{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2921-s0", "verdict_number": "2921", "title": "Close contact casting × Equivalent six-month function in older adults with unstable ankle fracture", "view_version": "1.0", "view_created_date": "2026-10-10", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Only the stored summary was read for production; external papers, registration, plans and original tables remain unread. Partial verification in this presentation does not mean clinical confirmation or completed review. Absent subclaim scores, status and axes are not filled with parent values. Original results, uncertainty, harms, design and denominators are kept distinct; no procedural guidance is provided.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "Equivalent six-month function to surgery in older adults with unstable ankle fracture", "intervention": "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", "endpoint": "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", "excluded_extensions": [ "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" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "What are the selected claim and existing verdict record?", "needed": "The relationship between the selected question/record wording and the parent verdict.", "role": "Required", "role_reason": "What are the selected claim and existing verdict record? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "What are the selected claim and existing verdict record? Distinguish The relationship between the selected question/record wording and the parent verdict in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Additional material is linked while distinguishing the existing question from other questions.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; The relationship between the selected question/record wording and the parent verdict.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The relationship between the selected question/record wording and the parent verdict." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "How are the subclaim grade/note and absent score, status and axes retained?", "needed": "Actual subclaim fields and separately preserved parent fields.", "role": "Required", "role_reason": "How are the subclaim grade/note and absent score, status and axes retained? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Absent subclaim values are not filled with the parent score, status or axes.", "criterion": "How are the subclaim grade/note and absent score, status and axes retained? Distinguish Actual subclaim fields and separately preserved parent fields in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "If the subclaim is corrected, the complete pre-change text and change event are retained.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Actual subclaim fields and separately preserved parent fields.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual subclaim fields and separately preserved parent fields." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What is the context of the parent grade, axes, safety, null, false and empty values?", "needed": "Parent verdict, axes, original study assessment and change history.", "role": "Required", "role_reason": "What is the context of the parent grade, axes, safety, null, false and empty values? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Historical B1 assessment/cross-check wording is not inherited as newly satisfied conditions.", "criterion": "What is the context of the parent grade, axes, safety, null, false and empty values? Distinguish Parent verdict, axes, original study assessment and change history in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "A new correction is preserved separately from original values, reasons and production status.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Parent verdict, axes, original study assessment and change history.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Parent verdict, axes, original study assessment and change history." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "How are Korean/English, the reference date, corrections and empty values preserved?", "needed": "Actual versions of original wording, dates, corrections and history in each language.", "role": "Required", "role_reason": "How are Korean/English, the reference date, corrections and empty values preserved? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "How are Korean/English, the reference date, corrections and empty values preserved? Distinguish Actual versions of original wording, dates, corrections and history in each language in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "When original wording or corrections are added, the complete pre-change text and a separate event are recorded.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Actual versions of original wording, dates, corrections and history in each language.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual versions of original wording, dates, corrections and history in each language." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Which materials were read for this production and which external materials remain unread?", "needed": "Actual acquisition/reading level for each material and original result locations.", "role": "Required", "role_reason": "Which materials were read for this production and which external materials remain unread? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "URLs only link original material; they do not certify link checking or reading.", "criterion": "Which materials were read for this production and which external materials remain unread? Distinguish Actual acquisition/reading level for each material and original result locations in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Separate later direct reading must record its scope, version and time as a new event.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Actual acquisition/reading level for each material and original result locations.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual acquisition/reading level for each material and original result locations." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "What are the AIM report identity and registration identifier?", "needed": "Original bibliography, paper, registration and material linking them to the same trial.", "role": "Required", "role_reason": "What are the AIM report identity and registration identifier? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Different lead-author wording in evidence and citation lists is not counted as separate trials.", "criterion": "What are the AIM report identity and registration identifier? Distinguish Original bibliography, paper, registration and material linking them to the same trial in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Added reports must distinguish the same trial/population from separate trials.