Close contact casting × Equivalent six-month function in older adults with unstable ankle fracture

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Evidence conditionWhat are the selected claim and existing verdict record?Required	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. R01	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.	The relationship between the selected question/record wording and the parent verdict.	Additional material is linked while distinguishing the existing question from other questions.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionHow are the subclaim grade/note and absent score, status and axes retained?Required	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. R01	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.	Actual subclaim fields and separately preserved parent fields.	If the subclaim is corrected, the complete pre-change text and change event are retained.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionWhat is the context of the parent grade, axes, safety, null, false and empty values?Required	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. R01	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.	Parent verdict, axes, original study assessment and change history.	A new correction is preserved separately from original values, reasons and production status.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionHow are Korean/English, the reference date, corrections and empty values preserved?Required	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. R01	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.	Actual versions of original wording, dates, corrections and history in each language.	When original wording or corrections are added, the complete pre-change text and a separate event are recorded.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionWhich materials were read for this production and which external materials remain unread?Required	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. R01	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.	Actual acquisition/reading level for each material and original result locations.	Separate later direct reading must record its scope, version and time as a new event.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionWhat are the AIM report identity and registration identifier?Required	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. R01	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.	Original bibliography, paper, registration and material linking them to the same trial.	Added reports must distinguish the same trial/population from separate trials.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionHow is sharing across reports, groups, outcomes and the parent question shown?Required	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. R01	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.	Material linking trials, reports, groups, analysis populations, outcomes and overlap.	Added follow-up/related reports must link actual population sharing within the existing AIM family.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionWhich older population with unstable ankle fractures is studied?Required	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. R01	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.	Original group tables of eligibility, recruitment, fracture status, baseline function and risk.	Function/harms in other populations are distinguished using direct comparison material for those populations.
9	Unverified	Full text not readStored summary read	N09 · Evidence conditionHow much is known about baseline risk, representativeness and treatment eligibility?Supplementary; required for general application	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. R01	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.	Eligibility, exclusions, baseline characteristics, recruitment setting and group distributions.	General application requires material showing actual population differences.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionWhat was the original study intervention of close contact casting?Required	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. R01	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.	Material on trial intervention identity, implementation, clinicians, actual exposure and changes.	Differences in other casting techniques/implementation conditions require direct comparison material.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionWhat are the surgical control and shared anaesthesia/operating-room conditions?Required	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. R01	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.	Planned and actual records of surgery, fixation, anaesthesia and shared care.	Material with differences in control or concurrent treatment must mark those conditions separately.
12	Unverified	Full text not readStored summary read	N12 · Evidence conditionHow much is verified about concurrent care, adherence and changes?Required	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. R01	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.	Original records of concurrent care, actual treatment adherence, changes, discontinuation and follow-up.	Answering the functional estimand requires material distinguishing the assigned strategy from actual implementation.
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionWhat is the verification scope of randomized equivalence design and allocation concealment?Required	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. R01	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.	Original plans/reports of sequence generation, concealment, stratification and implementation.	Added allocation details must distinguish historical quotations from direct verification.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionHow do participant masking and six-month assessor masking differ?Required	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. R01	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.	Original procedures for assessors, participants, scale responses and actual maintenance of masking.	Details of masking, response and measurement processes must each be linked to material.
15	Partly verified	Full text not readStored summary read	N15 · Evidence conditionWhat are the denominators for 620 randomized participants and PP/ITT analysis?Required	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. R01	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.	Group flows and inclusion criteria for allocation, treatment, conversion, follow-up, PP and ITT.	Added original analysis-population definitions must link to the relevant functional outcome.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionWhat is the original explanation of primary PP analysis and concordant ITT?Required	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. R01	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.	Analysis plans, PP/ITT definitions, each estimate/interval and sensitivity tables.	Equivalence robustness must be distinguished using direct results for each analysis population/assumption.
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionIs primary-endpoint missingness the same as overall follow-up or analysis exclusion?Required	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. R01	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.	Overall flow, analysis exclusions, missingness/sensitivity handling and group-specific reasons.	Results under missingness/conversion assumptions require original analysis material.
18	Partly verified	Full text not readStored summary read	N18 · Evidence conditionWhat are the scale, units and direction of six-month OMAS?Required	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. R01	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.	Original OMAS definitions, measurement, responses, scale, units and assessment procedures.	Direct functional/other patient outcomes must link with their respective scales and timepoints distinguished.
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionAre group OMAS scores and the adjusted difference the same quantity?Required	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. R01	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.	Original tables of group-score estimation, adjustment variables, models and analysis populations.	Material explaining baseline adjustment and the estimand in detail is needed.
20	Partly verified	Full text not readStored summary read	N20 · Evidence conditionWhy are prespecified equivalence limits shown on both sides?Required	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. R01	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.	Rationale for the margin, prespecified versions, two-sided equivalence plans and original analyses.	Added original margin/analysis-plan material must link its relevant scope.
21	Partly verified	Full text not readStored summary read	N21 · Evidence conditionDoes functional equivalence mean exactly equal scores or equivalence of all outcomes?Required	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. R01	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.	Definitions and scope of estimands, margins, analysis populations and each outcome.	Equivalence at other outcomes/timepoints requires direct comparisons and relevant plans.
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionWhat is the verification level of the six-month primary endpoint and prespecified plans?Required	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. R01	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.	Actual registration/protocol/SAP versions, changes, primary endpoints and analysis plans.	Comparison of prespecification with reports is recorded separately when direct material is added.
23	Unverified	Full text not readStored summary read	N23 · Evidence conditionWhat is unverified about adjustment variables, scale error and sensitivity results?Required	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. R01	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.	Original adjustment, measurement and sensitivity-analysis tables, plans and assumptions.	Direct material for each estimand/model must link separately.
24	Partly verified	Full text not readStored summary read	N24 · Evidence conditionWhat are the event counts, denominators and group order for infection or wound breakdown?Required	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. R01	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.	Wound-outcome definitions, timing, denominators, collection and original between-group analyses.	Wound benefits require direct estimation/precision material for that outcome.
25	Partly verified	Full text not readStored summary read	N25 · Evidence conditionWhat are the original observations of treatment-related additional surgery?Required	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. R01	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.	Definitions, collection, timing, group denominators and relationship to conversion for additional surgery.	Original material showing how repeated surgery and conversion are counted is needed.
26	Partly verified	Full text not readStored summary read	N26 · Evidence conditionWhat are the original malunion events, denominators and group order?Required	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. R01	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.	Radiographic malunion definitions, assessment, timing, group denominators, effects and intervals.	Anatomical-harm details must link separately from functional outcomes.
27	Partly verified	Full text not readStored summary read	N27 · Evidence conditionWhat strategy outcome is conversion to surgery after loss of reduction?Required	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. R01	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.	Conversion criteria, timing, causes, actual treatment and inclusion handling in PP/ITT.	Material linking the assigned strategy to actual treatment course is needed.
28	Partly verified	Full text not readStored summary read	N28 · Evidence conditionHow are functional equivalence, anatomical alignment and harms retained together?Required	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. R01	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.	Links between function, imaging, conversion and harms, with separate direct outcome material.	The long-term relationship between functional and anatomical outcomes requires direct follow-up material.
29	Unverified	Full text not readStored summary read	N29 · Evidence conditionAre group-specific data available on anaesthetic complications?Required	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. R01	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.	Plans, collection, group tables, denominators and follow-up for anaesthesia-related events.	Anaesthetic harms require material with actual exposure, definitions, ascertainment and comparisons.
30	Partly verified	Full text not readStored summary read	N30 · Evidence conditionHow do units and denominators differ for function, wounds, imaging and conversion?Required	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. R01	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.	Original tables of outcome-specific analysis units, at-risk populations, recurrence, group denominators and missingness.	Each row must link to material explaining outcome-specific aggregation rules.
31	Unverified	Full text not readStored summary read	N31 · Evidence conditionAre detailed event collection, adjudication, recurrence and severity verified?Required	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. R01	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.	Original safety, surgical and imaging tables, definitions, collection, adjudication and missingness material.	Answering harms requires direct event-specific material and sufficient follow-up.
32	Unverified	Full text not readStored summary read	N32 · Evidence conditionAre function, durability and long-term harms beyond six months directly verified?Supplementary; required for long-term extension	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. R01	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.	Follow-up material linking the same population, scales, timepoints, denominators and harms.	Long-term outcomes require material with sufficient follow-up and direct comparison.
33	Unverified	Full text not readStored summary read	N33 · Evidence conditionWhat alternative factors link baseline fracture, concurrent care, conversion and harms?Required	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. R01	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.	Original records/analyses of baseline risk, actual care, changes and events.	Explanations of harm require event ascertainment, comparison and temporal-relationship material.
34	Partly verified	Full text not readStored summary read	N34 · Evidence conditionHow are NIHR HTA public funding and pilot funding linked?Required	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. R01	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.	Disclosures of main-trial/pilot sponsorship, reports, populations and roles.	Added funding/report relationships must distinguish actual trial/population sharing.
35	Unverified	Full text not readStored summary read	N35 · Evidence conditionWhat are the detailed sponsor, author, data-access and publication roles?Required	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. R01	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.	Disclosures of sponsorship, COI, data access, analysis and publication roles.	Broader independence claims require material showing actual involvement and data sharing.
36	Unverified	Full text not readStored summary read	N36 · Evidence conditionIs there independent replication in the same population, intervention and timepoint?Supplementary; required to claim independent replication	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. R01	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.	Independent material linking bibliography, registration, populations, interventions and outcomes.	New reports must first distinguish the same population from separate trials.
37	Unverified	Full text not readStored summary read	N37 · Evidence conditionCan results extend to other ages, fractures, techniques or clinical settings?Supplementary; required for general application	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. R01	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.	Direct comparisons of population, fracture, technique, clinician and shared-care differences.	Other-condition outcomes must be answered with material for their respective question, scale and period.
38	Unverified	Full text not readStored summary read	N38 · Evidence conditionWhat is unverified about the importance of six-month function and individual responses?Required	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. R01	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.	Rationale for margins, score distributions, direct responders and planned subgroup material.	Extension to individual response/importance requires prespecified direct analysis material.
39	Unverified	Full text not readStored summary read	N39 · Evidence conditionHow much is verified about secondary-outcome, multiple-comparison and subgroup plans?Required	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. R01	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.	Registration/protocol/SAP outcome hierarchy, multiple comparisons, subgroups and original analyses.	Plans and actual results must link with each measure distinguished.
40	Partly verified	Full text not readStored summary read	N40 · Evidence conditionWhat is retained when material is updated or corrected?Required (update boundaries)	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. R01	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.	New material versions, original locations, question changes and reasons for condition/observation changes.	Separately added follow-up material must retain its scope and user-review requirements.

