{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2968-s0", "verdict_number": "2968", "title": "Iodine-alcohol preparation · Closed-fracture surgical-site infection — Evidence Check", "view_version": "1.0", "view_created_date": "2026-10-13", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "PREPARE participants undergoing fixation of closed lower-extremity or pelvic fractures. Distinguish the 25-hospital US/Canadian cluster-randomized crossover design from 6,785 closed-fracture patients (3,360/3,425). The separate 1,700 open-fracture patients are other-population context in the same report and are not a new summed denominator. Detailed eligibility, baseline risk, period-specific populations and withdrawals/missingness are unverified.", "intervention": "Specific research preoperative skin-antiseptic preparation containing 0.7% free iodine povacrylex and 74% isopropyl alcohol. Do not transfer the result to all iodine, aqueous formulations, other surgeries or isolated-ingredient effects. No application, dilution, drying, surgery or treatment instructions are created.", "dose": "Concentrations and formulations of the two specific preparations are preserved as original research exposure. Distinguish hospital assignment periods alternating preparations every two months from individual application. Product batches, actual applied amount, adherence/changes and exposure are unverified.", "comparator": "Specific preparation containing 2% chlorhexidine gluconate and 70% isopropyl alcohol. Preserve historical statements of computerized initial hospital assignment, unmasked surgical teams, masked central infection adjudication and analysis by assigned hospital-period preparation. Cluster/period models, concurrent care and actual implementation details are unverified.", "endpoint": "Primary closed-fracture SSI: superficial incisional infection within 30 days, or deep incisional or organ-space infection within 90 days. Preserve the original numbers separately: 77/3,360 (2.4%) versus 108/3,425 (3.3%); adjusted OR 0.74 (95% CI 0.55–0.999), P=.049; adjusted risk difference -0.8 percentage points (-1.6–0.0). No new RR, proportions, risk difference/NNT, effect or CI is created. Separate open-fracture, one-year reoperation and whole-trial harms reports are not the same estimand as selected infection.", "duration": "Distinguish infection components’ 30/90-day windows from unplanned one-year reoperation. Preserve the original 95% primary follow-up statement without calculating group/endpoint-specific missingness or reusing closed-fracture denominators for reoperation.", "excluded_extensions": [ "Summing closed/open fractures, hospitals/periods, groups, endpoints or related sheets as new independent trials or participants", "Changing a cluster-crossover design into an individually randomized independent trial", "Mixing populations, denominators or estimands across 30/90-day infection components, one-year reoperation and whole-trial harms", "Converting OR to RR or new risk difference/NNT, or recalculating reported proportions, rounding or CI endpoints", "Changing the original borderline-P/CI interpretation into new fragility numbers or efficacy grades", "Transferring the specific two-alcohol-preparation comparison to all iodine/aqueous preparations, other surgeries or open fractures", "Converting unreported product, analysis, writing or publication-cost support into certification of no support or no COI", "Inheriting parent score/axes or historical narratives as subclaim score, current review or original-text reading", "New calculations, invented values, effects/CI, grades, independence certification or medication/antisepsis/surgery/treatment implementation guidance" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Selected closed-fracture infection question and original values", "needed": "Selected subclaim B grade/note, parent verdict context and presence of subclaim score, status and axes", "role": "Required", "role_reason": "Applicability item distinguishing selected subclaim B grade/note, parent verdict context and presence of subclaim score, status and axes and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for selected subclaim B grade/note, parent verdict context and presence of subclaim score, status and axes should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed update research connecting the original question scope with subsequent materials; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The selected existing question is reduced surgical-site infection after closed-fracture fixation; the subclaim B grade is preserved. Parent B with 76 points and axes belong to the original parent prose.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. The selected subclaim has no score, status or axes; parent values are not used to fill them. Existing content review remains incomplete.", "missingness": "The selected subclaim has no score, status or axes; parent values are not used to fill them.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Materials distinguishing the selected subclaim from the parent verdict" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Closed lower-extremity and pelvic fracture population", "needed": "Population, recruitment conditions and population-specific results for closed-fracture fixation", "role": "Required", "role_reason": "Applicability item distinguishing population, recruitment conditions and population-specific results for closed-fracture fixation and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for population, recruitment conditions and population-specific results for closed-fracture fixation should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M03 §3.2.1; Detailed population criteria are designed by CHAMGAP; M03 §3.2.1–3.2.4; Dose, duration and effect-modification details are designed by CHAMGAP; M03 §3.2.2–3.2.3; Reverse labels and test adaptations are designed by CHAMGAP", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research examining reproducibility and heterogeneity within the same population scope; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The selected PREPARE result concerns fixation of closed lower-extremity or pelvic fractures within the original-material scope.