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Twenty-four-hour antibiotic prophylaxis × Noninferior 90-day SSI — Evidence sheet distinguishing the prespecified margin and denominators

Select a review item to see its details.
Required evidence, verification status and materials actually read
ItemAVerification statusBReading scopeCReview itemDCurrent findingsEWhy unverifiedFRequired materials and conditionsGFurther research
1 Partly verified Full text not readStored summary read N01 · Comparative efficacyAre the original subclaim and grade distinguished from the parent judgment context?Required
The selected claim is noninferior 90-day surgical-site infection, with subclaim grade C and a note that the prespecified 10%p margin was met. The parent verdict is C, 56 points, Caution.
R01
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Absent subclaim score, status and axes are not filled with parent values. This production does not establish a new verdict or grade certification.
Separate records of the selected subclaim, grade and note, and the original parent verdict
Link additional materials separately to the relevant subclaim and parent context.
2 Partly verified Full text not readStored summary read N02 · Comparative efficacyWhat surgery, population and center were actually studied?Required
PAPRAC included patients undergoing open cystectomy and urinary diversion at a single Swiss center.
R01
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. The preserved summary lacks detailed tables of age, eligibility exclusions, baseline risk and surgical details. Results are not automatically extended to robotic surgery or other populations.
Eligibility, surgery type, urinary diversion, baseline characteristics and denominators
Obtain the original eligibility, baseline characteristics, surgery, center and denominator records.
3 Partly verified Full text not readStored summary read N03 · Comparative efficacyWhat were the historical intervention and comparator exposure until catheter and stent removal?Required
The original study conditions were stopping prophylactic antibiotics 24 hours after surgery in the short arm and continuing until catheter and stent removal in the extended arm.
R01
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. No individual antibiotic type, duration, use or stopping recommendation is made. Details of exact drug combinations, doses, concomitant drugs and additional treatment exposure remain unread.
Original intervention, comparator, stopping criteria, actual exposure and accompanying care
Obtain the original arm-specific tables of drugs, prophylactic and treatment exposure, actual duration and accompanying care.
4 Partly verified Full text not readStored summary read N04 · Comparative efficacyAre 196 randomized participants distinguished from 193 in the primary analysis and denominators 95/98?Required
After 196 participants were randomized, the prespecified per-protocol primary analysis included 193 (95/98), excluding 3 canceled surgeries.
R01
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. The summary lacks original arm-specific randomized counts, cancellations by arm and additional follow-up losses. No new totals, dropout rates or certification of an all-randomized ITT analysis are produced.
Arm-specific randomization, canceled surgery, analysis and follow-up flow
Obtain the original participant flow, exclusion reasons, arm-specific allocation and analysis counts, and missing-data tables.
5 Partly verified Full text not readStored summary read N05 · Comparative efficacyAre the open-label design and infection adjudicators' roles distinguished?Required
The original design was a single-center open-label noninferiority randomized trial. The record states that infectious-disease specialists and clinicians not involved in care adjudicated 90-day CDC-defined SSI.
R01
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Non-involvement in care is not newly certified as blinding to allocation. Details of allocation concealment, assessor blinding and analyst independence remain unread.
Allocation, concealment, measurement, adjudicator and analyst procedures
Obtain the original allocation, adjudication, blinding and analysis procedures.
6 Partly verified Full text not readStored summary read N06 · Comparative efficacyWhat is the actual access status of registration, protocol and analysis-plan materials?Required
The registration identifier in the original evidence list is NCT03305627. The preserved summary records a prespecified per-protocol primary analysis and a prespecified 10%p margin.
R01
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. No new URL was constructed from the registration identifier, and registration, full text and plans were not read. Details of the original primary/secondary exposure hierarchy and testing plan remain unread.
Original registration, protocol, SAP, outcome hierarchy and amendment history
Obtain the original registration, plans, analysis populations, hierarchy, amendments and multiplicity information.
7 Partly verified Full text not readStored summary read N07 · Comparative efficacyWhat direct outcome is 90-day CDC-defined SSI?Required
The selected question is noninferiority for CDC-defined surgical-site infection within 90 days. Infectious-disease specialists and clinicians not involved in care adjudicated the outcome.
R01
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. The summary lacks detailed definitions and results for superficial, deep and organ-space categories, and visit schedules. Other infection or wound measures are not substituted.
Infection definition, categories, ascertainment, time points and denominators
Obtain the original CDC definitions, classification, ascertainment, results by time point and denominators.
8 Partly verified Full text not readStored summary read N08 · Comparative efficacyAre arm-specific SSI events 8/95 and 12/98 and original percentages preserved?Required
The original materials record 90-day SSI as 8/95 (8.4%) in the short arm versus 12/98 (12.2%) in the extended arm.
R01
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. People, repeated events, original denominators and all infections are not mixed. No new percentages, RR, event totals, P values or CI are calculated.
Arm-specific events, people, denominators, original percentages and time window
Obtain the original event tables, arm-specific denominators, repeated-infection records and analysis definitions.
9 Partly verified Full text not readStored summary read N09 · Comparative efficacyAre the risk-difference direction and 90% CI preserved as originally recorded?Required
The original SSI risk difference is −3.8%p (90% CI −11.1~3.4).
R01
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. 90% is not changed to 95%. No new reverse-direction effect, risk ratio, test P value or adjusted model is produced. Details of the original risk-difference calculation remain unread.
Risk difference of interest, arm order, CI level and original model
Obtain the original comparison direction, risk-difference model, CI calculation and denominators.
10 Partly verified Full text not readStored summary read N10 · Comparative efficacyAre the prespecified 10%p noninferiority margin and scope of the original conclusion distinguished?Required
The original materials state that the prespecified 10%p noninferiority margin was met, with 90% CI −11.1~3.4.
R01
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. No new certification is made without reading the clinical margin rationale, original assumptions, α, test P value and plans. No new margin or examples of allowable events are produced.
Margin, direction, rationale, prespecification, CI and plans
Obtain the margin rationale, prespecification, testing and analysis plans, and original CI.
11 Partly verified Full text not readStored summary read N11 · Comparative efficacyHas noninferiority been kept separate from superiority for reducing infection and exact equivalence?Required
The original trial used a noninferiority design and records SSI risk difference −3.8%p and 90% CI −11.1~3.4.
R01
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. The direction of the original percentages alone does not establish superiority for reducing infection or equivalence with exactly no difference.
Original design, effect, interval, hypothesis and interpretation
Link the original hypothesis, interval, margin and effect interpretation to the relevant question.
12 Partly verified Full text not readStored summary read N12 · Comparative efficacyAre the per-protocol primary analysis and gaps in ITT and sensitivity analyses distinguished?Required
The prespecified per-protocol primary analysis included 193 participants after excluding 3 canceled surgeries.
R01
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. This analysis is not converted into an ITT analysis of all 196 randomized participants. Details of ITT, sensitivity analyses, arm-specific cancellations, losses and original analysis mapping are unavailable.
Original PP, ITT, cancellation, adherence, missingness and sensitivity-analysis definitions
Obtain the original PP/ITT definitions, exclusions, adherence, missing-data assumptions, sensitivity analyses and original CI.
13 Partly verified Full text not readStored summary read N13 · Comparative efficacyWhat are the follow-up, missingness and ascertainment limits within the original infection period?Required
The original primary endpoint period is 90 days, and the SSI analysis denominators are 95/98.
R01
