{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Iodine-alcohol preparation · Closed-fracture surgical-site infection — Evidence Check",
  "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": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "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": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "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": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "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": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "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": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    }
  ],
  "status_dictionary": {
    "Met": "Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.",
    "Partly verified": "Some information in the stored summary is linked into the table. External comparison/content review is not complete.",
    "Unverified": "The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.",
    "Review incomplete": "Existing content review remains incomplete.",
    "Not reported": "Not reported within the stored material actually read; not extended to the entire primary paper.",
    "Inaccessible": "Means an actual access failure. Access not attempted here is not assigned this state.",
    "Not applicable": "Not used as a substitute for an evidence gap.",
    "Conflicting data": "Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.",
    "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "Selected closed-fracture infection question and original values",
      "needed": "Selected subclaim B grade/note, parent verdict context and presence of subclaim score, status and axes",
      "role": "Required",
      "role_reason": "Applicability item distinguishing selected subclaim B grade/note, parent verdict context and presence of subclaim score, status and axes and connecting materials needed for the selected question with current materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original materials and analysis scope for selected subclaim B grade/note, parent verdict context and presence of subclaim score, status and axes should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed update research connecting the original question scope with subsequent materials; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Closed lower-extremity and pelvic fracture population",
      "needed": "Population, recruitment conditions and population-specific results for closed-fracture fixation",
      "role": "Required",
      "role_reason": "Applicability item distinguishing population, recruitment conditions and population-specific results for closed-fracture fixation and connecting materials needed for the selected question with current materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original materials and analysis scope for population, recruitment conditions and population-specific results for closed-fracture fixation should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M03 §3.2.1; Detailed population criteria are designed by CHAMGAP; M03 §3.2.1–3.2.4; Dose, duration and effect-modification details are designed by CHAMGAP; M03 §3.2.2–3.2.3; Reverse labels and test adaptations are designed by CHAMGAP",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research examining reproducibility and heterogeneity within the same population scope; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Iodine-alcohol research preparation",
      "needed": "Identity, concentration and formulation of the iodine preparation used in the trial",
      "role": "Required",
      "role_reason": "Applicability item distinguishing identity, concentration and formulation of the iodine preparation used in the trial and connecting materials needed for the selected question with current materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original materials and analysis scope for identity, concentration and formulation of the iodine preparation used in the trial should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labels and checking adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on applicability across formulation differences; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Chlorhexidine-alcohol comparator",
      "needed": "Actual comparator preparation and concurrent-exposure scope",
      "role": "Required",
      "role_reason": "Applicability item distinguishing actual comparator preparation and concurrent-exposure scope and connecting materials needed for the selected question with current materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original materials and analysis scope for actual comparator preparation and concurrent-exposure scope should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction markers and test adaptation are in-house design; M03 §3.2.3, M08 §8.2.2–8.2.3; in-house application; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is in-house design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research separating differences within the same preparation comparison; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Research exposure and preoperative antisepsis scope",
      "needed": "Records of research preoperative skin-antisepsis exposure, changes and adherence",
      "role": "Required",
      "role_reason": "Applicability item distinguishing records of research preoperative skin-antisepsis exposure, changes and adherence and connecting materials needed for the selected question with current materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original materials and analysis scope for records of research preoperative skin-antisepsis exposure, changes and adherence should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction markers and test adaptation are in-house design; M03 §3.2.3, M08 §8.2.2–8.2.3; in-house application; M04 §4.5–4.6 material collection/selection principles; access/reading separation and the hyperlink scope are in-house design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research examining exposure fidelity and attribution of results; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "25-hospital clusters and two-month alternation",
      "needed": "Hospital and period units of the cluster-randomized crossover design",
      "role": "Required",
      "role_reason": "Applicability item distinguishing hospital and period units of the cluster-randomized crossover design and connecting materials needed for the selected question with current materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original materials and analysis scope for hospital and period units of the cluster-randomized crossover design should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M08 §8.1–8.2.3; in-house application; M08 §8.2.2, M15 §15.3.1; in-house application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome connections are in-house application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is in-house design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research examining cluster/period heterogeneity and period effects; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "Computer assignment of initial preparation",
      "needed": "Generation, concealment and responsible roles for initial hospital assignment",
      "role": "Required",