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Detailed eligibility, fracture characteristics, baseline risk and individual hospital/period distribution are unverified. Existing content review remains incomplete.", "missingness": "Detailed eligibility, fracture characteristics, baseline risk and individual hospital/period distribution are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Recruitment, eligibility, baseline characteristics and closed-fracture analysis-population materials" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Iodine-alcohol research preparation", "needed": "Identity, concentration and formulation of the iodine preparation used in the trial", "role": "Required", "role_reason": "Applicability item distinguishing identity, concentration and formulation of the iodine preparation used in the trial and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for identity, concentration and formulation of the iodine preparation used in the trial should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labels and checking adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research on applicability across formulation differences; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original research preparation contains 0.7% free iodine povacrylex and 74% isopropyl alcohol. This does not stand for aqueous iodine or every iodine preparation.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original product batches, additional ingredients, applied amount, individual exposure and actual product correspondence are unverified. Existing content review remains incomplete.", "missingness": "Original product batches, additional ingredients, applied amount, individual exposure and actual product correspondence are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Research preparation identity, batch and exposure records" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Chlorhexidine-alcohol comparator", "needed": "Actual comparator preparation and concurrent-exposure scope", "role": "Required", "role_reason": "Applicability item distinguishing actual comparator preparation and concurrent-exposure scope and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for actual comparator preparation and concurrent-exposure scope should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M03 §3.2.2–3.2.3; reverse-direction markers and test adaptation are in-house design; M03 §3.2.3, M08 §8.2.2–8.2.3; in-house application; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is in-house design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research separating differences within the same preparation comparison; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The comparator contains 2% chlorhexidine gluconate and 70% isopropyl alcohol. Do not change this into an isolated iodine-versus-chlorhexidine ingredient comparison.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Products, batches, additional ingredients, individual exposure and equality of conditions beyond the two preparations are unverified. Existing content review remains incomplete.", "missingness": "Products, batches, additional ingredients, individual exposure and equality of conditions beyond the two preparations are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Comparator preparation and actual exposure by group" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Research exposure and preoperative antisepsis scope", "needed": "Records of research preoperative skin-antisepsis exposure, changes and adherence", "role": "Required", "role_reason": "Applicability item distinguishing records of research preoperative skin-antisepsis exposure, changes and adherence and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for records of research preoperative skin-antisepsis exposure, changes and adherence should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M03 §3.2.2–3.2.3; reverse-direction markers and test adaptation are in-house design; M03 §3.2.3, M08 §8.2.2–8.2.3; in-house application; M04 §4.5–4.6 material collection/selection principles; access/reading separation and the hyperlink scope are in-house design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research examining exposure fidelity and attribution of results; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The scope is a research comparison of specific alcohol-based antiseptic preparations. This sheet does not create application, dilution, drying or surgical instructions.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Individual application, adherence, preparation changes, discontinuations and surrounding surgical-care details are unverified. Existing content review remains incomplete.", "missingness": "Individual application, adherence, preparation changes, discontinuations and surrounding surgical-care details are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original planned exposure definitions, actual application and deviation records" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "25-hospital clusters and two-month alternation", "needed": "Hospital and period units of the cluster-randomized crossover design", "role": "Required", "role_reason": "Applicability item distinguishing hospital and period units of the cluster-randomized crossover design and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for hospital and period units of the cluster-randomized crossover design should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M08 §8.1–8.2.3; in-house application; M08 §8.2.2, M15 §15.3.1; in-house application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome connections are in-house application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is in-house design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research examining cluster/period heterogeneity and period effects; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "This was a cluster-randomized crossover trial in 25 US and Canadian hospitals, alternating each hospital’s preparation every two months. Hospitals, periods and patients are not treated as the same randomization unit.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Periods per hospital, participants per period, correlation structure and actual alternation implementation are unverified. Existing content review remains incomplete.", "missingness": "Periods per hospital, participants per period, correlation structure and actual alternation implementation are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Cluster/period allocation tables and cluster analysis plans/materials" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Computer assignment of initial preparation", "needed": "Generation, concealment and responsible roles for initial hospital assignment", "role": "Required", "role_reason": "Applicability item distinguishing generation, concealment and responsible roles for initial hospital assignment and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for generation, concealment and responsible roles for initial hospital assignment should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M08 §8.1–8.2.3; in-house application; M04 §4.5–4.6 material collection/selection principles; access/reading separation and the hyperlink scope are in-house design; M08 Table 8.2.a, M04 §4.6.3; in-house application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research examining cluster-allocation procedures and implementation; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The historical original narrative that the Methods Centre assigned initial hospital preparations by computer is preserved.