly verified	Full text not readStored summary read	N24 · Evidence conditionAre historical registration/prespecification and current reading separated?Required	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. R01 R02	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.	Original registration identifiers, timing and plans	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.
25	Unverified	Full text not readStored summary read	N25 · Evidence conditionHave protocol/SAP and analysis/missing-data plans been acquired?Required	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. R01 R02	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.	Separate materials for prespecified plans/changes	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.
26	Partly verified	Full text not readStored summary read	N26 · Evidence conditionAre sponsorship/funding, products, authors and research involvement separated?Required	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. R01 R02	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.	Four company-involvement items and institution/foundation support	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.
27	Partly verified	Full text not readStored summary read	N27 · Evidence conditionAre unmeasured outcomes, null endpoints and unverified details separated?Required	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. R01 R02	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.	Question/results and access gaps	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.
28	Partly verified	Full text not readStored summary read	N28 · Evidence conditionAre reports, trials, people, tests/timepoints and sibling sheets separated?Required	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. R01 R02	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.	Linked records versus unique trials/participants	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.
29	Unverified	Full text not readStored summary read	N29 · Evidence conditionAre the original single trial and separate independent replication distinguished?Supplementary	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. R01 R02	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.	Parent R1/I2, follow-up and confirmation	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.
30	Partly verified	Full text not readStored summary read	N30 · Evidence conditionAre the subclaim grade and parent score/axes preserved?Required	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. R01	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.	Selected D grade, absent subclaim values and parent D34	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.
31	Partly verified	Full text not readStored summary read	N31 · Evidence conditionAre Korean/English manuscripts, original citations and absent fields preserved?Required	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. R01	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.	Both original languages and absent separate classification information	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.
32	Partly verified	Full text not readStored summary read	N32 · Evidence conditionAre source dates/corrections/history separated from production dates?Required	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. R01	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.	Original 2026-08-26 and new conditions/application	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.
33	Unverified	Full text not readStored summary read	N33 · Evidence conditionWhat direct materials would fill the selected gaps?Supplementary	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. R01 R02	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.	Direct endpoints, estimands/CI and denominators/follow-up	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.
34	Partly verified	Full text not readStored summary read	N34 · Evidence conditionAre applicability records distinguished from content review and treatment instructions?Supplementary	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. R01	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.	Applicability records, existing candidate history and content review	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.

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34 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-08-26
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
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

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

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

Material type: Multicenter participant- and assessor-blinded randomized placebo-controlled superiority trial
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/plans unread
Findings recorded in the stored 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
Study overlap and 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.

Public availability, access and reading status by material
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

Material type: Two-year follow-up report of the same PATH-2 participants; not a separate clinical trial
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/plans unread
Findings recorded in the stored 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
Study overlap and 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.

Public availability, access and reading status by material
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.

Report counts versus independent study counts

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.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

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

Required materials and conditions: Selected wording, subclaim grade D and parent context
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

N02 · Which acute rupture population?

Required materials and conditions: Complete acute midsubstance rupture within 12 days; nonoperative care
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

N03 · What was the study PRP exposure?

Required materials and conditions: One autologous PRP injection versus other preparations/repeated injections
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

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

Required materials and conditions: Imitation dry needling and common local anesthesia/blood draw
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

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

Required materials and conditions: Concurrent-care plans and actual exposure
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

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

Required materials and conditions: 230 allocated, 114/116; endpoint-specific observation
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

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

Required materials and conditions: Maximal heel-rise work; injured/uninjured ×100
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

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

Required materials and conditions: 34.67% versus 38.54%; adjusted difference
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

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

Required materials and conditions: −3.87%p·CI−10.45~2.71·P=.23
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

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

Required materials and conditions: Sample-size/power assumption and original exclusion statement
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

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

Required materials and conditions: Previous-trial observation versus clinical threshold
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

N12 · Are objective functional testing and patient reports separated?

Required materials and conditions: 24-week work index and ATRS
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

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

Required materials and conditions: 64.99 versus 65.53; adjusted difference −.54
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.
Requirement and applicability: Supplementary
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

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

Required materials and conditions: 82.2 versus 83.8; adjusted difference −.752
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.
Requirement and applicability: Supplementary
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

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

Required materials and conditions: Long-term ATRS and unverified long-term work testing
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

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

Required materials and conditions: Allocated-group primary analysis and prespecified imputation checks
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

N17 · Are original allocation/masking roles preserved?

Required materials and conditions: Central web allocation; participant/assessor masking
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

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

Required materials and conditions: NCT/ISRCTN and the same PATH-2 registrations
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

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

Required materials and conditions: Original superiority design, effect and importance
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

N20 · Are complication denominators distinguished from total event counts?

Required materials and conditions: At least one complication: 84/113 versus 90/116
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.
Requirement and applicability: Supplementary
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

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

Required materials and conditions: Similarity; one STEMI 2.5 hours later; possible indirect relation
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.
Requirement and applicability: Supplementary
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

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

Required materials and conditions: Boundaries across population, preparation, repeated injections and surgery
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

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

Required materials and conditions: Preserved summary and external materials
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

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

Required materials and conditions: Original registration identifiers, timing and plans
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

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

Required materials and conditions: Separate materials for prespecified plans/changes
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

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

Required materials and conditions: Four company-involvement items and institution/foundation support
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

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

Required materials and conditions: Question/results and access gaps
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

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

Required materials and conditions: Linked records versus unique trials/participants
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

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

Required materials and conditions: Parent R1/I2, follow-up and confirmation
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.
Requirement and applicability: Supplementary
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

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

Required materials and conditions: Selected D grade, absent subclaim values and parent D34
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

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

Required materials and conditions: Both original languages and absent separate classification information
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

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

Required materials and conditions: Original 2026-08-26 and new conditions/application
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

N33 · What direct materials would fill the selected gaps?

Required materials and conditions: Direct endpoints, estimands/CI and denominators/follow-up
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.
Requirement and applicability: Supplementary
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

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

Required materials and conditions: Applicability records, existing candidate history and content review
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.
Requirement and applicability: Supplementary
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.
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.
Referenced methods: Existing C/E/H distinctions among questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms are referenced for production

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: 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

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: 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

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: 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

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: 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

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: 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/material version 1.0

Public views and materials were prepared from the existing 34 items. No new clinical search, verification-status changes or scoring were performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-08-26) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

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

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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: 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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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: 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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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: 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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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: 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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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: 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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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: 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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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: 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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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: 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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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: 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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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: 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.
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.
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.
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?

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.
Verification status: Unverified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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: 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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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: 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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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: 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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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: 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.
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.
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.
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?

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.
Verification status: Unverified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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: 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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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: 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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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: 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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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: 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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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: 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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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: 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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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: 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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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: 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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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: 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.
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.
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.
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?

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.
Verification status: Unverified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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: 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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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: 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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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: 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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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: 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.
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.
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.
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?

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.
Verification status: Unverified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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: 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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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: 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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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: 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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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: 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.
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.
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.
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?

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.
Verification status: Unverified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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: 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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP 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: 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.
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.
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.
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