# Iodine-alcohol preparation · Open-fracture surgical-site infection — Evidence Check Verdict 2968 · Evidence Check Stored-material review date: Not recorded Original evidence cut-off: 2026-08-26 Review-criteria version: 1.0 Public page/material preparation date: 2026-10-13 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - Population: PREPARE’s separate prespecified open-fracture population of 1,700 patients; detailed locations, severity and eligibility criteria unverified - Ingredient, formulation and route: Trial iodine povacrylex-alcohol preparation - Dose: Research formulation: 0.7% free iodine and 74% isopropyl alcohol; not implementation guidance - Comparator: Research formulation: 2% chlorhexidine gluconate and 70% isopropyl alcohol - Measured outcome: Surgical-site infection; distinguish the trial’s superficial 30-day and deep/organ-space 90-day definitions from open-fracture-specific material gaps - Duration: Infection adjudication at 30 or 90 days; one-year reoperation is a separate outcome with open-fracture-specific scope unverified - Questions outside this scope: No new formulations, populations, clinical effects, CI, verdicts, independence certification, participant totals, implementation or treatment instructions are created ## Checklist items ### N01 · Is the selected subclaim reduced infection after open-fracture fixation? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The preserved subclaim is reduced SSI after open-fracture fixation, originally graded D, with a note that the separate population was null at P=0.45. Parent B with 76 points and axes concern closed fractures. The selected row has no score, status or axes in the summary. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Do not fill subclaim score, status or axes with parent values. No new verdict or boundary certification was written. - Required materials and conditions: Distinction between original selected question, subclaim grade/note and parent verdict - Materials to obtain first: Original selected subclaim and parent verdict - Further research: Present the original records so the user can read the subclaim separately from parent context - Conditions for verification: Distinction between original selected question, subclaim grade/note and parent verdict; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N02 · Can the positive closed-fracture result be applied to open fractures? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The preserved summary distinguishes closed and open fractures as separate prespecified populations. It records a null open-fracture result and states that the positive closed-fracture result cannot be extended. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Closed-fracture B with 76 points and -0.8 percentage points cannot be transferred as an open-fracture effect or score. - Required materials and conditions: Materials separating populations and estimated results of the two prespecified cohorts - Materials to obtain first: Original result tables and registration plan for both populations - Further research: Present population-specific estimates and applicability side by side - Conditions for verification: Materials separating populations and estimated results of the two prespecified cohorts; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N03 · What is the actual denominator for the open-fracture analysis? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The preserved summary gives 1,700 open-fracture patients. The evidence table’s 6,785 and 3,360/3,425 belong to closed fractures. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Group-specific open-fracture allocation, analysis and follow-up denominators are absent from the summary. Do not sum the two populations as a participant total. - Required materials and conditions: Open-fracture denominators for recruitment, assignment and analysis populations - Materials to obtain first: Open-fracture CONSORT flow and group-specific analysis tables - Further research: Present clusters, people and group-specific analysis denominators separately - Conditions for verification: Open-fracture denominators for recruitment, assignment and analysis populations; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N04 · Are open-fracture severity and anatomical scope verified? Verification status: Unverified Reading scope: Summary read; related external material unread - Current findings: The summary identifies only the open-fracture population. The parent closed lower-extremity/pelvic-fracture label is not reused as an exact open-fracture location or severity criterion. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Open-fracture classification, contamination, injury location and detailed patient characteristics are unverified within the preserved scope. - Required materials and conditions: Open-fracture locations, injury severity, eligibility and exclusion criteria - Materials to obtain first: Open-fracture eligibility, baseline characteristics and prespecified subgroup tables - Further research: Present the actual selected population and scope separately in the original report - Conditions for verification: Open-fracture locations, injury severity, eligibility and exclusion criteria; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N05 · What are the two alcohol preparations compared in the trial? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: Recorded preparations are 0.7% free iodine povacrylex with 74% isopropyl alcohol, and 2% chlorhexidine gluconate with 70% isopropyl alcohol. These identify research formulations and are not usage instructions. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Product, batch, application-process and shared-care details remain unread; equivalence of aqueous iodine or other concentrations is not established. - Required materials and conditions: Original identities of iodine-alcohol and chlorhexidine-alcohol formulations - Materials to obtain first: Trial-preparation specifications and original intervention descriptions - Further research: Preserve formulation identities and applicability limits - Conditions for verification: Original identities of iodine-alcohol and chlorhexidine-alcohol formulations; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N06 · Can this be extended to other antiseptics or surgeries? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The parent summary specifies a comparison of two particular alcohol preparations and states that it cannot be extended to open fractures, other surgeries or aqueous iodine. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: The selected question’s null result does not prove equivalence of every iodine or chlorhexidine preparation. - Required materials and conditions: Direct evidence matching the actual formulations and surgical context - Materials to obtain first: Direct comparison of the same open-fracture population and formulations - Further research: Express formulation- and surgery-specific results as separate questions - Conditions for verification: Direct evidence matching the actual formulations and surgical context; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N07 · Are concurrent antibiotics, irrigation and fixation exposures accounted for in the group comparison? Verification status: Unverified Reading scope: Summary read; related external material unread - Current findings: The preserved material describes skin-antiseptic comparisons but no open-fracture-specific antibiotic, irrigation, fixation or other concurrent-exposure details. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Balance, changes and separation of concurrent-treatment effects remain unverified. No implementation or treatment-change instructions are written. - Required materials and conditions: Actual surgery, antibiotics, injury care and deviation information by group - Materials to obtain first: Open-fracture shared-care and concurrent-exposure tables - Further research: Present concurrent exposures and deviations by group - Conditions for verification: Actual surgery, antibiotics, injury care and deviation information by group; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N08 · What are the randomization unit and alternating-use structure? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: This was a cluster-randomized crossover trial in which 25 US/Canadian hospitals alternated the two preparations every two months. Assignment was at cluster-period level and is not relabeled as individual assignment. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Cluster counts, cluster-periods and patients are different units. Open-fracture recruitment distribution by period is absent from the summary. - Required materials and conditions: Design materials distinguishing hospitals, cluster-periods and individuals - Materials to obtain first: Cluster-period allocation tables and recruitment distribution - Further research: Present assignment units separately from participant units - Conditions for verification: Design materials distinguishing hospitals, cluster-periods and individuals; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N09 · What is the scope of current evidence on allocation sequence and concealment? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The preserved summary quotes a Methods Centre computer-generated sequence and cluster-period allocation implementation. Parent B0 is historical verdict information; the original paper’s methods were not reviewed here. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Actual concealment processes, advance accessibility and open-fracture recruitment implications remain externally unread. - Required materials and conditions: Allocation wording in the preserved summary actually read and original methods materials - Materials to obtain first: Original paper allocation methods and operating records - Further research: Present cluster-allocation implementation separately from recruitment timing - Conditions for verification: Allocation wording in the preserved summary actually read and original methods materials; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N10 · Were crossover periods and temporal effects reflected in open-fracture effect estimation? Verification status: Unverified Reading scope: Summary read; related external material unread - Current findings: The summary describes two-month alternation but no detailed period/cluster effects or crossover handling in the open-fracture model. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: No new inference is made about analysis of temporal changes, cluster-period correlation or carryover. - Required materials and conditions: Specifications of period effects, cluster correlation, crossover and analysis model - Materials to obtain first: Open-fracture analysis model and prespecified statistical plan - Further research: Present period and cluster handling from the original model - Conditions for verification: Specifications of period effects, cluster correlation, crossover and analysis model; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N11 · What are the SSI definition and ascertainment times? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The trial’s primary endpoint is summarized as superficial incisional infection within 30 days or deep/organ-space infection within 90 days. Symptom scores or all infections are not labeled as this same endpoint. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Open-fracture infection subtypes, specific diagnostic documents and event-level ascertainment remain unread in the original report. - Required materials and conditions: Adjudication criteria and periods for superficial, deep and organ-space infection - Materials to obtain first: Infection-adjudication manual and open-fracture subtype event tables - Further research: Present results by definition, time and infection type - Conditions for verification: Adjudication criteria and periods for superficial, deep and organ-space infection; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N12 · Are infection-adjudication masking and surgical-team masking distinguished? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The preserved summary records central adjudication unaware of assignment and infeasible surgical-team masking due to preparation characteristics. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Missing open-fracture adjudication materials, agreement and reassessment processes remain unread. Perfect masking of everything is not certified. - Required materials and conditions: Masking scope for outcome adjudicators and actual surgical teams - Materials to obtain first: Central-adjudication procedures and material flow - Further research: Distinguish masking of outcome adjudication from intervention implementation - Conditions for verification: Masking scope for outcome adjudicators and actual surgical teams; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N13 · Can the follow-up completion rate be used as an open-fracture denominator? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The preserved summary gives 95% primary-analysis follow-up. It does not explicitly state that this sentence applies exclusively to open fractures. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Do not calculate open-fracture follow-up numbers from 95% or establish it as the completion rate of every group. - Required materials and conditions: Open-fracture group-specific follow-up completion, missingness and withdrawal reasons - Materials to obtain first: Population-specific follow-up flow and missing-data handling tables - Further research: Present actual open-fracture follow-up and missingness denominators separately - Conditions for verification: Open-fracture group-specific follow-up completion, missingness and withdrawal reasons; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N14 · What are the analysis population of interest and assignment basis? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The preserved analysis sentence describes eligible enrolled patients analyzed according to the antiseptic assigned to their hospital during that crossover period. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Actual open-fracture analysis numbers, allocation deviations, preparation changes and inclusion/exclusion reasons are unverified in original materials. - Required materials and conditions: Assignment-based analysis principles and actual inclusion/exclusion materials - Materials to obtain first: Open-fracture analysis-population specifications and deviation tables - Further research: Distinguish assignment effects from effects of preparations actually received - Conditions for verification: Assignment-based analysis principles and actual inclusion/exclusion materials; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N15 · Are infection event counts and group denominators provided for open fractures? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: Open-fracture results are summarized as 6.5% versus 7.3%. That summary gives no group event counts or denominators. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Do not copy closed-fracture 77/3,360 or 108/3,425 or calculate open-fracture event counts from proportions. - Required materials and conditions: Original result tables including each group’s events, denominators and analysis units - Materials to obtain first: Original open-fracture infection-event and denominator tables - Further research: Present actual open-fracture events together with analysis denominators - Conditions for verification: Original result tables including each group’s events, denominators and analysis units; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N16 · How are the open-fracture comparison effect and confidence interval recorded? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The open-fracture summary records a null result: OR 0.86, 95% CI 0.58–1.27, P=0.45. The original effect and scope are preserved. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Do not turn a null result with a wide interval into exactly zero effect or proof that the two preparations are equivalent. - Required materials and conditions: Effect measure, interval and P value for the selected population - Materials to obtain first: Original open-fracture OR results and model explanation - Further research: Present the original effect, interval, test and interpretation scope separately - Conditions for verification: Effect measure, interval and P value for the selected population; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N17 · Are an open-fracture absolute risk difference and interval available? Verification status: Unverified Reading scope: Summary read; related external material unread - Current findings: The preserved summary has open-fracture proportions and OR, but no open-fracture absolute risk difference or its interval. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Do not reuse closed-fracture adjusted -0.8 percentage points and its interval or calculate a new absolute difference/NNT from 6.5% and 7.3%. - Required materials and conditions: Directly reported absolute effect and uncertainty for the selected population - Materials to obtain first: Directly reported open-fracture absolute-effect table - Further research: If an absolute effect is reported, present the selected population’s value and interval - Conditions for verification: Directly reported absolute effect and uncertainty for the selected population; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N18 · Are open-fracture OR adjustment terms and target effect verified? Verification status: Unverified Reading scope: Summary read; related external material unread - Current findings: The closed-fracture summary explicitly says adjusted OR; the existing open-fracture counterview records OR 0.86. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Do not automatically apply closed-fracture adjustment specifications to open fractures or create adjusted effects absent from the original. - Required materials and conditions: Open-fracture adjustment model, covariates, cluster handling and effect of interest - Materials to obtain first: Open-fracture model, estimand and covariate specifications - Further research: Present population-specific estimates’ meaning from the original report - Conditions for verification: Open-fracture adjustment model, covariates, cluster handling and effect of interest; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N19 · Were the open-fracture population and registration timing distinguished prospectively? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The summary records closed/open fractures as separate prespecified populations and registration in 2018 before recruitment. The registration number is NCT03523962. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Original registration, revision history and detailed open-fracture plans were not read here. - Required materials and conditions: Original population distinction, registration contents and dates - Materials to obtain first: Original NCT03523962 registration and revision history - Further research: Present connections between population-specific plans and reported results - Conditions for verification: Original population distinction, registration contents and dates; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N20 · Are analysis plans, multiplicity and infection-subtype hierarchy verified? Verification status: Unverified Reading scope: Summary read; related external material unread - Current findings: The preserved summary describes the primary infection endpoint and advance population distinction. It gives no detailed within-open-fracture analysis hierarchy or multiplicity handling. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Do not establish planning-document existence, contents, agreement or all additional open-fracture analyses. - Required materials and conditions: Protocol, SAP, subtype and population-specific testing plans - Materials to obtain first: Protocol, SAP and endpoint-hierarchy documents - Further research: Connect the selected population’s prespecified analysis hierarchy with result tables - Conditions for verification: Protocol, SAP, subtype and population-specific testing plans; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N21 · Do different closed/open-fracture results prove interaction? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: Closed-fracture results are borderline at P=0.049 and OR CI upper limit 0.999; open-fracture P=0.45. The preserved review summary distinguishes the populations. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Significance in one population and a null result in another do not newly establish interaction or superiority between populations. - Required materials and conditions: Population-specific effects and formal interaction or direct-comparison analyses - Materials to obtain first: Original prespecified population effects and interaction analyses - Further research: Distinguish different-population results from direct tests of differences - Conditions for verification: Population-specific effects and formal interaction or direct-comparison analyses; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N22 · Were the report, registration and related sheets counted as independent repeat trials? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The original bibliography is one PREP-IT 2024 paper linked to NCT03523962. Related closed-fracture and selected open-fracture sheets share the parent summary. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Do not sum the paper, registration, two populations or related sheets as new independent trials or participant totals. Confirmed independent-trial count remains unrecorded. - Required materials and conditions: Population, bibliography and registration connections in the same PREPARE report - Materials to obtain first: Connections among the same report, registration and populations - Further research: Preserve report slots separately from trial and participant units - Conditions for verification: Population, bibliography and registration connections in the same PREPARE report; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N23 · What evidence supports contrary results in other surgeries? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The existing counterview mentions results favoring chlorhexidine in clean/contaminated surgeries and cesarean sections. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Exact bibliographies, trial counts, denominators and effects for those reports are absent from the summary. Do not invent papers or elevate them to open-fracture replication evidence. - Required materials and conditions: Actual bibliography and populations for clean/contaminated-surgery and cesarean reports - Materials to obtain first: Identifying materials for other-surgery reports mentioned as context - Further research: Present other-surgery results only as context for their own populations - Conditions for verification: Actual bibliography and populations for clean/contaminated-surgery and cesarean reports; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N24 · Are long-term results and infection-type follow-up verified for the selected population? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The preserved summary defines infection adjudication at 30/90 days and separately describes one-year reoperation in safety information. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Do not fill open-fracture-specific long-term infection, recovery, reoperation effects or other clinical outcomes with short-term infection rates. - Required materials and conditions: Open-fracture infection results by time and long-term clinical outcomes - Materials to obtain first: Open-fracture infection results by time and long-term outcome tables - Further research: Present infection-adjudication times separately from long-term clinical follow-up - Conditions for verification: Open-fracture infection results by time and long-term clinical outcomes; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N25 · Is the material currently read the full original open-fracture paper? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The preserved summary was actually read. The citation list contains the paper bibliography, but the evidence list’s title, population size and results are PREPARE Closed. Selected open-fracture results appear in the existing counterview. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: External abstract, full text, registration, protocol and SAP remain unread. URL existence does not establish reading or content certification. - Required materials and conditions: Access distinctions among summary copy, external abstract/full text, registration and plans - Materials to obtain first: Original report, abstract/full text, registration and plans for the selected population - Further research: Mark summary reading separately from unread external materials - Conditions for verification: Access distinctions among summary copy, external abstract/full text, registration and plans; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N26 · Are public funding and manufacturer-involvement items distinguished? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: PCORI and CIHR supported the trial, operated by McMaster University and the University of Maryland Baltimore. The summary states that manufacturer product donations, commercial analysis, medical writing and publication funding were not reported. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Scope of unreported disclosures differs from certification of no involvement. Separate open-fracture support, contracts and full COI remain externally unread. - Required materials and conditions: Original research-funding, product-support, outsourced-analysis, medical-writing and publication-cost disclosures - Materials to obtain first: Funding, product, analysis, writing and publication disclosures and role specifications - Further research: Distinguish reported support from unknown involvement - Conditions for verification: Original research-funding, product-support, outsourced-analysis, medical-writing and publication-cost disclosures; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N27 · Are author affiliations, company roles and data control verified? Verification status: Unverified Reading scope: Summary read; related external material unread - Current findings: The preserved summary describes public funding, operating institutions and nonreporting of some manufacturer support. It has no complete author-specific company-relationship or data-control items. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Do not newly certify no company employee authors or no commercial relationships of any kind. - Required materials and conditions: Employee-author, advisory, data-access, design, analysis and publication-role disclosures - Materials to obtain first: Author disclosures, contributions and data/publication-rights records - Further research: Present public funding separately from author-specific independence - Conditions for verification: Employee-author, advisory, data-access, design, analysis and publication-role disclosures; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N28 · Can one-year reoperation be used as open-fracture harms or efficacy evidence? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The safety summary describes similar unplanned one-year reoperation: 5.5% versus 5.9%, OR 0.96, 95% CI 0.77–1.20. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: The preserved summary does not establish whether this sentence is open-fracture-specific, parent closed-fracture context or whole-trial scope. Do not combine it as the same endpoint as infection OR. - Required materials and conditions: Actual population, group-specific denominators and definition for that outcome - Materials to obtain first: Reoperation population, event-definition and group-denominator tables - Further research: Present reoperation, infection and populations separately - Conditions for verification: Actual population, group-specific denominators and definition for that outcome; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Supplementary condition showing limits of harms/safety information separately from efficacy - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N29 · What is the scope of unreported chemical burns and intraoperative fires? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The original safety sentence states that no alcohol-preparation-related chemical burns or intraoperative fires were reported in the overall trial. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Do not convert whole-trial nonreporting into zero open-fracture adverse events, no risk or complete collection. - Required materials and conditions: Harms collection, event definitions, exposure and population denominators - Materials to obtain first: Harms-collection methods and whole-trial/open-fracture event tables - Further research: Present harms-reporting scope together with actual observation denominators - Conditions for verification: Harms collection, event definitions, exposure and population denominators; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Supplementary condition showing limits of harms/safety information separately from efficacy - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N30 · Are long-term/rare harms and other wound-related events verified? Verification status: Unverified Reading scope: Summary read; related external material unread - Current findings: The preserved safety summary contains some reoperation and chemical-burn/fire information, but no complete open-fracture rare-harms or long-term-outcome table. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Selected-population long-term safety is not established; the historical parent Good safety label is preserved as historical context. - Required materials and conditions: Long-term exposure, follow-up and rare-event materials for the selected population - Materials to obtain first: Selected-population long-term follow-up and event/exposure denominators - Further research: Present long-term harms gaps separately from efficacy - Conditions for verification: Long-term exposure, follow-up and rare-event materials for the selected population; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Supplementary condition showing limits of harms/safety information separately from efficacy - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N31 · Are Korean/English prose, axes, reference date and correction history preserved in original form? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: Parent Korean/English prose, axes, the 2026-08-26 reference date, empty corrections array and deliberation string, and selected subclaim are preserved in the complete existing summary. The reference date is not the current review date. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Retain absent subclaim score, status and axes; do not recalculate parent axes or grade as a new selected verdict. - Required materials and conditions: Copies of parent Korean/English prose, axes, reference date, corrections and original subclaim - Materials to obtain first: Preserved original review summary and change-event materials - Further research: Separate existing verdict, dates and corrections from this preparation event - Conditions for verification: Copies of parent Korean/English prose, axes, reference date, corrections and original subclaim; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N32 · Are historical candidate metadata and current preparation status separated? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: Only the existing subclaim unit is prepared, with parent and selected-row connections distinguished. Candidate review-pending, production-eligibility and independence markers remain historical original-selection metadata. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Content review belongs to the user; completed model/content/boundary review is not marked. Retain zero new structural units and unrecorded confirmed independent-trial/participant totals. - Required materials and conditions: Distinction between existing selection and preparation, review and independence status - Materials to obtain first: Existing selection original and condition/application preparation events - Further research: Connect original-record changes separately from preparation and existing content-review events - Conditions for verification: Distinction between existing selection and preparation, review and independence status; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ## Evidence and sources ### R01 PREP-IT Investigators. Skin Antisepsis before Surgical Fixation of Extremity Fractures. N Engl J Med. 2024;390:409-420. PMID: 38294973. [PubMed](https://pubmed.ncbi.nlm.nih.gov/38294973/) Materials actually read: Stored summary read; external abstracts, full texts, registrations and plans unread Findings recorded in the summary: The separate prespecified open-fracture population of 1,700 patients had a null result: 6.5% versus 7.3%, OR 0.86 (95% CI 0.58–1.27), P=0.45. Closed-fracture results cannot be extended to open fractures, other surgeries or aqueous iodine; clean/contaminated-surgery and cesarean trials also included results favoring chlorhexidine. Record level: OR, CI and P in the existing open-fracture counterview; the first evidence record’s closed-fracture population size and effect are not reused Independent replication: Preserve connections among selected open fractures, parent closed fractures, the same paper and registration; different populations are not certified as independent replication | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Stored summary | Summary read | Stored summary read | Summary read | Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented | | External abstract | Not read | External material unread | Not read | Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented | | External full text | Not read | External material unread | Not read | Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented | | Original registration | Not read | External material unread | Not read | Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented | | Protocol/SAP | Not read | External material unread | Not read | Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed. - M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed. - M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed. - M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed. - M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed. ## What the statuses mean - Partly verified: Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy. - Unverified: Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety - Review incomplete: Review of existing content incomplete - Met: Use only within the relevant conditions after existing content review; no automatic designation in this preparation - Not reported: Distinguish only within materials actually read; do not turn unread external materials into unreported findings - Inaccessible: Not applied during this preparation because actual access was not tested - Not applicable: Use with a reason for non-applicability based on an explicit question boundary - Conflicting data: Judge after actual material comparison; review was not performed during this preparation - Insufficient evidence for the conditions: Do not use as a clinical grade encompassing currently unread materials ## Change history 2026-10-13 · Public page/materials 1.0. Public pages and materials were prepared from the existing 32 items. No new clinical search, verification-status change or scoring was performed.