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original allocation algorithms, timing, access rights, concealment procedures and change history remain unread. Existing content review remains incomplete.", "missingness": "Original allocation algorithms, timing, access rights, concealment procedures and change history remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Initial allocation procedures and access/change-history materials" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Crossover, period and carryover effects", "needed": "Analysis scope for hospital crossover, periods, sequence and carryover", "role": "Required", "role_reason": "Applicability item distinguishing analysis scope for hospital crossover, periods, sequence and carryover and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for analysis scope for hospital crossover, periods, sequence and carryover should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M08 §8.2.2, M15 §15.3.1; in-house application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is in-house design; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome connections are in-house application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up analysis research separating period and sequence effects; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The same hospitals alternate preparations by period. Crossover periods are not counted as separate independent trials.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Handling of period, sequence, cluster correlation and carryover and actual period-specific analyses are unverified. Existing content review remains incomplete.", "missingness": "Handling of period, sequence, cluster correlation and carryover and actual period-specific analyses are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Cluster-crossover analysis plans and period-specific results" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Surgical-team and central-adjudication masking", "needed": "Masking by role in surgery and infection-outcome adjudication", "role": "Required", "role_reason": "Applicability item distinguishing masking by role in surgery and infection-outcome adjudication and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for masking by role in surgery and infection-outcome adjudication should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M03 §3.2.4; CHAMGAP adaptation; Material collection/selection principles in M04 §4.5–4.6; Separating access from reading and defining hyperlink behavior are designed by CHAMGAP", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research examining measurement and adjudication bias by role; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original narrative states that surgical-team masking was infeasible and the primary SSI outcome was adjudicated by a masked central committee.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Actual adjudication materials, maintenance/release of masking, dispute handling and adjudicator-specific procedures are unverified. Existing content review remains incomplete.", "missingness": "Actual adjudication materials, maintenance/release of masking, dispute handling and adjudicator-specific procedures are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Outcome-adjudication criteria, material flow and masking records" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "30-day and 90-day infection windows", "needed": "Infection-component definitions and actual observation times", "role": "Required", "role_reason": "Applicability item distinguishing infection-component definitions and actual observation times and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for infection-component definitions and actual observation times should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation to each question is internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research examining results over time under the same infection definitions; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The primary endpoint is SSI: superficial incisional infection within 30 days, or deep incisional or organ-space infection within 90 days. Do not relabel every component as a 90-day outcome.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Component-specific events, adjudication times, observation windows and distinctions from delayed/recurrent infection are unverified. Existing content review remains incomplete.", "missingness": "Component-specific events, adjudication times, observation windows and distinctions from delayed/recurrent infection are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Component-specific infection definitions and observation/adjudication materials" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Infection measurement and event units", "needed": "Infection ascertainment/adjudication criteria and person/event relationships", "role": "Required", "role_reason": "Applicability item distinguishing infection ascertainment/adjudication criteria and person/event relationships and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for infection ascertainment/adjudication criteria and person/event relationships should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is in-house design; M08 Table 8.2.a, M03 §3.2.4; in-house application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome connections are in-house application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is in-house design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research distinguishing people from events; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The selected SSI outcome is connected to the preserved central-adjudication narrative. Infection components or repeated adjudications in one person are not counted as independent participants.