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. These denominators alone do not certify complete follow-up of all randomized participants, capture of infections at outside healthcare facilities or absence of missing information.
90-day follow-up, visits, administrative/clinical ascertainment, missingness and denominators
Obtain the original follow-up, infection ascertainment, missingness, denominators and handling of events outside the study center.
14 Partly verified Full text not readStored summary read N14 · Comparative efficacyIs antibiotic duration the same outcome as SSI?Required
In the same trial, antibiotic duration was 1 day (IQR1~1) versus 8 days (IQR7~10), with the original reduction of 7 days and 87.5%.
R01
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Reduced duration is not combined with SSI reduction, direct resistance reduction or safety as the same effect. Details of exposure-analysis denominators and hierarchy remain unread.
Distinguishing exposure duration, endpoint, summary statistics and denominators
Share the exposure outcome with the related question while linking it separately from the direct infection outcome.
15 Partly verified Full text not readStored summary read N15 · Comparative efficacyAre clinical importance and original small-study limitations preserved without new assessment?Required
The parent record describes objective 90-day SSI and a prespecified margin as strengths, and noninferiority, small size and exclusion of canceled surgery as limitations, preserving C56.
R01
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Unrecorded precision, the original parent verdict and axes are not repurposed as a new or subclaim score. No new sample-size, power or MCID calculations are made.
Infection, margin, precision, sample size and original limitations
Obtain the original sample-size assumptions, clinical margin rationale and precision information.
16 Partly verified Full text not readStored summary read N16 · Comparative efficacyAre the two subclaims from the same trial kept separate from independent replications?Required
One PAPRAC report records both 90-day SSI and antibiotic duration, so the two subclaim tables share the same trial and population.
R01
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Report entries, two questions, outcomes and time points are not added as new independent trials or participants. Final independent-study and total-participant counts remain unrecorded.
Relationships among report, trial, shared participants, outcomes and related questions
Link additional reports while preserving original identifiers and population and time-point relationships.
17 Partly verified Full text not readStored summary read N17 · Comparative efficacyWhat is known about company and institutional funding, in-kind support, affiliations and analysis roles?Required
The original summary records no reported external grant or company in-kind support, and sponsorship and conduct by Insel Gruppe AG and University Hospital Bern.
R01
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. No reported support is not converted into certification of no support or company involvement. Separate details of employee authors, external analysis, design and writing roles remain unread.
Cash, products/in-kind support, author affiliations, external analysis and study roles
Obtain the original support, in-kind, affiliation, analysis, design and writing disclosures separately.
18 Partly verified Full text not readStored summary read N18 · Supplementary harm evidenceAre 90-day mortality counts, denominators and P distinguished from SSI?Required
The original safety record gives 90-day all-cause mortality as 6/95 (6.3%) versus 5/98 (5.1%), P=.96.
R01
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. These results are not converted into antibiotic-related mortality, survival noninferiority or absence of rare harms. CI, causes, relatedness and hierarchy for the original mortality outcome remain unread, with no new calculation.
Mortality definition, duration, arm-specific denominators, original events and testing
Obtain original mortality, relatedness, denominator, plan, CI and follow-up materials.
19 Partly verified Full text not readStored summary read N19 · Supplementary harm evidenceWhat do the infection-resolution statement and treatment and safety collection cover?Required
The original safety record states that all infections resolved with appropriate treatment.
R01
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. This statement is not extended to mean no infections, systematic collection of all harms or no risk. Details of other infections, treatments, people/events and recovery timing remain unread.
Infection types, treatment exposure, follow-up, recovery, relatedness and denominators
Obtain original infection, treatment-exposure, treatment-success definition, follow-up, relatedness and denominator records.
20 Unverified Full text not readStored summary read N20 · Supplementary harm evidenceDoes shorter antibiotic exposure directly demonstrate reduced harms?Required
The original materials record shorter prophylactic antibiotic exposure, 90-day SSI and mortality; parent safety is Caution.
R01
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Shorter exposure alone does not newly establish reductions in adverse drug reactions, kidney injury, allergy or other harms. The summary lacks the relevant original outcomes, denominators and collection details.
Drug harms, collection, exposure, arm-specific events and denominators
Obtain original harm-collection records, arm-specific events/people, exposure, discontinuation, relatedness and duration.
21 Unverified Full text not readStored summary read N21 · Supplementary harm evidenceAre resistance selection pressure, individual resistance, costs and other infections distinguished?Required
The original review summary records both a possible reduction in resistance selection pressure and costs through less exposure, and the limitation that individual resistance emergence and costs were not directly tested.
R01
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Mechanistic or stewardship advantages are not converted into established direct reductions in resistance or costs or prevention of other infections.
Direct outcomes, definitions and denominators for resistance, costs and infection types
Obtain prespecified direct measurements, denominators, effects and follow-up for resistance, costs and other infections.
22 Unverified Full text not readStored summary read N22 · Supplementary harm evidenceWhat application gaps remain for populations, surgery, drugs and resistance environments outside the single center?Required
The parent counterview records that results cannot be directly applied to robotic surgery, other antibiotic combinations or different resistance environments.
R01
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. No individual antibiotic choice, duration, postoperative-care or treatment-substitution guidance is generated. Efficacy and safety outside the original study conditions are not newly certified.
Direct comparisons in new populations, surgeries, drug combinations and settings
Obtain direct effects/harms, denominators and follow-up for each new population, surgery, drug and setting.
23 Partly verified Full text not readStored summary read N23 · Comparative efficacyDo gaps remain in durability beyond 90 days and independent replication?Required
The currently designated preserved summary contains one PAPRAC report and 90-day SSI.
R01
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Duration, outcomes and related tables are not counted as replication trials or extended to long-term resistance, readmission, mortality or all infections.
Long-term follow-up, new trials, populations, centers and independence relationships
Obtain long-term direct outcomes, independent-report relationships and center-specific materials.
24 Partly verified Full text not readStored summary read N24 · Comparative efficacyAre the preserved summary and external abstract, full text, registration and plans distinguished?Required
The complete parent-verdict summary was read for production, linking the existing PubMed URL for Thurnheer et al. 2024, PMID39422911 and identifier NCT03305627.
R01
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. External abstract, full text, registration, protocol and SAP remain unread; no separate link test was performed. No new URL or DOI is constructed from identifiers.
Bibliography, existing links, registration identifiers and material-specific access status
Link individual original materials supplied by the user separately from their actual access status.
25 Partly verified Full text not readStored summary read N25 · Comparative efficacyAre the reference date, Korean/English texts, corrections, empty values, candidate history and production state preserved?Supplementary
2026-08-26, empty correction and deliberation values, Korean/English texts, parent C56, Caution and axes, and the subclaim C grade and note are preserved in their original form.
R01
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Original statements, including the sample-size wording in the parent rationale, remain historical records without new correction or reassessment. Original review-pending and production-eligibility indicators are candidate history, not current review or completion.
Distinguishing the complete preserved summary, selected verdict record, parent values, original languages and history
Preserve original texts before linking additional user materials or decisions as separate events.
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25 itemsWhat the statuses mean

