# Close contact casting × Equivalent six-month function in older adults with unstable ankle fracture Verdict 2921 · Evidence Check Stored-material review date: Not recorded Original evidence cut-off: 2026-08-26 Review-criteria version: 1.0 Public page/material preparation date: 2026-10-10 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - Population: Equivalent six-month function to surgery in older adults with unstable ankle fracture - Ingredient, formulation and route: Close contact casting - Dose: Original intervention identity and shared anaesthesia/operating-room conditions are retained; no new casting, reduction or procedural guidance is created - Comparator: Surgery. The adjusted functional difference is casting versus surgery - Measured outcome: Six-month OMAS; higher scores mean better function; prespecified equivalence limits ±6 points - Duration: Six-month OMAS primary endpoint; detailed observation windows for other outcomes are unverified - Questions outside this scope: Generalizing effects/safety to other populations, diseases, surgical risks, formulations or timepoints; Adding the same report, population, groups, timepoints or outcomes as new independent trials/participants; Recommending individual treatments, procedures, doses, suitability or usage choices ## Checklist items ### N01 · What are the selected claim and existing verdict record? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The selected stored summary concerns equivalent six-month function. The selected claim and its verdict record are distinguished, with parent-verdict context preserved. No new verdict, split or independent certification is created. - Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. The relationship between the selected question/record wording and the parent verdict remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; The relationship between the selected question/record wording and the parent verdict. - Required materials and conditions: The relationship between the selected question/record wording and the parent verdict. - Materials to obtain first: The relationship between the selected question/record wording and the parent verdict. - Further research: Additional material is linked while distinguishing the existing question from other questions. - Conditions for verification: 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. - Why this condition is needed: What are the selected claim and existing verdict record? This is needed to distinguish the relevant outcome, population and design from other scopes. - Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N02 · How are the subclaim grade/note and absent score, status and axes retained? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The subclaim grade is B and its note says the entire OMAS CI was within ±6 points. Subclaim score, status and axes are absent from the stored summary and are not filled with parent B, 70 points or axes. - Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Actual subclaim fields and separately preserved parent fields remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Actual subclaim fields and separately preserved parent fields. - Required materials and conditions: Actual subclaim fields and separately preserved parent fields. - Materials to obtain first: Actual subclaim fields and separately preserved parent fields. - Further research: If the subclaim is corrected, the complete pre-change text and change event are retained. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Absent subclaim values are not filled with the parent score, status or axes. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N03 · What is the context of the parent grade, axes, safety, null, false and empty values? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Parent B, 70 points, safety caution and B/P/R1/I2/E+/B1 are preserved. Precision is unrecorded; coprimary splitting, large hard-endpoint RCT and no-human-study flags are false; grade-override reasons are empty in both languages. Historical clause 105 and the one-design-defect explanation are not run as a new assessment. - Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Parent verdict, axes, original study assessment and change history remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Parent verdict, axes, original study assessment and change history. - Required materials and conditions: Parent verdict, axes, original study assessment and change history. - Materials to obtain first: Parent verdict, axes, original study assessment and change history. - Further research: A new correction is preserved separately from original values, reasons and production status. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Historical B1 assessment/cross-check wording is not inherited as newly satisfied conditions. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N04 · How are Korean/English, the reference date, corrections and empty values preserved? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Complete Korean/English articles, reference date 2026-08-26 and existing empty correction/deliberation values are preserved. Differences in Korean/English PP/ITT detail do not overwrite each other. - Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Actual versions of original wording, dates, corrections and history in each language remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Actual versions of original wording, dates, corrections and history in each language. - Required materials and conditions: Actual versions of original wording, dates, corrections and history in each language. - Materials to obtain first: Actual versions of original wording, dates, corrections and history in each language. - Further research: When original wording or corrections are added, the complete pre-change text and a separate event are recorded. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N05 · Which materials were read for this production and which external materials remain unread? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The complete stored existing review summary was read for production. Abstracts, full texts, registration, plans, SAPs and original outcome tables were not accessed. Stored citations and historical review wording do not mean current external reading or completed review. - Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Actual acquisition/reading level for each material and original result locations remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Actual acquisition/reading level for each material and original result locations. - Required materials and conditions: Actual acquisition/reading level for each material and original result locations. - Materials to obtain first: Actual acquisition/reading level for each material and original result locations. - Further research: Separate later direct reading must record its scope, version and time as a new event. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: URLs only link original material; they do not certify link checking or reading. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N06 · What are the AIM report identity and registration identifier? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The evidence list names Keene DJ et al., 2016 AIM; the citation list names Willett K, Keene DJ, Mistry D et al., JAMA 2016. PMID 27727383 and ISRCTN04180738 link to the same stored report. DOI, PMCID and external registration content are unverified. - Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original bibliography, paper, registration and material linking them to the same trial remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original bibliography, paper, registration and material linking them to the same trial. - Required materials and conditions: Original bibliography, paper, registration and material linking them to the same trial. - Materials to obtain first: Original bibliography, paper, registration and material linking them to the same trial. - Further research: Added reports must distinguish the same trial/population from separate trials. - Conditions for verification: 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. - Why this condition is needed: What are the AIM report identity and registration identifier? This is needed to distinguish the relevant outcome, population and design from other scopes. - Application exceptions: Different lead-author wording in evidence and citation lists is not counted as separate trials. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N07 · How is sharing across reports, groups, outcomes and the parent question shown? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The stored direct-report entry is one AIM trial. PP, ITT, function, wounds, malunion, conversion to surgery and parent-verdict context are not added as new independent trials/participants. - Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Material linking trials, reports, groups, analysis populations, outcomes and overlap remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Material linking trials, reports, groups, analysis populations, outcomes and overlap. - Required materials and conditions: Material linking trials, reports, groups, analysis populations, outcomes and overlap. - Materials to obtain first: Material linking trials, reports, groups, analysis populations, outcomes and overlap. - Further research: Added follow-up/related reports must link actual population sharing within the existing AIM family. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: The number of report entries does not certify independent unique trial or participant counts. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N08 · Which older population with unstable ankle fractures is studied? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The question concerns unstable ankle fracture in older adults. Detailed age criteria, fracture classifications, eligibility, exclusions, baseline function and comorbidities are absent from the summary; results are not automatically applied to all fractures or ages. - Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original group tables of eligibility, recruitment, fracture status, baseline function and risk remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original group tables of eligibility, recruitment, fracture status, baseline function and risk. - Required materials and conditions: Original group tables of eligibility, recruitment, fracture status, baseline function and risk. - Materials to obtain first: Original group tables of eligibility, recruitment, fracture status, baseline function and risk. - Further research: Function/harms in other populations are distinguished using direct comparison material for those populations. - Conditions for verification: 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. - Why this condition is needed: Which older population with unstable ankle fractures is studied? This is needed to distinguish the relevant outcome, population and design from other scopes. - Application exceptions: Age thresholds or fracture types absent from the current source are not filled in. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N09 · How much is known about baseline risk, representativeness and treatment eligibility? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: Detailed recruitment pathways, centres, fracture severity, baseline walking ability and distributions of treatment eligibility are unverified in the current summary. A population name does not establish treatment suitability for an individual patient. - Why unverified: Required direct details are unverified within the current summary and unread external material. Eligibility, exclusions, baseline characteristics, recruitment setting and group distributions remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Eligibility, exclusions, baseline characteristics, recruitment setting and group distributions. - Required materials and conditions: Eligibility, exclusions, baseline characteristics, recruitment setting and group distributions. - Materials to obtain first: Eligibility, exclusions, baseline characteristics, recruitment setting and group distributions. - Further research: General application requires material showing actual population differences. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N10 · What was the original study intervention of close contact casting? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original explanation that close contact casting maintains reduction through minimal padding and close moulding is retained. Actual application techniques, timing, repeated procedures and clinician experience remain unverified. No new procedural guidance is written. - Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Material on trial intervention identity, implementation, clinicians, actual exposure and changes remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Material on trial intervention identity, implementation, clinicians, actual exposure and changes. - Required materials and conditions: Material on trial intervention identity, implementation, clinicians, actual exposure and changes. - Materials to obtain first: Material on trial intervention identity, implementation, clinicians, actual exposure and changes. - Further research: Differences in other casting techniques/implementation conditions require direct comparison material. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: No casting, reduction, treatment or exercise instructions are written. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N11 · What are the surgical control and shared anaesthesia/operating-room conditions? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Both groups received initial treatment in an operating room under general or spinal anaesthesia. Casting is distinguished from initial incisions/internal fixation, but the trial did not avoid anaesthesia itself. Detailed techniques of the surgical control are unverified. - Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Planned and actual records of surgery, fixation, anaesthesia and shared care remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Planned and actual records of surgery, fixation, anaesthesia and shared care. - Required materials and conditions: Planned and actual records of surgery, fixation, anaesthesia and shared care. - Materials to obtain first: Planned and actual records of surgery, fixation, anaesthesia and shared care. - Further research: Material with differences in control or concurrent treatment must mark those conditions separately. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Results are not extended to avoiding anaesthesia or recommendations on surgical suitability/treatment choice. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N12 · How much is verified about concurrent care, adherence and changes? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: Detailed rehabilitation, adjunctive care, clinicians, actual adherence and management differences are unverified. Conversion to surgery after loss of reduction is retained as a separate observation; other concurrent care is not invented. - Why unverified: Required direct details are unverified within the current summary and unread external material. Original records of concurrent care, actual treatment adherence, changes, discontinuation and follow-up remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original records of concurrent care, actual treatment adherence, changes, discontinuation and follow-up. - Required materials and conditions: Original records of concurrent care, actual treatment adherence, changes, discontinuation and follow-up. - Materials to obtain first: Original records of concurrent care, actual treatment adherence, changes, discontinuation and follow-up. - Further research: Answering the functional estimand requires material distinguishing the assigned strategy from actual implementation. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N13 · What is the verification scope of randomized equivalence design and allocation concealment? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: This is a multicentre randomized equivalence trial. The original account says concealment used an independent Aberdeen University 24-hour telephone service, registering participants before computer-generated allocation. External procedures were not reverified here. - Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original plans/reports of sequence generation, concealment, stratification and implementation remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original plans/reports of sequence generation, concealment, stratification and implementation. - Required materials and conditions: Original plans/reports of sequence generation, concealment, stratification and implementation. - Materials to obtain first: Original plans/reports of sequence generation, concealment, stratification and implementation. - Further research: Added allocation details must distinguish historical quotations from direct verification. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N14 · How do participant masking and six-month assessor masking differ? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The historical assessment that participant masking was inherently impossible for surgery versus casting is distinguished from six-month assessor masking. The original account of opaque ankle bandages and a James index of 0.8 is retained. - Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original procedures for assessors, participants, scale responses and actual maintenance of masking remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original procedures for assessors, participants, scale responses and actual maintenance of masking. - Required materials and conditions: Original procedures for assessors, participants, scale responses and actual maintenance of masking. - Materials to obtain first: Original procedures for assessors, participants, scale responses and actual maintenance of masking. - Further research: Details of masking, response and measurement processes must each be linked to material. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Clause 105 and the original decision not to count a defect are not run as new review. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N15 · What are the denominators for 620 randomized participants and PP/ITT analysis? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: There were 620 randomized participants, 558 in six-month PP analysis and 593 in ITT. These three denominators are distinguished; no new dropout counts or proportions are calculated from their differences. - Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Group flows and inclusion criteria for allocation, treatment, conversion, follow-up, PP and ITT remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Group flows and inclusion criteria for allocation, treatment, conversion, follow-up, PP and ITT. - Required materials and conditions: Group flows and inclusion criteria for allocation, treatment, conversion, follow-up, PP and ITT. - Materials to obtain first: Group flows and inclusion criteria for allocation, treatment, conversion, follow-up, PP and ITT. - Further research: Added original analysis-population definitions must link to the relevant functional outcome. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: PP, ITT, safety and imaging denominators are not merged. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N16 · What is the original explanation of primary PP analysis and concordant ITT? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original account says primary analysis was per protocol, with an ITT analysis also supporting equivalence. Exact adjusted differences, CIs and inclusion criteria for PP and ITT each remain externally unread; one stored difference is not duplicated into both. - Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Analysis plans, PP/ITT definitions, each estimate/interval and sensitivity tables remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Analysis plans, PP/ITT definitions, each estimate/interval and sensitivity tables. - Required materials and conditions: Analysis plans, PP/ITT definitions, each estimate/interval and sensitivity tables. - Materials to obtain first: Analysis plans, PP/ITT definitions, each estimate/interval and sensitivity tables. - Further research: Equivalence robustness must be distinguished using direct results for each analysis population/assumption. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: One adjusted difference/CI is not newly attributed to a separate analysis population. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N17 · Is primary-endpoint missingness the same as overall follow-up or analysis exclusion? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Historical assessment gives primary-endpoint missingness of PP 0% and ITT 0.2%. This wording links to PP/ITT denominators and does not mean complete follow-up of all 620 or no exclusions/conversions. Group-specific missingness, reasons and imputation details are unverified. - Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Overall flow, analysis exclusions, missingness/sensitivity handling and group-specific reasons remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Overall flow, analysis exclusions, missingness/sensitivity handling and group-specific reasons. - Required materials and conditions: Overall flow, analysis exclusions, missingness/sensitivity handling and group-specific reasons. - Materials to obtain first: Overall flow, analysis exclusions, missingness/sensitivity handling and group-specific reasons. - Further research: Results under missingness/conversion assumptions require original analysis material. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N18 · What are the scale, units and direction of six-month OMAS? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original explanation describes OMAS as a 0–100 patient-reported ankle-function scale, with higher scores meaning better function and fewer symptoms. It is not the same outcome as radiographic alignment, injury healing or all activities. - Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original OMAS definitions, measurement, responses, scale, units and assessment procedures remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original OMAS definitions, measurement, responses, scale, units and assessment procedures. - Required materials and conditions: Original OMAS definitions, measurement, responses, scale, units and assessment procedures. - Materials to obtain first: Original OMAS definitions, measurement, responses, scale, units and assessment procedures. - Further research: Direct functional/other patient outcomes must link with their respective scales and timepoints distinguished. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N19 · Are group OMAS scores and the adjusted difference the same quantity? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Surgery scored 66.0 and casting 64.5; the adjusted casting-versus-surgery difference was -0.6 points (95% CI -3.9–2.6). Original group scores and the adjusted difference are distinguished; no simple difference or reversed-direction value is calculated. - Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original tables of group-score estimation, adjustment variables, models and analysis populations remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original tables of group-score estimation, adjustment variables, models and analysis populations. - Required materials and conditions: Original tables of group-score estimation, adjustment variables, models and analysis populations. - Materials to obtain first: Original tables of group-score estimation, adjustment variables, models and analysis populations. - Further research: Material explaining baseline adjustment and the estimand in detail is needed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: The adjusted difference is not shown as a simple arithmetic difference of group scores. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N20 · Why are prespecified equivalence limits shown on both sides? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The prespecified limits were ±6 points, or -6 to +6; the entire stored 95% CI -3.9–2.6 reportedly fell within both sides. Comparing the whole interval to both limits is distinguished from one-sided noninferiority and conventional nonsignificance testing. - Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Rationale for the margin, prespecified versions, two-sided equivalence plans and original analyses remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Rationale for the margin, prespecified versions, two-sided equivalence plans and original analyses. - Required materials and conditions: Rationale for the margin, prespecified versions, two-sided equivalence plans and original analyses. - Materials to obtain first: Rationale for the margin, prespecified versions, two-sided equivalence plans and original analyses. - Further research: Added original margin/analysis-plan material must link its relevant scope. - Conditions for verification: 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. - Why this condition is needed: Why are prespecified equivalence limits shown on both sides? This is needed to distinguish the relevant outcome, population and design from other scopes. - Application exceptions: No new margin, effect or precision calculation or new equivalence verdict is made. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N21 · Does functional equivalence mean exactly equal scores or equivalence of all outcomes? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The stored result is functional equivalence within the specified six-month OMAS limits. It is not extended to an exact zero effect, the same response in every individual, all timepoints or equal anatomical outcomes. - Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Definitions and scope of estimands, margins, analysis populations and each outcome remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Definitions and scope of estimands, margins, analysis populations and each outcome. - Required materials and conditions: Definitions and scope of estimands, margins, analysis populations and each outcome. - Materials to obtain first: Definitions and scope of estimands, margins, analysis populations and each outcome. - Further research: Equivalence at other outcomes/timepoints requires direct comparisons and relevant plans. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N22 · What is the verification level of the six-month primary endpoint and prespecified plans? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original parent assessment says six-month OMAS and the ±6-point margin matched ISRCTN04180738 and the prespecified protocol. Registration/protocol were not opened here, so this is retained only as historical wording. - Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Actual registration/protocol/SAP versions, changes, primary endpoints and analysis plans remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Actual registration/protocol/SAP versions, changes, primary endpoints and analysis plans. - Required materials and conditions: Actual registration/protocol/SAP versions, changes, primary endpoints and analysis plans. - Materials to obtain first: Actual registration/protocol/SAP versions, changes, primary endpoints and analysis plans. - Further research: Comparison of prespecification with reports is recorded separately when direct material is added. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Historical confirmation of prespecification is not displayed as current registration-content certification. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N23 · What is unverified about adjustment variables, scale error and sensitivity results? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: The adjusted difference and CI are preserved, but detailed adjustment variables, model assumptions, baseline function, measurement error, sensitivity and additional analyses remain externally unread. Absent P values or other effects are not created. - Why unverified: Required direct details are unverified within the current summary and unread external material. Original adjustment, measurement and sensitivity-analysis tables, plans and assumptions remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original adjustment, measurement and sensitivity-analysis tables, plans and assumptions. - Required materials and conditions: Original adjustment, measurement and sensitivity-analysis tables, plans and assumptions. - Materials to obtain first: Original adjustment, measurement and sensitivity-analysis tables, plans and assumptions. - Further research: Direct material for each estimand/model must link separately. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N24 · What are the event counts, denominators and group order for infection or wound breakdown? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original summary order is surgery 29/298 (10%) versus casting 4/275 (1%). These denominators differ from functional analysis; detailed event definitions, between-group effects, CIs and periods are unverified. - Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Wound-outcome definitions, timing, denominators, collection and original between-group analyses remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Wound-outcome definitions, timing, denominators, collection and original between-group analyses. - Required materials and conditions: Wound-outcome definitions, timing, denominators, collection and original between-group analyses. - Materials to obtain first: Wound-outcome definitions, timing, denominators, collection and original between-group analyses. - Further research: Wound benefits require direct estimation/precision material for that outcome. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: No new difference, risk ratio, CI, P value or NNT is calculated. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N25 · What are the original observations of treatment-related additional surgery? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Original values are surgery 18/298 (6%) versus casting 3/275 (1%). Treatment-related additional surgery and the 52/275 initially cast participants converted to surgery do not substitute for each other and are not added together. - Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Definitions, collection, timing, group denominators and relationship to conversion for additional surgery remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Definitions, collection, timing, group denominators and relationship to conversion for additional surgery. - Required materials and conditions: Definitions, collection, timing, group denominators and relationship to conversion for additional surgery. - Materials to obtain first: Definitions, collection, timing, group denominators and relationship to conversion for additional surgery. - Further research: Original material showing how repeated surgery and conversion are counted is needed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Additional surgery and conversion are not added as independent events/people. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N26 · What are the original malunion events, denominators and group order? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Malunion was casting 38/249 (15%) versus surgery 8/274 (3%). This order is opposite to wound/additional-surgery results. Imaging denominators are not changed to 275/298 or functional denominators. - Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Radiographic malunion definitions, assessment, timing, group denominators, effects and intervals remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Radiographic malunion definitions, assessment, timing, group denominators, effects and intervals. - Required materials and conditions: Radiographic malunion definitions, assessment, timing, group denominators, effects and intervals. - Materials to obtain first: Radiographic malunion definitions, assessment, timing, group denominators, effects and intervals. - Further research: Anatomical-harm details must link separately from functional outcomes. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: No new difference, proportion, effect or CI is calculated. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N27 · What strategy outcome is conversion to surgery after loss of reduction? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Among 275 initially cast participants, 52 (19%) converted to surgery after loss of reduction. Initial strategy, actual treatment and analysis populations are distinguished; no statement that everyone avoided surgery is created. - Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Conversion criteria, timing, causes, actual treatment and inclusion handling in PP/ITT remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Conversion criteria, timing, causes, actual treatment and inclusion handling in PP/ITT. - Required materials and conditions: Conversion criteria, timing, causes, actual treatment and inclusion handling in PP/ITT. - Materials to obtain first: Conversion criteria, timing, causes, actual treatment and inclusion handling in PP/ITT. - Further research: Material linking the assigned strategy to actual treatment course is needed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N28 · How are functional equivalence, anatomical alignment and harms retained together? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Six-month functional equivalence is retained alongside casting’s costs of malunion, loss of reduction and subsequent conversion to surgery. Function alone does not establish anatomical equivalence or absence of harm. - Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Links between function, imaging, conversion and harms, with separate direct outcome material remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Links between function, imaging, conversion and harms, with separate direct outcome material. - Required materials and conditions: Links between function, imaging, conversion and harms, with separate direct outcome material. - Materials to obtain first: Links between function, imaging, conversion and harms, with separate direct outcome material. - Further research: The long-term relationship between functional and anatomical outcomes requires direct follow-up material. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N29 · Are group-specific data available on anaesthetic complications? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: The stored parent summary says separate group-specific counts of anaesthetic complications were not reported. This is not a new nonreporting judgment based on reading the full text here; relevant original tables, definitions and denominators are unverified. - Why unverified: Required direct details are unverified within the current summary and unread external material. Plans, collection, group tables, denominators and follow-up for anaesthesia-related events remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Plans, collection, group tables, denominators and follow-up for anaesthesia-related events. - Required materials and conditions: Plans, collection, group tables, denominators and follow-up for anaesthesia-related events. - Materials to obtain first: Plans, collection, group tables, denominators and follow-up for anaesthesia-related events. - Further research: Anaesthetic harms require material with actual exposure, definitions, ascertainment and comparisons. - Conditions for verification: 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. - Why this condition is needed: Are group-specific data available on anaesthetic complications? This is needed to distinguish the relevant outcome, population and design from other scopes. - Application exceptions: Historical nonreporting wording is not changed to zero events, currently inaccessible material or avoidance of anaesthesia. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N30 · How do units and denominators differ for function, wounds, imaging and conversion? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Functional PP/ITT, wound/additional-surgery 298/275, malunion 249/274 and initially cast 275 are attributed to their original outcomes. Exact analysis units/overlap for people, imaging assessments, procedures and recurrent events are unverified. - Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original tables of outcome-specific analysis units, at-risk populations, recurrence, group denominators and missingness remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original tables of outcome-specific analysis units, at-risk populations, recurrence, group denominators and missingness. - Required materials and conditions: Original tables of outcome-specific analysis units, at-risk populations, recurrence, group denominators and missingness. - Materials to obtain first: Original tables of outcome-specific analysis units, at-risk populations, recurrence, group denominators and missingness. - Further research: Each row must link to material explaining outcome-specific aggregation rules. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N31 · Are detailed event collection, adjudication, recurrence and severity verified? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: Some original wound, additional-surgery, malunion and conversion values are available, but detailed collection, adjudicators, recurrence, severity, period-specific ascertainment and missingness are unverified. These aggregates are not changed into complete safety certification. - Why unverified: Required direct details are unverified within the current summary and unread external material. Original safety, surgical and imaging tables, definitions, collection, adjudication and missingness material remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original safety, surgical and imaging tables, definitions, collection, adjudication and missingness material. - Required materials and conditions: Original safety, surgical and imaging tables, definitions, collection, adjudication and missingness material. - Materials to obtain first: Original safety, surgical and imaging tables, definitions, collection, adjudication and missingness material. - Further research: Answering harms requires direct event-specific material and sufficient follow-up. - Conditions for verification: 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. - Why this condition is needed: Are detailed event collection, adjudication, recurrence and severity verified? This is needed to distinguish the relevant outcome, population and design from other scopes. - Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N32 · Are function, durability and long-term harms beyond six months directly verified? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: The selected functional timepoint in this source is six months. Direct later function, daily life, long-term alignment, reoperation and rare-harm values are absent from the current summary; results are not extended to sustained equivalence. - Why unverified: Required direct details are unverified within the current summary and unread external material. Follow-up material linking the same population, scales, timepoints, denominators and harms remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Follow-up material linking the same population, scales, timepoints, denominators and harms. - Required materials and conditions: Follow-up material linking the same population, scales, timepoints, denominators and harms. - Materials to obtain first: Follow-up material linking the same population, scales, timepoints, denominators and harms. - Further research: Long-term outcomes require material with sufficient follow-up and direct comparison. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N33 · What alternative factors link baseline fracture, concurrent care, conversion and harms? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: Detailed relationships between baseline fracture status, reduction, comorbidities, treatment adherence, conversion and events are unverified. Randomization alone does not establish that the intervention was the sole cause of every individual harm. - Why unverified: Required direct details are unverified within the current summary and unread external material. Original records/analyses of baseline risk, actual care, changes and events remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original records/analyses of baseline risk, actual care, changes and events. - Required materials and conditions: Original records/analyses of baseline risk, actual care, changes and events. - Materials to obtain first: Original records/analyses of baseline risk, actual care, changes and events. - Further research: Explanations of harm require event ascertainment, comparison and temporal-relationship material. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N34 · How are NIHR HTA public funding and pilot funding linked? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The main trial had public NIHR HTA programme project 07/37/61 funding; the evidence entry also lists pilot AO Research Foundation support. Pilot funding is not changed into separate clinical replication or a new participant total. - Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Disclosures of main-trial/pilot sponsorship, reports, populations and roles remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Disclosures of main-trial/pilot sponsorship, reports, populations and roles. - Required materials and conditions: Disclosures of main-trial/pilot sponsorship, reports, populations and roles. - Materials to obtain first: Disclosures of main-trial/pilot sponsorship, reports, populations and roles. - Further research: Added funding/report relationships must distinguish actual trial/population sharing. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Public funding does not certify all analytical independence or absence of COI. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N35 · What are the detailed sponsor, author, data-access and publication roles? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: Funding sources are in the current summary, but contracts, data access, design/analysis/publication involvement and author-specific conflicts are unverified. Historical I2 is not inherited as new confirmation of independence. - Why unverified: Required direct details are unverified within the current summary and unread external material. Disclosures of sponsorship, COI, data access, analysis and publication roles remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Disclosures of sponsorship, COI, data access, analysis and publication roles. - Required materials and conditions: Disclosures of sponsorship, COI, data access, analysis and publication roles. - Materials to obtain first: Disclosures of sponsorship, COI, data access, analysis and publication roles. - Further research: Broader independence claims require material showing actual involvement and data sharing. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N36 · Is there independent replication in the same population, intervention and timepoint? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: AIM is the only direct report in the designated source. Additional independent trials or replication of the same strategy are unverified in this production input; reports, groups and analysis populations are not combined as independent repetitions. - Why unverified: Required direct details are unverified within the current summary and unread external material. Independent material linking bibliography, registration, populations, interventions and outcomes remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Independent material linking bibliography, registration, populations, interventions and outcomes. - Required materials and conditions: Independent material linking bibliography, registration, populations, interventions and outcomes. - Materials to obtain first: Independent material linking bibliography, registration, populations, interventions and outcomes. - Further research: New reports must first distinguish the same population from separate trials. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N37 · Can results extend to other ages, fractures, techniques or clinical settings? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: The original close contact casting strategy versus surgery in the selected older unstable-ankle-fracture population is not automatically transferred to other ages, fractures, casting methods or implementation settings. Direct material for those conditions is unverified. - Why unverified: Required direct details are unverified within the current summary and unread external material. Direct comparisons of population, fracture, technique, clinician and shared-care differences remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Direct comparisons of population, fracture, technique, clinician and shared-care differences. - Required materials and conditions: Direct comparisons of population, fracture, technique, clinician and shared-care differences. - Materials to obtain first: Direct comparisons of population, fracture, technique, clinician and shared-care differences. - Further research: Other-condition outcomes must be answered with material for their respective question, scale and period. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: No recommendation on individual treatment suitability or procedural choice is given. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N38 · What is unverified about the importance of six-month function and individual responses? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: The original prespecified ±6-point margin and between-group results are preserved. Detailed margin rationale, individually important changes, responders, group distributions and baseline-function differences are unverified. Average equivalence is not changed to equivalence of every individual response. - Why unverified: Required direct details are unverified within the current summary and unread external material. Rationale for margins, score distributions, direct responders and planned subgroup material remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Rationale for margins, score distributions, direct responders and planned subgroup material. - Required materials and conditions: Rationale for margins, score distributions, direct responders and planned subgroup material. - Materials to obtain first: Rationale for margins, score distributions, direct responders and planned subgroup material. - Further research: Extension to individual response/importance requires prespecified direct analysis material. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N39 · How much is verified about secondary-outcome, multiple-comparison and subgroup plans? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: Primary function and some harm/procedure outcomes are summarized, but detailed prespecified hierarchy, multiple comparisons and intervals for each secondary outcome/subgroup are unverified. Functional-equivalence evidence is not copied to testing of all secondary outcomes. - Why unverified: Required direct details are unverified within the current summary and unread external material. Registration/protocol/SAP outcome hierarchy, multiple comparisons, subgroups and original analyses remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Registration/protocol/SAP outcome hierarchy, multiple comparisons, subgroups and original analyses. - Required materials and conditions: Registration/protocol/SAP outcome hierarchy, multiple comparisons, subgroups and original analyses. - Materials to obtain first: Registration/protocol/SAP outcome hierarchy, multiple comparisons, subgroups and original analyses. - Further research: Plans and actual results must link with each measure distinguished. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ### N40 · What is retained when material is updated or corrected? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Existing numbers, grades, axes, language-specific content, dates and empty correction history are preserved. New material must distinguish the complete pre-change stored summary, version/reason, condition changes and events applying observations. - Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. New material versions, original locations, question changes and reasons for condition/observation changes remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; New material versions, original locations, question changes and reasons for condition/observation changes. - Required materials and conditions: New material versions, original locations, question changes and reasons for condition/observation changes. - Materials to obtain first: New material versions, original locations, question changes and reasons for condition/observation changes. - Further research: Separately added follow-up material must retain its scope and user-review requirements. - Conditions for verification: 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. - Why this condition is needed: What is retained when material is updated or corrected? This is needed to distinguish the relevant outcome, population and design from other scopes. - Application exceptions: No new searches, calculations, scores, grades or treatment guidance are created in this production. - Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict. - Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run. - Related sources: R01 ## Evidence and sources ### R01 Willett K, Keene DJ, Mistry D, et al. Close Contact Casting vs Surgery for Initial Treatment of Unstable Ankle Fractures in Older Adults. JAMA. 2016;316(14):1455-1463. PMID: 27727383. [PubMed](https://pubmed.ncbi.nlm.nih.gov/27727383/) Materials actually read: Summary read; external papers and registration unread Findings recorded in the summary: Casting 64.5 versus surgery 66.0; difference -0.6 points (95% CI -3.9–2.6), within both limits Record level: Reported values from the existing review summary. The original paper was not directly verified in this work. Independent replication: Original functional/clinical outcomes, analyses, harms and related timepoints share one AIM report/population; they are not added as new independent replications. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Stored existing review summary | Stored summary | Locally stored existing review summary read for preparation | Summary read | The existing complete review summary was read for production; the original paper was not acquired or read. | | Paper abstract | External material unread; needed | Access not attempted; not obtained | Not read | Only the bibliographic PMID link was connected. The actual abstract and result locations were not directly verified. | | Full paper | External material unread; needed | Access not attempted; not obtained | Not read | The URL is a bibliographic link; full-text acquisition and accessibility were not verified. | | Clinical trial registration | External material unread; needed | Access not attempted; not obtained | Not read | Only original registration-identifier text is preserved. Registration content, versions, first date, changes and comparison with reports are unverified. | | Study protocol | External material unread; needed | Access not attempted; not obtained | Not read | Original plans for equivalence limits, scales, exposure, assessment, PP/ITT and conversion have not been acquired. | | Statistical analysis plan | External material unread; needed | Access not attempted; not obtained | Not read | Direct plans for analysis populations, estimands, adjustment, missingness, sensitivity, hierarchy and precision have not been acquired. | | Original results and safety tables | External material unread; needed | Access not attempted; not obtained | Not read | Detailed definitions, original denominators, periods, measurement, estimation and intervals are needed for function, wounds, additional surgery, malunion, conversion and anaesthesia. | | Sponsorship and interest disclosures | External material unread; needed | Access not attempted; not obtained | Not read | Beyond stored funding/role information, original contract, data-access, publication-decision and author-specific COI documents have not been acquired. | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work. - M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work. - M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work. - M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work. - M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work. ## What the statuses mean - Met: The original content has been reviewed as meeting the conditions. This status is not used in this preparation. - Partly verified: Some information in the stored summary was linked during preparation; clinical verification or review is not complete. - Unverified: Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access. - Review incomplete: 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. ## Change history 2026-10-10 · Public page/materials 1.0. The public page and data were prepared from the existing 40 items. No new clinical search, verification-status change or scoring was performed.