{ "schema_version": "chamgap-public-criteria-1.0", "title": "Close contact casting × Equivalent six-month function in older adults with unstable ankle fracture", "language": "en", "translation_date": "2026-10-10", "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": "Awaiting user review, or actual review remains 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": "Evidence condition", "question": "What are the selected claim and existing verdict record?", "needed": "The relationship between the selected question/record wording and the parent verdict.", "role": "Required", "role_reason": "What are the selected claim and existing verdict record? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "What are the selected claim and existing verdict record? Distinguish The relationship between the selected question/record wording and the parent verdict in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Additional material is linked while distinguishing the existing question from other questions." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "How are the subclaim grade/note and absent score, status and axes retained?", "needed": "Actual subclaim fields and separately preserved parent fields.", "role": "Required", "role_reason": "How are the subclaim grade/note and absent score, status and axes retained? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Absent subclaim values are not filled with the parent score, status or axes.", "criterion": "How are the subclaim grade/note and absent score, status and axes retained? Distinguish Actual subclaim fields and separately preserved parent fields in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "If the subclaim is corrected, the complete pre-change text and change event are retained." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What is the context of the parent grade, axes, safety, null, false and empty values?", "needed": "Parent verdict, axes, original study assessment and change history.", "role": "Required", "role_reason": "What is the context of the parent grade, axes, safety, null, false and empty values? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Historical B1 assessment/cross-check wording is not inherited as newly satisfied conditions.", "criterion": "What is the context of the parent grade, axes, safety, null, false and empty values? Distinguish Parent verdict, axes, original study assessment and change history in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "A new correction is preserved separately from original values, reasons and production status." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "How are Korean/English, the reference date, corrections and empty values preserved?", "needed": "Actual versions of original wording, dates, corrections and history in each language.", "role": "Required", "role_reason": "How are Korean/English, the reference date, corrections and empty values preserved? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "How are Korean/English, the reference date, corrections and empty values preserved? Distinguish Actual versions of original wording, dates, corrections and history in each language in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "When original wording or corrections are added, the complete pre-change text and a separate event are recorded." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Which materials were read for this production and which external materials remain unread?", "needed": "Actual acquisition/reading level for each material and original result locations.", "role": "Required", "role_reason": "Which materials were read for this production and which external materials remain unread? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "URLs only link original material; they do not certify link checking or reading.", "criterion": "Which materials were read for this production and which external materials remain unread? Distinguish Actual acquisition/reading level for each material and original result locations in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Separate later direct reading must record its scope, version and time as a new event." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "What are the AIM report identity and registration identifier?", "needed": "Original bibliography, paper, registration and material linking them to the same trial.", "role": "Required", "role_reason": "What are the AIM report identity and registration identifier? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Different lead-author wording in evidence and citation lists is not counted as separate trials.", "criterion": "What are the AIM report identity and registration identifier? Distinguish Original bibliography, paper, registration and material linking them to the same trial in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Added reports must distinguish the same trial/population from separate trials." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "How is sharing across reports, groups, outcomes and the parent question shown?", "needed": "Material linking trials, reports, groups, analysis populations, outcomes and overlap.", "role": "Required", "role_reason": "How is sharing across reports, groups, outcomes and the parent question shown? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "The number of report entries does not certify independent unique trial or participant counts.", "criterion": "How is sharing across reports, groups, outcomes and the parent question shown? Distinguish Material linking trials, reports, groups, analysis populations, outcomes and overlap in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Added follow-up/related reports must link actual population sharing within the existing AIM family." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Which older population with unstable ankle fractures is studied?", "needed": "Original group tables of eligibility, recruitment, fracture status, baseline function and risk.", "role": "Required", "role_reason": "Which older population with unstable ankle fractures is studied? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Age thresholds or fracture types absent from the current source are not filled in.", "criterion": "Which older population with unstable ankle fractures is studied? Distinguish Original group tables of eligibility, recruitment, fracture status, baseline function and risk in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Function/harms in other populations are distinguished using direct comparison material for those populations." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "How much is known about baseline risk, representativeness and treatment eligibility?", "needed": "Eligibility, exclusions, baseline characteristics, recruitment setting and group distributions.", "role": "Supplementary; required for general application", "role_reason": "How much is known about baseline risk, representativeness and treatment eligibility? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "How much is known about baseline risk, representativeness and treatment eligibility? Distinguish Eligibility, exclusions, baseline characteristics, recruitment setting and group distributions in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "General application requires material showing actual population differences." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "What was the original study intervention of close contact casting?", "needed": "Material on trial intervention identity, implementation, clinicians, actual exposure and changes.", "role": "Required", "role_reason": "What was the original study intervention of close contact casting? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "No casting, reduction, treatment or exercise instructions are written.", "criterion": "What was the original study intervention of close contact casting? Distinguish Material on trial intervention identity, implementation, clinicians, actual exposure and changes in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Differences in other casting techniques/implementation conditions require direct comparison material." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "What are the surgical control and shared anaesthesia/operating-room conditions?", "needed": "Planned and actual records of surgery, fixation, anaesthesia and shared care.", "role": "Required", "role_reason": "What are the surgical control and shared anaesthesia/operating-room conditions? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Results are not extended to avoiding anaesthesia or recommendations on surgical suitability/treatment choice.", "criterion": "What are the surgical control and shared anaesthesia/operating-room conditions? Distinguish Planned and actual records of surgery, fixation, anaesthesia and shared care in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Material with differences in control or concurrent treatment must mark those conditions separately." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "How much is verified about concurrent care, adherence and changes?", "needed": "Original records of concurrent care, actual treatment adherence, changes, discontinuation and follow-up.", "role": "Required", "role_reason": "How much is verified about concurrent care, adherence and changes? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "How much is verified about concurrent care, adherence and changes? Distinguish Original records of concurrent care, actual treatment adherence, changes, discontinuation and follow-up in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Answering the functional estimand requires material distinguishing the assigned strategy from actual implementation." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "What is the verification scope of randomized equivalence design and allocation concealment?", "needed": "Original plans/reports of sequence generation, concealment, stratification and implementation.", "role": "Required", "role_reason": "What is the verification scope of randomized equivalence design and allocation concealment? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "What is the verification scope of randomized equivalence design and allocation concealment? Distinguish Original plans/reports of sequence generation, concealment, stratification and implementation in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Added allocation details must distinguish historical quotations from direct verification." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "How do participant masking and six-month assessor masking differ?", "needed": "Original procedures for assessors, participants, scale responses and actual maintenance of masking.", "role": "Required", "role_reason": "How do participant masking and six-month assessor masking differ? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Clause 105 and the original decision not to count a defect are not run as new review.", "criterion": "How do participant masking and six-month assessor masking differ? Distinguish Original procedures for assessors, participants, scale responses and actual maintenance of masking in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Details of masking, response and measurement processes must each be linked to material." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "What are the denominators for 620 randomized participants and PP/ITT analysis?", "needed": "Group flows and inclusion criteria for allocation, treatment, conversion, follow-up, PP and ITT.", "role": "Required", "role_reason": "What are the denominators for 620 randomized participants and PP/ITT analysis? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "PP, ITT, safety and imaging denominators are not merged.", "criterion": "What are the denominators for 620 randomized participants and PP/ITT analysis? Distinguish Group flows and inclusion criteria for allocation, treatment, conversion, follow-up, PP and ITT in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Added original analysis-population definitions must link to the relevant functional outcome." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "What is the original explanation of primary PP analysis and concordant ITT?", "needed": "Analysis plans, PP/ITT definitions, each estimate/interval and sensitivity tables.", "role": "Required", "role_reason": "What is the original explanation of primary PP analysis and concordant ITT? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "One adjusted difference/CI is not newly attributed to a separate analysis population.", "criterion": "What is the original explanation of primary PP analysis and concordant ITT? Distinguish Analysis plans, PP/ITT definitions, each estimate/interval and sensitivity tables in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Equivalence robustness must be distinguished using direct results for each analysis population/assumption." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Is primary-endpoint missingness the same as overall follow-up or analysis exclusion?", "needed": "Overall flow, analysis exclusions, missingness/sensitivity handling and group-specific reasons.", "role": "Required", "role_reason": "Is primary-endpoint missingness the same as overall follow-up or analysis exclusion? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "Is primary-endpoint missingness the same as overall follow-up or analysis exclusion? Distinguish Overall flow, analysis exclusions, missingness/sensitivity handling and group-specific reasons in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Results under missingness/conversion assumptions require original analysis material." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "What are the scale, units and direction of six-month OMAS?", "needed": "Original OMAS definitions, measurement, responses, scale, units and assessment procedures.", "role": "Required", "role_reason": "What are the scale, units and direction of six-month OMAS? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "What are the scale, units and direction of six-month OMAS? Distinguish Original OMAS definitions, measurement, responses, scale, units and assessment procedures in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Direct functional/other patient outcomes must link with their respective scales and timepoints distinguished." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Are group OMAS scores and the adjusted difference the same quantity?", "needed": "Original tables of group-score estimation, adjustment variables, models and analysis populations.", "role": "Required", "role_reason": "Are group OMAS scores and the adjusted difference the same quantity? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "The adjusted difference is not shown as a simple arithmetic difference of group scores.", "criterion": "Are group OMAS scores and the adjusted difference the same quantity? Distinguish Original tables of group-score estimation, adjustment variables, models and analysis populations in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Material explaining baseline adjustment and the estimand in detail is needed." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Why are prespecified equivalence limits shown on both sides?", "needed": "Rationale for the margin, prespecified versions, two-sided equivalence plans and original analyses.", "role": "Required", "role_reason": "Why are prespecified equivalence limits shown on both sides? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "No new margin, effect or precision calculation or new equivalence verdict is made.", "criterion": "Why are prespecified equivalence limits shown on both sides? Distinguish Rationale for the margin, prespecified versions, two-sided equivalence plans and original analyses in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Added original margin/analysis-plan material must link its relevant scope." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Does functional equivalence mean exactly equal scores or equivalence of all outcomes?", "needed": "Definitions and scope of estimands, margins, analysis populations and each outcome.", "role": "Required", "role_reason": "Does functional equivalence mean exactly equal scores or equivalence of all outcomes? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "Does functional equivalence mean exactly equal scores or equivalence of all outcomes? Distinguish Definitions and scope of estimands, margins, analysis populations and each outcome in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Equivalence at other outcomes/timepoints requires direct comparisons and relevant plans." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "What is the verification level of the six-month primary endpoint and prespecified plans?", "needed": "Actual registration/protocol/SAP versions, changes, primary endpoints and analysis plans.", "role": "Required", "role_reason": "What is the verification level of the six-month primary endpoint and prespecified plans? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Historical confirmation of prespecification is not displayed as current registration-content certification.", "criterion": "What is the verification level of the six-month primary endpoint and prespecified plans? Distinguish Actual registration/protocol/SAP versions, changes, primary endpoints and analysis plans in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Comparison of prespecification with reports is recorded separately when direct material is added." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "What is unverified about adjustment variables, scale error and sensitivity results?", "needed": "Original adjustment, measurement and sensitivity-analysis tables, plans and assumptions.", "role": "Required", "role_reason": "What is unverified about adjustment variables, scale error and sensitivity results? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "What is unverified about adjustment variables, scale error and sensitivity results? Distinguish Original adjustment, measurement and sensitivity-analysis tables, plans and assumptions in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Direct material for each estimand/model must link separately." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "What are the event counts, denominators and group order for infection or wound breakdown?", "needed": "Wound-outcome definitions, timing, denominators, collection and original between-group analyses.", "role": "Required", "role_reason": "What are the event counts, denominators and group order for infection or wound breakdown? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "No new difference, risk ratio, CI, P value or NNT is calculated.", "criterion": "What are the event counts, denominators and group order for infection or wound breakdown? Distinguish Wound-outcome definitions, timing, denominators, collection and original between-group analyses in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Wound benefits require direct estimation/precision material for that outcome." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "What are the original observations of treatment-related additional surgery?", "needed": "Definitions, collection, timing, group denominators and relationship to conversion for additional surgery.", "role": "Required", "role_reason": "What are the original observations of treatment-related additional surgery? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Additional surgery and conversion are not added as independent events/people.", "criterion": "What are the original observations of treatment-related additional surgery? Distinguish Definitions, collection, timing, group denominators and relationship to conversion for additional surgery in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Original material showing how repeated surgery and conversion are counted is needed." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "What are the original malunion events, denominators and group order?", "needed": "Radiographic malunion definitions, assessment, timing, group denominators, effects and intervals.", "role": "Required", "role_reason": "What are the original malunion events, denominators and group order? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "No new difference, proportion, effect or CI is calculated.", "criterion": "What are the original malunion events, denominators and group order? Distinguish Radiographic malunion definitions, assessment, timing, group denominators, effects and intervals in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Anatomical-harm details must link separately from functional outcomes." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "What strategy outcome is conversion to surgery after loss of reduction?", "needed": "Conversion criteria, timing, causes, actual treatment and inclusion handling in PP/ITT.", "role": "Required", "role_reason": "What strategy outcome is conversion to surgery after loss of reduction? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "What strategy outcome is conversion to surgery after loss of reduction? Distinguish Conversion criteria, timing, causes, actual treatment and inclusion handling in PP/ITT in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Material linking the assigned strategy to actual treatment course is needed." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "How are functional equivalence, anatomical alignment and harms retained together?", "needed": "Links between function, imaging, conversion and harms, with separate direct outcome material.", "role": "Required", "role_reason": "How are functional equivalence, anatomical alignment and harms retained together? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "How are functional equivalence, anatomical alignment and harms retained together? Distinguish Links between function, imaging, conversion and harms, with separate direct outcome material in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "The long-term relationship between functional and anatomical outcomes requires direct follow-up material." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Are group-specific data available on anaesthetic complications?", "needed": "Plans, collection, group tables, denominators and follow-up for anaesthesia-related events.", "role": "Required", "role_reason": "Are group-specific data available on anaesthetic complications? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Historical nonreporting wording is not changed to zero events, currently inaccessible material or avoidance of anaesthesia.", "criterion": "Are group-specific data available on anaesthetic complications? Distinguish Plans, collection, group tables, denominators and follow-up for anaesthesia-related events in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Anaesthetic harms require material with actual exposure, definitions, ascertainment and comparisons." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "How do units and denominators differ for function, wounds, imaging and conversion?", "needed": "Original tables of outcome-specific analysis units, at-risk populations, recurrence, group denominators and missingness.", "role": "Required", "role_reason": "How do units and denominators differ for function, wounds, imaging and conversion? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "How do units and denominators differ for function, wounds, imaging and conversion? Distinguish Original tables of outcome-specific analysis units, at-risk populations, recurrence, group denominators and missingness in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Each row must link to material explaining outcome-specific aggregation rules." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Are detailed event collection, adjudication, recurrence and severity verified?", "needed": "Original safety, surgical and imaging tables, definitions, collection, adjudication and missingness material.", "role": "Required", "role_reason": "Are detailed event collection, adjudication, recurrence and severity verified? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "Are detailed event collection, adjudication, recurrence and severity verified? Distinguish Original safety, surgical and imaging tables, definitions, collection, adjudication and missingness material in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Answering harms requires direct event-specific material and sufficient follow-up." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "Are function, durability and long-term harms beyond six months directly verified?", "needed": "Follow-up material linking the same population, scales, timepoints, denominators and harms.", "role": "Supplementary; required for long-term extension", "role_reason": "Are function, durability and long-term harms beyond six months directly verified? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "Are function, durability and long-term harms beyond six months directly verified? Distinguish Follow-up material linking the same population, scales, timepoints, denominators and harms in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Long-term outcomes require material with sufficient follow-up and direct comparison." }, { "item_id": "N33", "question_type": "Evidence condition", "question": "What alternative factors link baseline fracture, concurrent care, conversion and harms?", "needed": "Original records/analyses of baseline risk, actual care, changes and events.", "role": "Required", "role_reason": "What alternative factors link baseline fracture, concurrent care, conversion and harms? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "What alternative factors link baseline fracture, concurrent care, conversion and harms? Distinguish Original records/analyses of baseline risk, actual care, changes and events in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Explanations of harm require event ascertainment, comparison and temporal-relationship material." }, { "item_id": "N34", "question_type": "Evidence condition", "question": "How are NIHR HTA public funding and pilot funding linked?", "needed": "Disclosures of main-trial/pilot sponsorship, reports, populations and roles.", "role": "Required", "role_reason": "How are NIHR HTA public funding and pilot funding linked? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Public funding does not certify all analytical independence or absence of COI.", "criterion": "How are NIHR HTA public funding and pilot funding linked? Distinguish Disclosures of main-trial/pilot sponsorship, reports, populations and roles in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Added funding/report relationships must distinguish actual trial/population sharing." }, { "item_id": "N35", "question_type": "Evidence condition", "question": "What are the detailed sponsor, author, data-access and publication roles?", "needed": "Disclosures of sponsorship, COI, data access, analysis and publication roles.", "role": "Required", "role_reason": "What are the detailed sponsor, author, data-access and publication roles? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "What are the detailed sponsor, author, data-access and publication roles? Distinguish Disclosures of sponsorship, COI, data access, analysis and publication roles in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Broader independence claims require material showing actual involvement and data sharing." }, { "item_id": "N36", "question_type": "Evidence condition", "question": "Is there independent replication in the same population, intervention and timepoint?", "needed": "Independent material linking bibliography, registration, populations, interventions and outcomes.", "role": "Supplementary; required to claim independent replication", "role_reason": "Is there independent replication in the same population, intervention and timepoint? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "Is there independent replication in the same population, intervention and timepoint? Distinguish Independent material linking bibliography, registration, populations, interventions and outcomes in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "New reports must first distinguish the same population from separate trials." }, { "item_id": "N37", "question_type": "Evidence condition", "question": "Can results extend to other ages, fractures, techniques or clinical settings?", "needed": "Direct comparisons of population, fracture, technique, clinician and shared-care differences.", "role": "Supplementary; required for general application", "role_reason": "Can results extend to other ages, fractures, techniques or clinical settings? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "No recommendation on individual treatment suitability or procedural choice is given.", "criterion": "Can results extend to other ages, fractures, techniques or clinical settings? Distinguish Direct comparisons of population, fracture, technique, clinician and shared-care differences in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Other-condition outcomes must be answered with material for their respective question, scale and period." }, { "item_id": "N38", "question_type": "Evidence condition", "question": "What is unverified about the importance of six-month function and individual responses?", "needed": "Rationale for margins, score distributions, direct responders and planned subgroup material.", "role": "Required", "role_reason": "What is unverified about the importance of six-month function and individual responses? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "What is unverified about the importance of six-month function and individual responses? Distinguish Rationale for margins, score distributions, direct responders and planned subgroup material in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Extension to individual response/importance requires prespecified direct analysis material." }, { "item_id": "N39", "question_type": "Evidence condition", "question": "How much is verified about secondary-outcome, multiple-comparison and subgroup plans?", "needed": "Registration/protocol/SAP outcome hierarchy, multiple comparisons, subgroups and original analyses.", "role": "Required", "role_reason": "How much is verified about secondary-outcome, multiple-comparison and subgroup plans? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "How much is verified about secondary-outcome, multiple-comparison and subgroup plans? Distinguish Registration/protocol/SAP outcome hierarchy, multiple comparisons, subgroups and original analyses in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Plans and actual results must link with each measure distinguished." }, { "item_id": "N40", "question_type": "Evidence condition", "question": "What is retained when material is updated or corrected?", "needed": "New material versions, original locations, question changes and reasons for condition/observation changes.", "role": "Required (update boundaries)", "role_reason": "What is retained when material is updated or corrected? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "No new searches, calculations, scores, grades or treatment guidance are created in this production.", "criterion": "What is retained when material is updated or corrected? Distinguish New material versions, original locations, question changes and reasons for condition/observation changes in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Separately added follow-up material must retain its scope and user-review requirements." } ] }