Assessment scope

Stored-material review date
Not recorded
Original evidence cut-off
2026-08-26
Scope actually checked
Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean
This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population
Patients undergoing open cystectomy and urinary diversion at a single Swiss center; original eligibility and baseline details remain unread
Ingredient, formulation and route
Historical study condition of stopping prophylactic antibiotics 24 hours after surgery; not instructions on duration or use
Dose
Drug-combination, dose and concomitant-use details remain unread; no individual antibiotic choice, use or stopping guidance is generated
Comparator
Prophylactic antibiotics continued until catheter and stent removal; original median 8 days
Measured outcome
Noninferior 90-day CDC-defined SSI; preserving the original 10%p margin, 90% CI and 193-participant PP analysis
Duration
Original SSI and mortality at 90 days; prophylaxis duration of 1 day (IQR1~1) versus 8 days (IQR7~10) is a historical exposure statistic
Questions outside this scope
Converting noninferiority into SSI superiority or exact equivalence; Converting median exposure into mean total exposure or the same reduction for each individual; Converting exposure or mechanism into direct reductions in resistance, costs or all harms; Certifying 193-participant PP as all-randomized 196-participant ITT or as the exposure denominator; Recommendations on antibiotic type, duration, use, stopping or treatment substitution

Evidence and sources

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

R01 · Thurnheer MC, et al. JAMA Netw Open. 2024;7:e2439382. PMID: 39422911.

PubMed

Material type
Noninferiority randomized-trial report
Materials actually read
Summary read; external materials not read
Findings recorded in the stored summary
8.4% versus 12.2%, risk difference −3.8%p (90% CI −11.1~3.4), margin 10%p; duration 1 versus 8 days
Record level
Preserved summary; not a result of newly comparing the external original report
Study overlap and independent replication
The same PAPRAC report and population for 90-day SSI and prophylactic-antibiotic exposure duration; shared by the two subclaims
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
local_summaryExisting link preservedSummary readSummary readStored parent-verdict summary
abstractExisting link preservedNot readNot readExternal material unread; a URL does not mean acquisition, reading or completed review
fulltextNo separate URL in the original materialNot readNot readExternal material unread; a URL does not mean acquisition, reading or completed review
registrationNo separate URL in the original materialNot readNot readExternal material unread; a URL does not mean acquisition, reading or completed review
protocol_sapNo separate URL in the original materialNot readNot readExternal material unread; a URL does not mean acquisition, reading or completed review

Report counts versus independent study counts

The same PAPRAC report and population for 90-day SSI and prophylactic-antibiotic exposure duration; shared by the two subclaims