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Confirmatory tests, detailed criteria, multiple infections, recurrence, unit-specific aggregation and original data are unverified. Existing content review remains incomplete.", "missingness": "Confirmatory tests, detailed criteria, multiple infections, recurrence, unit-specific aggregation and original data are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Infection-component adjudication and overlap/repetition handling materials" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "6,785 patients and group-specific infection denominators", "needed": "Group-specific analysis denominators, events and reported proportions for closed fractures", "role": "Required", "role_reason": "Applicability item distinguishing group-specific analysis denominators, events and reported proportions for closed fractures and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for group-specific analysis denominators, events and reported proportions for closed fractures should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design; M08 §8.2.2, M15 §15.3.1; custom application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research reproducing results within the same denominator scope; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original values are retained: 6,785 closed-fracture patients, 3,360/3,425 by group; infection 77/3,360 (2.4%) versus 108/3,425 (3.3%), exactly as reported.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Individual event data, time/component-specific denominators and inclusion/exclusion details are unverified. Proportions, event totals and new effects are not calculated. Existing content review remains incomplete.", "missingness": "Individual event data, time/component-specific denominators and inclusion/exclusion details are unverified. Proportions, event totals and new effects are not calculated.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Closed-fracture group-specific analysis flow and infection materials" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Adjusted OR, CI and P", "needed": "Adjusted between-group estimate, confidence interval and model", "role": "Required", "role_reason": "Applicability item distinguishing adjusted between-group estimate, confidence interval and model and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for adjusted between-group estimate, confidence interval and model should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M08 §8.2.2, M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap's own design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research applying the same estimand and analysis scope; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "For closed-fracture infection, adjusted OR 0.74, 95% CI 0.55–0.999 and P=.049 are preserved. These are not converted into RR or a new risk difference.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Details of the model, cluster/period handling, covariates and original analysis/code remain unread. Existing content review remains incomplete.", "missingness": "Details of the model, cluster/period handling, covariates and original analysis/code remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original analysis plan, model and adjusted estimates" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Adjusted risk difference and units", "needed": "Separate reporting of adjusted risk difference, units and confidence interval", "role": "Required", "role_reason": "Applicability item distinguishing separate reporting of adjusted risk difference, units and confidence interval and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for separate reporting of adjusted risk difference, units and confidence interval should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M15 §15.3.1–15.3.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research examining precision and interpretation by estimand; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original adjusted risk difference -0.8 percentage points, 95% CI -1.6–0.0, is retained separately. Do not mix it with the OR interval or revise endpoint rounding.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original calculation model, precision, output, covariates and cluster/period handling are unverified. Existing content review remains incomplete.", "missingness": "Original calculation model, precision, output, covariates and cluster/period handling are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Risk-difference estimation methods and original outputs" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Borderline precision and clinical meaning", "needed": "Distinction among prespecified important differences, precision and uncertainty", "role": "Required", "role_reason": "Applicability item distinguishing distinction among prespecified important differences, precision and uncertainty and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for distinction among prespecified important differences, precision and uncertainty should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M15 §15.3.1–15.3.3; in-house application; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is in-house design; M03 §3.2.4; in-house extension boundaries", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research distinguishing important differences from uncertainty; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original prose highlights the borderline P=.049 and upper CI limit 0.999. The reported risk-difference CI endpoint 0.0 is also retained.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Prespecified minimum important differences, fragility analyses and detailed original outputs are unverified. No new fragility number, NNT, effect or CI is created. Existing content review remains incomplete.", "missingness": "Prespecified minimum important differences, fragility analyses and detailed original outputs are unverified. No new fragility number, NNT, effect or CI is created.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Prespecified important differences, original analysis and sensitivity materials" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Analysis by hospital-period assignment", "needed": "Analysis population and handling according to hospital/period assignment", "role": "Required", "role_reason": "Applicability item distinguishing analysis population and handling according to hospital/period assignment and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for analysis population and handling according to hospital/period assignment should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M08 §8.2.2, M15 §15.3.1; in-house application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is in-house design; M03 §3.2.3, M08 §8.2.2–8.2.3; in-house application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research examining cluster assignment and actual exposure; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original narrative states that the primary analysis followed the preparation assigned to each eligible enrolled patient’s hospital-period. Do not convert this into an individually randomized trial analysis.