      "role_reason": "Applicability item distinguishing generation, concealment and responsible roles for initial hospital assignment and connecting materials needed for the selected question with current materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original materials and analysis scope for generation, concealment and responsible roles for initial hospital assignment should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M08 §8.1–8.2.3; in-house application; M04 §4.5–4.6 material collection/selection principles; access/reading separation and the hyperlink scope are in-house design; M08 Table 8.2.a, M04 §4.6.3; in-house application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research examining cluster-allocation procedures and implementation; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "Crossover, period and carryover effects",
      "needed": "Analysis scope for hospital crossover, periods, sequence and carryover",
      "role": "Required",
      "role_reason": "Applicability item distinguishing analysis scope for hospital crossover, periods, sequence and carryover and connecting materials needed for the selected question with current materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original materials and analysis scope for analysis scope for hospital crossover, periods, sequence and carryover should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M08 §8.2.2, M15 §15.3.1; in-house application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is in-house design; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome connections are in-house application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up analysis research separating period and sequence effects; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "Surgical-team and central-adjudication masking",
      "needed": "Masking by role in surgery and infection-outcome adjudication",
      "role": "Required",
      "role_reason": "Applicability item distinguishing masking by role in surgery and infection-outcome adjudication and connecting materials needed for the selected question with current materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original materials and analysis scope for masking by role in surgery and infection-outcome adjudication should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M03 §3.2.4; CHAMGAP adaptation; Material collection/selection principles in M04 §4.5–4.6; Separating access from reading and defining hyperlink behavior are designed by CHAMGAP",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research examining measurement and adjudication bias by role; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "30-day and 90-day infection windows",
      "needed": "Infection-component definitions and actual observation times",
      "role": "Required",
      "role_reason": "Applicability item distinguishing infection-component definitions and actual observation times and connecting materials needed for the selected question with current materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original materials and analysis scope for infection-component definitions and actual observation times should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation to each question is internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research examining results over time under the same infection definitions; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Infection measurement and event units",
      "needed": "Infection ascertainment/adjudication criteria and person/event relationships",
      "role": "Required",
      "role_reason": "Applicability item distinguishing infection ascertainment/adjudication criteria and person/event relationships and connecting materials needed for the selected question with current materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original materials and analysis scope for infection ascertainment/adjudication criteria and person/event relationships should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is in-house design; M08 Table 8.2.a, M03 §3.2.4; in-house application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome connections are in-house application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is in-house design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing people from events; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "6,785 patients and group-specific infection denominators",
      "needed": "Group-specific analysis denominators, events and reported proportions for closed fractures",
      "role": "Required",
      "role_reason": "Applicability item distinguishing group-specific analysis denominators, events and reported proportions for closed fractures and connecting materials needed for the selected question with current materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original materials and analysis scope for group-specific analysis denominators, events and reported proportions for closed fractures should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design; M08 §8.2.2, M15 §15.3.1; custom application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research reproducing results within the same denominator scope; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "Adjusted OR, CI and P",
      "needed": "Adjusted between-group estimate, confidence interval and model",
      "role": "Required",
      "role_reason": "Applicability item distinguishing adjusted between-group estimate, confidence interval and model and connecting materials needed for the selected question with current materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original materials and analysis scope for adjusted between-group estimate, confidence interval and model should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M08 §8.2.2, M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap's own design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research applying the same estimand and analysis scope; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "Adjusted risk difference and units",
      "needed": "Separate reporting of adjusted risk difference, units and confidence interval",
      "role": "Required",
      "role_reason": "Applicability item distinguishing separate reporting of adjusted risk difference, units and confidence interval and connecting materials needed for the selected question with current materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original materials and analysis scope for separate reporting of adjusted risk difference, units and confidence interval should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M15 §15.3.1–15.3.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed.",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research examining precision and interpretation by estimand; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Borderline precision and clinical meaning",
      "needed": "Distinction among prespecified important differences, precision and uncertainty",
      "role": "Required",
      "role_reason": "Applicability item distinguishing distinction among prespecified important differences, precision and uncertainty and connecting materials needed for the selected question with current materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original materials and analysis scope for distinction among prespecified important differences, precision and uncertainty should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M15 §15.3.1–15.3.3; in-house application; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is in-house design; M03 §3.2.4; in-house extension boundaries",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing important differences from uncertainty; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "Analysis by hospital-period assignment",