Review criteria

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

N01 · Are the original subclaim and grade distinguished from the parent judgment context?
Required materials and conditions
Separate records of the selected subclaim, grade and note, and the original parent verdict
Conditions for verification
Separate records of the selected subclaim, grade and note, and the original parent verdict
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods
Noninferior 90-day surgical-site infection
N02 · What surgery, population and center were actually studied?
Required materials and conditions
Eligibility, surgery type, urinary diversion, baseline characteristics and denominators
Conditions for verification
Eligibility, surgery type, urinary diversion, baseline characteristics and denominators
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods
Noninferior 90-day surgical-site infection
N03 · What were the historical intervention and comparator exposure until catheter and stent removal?
Required materials and conditions
Original intervention, comparator, stopping criteria, actual exposure and accompanying care
Conditions for verification
Original intervention, comparator, stopping criteria, actual exposure and accompanying care
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods
Noninferior 90-day surgical-site infection
N04 · Are 196 randomized participants distinguished from 193 in the primary analysis and denominators 95/98?
Required materials and conditions
Arm-specific randomization, canceled surgery, analysis and follow-up flow
Conditions for verification
Arm-specific randomization, canceled surgery, analysis and follow-up flow
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods
Noninferior 90-day surgical-site infection
N05 · Are the open-label design and infection adjudicators' roles distinguished?
Required materials and conditions
Allocation, concealment, measurement, adjudicator and analyst procedures
Conditions for verification
Allocation, concealment, measurement, adjudicator and analyst procedures
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods
Noninferior 90-day surgical-site infection
N06 · What is the actual access status of registration, protocol and analysis-plan materials?
Required materials and conditions
Original registration, protocol, SAP, outcome hierarchy and amendment history
Conditions for verification
Original registration, protocol, SAP, outcome hierarchy and amendment history
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods
Noninferior 90-day surgical-site infection
N07 · What direct outcome is 90-day CDC-defined SSI?
Required materials and conditions
Infection definition, categories, ascertainment, time points and denominators
Conditions for verification
Infection definition, categories, ascertainment, time points and denominators
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods
Noninferior 90-day surgical-site infection
N08 · Are arm-specific SSI events 8/95 and 12/98 and original percentages preserved?
Required materials and conditions
Arm-specific events, people, denominators, original percentages and time window
Conditions for verification
Arm-specific events, people, denominators, original percentages and time window
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods
Noninferior 90-day surgical-site infection
N09 · Are the risk-difference direction and 90% CI preserved as originally recorded?
Required materials and conditions
Risk difference of interest, arm order, CI level and original model
Conditions for verification
Risk difference of interest, arm order, CI level and original model
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods
Noninferior 90-day surgical-site infection
N10 · Are the prespecified 10%p noninferiority margin and scope of the original conclusion distinguished?
Required materials and conditions
Margin, direction, rationale, prespecification, CI and plans
Conditions for verification
Margin, direction, rationale, prespecification, CI and plans
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods
Noninferior 90-day surgical-site infection
N11 · Has noninferiority been kept separate from superiority for reducing infection and exact equivalence?
Required materials and conditions
Original design, effect, interval, hypothesis and interpretation
Conditions for verification
Original design, effect, interval, hypothesis and interpretation
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods
Noninferior 90-day surgical-site infection
N12 · Are the per-protocol primary analysis and gaps in ITT and sensitivity analyses distinguished?
Required materials and conditions
Original PP, ITT, cancellation, adherence, missingness and sensitivity-analysis definitions
Conditions for verification
Original PP, ITT, cancellation, adherence, missingness and sensitivity-analysis definitions
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods
Noninferior 90-day surgical-site infection
N13 · What are the follow-up, missingness and ascertainment limits within the original infection period?
Required materials and conditions
90-day follow-up, visits, administrative/clinical ascertainment, missingness and denominators
Conditions for verification
90-day follow-up, visits, administrative/clinical ascertainment, missingness and denominators
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods
Noninferior 90-day surgical-site infection
N14 · Is antibiotic duration the same outcome as SSI?
Required materials and conditions
Distinguishing exposure duration, endpoint, summary statistics and denominators
Conditions for verification
Distinguishing exposure duration, endpoint, summary statistics and denominators
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods
Noninferior 90-day surgical-site infection
N15 · Are clinical importance and original small-study limitations preserved without new assessment?
Required materials and conditions
Infection, margin, precision, sample size and original limitations
Conditions for verification
Infection, margin, precision, sample size and original limitations
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods
Noninferior 90-day surgical-site infection
N16 · Are the two subclaims from the same trial kept separate from independent replications?
Required materials and conditions
Relationships among report, trial, shared participants, outcomes and related questions
Conditions for verification
Relationships among report, trial, shared participants, outcomes and related questions
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods
Noninferior 90-day surgical-site infection
N17 · What is known about company and institutional funding, in-kind support, affiliations and analysis roles?
Required materials and conditions
Cash, products/in-kind support, author affiliations, external analysis and study roles
Conditions for verification
Cash, products/in-kind support, author affiliations, external analysis and study roles
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods
Noninferior 90-day surgical-site infection
N18 · Are 90-day mortality counts, denominators and P distinguished from SSI?
Required materials and conditions
Mortality definition, duration, arm-specific denominators, original events and testing
Conditions for verification
Mortality definition, duration, arm-specific denominators, original events and testing
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods
Noninferior 90-day surgical-site infection
N19 · What do the infection-resolution statement and treatment and safety collection cover?
Required materials and conditions
Infection types, treatment exposure, follow-up, recovery, relatedness and denominators
Conditions for verification
Infection types, treatment exposure, follow-up, recovery, relatedness and denominators
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods
Noninferior 90-day surgical-site infection
N20 · Does shorter antibiotic exposure directly demonstrate reduced harms?
Required materials and conditions
Drug harms, collection, exposure, arm-specific events and denominators
Conditions for verification
Drug harms, collection, exposure, arm-specific events and denominators
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods
Noninferior 90-day surgical-site infection
N21 · Are resistance selection pressure, individual resistance, costs and other infections distinguished?
Required materials and conditions
Direct outcomes, definitions and denominators for resistance, costs and infection types
Conditions for verification
Direct outcomes, definitions and denominators for resistance, costs and infection types
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods
Noninferior 90-day surgical-site infection
N22 · What application gaps remain for populations, surgery, drugs and resistance environments outside the single center?
Required materials and conditions
Direct comparisons in new populations, surgeries, drug combinations and settings
Conditions for verification
Direct comparisons in new populations, surgeries, drug combinations and settings
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods
Noninferior 90-day surgical-site infection
N23 · Do gaps remain in durability beyond 90 days and independent replication?
Required materials and conditions
Long-term follow-up, new trials, populations, centers and independence relationships
Conditions for verification
Long-term follow-up, new trials, populations, centers and independence relationships
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods
Noninferior 90-day surgical-site infection
N24 · Are the preserved summary and external abstract, full text, registration and plans distinguished?
Required materials and conditions
Bibliography, existing links, registration identifiers and material-specific access status
Conditions for verification
Bibliography, existing links, registration identifiers and material-specific access status
Requirement and applicability
Required
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods
Noninferior 90-day surgical-site infection
N25 · Are the reference date, Korean/English texts, corrections, empty values, candidate history and production state preserved?
Required materials and conditions
Distinguishing the complete preserved summary, selected verdict record, parent values, original languages and history
Conditions for verification
Distinguishing the complete preserved summary, selected verdict record, parent values, original languages and history
Requirement and applicability
Supplementary
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods
Noninferior 90-day surgical-site infection
Referenced methods and the sections actually reviewed

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

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

Referenced principle
Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review
Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.

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

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

Referenced principle
Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review
Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.

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

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

Referenced principle
Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review
Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.

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

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle
Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review
Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.