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40 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-08-26
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population: Equivalent six-month function to surgery in older adults with unstable ankle fracture
Ingredient, formulation and route: Close contact casting
Dose: Original intervention identity and shared anaesthesia/operating-room conditions are retained; no new casting, reduction or procedural guidance is created
Comparator: Surgery. The adjusted functional difference is casting versus surgery
Measured outcome: Six-month OMAS; higher scores mean better function; prespecified equivalence limits ±6 points
Duration: Six-month OMAS primary endpoint; detailed observation windows for other outcomes are unverified
Questions outside this scope: Generalizing effects/safety to other populations, diseases, surgical risks, formulations or timepoints; Adding the same report, population, groups, timepoints or outcomes as new independent trials/participants; Recommending individual treatments, procedures, doses, suitability or usage choices

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

R01 · Willett K, Keene DJ, Mistry D, et al. Close Contact Casting vs Surgery for Initial Treatment of Unstable Ankle Fractures in Older Adults. JAMA. 2016;316(14):1455-1463. PMID: 27727383.

PubMed

Material type: Multicentre randomized equivalence trial
Materials actually read: Summary read; external papers and registration unread
Findings recorded in the stored summary: Casting 64.5 versus surgery 66.0; difference -0.6 points (95% CI -3.9–2.6), within both limits
Record level: Reported values from the existing review summary. The original paper was not directly verified in this work.
Study overlap and independent replication: Original functional/clinical outcomes, analyses, harms and related timepoints share one AIM report/population; they are not added as new independent replications.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored existing review summary	Stored summary	Locally stored existing review summary read for preparation	Summary read	The existing complete review summary was read for production; the original paper was not acquired or read.
Paper abstract	External material unread; needed	Access not attempted; not obtained	Not read	Only the bibliographic PMID link was connected. The actual abstract and result locations were not directly verified.
Full paper	External material unread; needed	Access not attempted; not obtained	Not read	The URL is a bibliographic link; full-text acquisition and accessibility were not verified.
Clinical trial registration	External material unread; needed	Access not attempted; not obtained	Not read	Only original registration-identifier text is preserved. Registration content, versions, first date, changes and comparison with reports are unverified.
Study protocol	External material unread; needed	Access not attempted; not obtained	Not read	Original plans for equivalence limits, scales, exposure, assessment, PP/ITT and conversion have not been acquired.
Statistical analysis plan	External material unread; needed	Access not attempted; not obtained	Not read	Direct plans for analysis populations, estimands, adjustment, missingness, sensitivity, hierarchy and precision have not been acquired.
Original results and safety tables	External material unread; needed	Access not attempted; not obtained	Not read	Detailed definitions, original denominators, periods, measurement, estimation and intervals are needed for function, wounds, additional surgery, malunion, conversion and anaesthesia.
Sponsorship and interest disclosures	External material unread; needed	Access not attempted; not obtained	Not read	Beyond stored funding/role information, original contract, data-access, publication-decision and author-specific COI documents have not been acquired.

Report counts versus independent study counts

Original functional/clinical outcomes, analyses, harms and related timepoints share one AIM report/population; they are not added as new independent replications.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · What are the selected claim and existing verdict record?

Required materials and conditions: The relationship between the selected question/record wording and the parent verdict.
Conditions for verification: What are the selected claim and existing verdict record? Distinguish The relationship between the selected question/record wording and the parent verdict in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: What are the selected claim and existing verdict record? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N02 · How are the subclaim grade/note and absent score, status and axes retained?

Required materials and conditions: Actual subclaim fields and separately preserved parent fields.
Conditions for verification: How are the subclaim grade/note and absent score, status and axes retained? Distinguish Actual subclaim fields and separately preserved parent fields in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Absent subclaim values are not filled with the parent score, status or axes.
Why this condition is needed: How are the subclaim grade/note and absent score, status and axes retained? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N03 · What is the context of the parent grade, axes, safety, null, false and empty values?

Required materials and conditions: Parent verdict, axes, original study assessment and change history.
Conditions for verification: What is the context of the parent grade, axes, safety, null, false and empty values? Distinguish Parent verdict, axes, original study assessment and change history in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Historical B1 assessment/cross-check wording is not inherited as newly satisfied conditions.
Why this condition is needed: What is the context of the parent grade, axes, safety, null, false and empty values? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N04 · How are Korean/English, the reference date, corrections and empty values preserved?

Required materials and conditions: Actual versions of original wording, dates, corrections and history in each language.
Conditions for verification: How are Korean/English, the reference date, corrections and empty values preserved? Distinguish Actual versions of original wording, dates, corrections and history in each language in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: How are Korean/English, the reference date, corrections and empty values preserved? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N05 · Which materials were read for this production and which external materials remain unread?

Required materials and conditions: Actual acquisition/reading level for each material and original result locations.
Conditions for verification: Which materials were read for this production and which external materials remain unread? Distinguish Actual acquisition/reading level for each material and original result locations in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: URLs only link original material; they do not certify link checking or reading.
Why this condition is needed: Which materials were read for this production and which external materials remain unread? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N06 · What are the AIM report identity and registration identifier?

Required materials and conditions: Original bibliography, paper, registration and material linking them to the same trial.
Conditions for verification: What are the AIM report identity and registration identifier? Distinguish Original bibliography, paper, registration and material linking them to the same trial in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Different lead-author wording in evidence and citation lists is not counted as separate trials.
Why this condition is needed: What are the AIM report identity and registration identifier? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N07 · How is sharing across reports, groups, outcomes and the parent question shown?

Required materials and conditions: Material linking trials, reports, groups, analysis populations, outcomes and overlap.
Conditions for verification: How is sharing across reports, groups, outcomes and the parent question shown? Distinguish Material linking trials, reports, groups, analysis populations, outcomes and overlap in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: The number of report entries does not certify independent unique trial or participant counts.
Why this condition is needed: How is sharing across reports, groups, outcomes and the parent question shown? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N08 · Which older population with unstable ankle fractures is studied?

Required materials and conditions: Original group tables of eligibility, recruitment, fracture status, baseline function and risk.
Conditions for verification: Which older population with unstable ankle fractures is studied? Distinguish Original group tables of eligibility, recruitment, fracture status, baseline function and risk in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Age thresholds or fracture types absent from the current source are not filled in.
Why this condition is needed: Which older population with unstable ankle fractures is studied? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N09 · How much is known about baseline risk, representativeness and treatment eligibility?

Required materials and conditions: Eligibility, exclusions, baseline characteristics, recruitment setting and group distributions.
Conditions for verification: How much is known about baseline risk, representativeness and treatment eligibility? Distinguish Eligibility, exclusions, baseline characteristics, recruitment setting and group distributions in the original material and retain the limits of direct verification.
Requirement and applicability: Supplementary; required for general application
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: How much is known about baseline risk, representativeness and treatment eligibility? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N10 · What was the original study intervention of close contact casting?

