One added autologous PRP injection · Original null two-year patient-reported-function result in acute Achilles rupture

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 · Efficacy, boundaries and materialsWhat is the selected question and its record?Required	The selected existing question is “Improved patient-reported function at two years.” Its subclaim verdict record is linked separately from the parent/sibling question about the 24-week work limb-symmetry index. R01 R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Separate certification of an independent claim was not performed.	Existing Korean/English wording and selected verdict record for improved two-year patient-reported function	If the question boundary changes, retain the existing wording and change event together.
2	Partly verified	Full text not readStored summary read	N02 · Efficacy, boundaries and materialsHow are the subclaim grade and parent score/axes distinguished?Required	Preserve subclaim D and the note “The same trial’s long-term follow-up was null at P=0.757.” Subclaim score/status/axes keys are absent. Parent D with 34 points, Caution and B/P/R1/I2/E0/B0/C0 are parent context. R01 R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Subclaim numerical score/status/axes remain not recorded and are not filled with parent values.	Selected D grade/note, absent score/status/axes, parent D34 and historical axes	Grade changes are considered only in a separate evidence-update event.
3	Partly verified	Full text not readStored summary read	N03 · Efficacy, boundaries and materialsWhich acute-rupture population is followed long term?Required	PATH-2 involved nonoperative treatment of acute complete midsubstance Achilles rupture within 12 days at 19 UK NHS hospitals. R01 R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Age, sex, injury mechanism, baseline activity, detailed eligibility/exclusions and representativeness of two-year respondents remain unverified.	Injury timing, complete rupture, anatomical location, nonoperative choice and recruitment setting	Applicability to other populations is distinguished using actual eligibility and long-term cohort characteristics.
4	Partly verified	Full text not readStored summary read	N04 · Efficacy, boundaries and materialsWhat PRP exposure was studied?Required	The original materials describe a trial adding one autologous PRP injection to nonoperative treatment of acute complete rupture. R01 R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. PRP preparation, platelet/leukocyte quantities, injection volume, individual components and actual delivered dose are absent from this summary.	One autologous PRP injection added to nonoperative care	Link later materials to the same PRP preparation and actual exposure scope.
5	Partly verified	Full text not readStored summary read	N05 · Efficacy, boundaries and materialsWhat was the actual comparator?Required	The control was imitation dry needling, with needle insertion only into the rupture gap. The original English wording is “imitation dry needling.” It is not changed to saline injection or no treatment. R01 R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Detailed reproducibility, actual control delivery and differences in additional care remain unverified.	Imitation dry needling and the actual comparison direction	Reports using a different comparator are not merged as repetitions of the same comparison.
6	Partly verified	Full text not readStored summary read	N06 · Efficacy, boundaries and materialsAre common nonoperative care and the added PRP effect distinguished?Required	The original materials describe local anesthesia, blood draw and identical immobilization/rehabilitation in both groups. The comparison concerns adding one PRP injection to that care. R01 R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Actual rehabilitation, repeat surgery, adjunctive care, other exposures and between-group differences over two years remain unverified.	Local anesthesia, blood draw, identical immobilization/rehabilitation and care during follow-up	Later studies interpreting long-term outcomes should record concurrent care and treatment changes during follow-up.
7	Partly verified	Full text not readStored summary read	N07 · Efficacy, boundaries and materialsWhat is the actual two-year outcome instrument?Required	The two-year patient-reported outcome is recorded as ATRS, separate from the objective 24-week heel-rise work limb-symmetry index. R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. ATRS items, full range, score direction, administration, language version and valid-response criteria are not stated in the summary.	Definitions and measurement of patient-reported function and ATRS	Link acquired instrument details to the original outcome without substituting objective work or another functional scale.
8	Partly verified	Full text not readStored summary read	N08 · Efficacy, boundaries and materialsAre ATRS units and types of reported values distinguished?Required	Two-year ATRS is preserved as PRP 82.2 versus control 83.8, recorded as original values for the patient-reported instrument. R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Unit names, precise mean/median definitions, variation, baseline values and final-value/change-score details remain unverified because the external report is unread.	Scale units, final values/change scores and variation	Link final values, change scores and units separately as materials arrive, preserving existing notation.
9	Partly verified	Full text not readStored summary read	N09 · Efficacy, boundaries and materialsWhat are the two-year timepoint and actual follow-up duration?Required	The 2022 citation is the PATH-2 two-year follow-up; the original subclaim concerns two-year patient-reported function. R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Individual actual follow-up duration, response/measurement windows and interim visit schedules remain unverified.	Nominal two years, response window and measurement timing	Attribute outcomes with different follow-up lengths to their own timepoints.
10	Partly verified	Full text not readStored summary read	N10 · Efficacy, boundaries and materialsHow are original group-specific two-year ATRS values retained?Required	Two-year ATRS in the same trial was 82.2 versus 83.8; the original description stated no long-term benefit. R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Actual group analysis denominators, variation and original result-table rows remain unverified.	Original PRP/control values and group correspondence	If original values are corrected, preserve the complete previous table and change event.
11	Partly verified	Full text not readStored summary read	N11 · Efficacy, boundaries and materialsAre adjusted between-group differences distinguished from group values?Required	Preserve the two-year adjusted difference −0.752 and original interval −5.523–4.020, separately from group values 82.2/83.8. R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Adjustment variables, model, estimand, baseline-scale adjustment and reported units remain unverified.	Direction, model and analysis definition of the two-year adjusted difference	Link within-group changes, simple differences and adjusted between-group differences separately when analysis materials arrive.
12	Partly verified	Full text not readStored summary read	N12 · Efficacy, boundaries and materialsWhat is recorded about the two-year interval and confidence level?Required	The preserved wording is adjusted difference −0.752(−5.523–4.020), P=0.757. The two-year interval numbers are retained. R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. The summary does not separately specify the two-year confidence level, calculation method, estimation units or analysis denominator.	Original interval, confidence level, estimation units and denominators	Directly link the original interval and confidence level when the external result table is acquired.
13	Partly verified	Full text not readStored summary read	N13 · Efficacy, boundaries and materialsHow far are P=0.757 and the original null description retained?Required	The subclaim D/note records a null long-term result from the same trial at P=0.757. Preserve the summary’s absence-of-long-term-benefit description. R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. This summary lacks equivalence/noninferiority criteria and validation of clinically important differences.	Subclaim note, P value and superiority-interpretation boundary	Link materials distinguishing nonsignificance from verified equivalence/absence of harm when available.
14	Partly verified	Full text not readStored summary read	N14 · Efficacy, boundaries and materialsIs the 24-week +10-percentage-point power assumption kept separate from two-year clinical thresholds?Required	The parent explicitly states that +10 percentage points came from a previous observation for the 24-week work limb-symmetry index and served as a power assumption, rather than a validated minimum clinically important difference. R01 R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Validated clinical thresholds, sample-size assumptions and corresponding interval interpretation for two-year ATRS remain unverified.	24-week sample-size assumptions and clinical importance of two-year ATRS	Link clinical-importance materials for different instruments to separate sources and original units.
15	Partly verified	Full text not readStored summary read	N15 · Efficacy, boundaries and materialsHow do randomized and two-year analysis denominators differ?Required	The main report records 230 randomized participants: PRP 114, imitation dry needling 116. These are allocation counts. R01 R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Two-year contact, response, valid ATRS response and analysis counts/group denominators are absent from the summary.	230 allocated, 114/116 by group, and actual long-term analysis counts	Record allocation, completion, valid instrument responses and analysis separately when original denominators arrive.
16	Unverified	Full text not readStored summary read	N16 · Efficacy, boundaries and materialsCan long-term loss to follow-up and response selection be determined?Required	The preserved materials link only the existence of a two-year report from the same trial and its ATRS result. R02	Required direct values/definitions/materials were not verified within the current preserved-summary and unread-external-material scope. Counts/reasons for failed contact, refusal, death, reinjury, dropout and complete responses remain unverified.	Contact/response/dropout reasons and group baseline characteristics	Follow-up studies should report response selection and outcome-missingness pathways alongside actual counts.
17	Partly verified	Full text not readStored summary read	N17 · Efficacy, boundaries and materialsIs 24-week ITT wording kept separate from two-year analysis?Required	The parent cites ITT analysis by allocated group for the 24-week primary analysis. Details of the two-year ATRS analysis population are not separately provided. R01 R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Two-year ITT/complete-case/other populations, retained allocation and deviation handling remain unverified.	Long-term analysis populations, retained allocation and intervention-deviation handling	Link the long-term estimand and actual analysis counts separately when materials become available.
18	Partly verified	Full text not readStored summary read	N18 · Efficacy, boundaries and materialsAre 24-week multiple imputation and two-year missing-data handling separated?Required	The preserved summary records checks of missing 24-week data with prespecified multiple-imputation sensitivity analyses. R01 R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Two-year missing-data handling, imputation variables, sensitivity and changes in conclusions remain unverified.	Timepoint-specific missingness definitions, imputation and sensitivity analyses	Record newly supplied two-year missing-data materials separately from 24-week handling.
19	Partly verified	Full text not readStored summary read	N19 · Efficacy, boundaries and materialsWhat is the scope of original allocation/concealment and follow-up design?Required	The main report cites a secure central web based service revealing allocation only to the treating surgeon after enrollment. The follow-up is not described as a newly randomized trial. R01 R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Original registration/paper methods were not externally read in this work, and actual two-year follow-up operations remain unverified.	Central web randomization and long-term follow-up design	Distinguish follow-up of the same allocation from a new randomized trial using registration/cohort linkage.
20	Partly verified	Full text not readStored summary read	N20 · Efficacy, boundaries and materialsHow far was participant/assessor masking maintained long term?Required	The parent preserves participant/outcome-assessor masking and inability to mask injectors. It also describes masking of 24-week objective-test assessors. R01 R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Maintenance of participant masking until two years, unmasking timing and questionnaire-response setting remain unverified.	Masked roles, unmasking timing and patient-report effects	Later patient-reported studies should distinguish maintained masking from response-collection procedures.
21	Partly verified	Full text not readStored summary read	N21 · Efficacy, boundaries and materialsWhat was the prespecified hierarchy of two-year ATRS?Required	The main primary endpoint was maximal work limb-symmetry index in the heel-rise endurance test at 24 weeks. Two-year ATRS is preserved as a follow-up-report outcome. R01 R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Prespecified primary/secondary/exploratory status, multiplicity plans and analysis-plan dates for long-term ATRS remain unverified.	Main primary endpoint and long-term ATRS plans/hierarchy	Link actual dates and long-term outcome hierarchy if external plans are provided.
22	Partly verified	Full text not readStored summary read	N22 · Efficacy, boundaries and materialsWhat is the status of identifiers and actual registration content?Required	The first existing evidence record lists “NCT02302664 · ISRCTN54992179.” The parent historically describes agreement with the main primary endpoint. R01 R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Registration content/dates/change histories and original two-year plans remain unread here. The two citation records have no separate registration-number key.	Original NCT02302664 · ISRCTN54992179 notation and report linkage	Separate current reading records from historical agreement statements when registration materials are provided.
23	Partly verified	Full text not readStored summary read	N23 · Efficacy, boundaries and materialsWhat are the identities of the 2019 main and 2022 follow-up reports?Required	R01 is Keene DJ et al., 2019 BMJ PATH-2, PMID 31748208. R02 is Alsousou J et al., 2022 Bone Joint J two-year PATH-2 follow-up, PMID 36317349. R01 R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. DOI, PMCID, original full-text locations and current external bibliographic verification were not provided. The evidence list has one grouped record and the citation list has two.	Report bibliography, PMID, outcome timepoint and preserved-summary location	Retain report identities and outcome attribution together if bibliographic corrections arise.
24	Partly verified	Full text not readStored summary read	N24 · Efficacy, boundaries and materialsIs long-term follow-up kept separate from independent replication?Required	Existing research-product information explicitly states that the two-year report follows the same PATH-2 participants and is not independent replication. R01 R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Unique trials/participant totals are not newly certified or calculated; report-specific n values are not to be summed.	Same PATH-2 participants, registrations and report family	Distinguish a new independent trial using separate registration and recruitment-cohort materials.
25	Partly verified	Full text not readStored summary read	N25 · Efficacy, boundaries and materialsWhat is the context of the objective 24-week work result?Required	The 24-week work limb-symmetry index was PRP 34.67% versus 38.54%, adjusted difference −3.87 percentage points (95% CI −10.45–2.71), P=0.23. Injured/uninjured ×100 and higher-is-better descriptions apply to this objective index. R01	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Whether two-year objective work testing was measured alongside follow-up ATRS remains unverified.	Objective 24-week test versus selected two-year patient report	Link new materials by their actual instrument and timepoint.
26	Partly verified	Full text not readStored summary read	N26 · Efficacy, boundaries and materialsAre 24-week and two-year ATRS separated?Required	24-week ATRS was 64.99 versus 65.53, adjusted difference −0.54 (95% CI −4.90–3.81), P=0.81. Two-year ATRS was 82.2 versus 83.8, adjusted difference −0.752(−5.523–4.020), P=0.757. R01 R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Overlap of actual respondents, denominators, baseline adjustment and individual changes across timepoints remain unverified.	Timepoint-specific original values, adjusted differences and denominators despite a shared instrument	Retain original timepoint values without newly calculating individual recovery.
27	Partly verified	Full text not readStored summary read	N27 · Efficacy, boundaries and materialsAre people, limbs, tests and questionnaires distinguished?Required	The main work limb-symmetry index uses injured/uninjured measurements, and allocation is recorded as 230 people. Two-year patient reporting is a separate response outcome. R01 R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Actual limb/repeated-measure/questionnaire analysis units and valid group-response n remain unverified.	Randomization unit, bilateral testing, ATRS responses and repeated-timepoint analysis units	Record separate person/limb/questionnaire/timepoint denominators in new result tables.
28	Partly verified	Full text not readStored summary read	N28 · Efficacy, boundaries and materialsCan results be generalized to other populations, PRP or repeated exposures?Required	Existing advertising-interpretation wording excludes extension to chronic Achilles tendinopathy, surgical augmentation, other PRP preparations or repeated injections. The parent’s tendinopathy classification name does not change the actual acute-rupture population. R01 R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Direct materials for other populations/exposures were not read within this selected-summary scope.	Applicability of one added injection in nonoperative acute complete midsubstance rupture	Distinguish new applicability questions when direct materials and user scope are supplied.
29	Partly verified	Full text not readStored summary read	N29 · Efficacy, boundaries and materialsIs patient-reported function kept separate from other clinical outcomes?Required	The selected question concerns two-year patient-reported function; the parent separately describes objective work and complications. R01 R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Direct two-year pain, sport/work return, quality of life, rerupture, surgery need and other clinical outcomes are absent from this summary.	ATRS, objective function, rerupture, pain, activity return and quality of life	Link separate outcomes to actual original-report locations and timepoints.
30	Partly verified	Full text not readStored summary read	N30 · Efficacy, boundaries and materialsWhat is the scope of public funding and conflict-of-interest records?Required	The parent records MRC/NIHR EME Programme, NIHR Oxford BRC/Fellowship/CLAHRC Oxford support and University of Oxford sponsorship. The declaration of no manufacturer product/analysis/writing/publication support appears alongside SEL’s Pleuristem consulting fees and KW’s Zimmer Biomet royalties. R01 R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Original individual contributions/support/author declarations in the 2022 report and current relationships remain unread.	Trial support/sponsor, manufacturer support and outside consulting/royalties	Retain report-specific timing if support histories are supplemented.
31	Partly verified	Full text not readStored summary read	N31 · Efficacy, boundaries and materialsHow are original dates, both languages, corrections and history retained?Required	The original evidence date is 2026-08-26; corrections are an empty array and deliberation is empty. Both languages, existing integrated summary, verdict-decision records, axes and false markers are preserved unchanged in the complete summary. R01 R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Empty corrections do not newly verify absence of external corrections/retractions. Separate classification and primary-failed/secondary-positive keys are absent from this summary.	Complete originals, evidence date, empty values, verdict history and current production timing	Separate full originals before changes, events, versions and application when correction materials arrive.
32	Partly verified	Full text not readStored summary read	N32 · Efficacy, boundaries and materialsWhat types of materials were actually read?Required	Production read the complete 2970 summary and its own existing selection. Each of two reports is linked to a summary-reading entry; external materials are marked unread. R01 R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. External papers/abstracts/registrations/protocols/SAP, supplementary results and disclosure originals were not accessed or acquired.	Local preserved summary versus external abstracts, full texts, registrations and plans	Distinguish material type, acquisition, reading scope and date for new supplied materials.
33	Partly verified	Full text not readStored summary read	H01 · HarmsHow were complications defined and collected?Supporting harm information	Parent safety wording records at least one complication, rerupture, deep-vein thrombosis and ST-elevation myocardial infarction, as separate harms context. R01 R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Complication scope, grading, active/passive collection and cumulative/repeated-event definitions remain unverified.	At least one complication, severity, collection and relatedness	Later studies should distinguish original complications, injection-related adverse reactions and underlying-disease events.
34	Partly verified	Full text not readStored summary read	H02 · HarmsWhat are the harms observation periods and long-term exposures?Supporting harm information	Myocardial infarction timing 2.5 hours after the original injection is recorded. The summary does not separately provide the general complication-table observation period. R01 R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Consistent collection until two years, event-specific risk periods and subsequent-care exposure remain unverified.	Complication follow-up, occurrence timing and long-term collection	Link timepoint-specific harms to actual risk periods and reports.
35	Partly verified	Full text not readStored summary read	H03 · HarmsHow are original group complication numbers preserved?Supporting harm information	At least one complication occurred in PRP 84/113(74%) versus control 90/116(78%). Rerupture and deep-vein thrombosis were summarized as similar. R01 R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Harms differences, RR, CI, tests and individual rerupture/DVT event counts remain unverified.	People with at least one complication, original denominators and group correspondence	Link original values to actual definitions/intervals when direct harms tables arrive.
36	Partly verified	Full text not readStored summary read	H04 · HarmsHow do harms and functional denominators differ?Supporting harm information	Allocation was 114/116, while complication denominators were 113/116. Preserve these original denominators separately. R01 R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Reasons for selection of safety-analysis 113, exposure/completion definitions and two-year safety/function denominators remain unverified.	Safety populations for 84/113 and 90/116 versus allocation/function denominators	Link allocation, injection exposure, follow-up and analysis counts separately in harms materials.
37	Partly verified	Full text not readStored summary read	H05 · HarmsHow far can the myocardial-infarction case relationship be expressed?Supporting harm information	One ST-elevation myocardial infarction occurred 2.5 hours after PRP injection; the preserved summary records acknowledgment of a possible indirect relation. R01 R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Baseline risk, diagnostic details, concurrent factors, independent adjudication, direct mechanism and definitive cause remain unverified.	One ST-elevation myocardial infarction, post-injection timing and possible indirect relation	Link timing and levels of causal judgment separately when additional harms materials arrive.
38	Unverified	Full text not readStored summary read	H06 · HarmsAre missing harms kept separate from zero events?Supporting harm information	External reports remain unread in this work, and only some complications appear in the preserved summary. R01 R02	Required direct values/definitions/materials were not verified within the current preserved-summary and unread-external-material scope. Complete infection/bleeding/injection-site-reaction/other-event lists and original collection/nonreporting status remain unverified.	Unacquired/unread, uncollected, unreported and actual zero	Distinguish uncollected, unreported, missing and zero events when materials arrive.
39	Partly verified	Full text not readStored summary read	H07 · HarmsAre same-trial harms reports kept separate from independent harms replication?Supporting harm information	The two functional reports concern the same PATH-2 participants in the main and long-term reports. Original follow-up harms materials were not read. R01 R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Duplicate versus new events and relationships across follow-up periods remain unverified.	Main/follow-up harms-report family and event-time relationships	Distinguish repeated reports of the same event from new events without summing them.
40	Partly verified	Full text not readStored summary read	H08 · HarmsWhat are the long-term/vulnerable-population safety gaps?Supporting harm information	Original safety is Caution; the actual population received one added PRP injection with nonoperative care for acute complete midsubstance rupture. R01 R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Safety in other risk populations, chronic tendinopathy, surgical augmentation, other PRP or repeated exposures remains unverified in this summary scope.	Selected versus other risk populations, long-term harms and repeated exposures	Record other risk populations as direct harms questions separately from efficacy outcomes.
41	Partly verified	Full text not readStored summary read	H09 · HarmsAre null functional outcomes and harms signals retained together?Supporting harm information	Two-year patient-reported function is originally D/null. Complication numbers and the myocardial-infarction case with possible indirect relation are retained as harms context. R01 R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. No new integrated long-term benefit/harms judgment or treatment choice was made.	Separate interpretation of selected function, complication numbers and case signals	Link function and harms separately to original texts and retain change events when additional events arise.
42	Partly verified	Full text not readStored summary read	N42 · Efficacy, boundaries and materialsWhat should be updated when new materials arrive?Required	This production preserves the existing summary and rows in a new format. Conditions were stored/frozen first, with observations authored at a separate application time. R01 R02	The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. That production performed no new clinical search, external-material verification, calculations, reassessment or model/self content review.	Separate reports, condition versions, original values, material reading and production-change events	For new materials, distinguish complete originals before changes, events, condition changes/freezing, separate application and current handoff.

