{
  "schema_version": "chamgap-public-evidence-check-1.0",
  "public_id": "v2970-s1",
  "verdict_number": "2970",
  "title": "One added autologous PRP injection · Original null two-year patient-reported-function result in acute Achilles rupture",
  "view_version": "1.0",
  "view_created_date": "2026-10-13",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "review_date": null,
  "legacy_evidence_date": "2026-08-26",
  "review_scope": {
    "materials_read": "Existing review summaries and stored records of methodological application",
    "clinical_papers_directly_read": false,
    "new_clinical_search": false,
    "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.",
    "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature."
  },
  "claim_context": {
    "population": "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.",
    "intervention": "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.",
    "endpoint": "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.",
    "excluded_extensions": [
      "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"
    ]
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Efficacy, boundaries and materials",
      "question": "What is the selected question and its record?",
      "needed": "Existing Korean/English wording and selected verdict record for improved two-year patient-reported function",
      "role": "Required",
      "role_reason": "An applicability condition preserving the original scope of existing Korean/English wording and selected verdict record for improved two-year patient-reported function.",
      "application_exception": "No invented verdict or additional subclaim is created.",
      "criterion": "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.",
      "basis": "Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are our own design",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "If the question boundary changes, retain the existing wording and change event together.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Separate certification of an independent claim was not performed.",
      "uncertainty": "Production is limited to the preserved summary. Separate certification of an independent claim was not performed.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Preserved copies of the selected existing row and complete parent verdict"
    },
    {
      "item_id": "N02",
      "question_type": "Efficacy, boundaries and materials",
      "question": "How are the subclaim grade and parent score/axes distinguished?",
      "needed": "Selected D grade/note, absent score/status/axes, parent D34 and historical axes",
      "role": "Required",
      "role_reason": "An applicability condition preserving the original scope of selected D grade/note, absent score/status/axes, parent D34 and historical axes.",
      "application_exception": "Parent D34 or historical cross-validation is not transferred to a new subclaim score or completed review.",
      "criterion": "Link selected D grade/note, absent score/status/axes, parent D34 and historical axes to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "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",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Grade changes are considered only in a separate evidence-update event.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Subclaim numerical score/status/axes remain not recorded and are not filled with parent values.",
      "uncertainty": "Production is limited to the preserved summary. Subclaim numerical score/status/axes remain not recorded and are not filled with parent values.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Existing subclaim record, parent grade/score/axes and verdict history"
    },
    {
      "item_id": "N03",
      "question_type": "Efficacy, boundaries and materials",
      "question": "Which acute-rupture population is followed long term?",
      "needed": "Injury timing, complete rupture, anatomical location, nonoperative choice and recruitment setting",
      "role": "Required",
      "role_reason": "An applicability condition preserving the original scope of injury timing, complete rupture, anatomical location, nonoperative choice and recruitment setting.",
      "application_exception": "Only preserved-summary information is presented; missing details/definitions are not filled in.",
      "criterion": "Link injury timing, complete rupture, anatomical location, nonoperative choice and recruitment setting to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "M03 §3.2.1; detailed population conditions are Chamgap's own design",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Applicability to other populations is distinguished using actual eligibility and long-term cohort characteristics.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "PATH-2 involved nonoperative treatment of acute complete midsubstance Achilles rupture within 12 days at 19 UK NHS hospitals.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Age, sex, injury mechanism, baseline activity, detailed eligibility/exclusions and representativeness of two-year respondents remain unverified.",
      "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.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original eligibility criteria, baseline characteristics and long-term participant flow"
    },
    {
      "item_id": "N04",
      "question_type": "Efficacy, boundaries and materials",
      "question": "What PRP exposure was studied?",
      "needed": "One autologous PRP injection added to nonoperative care",
      "role": "Required",
      "role_reason": "An applicability condition preserving the original scope of one autologous PRP injection added to nonoperative care.",
      "application_exception": "No preparation/blood-draw/injection instructions or repeated-injection effects are generated.",
      "criterion": "Link one autologous PRP injection added to nonoperative care to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Link later materials to the same PRP preparation and actual exposure scope.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The original materials describe a trial adding one autologous PRP injection to nonoperative treatment of acute complete rupture.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "PRP preparation, platelet/leukocyte quantities, injection volume, individual components and actual delivered dose are absent from this summary.",
      "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.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Preparation/component/exposure records and actual group procedures"
    },
    {
      "item_id": "N05",
      "question_type": "Efficacy, boundaries and materials",
      "question": "What was the actual comparator?",
      "needed": "Imitation dry needling and the actual comparison direction",
      "role": "Required",
      "role_reason": "An applicability condition preserving the original scope of imitation dry needling and the actual comparison direction.",
      "application_exception": "Only preserved-summary information is presented; missing details/definitions are not filled in.",
      "criterion": "Link imitation dry needling and the actual comparison direction to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "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",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Reports using a different comparator are not merged as repetitions of the same comparison.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Detailed reproducibility, actual control delivery and differences in additional care remain unverified.",
      "uncertainty": "Production is limited to the preserved summary. Detailed reproducibility, actual control delivery and differences in additional care remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Control-procedure, actual-delivery and concurrent-care tables"
    },
    {
      "item_id": "N06",
      "question_type": "Efficacy, boundaries and materials",
      "question": "Are common nonoperative care and the added PRP effect distinguished?",
      "needed": "Local anesthesia, blood draw, identical immobilization/rehabilitation and care during follow-up",
      "role": "Required",
      "role_reason": "An applicability condition preserving the original scope of local anesthesia, blood draw, identical immobilization/rehabilitation and care during follow-up.",
      "application_exception": "No rehabilitation/exercise/tendon-care procedures or treatment-replacement guidance.",
      "criterion": "Link local anesthesia, blood draw, identical immobilization/rehabilitation and care during follow-up to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "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",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Later studies interpreting long-term outcomes should record concurrent care and treatment changes during follow-up.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Actual rehabilitation, repeat surgery, adjunctive care, other exposures and between-group differences over two years remain unverified.",