Required materials and conditions: Material on trial intervention identity, implementation, clinicians, actual exposure and changes.
Conditions for verification: What was the original study intervention of close contact casting? Distinguish Material on trial intervention identity, implementation, clinicians, actual exposure and changes in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: No casting, reduction, treatment or exercise instructions are written.
Why this condition is needed: What was the original study intervention of close contact casting? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N11 · What are the surgical control and shared anaesthesia/operating-room conditions?

Required materials and conditions: Planned and actual records of surgery, fixation, anaesthesia and shared care.
Conditions for verification: What are the surgical control and shared anaesthesia/operating-room conditions? Distinguish Planned and actual records of surgery, fixation, anaesthesia and shared care in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Results are not extended to avoiding anaesthesia or recommendations on surgical suitability/treatment choice.
Why this condition is needed: What are the surgical control and shared anaesthesia/operating-room conditions? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N12 · How much is verified about concurrent care, adherence and changes?

Required materials and conditions: Original records of concurrent care, actual treatment adherence, changes, discontinuation and follow-up.
Conditions for verification: How much is verified about concurrent care, adherence and changes? Distinguish Original records of concurrent care, actual treatment adherence, changes, discontinuation and follow-up in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: How much is verified about concurrent care, adherence and changes? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N13 · What is the verification scope of randomized equivalence design and allocation concealment?

Required materials and conditions: Original plans/reports of sequence generation, concealment, stratification and implementation.
Conditions for verification: What is the verification scope of randomized equivalence design and allocation concealment? Distinguish Original plans/reports of sequence generation, concealment, stratification and implementation in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: What is the verification scope of randomized equivalence design and allocation concealment? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N14 · How do participant masking and six-month assessor masking differ?

Required materials and conditions: Original procedures for assessors, participants, scale responses and actual maintenance of masking.
Conditions for verification: How do participant masking and six-month assessor masking differ? Distinguish Original procedures for assessors, participants, scale responses and actual maintenance of masking in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Clause 105 and the original decision not to count a defect are not run as new review.
Why this condition is needed: How do participant masking and six-month assessor masking differ? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N15 · What are the denominators for 620 randomized participants and PP/ITT analysis?

Required materials and conditions: Group flows and inclusion criteria for allocation, treatment, conversion, follow-up, PP and ITT.
Conditions for verification: What are the denominators for 620 randomized participants and PP/ITT analysis? Distinguish Group flows and inclusion criteria for allocation, treatment, conversion, follow-up, PP and ITT in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: PP, ITT, safety and imaging denominators are not merged.
Why this condition is needed: What are the denominators for 620 randomized participants and PP/ITT analysis? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N16 · What is the original explanation of primary PP analysis and concordant ITT?

Required materials and conditions: Analysis plans, PP/ITT definitions, each estimate/interval and sensitivity tables.
Conditions for verification: What is the original explanation of primary PP analysis and concordant ITT? Distinguish Analysis plans, PP/ITT definitions, each estimate/interval and sensitivity tables in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: One adjusted difference/CI is not newly attributed to a separate analysis population.
Why this condition is needed: What is the original explanation of primary PP analysis and concordant ITT? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N17 · Is primary-endpoint missingness the same as overall follow-up or analysis exclusion?

Required materials and conditions: Overall flow, analysis exclusions, missingness/sensitivity handling and group-specific reasons.
Conditions for verification: Is primary-endpoint missingness the same as overall follow-up or analysis exclusion? Distinguish Overall flow, analysis exclusions, missingness/sensitivity handling and group-specific reasons in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: Is primary-endpoint missingness the same as overall follow-up or analysis exclusion? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N18 · What are the scale, units and direction of six-month OMAS?

Required materials and conditions: Original OMAS definitions, measurement, responses, scale, units and assessment procedures.
Conditions for verification: What are the scale, units and direction of six-month OMAS? Distinguish Original OMAS definitions, measurement, responses, scale, units and assessment procedures in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: What are the scale, units and direction of six-month OMAS? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N19 · Are group OMAS scores and the adjusted difference the same quantity?

Required materials and conditions: Original tables of group-score estimation, adjustment variables, models and analysis populations.
Conditions for verification: Are group OMAS scores and the adjusted difference the same quantity? Distinguish Original tables of group-score estimation, adjustment variables, models and analysis populations in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: The adjusted difference is not shown as a simple arithmetic difference of group scores.
Why this condition is needed: Are group OMAS scores and the adjusted difference the same quantity? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N20 · Why are prespecified equivalence limits shown on both sides?

Required materials and conditions: Rationale for the margin, prespecified versions, two-sided equivalence plans and original analyses.
Conditions for verification: Why are prespecified equivalence limits shown on both sides? Distinguish Rationale for the margin, prespecified versions, two-sided equivalence plans and original analyses in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: No new margin, effect or precision calculation or new equivalence verdict is made.
Why this condition is needed: Why are prespecified equivalence limits shown on both sides? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N21 · Does functional equivalence mean exactly equal scores or equivalence of all outcomes?

Required materials and conditions: Definitions and scope of estimands, margins, analysis populations and each outcome.
Conditions for verification: Does functional equivalence mean exactly equal scores or equivalence of all outcomes? Distinguish Definitions and scope of estimands, margins, analysis populations and each outcome in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: Does functional equivalence mean exactly equal scores or equivalence of all outcomes? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N22 · What is the verification level of the six-month primary endpoint and prespecified plans?

Required materials and conditions: Actual registration/protocol/SAP versions, changes, primary endpoints and analysis plans.
Conditions for verification: What is the verification level of the six-month primary endpoint and prespecified plans? Distinguish Actual registration/protocol/SAP versions, changes, primary endpoints and analysis plans in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Historical confirmation of prespecification is not displayed as current registration-content certification.
Why this condition is needed: What is the verification level of the six-month primary endpoint and prespecified plans? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N23 · What is unverified about adjustment variables, scale error and sensitivity results?

Required materials and conditions: Original adjustment, measurement and sensitivity-analysis tables, plans and assumptions.
Conditions for verification: What is unverified about adjustment variables, scale error and sensitivity results? Distinguish Original adjustment, measurement and sensitivity-analysis tables, plans and assumptions in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: What is unverified about adjustment variables, scale error and sensitivity results? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N24 · What are the event counts, denominators and group order for infection or wound breakdown?

Required materials and conditions: Wound-outcome definitions, timing, denominators, collection and original between-group analyses.
Conditions for verification: What are the event counts, denominators and group order for infection or wound breakdown? Distinguish Wound-outcome definitions, timing, denominators, collection and original between-group analyses in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: No new difference, risk ratio, CI, P value or NNT is calculated.
Why this condition is needed: What are the event counts, denominators and group order for infection or wound breakdown? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N25 · What are the original observations of treatment-related additional surgery?

Required materials and conditions: Definitions, collection, timing, group denominators and relationship to conversion for additional surgery.
Conditions for verification: What are the original observations of treatment-related additional surgery? Distinguish Definitions, collection, timing, group denominators and relationship to conversion for additional surgery in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Additional surgery and conversion are not added as independent events/people.
Why this condition is needed: What are the original observations of treatment-related additional surgery? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N26 · What are the original malunion events, denominators and group order?

Required materials and conditions: Radiographic malunion definitions, assessment, timing, group denominators, effects and intervals.
Conditions for verification: What are the original malunion events, denominators and group order? Distinguish Radiographic malunion definitions, assessment, timing, group denominators, effects and intervals in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: No new difference, proportion, effect or CI is calculated.
Why this condition is needed: What are the original malunion events, denominators and group order? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N27 · What strategy outcome is conversion to surgery after loss of reduction?

Required materials and conditions: Conversion criteria, timing, causes, actual treatment and inclusion handling in PP/ITT.
Conditions for verification: What strategy outcome is conversion to surgery after loss of reduction? Distinguish Conversion criteria, timing, causes, actual treatment and inclusion handling in PP/ITT in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: What strategy outcome is conversion to surgery after loss of reduction? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N28 · How are functional equivalence, anatomical alignment and harms retained together?

Required materials and conditions: Links between function, imaging, conversion and harms, with separate direct outcome material.
Conditions for verification: How are functional equivalence, anatomical alignment and harms retained together? Distinguish Links between function, imaging, conversion and harms, with separate direct outcome material in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: How are functional equivalence, anatomical alignment and harms retained together? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N29 · Are group-specific data available on anaesthetic complications?

Required materials and conditions: Plans, collection, group tables, denominators and follow-up for anaesthesia-related events.
Conditions for verification: Are group-specific data available on anaesthetic complications? Distinguish Plans, collection, group tables, denominators and follow-up for anaesthesia-related events in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Historical nonreporting wording is not changed to zero events, currently inaccessible material or avoidance of anaesthesia.
Why this condition is needed: Are group-specific data available on anaesthetic complications? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N30 · How do units and denominators differ for function, wounds, imaging and conversion?