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42 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: Nonoperative acute complete midsubstance Achilles rupture within 12 days at 19 UK NHS hospitals. Age, detailed baseline characteristics and actual two-year respondents remain unverified.
Ingredient, formulation and route: One autologous PRP injection added to nonoperative treatment of acute complete midsubstance Achilles rupture
Dose: One added autologous PRP injection in the original trial. Preparation, quantities, injection volume and actual delivered dose remain unverified. This is not procedural guidance.
Comparator: Imitation dry needling; both groups received local anesthesia, blood draw and identical immobilization/rehabilitation. Detailed long-term concurrent care remains unverified.
Measured outcome: Two-year patient-reported ATRS: 82.2 versus 83.8; adjusted difference −0.752(−5.523–4.020), P=0.757. Scale units, variation, interval confidence level, denominators and model details remain unverified.
Duration: Two-year follow-up of the same PATH-2 trial. Actual response windows and individual follow-up lengths remain unverified.
Questions outside this scope: Transferring objective 24-week work-index effects, units or power thresholds to two-year ATRS; Automatically inheriting 24-week ITT, multiple imputation or masking as verified two-year implementation; Extending to chronic tendinopathy, surgical augmentation, other PRP or repeated injections; Extending efficacy conclusions to all other function, activity return, pain or safety outcomes; PRP/blood-draw/injection/rehabilitation/exercise/tendon-care/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: PATH-2 24-week main report
Materials actually read: Summary read; external materials not read
Findings recorded in the stored summary: 34.67% versus 38.54%; adjusted difference −3.87 percentage points (95% CI −10.45–2.71), P=0.23. Separate 24-week ATRS/harms appear in the parent summary and are not transferred to two-year analysis denominators/results.
Record level: Main-report results in the first preserved evidence-list record
Study overlap and independent replication: R01 is the 2019 PATH-2 24-week main report; R02 is the 2022 two-year follow-up of the same participants. The original summary specifies shared registrations/the same trial and excludes independent replication. Allocation, follow-up, instruments and sibling sheets are not summed.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Local preserved summary	Local copy acquired	Summary read	The corresponding citation and result context were read in the complete local preserved summary. No external paper reading.
External abstract	Current publication/access unverified	Access not attempted; not obtained	Not read	Only the original citation link is connected. Current abstract content/successful access were not verified.
External full text	Current publication/access unverified	Access not attempted; not obtained	Not read	Only the original citation-list identity link is connected. Full-text URLs/public availability/access were not verified.
Registration	Current publication/access unverified	Access not attempted; not obtained	Not read	Original NCT02302664 · ISRCTN54992179 notation is linked within the same trial family; registration content remains unread.
Protocol	Current publication/access unverified	Access not attempted; not obtained	Not read	Required-material entry. Actual file existence, public availability and long-term plan hierarchy remain unverified.
Statistical analysis plan	Current publication/access unverified	Access not attempted; not obtained	Not read	Required-material entry for timepoint-specific models, denominators, missing-data handling and prespecified plans.
Results, denominator and harm details	Current publication/access unverified	Access not attempted; not obtained	Not read	Required-material entry for original function, denominator, loss, instrument and harms results. Values/existence were not newly verified.
Support and interests	Current publication/access unverified	Access not attempted; not obtained	Not read	Parent-trial support context is distinguished from individual report declarations. External originals remain unread.