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

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle
Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review
Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.
What the statuses mean
Partly verified
Some information exists in the preserved review summary, with detailed original materials still unverified; no certification of a passed review or clinical efficacy
Unverified
Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety
Review incomplete
Existing content review pending
Met
Use only within the relevant conditions after existing content review; no automatic designation in this preparation
Not reported
Distinguish only within materials actually read; do not turn unread external materials into unreported findings
Inaccessible
Not applied during this preparation because actual access was not tested
Not applicable
Use with a reason for non-applicability based on an explicit question boundary
Conflicting data
Judge after actual material comparison; review was not performed during this preparation
Insufficient evidence for the conditions
Do not use as a clinical grade encompassing currently unread materials

Change history

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

The public page and data were prepared from the existing 25 items. No new clinical search, verification-status change or scoring was performed.

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

Researcher downloads

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

View all item details

N01 · Are the original subclaim and grade distinguished from the parent judgment context?

Current findings
The selected claim is noninferior 90-day surgical-site infection, with subclaim grade C and a note that the prespecified 10%p margin was met. The parent verdict is C, 56 points, Caution.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Absent subclaim score, status and axes are not filled with parent values. This production does not establish a new verdict or grade certification.
Reason for missing information
Absent subclaim score, status and axes are not filled with parent values. This production does not establish a new verdict or grade certification.
Required materials and conditions
Separate records of the selected subclaim, grade and note, and the original parent verdict
Materials to obtain first
Absent subclaim score, status and axes are not filled with parent values. This production does not establish a new verdict or grade certification.
Further research
Link additional materials separately to the relevant subclaim and parent context.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Separate records of the selected subclaim, grade and note, and the original parent verdict
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Noninferior 90-day surgical-site infection

Related sources R01

N02 · What surgery, population and center were actually studied?

Current findings
PAPRAC included patients undergoing open cystectomy and urinary diversion at a single Swiss center.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. The preserved summary lacks detailed tables of age, eligibility exclusions, baseline risk and surgical details. Results are not automatically extended to robotic surgery or other populations.
Reason for missing information
The preserved summary lacks detailed tables of age, eligibility exclusions, baseline risk and surgical details. Results are not automatically extended to robotic surgery or other populations.
Required materials and conditions
Eligibility, surgery type, urinary diversion, baseline characteristics and denominators
Materials to obtain first
The preserved summary lacks detailed tables of age, eligibility exclusions, baseline risk and surgical details. Results are not automatically extended to robotic surgery or other populations.
Further research
Obtain the original eligibility, baseline characteristics, surgery, center and denominator records.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Eligibility, surgery type, urinary diversion, baseline characteristics and denominators
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Noninferior 90-day surgical-site infection

Related sources R01

N03 · What were the historical intervention and comparator exposure until catheter and stent removal?

Current findings
The original study conditions were stopping prophylactic antibiotics 24 hours after surgery in the short arm and continuing until catheter and stent removal in the extended arm.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. No individual antibiotic type, duration, use or stopping recommendation is made. Details of exact drug combinations, doses, concomitant drugs and additional treatment exposure remain unread.
Reason for missing information
No individual antibiotic type, duration, use or stopping recommendation is made. Details of exact drug combinations, doses, concomitant drugs and additional treatment exposure remain unread.
Required materials and conditions
Original intervention, comparator, stopping criteria, actual exposure and accompanying care
Materials to obtain first
No individual antibiotic type, duration, use or stopping recommendation is made. Details of exact drug combinations, doses, concomitant drugs and additional treatment exposure remain unread.
Further research
Obtain the original arm-specific tables of drugs, prophylactic and treatment exposure, actual duration and accompanying care.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original intervention, comparator, stopping criteria, actual exposure and accompanying care
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Noninferior 90-day surgical-site infection

Related sources R01

N04 · Are 196 randomized participants distinguished from 193 in the primary analysis and denominators 95/98?

Current findings
After 196 participants were randomized, the prespecified per-protocol primary analysis included 193 (95/98), excluding 3 canceled surgeries.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. The summary lacks original arm-specific randomized counts, cancellations by arm and additional follow-up losses. No new totals, dropout rates or certification of an all-randomized ITT analysis are produced.
Reason for missing information
The summary lacks original arm-specific randomized counts, cancellations by arm and additional follow-up losses. No new totals, dropout rates or certification of an all-randomized ITT analysis are produced.
Required materials and conditions
Arm-specific randomization, canceled surgery, analysis and follow-up flow
Materials to obtain first
The summary lacks original arm-specific randomized counts, cancellations by arm and additional follow-up losses. No new totals, dropout rates or certification of an all-randomized ITT analysis are produced.
Further research
Obtain the original participant flow, exclusion reasons, arm-specific allocation and analysis counts, and missing-data tables.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Arm-specific randomization, canceled surgery, analysis and follow-up flow
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Noninferior 90-day surgical-site infection

Related sources R01

N05 · Are the open-label design and infection adjudicators' roles distinguished?

Current findings
The original design was a single-center open-label noninferiority randomized trial. The record states that infectious-disease specialists and clinicians not involved in care adjudicated 90-day CDC-defined SSI.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Non-involvement in care is not newly certified as blinding to allocation. Details of allocation concealment, assessor blinding and analyst independence remain unread.
Reason for missing information
Non-involvement in care is not newly certified as blinding to allocation. Details of allocation concealment, assessor blinding and analyst independence remain unread.
Required materials and conditions
Allocation, concealment, measurement, adjudicator and analyst procedures
Materials to obtain first
Non-involvement in care is not newly certified as blinding to allocation. Details of allocation concealment, assessor blinding and analyst independence remain unread.
Further research
Obtain the original allocation, adjudication, blinding and analysis procedures.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Allocation, concealment, measurement, adjudicator and analyst procedures
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Noninferior 90-day surgical-site infection

Related sources R01

N06 · What is the actual access status of registration, protocol and analysis-plan materials?

Current findings
The registration identifier in the original evidence list is NCT03305627. The preserved summary records a prespecified per-protocol primary analysis and a prespecified 10%p margin.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. No new URL was constructed from the registration identifier, and registration, full text and plans were not read. Details of the original primary/secondary exposure hierarchy and testing plan remain unread.
Reason for missing information
No new URL was constructed from the registration identifier, and registration, full text and plans were not read. Details of the original primary/secondary exposure hierarchy and testing plan remain unread.
Required materials and conditions
Original registration, protocol, SAP, outcome hierarchy and amendment history
Materials to obtain first
No new URL was constructed from the registration identifier, and registration, full text and plans were not read. Details of the original primary/secondary exposure hierarchy and testing plan remain unread.
Further research
Obtain the original registration, plans, analysis populations, hierarchy, amendments and multiplicity information.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original registration, protocol, SAP, outcome hierarchy and amendment history
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Noninferior 90-day surgical-site infection

Related sources R01

N07 · What direct outcome is 90-day CDC-defined SSI?