      "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.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Group-specific immobilization/rehabilitation, additional care and long-term exposure records"
    },
    {
      "item_id": "N07",
      "question_type": "Efficacy, boundaries and materials",
      "question": "What is the actual two-year outcome instrument?",
      "needed": "Definitions and measurement of patient-reported function and ATRS",
      "role": "Required",
      "role_reason": "An applicability condition preserving the original scope of definitions and measurement of patient-reported function and ATRS.",
      "application_exception": "Only preserved-summary information is presented; missing details/definitions are not filled in.",
      "criterion": "Link definitions and measurement of patient-reported function and ATRS to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "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",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Link acquired instrument details to the original outcome without substituting objective work or another functional scale.",
      "current_reports": [
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The two-year patient-reported outcome is recorded as ATRS, separate from the objective 24-week heel-rise work limb-symmetry index.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "ATRS items, full range, score direction, administration, language version and valid-response criteria are not stated in the summary.",
      "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.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Two-year report instrument definitions, questionnaire and measurement methods"
    },
    {
      "item_id": "N08",
      "question_type": "Efficacy, boundaries and materials",
      "question": "Are ATRS units and types of reported values distinguished?",
      "needed": "Scale units, final values/change scores and variation",
      "role": "Required",
      "role_reason": "An applicability condition preserving the original scope of scale units, final values/change scores and variation.",
      "application_exception": "ATRS values are not converted to work percentages/percentage points or other scale units.",
      "criterion": "Link scale units, final values/change scores and variation to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "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",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Link final values, change scores and units separately as materials arrive, preserving existing notation.",
      "current_reports": [
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Two-year ATRS is preserved as PRP 82.2 versus control 83.8, recorded as original values for the patient-reported instrument.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Unit names, precise mean/median definitions, variation, baseline values and final-value/change-score details remain unverified because the external report is unread.",
      "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.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Two-year ATRS tables, instrument description, baseline values and variation"
    },
    {
      "item_id": "N09",
      "question_type": "Efficacy, boundaries and materials",
      "question": "What are the two-year timepoint and actual follow-up duration?",
      "needed": "Nominal two years, response window and measurement timing",
      "role": "Required",
      "role_reason": "An applicability condition preserving the original scope of nominal two years, response window and measurement timing.",
      "application_exception": "Only preserved-summary information is presented; missing details/definitions are not filled in.",
      "criterion": "Link nominal two years, response window and measurement timing to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "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",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Attribute outcomes with different follow-up lengths to their own timepoints.",
      "current_reports": [
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The 2022 citation is the PATH-2 two-year follow-up; the original subclaim concerns two-year patient-reported function.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Individual actual follow-up duration, response/measurement windows and interim visit schedules remain unverified.",
      "uncertainty": "Production is limited to the preserved summary. Individual actual follow-up duration, response/measurement windows and interim visit schedules remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Long-term visit/response timing and outcome-measurement records"
    },
    {
      "item_id": "N10",
      "question_type": "Efficacy, boundaries and materials",
      "question": "How are original group-specific two-year ATRS values retained?",
      "needed": "Original PRP/control values and group correspondence",
      "role": "Required",
      "role_reason": "An applicability condition preserving the original scope of original PRP/control values and group correspondence.",
      "application_exception": "The two numbers are not subtracted to create a new effect.",
      "criterion": "Link original PRP/control values and group correspondence to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "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",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "If original values are corrected, preserve the complete previous table and change event.",
      "current_reports": [
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Two-year ATRS in the same trial was 82.2 versus 83.8; the original description stated no long-term benefit.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Actual group analysis denominators, variation and original result-table rows remain unverified.",
      "uncertainty": "Production is limited to the preserved summary. Actual group analysis denominators, variation and original result-table rows remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Two-year tables with group ATRS values, denominators and variation"
    },
    {
      "item_id": "N11",
      "question_type": "Efficacy, boundaries and materials",
      "question": "Are adjusted between-group differences distinguished from group values?",
      "needed": "Direction, model and analysis definition of the two-year adjusted difference",
      "role": "Required",
      "role_reason": "An applicability condition preserving the original scope of direction, model and analysis definition of the two-year adjusted difference.",
      "application_exception": "Arithmetic differences between group values are not relabeled as adjusted differences, and adjustment from another timepoint is not transferred.",
      "criterion": "Link direction, model and analysis definition of the two-year adjusted difference to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "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",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Link within-group changes, simple differences and adjusted between-group differences separately when analysis materials arrive.",
      "current_reports": [
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Preserve the two-year adjusted difference −0.752 and original interval −5.523–4.020, separately from group values 82.2/83.8.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Adjustment variables, model, estimand, baseline-scale adjustment and reported units remain unverified.",
      "uncertainty": "Production is limited to the preserved summary. Adjustment variables, model, estimand, baseline-scale adjustment and reported units remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Long-term adjusted model, estimand and original result tables"
    },
    {
      "item_id": "N12",
      "question_type": "Efficacy, boundaries and materials",
      "question": "What is recorded about the two-year interval and confidence level?",
      "needed": "Original interval, confidence level, estimation units and denominators",
      "role": "Required",
      "role_reason": "An applicability condition preserving the original scope of original interval, confidence level, estimation units and denominators.",
      "application_exception": "The 24-week 95% CI label is not automatically inherited as new verification of the two-year interval.",
      "criterion": "Link original interval, confidence level, estimation units and denominators to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "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",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Directly link the original interval and confidence level when the external result table is acquired.",
      "current_reports": [
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The preserved wording is adjusted difference −0.752(−5.523–4.020), P=0.757. The two-year interval numbers are retained.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "The summary does not separately specify the two-year confidence level, calculation method, estimation units or analysis denominator.",
