{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2930-s1", "verdict_number": "2930", "title": "Evidence check: 7 versus 14 days of antibiotics × 28-day symptom recurrence in afebrile men with UTI", "view_version": "1.0", "view_created_date": "2026-10-10", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Review of the existing content is incomplete. External abstracts, full texts, registration records, protocols and SAPs have not been read, and access has not been attempted.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "Distinguishing the scope of 272 randomized participants, 254 in the adherent primary analysis, and recurrence denominators 131/123 in afebrile men with UTI at two US VA centers", "intervention": "The historical comparison of ciprofloxacin/TMP-SMX for 7 versus 14 days; no antibiotic or duration instructions", "dose": null, "comparator": "The 7-versus-14-day strategies, distinguishing resolution noninferiority from the definition, timing and denominators of 28-day recurrence", "endpoint": "The selected 28-day symptom-recurrence record: original 13/131(9.9%) versus 15/123(12.9%), difference −3.0%p(CI −10.8~6.2)", "duration": "The original 28-day/by28days question; the observation window's exact reference point remains unverified and is separate from resolution within 14 days after treatment ended", "excluded_extensions": [ "Changing the original recurrence fractions, parenthetical rates, difference or CI through arithmetic comparison, recalculation, correction or adjudication of conflicts with new materials", "Filling the 28-day reference point, recurrence definition, resolved-symptom conditions or denominators with information absent from the summary", "Repurposing the resolution margin −10%p, one-sided 97.5% CI, primary analysis or all-participant consistency values for recurrence noninferiority, precision or a prespecified hierarchy", "Repurposing the recurrence CI as zero effect, equivalence, definite recurrence reduction, complete long-term cure or reduced individual resistance", "Calculating new populations, exclusion rates or event counts or rates from the adherent primary analysis of 254/131/123, completed follow-up in 272, or safety denominators 136/136", "Repurposing articles 1793/862 in women, their drugs or clinical-cure findings as direct trials, replications or drug-selection evidence for recurrence in men", "Repurposing safety counts 28/136 and 33/136, difference −3.7 and the absence of a reported test as statistical benefit, zero risk or recurrence values", "Changing original public support, existing cross-citation verification wording or I2 into claims about absence of product support, employees or COI, or an independence or QA certification in this preparation", "Extending the study's 7/14 days, two drugs or adherence-selection criteria to antibiotic selection, dosing, dose reduction, individual suitability or treatment instructions", "Adding references to the same report, trial, population, group, time point, sibling question or manuscript as new independent trials or total participants", "Inheriting the parent score or axes, historical cross-checks, original-paper review or existing cross-citation checks as subclaim values, current content review or external reading", "New searches or APIs, numerical calculations, hypothetical values, new effects, CIs or grades, certification of independence, or guidance on antibiotic or vaccine selection, use, suitability or treatment" ] }, "requirements": [ { "item_id": "N01", "question_type": "Efficacy comparison and presentation of stored material", "question": "How does 28-day recurrence differ from the parent symptom-resolution judgment?", "needed": "Distinguishing the subclaim's D grade and note, absent score, status and axes, from the parent's B70 and axes", "role": "Required", "role_reason": "An item prepared to distinguish Distinguishing the subclaim's D grade and note, absent score, status and axes, from the parent's B70 and axes and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for Distinguishing the subclaim's D grade and note, absent score, status and axes, from the parent's B70 and axes must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking Distinguishing the subclaim's D grade and note, absent score, status and axes, from the parent's B70 and axes as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The selected question is ‘28-day symptom recurrence’, with grade D and the note ‘9.9% versus 12.9%, with a wide CI’. The parent judgment concerns noninferiority of symptom resolution within 14 days after treatment ended, B70 and Caution; the subclaim has no score, status or axes.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but No new recurrence score or judgment is assigned, and parent values are not inherited. Review of existing content remains incomplete.", "missingness": "No new recurrence score or judgment is assigned, and parent values are not inherited.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for Distinguishing the subclaim's D grade and note, absent score, status and axes, from the parent's B70 and axes." }, { "item_id": "N02", "question_type": "Efficacy comparison and presentation of stored material", "question": "What are the originally recorded recurrence fractions and rates?", "needed": "The original records of 13/131(9.9%) and 15/123(12.9%)", "role": "Required", "role_reason": "An item prepared to distinguish The original records of 13/131(9.9%) and 15/123(12.9%) and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for The original records of 13/131(9.9%) and 15/123(12.9%) must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are our own design", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking The original records of 13/131(9.9%) and 15/123(12.9%) as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The existing Korean counterview records recurrence as 13/131(9.9%) versus 15/123(12.9%). Fractions and parenthetical rates are preserved separately, without division, recalculation or correction to other values.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but The original result table's fraction and rate definitions, rounding or estimation, and denominator correspondence have not been read externally. Review of existing content remains incomplete.", "missingness": "The original result table's fraction and rate definitions, rounding or estimation, and denominator correspondence have not been read externally.