Required materials and conditions: Original tables of outcome-specific analysis units, at-risk populations, recurrence, group denominators and missingness.
Conditions for verification: How do units and denominators differ for function, wounds, imaging and conversion? Distinguish Original tables of outcome-specific analysis units, at-risk populations, recurrence, group denominators and missingness in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: How do units and denominators differ for function, wounds, imaging and conversion? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N31 · Are detailed event collection, adjudication, recurrence and severity verified?

Required materials and conditions: Original safety, surgical and imaging tables, definitions, collection, adjudication and missingness material.
Conditions for verification: Are detailed event collection, adjudication, recurrence and severity verified? Distinguish Original safety, surgical and imaging tables, definitions, collection, adjudication and missingness material in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: Are detailed event collection, adjudication, recurrence and severity verified? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N32 · Are function, durability and long-term harms beyond six months directly verified?

Required materials and conditions: Follow-up material linking the same population, scales, timepoints, denominators and harms.
Conditions for verification: Are function, durability and long-term harms beyond six months directly verified? Distinguish Follow-up material linking the same population, scales, timepoints, denominators and harms in the original material and retain the limits of direct verification.
Requirement and applicability: Supplementary; required for long-term extension
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: Are function, durability and long-term harms beyond six months directly verified? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N33 · What alternative factors link baseline fracture, concurrent care, conversion and harms?

Required materials and conditions: Original records/analyses of baseline risk, actual care, changes and events.
Conditions for verification: What alternative factors link baseline fracture, concurrent care, conversion and harms? Distinguish Original records/analyses of baseline risk, actual care, changes and events in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: What alternative factors link baseline fracture, concurrent care, conversion and harms? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N34 · How are NIHR HTA public funding and pilot funding linked?

Required materials and conditions: Disclosures of main-trial/pilot sponsorship, reports, populations and roles.
Conditions for verification: How are NIHR HTA public funding and pilot funding linked? Distinguish Disclosures of main-trial/pilot sponsorship, reports, populations and roles in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Public funding does not certify all analytical independence or absence of COI.
Why this condition is needed: How are NIHR HTA public funding and pilot funding linked? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N35 · What are the detailed sponsor, author, data-access and publication roles?

Required materials and conditions: Disclosures of sponsorship, COI, data access, analysis and publication roles.
Conditions for verification: What are the detailed sponsor, author, data-access and publication roles? Distinguish Disclosures of sponsorship, COI, data access, analysis and publication roles in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: What are the detailed sponsor, author, data-access and publication roles? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N36 · Is there independent replication in the same population, intervention and timepoint?

Required materials and conditions: Independent material linking bibliography, registration, populations, interventions and outcomes.
Conditions for verification: Is there independent replication in the same population, intervention and timepoint? Distinguish Independent material linking bibliography, registration, populations, interventions and outcomes in the original material and retain the limits of direct verification.
Requirement and applicability: Supplementary; required to claim independent replication
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: Is there independent replication in the same population, intervention and timepoint? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N37 · Can results extend to other ages, fractures, techniques or clinical settings?

Required materials and conditions: Direct comparisons of population, fracture, technique, clinician and shared-care differences.
Conditions for verification: Can results extend to other ages, fractures, techniques or clinical settings? Distinguish Direct comparisons of population, fracture, technique, clinician and shared-care differences in the original material and retain the limits of direct verification.
Requirement and applicability: Supplementary; required for general application
Application exceptions: No recommendation on individual treatment suitability or procedural choice is given.
Why this condition is needed: Can results extend to other ages, fractures, techniques or clinical settings? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N38 · What is unverified about the importance of six-month function and individual responses?

Required materials and conditions: Rationale for margins, score distributions, direct responders and planned subgroup material.
Conditions for verification: What is unverified about the importance of six-month function and individual responses? Distinguish Rationale for margins, score distributions, direct responders and planned subgroup material in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: What is unverified about the importance of six-month function and individual responses? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N39 · How much is verified about secondary-outcome, multiple-comparison and subgroup plans?

Required materials and conditions: Registration/protocol/SAP outcome hierarchy, multiple comparisons, subgroups and original analyses.
Conditions for verification: How much is verified about secondary-outcome, multiple-comparison and subgroup plans? Distinguish Registration/protocol/SAP outcome hierarchy, multiple comparisons, subgroups and original analyses in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: How much is verified about secondary-outcome, multiple-comparison and subgroup plans? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N40 · What is retained when material is updated or corrected?

Required materials and conditions: New material versions, original locations, question changes and reasons for condition/observation changes.
Conditions for verification: What is retained when material is updated or corrected? Distinguish New material versions, original locations, question changes and reasons for condition/observation changes in the original material and retain the limits of direct verification.
Requirement and applicability: Required (update boundaries)
Application exceptions: No new searches, calculations, scores, grades or treatment guidance are created in this production.
Why this condition is needed: What is retained when material is updated or corrected? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

What the statuses mean

Met: The original content has been reviewed as meeting the conditions. This status is not used in this preparation.
Partly verified: Some information in the stored summary was linked during preparation; clinical verification or review is not complete.
Unverified: Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.
Review incomplete: Awaiting user review, or actual review remains incomplete.
Not reported: Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.
Inaccessible: Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.
Insufficient evidence for the conditions: Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.
Not applicable: Used when the reason it does not apply to the original question is stated.
Conflicting data: Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment.

Change history

2026-10-10 · Public page/material version 1.0

The public page and data were prepared from the existing 40 items. No new clinical search, verification-status change or scoring was performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-08-26) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · What are the selected claim and existing verdict record?

Current findings: The selected stored summary concerns equivalent six-month function. The selected claim and its verdict record are distinguished, with parent-verdict context preserved. No new verdict, split or independent certification is created.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. The relationship between the selected question/record wording and the parent verdict remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; The relationship between the selected question/record wording and the parent verdict.
Required materials and conditions: The relationship between the selected question/record wording and the parent verdict.
Materials to obtain first: The relationship between the selected question/record wording and the parent verdict.
Further research: Additional material is linked while distinguishing the existing question from other questions.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What are the selected claim and existing verdict record? Distinguish The relationship between the selected question/record wording and the parent verdict in the original material and retain the limits of direct verification.
Why this condition is needed: What are the selected claim and existing verdict record? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N02 · How are the subclaim grade/note and absent score, status and axes retained?

Current findings: The subclaim grade is B and its note says the entire OMAS CI was within ±6 points. Subclaim score, status and axes are absent from the stored summary and are not filled with parent B, 70 points or axes.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Actual subclaim fields and separately preserved parent fields remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Actual subclaim fields and separately preserved parent fields.
Required materials and conditions: Actual subclaim fields and separately preserved parent fields.
Materials to obtain first: Actual subclaim fields and separately preserved parent fields.
Further research: If the subclaim is corrected, the complete pre-change text and change event are retained.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: How are the subclaim grade/note and absent score, status and axes retained? Distinguish Actual subclaim fields and separately preserved parent fields in the original material and retain the limits of direct verification.
Why this condition is needed: How are the subclaim grade/note and absent score, status and axes retained? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Absent subclaim values are not filled with the parent score, status or axes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N03 · What is the context of the parent grade, axes, safety, null, false and empty values?

Current findings: Parent B, 70 points, safety caution and B/P/R1/I2/E+/B1 are preserved. Precision is unrecorded; coprimary splitting, large hard-endpoint RCT and no-human-study flags are false; grade-override reasons are empty in both languages. Historical clause 105 and the one-design-defect explanation are not run as a new assessment.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Parent verdict, axes, original study assessment and change history remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Parent verdict, axes, original study assessment and change history.
Required materials and conditions: Parent verdict, axes, original study assessment and change history.
Materials to obtain first: Parent verdict, axes, original study assessment and change history.
Further research: A new correction is preserved separately from original values, reasons and production status.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What is the context of the parent grade, axes, safety, null, false and empty values? Distinguish Parent verdict, axes, original study assessment and change history in the original material and retain the limits of direct verification.
Why this condition is needed: What is the context of the parent grade, axes, safety, null, false and empty values? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Historical B1 assessment/cross-check wording is not inherited as newly satisfied conditions.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N04 · How are Korean/English, the reference date, corrections and empty values preserved?

Current findings: Complete Korean/English articles, reference date 2026-08-26 and existing empty correction/deliberation values are preserved. Differences in Korean/English PP/ITT detail do not overwrite each other.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Actual versions of original wording, dates, corrections and history in each language remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Actual versions of original wording, dates, corrections and history in each language.
Required materials and conditions: Actual versions of original wording, dates, corrections and history in each language.
Materials to obtain first: Actual versions of original wording, dates, corrections and history in each language.
Further research: When original wording or corrections are added, the complete pre-change text and a separate event are recorded.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: How are Korean/English, the reference date, corrections and empty values preserved? Distinguish Actual versions of original wording, dates, corrections and history in each language in the original material and retain the limits of direct verification.
Why this condition is needed: How are Korean/English, the reference date, corrections and empty values preserved? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N05 · Which materials were read for this production and which external materials remain unread?