      "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.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Two-year interval notation, confidence level, model and denominators"
    },
    {
      "item_id": "N13",
      "question_type": "Efficacy, boundaries and materials",
      "question": "How far are P=0.757 and the original null description retained?",
      "needed": "Subclaim note, P value and superiority-interpretation boundary",
      "role": "Required",
      "role_reason": "An applicability condition preserving the original scope of subclaim note, P value and superiority-interpretation boundary.",
      "application_exception": "Nonsignificance is not changed to an exactly zero effect, equivalence or guaranteed safety.",
      "criterion": "Link subclaim note, P value and superiority-interpretation boundary to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "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",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Link materials distinguishing nonsignificance from verified equivalence/absence of harm when available.",
      "current_reports": [
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "This summary lacks equivalence/noninferiority criteria and validation of clinically important differences.",
      "uncertainty": "Production is limited to the preserved summary. This summary lacks equivalence/noninferiority criteria and validation of clinically important differences.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Long-term analysis plans, superiority hypothesis and clinical thresholds for the instrument"
    },
    {
      "item_id": "N14",
      "question_type": "Efficacy, boundaries and materials",
      "question": "Is the 24-week +10-percentage-point power assumption kept separate from two-year clinical thresholds?",
      "needed": "24-week sample-size assumptions and clinical importance of two-year ATRS",
      "role": "Required",
      "role_reason": "An applicability condition preserving the original scope of 24-week sample-size assumptions and clinical importance of two-year ATRS.",
      "application_exception": "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.",
      "criterion": "Link 24-week sample-size assumptions and clinical importance of two-year ATRS to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "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",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Link clinical-importance materials for different instruments to separate sources and original units.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Validated clinical thresholds, sample-size assumptions and corresponding interval interpretation for two-year ATRS remain unverified.",
      "uncertainty": "Production is limited to the preserved summary. Validated clinical thresholds, sample-size assumptions and corresponding interval interpretation for two-year ATRS remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Two-year ATRS clinical-importance validation and long-term analysis plans"
    },
    {
      "item_id": "N15",
      "question_type": "Efficacy, boundaries and materials",
      "question": "How do randomized and two-year analysis denominators differ?",
      "needed": "230 allocated, 114/116 by group, and actual long-term analysis counts",
      "role": "Required",
      "role_reason": "An applicability condition preserving the original scope of 230 allocated, 114/116 by group, and actual long-term analysis counts.",
      "application_exception": "230 or 114/116 are not copied as actual two-year analysis denominators.",
      "criterion": "Link 230 allocated, 114/116 by group, and actual long-term analysis counts to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Record allocation, completion, valid instrument responses and analysis separately when original denominators arrive.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The main report records 230 randomized participants: PRP 114, imitation dry needling 116. These are allocation counts.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Two-year contact, response, valid ATRS response and analysis counts/group denominators are absent from the summary.",
      "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.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Two-year follow-up flow and group analysis/response counts"
    },
    {
      "item_id": "N16",
      "question_type": "Efficacy, boundaries and materials",
      "question": "Can long-term loss to follow-up and response selection be determined?",
      "needed": "Contact/response/dropout reasons and group baseline characteristics",
      "role": "Required",
      "role_reason": "An applicability condition preserving the original scope of contact/response/dropout reasons and group baseline characteristics.",
      "application_exception": "Only preserved-summary information is presented; missing details/definitions are not filled in.",
      "criterion": "Link contact/response/dropout reasons and group baseline characteristics to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "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",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Follow-up studies should report response selection and outcome-missingness pathways alongside actual counts.",
      "current_reports": [
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The preserved materials link only the existence of a two-year report from the same trial and its ATRS result.",
      "condition_status": "Unverified",
      "status_reason": "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.",
      "missingness": "Counts/reasons for failed contact, refusal, death, reinjury, dropout and complete responses remain unverified.",
      "uncertainty": "Production is limited to the preserved summary. Counts/reasons for failed contact, refusal, death, reinjury, dropout and complete responses remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Two-year loss-to-follow-up reasons, respondent/nonrespondent characteristics and group flow"
    },
    {
      "item_id": "N17",
      "question_type": "Efficacy, boundaries and materials",
      "question": "Is 24-week ITT wording kept separate from two-year analysis?",
      "needed": "Long-term analysis populations, retained allocation and intervention-deviation handling",
      "role": "Required",
      "role_reason": "An applicability condition preserving the original scope of long-term analysis populations, retained allocation and intervention-deviation handling.",
      "application_exception": "Reading the main report’s ITT citation does not newly verify two-year ITT implementation.",
      "criterion": "Link long-term analysis populations, retained allocation and intervention-deviation handling to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "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.",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Link the long-term estimand and actual analysis counts separately when materials become available.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Two-year ITT/complete-case/other populations, retained allocation and deviation handling remain unverified.",
      "uncertainty": "Production is limited to the preserved summary. Two-year ITT/complete-case/other populations, retained allocation and deviation handling remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Two-year analysis methods, populations and deviation-handling tables"
    },
    {
      "item_id": "N18",
      "question_type": "Efficacy, boundaries and materials",
      "question": "Are 24-week multiple imputation and two-year missing-data handling separated?",
      "needed": "Timepoint-specific missingness definitions, imputation and sensitivity analyses",
      "role": "Required",
      "role_reason": "An applicability condition preserving the original scope of timepoint-specific missingness definitions, imputation and sensitivity analyses.",
      "application_exception": "The 24-week multiple-imputation record is not marked as completed two-year handling.",
      "criterion": "Link timepoint-specific missingness definitions, imputation and sensitivity analyses to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "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.",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Record newly supplied two-year missing-data materials separately from 24-week handling.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The preserved summary records checks of missing 24-week data with prespecified multiple-imputation sensitivity analyses.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Two-year missing-data handling, imputation variables, sensitivity and changes in conclusions remain unverified.",
      "uncertainty": "Production is limited to the preserved summary. Two-year missing-data handling, imputation variables, sensitivity and changes in conclusions remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Long-term missing-data plans and actual imputation/sensitivity results"
    },
    {
      "item_id": "N19",