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Original bibliography, paper, registration and material linking them to the same trial.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original bibliography, paper, registration and material linking them to the same trial." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "How is sharing across reports, groups, outcomes and the parent question shown?", "needed": "Material linking trials, reports, groups, analysis populations, outcomes and overlap.", "role": "Required", "role_reason": "How is sharing across reports, groups, outcomes and the parent question shown? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "The number of report entries does not certify independent unique trial or participant counts.", "criterion": "How is sharing across reports, groups, outcomes and the parent question shown? Distinguish Material linking trials, reports, groups, analysis populations, outcomes and overlap in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Added follow-up/related reports must link actual population sharing within the existing AIM family.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Material linking trials, reports, groups, analysis populations, outcomes and overlap.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Material linking trials, reports, groups, analysis populations, outcomes and overlap." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Which older population with unstable ankle fractures is studied?", "needed": "Original group tables of eligibility, recruitment, fracture status, baseline function and risk.", "role": "Required", "role_reason": "Which older population with unstable ankle fractures is studied? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Age thresholds or fracture types absent from the current source are not filled in.", "criterion": "Which older population with unstable ankle fractures is studied? Distinguish Original group tables of eligibility, recruitment, fracture status, baseline function and risk in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Function/harms in other populations are distinguished using direct comparison material for those populations.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Original group tables of eligibility, recruitment, fracture status, baseline function and risk.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original group tables of eligibility, recruitment, fracture status, baseline function and risk." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "How much is known about baseline risk, representativeness and treatment eligibility?", "needed": "Eligibility, exclusions, baseline characteristics, recruitment setting and group distributions.", "role": "Supplementary; required for general application", "role_reason": "How much is known about baseline risk, representativeness and treatment eligibility? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "How much is known about baseline risk, representativeness and treatment eligibility? Distinguish Eligibility, exclusions, baseline characteristics, recruitment setting and group distributions in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "General application requires material showing actual population differences.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Eligibility, exclusions, baseline characteristics, recruitment setting and group distributions.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Eligibility, exclusions, baseline characteristics, recruitment setting and group distributions." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "What was the original study intervention of close contact casting?", "needed": "Material on trial intervention identity, implementation, clinicians, actual exposure and changes.", "role": "Required", "role_reason": "What was the original study intervention of close contact casting? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "No casting, reduction, treatment or exercise instructions are written.", "criterion": "What was the original study intervention of close contact casting? Distinguish Material on trial intervention identity, implementation, clinicians, actual exposure and changes in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Differences in other casting techniques/implementation conditions require direct comparison material.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Material on trial intervention identity, implementation, clinicians, actual exposure and changes.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Material on trial intervention identity, implementation, clinicians, actual exposure and changes." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "What are the surgical control and shared anaesthesia/operating-room conditions?", "needed": "Planned and actual records of surgery, fixation, anaesthesia and shared care.", "role": "Required", "role_reason": "What are the surgical control and shared anaesthesia/operating-room conditions? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Results are not extended to avoiding anaesthesia or recommendations on surgical suitability/treatment choice.", "criterion": "What are the surgical control and shared anaesthesia/operating-room conditions? Distinguish Planned and actual records of surgery, fixation, anaesthesia and shared care in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Material with differences in control or concurrent treatment must mark those conditions separately.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Planned and actual records of surgery, fixation, anaesthesia and shared care.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Planned and actual records of surgery, fixation, anaesthesia and shared care." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "How much is verified about concurrent care, adherence and changes?", "needed": "Original records of concurrent care, actual treatment adherence, changes, discontinuation and follow-up.", "role": "Required", "role_reason": "How much is verified about concurrent care, adherence and changes? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "How much is verified about concurrent care, adherence and changes? Distinguish Original records of concurrent care, actual treatment adherence, changes, discontinuation and follow-up in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Answering the functional estimand requires material distinguishing the assigned strategy from actual implementation.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Original records of concurrent care, actual treatment adherence, changes, discontinuation and follow-up.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original records of concurrent care, actual treatment adherence, changes, discontinuation and follow-up." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "What is the verification scope of randomized equivalence design and allocation concealment?", "needed": "Original plans/reports of sequence generation, concealment, stratification and implementation.", "role": "Required", "role_reason": "What is the verification scope of randomized equivalence design and allocation concealment? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "What is the verification scope of randomized equivalence design and allocation concealment? Distinguish Original plans/reports of sequence generation, concealment, stratification and implementation in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Added allocation details must distinguish historical quotations from direct verification.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Original plans/reports of sequence generation, concealment, stratification and implementation.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original plans/reports of sequence generation, concealment, stratification and implementation." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "How do participant masking and six-month assessor masking differ?", "needed": "Original procedures for assessors, participants, scale responses and actual maintenance of masking.", "role": "Required", "role_reason": "How do participant masking and six-month assessor masking differ? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Clause 105 and the original decision not to count a defect are not run as new review.", "criterion": "How do participant masking and six-month assessor masking differ? Distinguish Original procedures for assessors, participants, scale responses and actual maintenance of masking in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Details of masking, response and measurement processes must each be linked to material.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Original procedures for assessors, participants, scale responses and actual maintenance of masking.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original procedures for assessors, participants, scale responses and actual maintenance of masking." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "What are the denominators for 620 randomized participants and PP/ITT analysis?", "needed": "Group flows and inclusion criteria for allocation, treatment, conversion, follow-up, PP and ITT.", "role": "Required", "role_reason": "What are the denominators for 620 randomized participants and PP/ITT analysis? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "PP, ITT, safety and imaging denominators are not merged.", "criterion": "What are the denominators for 620 randomized participants and PP/ITT analysis? Distinguish Group flows and inclusion criteria for allocation, treatment, conversion, follow-up, PP and ITT in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Added original analysis-population definitions must link to the relevant functional outcome.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group flows and inclusion criteria for allocation, treatment, conversion, follow-up, PP and ITT." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "What is the original explanation of primary PP analysis and concordant ITT?", "needed": "Analysis plans, PP/ITT definitions, each estimate/interval and sensitivity tables.", "role": "Required", "role_reason": "What is the original explanation of primary PP analysis and concordant ITT? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "One adjusted difference/CI is not newly attributed to a separate analysis population.", "criterion": "What is the original explanation of primary PP analysis and concordant ITT? Distinguish Analysis plans, PP/ITT definitions, each estimate/interval and sensitivity tables in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Equivalence robustness must be distinguished using direct results for each analysis population/assumption.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Analysis plans, PP/ITT definitions, each estimate/interval and sensitivity tables.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Analysis plans, PP/ITT definitions, each estimate/interval and sensitivity tables." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Is primary-endpoint missingness the same as overall follow-up or analysis exclusion?", "needed": "Overall flow, analysis exclusions, missingness/sensitivity handling and group-specific reasons.", "role": "Required", "role_reason": "Is primary-endpoint missingness the same as overall follow-up or analysis exclusion? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "Is primary-endpoint missingness the same as overall follow-up or analysis exclusion? Distinguish Overall flow, analysis exclusions, missingness/sensitivity handling and group-specific reasons in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Results under missingness/conversion assumptions require original analysis material.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Overall flow, analysis exclusions, missingness/sensitivity handling and group-specific reasons.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Overall flow, analysis exclusions, missingness/sensitivity handling and group-specific reasons." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "What are the scale, units and direction of six-month OMAS?", "needed": "Original OMAS definitions, measurement, responses, scale, units and assessment procedures.", "role": "Required", "role_reason": "What are the scale, units and direction of six-month OMAS? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "What are the scale, units and direction of six-month OMAS? Distinguish Original OMAS definitions, measurement, responses, scale, units and assessment procedures in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Direct functional/other patient outcomes must link with their respective scales and timepoints distinguished.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Original OMAS definitions, measurement, responses, scale, units and assessment procedures.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original OMAS definitions, measurement, responses, scale, units and assessment procedures." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Are group OMAS scores and the adjusted difference the same quantity?", "needed": "Original tables of group-score estimation, adjustment variables, models and analysis populations.", "role": "Required", "role_reason": "Are group OMAS scores and the adjusted difference the same quantity? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "The adjusted difference is not shown as a simple arithmetic difference of group scores.", "criterion": "Are group OMAS scores and the adjusted difference the same quantity? Distinguish Original tables of group-score estimation, adjustment variables, models and analysis populations in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Material explaining baseline adjustment and the estimand in detail is needed.