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for The original records of 13/131(9.9%) and 15/123(12.9%)." }, { "item_id": "N03", "question_type": "Efficacy comparison and presentation of stored material", "question": "What estimand does the recurrence difference and its 95% interval represent?", "needed": "The original −3.0%p and 95% CI −10.8~6.2, and the direction of comparison", "role": "Required", "role_reason": "An item prepared to distinguish The original −3.0%p and 95% CI −10.8~6.2, and the direction of comparison and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for The original −3.0%p and 95% CI −10.8~6.2, and the direction of comparison must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M08 §8.2.2, M15 §15.3.1; Chamgap's own application; M15 §15.3.1–15.3.3; Chamgap's own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking The original −3.0%p and 95% CI −10.8~6.2, and the direction of comparison as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The recurrence difference −3.0%p(95% CI −10.8~6.2) is preserved as recorded. No new difference is calculated from the fractions or rates, and the CI is not narrowed to present a definite benefit, absence of harm or equivalence.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but The exact group contrast, adjustment or model, original P value and threshold for an important recurrence difference remain unverified. Review of existing content remains incomplete.", "missingness": "The exact group contrast, adjustment or model, original P value and threshold for an important recurrence difference remain unverified.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for The original −3.0%p and 95% CI −10.8~6.2, and the direction of comparison." }, { "item_id": "N04", "question_type": "Efficacy comparison and presentation of stored material", "question": "Where does the 28-day observation window begin?", "needed": "The existing 28-day timing definition, treatment start or end, and first or repeated recurrence", "role": "Required", "role_reason": "An item prepared to distinguish The existing 28-day timing definition, treatment start or end, and first or repeated recurrence and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for The existing 28-day timing definition, treatment start or end, and first or repeated recurrence must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M04 §4.6.3; our own application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are our own design", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking The existing 28-day timing definition, treatment start or end, and first or repeated recurrence as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The subclaim question and English text concern recurrence at 28 days/by28days. The parent's primary endpoint is symptom resolution within 14 days after treatment ended; these are not converted to the same observation window.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but The 28-day reference point or assessment day, first or repeated recurrence, and whether recurrence is conditional on symptom resolution remain unverified. Review of existing content remains incomplete.", "missingness": "The 28-day reference point or assessment day, first or repeated recurrence, and whether recurrence is conditional on symptom resolution remain unverified.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for The existing 28-day timing definition, treatment start or end, and first or repeated recurrence." }, { "item_id": "N05", "question_type": "Efficacy comparison and presentation of stored material", "question": "How is symptom recurrence defined?", "needed": "Distinguishing symptom criteria, patient reporting or culture, and a new event after resolution", "role": "Required", "role_reason": "An item prepared to distinguish Distinguishing symptom criteria, patient reporting or culture, and a new event after resolution and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for Distinguishing symptom criteria, patient reporting or culture, and a new event after resolution must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M03 §3.2.4; our own application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking Distinguishing symptom criteria, patient reporting or culture, and a new event after resolution as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original materials report the rate of symptom recurrence. This is not arbitrarily redefined as measuring microbiological reinfection, same-organism relapse, persistent symptoms or severe events.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but Symptom and duration thresholds, reporting methods, culture or retreatment, and adjudication rules remain unverified. Review of existing content remains incomplete.", "missingness": "Symptom and duration thresholds, reporting methods, culture or retreatment, and adjudication rules remain unverified.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for Distinguishing symptom criteria, patient reporting or culture, and a new event after resolution." }, { "item_id": "N06", "question_type": "Efficacy comparison and presentation of stored material", "question": "How do the recurrence denominators 131/123 relate to the 272/254 participants?", "needed": "Distinguishing randomized participants, the adherent primary analysis, and the recurrence observation population or missing data", "role": "Required", "role_reason": "An item prepared to distinguish Distinguishing randomized participants, the adherent primary analysis, and the recurrence observation population or missing data and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for Distinguishing randomized participants, the adherent primary analysis, and the recurrence observation population or missing data must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking Distinguishing randomized participants, the adherent primary analysis, and the recurrence observation population or missing data as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original records of 272 randomized participants, all with completed follow-up, and the prespecified as-treated analysis of 254 participants (131/123) are preserved. Even though the recurrence denominators are also 131/123, conditions concerning resolved symptoms, assessment populations or the definitions of all actual denominators are not newly filled in.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but Details of inclusion and exclusion in the recurrence population, initial resolution or observation, adherence and group-specific missingness remain unverified. Review of existing content remains incomplete.", "missingness": "Details of inclusion and exclusion in the recurrence population, initial resolution or observation, adherence and group-specific missingness remain unverified.