      "question_type": "Efficacy, boundaries and materials",
      "question": "What is the scope of original allocation/concealment and follow-up design?",
      "needed": "Central web randomization and long-term follow-up design",
      "role": "Required",
      "role_reason": "An applicability condition preserving the original scope of central web randomization and long-term follow-up design.",
      "application_exception": "Only preserved-summary information is presented; missing details/definitions are not filled in.",
      "criterion": "Link central web randomization and long-term follow-up design to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "M08 §8.1–8.2.3; own application",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Distinguish follow-up of the same allocation from a new randomized trial using registration/cohort linkage.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Original registration/paper methods were not externally read in this work, and actual two-year follow-up operations remain unverified.",
      "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.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original main/long-term methods and participant-linkage tables"
    },
    {
      "item_id": "N20",
      "question_type": "Efficacy, boundaries and materials",
      "question": "How far was participant/assessor masking maintained long term?",
      "needed": "Masked roles, unmasking timing and patient-report effects",
      "role": "Required",
      "role_reason": "An applicability condition preserving the original scope of masked roles, unmasking timing and patient-report effects.",
      "application_exception": "24-week assessor masking is not expanded into newly verified long-term patient-report masking.",
      "criterion": "Link masked roles, unmasking timing and patient-report effects to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M08 §§8.1–8.2.3; Chamgap adaptation",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Later patient-reported studies should distinguish maintained masking from response-collection procedures.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The parent preserves participant/outcome-assessor masking and inability to mask injectors. It also describes masking of 24-week objective-test assessors.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Maintenance of participant masking until two years, unmasking timing and questionnaire-response setting remain unverified.",
      "uncertainty": "Production is limited to the preserved summary. Maintenance of participant masking until two years, unmasking timing and questionnaire-response setting remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Two-year masking/unmasking and questionnaire collection processes"
    },
    {
      "item_id": "N21",
      "question_type": "Efficacy, boundaries and materials",
      "question": "What was the prespecified hierarchy of two-year ATRS?",
      "needed": "Main primary endpoint and long-term ATRS plans/hierarchy",
      "role": "Required",
      "role_reason": "An applicability condition preserving the original scope of main primary endpoint and long-term ATRS plans/hierarchy.",
      "application_exception": "Parent endpoint axis P or main primary hierarchy is not transferred to certification of long-term ATRS as primary.",
      "criterion": "Link main primary endpoint and long-term ATRS plans/hierarchy to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; Chamgap's own application",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Link actual dates and long-term outcome hierarchy if external plans are provided.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Prespecified primary/secondary/exploratory status, multiplicity plans and analysis-plan dates for long-term ATRS remain unverified.",
      "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.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original long-term protocol/SAP plans for ATRS timing/hierarchy"
    },
    {
      "item_id": "N22",
      "question_type": "Efficacy, boundaries and materials",
      "question": "What is the status of identifiers and actual registration content?",
      "needed": "Original NCT02302664 · ISRCTN54992179 notation and report linkage",
      "role": "Required",
      "role_reason": "An applicability condition preserving the original scope of original NCT02302664 · ISRCTN54992179 notation and report linkage.",
      "application_exception": "The combined nct-key value is not forced into a single NCT format or upgraded to verified registration content.",
      "criterion": "Link original NCT02302664 · ISRCTN54992179 notation and report linkage to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "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",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Separate current reading records from historical agreement statements when registration materials are provided.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The first existing evidence record lists “NCT02302664 · ISRCTN54992179.” The parent historically describes agreement with the main primary endpoint.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Registration content/dates/change histories and original two-year plans remain unread here. The two citation records have no separate registration-number key.",
      "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.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Both original registrations/histories and long-term plans"
    },
    {
      "item_id": "N23",
      "question_type": "Efficacy, boundaries and materials",
      "question": "What are the identities of the 2019 main and 2022 follow-up reports?",
      "needed": "Report bibliography, PMID, outcome timepoint and preserved-summary location",
      "role": "Required",
      "role_reason": "An applicability condition preserving the original scope of report bibliography, PMID, outcome timepoint and preserved-summary location.",
      "application_exception": "R02 is not invented as a second existing evidence-list index.",
      "criterion": "Link report bibliography, PMID, outcome timepoint and preserved-summary location to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Retain report identities and outcome attribution together if bibliographic corrections arise.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "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.",
      "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.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original bibliographies, full texts and registration linkage for both reports"
    },
    {
      "item_id": "N24",
      "question_type": "Efficacy, boundaries and materials",
      "question": "Is long-term follow-up kept separate from independent replication?",
      "needed": "Same PATH-2 participants, registrations and report family",
      "role": "Required",
      "role_reason": "An applicability condition preserving the original scope of same PATH-2 participants, registrations and report family.",
      "application_exception": "Two reports/timepoints/sibling sheets are not summed as two sets of participants or trials.",
      "criterion": "Link same PATH-2 participants, registrations and report family to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "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",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Distinguish a new independent trial using separate registration and recruitment-cohort materials.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Existing research-product information explicitly states that the two-year report follows the same PATH-2 participants and is not independent replication.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Unique trials/participant totals are not newly certified or calculated; report-specific n values are not to be summed.",
      "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.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Trial/report/instrument/timepoint linkage and long-term participant flow"
    },
    {
      "item_id": "N25",
      "question_type": "Efficacy, boundaries and materials",
      "question": "What is the context of the objective 24-week work result?",
      "needed": "Objective 24-week test versus selected two-year patient report",
      "role": "Required",
      "role_reason": "An applicability condition preserving the original scope of objective 24-week test versus selected two-year patient report.",
      "application_exception": "24-week index percentages/percentage points, denominators and CI are not transferred to two-year ATRS.",
      "criterion": "Link objective 24-week test versus selected two-year patient report to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "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",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Link new materials by their actual instrument and timepoint.",
      "current_reports": [
        "R01"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Whether two-year objective work testing was measured alongside follow-up ATRS remains unverified.",