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Analysis exclusions, crossover application, actual exposure, period-specific results and analysis code are unverified. Existing content review remains incomplete.", "missingness": "Analysis exclusions, crossover application, actual exposure, period-specific results and analysis code are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Eligible/enrolled/analyzed population flow and hospital-period handling materials" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "95% primary follow-up and missing data", "needed": "Follow-up completeness, group-specific missingness/withdrawals and handling", "role": "Required", "role_reason": "Applicability item distinguishing follow-up completeness, group-specific missingness/withdrawals and handling and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for follow-up completeness, group-specific missingness/withdrawals and handling should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research on result uncertainty under missing-data assumptions; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original 95% primary follow-up statement is preserved. No group-specific missing-infection counts or individually analyzed denominator for everyone randomized is newly calculated.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Missingness and withdrawal reasons by group/component, follow-up windows, missing-data models and sensitivity materials are unverified. Existing content review remains incomplete.", "missingness": "Missingness and withdrawal reasons by group/component, follow-up windows, missing-data models and sensitivity materials are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group-specific follow-up flow, missingness reasons and handling materials" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "NCT identifier and preregistration history", "needed": "Original registration, prespecified endpoints/analyses and change history", "role": "Required", "role_reason": "Applicability item distinguishing original registration, prespecified endpoints/analyses and change history and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for original registration, prespecified endpoints/analyses and change history should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; custom application; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research linking prespecified plans with reported results; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original registration identifier is NCT03523962. Registration before recruitment and the existing Korean narrative’s 2018 registration statement are preserved; the stored English summary is retained as well.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Registration full text/history, protocol/SAP and comparisons with recruitment/analysis timing remain unread here. Existing content review remains incomplete.", "missingness": "Registration full text/history, protocol/SAP and comparisons with recruitment/analysis timing remain unread here.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original registration history, protocol and SAP" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Prespecified closed/open population distinction", "needed": "Prespecification of closed/open analyses and multiple-comparison scope", "role": "Required", "role_reason": "Applicability item distinguishing prespecification of closed/open analyses and multiple-comparison scope and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for prespecification of closed/open analyses and multiple-comparison scope should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; internal application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research on population-specific estimates and interactions; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original advance distinction between closed-fracture and separate open-fracture analyses is preserved. The selected closed-fracture B grade is not transferred to open-fracture results.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Detailed original advance plans, interactions, multiplicity handling and analysis hierarchy are unverified. Existing content review remains incomplete.", "missingness": "Detailed original advance plans, interactions, multiplicity handling and analysis hierarchy are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original planned population analyses and multiplicity materials" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Open-fracture results as separate context", "needed": "Relationship between open-fracture results in the same report and the selected question", "role": "Required", "role_reason": "Applicability item distinguishing relationship between open-fracture results in the same report and the selected question and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for relationship between open-fracture results in the same report and the selected question should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is in-house design; M03 §3.2.1; detailed population conditions are in-house design; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome connections are in-house application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are in-house design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research separating population-specific differences; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Separate open-fracture results for 1,700 patients are linked as preserved context: 6.5% versus 7.3%, OR 0.86 (95% CI 0.58–1.27), P=.45. Do not create them as the selected closed-fracture result or a new report.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Group-specific open-fracture denominators, events, detailed analyses and direct comparison with closed-fracture results are unverified. The two populations are not newly summed. Existing content review remains incomplete.", "missingness": "Group-specific open-fracture denominators, events, detailed analyses and direct comparison with closed-fracture results are unverified. The two populations are not newly summed.