      "needed": "Analysis population and handling according to hospital/period assignment",
      "role": "Required",
      "role_reason": "Applicability item distinguishing analysis population and handling according to hospital/period assignment and connecting materials needed for the selected question with current materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original materials and analysis scope for analysis population and handling according to hospital/period assignment should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M08 §8.2.2, M15 §15.3.1; in-house application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is in-house design; M03 §3.2.3, M08 §8.2.2–8.2.3; in-house application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research examining cluster assignment and actual exposure; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "95% primary follow-up and missing data",
      "needed": "Follow-up completeness, group-specific missingness/withdrawals and handling",
      "role": "Required",
      "role_reason": "Applicability item distinguishing follow-up completeness, group-specific missingness/withdrawals and handling and connecting materials needed for the selected question with current materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original materials and analysis scope for follow-up completeness, group-specific missingness/withdrawals and handling should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "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": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on result uncertainty under missing-data assumptions; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "NCT identifier and preregistration history",
      "needed": "Original registration, prespecified endpoints/analyses and change history",
      "role": "Required",
      "role_reason": "Applicability item distinguishing original registration, prespecified endpoints/analyses and change history and connecting materials needed for the selected question with current materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original materials and analysis scope for original registration, prespecified endpoints/analyses and change history should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; custom application; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research linking prespecified plans with reported results; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Prespecified closed/open population distinction",
      "needed": "Prespecification of closed/open analyses and multiple-comparison scope",
      "role": "Required",
      "role_reason": "Applicability item distinguishing prespecification of closed/open analyses and multiple-comparison scope and connecting materials needed for the selected question with current materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original materials and analysis scope for prespecification of closed/open analyses and multiple-comparison scope should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; internal application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed.",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on population-specific estimates and interactions; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Open-fracture results as separate context",
      "needed": "Relationship between open-fracture results in the same report and the selected question",
      "role": "Required",
      "role_reason": "Applicability item distinguishing relationship between open-fracture results in the same report and the selected question and connecting materials needed for the selected question with current materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original materials and analysis scope for relationship between open-fracture results in the same report and the selected question should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is in-house design; M03 §3.2.1; detailed population conditions are in-house design; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome connections are in-house application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are in-house design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research separating population-specific differences; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Contrary materials from other surgeries/formulations",
      "needed": "Identity, populations and comparison relationships of other-surgery/formulation results",
      "role": "Required",
      "role_reason": "Applicability item distinguishing identity, populations and comparison relationships of other-surgery/formulation results and connecting materials needed for the selected question with current materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original materials and analysis scope for identity, populations and comparison relationships of other-surgery/formulation results should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is in-house design; M03 §3.2.2–3.2.3; reverse-direction markers and test adaptation are in-house design; M03 §3.2.1; detailed population conditions are in-house design; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are in-house design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing results from different surgeries/formulations; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Concurrent surgical care and attribution",
      "needed": "Concurrent exposures and actual care differences between groups",
      "role": "Required",
      "role_reason": "Applicability item distinguishing concurrent exposures and actual care differences between groups and connecting materials needed for the selected question with current materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original materials and analysis scope for concurrent exposures and actual care differences between groups should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; custom application; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are custom design; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research examining concurrent exposures and attribution to preparations; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Overlap among reports, hospitals and people",
      "needed": "Relationships among the same report, clusters, periods, populations and subsequent endpoints",
      "role": "Required",
      "role_reason": "Applicability item distinguishing relationships among the same report, clusters, periods, populations and subsequent endpoints and connecting materials needed for the selected question with current materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original materials and analysis scope for relationships among the same report, clusters, periods, populations and subsequent endpoints should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome connections are in-house application; M04 §4.6.1–4.6.2, M15 §15.3.1; in-house application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is in-house design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research connecting bibliography with actual trial/population relationships; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "PCORI and CIHR funding",