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Original tables of group-score estimation, adjustment variables, models and analysis populations.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original tables of group-score estimation, adjustment variables, models and analysis populations." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Why are prespecified equivalence limits shown on both sides?", "needed": "Rationale for the margin, prespecified versions, two-sided equivalence plans and original analyses.", "role": "Required", "role_reason": "Why are prespecified equivalence limits shown on both sides? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "No new margin, effect or precision calculation or new equivalence verdict is made.", "criterion": "Why are prespecified equivalence limits shown on both sides? Distinguish Rationale for the margin, prespecified versions, two-sided equivalence plans and original analyses in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Added original margin/analysis-plan material must link its relevant scope.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Rationale for the margin, prespecified versions, two-sided equivalence plans and original analyses.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Rationale for the margin, prespecified versions, two-sided equivalence plans and original analyses." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Does functional equivalence mean exactly equal scores or equivalence of all outcomes?", "needed": "Definitions and scope of estimands, margins, analysis populations and each outcome.", "role": "Required", "role_reason": "Does functional equivalence mean exactly equal scores or equivalence of all outcomes? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "Does functional equivalence mean exactly equal scores or equivalence of all outcomes? Distinguish Definitions and scope of estimands, margins, analysis populations and each outcome in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Equivalence at other outcomes/timepoints requires direct comparisons and relevant plans.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Definitions and scope of estimands, margins, analysis populations and each outcome.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Definitions and scope of estimands, margins, analysis populations and each outcome." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "What is the verification level of the six-month primary endpoint and prespecified plans?", "needed": "Actual registration/protocol/SAP versions, changes, primary endpoints and analysis plans.", "role": "Required", "role_reason": "What is the verification level of the six-month primary endpoint and prespecified plans? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Historical confirmation of prespecification is not displayed as current registration-content certification.", "criterion": "What is the verification level of the six-month primary endpoint and prespecified plans? Distinguish Actual registration/protocol/SAP versions, changes, primary endpoints and analysis plans in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Comparison of prespecification with reports is recorded separately when direct material is added.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Actual registration/protocol/SAP versions, changes, primary endpoints and analysis plans.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual registration/protocol/SAP versions, changes, primary endpoints and analysis plans." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "What is unverified about adjustment variables, scale error and sensitivity results?", "needed": "Original adjustment, measurement and sensitivity-analysis tables, plans and assumptions.", "role": "Required", "role_reason": "What is unverified about adjustment variables, scale error and sensitivity results? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "What is unverified about adjustment variables, scale error and sensitivity results? Distinguish Original adjustment, measurement and sensitivity-analysis tables, plans and assumptions in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Direct material for each estimand/model must link separately.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Original adjustment, measurement and sensitivity-analysis tables, plans and assumptions.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original adjustment, measurement and sensitivity-analysis tables, plans and assumptions." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "What are the event counts, denominators and group order for infection or wound breakdown?", "needed": "Wound-outcome definitions, timing, denominators, collection and original between-group analyses.", "role": "Required", "role_reason": "What are the event counts, denominators and group order for infection or wound breakdown? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "No new difference, risk ratio, CI, P value or NNT is calculated.", "criterion": "What are the event counts, denominators and group order for infection or wound breakdown? Distinguish Wound-outcome definitions, timing, denominators, collection and original between-group analyses in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Wound benefits require direct estimation/precision material for that outcome.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Wound-outcome definitions, timing, denominators, collection and original between-group analyses.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Wound-outcome definitions, timing, denominators, collection and original between-group analyses." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "What are the original observations of treatment-related additional surgery?", "needed": "Definitions, collection, timing, group denominators and relationship to conversion for additional surgery.", "role": "Required", "role_reason": "What are the original observations of treatment-related additional surgery? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Additional surgery and conversion are not added as independent events/people.", "criterion": "What are the original observations of treatment-related additional surgery? Distinguish Definitions, collection, timing, group denominators and relationship to conversion for additional surgery in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Original material showing how repeated surgery and conversion are counted is needed.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Definitions, collection, timing, group denominators and relationship to conversion for additional surgery.