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Population-specific analysis and denominator materials from the same report" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Contrary materials from other surgeries/formulations", "needed": "Identity, populations and comparison relationships of other-surgery/formulation results", "role": "Required", "role_reason": "Applicability item distinguishing identity, populations and comparison relationships of other-surgery/formulation results and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for identity, populations and comparison relationships of other-surgery/formulation results should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is in-house design; M03 §3.2.2–3.2.3; reverse-direction markers and test adaptation are in-house design; M03 §3.2.1; detailed population conditions are in-house design; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are in-house design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research distinguishing results from different surgeries/formulations; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original context mentions results favoring chlorhexidine in other clean/contaminated surgeries and cesarean trials. Do not transfer them to the same direct comparison of the selected preparation in closed fractures.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Individual bibliographies, preparations, populations and estimates for those reports are not connected in the current preserved summary and remain unverified. Existing content review remains incomplete.", "missingness": "Individual bibliographies, preparations, populations and estimates for those reports are not connected in the current preserved summary and remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Each mentioned report and formulation/surgery-specific materials" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Concurrent surgical care and attribution", "needed": "Concurrent exposures and actual care differences between groups", "role": "Required", "role_reason": "Applicability item distinguishing concurrent exposures and actual care differences between groups and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for concurrent exposures and actual care differences between groups should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; custom application; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are custom design; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research examining concurrent exposures and attribution to preparations; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original scope is a comparison of specific skin-antiseptic preparations.", "condition_status": "Unverified", "status_reason": "Information currently required is unverified in the preserved summary. Antibiotics, surgery/wound care, fixation characteristics, other institutional exposures and adherence/change materials are unverified. No new care or treatment instructions are provided. Existing content review remains incomplete.", "missingness": "Antibiotics, surgery/wound care, fixation characteristics, other institutional exposures and adherence/change materials are unverified. No new care or treatment instructions are provided.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group-specific concurrent-exposure/care and adherence records" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Overlap among reports, hospitals and people", "needed": "Relationships among the same report, clusters, periods, populations and subsequent endpoints", "role": "Required", "role_reason": "Applicability item distinguishing relationships among the same report, clusters, periods, populations and subsequent endpoints and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for relationships among the same report, clusters, periods, populations and subsequent endpoints should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome connections are in-house application; M04 §4.6.1–4.6.2, M15 §15.3.1; in-house application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is in-house design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research connecting bibliography with actual trial/population relationships; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Closed/open populations, hospital crossover, infection components and one-year reoperation in one PREPARE bibliography are distinguished. Hospitals, periods, groups, endpoints and related sheets are not summed as independent trials or participants.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. External comparisons of patient overlap, period-specific flow, individual subsequent-report correspondence and independence are unverified. Existing content review remains incomplete.", "missingness": "External comparisons of patient overlap, period-specific flow, individual subsequent-report correspondence and independence are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report-cluster-period-population-endpoint relationship materials" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "PCORI and CIHR funding", "needed": "Original funders and separate support roles", "role": "Required", "role_reason": "Applicability item distinguishing original funders and separate support roles and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for original funders and separate support roles should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research distinguishing support roles and report relationships; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original funding statements concerning PCORI and the Canadian Institutes of Health Research are preserved.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Contracts, roles, analysis/prose/publication involvement and original funding/COI materials remain unread. Existing content review remains incomplete.", "missingness": "Contracts, roles, analysis/prose/publication involvement and original funding/COI materials remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Funding contracts, funder roles and original disclosures" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "University operational roles", "needed": "Operating institutions and funding/product-provision roles", "role": "Required", "role_reason": "Applicability item distinguishing operating institutions and funding/product-provision roles and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for operating institutions and funding/product-provision roles should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research examining operational roles and result-reporting relationships; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Operational roles of McMaster University and the University of Maryland Baltimore are preserved within the original narrative scope.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Institution/author-specific roles and detailed analysis/writing/publication involvement are unverified. Institution names alone do not certify independence. Existing content review remains incomplete.", "missingness": "Institution/author-specific roles and detailed analysis/writing/publication involvement are unverified. Institution names alone do not certify independence.