Current findings: The complete stored existing review summary was read for production. Abstracts, full texts, registration, plans, SAPs and original outcome tables were not accessed. Stored citations and historical review wording do not mean current external reading or completed review.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Actual acquisition/reading level for each material and original result locations remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Actual acquisition/reading level for each material and original result locations.
Required materials and conditions: Actual acquisition/reading level for each material and original result locations.
Materials to obtain first: Actual acquisition/reading level for each material and original result locations.
Further research: Separate later direct reading must record its scope, version and time as a new event.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: Which materials were read for this production and which external materials remain unread? Distinguish Actual acquisition/reading level for each material and original result locations in the original material and retain the limits of direct verification.
Why this condition is needed: Which materials were read for this production and which external materials remain unread? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: URLs only link original material; they do not certify link checking or reading.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N06 · What are the AIM report identity and registration identifier?

Current findings: The evidence list names Keene DJ et al., 2016 AIM; the citation list names Willett K, Keene DJ, Mistry D et al., JAMA 2016. PMID 27727383 and ISRCTN04180738 link to the same stored report. DOI, PMCID and external registration content are unverified.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original bibliography, paper, registration and material linking them to the same trial remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original bibliography, paper, registration and material linking them to the same trial.
Required materials and conditions: Original bibliography, paper, registration and material linking them to the same trial.
Materials to obtain first: Original bibliography, paper, registration and material linking them to the same trial.
Further research: Added reports must distinguish the same trial/population from separate trials.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What are the AIM report identity and registration identifier? Distinguish Original bibliography, paper, registration and material linking them to the same trial in the original material and retain the limits of direct verification.
Why this condition is needed: What are the AIM report identity and registration identifier? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Different lead-author wording in evidence and citation lists is not counted as separate trials.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N07 · How is sharing across reports, groups, outcomes and the parent question shown?

Current findings: The stored direct-report entry is one AIM trial. PP, ITT, function, wounds, malunion, conversion to surgery and parent-verdict context are not added as new independent trials/participants.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Material linking trials, reports, groups, analysis populations, outcomes and overlap remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Material linking trials, reports, groups, analysis populations, outcomes and overlap.
Required materials and conditions: Material linking trials, reports, groups, analysis populations, outcomes and overlap.
Materials to obtain first: Material linking trials, reports, groups, analysis populations, outcomes and overlap.
Further research: Added follow-up/related reports must link actual population sharing within the existing AIM family.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: How is sharing across reports, groups, outcomes and the parent question shown? Distinguish Material linking trials, reports, groups, analysis populations, outcomes and overlap in the original material and retain the limits of direct verification.
Why this condition is needed: How is sharing across reports, groups, outcomes and the parent question shown? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: The number of report entries does not certify independent unique trial or participant counts.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N08 · Which older population with unstable ankle fractures is studied?

Current findings: The question concerns unstable ankle fracture in older adults. Detailed age criteria, fracture classifications, eligibility, exclusions, baseline function and comorbidities are absent from the summary; results are not automatically applied to all fractures or ages.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original group tables of eligibility, recruitment, fracture status, baseline function and risk remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original group tables of eligibility, recruitment, fracture status, baseline function and risk.
Required materials and conditions: Original group tables of eligibility, recruitment, fracture status, baseline function and risk.
Materials to obtain first: Original group tables of eligibility, recruitment, fracture status, baseline function and risk.
Further research: Function/harms in other populations are distinguished using direct comparison material for those populations.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: Which older population with unstable ankle fractures is studied? Distinguish Original group tables of eligibility, recruitment, fracture status, baseline function and risk in the original material and retain the limits of direct verification.
Why this condition is needed: Which older population with unstable ankle fractures is studied? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Age thresholds or fracture types absent from the current source are not filled in.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N09 · How much is known about baseline risk, representativeness and treatment eligibility?

Current findings: Detailed recruitment pathways, centres, fracture severity, baseline walking ability and distributions of treatment eligibility are unverified in the current summary. A population name does not establish treatment suitability for an individual patient.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct details are unverified within the current summary and unread external material. Eligibility, exclusions, baseline characteristics, recruitment setting and group distributions remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Eligibility, exclusions, baseline characteristics, recruitment setting and group distributions.
Required materials and conditions: Eligibility, exclusions, baseline characteristics, recruitment setting and group distributions.
Materials to obtain first: Eligibility, exclusions, baseline characteristics, recruitment setting and group distributions.
Further research: General application requires material showing actual population differences.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: How much is known about baseline risk, representativeness and treatment eligibility? Distinguish Eligibility, exclusions, baseline characteristics, recruitment setting and group distributions in the original material and retain the limits of direct verification.
Why this condition is needed: How much is known about baseline risk, representativeness and treatment eligibility? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N10 · What was the original study intervention of close contact casting?

Current findings: The original explanation that close contact casting maintains reduction through minimal padding and close moulding is retained. Actual application techniques, timing, repeated procedures and clinician experience remain unverified. No new procedural guidance is written.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Material on trial intervention identity, implementation, clinicians, actual exposure and changes remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Material on trial intervention identity, implementation, clinicians, actual exposure and changes.
Required materials and conditions: Material on trial intervention identity, implementation, clinicians, actual exposure and changes.
Materials to obtain first: Material on trial intervention identity, implementation, clinicians, actual exposure and changes.
Further research: Differences in other casting techniques/implementation conditions require direct comparison material.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What was the original study intervention of close contact casting? Distinguish Material on trial intervention identity, implementation, clinicians, actual exposure and changes in the original material and retain the limits of direct verification.
Why this condition is needed: What was the original study intervention of close contact casting? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: No casting, reduction, treatment or exercise instructions are written.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N11 · What are the surgical control and shared anaesthesia/operating-room conditions?

Current findings: Both groups received initial treatment in an operating room under general or spinal anaesthesia. Casting is distinguished from initial incisions/internal fixation, but the trial did not avoid anaesthesia itself. Detailed techniques of the surgical control are unverified.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Planned and actual records of surgery, fixation, anaesthesia and shared care remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Planned and actual records of surgery, fixation, anaesthesia and shared care.
Required materials and conditions: Planned and actual records of surgery, fixation, anaesthesia and shared care.
Materials to obtain first: Planned and actual records of surgery, fixation, anaesthesia and shared care.
Further research: Material with differences in control or concurrent treatment must mark those conditions separately.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What are the surgical control and shared anaesthesia/operating-room conditions? Distinguish Planned and actual records of surgery, fixation, anaesthesia and shared care in the original material and retain the limits of direct verification.
Why this condition is needed: What are the surgical control and shared anaesthesia/operating-room conditions? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Results are not extended to avoiding anaesthesia or recommendations on surgical suitability/treatment choice.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N12 · How much is verified about concurrent care, adherence and changes?

Current findings: Detailed rehabilitation, adjunctive care, clinicians, actual adherence and management differences are unverified. Conversion to surgery after loss of reduction is retained as a separate observation; other concurrent care is not invented.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct details are unverified within the current summary and unread external material. Original records of concurrent care, actual treatment adherence, changes, discontinuation and follow-up remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original records of concurrent care, actual treatment adherence, changes, discontinuation and follow-up.
Required materials and conditions: Original records of concurrent care, actual treatment adherence, changes, discontinuation and follow-up.
Materials to obtain first: Original records of concurrent care, actual treatment adherence, changes, discontinuation and follow-up.
Further research: Answering the functional estimand requires material distinguishing the assigned strategy from actual implementation.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: How much is verified about concurrent care, adherence and changes? Distinguish Original records of concurrent care, actual treatment adherence, changes, discontinuation and follow-up in the original material and retain the limits of direct verification.
Why this condition is needed: How much is verified about concurrent care, adherence and changes? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N13 · What is the verification scope of randomized equivalence design and allocation concealment?

Current findings: This is a multicentre randomized equivalence trial. The original account says concealment used an independent Aberdeen University 24-hour telephone service, registering participants before computer-generated allocation. External procedures were not reverified here.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original plans/reports of sequence generation, concealment, stratification and implementation remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original plans/reports of sequence generation, concealment, stratification and implementation.
Required materials and conditions: Original plans/reports of sequence generation, concealment, stratification and implementation.
Materials to obtain first: Original plans/reports of sequence generation, concealment, stratification and implementation.
Further research: Added allocation details must distinguish historical quotations from direct verification.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What is the verification scope of randomized equivalence design and allocation concealment? Distinguish Original plans/reports of sequence generation, concealment, stratification and implementation in the original material and retain the limits of direct verification.
Why this condition is needed: What is the verification scope of randomized equivalence design and allocation concealment? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N14 · How do participant masking and six-month assessor masking differ?