Current findings
The selected question is noninferiority for CDC-defined surgical-site infection within 90 days. Infectious-disease specialists and clinicians not involved in care adjudicated the outcome.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. The summary lacks detailed definitions and results for superficial, deep and organ-space categories, and visit schedules. Other infection or wound measures are not substituted.
Reason for missing information
The summary lacks detailed definitions and results for superficial, deep and organ-space categories, and visit schedules. Other infection or wound measures are not substituted.
Required materials and conditions
Infection definition, categories, ascertainment, time points and denominators
Materials to obtain first
The summary lacks detailed definitions and results for superficial, deep and organ-space categories, and visit schedules. Other infection or wound measures are not substituted.
Further research
Obtain the original CDC definitions, classification, ascertainment, results by time point and denominators.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Infection definition, categories, ascertainment, time points and denominators
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Noninferior 90-day surgical-site infection

Related sources R01

N08 · Are arm-specific SSI events 8/95 and 12/98 and original percentages preserved?

Current findings
The original materials record 90-day SSI as 8/95 (8.4%) in the short arm versus 12/98 (12.2%) in the extended arm.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. People, repeated events, original denominators and all infections are not mixed. No new percentages, RR, event totals, P values or CI are calculated.
Reason for missing information
People, repeated events, original denominators and all infections are not mixed. No new percentages, RR, event totals, P values or CI are calculated.
Required materials and conditions
Arm-specific events, people, denominators, original percentages and time window
Materials to obtain first
People, repeated events, original denominators and all infections are not mixed. No new percentages, RR, event totals, P values or CI are calculated.
Further research
Obtain the original event tables, arm-specific denominators, repeated-infection records and analysis definitions.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Arm-specific events, people, denominators, original percentages and time window
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Noninferior 90-day surgical-site infection

Related sources R01

N09 · Are the risk-difference direction and 90% CI preserved as originally recorded?

Current findings
The original SSI risk difference is −3.8%p (90% CI −11.1~3.4).
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. 90% is not changed to 95%. No new reverse-direction effect, risk ratio, test P value or adjusted model is produced. Details of the original risk-difference calculation remain unread.
Reason for missing information
90% is not changed to 95%. No new reverse-direction effect, risk ratio, test P value or adjusted model is produced. Details of the original risk-difference calculation remain unread.
Required materials and conditions
Risk difference of interest, arm order, CI level and original model
Materials to obtain first
90% is not changed to 95%. No new reverse-direction effect, risk ratio, test P value or adjusted model is produced. Details of the original risk-difference calculation remain unread.
Further research
Obtain the original comparison direction, risk-difference model, CI calculation and denominators.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Risk difference of interest, arm order, CI level and original model
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Noninferior 90-day surgical-site infection

Related sources R01

N10 · Are the prespecified 10%p noninferiority margin and scope of the original conclusion distinguished?

Current findings
The original materials state that the prespecified 10%p noninferiority margin was met, with 90% CI −11.1~3.4.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. No new certification is made without reading the clinical margin rationale, original assumptions, α, test P value and plans. No new margin or examples of allowable events are produced.
Reason for missing information
No new certification is made without reading the clinical margin rationale, original assumptions, α, test P value and plans. No new margin or examples of allowable events are produced.
Required materials and conditions
Margin, direction, rationale, prespecification, CI and plans
Materials to obtain first
No new certification is made without reading the clinical margin rationale, original assumptions, α, test P value and plans. No new margin or examples of allowable events are produced.
Further research
Obtain the margin rationale, prespecification, testing and analysis plans, and original CI.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Margin, direction, rationale, prespecification, CI and plans
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Noninferior 90-day surgical-site infection

Related sources R01

N11 · Has noninferiority been kept separate from superiority for reducing infection and exact equivalence?

Current findings
The original trial used a noninferiority design and records SSI risk difference −3.8%p and 90% CI −11.1~3.4.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. The direction of the original percentages alone does not establish superiority for reducing infection or equivalence with exactly no difference.
Reason for missing information
The direction of the original percentages alone does not establish superiority for reducing infection or equivalence with exactly no difference.
Required materials and conditions
Original design, effect, interval, hypothesis and interpretation
Materials to obtain first
The direction of the original percentages alone does not establish superiority for reducing infection or equivalence with exactly no difference.
Further research
Link the original hypothesis, interval, margin and effect interpretation to the relevant question.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original design, effect, interval, hypothesis and interpretation
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Noninferior 90-day surgical-site infection

Related sources R01

N12 · Are the per-protocol primary analysis and gaps in ITT and sensitivity analyses distinguished?

Current findings
The prespecified per-protocol primary analysis included 193 participants after excluding 3 canceled surgeries.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. This analysis is not converted into an ITT analysis of all 196 randomized participants. Details of ITT, sensitivity analyses, arm-specific cancellations, losses and original analysis mapping are unavailable.
Reason for missing information
This analysis is not converted into an ITT analysis of all 196 randomized participants. Details of ITT, sensitivity analyses, arm-specific cancellations, losses and original analysis mapping are unavailable.
Required materials and conditions
Original PP, ITT, cancellation, adherence, missingness and sensitivity-analysis definitions
Materials to obtain first
This analysis is not converted into an ITT analysis of all 196 randomized participants. Details of ITT, sensitivity analyses, arm-specific cancellations, losses and original analysis mapping are unavailable.
Further research
Obtain the original PP/ITT definitions, exclusions, adherence, missing-data assumptions, sensitivity analyses and original CI.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original PP, ITT, cancellation, adherence, missingness and sensitivity-analysis definitions
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Noninferior 90-day surgical-site infection

Related sources R01

N13 · What are the follow-up, missingness and ascertainment limits within the original infection period?