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 from the same PATH-2 trial
Materials actually read: Summary read; external materials not read
Findings recorded in the stored summary: Two-year ATRS in the same PATH-2 trial: 82.2 versus 83.8; adjusted difference −0.752(−5.523–4.020), P=0.757. Actual two-year analysis denominators, instrument details, model and confidence level remain unverified.
Record level: Follow-up context in the preserved summary
Study overlap and independent replication: R01 is the 2019 PATH-2 24-week main report; R02 is the 2022 two-year follow-up of the same participants. The original summary specifies shared registrations/the same trial and excludes independent replication. Allocation, follow-up, instruments and sibling sheets are not summed.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Local preserved summary	Local copy acquired	Summary read	The corresponding citation and result context were read in the complete local preserved summary. No external paper reading.
External abstract	Current publication/access unverified	Access not attempted; not obtained	Not read	Only the original citation link is connected. Current abstract content/successful access were not verified.
External full text	Current publication/access unverified	Access not attempted; not obtained	Not read	Only the original citation-list identity link is connected. Full-text URLs/public availability/access were not verified.
Registration	Current publication/access unverified	Access not attempted; not obtained	Not read	Original NCT02302664 · ISRCTN54992179 notation is linked within the same trial family; registration content remains unread.
Protocol	Current publication/access unverified	Access not attempted; not obtained	Not read	Required-material entry. Actual file existence, public availability and long-term plan hierarchy remain unverified.
Statistical analysis plan	Current publication/access unverified	Access not attempted; not obtained	Not read	Required-material entry for timepoint-specific models, denominators, missing-data handling and prespecified plans.
Results, denominator and harm details	Current publication/access unverified	Access not attempted; not obtained	Not read	Required-material entry for original function, denominator, loss, instrument and harms results. Values/existence were not newly verified.
Support and interests	Current publication/access unverified	Access not attempted; not obtained	Not read	Parent-trial support context is distinguished from individual report declarations. External originals remain unread.

Report counts versus independent study counts

R01 is the 2019 PATH-2 24-week main report; R02 is the 2022 two-year follow-up of the same participants. The original summary specifies shared registrations/the same trial and excludes independent replication. Allocation, follow-up, instruments and sibling sheets are not summed.

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 · What is the selected question and its record?

Required materials and conditions: Existing Korean/English wording and selected verdict record for improved two-year patient-reported function
Conditions for verification: Link existing Korean/English wording and selected verdict record for improved two-year patient-reported function to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Required
Application exceptions: No invented verdict or additional subclaim is created.
Why this condition is needed: An applicability condition preserving the original scope of existing Korean/English wording and selected verdict record for improved two-year patient-reported function.
Referenced methods: Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are our own design

N02 · How are the subclaim grade and parent score/axes distinguished?

Required materials and conditions: Selected D grade/note, absent score/status/axes, parent D34 and historical axes
Conditions for verification: Link selected D grade/note, absent score/status/axes, parent D34 and historical axes to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Required
Application exceptions: Parent D34 or historical cross-validation is not transferred to a new subclaim score or completed review.
Why this condition is needed: An applicability condition preserving the original scope of selected D grade/note, absent score/status/axes, parent D34 and historical axes.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

N03 · Which acute-rupture population is followed long term?

Required materials and conditions: Injury timing, complete rupture, anatomical location, nonoperative choice and recruitment setting
Conditions for verification: Link injury timing, complete rupture, anatomical location, nonoperative choice and recruitment setting to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Required
Application exceptions: Only preserved-summary information is presented; missing details/definitions are not filled in.
Why this condition is needed: An applicability condition preserving the original scope of injury timing, complete rupture, anatomical location, nonoperative choice and recruitment setting.
Referenced methods: M03 §3.2.1; detailed population conditions are Chamgap's own design

N04 · What PRP exposure was studied?

Required materials and conditions: One autologous PRP injection added to nonoperative care
Conditions for verification: Link one autologous PRP injection added to nonoperative care to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Required
Application exceptions: No preparation/blood-draw/injection instructions or repeated-injection effects are generated.
Why this condition is needed: An applicability condition preserving the original scope of one autologous PRP injection added to nonoperative care.
Referenced methods: M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design

N05 · What was the actual comparator?

Required materials and conditions: Imitation dry needling and the actual comparison direction
Conditions for verification: Link imitation dry needling and the actual comparison direction to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Required
Application exceptions: Only preserved-summary information is presented; missing details/definitions are not filled in.
Why this condition is needed: An applicability condition preserving the original scope of imitation dry needling and the actual comparison direction.
Referenced methods: M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application

N06 · Are common nonoperative care and the added PRP effect distinguished?

Required materials and conditions: Local anesthesia, blood draw, identical immobilization/rehabilitation and care during follow-up
Conditions for verification: Link local anesthesia, blood draw, identical immobilization/rehabilitation and care during follow-up to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Required
Application exceptions: No rehabilitation/exercise/tendon-care procedures or treatment-replacement guidance.
Why this condition is needed: An applicability condition preserving the original scope of local anesthesia, blood draw, identical immobilization/rehabilitation and care during follow-up.
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are our own design

N07 · What is the actual two-year outcome instrument?

Required materials and conditions: Definitions and measurement of patient-reported function and ATRS
Conditions for verification: Link definitions and measurement of patient-reported function and ATRS to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Required
Application exceptions: Only preserved-summary information is presented; missing details/definitions are not filled in.
Why this condition is needed: An applicability condition preserving the original scope of definitions and measurement of patient-reported function and ATRS.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M03 §3.2.4; our own application

N08 · Are ATRS units and types of reported values distinguished?

Required materials and conditions: Scale units, final values/change scores and variation
Conditions for verification: Link scale units, final values/change scores and variation to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Required
Application exceptions: ATRS values are not converted to work percentages/percentage points or other scale units.
Why this condition is needed: An applicability condition preserving the original scope of scale units, final values/change scores and variation.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M03 §3.2.4; our own application

N09 · What are the two-year timepoint and actual follow-up duration?

Required materials and conditions: Nominal two years, response window and measurement timing
Conditions for verification: Link nominal two years, response window and measurement timing to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Required
Application exceptions: Only preserved-summary information is presented; missing details/definitions are not filled in.
Why this condition is needed: An applicability condition preserving the original scope of nominal two years, response window and measurement timing.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed

N10 · How are original group-specific two-year ATRS values retained?

Required materials and conditions: Original PRP/control values and group correspondence
Conditions for verification: Link original PRP/control values and group correspondence to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Required
Application exceptions: The two numbers are not subtracted to create a new effect.
Why this condition is needed: An applicability condition preserving the original scope of original PRP/control values and group correspondence.
Referenced methods: M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M04 §4.6.3 and M15 §§15.3.1–15.3.3; status separation is Chamgap-designed

N11 · Are adjusted between-group differences distinguished from group values?

Required materials and conditions: Direction, model and analysis definition of the two-year adjusted difference
Conditions for verification: Link direction, model and analysis definition of the two-year adjusted difference to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Required
Application exceptions: Arithmetic differences between group values are not relabeled as adjusted differences, and adjustment from another timepoint is not transferred.
Why this condition is needed: An applicability condition preserving the original scope of direction, model and analysis definition of the two-year adjusted difference.
Referenced methods: M08 §8.2.2, M15 §15.3.1; CHAMGAP adaptation; M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are designed by CHAMGAP

N12 · What is recorded about the two-year interval and confidence level?

Required materials and conditions: Original interval, confidence level, estimation units and denominators
Conditions for verification: Link original interval, confidence level, estimation units and denominators to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Required
Application exceptions: The 24-week 95% CI label is not automatically inherited as new verification of the two-year interval.
Why this condition is needed: An applicability condition preserving the original scope of original interval, confidence level, estimation units and denominators.
Referenced methods: M15 §15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design

N13 · How far are P=0.757 and the original null description retained?

Required materials and conditions: Subclaim note, P value and superiority-interpretation boundary
Conditions for verification: Link subclaim note, P value and superiority-interpretation boundary to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Required
Application exceptions: Nonsignificance is not changed to an exactly zero effect, equivalence or guaranteed safety.
Why this condition is needed: An applicability condition preserving the original scope of subclaim note, P value and superiority-interpretation boundary.
Referenced methods: M04 §4.6.3 and M15 §15.3.1–15.3.3; Status separation is Chamgap design; M15 §15.3.1–15.3.3; Chamgap application

N14 · Is the 24-week +10-percentage-point power assumption kept separate from two-year clinical thresholds?

Required materials and conditions: 24-week sample-size assumptions and clinical importance of two-year ATRS
Conditions for verification: Link 24-week sample-size assumptions and clinical importance of two-year ATRS to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Required
Application exceptions: Work +10 percentage points or CI upper bound +2.71 percentage points are not used as a two-year ATRS clinical threshold or upper bound.
Why this condition is needed: An applicability condition preserving the original scope of 24-week sample-size assumptions and clinical importance of two-year ATRS.
Referenced methods: M15 §15.3.1–15.3.3; own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is independently designed

N15 · How do randomized and two-year analysis denominators differ?

Required materials and conditions: 230 allocated, 114/116 by group, and actual long-term analysis counts
Conditions for verification: Link 230 allocated, 114/116 by group, and actual long-term analysis counts to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Required
Application exceptions: 230 or 114/116 are not copied as actual two-year analysis denominators.
Why this condition is needed: An applicability condition preserving the original scope of 230 allocated, 114/116 by group, and actual long-term analysis counts.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design

N16 · Can long-term loss to follow-up and response selection be determined?

Required materials and conditions: Contact/response/dropout reasons and group baseline characteristics
Conditions for verification: Link contact/response/dropout reasons and group baseline characteristics to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Required
Application exceptions: Only preserved-summary information is presented; missing details/definitions are not filled in.
Why this condition is needed: An applicability condition preserving the original scope of contact/response/dropout reasons and group baseline characteristics.
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application

N17 · Is 24-week ITT wording kept separate from two-year analysis?

Required materials and conditions: Long-term analysis populations, retained allocation and intervention-deviation handling
Conditions for verification: Link long-term analysis populations, retained allocation and intervention-deviation handling to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Required
Application exceptions: Reading the main report’s ITT citation does not newly verify two-year ITT implementation.
Why this condition is needed: An applicability condition preserving the original scope of long-term analysis populations, retained allocation and intervention-deviation handling.
Referenced methods: M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.

N18 · Are 24-week multiple imputation and two-year missing-data handling separated?

Required materials and conditions: Timepoint-specific missingness definitions, imputation and sensitivity analyses
Conditions for verification: Link timepoint-specific missingness definitions, imputation and sensitivity analyses to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Required
Application exceptions: The 24-week multiple-imputation record is not marked as completed two-year handling.
Why this condition is needed: An applicability condition preserving the original scope of timepoint-specific missingness definitions, imputation and sensitivity analyses.
Referenced methods: M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.

N19 · What is the scope of original allocation/concealment and follow-up design?

Required materials and conditions: Central web randomization and long-term follow-up design
Conditions for verification: Link central web randomization and long-term follow-up design to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Required
Application exceptions: Only preserved-summary information is presented; missing details/definitions are not filled in.
Why this condition is needed: An applicability condition preserving the original scope of central web randomization and long-term follow-up design.
Referenced methods: M08 §8.1–8.2.3; own application

N20 · How far was participant/assessor masking maintained long term?