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Operational, author-contribution and disclosure materials" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Manufacturer and product/writing-support gaps", "needed": "Separate disclosures of product donation, analysis, writing, publication costs, employee authors and COI", "role": "Required", "role_reason": "Applicability item distinguishing separate disclosures of product donation, analysis, writing, publication costs, employee authors and COI and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for separate disclosures of product donation, analysis, writing, publication costs, employee authors and COI should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research distinguishing reporting gaps for each support/relationship; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original statement that manufacturer product donation, analysis, medical writing and publication-cost support were not reported is preserved.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Nonreporting is not converted into no support, no employee authors, no COI or verified independence. Detailed disclosures remain unread. Existing content review remains incomplete.", "missingness": "Nonreporting is not converted into no support, no employee authors, no COI or verified independence. Detailed disclosures remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Individual original disclosures of products, analysis, writing, publication costs, employee involvement and COI" }, { "item_id": "N27", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "One-year reoperation as an additional endpoint", "needed": "Separation of reoperation timing, definition, population and denominator from primary infection", "role": "Supplementary", "role_reason": "Applicability item distinguishing separation of reoperation timing, definition, population and denominator from primary infection and connecting materials needed for the selected question with current materials.", "application_exception": "Supplement the selected subclaim’s safety-material gaps. Functional-status/infection efficacy results or parent safety wording do not establish safety or create harms rates or new usage instructions.", "criterion": "Corresponding original materials and analysis scope for separation of reoperation timing, definition, population and denominator from primary infection should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is in-house design; M08 Table 8.2.a, M04 §4.6.3; in-house application; M19 §19.1.2–19.2.4; in-house application; M19 §19.1.2–19.2.4; in-house application; M19 §19.1.2–19.2.4; in-house application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research distinguishing infection from subsequent reoperation; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Unplanned one-year reoperation is preserved within the reported scope: 5.5% versus 5.9%, OR 0.96 (95% CI 0.77–1.20). Do not convert it into the same 30/90-day infection outcome or primary efficacy.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Reoperation population, group denominators, events, definition and analysis hierarchy are unspecified; closed-fracture denominators are not reused. Existing content review remains incomplete.", "missingness": "Reoperation population, group denominators, events, definition and analysis hierarchy are unspecified; closed-fracture denominators are not reused.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Reoperation population, denominator, definition and analysis materials" }, { "item_id": "N28", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Whole-trial burn/fire narrative", "needed": "Harms collection/reporting scope, populations, periods and denominators", "role": "Supplementary", "role_reason": "Applicability item distinguishing harms collection/reporting scope, populations, periods and denominators and connecting materials needed for the selected question with current materials.", "application_exception": "Supplement the selected subclaim’s safety-material gaps. Functional-status/infection efficacy results or parent safety wording do not establish safety or create harms rates or new usage instructions.", "criterion": "Corresponding original materials and analysis scope for harms collection/reporting scope, populations, periods and denominators should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M19 §19.1.2–19.2.4; detailed distinctions are custom design; M19 §19.1.2–19.2.4; custom application; M19 §19.1.2–19.2.4, M04 §4.6.3; custom application; M19 §19.1.2–19.2.4; custom application; M19 §19.1.2–19.2.4; custom application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed research on harms-reporting scope and subsequent safety materials; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The preserved summary scope states that no alcohol-related chemical burns or operating-room fires were reported in the overall trial.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Nonreporting is not converted into zero events, complete collection, all safety or closed-fracture-only safety certification. Detailed collection/populations/denominators are unverified. Existing content review remains incomplete.", "missingness": "Nonreporting is not converted into zero events, complete collection, all safety or closed-fracture-only safety certification. Detailed collection/populations/denominators are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Harms collection criteria, populations, denominators and event/discontinuation materials" }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Generalization to other formulations/settings", "needed": "Applicability beyond the selected preparation, surgery and fracture conditions", "role": "Required", "role_reason": "Applicability item distinguishing applicability beyond the selected preparation, surgery and fracture conditions and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for applicability beyond the selected preparation, surgery and fracture conditions should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M03 §3.2.1–3.2.4; dose, duration and effect-modification details are in-house design; M03 §3.2.2–3.2.3; reverse-direction markers and test adaptation are in-house design; M03 §3.2.1; detailed population conditions are in-house design; M03 §3.2.4; in-house extension boundaries", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research distinguishing the same question from different conditions; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original result compares two specific alcohol-based preparations in closed-fracture fixation. Do not generalize to all iodine preparations, aqueous preparations, other surgeries or open fractures.