Current findings
The original primary endpoint period is 90 days, and the SSI analysis denominators are 95/98.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. These denominators alone do not certify complete follow-up of all randomized participants, capture of infections at outside healthcare facilities or absence of missing information.
Reason for missing information
These denominators alone do not certify complete follow-up of all randomized participants, capture of infections at outside healthcare facilities or absence of missing information.
Required materials and conditions
90-day follow-up, visits, administrative/clinical ascertainment, missingness and denominators
Materials to obtain first
These denominators alone do not certify complete follow-up of all randomized participants, capture of infections at outside healthcare facilities or absence of missing information.
Further research
Obtain the original follow-up, infection ascertainment, missingness, denominators and handling of events outside the study center.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
90-day follow-up, visits, administrative/clinical ascertainment, missingness and denominators
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Noninferior 90-day surgical-site infection

Related sources R01

N14 · Is antibiotic duration the same outcome as SSI?

Current findings
In the same trial, antibiotic duration was 1 day (IQR1~1) versus 8 days (IQR7~10), with the original reduction of 7 days and 87.5%.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Reduced duration is not combined with SSI reduction, direct resistance reduction or safety as the same effect. Details of exposure-analysis denominators and hierarchy remain unread.
Reason for missing information
Reduced duration is not combined with SSI reduction, direct resistance reduction or safety as the same effect. Details of exposure-analysis denominators and hierarchy remain unread.
Required materials and conditions
Distinguishing exposure duration, endpoint, summary statistics and denominators
Materials to obtain first
Reduced duration is not combined with SSI reduction, direct resistance reduction or safety as the same effect. Details of exposure-analysis denominators and hierarchy remain unread.
Further research
Share the exposure outcome with the related question while linking it separately from the direct infection outcome.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Distinguishing exposure duration, endpoint, summary statistics and denominators
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Noninferior 90-day surgical-site infection

Related sources R01

N15 · Are clinical importance and original small-study limitations preserved without new assessment?

Current findings
The parent record describes objective 90-day SSI and a prespecified margin as strengths, and noninferiority, small size and exclusion of canceled surgery as limitations, preserving C56.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Unrecorded precision, the original parent verdict and axes are not repurposed as a new or subclaim score. No new sample-size, power or MCID calculations are made.
Reason for missing information
Unrecorded precision, the original parent verdict and axes are not repurposed as a new or subclaim score. No new sample-size, power or MCID calculations are made.
Required materials and conditions
Infection, margin, precision, sample size and original limitations
Materials to obtain first
Unrecorded precision, the original parent verdict and axes are not repurposed as a new or subclaim score. No new sample-size, power or MCID calculations are made.
Further research
Obtain the original sample-size assumptions, clinical margin rationale and precision information.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Infection, margin, precision, sample size and original limitations
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Noninferior 90-day surgical-site infection

Related sources R01

N16 · Are the two subclaims from the same trial kept separate from independent replications?

Current findings
One PAPRAC report records both 90-day SSI and antibiotic duration, so the two subclaim tables share the same trial and population.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Report entries, two questions, outcomes and time points are not added as new independent trials or participants. Final independent-study and total-participant counts remain unrecorded.
Reason for missing information
Report entries, two questions, outcomes and time points are not added as new independent trials or participants. Final independent-study and total-participant counts remain unrecorded.
Required materials and conditions
Relationships among report, trial, shared participants, outcomes and related questions
Materials to obtain first
Report entries, two questions, outcomes and time points are not added as new independent trials or participants. Final independent-study and total-participant counts remain unrecorded.
Further research
Link additional reports while preserving original identifiers and population and time-point relationships.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Relationships among report, trial, shared participants, outcomes and related questions
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Noninferior 90-day surgical-site infection

Related sources R01

N17 · What is known about company and institutional funding, in-kind support, affiliations and analysis roles?

Current findings
The original summary records no reported external grant or company in-kind support, and sponsorship and conduct by Insel Gruppe AG and University Hospital Bern.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. No reported support is not converted into certification of no support or company involvement. Separate details of employee authors, external analysis, design and writing roles remain unread.
Reason for missing information
No reported support is not converted into certification of no support or company involvement. Separate details of employee authors, external analysis, design and writing roles remain unread.
Required materials and conditions
Cash, products/in-kind support, author affiliations, external analysis and study roles
Materials to obtain first
No reported support is not converted into certification of no support or company involvement. Separate details of employee authors, external analysis, design and writing roles remain unread.
Further research
Obtain the original support, in-kind, affiliation, analysis, design and writing disclosures separately.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Cash, products/in-kind support, author affiliations, external analysis and study roles
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Noninferior 90-day surgical-site infection

Related sources R01

N18 · Are 90-day mortality counts, denominators and P distinguished from SSI?

Current findings
The original safety record gives 90-day all-cause mortality as 6/95 (6.3%) versus 5/98 (5.1%), P=.96.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. These results are not converted into antibiotic-related mortality, survival noninferiority or absence of rare harms. CI, causes, relatedness and hierarchy for the original mortality outcome remain unread, with no new calculation.
Reason for missing information
These results are not converted into antibiotic-related mortality, survival noninferiority or absence of rare harms. CI, causes, relatedness and hierarchy for the original mortality outcome remain unread, with no new calculation.
Required materials and conditions
Mortality definition, duration, arm-specific denominators, original events and testing
Materials to obtain first
These results are not converted into antibiotic-related mortality, survival noninferiority or absence of rare harms. CI, causes, relatedness and hierarchy for the original mortality outcome remain unread, with no new calculation.
Further research
Obtain original mortality, relatedness, denominator, plan, CI and follow-up materials.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Mortality definition, duration, arm-specific denominators, original events and testing
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Noninferior 90-day surgical-site infection

Related sources R01

N19 · What do the infection-resolution statement and treatment and safety collection cover?

Current findings
The original safety record states that all infections resolved with appropriate treatment.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. This statement is not extended to mean no infections, systematic collection of all harms or no risk. Details of other infections, treatments, people/events and recovery timing remain unread.
Reason for missing information
This statement is not extended to mean no infections, systematic collection of all harms or no risk. Details of other infections, treatments, people/events and recovery timing remain unread.
Required materials and conditions
Infection types, treatment exposure, follow-up, recovery, relatedness and denominators
Materials to obtain first
This statement is not extended to mean no infections, systematic collection of all harms or no risk. Details of other infections, treatments, people/events and recovery timing remain unread.
Further research
Obtain original infection, treatment-exposure, treatment-success definition, follow-up, relatedness and denominator records.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Infection types, treatment exposure, follow-up, recovery, relatedness and denominators
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Noninferior 90-day surgical-site infection

Related sources R01

N20 · Does shorter antibiotic exposure directly demonstrate reduced harms?