Required materials and conditions: Masked roles, unmasking timing and patient-report effects
Conditions for verification: Link masked roles, unmasking timing and patient-report effects to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Required
Application exceptions: 24-week assessor masking is not expanded into newly verified long-term patient-report masking.
Why this condition is needed: An applicability condition preserving the original scope of masked roles, unmasking timing and patient-report effects.
Referenced methods: M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M08 §§8.1–8.2.3; Chamgap adaptation

N21 · What was the prespecified hierarchy of two-year ATRS?

Required materials and conditions: Main primary endpoint and long-term ATRS plans/hierarchy
Conditions for verification: Link main primary endpoint and long-term ATRS plans/hierarchy to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Required
Application exceptions: Parent endpoint axis P or main primary hierarchy is not transferred to certification of long-term ATRS as primary.
Why this condition is needed: An applicability condition preserving the original scope of main primary endpoint and long-term ATRS plans/hierarchy.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; Chamgap's own application

N22 · What is the status of identifiers and actual registration content?

Required materials and conditions: Original NCT02302664 · ISRCTN54992179 notation and report linkage
Conditions for verification: Link original NCT02302664 · ISRCTN54992179 notation and report linkage to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Required
Application exceptions: The combined nct-key value is not forced into a single NCT format or upgraded to verified registration content.
Why this condition is needed: An applicability condition preserving the original scope of original NCT02302664 · ISRCTN54992179 notation and report linkage.
Referenced methods: M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/result links are a Chamgap application; M08 Table 8.2.a and M04 §4.6.3; Chamgap application

N23 · What are the identities of the 2019 main and 2022 follow-up reports?

Required materials and conditions: Report bibliography, PMID, outcome timepoint and preserved-summary location
Conditions for verification: Link report bibliography, PMID, outcome timepoint and preserved-summary location to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Required
Application exceptions: R02 is not invented as a second existing evidence-list index.
Why this condition is needed: An applicability condition preserving the original scope of report bibliography, PMID, outcome timepoint and preserved-summary location.
Referenced methods: M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations

N24 · Is long-term follow-up kept separate from independent replication?

Required materials and conditions: Same PATH-2 participants, registrations and report family
Conditions for verification: Link same PATH-2 participants, registrations and report family to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Required
Application exceptions: Two reports/timepoints/sibling sheets are not summed as two sets of participants or trials.
Why this condition is needed: An applicability condition preserving the original scope of same PATH-2 participants, registrations and report family.
Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

N25 · What is the context of the objective 24-week work result?

Required materials and conditions: Objective 24-week test versus selected two-year patient report
Conditions for verification: Link objective 24-week test versus selected two-year patient report to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Required
Application exceptions: 24-week index percentages/percentage points, denominators and CI are not transferred to two-year ATRS.
Why this condition is needed: An applicability condition preserving the original scope of objective 24-week test versus selected two-year patient report.
Referenced methods: M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M04 §4.6.3 and M15 §§15.3.1–15.3.3; status separation is Chamgap-designed

N26 · Are 24-week and two-year ATRS separated?

Required materials and conditions: Timepoint-specific original values, adjusted differences and denominators despite a shared instrument
Conditions for verification: Link timepoint-specific original values, adjusted differences and denominators despite a shared instrument to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Required
Application exceptions: No new between-timepoint subtraction, recovery rates or long-term increases are calculated.
Why this condition is needed: An applicability condition preserving the original scope of timepoint-specific original values, adjusted differences and denominators despite a shared instrument.
Referenced methods: M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M04 §4.6.3 and M15 §§15.3.1–15.3.3; status separation is Chamgap-designed

N27 · Are people, limbs, tests and questionnaires distinguished?

Required materials and conditions: Randomization unit, bilateral testing, ATRS responses and repeated-timepoint analysis units
Conditions for verification: Link randomization unit, bilateral testing, ATRS responses and repeated-timepoint analysis units to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Required
Application exceptions: Bilateral measurements or two timepoints are not summed as additional participants.
Why this condition is needed: An applicability condition preserving the original scope of randomization unit, bilateral testing, ATRS responses and repeated-timepoint analysis units.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is independently designed; M08 Table 8.2.a, M03 §3.2.4; own application

N28 · Can results be generalized to other populations, PRP or repeated exposures?

Required materials and conditions: Applicability of one added injection in nonoperative acute complete midsubstance rupture
Conditions for verification: Link applicability of one added injection in nonoperative acute complete midsubstance rupture to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Required
Application exceptions: Verdict 1699 is retained only as parent historical wording; its file/page is not opened.
Why this condition is needed: An applicability condition preserving the original scope of applicability of one added injection in nonoperative acute complete midsubstance rupture.
Referenced methods: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap’s own design; M03 §3.2.1; detailed population conditions are Chamgap’s own design

N29 · Is patient-reported function kept separate from other clinical outcomes?

Required materials and conditions: ATRS, objective function, rerupture, pain, activity return and quality of life
Conditions for verification: Link aTRS, objective function, rerupture, pain, activity return and quality of life to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Required
Application exceptions: Null ATRS is not expanded into a conclusion about all clinical outcomes or treatment strategies.
Why this condition is needed: An applicability condition preserving the original scope of aTRS, objective function, rerupture, pain, activity return and quality of life.
Referenced methods: M03 §3.2.4; internally defined extension boundary; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed

N30 · What is the scope of public funding and conflict-of-interest records?

Required materials and conditions: Trial support/sponsor, manufacturer support and outside consulting/royalties
Conditions for verification: Link trial support/sponsor, manufacturer support and outside consulting/royalties to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Required
Application exceptions: Public funding/historical no-support wording is not changed to new independence certification or absence of conflicts.
Why this condition is needed: An applicability condition preserving the original scope of trial support/sponsor, manufacturer support and outside consulting/royalties.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

N31 · How are original dates, both languages, corrections and history retained?

Required materials and conditions: Complete originals, evidence date, empty values, verdict history and current production timing
Conditions for verification: Link complete originals, evidence date, empty values, verdict history and current production timing to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Required
Application exceptions: Historical cross-validation/prospective-registration wording is not inherited as completed content review here.
Why this condition is needed: An applicability condition preserving the original scope of complete originals, evidence date, empty values, verdict history and current production timing.
Referenced methods: M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design; M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are our own design

N32 · What types of materials were actually read?

Required materials and conditions: Local preserved summary versus external abstracts, full texts, registrations and plans
Conditions for verification: Link local preserved summary versus external abstracts, full texts, registrations and plans to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Required
Application exceptions: URL existence, preserved citations or copied files do not establish external full-text reading or completed link checks.
Why this condition is needed: An applicability condition preserving the original scope of local preserved summary versus external abstracts, full texts, registrations and plans.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

H01 · How were complications defined and collected?

Required materials and conditions: At least one complication, severity, collection and relatedness
Conditions for verification: Link at least one complication, severity, collection and relatedness to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Supporting harm information
Application exceptions: Only preserved-summary information is presented; missing details/definitions are not filled in.
Why this condition is needed: An applicability condition preserving the original scope of at least one complication, severity, collection and relatedness.
Referenced methods: M19 §§19.1.2–19.2.4; detailed distinctions are Chamgap-designed; M19 §§19.1.2–19.2.4; Chamgap adaptation

H02 · What are the harms observation periods and long-term exposures?

Required materials and conditions: Complication follow-up, occurrence timing and long-term collection
Conditions for verification: Link complication follow-up, occurrence timing and long-term collection to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Supporting harm information
Application exceptions: Existence of a two-year functional follow-up report is not treated as completed two-year harms follow-up.
Why this condition is needed: An applicability condition preserving the original scope of complication follow-up, occurrence timing and long-term collection.
Referenced methods: M19 §19.2 design-specific harm questions; timing details are Chamgap-designed

H03 · How are original group complication numbers preserved?

Required materials and conditions: People with at least one complication, original denominators and group correspondence
Conditions for verification: Link people with at least one complication, original denominators and group correspondence to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Supporting harm information
Application exceptions: Similarity is not relabeled as equivalence; no new harms difference is calculated from 84/113 and 90/116.
Why this condition is needed: An applicability condition preserving the original scope of people with at least one complication, original denominators and group correspondence.
Referenced methods: M19 §§19.2.2–19.2.4 and M03 §3.2.3; Chamgap adaptation

H04 · How do harms and functional denominators differ?

Required materials and conditions: Safety populations for 84/113 and 90/116 versus allocation/function denominators
Conditions for verification: Link safety populations for 84/113 and 90/116 versus allocation/function denominators to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Supporting harm information
Application exceptions: Denominator differences are not calculated to establish dropout/nonadministration/missingness causes or transferred to two-year n.
Why this condition is needed: An applicability condition preserving the original scope of safety populations for 84/113 and 90/116 versus allocation/function denominators.
Referenced methods: M19 §§19.1.2–19.2.4; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3 and M19 §§19.1.2–19.2.4; design-specific adaptation is Chamgap-designed

H05 · How far can the myocardial-infarction case relationship be expressed?

Required materials and conditions: One ST-elevation myocardial infarction, post-injection timing and possible indirect relation
Conditions for verification: Link one ST-elevation myocardial infarction, post-injection timing and possible indirect relation to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Supporting harm information
Application exceptions: One case is not converted into definite PRP causation, a general incidence estimate or evidence of no harm.
Why this condition is needed: An applicability condition preserving the original scope of one ST-elevation myocardial infarction, post-injection timing and possible indirect relation.
Referenced methods: M19 §19.2.2–19.2.4 design considerations; detailed confounding records are internally designed; Chamgap’s own interpretation boundaries. M19 principles are referenced; no official causality tool was executed

H06 · Are missing harms kept separate from zero events?

Required materials and conditions: Unacquired/unread, uncollected, unreported and actual zero
Conditions for verification: Link unacquired/unread, uncollected, unreported and actual zero to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Supporting harm information
Application exceptions: Unread external materials are not marked as zero adverse events, failed access or nonexistent materials.
Why this condition is needed: An applicability condition preserving the original scope of unacquired/unread, uncollected, unreported and actual zero.
Referenced methods: M19 §§19.1.2–19.2.4 and M04 §4.6.3; Chamgap adaptation

H07 · Are same-trial harms reports kept separate from independent harms replication?

Required materials and conditions: Main/follow-up harms-report family and event-time relationships
Conditions for verification: Link main/follow-up harms-report family and event-time relationships to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Supporting harm information
Application exceptions: Two reports/timepoints are not summed as additional harms events, people or independent trials.
Why this condition is needed: An applicability condition preserving the original scope of main/follow-up harms-report family and event-time relationships.
Referenced methods: M04 §§4.6.1–4.6.2; harm-material adaptation is Chamgap-designed; M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations

H08 · What are the long-term/vulnerable-population safety gaps?

Required materials and conditions: Selected versus other risk populations, long-term harms and repeated exposures
Conditions for verification: Link selected versus other risk populations, long-term harms and repeated exposures to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Supporting harm information
Application exceptions: Null two-year ATRS or a single-trial complication summary is not expanded into guaranteed safety of all PRP.
Why this condition is needed: An applicability condition preserving the original scope of selected versus other risk populations, long-term harms and repeated exposures.
Referenced methods: M19 §§19.1.2–19.2.4; Chamgap adaptation

H09 · Are null functional outcomes and harms signals retained together?

Required materials and conditions: Separate interpretation of selected function, complication numbers and case signals
Conditions for verification: Link separate interpretation of selected function, complication numbers and case signals to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Supporting harm information
Application exceptions: Null efficacy is not changed to harmlessness; a case signal is not upgraded to a definitive overall harms verdict.
Why this condition is needed: An applicability condition preserving the original scope of separate interpretation of selected function, complication numbers and case signals.
Referenced methods: Chamgap interpretive boundary informed by M19 principles; no formal causality tool was run

N42 · What should be updated when new materials arrive?