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Other formulations, hospital/era settings, vulnerable populations and long-term outcomes are unverified. Existing content review remains incomplete.", "missingness": "Other formulations, hospital/era settings, vulnerable populations and long-term outcomes are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional materials by population, formulation and surgery" }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Existing axes, Korean/English prose and dates/corrections", "needed": "Distinction among original subclaim, parent verdict and historical records", "role": "Required", "role_reason": "Applicability item distinguishing distinction among original subclaim, parent verdict and historical records and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for distinction among original subclaim, parent verdict and historical records should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed updating research distinguishing original-material changes from preparation versions; no new search, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Parent B with 76 points, existing axes, Korean/English prose, 2026-08-26, the empty corrections array and deliberation string, and selected subclaim B grade/note are preserved in original form in the complete summary. Absent subclaim score/status/axes and parent classification fields are not filled.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Historical cross-checks and registration/review narratives are not current original-text reading, completed review or certification of fulfilled conditions. New evidence currency is unverified. Existing content review remains incomplete.", "missingness": "Historical cross-checks and registration/review narratives are not current original-text reading, completed review or certification of fulfilled conditions. New evidence currency is unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original verdict/corrections, changed prose and user comments" }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Actual summary reading and unread external materials", "needed": "Actual reading, identity, URLs and needed additional materials by source", "role": "Required", "role_reason": "Applicability item distinguishing actual reading, identity, URLs and needed additional materials by source and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for actual reading, identity, URLs and needed additional materials by source should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A research proposal for scope-specific updates based on actually acquired material; no new investigation, calculation or trial is performed in this conversion.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The preserved summary was read for preparation and PREPARE bibliography/URL linked. External papers, registration, protocol, SAP and funding/COI originals remain unread, with no access attempted.", "condition_status": "Partly verified", "status_reason": "Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Bibliographic links or original registration numbers do not elevate external acquisition, reading or review status. External click/link checks were not performed. Existing content review remains incomplete.", "missingness": "Bibliographic links or original registration numbers do not elevate external acquisition, reading or review status. External click/link checks were not performed.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original paper, registration history, protocol/SAP, individual disclosures and existing content-review comments" } ], "reports": [ { "report_id": "S01", "title": "PREP-IT Investigators. 2024 PREPARE Closed", "url": "https://pubmed.ncbi.nlm.nih.gov/38294973/", "report_type": "25-hospital cluster-randomized crossover trial", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2968-PREPARE", "independent_replication": null, "observed_result": "2.4% versus 3.3%; adjusted OR 0.74 (95% CI 0.55–0.999), P=0.049; risk difference -0.8 percentage points (-1.6–0.0). Grade B. In 6,785 closed-fracture patients, SSI was 77/3,360 (2.4%) versus 108/3,425 (3.3%): adjusted OR 0.74 (95% CI 0.55–0.999), P=0.049; adjusted risk difference -0.8 percentage points (95% CI -1.6–0.0). The original interpretation states that the P value and upper CI limit were extremely borderline, so a small difference could have made the result null.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only stored-summary and bibliographic content was used for production. External material verification/review is not complete." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/38294973/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" } ], "status_dictionary": { "Met": "Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.", "Partly verified": "Some information in the stored summary is linked into the table. External comparison/content review is not complete.", "Unverified": "The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.", "Review incomplete": "Existing content review remains incomplete.", "Not reported": "Not reported within the stored material actually read; not extended to the entire primary paper.", "Inaccessible": "Means an actual access failure. Access not attempted here is not assigned this state.", "Not applicable": "Not used as a substitute for an evidence gap.", "Conflicting data": "Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.", "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "S01 PREPARE is a cluster-randomized crossover report from 25 US/Canadian hospitals alternating preparations every two months. Preserve closed lower-extremity/pelvic fracture values separately: 6,785 patients (3,360/3,425), infection 77/3,360 (2.4%) versus 108/3,425 (3.3%), adjusted OR 0.74 (0.55–0.999), P=.049, and original adjusted risk difference -0.8 percentage points (-1.6–0.0). Distinguish superficial 30-day and deep/organ-space 90-day infection windows from separate 1,700 open-fracture patients, one-year reoperation and whole-trial harms narratives. Do not sum the same hospitals/periods, populations, people, groups, infection components, bibliography or related sheets as new independent trials or participants. Report/material-slot counts are not unique clinical-trial, participant or independent-replication totals; no new sums or independence certification are created." }, "history": [ { "date": "2026-10-13", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "A public view and materials were prepared from the existing31 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-13" }