      "needed": "Original funders and separate support roles",
      "role": "Required",
      "role_reason": "Applicability item distinguishing original funders and separate support roles and connecting materials needed for the selected question with current materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original materials and analysis scope for original funders and separate support roles should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing support roles and report relationships; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "University operational roles",
      "needed": "Operating institutions and funding/product-provision roles",
      "role": "Required",
      "role_reason": "Applicability item distinguishing operating institutions and funding/product-provision roles and connecting materials needed for the selected question with current materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original materials and analysis scope for operating institutions and funding/product-provision roles should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research examining operational roles and result-reporting relationships; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Manufacturer and product/writing-support gaps",
      "needed": "Separate disclosures of product donation, analysis, writing, publication costs, employee authors and COI",
      "role": "Required",
      "role_reason": "Applicability item distinguishing separate disclosures of product donation, analysis, writing, publication costs, employee authors and COI and connecting materials needed for the selected question with current materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original materials and analysis scope for separate disclosures of product donation, analysis, writing, publication costs, employee authors and COI should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing reporting gaps for each support/relationship; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N27",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "One-year reoperation as an additional endpoint",
      "needed": "Separation of reoperation timing, definition, population and denominator from primary infection",
      "role": "Supplementary",
      "role_reason": "Applicability item distinguishing separation of reoperation timing, definition, population and denominator from primary infection and connecting materials needed for the selected question with current materials.",
      "application_exception": "Supplement the selected subclaim’s safety-material gaps. Functional-status/infection efficacy results or parent safety wording do not establish safety or create harms rates or new usage instructions.",
      "criterion": "Corresponding original materials and analysis scope for separation of reoperation timing, definition, population and denominator from primary infection should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is in-house design; M08 Table 8.2.a, M04 §4.6.3; in-house application; M19 §19.1.2–19.2.4; in-house application; M19 §19.1.2–19.2.4; in-house application; M19 §19.1.2–19.2.4; in-house application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing infection from subsequent reoperation; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N28",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Whole-trial burn/fire narrative",
      "needed": "Harms collection/reporting scope, populations, periods and denominators",
      "role": "Supplementary",
      "role_reason": "Applicability item distinguishing harms collection/reporting scope, populations, periods and denominators and connecting materials needed for the selected question with current materials.",
      "application_exception": "Supplement the selected subclaim’s safety-material gaps. Functional-status/infection efficacy results or parent safety wording do not establish safety or create harms rates or new usage instructions.",
      "criterion": "Corresponding original materials and analysis scope for harms collection/reporting scope, populations, periods and denominators should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; detailed distinctions are custom design; M19 §19.1.2–19.2.4; custom application; M19 §19.1.2–19.2.4, M04 §4.6.3; custom application; M19 §19.1.2–19.2.4; custom application; M19 §19.1.2–19.2.4; custom application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed research on harms-reporting scope and subsequent safety materials; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "Generalization to other formulations/settings",
      "needed": "Applicability beyond the selected preparation, surgery and fracture conditions",
      "role": "Required",
      "role_reason": "Applicability item distinguishing applicability beyond the selected preparation, surgery and fracture conditions and connecting materials needed for the selected question with current materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original materials and analysis scope for applicability beyond the selected preparation, surgery and fracture conditions should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M03 §3.2.1–3.2.4; dose, duration and effect-modification details are in-house design; M03 §3.2.2–3.2.3; reverse-direction markers and test adaptation are in-house design; M03 §3.2.1; detailed population conditions are in-house design; M03 §3.2.4; in-house extension boundaries",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing the same question from different conditions; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "Existing axes, Korean/English prose and dates/corrections",
      "needed": "Distinction among original subclaim, parent verdict and historical records",
      "role": "Required",
      "role_reason": "Applicability item distinguishing distinction among original subclaim, parent verdict and historical records and connecting materials needed for the selected question with current materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original materials and analysis scope for distinction among original subclaim, parent verdict and historical records should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed updating research distinguishing original-material changes from preparation versions; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "Actual summary reading and unread external materials",
      "needed": "Actual reading, identity, URLs and needed additional materials by source",
      "role": "Required",
      "role_reason": "Applicability item distinguishing actual reading, identity, URLs and needed additional materials by source and connecting materials needed for the selected question with current materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original materials and analysis scope for actual reading, identity, URLs and needed additional materials by source should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "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": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A research proposal for scope-specific updates based on actually acquired material; no new investigation, calculation or trial is performed in this conversion."
    }
  ]
}