Required materials and conditions: Separate reports, condition versions, original values, material reading and production-change events
Conditions for verification: Link separate reports, condition versions, original values, material reading and production-change events to the corresponding report/timepoint/analysis, distinguishing missing details.
Requirement and applicability: Required
Application exceptions: Historical candidate pending/eligible values are not revived as an active review procedure, and verdict values are not changed without new materials.
Why this condition is needed: An applicability condition preserving the original scope of separate reports, condition versions, original values, material reading and production-change events.
Referenced methods: M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design

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: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

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: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

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: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

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: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

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: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

What the statuses mean

Met: The original content has been reviewed as meeting the conditions. This status is not used in this preparation.
Partly verified: Some information in the stored summary was linked during preparation; clinical verification or review is not complete.
Unverified: Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.
Review incomplete: Review of existing content or actual review incomplete.
Not reported: Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.
Inaccessible: Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.
Insufficient evidence for the conditions: Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.
Not applicable: Used when the reason it does not apply to the original question is stated.
Conflicting data: Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment.

Change history

2026-10-13 · Public page/material version 1.0

Public pages and materials were created from the existing 42 items. No new clinical search, verification-status change, or scoring was 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 · What is the selected question and its record?

Current findings: The selected existing question is “Improved patient-reported function at two years.” Its subclaim verdict record is linked separately from the parent/sibling question about the 24-week work limb-symmetry index.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Separate certification of an independent claim was not performed.
Reason for missing information: Separate certification of an independent claim was not performed.
Required materials and conditions: Existing Korean/English wording and selected verdict record for improved two-year patient-reported function
Materials to obtain first: Preserved copies of the selected existing row and complete parent verdict
Further research: If the question boundary changes, retain the existing wording and change event together.
Remaining uncertainty: Production is limited to the preserved summary. Separate certification of an independent claim was not performed.
Conditions for verification: Link existing Korean/English wording and selected verdict record for improved two-year patient-reported function to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of existing Korean/English wording and selected verdict record for improved two-year patient-reported function.
Application exceptions: No invented verdict or additional subclaim is created.
Referenced methods: Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are our own design

Related sources R01 R02

N02 · How are the subclaim grade and parent score/axes distinguished?

Current findings: Preserve subclaim D and the note “The same trial’s long-term follow-up was null at P=0.757.” Subclaim score/status/axes keys are absent. Parent D with 34 points, Caution and B/P/R1/I2/E0/B0/C0 are parent context.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Subclaim numerical score/status/axes remain not recorded and are not filled with parent values.
Reason for missing information: Subclaim numerical score/status/axes remain not recorded and are not filled with parent values.
Required materials and conditions: Selected D grade/note, absent score/status/axes, parent D34 and historical axes
Materials to obtain first: Existing subclaim record, parent grade/score/axes and verdict history
Further research: Grade changes are considered only in a separate evidence-update event.
Remaining uncertainty: Production is limited to the preserved summary. Subclaim numerical score/status/axes remain not recorded and are not filled with parent values.
Conditions for verification: Link selected D grade/note, absent score/status/axes, parent D34 and historical axes to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of selected D grade/note, absent score/status/axes, parent D34 and historical axes.
Application exceptions: Parent D34 or historical cross-validation is not transferred to a new subclaim score or completed review.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

Related sources R01 R02

N03 · Which acute-rupture population is followed long term?

Current findings: PATH-2 involved nonoperative treatment of acute complete midsubstance Achilles rupture within 12 days at 19 UK NHS hospitals.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Age, sex, injury mechanism, baseline activity, detailed eligibility/exclusions and representativeness of two-year respondents remain unverified.
Reason for missing information: Age, sex, injury mechanism, baseline activity, detailed eligibility/exclusions and representativeness of two-year respondents remain unverified.
Required materials and conditions: Injury timing, complete rupture, anatomical location, nonoperative choice and recruitment setting
Materials to obtain first: Original eligibility criteria, baseline characteristics and long-term participant flow
Further research: Applicability to other populations is distinguished using actual eligibility and long-term cohort characteristics.
Remaining uncertainty: Production is limited to the preserved summary. Age, sex, injury mechanism, baseline activity, detailed eligibility/exclusions and representativeness of two-year respondents remain unverified.
Conditions for verification: Link injury timing, complete rupture, anatomical location, nonoperative choice and recruitment setting to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of injury timing, complete rupture, anatomical location, nonoperative choice and recruitment setting.
Application exceptions: Only preserved-summary information is presented; missing details/definitions are not filled in.
Referenced methods: M03 §3.2.1; detailed population conditions are Chamgap's own design

Related sources R01 R02

N04 · What PRP exposure was studied?

Current findings: The original materials describe a trial adding one autologous PRP injection to nonoperative treatment of acute complete rupture.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. PRP preparation, platelet/leukocyte quantities, injection volume, individual components and actual delivered dose are absent from this summary.
Reason for missing information: PRP preparation, platelet/leukocyte quantities, injection volume, individual components and actual delivered dose are absent from this summary.
Required materials and conditions: One autologous PRP injection added to nonoperative care
Materials to obtain first: Preparation/component/exposure records and actual group procedures
Further research: Link later materials to the same PRP preparation and actual exposure scope.
Remaining uncertainty: Production is limited to the preserved summary. PRP preparation, platelet/leukocyte quantities, injection volume, individual components and actual delivered dose are absent from this summary.
Conditions for verification: Link one autologous PRP injection added to nonoperative care to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of one autologous PRP injection added to nonoperative care.
Application exceptions: No preparation/blood-draw/injection instructions or repeated-injection effects are generated.
Referenced methods: M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design

Related sources R01 R02

N05 · What was the actual comparator?

Current findings: The control was imitation dry needling, with needle insertion only into the rupture gap. The original English wording is “imitation dry needling.” It is not changed to saline injection or no treatment.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Detailed reproducibility, actual control delivery and differences in additional care remain unverified.
Reason for missing information: Detailed reproducibility, actual control delivery and differences in additional care remain unverified.
Required materials and conditions: Imitation dry needling and the actual comparison direction
Materials to obtain first: Control-procedure, actual-delivery and concurrent-care tables
Further research: Reports using a different comparator are not merged as repetitions of the same comparison.
Remaining uncertainty: Production is limited to the preserved summary. Detailed reproducibility, actual control delivery and differences in additional care remain unverified.
Conditions for verification: Link imitation dry needling and the actual comparison direction to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of imitation dry needling and the actual comparison direction.
Application exceptions: Only preserved-summary information is presented; missing details/definitions are not filled in.
Referenced methods: M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application

Related sources R01 R02

N06 · Are common nonoperative care and the added PRP effect distinguished?

Current findings: The original materials describe local anesthesia, blood draw and identical immobilization/rehabilitation in both groups. The comparison concerns adding one PRP injection to that care.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Actual rehabilitation, repeat surgery, adjunctive care, other exposures and between-group differences over two years remain unverified.
Reason for missing information: Actual rehabilitation, repeat surgery, adjunctive care, other exposures and between-group differences over two years remain unverified.
Required materials and conditions: Local anesthesia, blood draw, identical immobilization/rehabilitation and care during follow-up
Materials to obtain first: Group-specific immobilization/rehabilitation, additional care and long-term exposure records
Further research: Later studies interpreting long-term outcomes should record concurrent care and treatment changes during follow-up.
Remaining uncertainty: Production is limited to the preserved summary. Actual rehabilitation, repeat surgery, adjunctive care, other exposures and between-group differences over two years remain unverified.
Conditions for verification: Link local anesthesia, blood draw, identical immobilization/rehabilitation and care during follow-up to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of local anesthesia, blood draw, identical immobilization/rehabilitation and care during follow-up.
Application exceptions: No rehabilitation/exercise/tendon-care procedures or treatment-replacement guidance.
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are our own design

Related sources R01 R02

N07 · What is the actual two-year outcome instrument?

Current findings: The two-year patient-reported outcome is recorded as ATRS, separate from the objective 24-week heel-rise work limb-symmetry index.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. ATRS items, full range, score direction, administration, language version and valid-response criteria are not stated in the summary.
Reason for missing information: ATRS items, full range, score direction, administration, language version and valid-response criteria are not stated in the summary.
Required materials and conditions: Definitions and measurement of patient-reported function and ATRS
Materials to obtain first: Two-year report instrument definitions, questionnaire and measurement methods
Further research: Link acquired instrument details to the original outcome without substituting objective work or another functional scale.
Remaining uncertainty: Production is limited to the preserved summary. ATRS items, full range, score direction, administration, language version and valid-response criteria are not stated in the summary.
Conditions for verification: Link definitions and measurement of patient-reported function and ATRS to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of definitions and measurement of patient-reported function and ATRS.
Application exceptions: Only preserved-summary information is presented; missing details/definitions are not filled in.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M03 §3.2.4; our own application

Related sources R02

N08 · Are ATRS units and types of reported values distinguished?

Current findings: Two-year ATRS is preserved as PRP 82.2 versus control 83.8, recorded as original values for the patient-reported instrument.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Unit names, precise mean/median definitions, variation, baseline values and final-value/change-score details remain unverified because the external report is unread.
Reason for missing information: Unit names, precise mean/median definitions, variation, baseline values and final-value/change-score details remain unverified because the external report is unread.
Required materials and conditions: Scale units, final values/change scores and variation
Materials to obtain first: Two-year ATRS tables, instrument description, baseline values and variation
Further research: Link final values, change scores and units separately as materials arrive, preserving existing notation.
Remaining uncertainty: Production is limited to the preserved summary. Unit names, precise mean/median definitions, variation, baseline values and final-value/change-score details remain unverified because the external report is unread.
Conditions for verification: Link scale units, final values/change scores and variation to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of scale units, final values/change scores and variation.
Application exceptions: ATRS values are not converted to work percentages/percentage points or other scale units.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M03 §3.2.4; our own application

Related sources R02

N09 · What are the two-year timepoint and actual follow-up duration?

Current findings: The 2022 citation is the PATH-2 two-year follow-up; the original subclaim concerns two-year patient-reported function.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Individual actual follow-up duration, response/measurement windows and interim visit schedules remain unverified.
Reason for missing information: Individual actual follow-up duration, response/measurement windows and interim visit schedules remain unverified.
Required materials and conditions: Nominal two years, response window and measurement timing
Materials to obtain first: Long-term visit/response timing and outcome-measurement records
Further research: Attribute outcomes with different follow-up lengths to their own timepoints.
Remaining uncertainty: Production is limited to the preserved summary. Individual actual follow-up duration, response/measurement windows and interim visit schedules remain unverified.
Conditions for verification: Link nominal two years, response window and measurement timing to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of nominal two years, response window and measurement timing.
Application exceptions: Only preserved-summary information is presented; missing details/definitions are not filled in.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed

Related sources R02

N10 · How are original group-specific two-year ATRS values retained?

Current findings: Two-year ATRS in the same trial was 82.2 versus 83.8; the original description stated no long-term benefit.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Actual group analysis denominators, variation and original result-table rows remain unverified.
Reason for missing information: Actual group analysis denominators, variation and original result-table rows remain unverified.
Required materials and conditions: Original PRP/control values and group correspondence
Materials to obtain first: Two-year tables with group ATRS values, denominators and variation
Further research: If original values are corrected, preserve the complete previous table and change event.
Remaining uncertainty: Production is limited to the preserved summary. Actual group analysis denominators, variation and original result-table rows remain unverified.
Conditions for verification: Link original PRP/control values and group correspondence to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of original PRP/control values and group correspondence.
Application exceptions: The two numbers are not subtracted to create a new effect.
Referenced methods: M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M04 §4.6.3 and M15 §§15.3.1–15.3.3; status separation is Chamgap-designed

Related sources R02

N11 · Are adjusted between-group differences distinguished from group values?

Current findings: Preserve the two-year adjusted difference −0.752 and original interval −5.523–4.020, separately from group values 82.2/83.8.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Adjustment variables, model, estimand, baseline-scale adjustment and reported units remain unverified.
Reason for missing information: Adjustment variables, model, estimand, baseline-scale adjustment and reported units remain unverified.
Required materials and conditions: Direction, model and analysis definition of the two-year adjusted difference
Materials to obtain first: Long-term adjusted model, estimand and original result tables
Further research: Link within-group changes, simple differences and adjusted between-group differences separately when analysis materials arrive.
Remaining uncertainty: Production is limited to the preserved summary. Adjustment variables, model, estimand, baseline-scale adjustment and reported units remain unverified.
Conditions for verification: Link direction, model and analysis definition of the two-year adjusted difference to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of direction, model and analysis definition of the two-year adjusted difference.
Application exceptions: Arithmetic differences between group values are not relabeled as adjusted differences, and adjustment from another timepoint is not transferred.
Referenced methods: M08 §8.2.2, M15 §15.3.1; CHAMGAP adaptation; M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are designed by CHAMGAP

Related sources R02

N12 · What is recorded about the two-year interval and confidence level?