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Definitions, collection, timing, group denominators and relationship to conversion for additional surgery." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "What are the original malunion events, denominators and group order?", "needed": "Radiographic malunion definitions, assessment, timing, group denominators, effects and intervals.", "role": "Required", "role_reason": "What are the original malunion events, denominators and group order? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "No new difference, proportion, effect or CI is calculated.", "criterion": "What are the original malunion events, denominators and group order? Distinguish Radiographic malunion definitions, assessment, timing, group denominators, effects and intervals in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Anatomical-harm details must link separately from functional outcomes.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Radiographic malunion definitions, assessment, timing, group denominators, effects and intervals.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Radiographic malunion definitions, assessment, timing, group denominators, effects and intervals." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "What strategy outcome is conversion to surgery after loss of reduction?", "needed": "Conversion criteria, timing, causes, actual treatment and inclusion handling in PP/ITT.", "role": "Required", "role_reason": "What strategy outcome is conversion to surgery after loss of reduction? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "What strategy outcome is conversion to surgery after loss of reduction? Distinguish Conversion criteria, timing, causes, actual treatment and inclusion handling in PP/ITT in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Material linking the assigned strategy to actual treatment course is needed.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Conversion criteria, timing, causes, actual treatment and inclusion handling in PP/ITT.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Conversion criteria, timing, causes, actual treatment and inclusion handling in PP/ITT." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "How are functional equivalence, anatomical alignment and harms retained together?", "needed": "Links between function, imaging, conversion and harms, with separate direct outcome material.", "role": "Required", "role_reason": "How are functional equivalence, anatomical alignment and harms retained together? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "How are functional equivalence, anatomical alignment and harms retained together? Distinguish Links between function, imaging, conversion and harms, with separate direct outcome material in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "The long-term relationship between functional and anatomical outcomes requires direct follow-up material.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Links between function, imaging, conversion and harms, with separate direct outcome material.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Links between function, imaging, conversion and harms, with separate direct outcome material." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Are group-specific data available on anaesthetic complications?", "needed": "Plans, collection, group tables, denominators and follow-up for anaesthesia-related events.", "role": "Required", "role_reason": "Are group-specific data available on anaesthetic complications? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Historical nonreporting wording is not changed to zero events, currently inaccessible material or avoidance of anaesthesia.", "criterion": "Are group-specific data available on anaesthetic complications? Distinguish Plans, collection, group tables, denominators and follow-up for anaesthesia-related events in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Anaesthetic harms require material with actual exposure, definitions, ascertainment and comparisons.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Plans, collection, group tables, denominators and follow-up for anaesthesia-related events.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Plans, collection, group tables, denominators and follow-up for anaesthesia-related events." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "How do units and denominators differ for function, wounds, imaging and conversion?", "needed": "Original tables of outcome-specific analysis units, at-risk populations, recurrence, group denominators and missingness.", "role": "Required", "role_reason": "How do units and denominators differ for function, wounds, imaging and conversion? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "How do units and denominators differ for function, wounds, imaging and conversion? Distinguish Original tables of outcome-specific analysis units, at-risk populations, recurrence, group denominators and missingness in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Each row must link to material explaining outcome-specific aggregation rules.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original tables of outcome-specific analysis units, at-risk populations, recurrence, group denominators and missingness." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Are detailed event collection, adjudication, recurrence and severity verified?", "needed": "Original safety, surgical and imaging tables, definitions, collection, adjudication and missingness material.", "role": "Required", "role_reason": "Are detailed event collection, adjudication, recurrence and severity verified? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "Are detailed event collection, adjudication, recurrence and severity verified? Distinguish Original safety, surgical and imaging tables, definitions, collection, adjudication and missingness material in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Answering harms requires direct event-specific material and sufficient follow-up.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Original safety, surgical and imaging tables, definitions, collection, adjudication and missingness material.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original safety, surgical and imaging tables, definitions, collection, adjudication and missingness material." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "Are function, durability and long-term harms beyond six months directly verified?", "needed": "Follow-up material linking the same population, scales, timepoints, denominators and harms.", "role": "Supplementary; required for long-term extension", "role_reason": "Are function, durability and long-term harms beyond six months directly verified? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "Are function, durability and long-term harms beyond six months directly verified? Distinguish Follow-up material linking the same population, scales, timepoints, denominators and harms in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Long-term outcomes require material with sufficient follow-up and direct comparison.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Follow-up material linking the same population, scales, timepoints, denominators and harms.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Follow-up material linking the same population, scales, timepoints, denominators and harms." }, { "item_id": "N33", "question_type": "Evidence condition", "question": "What alternative factors link baseline fracture, concurrent care, conversion and harms?", "needed": "Original records/analyses of baseline risk, actual care, changes and events.", "role": "Required", "role_reason": "What alternative factors link baseline fracture, concurrent care, conversion and harms? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "What alternative factors link baseline fracture, concurrent care, conversion and harms? Distinguish Original records/analyses of baseline risk, actual care, changes and events in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Explanations of harm require event ascertainment, comparison and temporal-relationship material.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Original records/analyses of baseline risk, actual care, changes and events.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original records/analyses of baseline risk, actual care, changes and events." }, { "item_id": "N34", "question_type": "Evidence condition", "question": "How are NIHR HTA public funding and pilot funding linked?", "needed": "Disclosures of main-trial/pilot sponsorship, reports, populations and roles.", "role": "Required", "role_reason": "How are NIHR HTA public funding and pilot funding linked? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Public funding does not certify all analytical independence or absence of COI.", "criterion": "How are NIHR HTA public funding and pilot funding linked? Distinguish Disclosures of main-trial/pilot sponsorship, reports, populations and roles in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Added funding/report relationships must distinguish actual trial/population sharing.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Disclosures of main-trial/pilot sponsorship, reports, populations and roles.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Disclosures of main-trial/pilot sponsorship, reports, populations and roles." }, { "item_id": "N35", "question_type": "Evidence condition", "question": "What are the detailed sponsor, author, data-access and publication roles?", "needed": "Disclosures of sponsorship, COI, data access, analysis and publication roles.", "role": "Required", "role_reason": "What are the detailed sponsor, author, data-access and publication roles? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "What are the detailed sponsor, author, data-access and publication roles? Distinguish Disclosures of sponsorship, COI, data access, analysis and publication roles in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Broader independence claims require material showing actual involvement and data sharing.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Disclosures of sponsorship, COI, data access, analysis and publication roles.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Disclosures of sponsorship, COI, data access, analysis and publication roles." }, { "item_id": "N36", "question_type": "Evidence condition", "question": "Is there independent replication in the same population, intervention and timepoint?", "needed": "Independent material linking bibliography, registration, populations, interventions and outcomes.", "role": "Supplementary; required to claim independent replication", "role_reason": "Is there independent replication in the same population, intervention and timepoint? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "Is there independent replication in the same population, intervention and timepoint? Distinguish Independent material linking bibliography, registration, populations, interventions and outcomes in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "New reports must first distinguish the same population from separate trials.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Independent material linking bibliography, registration, populations, interventions and outcomes.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Independent material linking bibliography, registration, populations, interventions and outcomes." }, { "item_id": "N37", "question_type": "Evidence condition", "question": "Can results extend to other ages, fractures, techniques or clinical settings?", "needed": "Direct comparisons of population, fracture, technique, clinician and shared-care differences.", "role": "Supplementary; required for general application", "role_reason": "Can results extend to other ages, fractures, techniques or clinical settings? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "No recommendation on individual treatment suitability or procedural choice is given.", "criterion": "Can results extend to other ages, fractures, techniques or clinical settings? Distinguish Direct comparisons of population, fracture, technique, clinician and shared-care differences in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Other-condition outcomes must be answered with material for their respective question, scale and period.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Direct comparisons of population, fracture, technique, clinician and shared-care differences.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct comparisons of population, fracture, technique, clinician and shared-care differences." }, { "item_id": "N38", "question_type": "Evidence condition", "question": "What is unverified about the importance of six-month function and individual responses?", "needed": "Rationale for margins, score distributions, direct responders and planned subgroup material.", "role": "Required", "role_reason": "What is unverified about the importance of six-month function and individual responses? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "What is unverified about the importance of six-month function and individual responses? Distinguish Rationale for margins, score distributions, direct responders and planned subgroup material in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Extension to individual response/importance requires prespecified direct analysis material.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Rationale for margins, score distributions, direct responders and planned subgroup material.