Current findings
The original materials record shorter prophylactic antibiotic exposure, 90-day SSI and mortality; parent safety is Caution.
Verification status
Unverified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Shorter exposure alone does not newly establish reductions in adverse drug reactions, kidney injury, allergy or other harms. The summary lacks the relevant original outcomes, denominators and collection details.
Reason for missing information
Shorter exposure alone does not newly establish reductions in adverse drug reactions, kidney injury, allergy or other harms. The summary lacks the relevant original outcomes, denominators and collection details.
Required materials and conditions
Drug harms, collection, exposure, arm-specific events and denominators
Materials to obtain first
Shorter exposure alone does not newly establish reductions in adverse drug reactions, kidney injury, allergy or other harms. The summary lacks the relevant original outcomes, denominators and collection details.
Further research
Obtain original harm-collection records, arm-specific events/people, exposure, discontinuation, relatedness and duration.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Drug harms, collection, exposure, arm-specific events and denominators
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Noninferior 90-day surgical-site infection

Related sources R01

N21 · Are resistance selection pressure, individual resistance, costs and other infections distinguished?

Current findings
The original review summary records both a possible reduction in resistance selection pressure and costs through less exposure, and the limitation that individual resistance emergence and costs were not directly tested.
Verification status
Unverified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Mechanistic or stewardship advantages are not converted into established direct reductions in resistance or costs or prevention of other infections.
Reason for missing information
Mechanistic or stewardship advantages are not converted into established direct reductions in resistance or costs or prevention of other infections.
Required materials and conditions
Direct outcomes, definitions and denominators for resistance, costs and infection types
Materials to obtain first
Mechanistic or stewardship advantages are not converted into established direct reductions in resistance or costs or prevention of other infections.
Further research
Obtain prespecified direct measurements, denominators, effects and follow-up for resistance, costs and other infections.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Direct outcomes, definitions and denominators for resistance, costs and infection types
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Noninferior 90-day surgical-site infection

Related sources R01

N22 · What application gaps remain for populations, surgery, drugs and resistance environments outside the single center?

Current findings
The parent counterview records that results cannot be directly applied to robotic surgery, other antibiotic combinations or different resistance environments.
Verification status
Unverified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. No individual antibiotic choice, duration, postoperative-care or treatment-substitution guidance is generated. Efficacy and safety outside the original study conditions are not newly certified.
Reason for missing information
No individual antibiotic choice, duration, postoperative-care or treatment-substitution guidance is generated. Efficacy and safety outside the original study conditions are not newly certified.
Required materials and conditions
Direct comparisons in new populations, surgeries, drug combinations and settings
Materials to obtain first
No individual antibiotic choice, duration, postoperative-care or treatment-substitution guidance is generated. Efficacy and safety outside the original study conditions are not newly certified.
Further research
Obtain direct effects/harms, denominators and follow-up for each new population, surgery, drug and setting.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Direct comparisons in new populations, surgeries, drug combinations and settings
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Noninferior 90-day surgical-site infection

Related sources R01

N23 · Do gaps remain in durability beyond 90 days and independent replication?

Current findings
The currently designated preserved summary contains one PAPRAC report and 90-day SSI.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Duration, outcomes and related tables are not counted as replication trials or extended to long-term resistance, readmission, mortality or all infections.
Reason for missing information
Duration, outcomes and related tables are not counted as replication trials or extended to long-term resistance, readmission, mortality or all infections.
Required materials and conditions
Long-term follow-up, new trials, populations, centers and independence relationships
Materials to obtain first
Duration, outcomes and related tables are not counted as replication trials or extended to long-term resistance, readmission, mortality or all infections.
Further research
Obtain long-term direct outcomes, independent-report relationships and center-specific materials.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Long-term follow-up, new trials, populations, centers and independence relationships
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Noninferior 90-day surgical-site infection

Related sources R01

N24 · Are the preserved summary and external abstract, full text, registration and plans distinguished?

Current findings
The complete parent-verdict summary was read for production, linking the existing PubMed URL for Thurnheer et al. 2024, PMID39422911 and identifier NCT03305627.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. External abstract, full text, registration, protocol and SAP remain unread; no separate link test was performed. No new URL or DOI is constructed from identifiers.
Reason for missing information
External abstract, full text, registration, protocol and SAP remain unread; no separate link test was performed. No new URL or DOI is constructed from identifiers.
Required materials and conditions
Bibliography, existing links, registration identifiers and material-specific access status
Materials to obtain first
External abstract, full text, registration, protocol and SAP remain unread; no separate link test was performed. No new URL or DOI is constructed from identifiers.
Further research
Link individual original materials supplied by the user separately from their actual access status.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Bibliography, existing links, registration identifiers and material-specific access status
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Noninferior 90-day surgical-site infection

Related sources R01

N25 · Are the reference date, Korean/English texts, corrections, empty values, candidate history and production state preserved?

Current findings
2026-08-26, empty correction and deliberation values, Korean/English texts, parent C56, Caution and axes, and the subclaim C grade and note are preserved in their original form.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Original statements, including the sample-size wording in the parent rationale, remain historical records without new correction or reassessment. Original review-pending and production-eligibility indicators are candidate history, not current review or completion.
Reason for missing information
Original statements, including the sample-size wording in the parent rationale, remain historical records without new correction or reassessment. Original review-pending and production-eligibility indicators are candidate history, not current review or completion.
Required materials and conditions
Distinguishing the complete preserved summary, selected verdict record, parent values, original languages and history
Materials to obtain first
Original statements, including the sample-size wording in the parent rationale, remain historical records without new correction or reassessment. Original review-pending and production-eligibility indicators are candidate history, not current review or completion.
Further research
Preserve original texts before linking additional user materials or decisions as separate events.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Distinguishing the complete preserved summary, selected verdict record, parent values, original languages and history
Why this condition is needed
Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions
Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods
Noninferior 90-day surgical-site infection

Related sources R01