Current findings: The preserved wording is adjusted difference −0.752(−5.523–4.020), P=0.757. The two-year interval numbers are retained.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. The summary does not separately specify the two-year confidence level, calculation method, estimation units or analysis denominator.
Reason for missing information: The summary does not separately specify the two-year confidence level, calculation method, estimation units or analysis denominator.
Required materials and conditions: Original interval, confidence level, estimation units and denominators
Materials to obtain first: Two-year interval notation, confidence level, model and denominators
Further research: Directly link the original interval and confidence level when the external result table is acquired.
Remaining uncertainty: Production is limited to the preserved summary. The summary does not separately specify the two-year confidence level, calculation method, estimation units or analysis denominator.
Conditions for verification: Link original interval, confidence level, estimation units and denominators to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of original interval, confidence level, estimation units and denominators.
Application exceptions: The 24-week 95% CI label is not automatically inherited as new verification of the two-year interval.
Referenced methods: M15 §15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design

Related sources R02

N13 · How far are P=0.757 and the original null description retained?

Current findings: The subclaim D/note records a null long-term result from the same trial at P=0.757. Preserve the summary’s absence-of-long-term-benefit description.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. This summary lacks equivalence/noninferiority criteria and validation of clinically important differences.
Reason for missing information: This summary lacks equivalence/noninferiority criteria and validation of clinically important differences.
Required materials and conditions: Subclaim note, P value and superiority-interpretation boundary
Materials to obtain first: Long-term analysis plans, superiority hypothesis and clinical thresholds for the instrument
Further research: Link materials distinguishing nonsignificance from verified equivalence/absence of harm when available.
Remaining uncertainty: Production is limited to the preserved summary. This summary lacks equivalence/noninferiority criteria and validation of clinically important differences.
Conditions for verification: Link subclaim note, P value and superiority-interpretation boundary to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of subclaim note, P value and superiority-interpretation boundary.
Application exceptions: Nonsignificance is not changed to an exactly zero effect, equivalence or guaranteed safety.
Referenced methods: M04 §4.6.3 and M15 §15.3.1–15.3.3; Status separation is Chamgap design; M15 §15.3.1–15.3.3; Chamgap application

Related sources R02

N14 · Is the 24-week +10-percentage-point power assumption kept separate from two-year clinical thresholds?

Current findings: The parent explicitly states that +10 percentage points came from a previous observation for the 24-week work limb-symmetry index and served as a power assumption, rather than a validated minimum clinically important difference.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Validated clinical thresholds, sample-size assumptions and corresponding interval interpretation for two-year ATRS remain unverified.
Reason for missing information: Validated clinical thresholds, sample-size assumptions and corresponding interval interpretation for two-year ATRS remain unverified.
Required materials and conditions: 24-week sample-size assumptions and clinical importance of two-year ATRS
Materials to obtain first: Two-year ATRS clinical-importance validation and long-term analysis plans
Further research: Link clinical-importance materials for different instruments to separate sources and original units.
Remaining uncertainty: Production is limited to the preserved summary. Validated clinical thresholds, sample-size assumptions and corresponding interval interpretation for two-year ATRS remain unverified.
Conditions for verification: Link 24-week sample-size assumptions and clinical importance of two-year ATRS to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of 24-week sample-size assumptions and clinical importance of two-year ATRS.
Application exceptions: Work +10 percentage points or CI upper bound +2.71 percentage points are not used as a two-year ATRS clinical threshold or upper bound.
Referenced methods: M15 §15.3.1–15.3.3; own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is independently designed

Related sources R01 R02

N15 · How do randomized and two-year analysis denominators differ?

Current findings: The main report records 230 randomized participants: PRP 114, imitation dry needling 116. These are allocation counts.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Two-year contact, response, valid ATRS response and analysis counts/group denominators are absent from the summary.
Reason for missing information: Two-year contact, response, valid ATRS response and analysis counts/group denominators are absent from the summary.
Required materials and conditions: 230 allocated, 114/116 by group, and actual long-term analysis counts
Materials to obtain first: Two-year follow-up flow and group analysis/response counts
Further research: Record allocation, completion, valid instrument responses and analysis separately when original denominators arrive.
Remaining uncertainty: Production is limited to the preserved summary. Two-year contact, response, valid ATRS response and analysis counts/group denominators are absent from the summary.
Conditions for verification: Link 230 allocated, 114/116 by group, and actual long-term analysis counts to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of 230 allocated, 114/116 by group, and actual long-term analysis counts.
Application exceptions: 230 or 114/116 are not copied as actual two-year analysis denominators.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design

Related sources R01 R02

N16 · Can long-term loss to follow-up and response selection be determined?

Current findings: The preserved materials link only the existence of a two-year report from the same trial and its ATRS result.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct values/definitions/materials were not verified within the current preserved-summary and unread-external-material scope. Counts/reasons for failed contact, refusal, death, reinjury, dropout and complete responses remain unverified.
Reason for missing information: Counts/reasons for failed contact, refusal, death, reinjury, dropout and complete responses remain unverified.
Required materials and conditions: Contact/response/dropout reasons and group baseline characteristics
Materials to obtain first: Two-year loss-to-follow-up reasons, respondent/nonrespondent characteristics and group flow
Further research: Follow-up studies should report response selection and outcome-missingness pathways alongside actual counts.
Remaining uncertainty: Production is limited to the preserved summary. Counts/reasons for failed contact, refusal, death, reinjury, dropout and complete responses remain unverified.
Conditions for verification: Link contact/response/dropout reasons and group baseline characteristics to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of contact/response/dropout reasons and group baseline characteristics.
Application exceptions: Only preserved-summary information is presented; missing details/definitions are not filled in.
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application

Related sources R02

N17 · Is 24-week ITT wording kept separate from two-year analysis?

Current findings: The parent cites ITT analysis by allocated group for the 24-week primary analysis. Details of the two-year ATRS analysis population are not separately provided.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Two-year ITT/complete-case/other populations, retained allocation and deviation handling remain unverified.
Reason for missing information: Two-year ITT/complete-case/other populations, retained allocation and deviation handling remain unverified.
Required materials and conditions: Long-term analysis populations, retained allocation and intervention-deviation handling
Materials to obtain first: Two-year analysis methods, populations and deviation-handling tables
Further research: Link the long-term estimand and actual analysis counts separately when materials become available.
Remaining uncertainty: Production is limited to the preserved summary. Two-year ITT/complete-case/other populations, retained allocation and deviation handling remain unverified.
Conditions for verification: Link long-term analysis populations, retained allocation and intervention-deviation handling to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of long-term analysis populations, retained allocation and intervention-deviation handling.
Application exceptions: Reading the main report’s ITT citation does not newly verify two-year ITT implementation.
Referenced methods: M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.

Related sources R01 R02

N18 · Are 24-week multiple imputation and two-year missing-data handling separated?

Current findings: The preserved summary records checks of missing 24-week data with prespecified multiple-imputation sensitivity analyses.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Two-year missing-data handling, imputation variables, sensitivity and changes in conclusions remain unverified.
Reason for missing information: Two-year missing-data handling, imputation variables, sensitivity and changes in conclusions remain unverified.
Required materials and conditions: Timepoint-specific missingness definitions, imputation and sensitivity analyses
Materials to obtain first: Long-term missing-data plans and actual imputation/sensitivity results
Further research: Record newly supplied two-year missing-data materials separately from 24-week handling.
Remaining uncertainty: Production is limited to the preserved summary. Two-year missing-data handling, imputation variables, sensitivity and changes in conclusions remain unverified.
Conditions for verification: Link timepoint-specific missingness definitions, imputation and sensitivity analyses to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of timepoint-specific missingness definitions, imputation and sensitivity analyses.
Application exceptions: The 24-week multiple-imputation record is not marked as completed two-year handling.
Referenced methods: M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.

Related sources R01 R02

N19 · What is the scope of original allocation/concealment and follow-up design?

Current findings: The main report cites a secure central web based service revealing allocation only to the treating surgeon after enrollment. The follow-up is not described as a newly randomized trial.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Original registration/paper methods were not externally read in this work, and actual two-year follow-up operations remain unverified.
Reason for missing information: Original registration/paper methods were not externally read in this work, and actual two-year follow-up operations remain unverified.
Required materials and conditions: Central web randomization and long-term follow-up design
Materials to obtain first: Original main/long-term methods and participant-linkage tables
Further research: Distinguish follow-up of the same allocation from a new randomized trial using registration/cohort linkage.
Remaining uncertainty: Production is limited to the preserved summary. Original registration/paper methods were not externally read in this work, and actual two-year follow-up operations remain unverified.
Conditions for verification: Link central web randomization and long-term follow-up design to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of central web randomization and long-term follow-up design.
Application exceptions: Only preserved-summary information is presented; missing details/definitions are not filled in.
Referenced methods: M08 §8.1–8.2.3; own application

Related sources R01 R02

N20 · How far was participant/assessor masking maintained long term?

Current findings: The parent preserves participant/outcome-assessor masking and inability to mask injectors. It also describes masking of 24-week objective-test assessors.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Maintenance of participant masking until two years, unmasking timing and questionnaire-response setting remain unverified.
Reason for missing information: Maintenance of participant masking until two years, unmasking timing and questionnaire-response setting remain unverified.
Required materials and conditions: Masked roles, unmasking timing and patient-report effects
Materials to obtain first: Two-year masking/unmasking and questionnaire collection processes
Further research: Later patient-reported studies should distinguish maintained masking from response-collection procedures.
Remaining uncertainty: Production is limited to the preserved summary. Maintenance of participant masking until two years, unmasking timing and questionnaire-response setting remain unverified.
Conditions for verification: Link masked roles, unmasking timing and patient-report effects to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of masked roles, unmasking timing and patient-report effects.
Application exceptions: 24-week assessor masking is not expanded into newly verified long-term patient-report masking.
Referenced methods: M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M08 §§8.1–8.2.3; Chamgap adaptation

Related sources R01 R02

N21 · What was the prespecified hierarchy of two-year ATRS?

Current findings: The main primary endpoint was maximal work limb-symmetry index in the heel-rise endurance test at 24 weeks. Two-year ATRS is preserved as a follow-up-report outcome.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Prespecified primary/secondary/exploratory status, multiplicity plans and analysis-plan dates for long-term ATRS remain unverified.
Reason for missing information: Prespecified primary/secondary/exploratory status, multiplicity plans and analysis-plan dates for long-term ATRS remain unverified.
Required materials and conditions: Main primary endpoint and long-term ATRS plans/hierarchy
Materials to obtain first: Original long-term protocol/SAP plans for ATRS timing/hierarchy
Further research: Link actual dates and long-term outcome hierarchy if external plans are provided.
Remaining uncertainty: Production is limited to the preserved summary. Prespecified primary/secondary/exploratory status, multiplicity plans and analysis-plan dates for long-term ATRS remain unverified.
Conditions for verification: Link main primary endpoint and long-term ATRS plans/hierarchy to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of main primary endpoint and long-term ATRS plans/hierarchy.
Application exceptions: Parent endpoint axis P or main primary hierarchy is not transferred to certification of long-term ATRS as primary.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; Chamgap's own application

Related sources R01 R02

N22 · What is the status of identifiers and actual registration content?