Current findings: The historical assessment that participant masking was inherently impossible for surgery versus casting is distinguished from six-month assessor masking. The original account of opaque ankle bandages and a James index of 0.8 is retained.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original procedures for assessors, participants, scale responses and actual maintenance of masking remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original procedures for assessors, participants, scale responses and actual maintenance of masking.
Required materials and conditions: Original procedures for assessors, participants, scale responses and actual maintenance of masking.
Materials to obtain first: Original procedures for assessors, participants, scale responses and actual maintenance of masking.
Further research: Details of masking, response and measurement processes must each be linked to material.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: How do participant masking and six-month assessor masking differ? Distinguish Original procedures for assessors, participants, scale responses and actual maintenance of masking in the original material and retain the limits of direct verification.
Why this condition is needed: How do participant masking and six-month assessor masking differ? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Clause 105 and the original decision not to count a defect are not run as new review.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N15 · What are the denominators for 620 randomized participants and PP/ITT analysis?

Current findings: There were 620 randomized participants, 558 in six-month PP analysis and 593 in ITT. These three denominators are distinguished; no new dropout counts or proportions are calculated from their differences.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Group flows and inclusion criteria for allocation, treatment, conversion, follow-up, PP and ITT remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Group flows and inclusion criteria for allocation, treatment, conversion, follow-up, PP and ITT.
Required materials and conditions: Group flows and inclusion criteria for allocation, treatment, conversion, follow-up, PP and ITT.
Materials to obtain first: Group flows and inclusion criteria for allocation, treatment, conversion, follow-up, PP and ITT.
Further research: Added original analysis-population definitions must link to the relevant functional outcome.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What are the denominators for 620 randomized participants and PP/ITT analysis? Distinguish Group flows and inclusion criteria for allocation, treatment, conversion, follow-up, PP and ITT in the original material and retain the limits of direct verification.
Why this condition is needed: What are the denominators for 620 randomized participants and PP/ITT analysis? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: PP, ITT, safety and imaging denominators are not merged.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N16 · What is the original explanation of primary PP analysis and concordant ITT?

Current findings: The original account says primary analysis was per protocol, with an ITT analysis also supporting equivalence. Exact adjusted differences, CIs and inclusion criteria for PP and ITT each remain externally unread; one stored difference is not duplicated into both.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Analysis plans, PP/ITT definitions, each estimate/interval and sensitivity tables remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Analysis plans, PP/ITT definitions, each estimate/interval and sensitivity tables.
Required materials and conditions: Analysis plans, PP/ITT definitions, each estimate/interval and sensitivity tables.
Materials to obtain first: Analysis plans, PP/ITT definitions, each estimate/interval and sensitivity tables.
Further research: Equivalence robustness must be distinguished using direct results for each analysis population/assumption.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What is the original explanation of primary PP analysis and concordant ITT? Distinguish Analysis plans, PP/ITT definitions, each estimate/interval and sensitivity tables in the original material and retain the limits of direct verification.
Why this condition is needed: What is the original explanation of primary PP analysis and concordant ITT? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: One adjusted difference/CI is not newly attributed to a separate analysis population.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N17 · Is primary-endpoint missingness the same as overall follow-up or analysis exclusion?

Current findings: Historical assessment gives primary-endpoint missingness of PP 0% and ITT 0.2%. This wording links to PP/ITT denominators and does not mean complete follow-up of all 620 or no exclusions/conversions. Group-specific missingness, reasons and imputation details are unverified.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Overall flow, analysis exclusions, missingness/sensitivity handling and group-specific reasons remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Overall flow, analysis exclusions, missingness/sensitivity handling and group-specific reasons.
Required materials and conditions: Overall flow, analysis exclusions, missingness/sensitivity handling and group-specific reasons.
Materials to obtain first: Overall flow, analysis exclusions, missingness/sensitivity handling and group-specific reasons.
Further research: Results under missingness/conversion assumptions require original analysis material.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: Is primary-endpoint missingness the same as overall follow-up or analysis exclusion? Distinguish Overall flow, analysis exclusions, missingness/sensitivity handling and group-specific reasons in the original material and retain the limits of direct verification.
Why this condition is needed: Is primary-endpoint missingness the same as overall follow-up or analysis exclusion? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N18 · What are the scale, units and direction of six-month OMAS?

Current findings: The original explanation describes OMAS as a 0–100 patient-reported ankle-function scale, with higher scores meaning better function and fewer symptoms. It is not the same outcome as radiographic alignment, injury healing or all activities.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original OMAS definitions, measurement, responses, scale, units and assessment procedures remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original OMAS definitions, measurement, responses, scale, units and assessment procedures.
Required materials and conditions: Original OMAS definitions, measurement, responses, scale, units and assessment procedures.
Materials to obtain first: Original OMAS definitions, measurement, responses, scale, units and assessment procedures.
Further research: Direct functional/other patient outcomes must link with their respective scales and timepoints distinguished.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What are the scale, units and direction of six-month OMAS? Distinguish Original OMAS definitions, measurement, responses, scale, units and assessment procedures in the original material and retain the limits of direct verification.
Why this condition is needed: What are the scale, units and direction of six-month OMAS? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N19 · Are group OMAS scores and the adjusted difference the same quantity?

Current findings: Surgery scored 66.0 and casting 64.5; the adjusted casting-versus-surgery difference was -0.6 points (95% CI -3.9–2.6). Original group scores and the adjusted difference are distinguished; no simple difference or reversed-direction value is calculated.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original tables of group-score estimation, adjustment variables, models and analysis populations remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original tables of group-score estimation, adjustment variables, models and analysis populations.
Required materials and conditions: Original tables of group-score estimation, adjustment variables, models and analysis populations.
Materials to obtain first: Original tables of group-score estimation, adjustment variables, models and analysis populations.
Further research: Material explaining baseline adjustment and the estimand in detail is needed.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: Are group OMAS scores and the adjusted difference the same quantity? Distinguish Original tables of group-score estimation, adjustment variables, models and analysis populations in the original material and retain the limits of direct verification.
Why this condition is needed: Are group OMAS scores and the adjusted difference the same quantity? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: The adjusted difference is not shown as a simple arithmetic difference of group scores.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N20 · Why are prespecified equivalence limits shown on both sides?

Current findings: The prespecified limits were ±6 points, or -6 to +6; the entire stored 95% CI -3.9–2.6 reportedly fell within both sides. Comparing the whole interval to both limits is distinguished from one-sided noninferiority and conventional nonsignificance testing.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Rationale for the margin, prespecified versions, two-sided equivalence plans and original analyses remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Rationale for the margin, prespecified versions, two-sided equivalence plans and original analyses.
Required materials and conditions: Rationale for the margin, prespecified versions, two-sided equivalence plans and original analyses.
Materials to obtain first: Rationale for the margin, prespecified versions, two-sided equivalence plans and original analyses.
Further research: Added original margin/analysis-plan material must link its relevant scope.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: Why are prespecified equivalence limits shown on both sides? Distinguish Rationale for the margin, prespecified versions, two-sided equivalence plans and original analyses in the original material and retain the limits of direct verification.
Why this condition is needed: Why are prespecified equivalence limits shown on both sides? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: No new margin, effect or precision calculation or new equivalence verdict is made.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N21 · Does functional equivalence mean exactly equal scores or equivalence of all outcomes?

Current findings: The stored result is functional equivalence within the specified six-month OMAS limits. It is not extended to an exact zero effect, the same response in every individual, all timepoints or equal anatomical outcomes.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Definitions and scope of estimands, margins, analysis populations and each outcome remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Definitions and scope of estimands, margins, analysis populations and each outcome.
Required materials and conditions: Definitions and scope of estimands, margins, analysis populations and each outcome.
Materials to obtain first: Definitions and scope of estimands, margins, analysis populations and each outcome.
Further research: Equivalence at other outcomes/timepoints requires direct comparisons and relevant plans.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: Does functional equivalence mean exactly equal scores or equivalence of all outcomes? Distinguish Definitions and scope of estimands, margins, analysis populations and each outcome in the original material and retain the limits of direct verification.
Why this condition is needed: Does functional equivalence mean exactly equal scores or equivalence of all outcomes? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N22 · What is the verification level of the six-month primary endpoint and prespecified plans?

Current findings: The original parent assessment says six-month OMAS and the ±6-point margin matched ISRCTN04180738 and the prespecified protocol. Registration/protocol were not opened here, so this is retained only as historical wording.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Actual registration/protocol/SAP versions, changes, primary endpoints and analysis plans remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Actual registration/protocol/SAP versions, changes, primary endpoints and analysis plans.
Required materials and conditions: Actual registration/protocol/SAP versions, changes, primary endpoints and analysis plans.
Materials to obtain first: Actual registration/protocol/SAP versions, changes, primary endpoints and analysis plans.
Further research: Comparison of prespecification with reports is recorded separately when direct material is added.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What is the verification level of the six-month primary endpoint and prespecified plans? Distinguish Actual registration/protocol/SAP versions, changes, primary endpoints and analysis plans in the original material and retain the limits of direct verification.
Why this condition is needed: What is the verification level of the six-month primary endpoint and prespecified plans? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Historical confirmation of prespecification is not displayed as current registration-content certification.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N23 · What is unverified about adjustment variables, scale error and sensitivity results?