      "uncertainty": "Production is limited to the preserved summary. Whether two-year objective work testing was measured alongside follow-up ATRS remains unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Objective-function and patient-report tables by timepoint"
    },
    {
      "item_id": "N26",
      "question_type": "Efficacy, boundaries and materials",
      "question": "Are 24-week and two-year ATRS separated?",
      "needed": "Timepoint-specific original values, adjusted differences and denominators despite a shared instrument",
      "role": "Required",
      "role_reason": "An applicability condition preserving the original scope of timepoint-specific original values, adjusted differences and denominators despite a shared instrument.",
      "application_exception": "No new between-timepoint subtraction, recovery rates or long-term increases are calculated.",
      "criterion": "Link timepoint-specific original values, adjusted differences and denominators despite a shared instrument to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "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",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Retain original timepoint values without newly calculating individual recovery.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Overlap of actual respondents, denominators, baseline adjustment and individual changes across timepoints remain unverified.",
      "uncertainty": "Production is limited to the preserved summary. Overlap of actual respondents, denominators, baseline adjustment and individual changes across timepoints remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "ATRS tables by timepoint, repeated-measures analyses and participant linkage"
    },
    {
      "item_id": "N27",
      "question_type": "Efficacy, boundaries and materials",
      "question": "Are people, limbs, tests and questionnaires distinguished?",
      "needed": "Randomization unit, bilateral testing, ATRS responses and repeated-timepoint analysis units",
      "role": "Required",
      "role_reason": "An applicability condition preserving the original scope of randomization unit, bilateral testing, ATRS responses and repeated-timepoint analysis units.",
      "application_exception": "Bilateral measurements or two timepoints are not summed as additional participants.",
      "criterion": "Link randomization unit, bilateral testing, ATRS responses and repeated-timepoint analysis units to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "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",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Record separate person/limb/questionnaire/timepoint denominators in new result tables.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Actual limb/repeated-measure/questionnaire analysis units and valid group-response n remain unverified.",
      "uncertainty": "Production is limited to the preserved summary. Actual limb/repeated-measure/questionnaire analysis units and valid group-response n remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Person/injured-limb/timepoint/questionnaire linkage and analysis-unit descriptions"
    },
    {
      "item_id": "N28",
      "question_type": "Efficacy, boundaries and materials",
      "question": "Can results be generalized to other populations, PRP or repeated exposures?",
      "needed": "Applicability of one added injection in nonoperative acute complete midsubstance rupture",
      "role": "Required",
      "role_reason": "An applicability condition preserving the original scope of applicability of one added injection in nonoperative acute complete midsubstance rupture.",
      "application_exception": "Verdict 1699 is retained only as parent historical wording; its file/page is not opened.",
      "criterion": "Link applicability of one added injection in nonoperative acute complete midsubstance rupture to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "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",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Distinguish new applicability questions when direct materials and user scope are supplied.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Direct materials for other populations/exposures were not read within this selected-summary scope.",
      "uncertainty": "Production is limited to the preserved summary. Direct materials for other populations/exposures were not read within this selected-summary scope.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Direct comparisons and long-term function for each different population/intervention"
    },
    {
      "item_id": "N29",
      "question_type": "Efficacy, boundaries and materials",
      "question": "Is patient-reported function kept separate from other clinical outcomes?",
      "needed": "ATRS, objective function, rerupture, pain, activity return and quality of life",
      "role": "Required",
      "role_reason": "An applicability condition preserving the original scope of aTRS, objective function, rerupture, pain, activity return and quality of life.",
      "application_exception": "Null ATRS is not expanded into a conclusion about all clinical outcomes or treatment strategies.",
      "criterion": "Link aTRS, objective function, rerupture, pain, activity return and quality of life to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "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",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Link separate outcomes to actual original-report locations and timepoints.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The selected question concerns two-year patient-reported function; the parent separately describes objective work and complications.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Direct two-year pain, sport/work return, quality of life, rerupture, surgery need and other clinical outcomes are absent from this summary.",
      "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.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Other long-term result tables and endpoint definitions"
    },
    {
      "item_id": "N30",
      "question_type": "Efficacy, boundaries and materials",
      "question": "What is the scope of public funding and conflict-of-interest records?",
      "needed": "Trial support/sponsor, manufacturer support and outside consulting/royalties",
      "role": "Required",
      "role_reason": "An applicability condition preserving the original scope of trial support/sponsor, manufacturer support and outside consulting/royalties.",
      "application_exception": "Public funding/historical no-support wording is not changed to new independence certification or absence of conflicts.",
      "criterion": "Link trial support/sponsor, manufacturer support and outside consulting/royalties to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Retain report-specific timing if support histories are supplemented.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Original individual contributions/support/author declarations in the 2022 report and current relationships remain unread.",
      "uncertainty": "Production is limited to the preserved summary. Original individual contributions/support/author declarations in the 2022 report and current relationships remain unread.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original support, author disclosures and manufacturer roles for each report"
    },
    {
      "item_id": "N31",
      "question_type": "Efficacy, boundaries and materials",
      "question": "How are original dates, both languages, corrections and history retained?",
      "needed": "Complete originals, evidence date, empty values, verdict history and current production timing",
      "role": "Required",
      "role_reason": "An applicability condition preserving the original scope of complete originals, evidence date, empty values, verdict history and current production timing.",
      "application_exception": "Historical cross-validation/prospective-registration wording is not inherited as completed content review here.",
      "criterion": "Link complete originals, evidence date, empty values, verdict history and current production timing to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "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",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Separate full originals before changes, events, versions and application when correction materials arrive.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Empty corrections do not newly verify absence of external corrections/retractions. Separate classification and primary-failed/secondary-positive keys are absent from this summary.",
      "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.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Complete original summary and supplied actual change/correction events"
    },
    {
      "item_id": "N32",
      "question_type": "Efficacy, boundaries and materials",
      "question": "What types of materials were actually read?",
      "needed": "Local preserved summary versus external abstracts, full texts, registrations and plans",