Current findings: The first existing evidence record lists “NCT02302664 · ISRCTN54992179.” The parent historically describes agreement with the main primary endpoint.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Registration content/dates/change histories and original two-year plans remain unread here. The two citation records have no separate registration-number key.
Reason for missing information: Registration content/dates/change histories and original two-year plans remain unread here. The two citation records have no separate registration-number key.
Required materials and conditions: Original NCT02302664 · ISRCTN54992179 notation and report linkage
Materials to obtain first: Both original registrations/histories and long-term plans
Further research: Separate current reading records from historical agreement statements when registration materials are provided.
Remaining uncertainty: Production is limited to the preserved summary. Registration content/dates/change histories and original two-year plans remain unread here. The two citation records have no separate registration-number key.
Conditions for verification: Link original NCT02302664 · ISRCTN54992179 notation and report linkage to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of original NCT02302664 · ISRCTN54992179 notation and report linkage.
Application exceptions: The combined nct-key value is not forced into a single NCT format or upgraded to verified registration content.
Referenced methods: M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/result links are a Chamgap application; M08 Table 8.2.a and M04 §4.6.3; Chamgap application

Related sources R01 R02

N23 · What are the identities of the 2019 main and 2022 follow-up reports?

Current findings: R01 is Keene DJ et al., 2019 BMJ PATH-2, PMID 31748208. R02 is Alsousou J et al., 2022 Bone Joint J two-year PATH-2 follow-up, PMID 36317349.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. DOI, PMCID, original full-text locations and current external bibliographic verification were not provided. The evidence list has one grouped record and the citation list has two.
Reason for missing information: DOI, PMCID, original full-text locations and current external bibliographic verification were not provided. The evidence list has one grouped record and the citation list has two.
Required materials and conditions: Report bibliography, PMID, outcome timepoint and preserved-summary location
Materials to obtain first: Original bibliographies, full texts and registration linkage for both reports
Further research: Retain report identities and outcome attribution together if bibliographic corrections arise.
Remaining uncertainty: Production is limited to the preserved summary. DOI, PMCID, original full-text locations and current external bibliographic verification were not provided. The evidence list has one grouped record and the citation list has two.
Conditions for verification: Link report bibliography, PMID, outcome timepoint and preserved-summary location to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of report bibliography, PMID, outcome timepoint and preserved-summary location.
Application exceptions: R02 is not invented as a second existing evidence-list index.
Referenced methods: M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations

Related sources R01 R02

N24 · Is long-term follow-up kept separate from independent replication?

Current findings: Existing research-product information explicitly states that the two-year report follows the same PATH-2 participants and is not independent replication.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Unique trials/participant totals are not newly certified or calculated; report-specific n values are not to be summed.
Reason for missing information: Unique trials/participant totals are not newly certified or calculated; report-specific n values are not to be summed.
Required materials and conditions: Same PATH-2 participants, registrations and report family
Materials to obtain first: Trial/report/instrument/timepoint linkage and long-term participant flow
Further research: Distinguish a new independent trial using separate registration and recruitment-cohort materials.
Remaining uncertainty: Production is limited to the preserved summary. Unique trials/participant totals are not newly certified or calculated; report-specific n values are not to be summed.
Conditions for verification: Link same PATH-2 participants, registrations and report family to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of same PATH-2 participants, registrations and report family.
Application exceptions: Two reports/timepoints/sibling sheets are not summed as two sets of participants or trials.
Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

Related sources R01 R02

N25 · What is the context of the objective 24-week work result?

Current findings: The 24-week work limb-symmetry index was PRP 34.67% versus 38.54%, adjusted difference −3.87 percentage points (95% CI −10.45–2.71), P=0.23. Injured/uninjured ×100 and higher-is-better descriptions apply to this objective index.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Whether two-year objective work testing was measured alongside follow-up ATRS remains unverified.
Reason for missing information: Whether two-year objective work testing was measured alongside follow-up ATRS remains unverified.
Required materials and conditions: Objective 24-week test versus selected two-year patient report
Materials to obtain first: Objective-function and patient-report tables by timepoint
Further research: Link new materials by their actual instrument and timepoint.
Remaining uncertainty: Production is limited to the preserved summary. Whether two-year objective work testing was measured alongside follow-up ATRS remains unverified.
Conditions for verification: Link objective 24-week test versus selected two-year patient report to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of objective 24-week test versus selected two-year patient report.
Application exceptions: 24-week index percentages/percentage points, denominators and CI are not transferred to two-year ATRS.
Referenced methods: M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M04 §4.6.3 and M15 §§15.3.1–15.3.3; status separation is Chamgap-designed

Related sources R01

N26 · Are 24-week and two-year ATRS separated?

Current findings: 24-week ATRS was 64.99 versus 65.53, adjusted difference −0.54 (95% CI −4.90–3.81), P=0.81. Two-year ATRS was 82.2 versus 83.8, adjusted difference −0.752(−5.523–4.020), P=0.757.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Overlap of actual respondents, denominators, baseline adjustment and individual changes across timepoints remain unverified.
Reason for missing information: Overlap of actual respondents, denominators, baseline adjustment and individual changes across timepoints remain unverified.
Required materials and conditions: Timepoint-specific original values, adjusted differences and denominators despite a shared instrument
Materials to obtain first: ATRS tables by timepoint, repeated-measures analyses and participant linkage
Further research: Retain original timepoint values without newly calculating individual recovery.
Remaining uncertainty: Production is limited to the preserved summary. Overlap of actual respondents, denominators, baseline adjustment and individual changes across timepoints remain unverified.
Conditions for verification: Link timepoint-specific original values, adjusted differences and denominators despite a shared instrument to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of timepoint-specific original values, adjusted differences and denominators despite a shared instrument.
Application exceptions: No new between-timepoint subtraction, recovery rates or long-term increases are calculated.
Referenced methods: M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M04 §4.6.3 and M15 §§15.3.1–15.3.3; status separation is Chamgap-designed

Related sources R01 R02

N27 · Are people, limbs, tests and questionnaires distinguished?

Current findings: The main work limb-symmetry index uses injured/uninjured measurements, and allocation is recorded as 230 people. Two-year patient reporting is a separate response outcome.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Actual limb/repeated-measure/questionnaire analysis units and valid group-response n remain unverified.
Reason for missing information: Actual limb/repeated-measure/questionnaire analysis units and valid group-response n remain unverified.
Required materials and conditions: Randomization unit, bilateral testing, ATRS responses and repeated-timepoint analysis units
Materials to obtain first: Person/injured-limb/timepoint/questionnaire linkage and analysis-unit descriptions
Further research: Record separate person/limb/questionnaire/timepoint denominators in new result tables.
Remaining uncertainty: Production is limited to the preserved summary. Actual limb/repeated-measure/questionnaire analysis units and valid group-response n remain unverified.
Conditions for verification: Link randomization unit, bilateral testing, ATRS responses and repeated-timepoint analysis units to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of randomization unit, bilateral testing, ATRS responses and repeated-timepoint analysis units.
Application exceptions: Bilateral measurements or two timepoints are not summed as additional participants.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is independently designed; M08 Table 8.2.a, M03 §3.2.4; own application

Related sources R01 R02

N28 · Can results be generalized to other populations, PRP or repeated exposures?

Current findings: Existing advertising-interpretation wording excludes extension to chronic Achilles tendinopathy, surgical augmentation, other PRP preparations or repeated injections. The parent’s tendinopathy classification name does not change the actual acute-rupture population.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Direct materials for other populations/exposures were not read within this selected-summary scope.
Reason for missing information: Direct materials for other populations/exposures were not read within this selected-summary scope.
Required materials and conditions: Applicability of one added injection in nonoperative acute complete midsubstance rupture
Materials to obtain first: Direct comparisons and long-term function for each different population/intervention
Further research: Distinguish new applicability questions when direct materials and user scope are supplied.
Remaining uncertainty: Production is limited to the preserved summary. Direct materials for other populations/exposures were not read within this selected-summary scope.
Conditions for verification: Link applicability of one added injection in nonoperative acute complete midsubstance rupture to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of applicability of one added injection in nonoperative acute complete midsubstance rupture.
Application exceptions: Verdict 1699 is retained only as parent historical wording; its file/page is not opened.
Referenced methods: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap’s own design; M03 §3.2.1; detailed population conditions are Chamgap’s own design

Related sources R01 R02

N29 · Is patient-reported function kept separate from other clinical outcomes?

Current findings: The selected question concerns two-year patient-reported function; the parent separately describes objective work and complications.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Direct two-year pain, sport/work return, quality of life, rerupture, surgery need and other clinical outcomes are absent from this summary.
Reason for missing information: Direct two-year pain, sport/work return, quality of life, rerupture, surgery need and other clinical outcomes are absent from this summary.
Required materials and conditions: ATRS, objective function, rerupture, pain, activity return and quality of life
Materials to obtain first: Other long-term result tables and endpoint definitions
Further research: Link separate outcomes to actual original-report locations and timepoints.
Remaining uncertainty: Production is limited to the preserved summary. Direct two-year pain, sport/work return, quality of life, rerupture, surgery need and other clinical outcomes are absent from this summary.
Conditions for verification: Link aTRS, objective function, rerupture, pain, activity return and quality of life to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of aTRS, objective function, rerupture, pain, activity return and quality of life.
Application exceptions: Null ATRS is not expanded into a conclusion about all clinical outcomes or treatment strategies.
Referenced methods: M03 §3.2.4; internally defined extension boundary; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed

Related sources R01 R02

N30 · What is the scope of public funding and conflict-of-interest records?

Current findings: The parent records MRC/NIHR EME Programme, NIHR Oxford BRC/Fellowship/CLAHRC Oxford support and University of Oxford sponsorship. The declaration of no manufacturer product/analysis/writing/publication support appears alongside SEL’s Pleuristem consulting fees and KW’s Zimmer Biomet royalties.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Original individual contributions/support/author declarations in the 2022 report and current relationships remain unread.
Reason for missing information: Original individual contributions/support/author declarations in the 2022 report and current relationships remain unread.
Required materials and conditions: Trial support/sponsor, manufacturer support and outside consulting/royalties
Materials to obtain first: Original support, author disclosures and manufacturer roles for each report
Further research: Retain report-specific timing if support histories are supplemented.
Remaining uncertainty: Production is limited to the preserved summary. Original individual contributions/support/author declarations in the 2022 report and current relationships remain unread.
Conditions for verification: Link trial support/sponsor, manufacturer support and outside consulting/royalties to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of trial support/sponsor, manufacturer support and outside consulting/royalties.
Application exceptions: Public funding/historical no-support wording is not changed to new independence certification or absence of conflicts.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

Related sources R01 R02

N31 · How are original dates, both languages, corrections and history retained?

Current findings: The original evidence date is 2026-08-26; corrections are an empty array and deliberation is empty. Both languages, existing integrated summary, verdict-decision records, axes and false markers are preserved unchanged in the complete summary.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Empty corrections do not newly verify absence of external corrections/retractions. Separate classification and primary-failed/secondary-positive keys are absent from this summary.
Reason for missing information: Empty corrections do not newly verify absence of external corrections/retractions. Separate classification and primary-failed/secondary-positive keys are absent from this summary.
Required materials and conditions: Complete originals, evidence date, empty values, verdict history and current production timing
Materials to obtain first: Complete original summary and supplied actual change/correction events
Further research: Separate full originals before changes, events, versions and application when correction materials arrive.
Remaining uncertainty: Production is limited to the preserved summary. Empty corrections do not newly verify absence of external corrections/retractions. Separate classification and primary-failed/secondary-positive keys are absent from this summary.
Conditions for verification: Link complete originals, evidence date, empty values, verdict history and current production timing to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of complete originals, evidence date, empty values, verdict history and current production timing.
Application exceptions: Historical cross-validation/prospective-registration wording is not inherited as completed content review here.
Referenced methods: M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design; M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are our own design

Related sources R01 R02

N32 · What types of materials were actually read?

Current findings: Production read the complete 2970 summary and its own existing selection. Each of two reports is linked to a summary-reading entry; external materials are marked unread.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. External papers/abstracts/registrations/protocols/SAP, supplementary results and disclosure originals were not accessed or acquired.
Reason for missing information: External papers/abstracts/registrations/protocols/SAP, supplementary results and disclosure originals were not accessed or acquired.
Required materials and conditions: Local preserved summary versus external abstracts, full texts, registrations and plans
Materials to obtain first: Original literature or user-supplied materials and actual reading records
Further research: Distinguish material type, acquisition, reading scope and date for new supplied materials.
Remaining uncertainty: Production is limited to the preserved summary. External papers/abstracts/registrations/protocols/SAP, supplementary results and disclosure originals were not accessed or acquired.
Conditions for verification: Link local preserved summary versus external abstracts, full texts, registrations and plans to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of local preserved summary versus external abstracts, full texts, registrations and plans.
Application exceptions: URL existence, preserved citations or copied files do not establish external full-text reading or completed link checks.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

Related sources R01 R02

H01 · How were complications defined and collected?