Current findings: The adjusted difference and CI are preserved, but detailed adjustment variables, model assumptions, baseline function, measurement error, sensitivity and additional analyses remain externally unread. Absent P values or other effects are not created.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct details are unverified within the current summary and unread external material. Original adjustment, measurement and sensitivity-analysis tables, plans and assumptions remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original adjustment, measurement and sensitivity-analysis tables, plans and assumptions.
Required materials and conditions: Original adjustment, measurement and sensitivity-analysis tables, plans and assumptions.
Materials to obtain first: Original adjustment, measurement and sensitivity-analysis tables, plans and assumptions.
Further research: Direct material for each estimand/model must link separately.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What is unverified about adjustment variables, scale error and sensitivity results? Distinguish Original adjustment, measurement and sensitivity-analysis tables, plans and assumptions in the original material and retain the limits of direct verification.
Why this condition is needed: What is unverified about adjustment variables, scale error and sensitivity results? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N24 · What are the event counts, denominators and group order for infection or wound breakdown?

Current findings: The original summary order is surgery 29/298 (10%) versus casting 4/275 (1%). These denominators differ from functional analysis; detailed event definitions, between-group effects, CIs and periods are unverified.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Wound-outcome definitions, timing, denominators, collection and original between-group analyses remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Wound-outcome definitions, timing, denominators, collection and original between-group analyses.
Required materials and conditions: Wound-outcome definitions, timing, denominators, collection and original between-group analyses.
Materials to obtain first: Wound-outcome definitions, timing, denominators, collection and original between-group analyses.
Further research: Wound benefits require direct estimation/precision material for that outcome.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What are the event counts, denominators and group order for infection or wound breakdown? Distinguish Wound-outcome definitions, timing, denominators, collection and original between-group analyses in the original material and retain the limits of direct verification.
Why this condition is needed: What are the event counts, denominators and group order for infection or wound breakdown? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: No new difference, risk ratio, CI, P value or NNT is calculated.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N25 · What are the original observations of treatment-related additional surgery?

Current findings: Original values are surgery 18/298 (6%) versus casting 3/275 (1%). Treatment-related additional surgery and the 52/275 initially cast participants converted to surgery do not substitute for each other and are not added together.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Definitions, collection, timing, group denominators and relationship to conversion for additional surgery remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Definitions, collection, timing, group denominators and relationship to conversion for additional surgery.
Required materials and conditions: Definitions, collection, timing, group denominators and relationship to conversion for additional surgery.
Materials to obtain first: Definitions, collection, timing, group denominators and relationship to conversion for additional surgery.
Further research: Original material showing how repeated surgery and conversion are counted is needed.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What are the original observations of treatment-related additional surgery? Distinguish Definitions, collection, timing, group denominators and relationship to conversion for additional surgery in the original material and retain the limits of direct verification.
Why this condition is needed: What are the original observations of treatment-related additional surgery? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Additional surgery and conversion are not added as independent events/people.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N26 · What are the original malunion events, denominators and group order?

Current findings: Malunion was casting 38/249 (15%) versus surgery 8/274 (3%). This order is opposite to wound/additional-surgery results. Imaging denominators are not changed to 275/298 or functional denominators.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Radiographic malunion definitions, assessment, timing, group denominators, effects and intervals remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Radiographic malunion definitions, assessment, timing, group denominators, effects and intervals.
Required materials and conditions: Radiographic malunion definitions, assessment, timing, group denominators, effects and intervals.
Materials to obtain first: Radiographic malunion definitions, assessment, timing, group denominators, effects and intervals.
Further research: Anatomical-harm details must link separately from functional outcomes.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What are the original malunion events, denominators and group order? Distinguish Radiographic malunion definitions, assessment, timing, group denominators, effects and intervals in the original material and retain the limits of direct verification.
Why this condition is needed: What are the original malunion events, denominators and group order? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: No new difference, proportion, effect or CI is calculated.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N27 · What strategy outcome is conversion to surgery after loss of reduction?

Current findings: Among 275 initially cast participants, 52 (19%) converted to surgery after loss of reduction. Initial strategy, actual treatment and analysis populations are distinguished; no statement that everyone avoided surgery is created.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Conversion criteria, timing, causes, actual treatment and inclusion handling in PP/ITT remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Conversion criteria, timing, causes, actual treatment and inclusion handling in PP/ITT.
Required materials and conditions: Conversion criteria, timing, causes, actual treatment and inclusion handling in PP/ITT.
Materials to obtain first: Conversion criteria, timing, causes, actual treatment and inclusion handling in PP/ITT.
Further research: Material linking the assigned strategy to actual treatment course is needed.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What strategy outcome is conversion to surgery after loss of reduction? Distinguish Conversion criteria, timing, causes, actual treatment and inclusion handling in PP/ITT in the original material and retain the limits of direct verification.
Why this condition is needed: What strategy outcome is conversion to surgery after loss of reduction? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N28 · How are functional equivalence, anatomical alignment and harms retained together?

Current findings: Six-month functional equivalence is retained alongside casting’s costs of malunion, loss of reduction and subsequent conversion to surgery. Function alone does not establish anatomical equivalence or absence of harm.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Links between function, imaging, conversion and harms, with separate direct outcome material remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Links between function, imaging, conversion and harms, with separate direct outcome material.
Required materials and conditions: Links between function, imaging, conversion and harms, with separate direct outcome material.
Materials to obtain first: Links between function, imaging, conversion and harms, with separate direct outcome material.
Further research: The long-term relationship between functional and anatomical outcomes requires direct follow-up material.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: How are functional equivalence, anatomical alignment and harms retained together? Distinguish Links between function, imaging, conversion and harms, with separate direct outcome material in the original material and retain the limits of direct verification.
Why this condition is needed: How are functional equivalence, anatomical alignment and harms retained together? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N29 · Are group-specific data available on anaesthetic complications?

Current findings: The stored parent summary says separate group-specific counts of anaesthetic complications were not reported. This is not a new nonreporting judgment based on reading the full text here; relevant original tables, definitions and denominators are unverified.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct details are unverified within the current summary and unread external material. Plans, collection, group tables, denominators and follow-up for anaesthesia-related events remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Plans, collection, group tables, denominators and follow-up for anaesthesia-related events.
Required materials and conditions: Plans, collection, group tables, denominators and follow-up for anaesthesia-related events.
Materials to obtain first: Plans, collection, group tables, denominators and follow-up for anaesthesia-related events.
Further research: Anaesthetic harms require material with actual exposure, definitions, ascertainment and comparisons.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: Are group-specific data available on anaesthetic complications? Distinguish Plans, collection, group tables, denominators and follow-up for anaesthesia-related events in the original material and retain the limits of direct verification.
Why this condition is needed: Are group-specific data available on anaesthetic complications? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Historical nonreporting wording is not changed to zero events, currently inaccessible material or avoidance of anaesthesia.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N30 · How do units and denominators differ for function, wounds, imaging and conversion?

Current findings: Functional PP/ITT, wound/additional-surgery 298/275, malunion 249/274 and initially cast 275 are attributed to their original outcomes. Exact analysis units/overlap for people, imaging assessments, procedures and recurrent events are unverified.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original tables of outcome-specific analysis units, at-risk populations, recurrence, group denominators and missingness remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original tables of outcome-specific analysis units, at-risk populations, recurrence, group denominators and missingness.
Required materials and conditions: Original tables of outcome-specific analysis units, at-risk populations, recurrence, group denominators and missingness.
Materials to obtain first: Original tables of outcome-specific analysis units, at-risk populations, recurrence, group denominators and missingness.
Further research: Each row must link to material explaining outcome-specific aggregation rules.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: How do units and denominators differ for function, wounds, imaging and conversion? Distinguish Original tables of outcome-specific analysis units, at-risk populations, recurrence, group denominators and missingness in the original material and retain the limits of direct verification.
Why this condition is needed: How do units and denominators differ for function, wounds, imaging and conversion? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N31 · Are detailed event collection, adjudication, recurrence and severity verified?

Current findings: Some original wound, additional-surgery, malunion and conversion values are available, but detailed collection, adjudicators, recurrence, severity, period-specific ascertainment and missingness are unverified. These aggregates are not changed into complete safety certification.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct details are unverified within the current summary and unread external material. Original safety, surgical and imaging tables, definitions, collection, adjudication and missingness material remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original safety, surgical and imaging tables, definitions, collection, adjudication and missingness material.
Required materials and conditions: Original safety, surgical and imaging tables, definitions, collection, adjudication and missingness material.
Materials to obtain first: Original safety, surgical and imaging tables, definitions, collection, adjudication and missingness material.
Further research: Answering harms requires direct event-specific material and sufficient follow-up.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: Are detailed event collection, adjudication, recurrence and severity verified? Distinguish Original safety, surgical and imaging tables, definitions, collection, adjudication and missingness material in the original material and retain the limits of direct verification.
Why this condition is needed: Are detailed event collection, adjudication, recurrence and severity verified? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N32 · Are function, durability and long-term harms beyond six months directly verified?