      "role": "Required",
      "role_reason": "An applicability condition preserving the original scope of local preserved summary versus external abstracts, full texts, registrations and plans.",
      "application_exception": "URL existence, preserved citations or copied files do not establish external full-text reading or completed link checks.",
      "criterion": "Link local preserved summary versus external abstracts, full texts, registrations and plans to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "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",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Distinguish material type, acquisition, reading scope and date for new supplied materials.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "External papers/abstracts/registrations/protocols/SAP, supplementary results and disclosure originals were not accessed or acquired.",
      "uncertainty": "Production is limited to the preserved summary. External papers/abstracts/registrations/protocols/SAP, supplementary results and disclosure originals were not accessed or acquired.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original literature or user-supplied materials and actual reading records"
    },
    {
      "item_id": "H01",
      "question_type": "Harms",
      "question": "How were complications defined and collected?",
      "needed": "At least one complication, severity, collection and relatedness",
      "role": "Supporting harm information",
      "role_reason": "An applicability condition preserving the original scope of at least one complication, severity, collection and relatedness.",
      "application_exception": "Only preserved-summary information is presented; missing details/definitions are not filled in.",
      "criterion": "Link at least one complication, severity, collection and relatedness to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "M19 §§19.1.2–19.2.4; detailed distinctions are Chamgap-designed; M19 §§19.1.2–19.2.4; Chamgap adaptation",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Later studies should distinguish original complications, injection-related adverse reactions and underlying-disease events.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Parent safety wording records at least one complication, rerupture, deep-vein thrombosis and ST-elevation myocardial infarction, as separate harms context.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Complication scope, grading, active/passive collection and cumulative/repeated-event definitions remain unverified.",
      "uncertainty": "Production is limited to the preserved summary. Complication scope, grading, active/passive collection and cumulative/repeated-event definitions remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Harms definitions, collection plans and event-specific tables"
    },
    {
      "item_id": "H02",
      "question_type": "Harms",
      "question": "What are the harms observation periods and long-term exposures?",
      "needed": "Complication follow-up, occurrence timing and long-term collection",
      "role": "Supporting harm information",
      "role_reason": "An applicability condition preserving the original scope of complication follow-up, occurrence timing and long-term collection.",
      "application_exception": "Existence of a two-year functional follow-up report is not treated as completed two-year harms follow-up.",
      "criterion": "Link complication follow-up, occurrence timing and long-term collection to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "M19 §19.2 design-specific harm questions; timing details are Chamgap-designed",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Link timepoint-specific harms to actual risk periods and reports.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Myocardial infarction timing 2.5 hours after the original injection is recorded. The summary does not separately provide the general complication-table observation period.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Consistent collection until two years, event-specific risk periods and subsequent-care exposure remain unverified.",
      "uncertainty": "Production is limited to the preserved summary. Consistent collection until two years, event-specific risk periods and subsequent-care exposure remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Harms periods, occurrence dates and two-year collection records"
    },
    {
      "item_id": "H03",
      "question_type": "Harms",
      "question": "How are original group complication numbers preserved?",
      "needed": "People with at least one complication, original denominators and group correspondence",
      "role": "Supporting harm information",
      "role_reason": "An applicability condition preserving the original scope of people with at least one complication, original denominators and group correspondence.",
      "application_exception": "Similarity is not relabeled as equivalence; no new harms difference is calculated from 84/113 and 90/116.",
      "criterion": "Link people with at least one complication, original denominators and group correspondence to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "M19 §§19.2.2–19.2.4 and M03 §3.2.3; Chamgap adaptation",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Link original values to actual definitions/intervals when direct harms tables arrive.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "At least one complication occurred in PRP 84/113(74%) versus control 90/116(78%). Rerupture and deep-vein thrombosis were summarized as similar.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Harms differences, RR, CI, tests and individual rerupture/DVT event counts remain unverified.",
      "uncertainty": "Production is limited to the preserved summary. Harms differences, RR, CI, tests and individual rerupture/DVT event counts remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Group complication/rerupture/DVT tables and intervals"
    },
    {
      "item_id": "H04",
      "question_type": "Harms",
      "question": "How do harms and functional denominators differ?",
      "needed": "Safety populations for 84/113 and 90/116 versus allocation/function denominators",
      "role": "Supporting harm information",
      "role_reason": "An applicability condition preserving the original scope of safety populations for 84/113 and 90/116 versus allocation/function denominators.",
      "application_exception": "Denominator differences are not calculated to establish dropout/nonadministration/missingness causes or transferred to two-year n.",
      "criterion": "Link safety populations for 84/113 and 90/116 versus allocation/function denominators to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "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",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Link allocation, injection exposure, follow-up and analysis counts separately in harms materials.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Allocation was 114/116, while complication denominators were 113/116. Preserve these original denominators separately.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Reasons for selection of safety-analysis 113, exposure/completion definitions and two-year safety/function denominators remain unverified.",
      "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.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Safety population definitions/flow and timepoint-specific denominators"
    },
    {
      "item_id": "H05",
      "question_type": "Harms",
      "question": "How far can the myocardial-infarction case relationship be expressed?",
      "needed": "One ST-elevation myocardial infarction, post-injection timing and possible indirect relation",
      "role": "Supporting harm information",
      "role_reason": "An applicability condition preserving the original scope of one ST-elevation myocardial infarction, post-injection timing and possible indirect relation.",
      "application_exception": "One case is not converted into definite PRP causation, a general incidence estimate or evidence of no harm.",
      "criterion": "Link one ST-elevation myocardial infarction, post-injection timing and possible indirect relation to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "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",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Link timing and levels of causal judgment separately when additional harms materials arrive.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "One ST-elevation myocardial infarction occurred 2.5 hours after PRP injection; the preserved summary records acknowledgment of a possible indirect relation.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Baseline risk, diagnostic details, concurrent factors, independent adjudication, direct mechanism and definitive cause remain unverified.",
      "uncertainty": "Production is limited to the preserved summary. Baseline risk, diagnostic details, concurrent factors, independent adjudication, direct mechanism and definitive cause remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original case record, alternative explanations and relatedness review"
