# One added autologous PRP injection · Original null two-year patient-reported-function result in acute Achilles rupture Verdict 2970 · Evidence Check Stored-material review date: Not recorded Original evidence cut-off: 2026-08-26 Review-criteria version: 1.0 Public page/material preparation date: 2026-10-13 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - Population: 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 ## Checklist items ### N01 · What is the selected question and its record? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Production is limited to the preserved summary. Separate certification of an independent claim was not performed. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Production is limited to the preserved summary. Subclaim numerical score/status/axes remain not recorded and are not filled with parent values. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: PATH-2 involved nonoperative treatment of acute complete midsubstance Achilles rupture within 12 days at 19 UK NHS hospitals. - 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. - 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. - 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. - Referenced methods: M03 §3.2.1; detailed population conditions are Chamgap's own design - Related sources: R01, R02 ### N04 · What PRP exposure was studied? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original materials describe a trial adding one autologous PRP injection to nonoperative treatment of acute complete rupture. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Production is limited to the preserved summary. Detailed reproducibility, actual control delivery and differences in additional care remain unverified. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The two-year patient-reported outcome is recorded as ATRS, separate from the objective 24-week heel-rise work limb-symmetry index. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Two-year ATRS is preserved as PRP 82.2 versus control 83.8, recorded as original values for the patient-reported instrument. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The 2022 citation is the PATH-2 two-year follow-up; the original subclaim concerns two-year patient-reported function. - 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. - 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. - Remaining uncertainty: Production is limited to the preserved summary. Individual actual follow-up duration, response/measurement windows and interim visit schedules remain unverified. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Two-year ATRS in the same trial was 82.2 versus 83.8; the original description stated no long-term benefit. - 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. - 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. - Remaining uncertainty: Production is limited to the preserved summary. Actual group analysis denominators, variation and original result-table rows remain unverified. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Production is limited to the preserved summary. Adjustment variables, model, estimand, baseline-scale adjustment and reported units remain unverified. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The preserved wording is adjusted difference −0.752(−5.523–4.020), P=0.757. The two-year interval numbers are retained. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Production is limited to the preserved summary. This summary lacks equivalence/noninferiority criteria and validation of clinically important differences. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The main report records 230 randomized participants: PRP 114, imitation dry needling 116. These are allocation counts. - 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. - 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. - 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. - 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? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: The preserved materials link only the existence of a two-year report from the same trial and its ATRS result. - 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. - 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. - Remaining uncertainty: Production is limited to the preserved summary. Counts/reasons for failed contact, refusal, death, reinjury, dropout and complete responses remain unverified. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Production is limited to the preserved summary. Two-year ITT/complete-case/other populations, retained allocation and deviation handling remain unverified. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The preserved summary records checks of missing 24-week data with prespecified multiple-imputation sensitivity analyses. - 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. - 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. - Remaining uncertainty: Production is limited to the preserved summary. Two-year missing-data handling, imputation variables, sensitivity and changes in conclusions remain unverified. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - 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. - Referenced methods: M08 §8.1–8.2.3; own application - Related sources: R01, R02 ### N20 · How far was participant/assessor masking maintained long term? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The parent preserves participant/outcome-assessor masking and inability to mask injectors. It also describes masking of 24-week objective-test assessors. - 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. - 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. - Remaining uncertainty: Production is limited to the preserved summary. Maintenance of participant masking until two years, unmasking timing and questionnaire-response setting remain unverified. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The first existing evidence record lists “NCT02302664 · ISRCTN54992179.” The parent historically describes agreement with the main primary endpoint. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Existing research-product information explicitly states that the two-year report follows the same PATH-2 participants and is not independent replication. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Production is limited to the preserved summary. Whether two-year objective work testing was measured alongside follow-up ATRS remains unverified. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Production is limited to the preserved summary. Overlap of actual respondents, denominators, baseline adjustment and individual changes across timepoints remain unverified. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Production is limited to the preserved summary. Actual limb/repeated-measure/questionnaire analysis units and valid group-response n remain unverified. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Production is limited to the preserved summary. Direct materials for other populations/exposures were not read within this selected-summary scope. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The selected question concerns two-year patient-reported function; the parent separately describes objective work and complications. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Production is limited to the preserved summary. Original individual contributions/support/author declarations in the 2022 report and current relationships remain unread. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Parent safety wording records at least one complication, rerupture, deep-vein thrombosis and ST-elevation myocardial infarction, as separate harms context. - 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. - 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. - Remaining uncertainty: Production is limited to the preserved summary. Complication scope, grading, active/passive collection and cumulative/repeated-event definitions remain unverified. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Production is limited to the preserved summary. Consistent collection until two years, event-specific risk periods and subsequent-care exposure remain unverified. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Production is limited to the preserved summary. Harms differences, RR, CI, tests and individual rerupture/DVT event counts remain unverified. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Allocation was 114/116, while complication denominators were 113/116. Preserve these original denominators separately. - 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. - 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. - 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. - 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 - Related sources: R01, R02 ### H05 · How far can the myocardial-infarction case relationship be expressed? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: One ST-elevation myocardial infarction occurred 2.5 hours after PRP injection; the preserved summary records acknowledgment of a possible indirect relation. - 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. - 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. - Remaining uncertainty: Production is limited to the preserved summary. Baseline risk, diagnostic details, concurrent factors, independent adjudication, direct mechanism and definitive cause remain unverified. - 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 - Related sources: R01, R02 ### H06 · Are missing harms kept separate from zero events? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: External reports remain unread in this work, and only some complications appear in the preserved summary. - 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. - 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. - 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. - Referenced methods: M19 §§19.1.2–19.2.4 and M04 §4.6.3; Chamgap adaptation - Related sources: R01, R02 ### H07 · Are same-trial harms reports kept separate from independent harms replication? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Production is limited to the preserved summary. Duplicate versus new events and relationships across follow-up periods remain unverified. - 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 - Related sources: R01, R02 ### H08 · What are the long-term/vulnerable-population safety gaps? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Original safety is Caution; the actual population received one added PRP injection with nonoperative care for acute complete midsubstance rupture. - 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. - 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. - 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. - Referenced methods: M19 §§19.1.2–19.2.4; Chamgap adaptation - Related sources: R01, R02 ### H09 · Are null functional outcomes and harms signals retained together? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Production is limited to the preserved summary. No new integrated long-term benefit/harms judgment or treatment choice was made. - Referenced methods: Chamgap interpretive boundary informed by M19 principles; no formal causality tool was run - Related sources: R01, R02 ### N42 · What should be updated when new materials arrive? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - 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. - Referenced methods: M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design - Related sources: R01, R02 ## Evidence and sources ### R01 Keene DJ, et al. Platelet rich plasma injection for acute Achilles tendon rupture: PATH-2 randomised, placebo controlled, superiority trial. BMJ. 2019;367:l6132. PMID: 31748208. [PubMed](https://pubmed.ncbi.nlm.nih.gov/31748208/) Materials actually read: Summary read; external materials not read Findings recorded in the 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 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. | 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](https://pubmed.ncbi.nlm.nih.gov/36317349/) Materials actually read: Summary read; external materials not read Findings recorded in the 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 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. | 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. | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · 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/materials 1.0. Public pages and materials were created from the existing 42 items. No new clinical search, verification-status change, or scoring was performed.