Current findings: Parent safety wording records at least one complication, rerupture, deep-vein thrombosis and ST-elevation myocardial infarction, as separate harms context.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Complication scope, grading, active/passive collection and cumulative/repeated-event definitions remain unverified.
Reason for missing information: Complication scope, grading, active/passive collection and cumulative/repeated-event definitions remain unverified.
Required materials and conditions: At least one complication, severity, collection and relatedness
Materials to obtain first: Harms definitions, collection plans and event-specific tables
Further research: Later studies should distinguish original complications, injection-related adverse reactions and underlying-disease events.
Remaining uncertainty: Production is limited to the preserved summary. Complication scope, grading, active/passive collection and cumulative/repeated-event definitions remain unverified.
Conditions for verification: Link at least one complication, severity, collection and relatedness to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of at least one complication, severity, collection and relatedness.
Application exceptions: Only preserved-summary information is presented; missing details/definitions are not filled in.
Referenced methods: M19 §§19.1.2–19.2.4; detailed distinctions are Chamgap-designed; M19 §§19.1.2–19.2.4; Chamgap adaptation

Related sources R01 R02

H02 · What are the harms observation periods and long-term exposures?

Current findings: Myocardial infarction timing 2.5 hours after the original injection is recorded. The summary does not separately provide the general complication-table observation period.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Consistent collection until two years, event-specific risk periods and subsequent-care exposure remain unverified.
Reason for missing information: Consistent collection until two years, event-specific risk periods and subsequent-care exposure remain unverified.
Required materials and conditions: Complication follow-up, occurrence timing and long-term collection
Materials to obtain first: Harms periods, occurrence dates and two-year collection records
Further research: Link timepoint-specific harms to actual risk periods and reports.
Remaining uncertainty: Production is limited to the preserved summary. Consistent collection until two years, event-specific risk periods and subsequent-care exposure remain unverified.
Conditions for verification: Link complication follow-up, occurrence timing and long-term collection to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of complication follow-up, occurrence timing and long-term collection.
Application exceptions: Existence of a two-year functional follow-up report is not treated as completed two-year harms follow-up.
Referenced methods: M19 §19.2 design-specific harm questions; timing details are Chamgap-designed

Related sources R01 R02

H03 · How are original group complication numbers preserved?

Current findings: At least one complication occurred in PRP 84/113(74%) versus control 90/116(78%). Rerupture and deep-vein thrombosis were summarized as similar.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Harms differences, RR, CI, tests and individual rerupture/DVT event counts remain unverified.
Reason for missing information: Harms differences, RR, CI, tests and individual rerupture/DVT event counts remain unverified.
Required materials and conditions: People with at least one complication, original denominators and group correspondence
Materials to obtain first: Group complication/rerupture/DVT tables and intervals
Further research: Link original values to actual definitions/intervals when direct harms tables arrive.
Remaining uncertainty: Production is limited to the preserved summary. Harms differences, RR, CI, tests and individual rerupture/DVT event counts remain unverified.
Conditions for verification: Link people with at least one complication, original denominators and group correspondence to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of people with at least one complication, original denominators and group correspondence.
Application exceptions: Similarity is not relabeled as equivalence; no new harms difference is calculated from 84/113 and 90/116.
Referenced methods: M19 §§19.2.2–19.2.4 and M03 §3.2.3; Chamgap adaptation

Related sources R01 R02

H04 · How do harms and functional denominators differ?

Current findings: Allocation was 114/116, while complication denominators were 113/116. Preserve these original denominators separately.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Reasons for selection of safety-analysis 113, exposure/completion definitions and two-year safety/function denominators remain unverified.
Reason for missing information: Reasons for selection of safety-analysis 113, exposure/completion definitions and two-year safety/function denominators remain unverified.
Required materials and conditions: Safety populations for 84/113 and 90/116 versus allocation/function denominators
Materials to obtain first: Safety population definitions/flow and timepoint-specific denominators
Further research: Link allocation, injection exposure, follow-up and analysis counts separately in harms materials.
Remaining uncertainty: Production is limited to the preserved summary. Reasons for selection of safety-analysis 113, exposure/completion definitions and two-year safety/function denominators remain unverified.
Conditions for verification: Link safety populations for 84/113 and 90/116 versus allocation/function denominators to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of safety populations for 84/113 and 90/116 versus allocation/function denominators.
Application exceptions: Denominator differences are not calculated to establish dropout/nonadministration/missingness causes or transferred to two-year n.
Referenced methods: M19 §§19.1.2–19.2.4; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3 and M19 §§19.1.2–19.2.4; design-specific adaptation is Chamgap-designed

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H05 · How far can the myocardial-infarction case relationship be expressed?

Current findings: One ST-elevation myocardial infarction occurred 2.5 hours after PRP injection; the preserved summary records acknowledgment of a possible indirect relation.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Baseline risk, diagnostic details, concurrent factors, independent adjudication, direct mechanism and definitive cause remain unverified.
Reason for missing information: Baseline risk, diagnostic details, concurrent factors, independent adjudication, direct mechanism and definitive cause remain unverified.
Required materials and conditions: One ST-elevation myocardial infarction, post-injection timing and possible indirect relation
Materials to obtain first: Original case record, alternative explanations and relatedness review
Further research: Link timing and levels of causal judgment separately when additional harms materials arrive.
Remaining uncertainty: Production is limited to the preserved summary. Baseline risk, diagnostic details, concurrent factors, independent adjudication, direct mechanism and definitive cause remain unverified.
Conditions for verification: Link one ST-elevation myocardial infarction, post-injection timing and possible indirect relation to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of one ST-elevation myocardial infarction, post-injection timing and possible indirect relation.
Application exceptions: One case is not converted into definite PRP causation, a general incidence estimate or evidence of no harm.
Referenced methods: M19 §19.2.2–19.2.4 design considerations; detailed confounding records are internally designed; Chamgap’s own interpretation boundaries. M19 principles are referenced; no official causality tool was executed

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H06 · Are missing harms kept separate from zero events?

Current findings: External reports remain unread in this work, and only some complications appear in the preserved summary.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct values/definitions/materials were not verified within the current preserved-summary and unread-external-material scope. Complete infection/bleeding/injection-site-reaction/other-event lists and original collection/nonreporting status remain unverified.
Reason for missing information: Complete infection/bleeding/injection-site-reaction/other-event lists and original collection/nonreporting status remain unverified.
Required materials and conditions: Unacquired/unread, uncollected, unreported and actual zero
Materials to obtain first: All harms outcomes, collection/omission reasons and supplementary materials
Further research: Distinguish uncollected, unreported, missing and zero events when materials arrive.
Remaining uncertainty: Production is limited to the preserved summary. Complete infection/bleeding/injection-site-reaction/other-event lists and original collection/nonreporting status remain unverified.
Conditions for verification: Link unacquired/unread, uncollected, unreported and actual zero to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of unacquired/unread, uncollected, unreported and actual zero.
Application exceptions: Unread external materials are not marked as zero adverse events, failed access or nonexistent materials.
Referenced methods: M19 §§19.1.2–19.2.4 and M04 §4.6.3; Chamgap adaptation

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H07 · Are same-trial harms reports kept separate from independent harms replication?

Current findings: The two functional reports concern the same PATH-2 participants in the main and long-term reports. Original follow-up harms materials were not read.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Duplicate versus new events and relationships across follow-up periods remain unverified.
Reason for missing information: Duplicate versus new events and relationships across follow-up periods remain unverified.
Required materials and conditions: Main/follow-up harms-report family and event-time relationships
Materials to obtain first: Same-trial harms event/timepoint/report linkage
Further research: Distinguish repeated reports of the same event from new events without summing them.
Remaining uncertainty: Production is limited to the preserved summary. Duplicate versus new events and relationships across follow-up periods remain unverified.
Conditions for verification: Link main/follow-up harms-report family and event-time relationships to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of main/follow-up harms-report family and event-time relationships.
Application exceptions: Two reports/timepoints are not summed as additional harms events, people or independent trials.
Referenced methods: M04 §§4.6.1–4.6.2; harm-material adaptation is Chamgap-designed; M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations

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H08 · What are the long-term/vulnerable-population safety gaps?

Current findings: Original safety is Caution; the actual population received one added PRP injection with nonoperative care for acute complete midsubstance rupture.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. Safety in other risk populations, chronic tendinopathy, surgical augmentation, other PRP or repeated exposures remains unverified in this summary scope.
Reason for missing information: Safety in other risk populations, chronic tendinopathy, surgical augmentation, other PRP or repeated exposures remains unverified in this summary scope.
Required materials and conditions: Selected versus other risk populations, long-term harms and repeated exposures
Materials to obtain first: Direct population-specific harms, long-term follow-up and actual exposures
Further research: Record other risk populations as direct harms questions separately from efficacy outcomes.
Remaining uncertainty: Production is limited to the preserved summary. Safety in other risk populations, chronic tendinopathy, surgical augmentation, other PRP or repeated exposures remains unverified in this summary scope.
Conditions for verification: Link selected versus other risk populations, long-term harms and repeated exposures to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of selected versus other risk populations, long-term harms and repeated exposures.
Application exceptions: Null two-year ATRS or a single-trial complication summary is not expanded into guaranteed safety of all PRP.
Referenced methods: M19 §§19.1.2–19.2.4; Chamgap adaptation

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H09 · Are null functional outcomes and harms signals retained together?

Current findings: Two-year patient-reported function is originally D/null. Complication numbers and the myocardial-infarction case with possible indirect relation are retained as harms context.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. No new integrated long-term benefit/harms judgment or treatment choice was made.
Reason for missing information: No new integrated long-term benefit/harms judgment or treatment choice was made.
Required materials and conditions: Separate interpretation of selected function, complication numbers and case signals
Materials to obtain first: Direct outcome-specific materials and actual supplementary harms materials supplied for review
Further research: Link function and harms separately to original texts and retain change events when additional events arise.
Remaining uncertainty: Production is limited to the preserved summary. No new integrated long-term benefit/harms judgment or treatment choice was made.
Conditions for verification: Link separate interpretation of selected function, complication numbers and case signals to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of separate interpretation of selected function, complication numbers and case signals.
Application exceptions: Null efficacy is not changed to harmlessness; a case signal is not upgraded to a definitive overall harms verdict.
Referenced methods: Chamgap interpretive boundary informed by M19 principles; no formal causality tool was run

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N42 · What should be updated when new materials arrive?

Current findings: This production preserves the existing summary and rows in a new format. Conditions were stored/frozen first, with observations authored at a separate application time.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: The preserved-summary information was linked for production; this does not establish condition fulfillment, clinical verification or completed review. That production performed no new clinical search, external-material verification, calculations, reassessment or model/self content review.
Reason for missing information: That production performed no new clinical search, external-material verification, calculations, reassessment or model/self content review.
Required materials and conditions: Separate reports, condition versions, original values, material reading and production-change events
Materials to obtain first: User-supplied long-term originals, flow, ATRS analysis, harms and actual correction events
Further research: For new materials, distinguish complete originals before changes, events, condition changes/freezing, separate application and current handoff.
Remaining uncertainty: Production is limited to the preserved summary. That production performed no new clinical search, external-material verification, calculations, reassessment or model/self content review.
Conditions for verification: Link separate reports, condition versions, original values, material reading and production-change events to the corresponding report/timepoint/analysis, distinguishing missing details.
Why this condition is needed: An applicability condition preserving the original scope of separate reports, condition versions, original values, material reading and production-change events.
Application exceptions: Historical candidate pending/eligible values are not revived as an active review procedure, and verdict values are not changed without new materials.
Referenced methods: M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design

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