Current findings: The selected functional timepoint in this source is six months. Direct later function, daily life, long-term alignment, reoperation and rare-harm values are absent from the current summary; results are not extended to sustained equivalence.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct details are unverified within the current summary and unread external material. Follow-up material linking the same population, scales, timepoints, denominators and harms remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Follow-up material linking the same population, scales, timepoints, denominators and harms.
Required materials and conditions: Follow-up material linking the same population, scales, timepoints, denominators and harms.
Materials to obtain first: Follow-up material linking the same population, scales, timepoints, denominators and harms.
Further research: Long-term outcomes require material with sufficient follow-up and direct comparison.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: Are function, durability and long-term harms beyond six months directly verified? Distinguish Follow-up material linking the same population, scales, timepoints, denominators and harms in the original material and retain the limits of direct verification.
Why this condition is needed: Are function, durability and long-term harms beyond six months directly verified? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N33 · What alternative factors link baseline fracture, concurrent care, conversion and harms?

Current findings: Detailed relationships between baseline fracture status, reduction, comorbidities, treatment adherence, conversion and events are unverified. Randomization alone does not establish that the intervention was the sole cause of every individual harm.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct details are unverified within the current summary and unread external material. Original records/analyses of baseline risk, actual care, changes and events remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original records/analyses of baseline risk, actual care, changes and events.
Required materials and conditions: Original records/analyses of baseline risk, actual care, changes and events.
Materials to obtain first: Original records/analyses of baseline risk, actual care, changes and events.
Further research: Explanations of harm require event ascertainment, comparison and temporal-relationship material.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What alternative factors link baseline fracture, concurrent care, conversion and harms? Distinguish Original records/analyses of baseline risk, actual care, changes and events in the original material and retain the limits of direct verification.
Why this condition is needed: What alternative factors link baseline fracture, concurrent care, conversion and harms? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N34 · How are NIHR HTA public funding and pilot funding linked?

Current findings: The main trial had public NIHR HTA programme project 07/37/61 funding; the evidence entry also lists pilot AO Research Foundation support. Pilot funding is not changed into separate clinical replication or a new participant total.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Disclosures of main-trial/pilot sponsorship, reports, populations and roles remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Disclosures of main-trial/pilot sponsorship, reports, populations and roles.
Required materials and conditions: Disclosures of main-trial/pilot sponsorship, reports, populations and roles.
Materials to obtain first: Disclosures of main-trial/pilot sponsorship, reports, populations and roles.
Further research: Added funding/report relationships must distinguish actual trial/population sharing.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: How are NIHR HTA public funding and pilot funding linked? Distinguish Disclosures of main-trial/pilot sponsorship, reports, populations and roles in the original material and retain the limits of direct verification.
Why this condition is needed: How are NIHR HTA public funding and pilot funding linked? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Public funding does not certify all analytical independence or absence of COI.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N35 · What are the detailed sponsor, author, data-access and publication roles?

Current findings: Funding sources are in the current summary, but contracts, data access, design/analysis/publication involvement and author-specific conflicts are unverified. Historical I2 is not inherited as new confirmation of independence.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct details are unverified within the current summary and unread external material. Disclosures of sponsorship, COI, data access, analysis and publication roles remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Disclosures of sponsorship, COI, data access, analysis and publication roles.
Required materials and conditions: Disclosures of sponsorship, COI, data access, analysis and publication roles.
Materials to obtain first: Disclosures of sponsorship, COI, data access, analysis and publication roles.
Further research: Broader independence claims require material showing actual involvement and data sharing.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What are the detailed sponsor, author, data-access and publication roles? Distinguish Disclosures of sponsorship, COI, data access, analysis and publication roles in the original material and retain the limits of direct verification.
Why this condition is needed: What are the detailed sponsor, author, data-access and publication roles? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N36 · Is there independent replication in the same population, intervention and timepoint?

Current findings: AIM is the only direct report in the designated source. Additional independent trials or replication of the same strategy are unverified in this production input; reports, groups and analysis populations are not combined as independent repetitions.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct details are unverified within the current summary and unread external material. Independent material linking bibliography, registration, populations, interventions and outcomes remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Independent material linking bibliography, registration, populations, interventions and outcomes.
Required materials and conditions: Independent material linking bibliography, registration, populations, interventions and outcomes.
Materials to obtain first: Independent material linking bibliography, registration, populations, interventions and outcomes.
Further research: New reports must first distinguish the same population from separate trials.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: Is there independent replication in the same population, intervention and timepoint? Distinguish Independent material linking bibliography, registration, populations, interventions and outcomes in the original material and retain the limits of direct verification.
Why this condition is needed: Is there independent replication in the same population, intervention and timepoint? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N37 · Can results extend to other ages, fractures, techniques or clinical settings?

Current findings: The original close contact casting strategy versus surgery in the selected older unstable-ankle-fracture population is not automatically transferred to other ages, fractures, casting methods or implementation settings. Direct material for those conditions is unverified.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct details are unverified within the current summary and unread external material. Direct comparisons of population, fracture, technique, clinician and shared-care differences remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Direct comparisons of population, fracture, technique, clinician and shared-care differences.
Required materials and conditions: Direct comparisons of population, fracture, technique, clinician and shared-care differences.
Materials to obtain first: Direct comparisons of population, fracture, technique, clinician and shared-care differences.
Further research: Other-condition outcomes must be answered with material for their respective question, scale and period.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: Can results extend to other ages, fractures, techniques or clinical settings? Distinguish Direct comparisons of population, fracture, technique, clinician and shared-care differences in the original material and retain the limits of direct verification.
Why this condition is needed: Can results extend to other ages, fractures, techniques or clinical settings? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: No recommendation on individual treatment suitability or procedural choice is given.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N38 · What is unverified about the importance of six-month function and individual responses?

Current findings: The original prespecified ±6-point margin and between-group results are preserved. Detailed margin rationale, individually important changes, responders, group distributions and baseline-function differences are unverified. Average equivalence is not changed to equivalence of every individual response.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct details are unverified within the current summary and unread external material. Rationale for margins, score distributions, direct responders and planned subgroup material remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Rationale for margins, score distributions, direct responders and planned subgroup material.
Required materials and conditions: Rationale for margins, score distributions, direct responders and planned subgroup material.
Materials to obtain first: Rationale for margins, score distributions, direct responders and planned subgroup material.
Further research: Extension to individual response/importance requires prespecified direct analysis material.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What is unverified about the importance of six-month function and individual responses? Distinguish Rationale for margins, score distributions, direct responders and planned subgroup material in the original material and retain the limits of direct verification.
Why this condition is needed: What is unverified about the importance of six-month function and individual responses? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N39 · How much is verified about secondary-outcome, multiple-comparison and subgroup plans?

Current findings: Primary function and some harm/procedure outcomes are summarized, but detailed prespecified hierarchy, multiple comparisons and intervals for each secondary outcome/subgroup are unverified. Functional-equivalence evidence is not copied to testing of all secondary outcomes.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct details are unverified within the current summary and unread external material. Registration/protocol/SAP outcome hierarchy, multiple comparisons, subgroups and original analyses remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Registration/protocol/SAP outcome hierarchy, multiple comparisons, subgroups and original analyses.
Required materials and conditions: Registration/protocol/SAP outcome hierarchy, multiple comparisons, subgroups and original analyses.
Materials to obtain first: Registration/protocol/SAP outcome hierarchy, multiple comparisons, subgroups and original analyses.
Further research: Plans and actual results must link with each measure distinguished.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: How much is verified about secondary-outcome, multiple-comparison and subgroup plans? Distinguish Registration/protocol/SAP outcome hierarchy, multiple comparisons, subgroups and original analyses in the original material and retain the limits of direct verification.
Why this condition is needed: How much is verified about secondary-outcome, multiple-comparison and subgroup plans? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N40 · What is retained when material is updated or corrected?

Current findings: Existing numbers, grades, axes, language-specific content, dates and empty correction history are preserved. New material must distinguish the complete pre-change stored summary, version/reason, condition changes and events applying observations.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. New material versions, original locations, question changes and reasons for condition/observation changes remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; New material versions, original locations, question changes and reasons for condition/observation changes.
Required materials and conditions: New material versions, original locations, question changes and reasons for condition/observation changes.
Materials to obtain first: New material versions, original locations, question changes and reasons for condition/observation changes.
Further research: Separately added follow-up material must retain its scope and user-review requirements.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What is retained when material is updated or corrected? Distinguish New material versions, original locations, question changes and reasons for condition/observation changes in the original material and retain the limits of direct verification.
Why this condition is needed: What is retained when material is updated or corrected? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: No new searches, calculations, scores, grades or treatment guidance are created in this production.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01