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Rationale for margins, score distributions, direct responders and planned subgroup material." }, { "item_id": "N39", "question_type": "Evidence condition", "question": "How much is verified about secondary-outcome, multiple-comparison and subgroup plans?", "needed": "Registration/protocol/SAP outcome hierarchy, multiple comparisons, subgroups and original analyses.", "role": "Required", "role_reason": "How much is verified about secondary-outcome, multiple-comparison and subgroup plans? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.", "criterion": "How much is verified about secondary-outcome, multiple-comparison and subgroup plans? Distinguish Registration/protocol/SAP outcome hierarchy, multiple comparisons, subgroups and original analyses in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Plans and actual results must link with each measure distinguished.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Registration/protocol/SAP outcome hierarchy, multiple comparisons, subgroups and original analyses.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration/protocol/SAP outcome hierarchy, multiple comparisons, subgroups and original analyses." }, { "item_id": "N40", "question_type": "Evidence condition", "question": "What is retained when material is updated or corrected?", "needed": "New material versions, original locations, question changes and reasons for condition/observation changes.", "role": "Required (update boundaries)", "role_reason": "What is retained when material is updated or corrected? This is needed to distinguish the relevant outcome, population and design from other scopes.", "application_exception": "No new searches, calculations, scores, grades or treatment guidance are created in this production.", "criterion": "What is retained when material is updated or corrected? Distinguish New material versions, original locations, question changes and reasons for condition/observation changes in the original material and retain the limits of direct verification.", "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Separately added follow-up material must retain its scope and user-review requirements.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; New material versions, original locations, question changes and reasons for condition/observation changes.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "New material versions, original locations, question changes and reasons for condition/observation changes." } ], "reports": [ { "report_id": "R01", "title": "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.", "url": "https://pubmed.ncbi.nlm.nih.gov/27727383/", "report_type": "Multicentre randomized equivalence trial", "existence": "Direct report linked in the existing review summary’s evidence/citation lists", "acquired_read": "Summary read; external papers and registration unread", "study_family": "F01", "independent_replication": false, "observed_result": "Casting 64.5 versus surgery 66.0; difference -0.6 points (95% CI -3.9–2.6), within both limits", "result_level": "Reported values from the existing review summary. The original paper was not directly verified in this work.", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Stored summary", "access_status": "Locally stored existing review summary read for preparation", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-06T19:16:28.793595+09:00", "qualification": "The existing complete review summary was read for production; the original paper was not acquired or read." }, { "material_type": "Paper abstract", "public_status": "External material unread; needed", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Only the bibliographic PMID link was connected. The actual abstract and result locations were not directly verified." }, { "material_type": "Full paper", "public_status": "External material unread; needed", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "The URL is a bibliographic link; full-text acquisition and accessibility were not verified." }, { "material_type": "Clinical trial registration", "public_status": "External material unread; needed", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Only original registration-identifier text is preserved. Registration content, versions, first date, changes and comparison with reports are unverified." }, { "material_type": "Study protocol", "public_status": "External material unread; needed", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original plans for equivalence limits, scales, exposure, assessment, PP/ITT and conversion have not been acquired." }, { "material_type": "Statistical analysis plan", "public_status": "External material unread; needed", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Direct plans for analysis populations, estimands, adjustment, missingness, sensitivity, hierarchy and precision have not been acquired." }, { "material_type": "Original results and safety tables", "public_status": "External material unread; needed", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Detailed definitions, original denominators, periods, measurement, estimation and intervals are needed for function, wounds, additional surgery, malunion, conversion and anaesthesia." }, { "material_type": "Sponsorship and interest disclosures", "public_status": "External material unread; needed", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Beyond stored funding/role information, original contract, data-access, publication-decision and author-specific COI documents have not been acquired." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/27727383/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." } ], "status_dictionary": { "Met": "The original content has been reviewed as meeting the conditions. This status is not used in this preparation.", "Partly verified": "Some information in the stored summary was linked during preparation; clinical verification or review is not complete.", "Unverified": "Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.", "Review incomplete": "Awaiting user review, or actual review remains incomplete.", "Not reported": "Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.", "Inaccessible": "Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.", "Insufficient evidence for the conditions": "Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.", "Not applicable": "Used when the reason it does not apply to the original question is stated.", "Conflicting data": "Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "Original functional/clinical outcomes, analyses, harms and related timepoints share one AIM report/population; they are not added as new independent replications." }, "history": [ { "date": "2026-10-10", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public page and data were prepared from the existing 40 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-10" }