    },
    {
      "item_id": "H06",
      "question_type": "Harms",
      "question": "Are missing harms kept separate from zero events?",
      "needed": "Unacquired/unread, uncollected, unreported and actual zero",
      "role": "Supporting harm information",
      "role_reason": "An applicability condition preserving the original scope of unacquired/unread, uncollected, unreported and actual zero.",
      "application_exception": "Unread external materials are not marked as zero adverse events, failed access or nonexistent materials.",
      "criterion": "Link unacquired/unread, uncollected, unreported and actual zero to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "M19 §§19.1.2–19.2.4 and M04 §4.6.3; Chamgap adaptation",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Distinguish uncollected, unreported, missing and zero events when materials arrive.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "External reports remain unread in this work, and only some complications appear in the preserved summary.",
      "condition_status": "Unverified",
      "status_reason": "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.",
      "missingness": "Complete infection/bleeding/injection-site-reaction/other-event lists and original collection/nonreporting status remain unverified.",
      "uncertainty": "Production is limited to the preserved summary. Complete infection/bleeding/injection-site-reaction/other-event lists and original collection/nonreporting status remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "All harms outcomes, collection/omission reasons and supplementary materials"
    },
    {
      "item_id": "H07",
      "question_type": "Harms",
      "question": "Are same-trial harms reports kept separate from independent harms replication?",
      "needed": "Main/follow-up harms-report family and event-time relationships",
      "role": "Supporting harm information",
      "role_reason": "An applicability condition preserving the original scope of main/follow-up harms-report family and event-time relationships.",
      "application_exception": "Two reports/timepoints are not summed as additional harms events, people or independent trials.",
      "criterion": "Link main/follow-up harms-report family and event-time relationships to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "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",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Distinguish repeated reports of the same event from new events without summing them.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Duplicate versus new events and relationships across follow-up periods remain unverified.",
      "uncertainty": "Production is limited to the preserved summary. Duplicate versus new events and relationships across follow-up periods remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Same-trial harms event/timepoint/report linkage"
    },
    {
      "item_id": "H08",
      "question_type": "Harms",
      "question": "What are the long-term/vulnerable-population safety gaps?",
      "needed": "Selected versus other risk populations, long-term harms and repeated exposures",
      "role": "Supporting harm information",
      "role_reason": "An applicability condition preserving the original scope of selected versus other risk populations, long-term harms and repeated exposures.",
      "application_exception": "Null two-year ATRS or a single-trial complication summary is not expanded into guaranteed safety of all PRP.",
      "criterion": "Link selected versus other risk populations, long-term harms and repeated exposures to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "M19 §§19.1.2–19.2.4; Chamgap adaptation",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Record other risk populations as direct harms questions separately from efficacy outcomes.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Original safety is Caution; the actual population received one added PRP injection with nonoperative care for acute complete midsubstance rupture.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Safety in other risk populations, chronic tendinopathy, surgical augmentation, other PRP or repeated exposures remains unverified in this summary scope.",
      "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.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Direct population-specific harms, long-term follow-up and actual exposures"
    },
    {
      "item_id": "H09",
      "question_type": "Harms",
      "question": "Are null functional outcomes and harms signals retained together?",
      "needed": "Separate interpretation of selected function, complication numbers and case signals",
      "role": "Supporting harm information",
      "role_reason": "An applicability condition preserving the original scope of separate interpretation of selected function, complication numbers and case signals.",
      "application_exception": "Null efficacy is not changed to harmlessness; a case signal is not upgraded to a definitive overall harms verdict.",
      "criterion": "Link separate interpretation of selected function, complication numbers and case signals to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "Chamgap interpretive boundary informed by M19 principles; no formal causality tool was run",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "Link function and harms separately to original texts and retain change events when additional events arise.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "No new integrated long-term benefit/harms judgment or treatment choice was made.",
      "uncertainty": "Production is limited to the preserved summary. No new integrated long-term benefit/harms judgment or treatment choice was made.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Direct outcome-specific materials and actual supplementary harms materials supplied for review"
    },
    {
      "item_id": "N42",
      "question_type": "Efficacy, boundaries and materials",
      "question": "What should be updated when new materials arrive?",
      "needed": "Separate reports, condition versions, original values, material reading and production-change events",
      "role": "Required",
      "role_reason": "An applicability condition preserving the original scope of separate reports, condition versions, original values, material reading and production-change events.",
      "application_exception": "Historical candidate pending/eligible values are not revived as an active review procedure, and verdict values are not changed without new materials.",
      "criterion": "Link separate reports, condition versions, original values, material reading and production-change events to the corresponding report/timepoint/analysis, distinguishing missing details.",
      "basis": "M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design",
      "condition_origin": "Chamgap’s own design and production based on original materials; existing content review incomplete",
      "proposed_research": "For new materials, distinguish complete originals before changes, events, condition changes/freezing, separate application and current handoff.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Preserved-summary linkage; existence/current public availability of required external details remain separately unverified",
      "acquired_read": "Summary read; external materials not read",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "That production performed no new clinical search, external-material verification, calculations, reassessment or model/self content review.",
      "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.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "User-supplied long-term originals, flow, ATRS analysis, harms and actual correction events"
    }
  ],
  "reports": [
    {
      "report_id": "R01",
      "title": "Keene DJ, et al. Platelet rich plasma injection for acute Achilles tendon rupture: PATH-2 randomised, placebo controlled, superiority trial. BMJ. 2019;367:l6132. PMID: 31748208.",
      "url": "https://pubmed.ncbi.nlm.nih.gov/31748208/",
      "report_type": "PATH-2 24-week main report",
      "existence": "Bibliography/URL preserved in the summary citation list",
      "acquired_read": "Summary read; external materials not read",
      "study_family": "PATH-2 · Same original randomized cohort",
      "independent_replication": false,
      "observed_result": "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.",
      "result_level": "Main-report results in the first preserved evidence-list record",
      "source_evidence_date": "2026-08-26",
      "materials": [
        {
          "material_type": "Stored summary",
          "public_status": "Local preserved summary",
          "access_status": "Local copy acquired",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-10-06T15:56:04.072638+09:00",
          "qualification": "The corresponding citation and result context were read in the complete local preserved summary. No external paper reading."
