{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "One added autologous PRP injection · Original null two-year patient-reported-function result in acute Achilles rupture",
  "language": "en",
  "translation_date": "2026-10-13",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "condition_origin": "Chamgap's own application conditions",
  "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."
  },
  "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    }
  ]
}