        },
        {
          "material_type": "External abstract",
          "public_status": "Current publication/access unverified",
          "access_status": "Access not attempted; not obtained",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Only the original citation link is connected. Current abstract content/successful access were not verified."
        },
        {
          "material_type": "External full text",
          "public_status": "Current publication/access unverified",
          "access_status": "Access not attempted; not obtained",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Only the original citation-list identity link is connected. Full-text URLs/public availability/access were not verified."
        },
        {
          "material_type": "Registration",
          "public_status": "Current publication/access unverified",
          "access_status": "Access not attempted; not obtained",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Original NCT02302664 · ISRCTN54992179 notation is linked within the same trial family; registration content remains unread."
        },
        {
          "material_type": "Protocol",
          "public_status": "Current publication/access unverified",
          "access_status": "Access not attempted; not obtained",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Required-material entry. Actual file existence, public availability and long-term plan hierarchy remain unverified."
        },
        {
          "material_type": "Statistical analysis plan",
          "public_status": "Current publication/access unverified",
          "access_status": "Access not attempted; not obtained",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Required-material entry for timepoint-specific models, denominators, missing-data handling and prespecified plans."
        },
        {
          "material_type": "Results, denominator and harm details",
          "public_status": "Current publication/access unverified",
          "access_status": "Access not attempted; not obtained",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Required-material entry for original function, denominator, loss, instrument and harms results. Values/existence were not newly verified."
        },
        {
          "material_type": "Support and interests",
          "public_status": "Current publication/access unverified",
          "access_status": "Access not attempted; not obtained",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Parent-trial support context is distinguished from individual report declarations. External originals remain unread."
        }
      ],
      "links": [
        {
          "label": "PubMed",
          "url": "https://pubmed.ncbi.nlm.nih.gov/31748208/"
        }
      ]
    },
    {
      "report_id": "R02",
      "title": "Alsousou J, et al. Platelet-rich plasma injection for acute Achilles tendon rupture: two-year follow-up of the PATH-2 trial. Bone Joint J. 2022. PMID: 36317349.",
      "url": "https://pubmed.ncbi.nlm.nih.gov/36317349/",
      "report_type": "Two-year follow-up report from the same PATH-2 trial",
      "existence": "Bibliography/URL preserved in the summary citation list",
      "acquired_read": "Summary read; external materials not read",
      "study_family": "PATH-2 · Same original randomized cohort",
      "independent_replication": false,
      "observed_result": "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.",
      "result_level": "Follow-up context in the preserved summary",
      "source_evidence_date": "2026-08-26",
      "materials": [
        {
          "material_type": "Stored summary",
          "public_status": "Local preserved summary",
          "access_status": "Local copy acquired",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-10-06T15:56:04.072638+09:00",
          "qualification": "The corresponding citation and result context were read in the complete local preserved summary. No external paper reading."
        },
        {
          "material_type": "External abstract",
          "public_status": "Current publication/access unverified",
          "access_status": "Access not attempted; not obtained",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Only the original citation link is connected. Current abstract content/successful access were not verified."
        },
        {
          "material_type": "External full text",
          "public_status": "Current publication/access unverified",
          "access_status": "Access not attempted; not obtained",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Only the original citation-list identity link is connected. Full-text URLs/public availability/access were not verified."
        },
        {
          "material_type": "Registration",
          "public_status": "Current publication/access unverified",
          "access_status": "Access not attempted; not obtained",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Original NCT02302664 · ISRCTN54992179 notation is linked within the same trial family; registration content remains unread."
        },
        {
          "material_type": "Protocol",
          "public_status": "Current publication/access unverified",
          "access_status": "Access not attempted; not obtained",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Required-material entry. Actual file existence, public availability and long-term plan hierarchy remain unverified."
        },
        {
          "material_type": "Statistical analysis plan",
          "public_status": "Current publication/access unverified",
          "access_status": "Access not attempted; not obtained",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Required-material entry for timepoint-specific models, denominators, missing-data handling and prespecified plans."
        },
        {
          "material_type": "Results, denominator and harm details",
          "public_status": "Current publication/access unverified",
          "access_status": "Access not attempted; not obtained",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Required-material entry for original function, denominator, loss, instrument and harms results. Values/existence were not newly verified."
        },
        {
          "material_type": "Support and interests",
          "public_status": "Current publication/access unverified",
          "access_status": "Access not attempted; not obtained",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Parent-trial support context is distinguished from individual report declarations. External originals remain unread."
        }
      ],
      "links": [
        {
          "label": "PubMed",
          "url": "https://pubmed.ncbi.nlm.nih.gov/36317349/"
        }
      ]
    }
  ],
  "method_sources": [
    {
      "id": "M03",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03",
      "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13",
      "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "id": "M04",
      "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
      "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "id": "M08",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
      "section": "§8.1–8.2.3, Table 8.2.a",
      "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "id": "M15",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
      "section": "§15.2.4, §15.3.1–15.3.3",
      "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    }
  ],
  "status_dictionary": {
    "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."
  },
  "study_overlap": {
    "state": "Unverified",
    "unique_trial_count": null,
    "unique_participant_count": null,
    "reason": "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."
  },
  "history": [
    {
      "date": "2026-10-13",
      "kind": "Separation of public-facing pages and materials",
      "view_version": "1.0",
      "change": "Public pages and materials were created from the existing 42 items. No new clinical search, verification-status change, or scoring was performed."
    }
  ],
  "language": "en",
  "translation_date": "2026-10-13"
}