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for Distinguishing randomized participants, the adherent primary analysis, and the recurrence observation population or missing data." }, { "item_id": "N07", "question_type": "Efficacy comparison and presentation of stored material", "question": "What scope do the prespecified adherence criteria have for recurrence?", "needed": "The original selection criteria of at least 26 of 28 doses and no more than 2 consecutive missed doses", "role": "Required", "role_reason": "An item prepared to distinguish The original selection criteria of at least 26 of 28 doses and no more than 2 consecutive missed doses and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for The original selection criteria of at least 26 of 28 doses and no more than 2 consecutive missed doses must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M08 §8.2.2, M15 §15.3.1; our own application; M03 §3.2.3, M08 §8.2.2–8.2.3; our own application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking The original selection criteria of at least 26 of 28 doses and no more than 2 consecutive missed doses as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original primary-analysis criteria selected 254 participants who took at least 26 of 28 doses and missed no more than 2 consecutive doses. These are historical analysis-selection criteria and are not repurposed as dosing instructions or recurrence effects for all randomized participants.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but Adherence selection or exposure applied to the recurrence analysis, outcomes of nonadherent participants and sensitivity analyses remain unverified. Review of existing content remains incomplete.", "missingness": "Adherence selection or exposure applied to the recurrence analysis, outcomes of nonadherent participants and sensitivity analyses remain unverified.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for The original selection criteria of at least 26 of 28 doses and no more than 2 consecutive missed doses." }, { "item_id": "N08", "question_type": "Efficacy comparison and presentation of stored material", "question": "Are the consistency-analysis results for all randomized participants recurrence results?", "needed": "The separate role of symptom resolution at 91.9/90.4%, +1.5 and the one-sided lower bound −5.8", "role": "Required", "role_reason": "An item prepared to distinguish The separate role of symptom resolution at 91.9/90.4%, +1.5 and the one-sided lower bound −5.8 and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for The separate role of symptom resolution at 91.9/90.4%, +1.5 and the one-sided lower bound −5.8 must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 §8.2.2, M15 §15.3.1; our own application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking The separate role of symptom resolution at 91.9/90.4%, +1.5 and the one-sided lower bound −5.8 as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The consistency analysis of all 272 participants, 91.9% versus 90.4%, difference +1.5%p and one-sided 97.5% lower bound −5.8, concerns symptom resolution. These values are not transferred to recurrence rates, a 95% interval or a recurrence sensitivity analysis.", "condition_status": "Unverified", "status_reason": "This is a record from the stored summary. The currently required information remains unverified. Recurrence values, intervals, missingness and plans for all randomized participants remain unverified in the stored summary. Review of existing content remains incomplete.", "missingness": "Recurrence values, intervals, missingness and plans for all randomized participants remain unverified in the stored summary.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for The separate role of symptom resolution at 91.9/90.4%, +1.5 and the one-sided lower bound −5.8." }, { "item_id": "N09", "question_type": "Efficacy comparison and presentation of stored material", "question": "Does the −10%p noninferiority margin for symptom resolution apply to recurrence?", "needed": "Distinguishing the parent's primary-resolution margin and one-sided CI from the two-sided recurrence interval", "role": "Required", "role_reason": "An item prepared to distinguish Distinguishing the parent's primary-resolution margin and one-sided CI from the two-sided recurrence interval and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for Distinguishing the parent's primary-resolution margin and one-sided CI from the two-sided recurrence interval must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M15 §15.3.1–15.3.3; our own application; M08 Table 8.2.a, M04 §4.6.3; our own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking Distinguishing the parent's primary-resolution margin and one-sided CI from the two-sided recurrence interval as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The parent's primary analysis records resolution as 122/131(93.1%) versus 111/123(90.2%), +2.9%p, a one-sided 97.5% lower bound −5.2 and margin −10; these define the resolution analysis. Neither the margin nor the noninferiority conclusion is inherited by the two-sided 95% CI for recurrence.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but The prespecified recurrence margin or important difference, separate power and analysis hierarchy remain unverified. Review of existing content remains incomplete.", "missingness": "The prespecified recurrence margin or important difference, separate power and analysis hierarchy remain unverified.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for Distinguishing the parent's primary-resolution margin and one-sided CI from the two-sided recurrence interval." }, { "item_id": "N10", "question_type": "Efficacy comparison and presentation of stored material", "question": "What position does recurrence have in the prespecified endpoint hierarchy?", "needed": "The primary symptom-resolution endpoint and prespecification or multiplicity for recurrence", "role": "Required", "role_reason": "An item prepared to distinguish The primary symptom-resolution endpoint and prespecification or multiplicity for recurrence and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for The primary symptom-resolution endpoint and prespecification or multiplicity for recurrence must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; Chamgap's own application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking The primary symptom-resolution endpoint and prespecification or multiplicity for recurrence as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The existing evidence list's endpoint and primary analysis concern noninferiority of symptom resolution. The selected 28-day recurrence question is not promoted to a primary endpoint, independent confirmation or a prespecified noninferiority question.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but The prespecified recurrence hierarchy, multiple comparisons, denominator or timing, and SAP remain unverified. Review of existing content remains incomplete.", "missingness": "The prespecified recurrence hierarchy, multiple comparisons, denominator or timing, and SAP remain unverified.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for The primary symptom-resolution endpoint and prespecification or multiplicity for recurrence." }, { "item_id": "N11", "question_type": "Efficacy comparison and presentation of stored material", "question": "What are the actual population and US VA study conditions?", "needed": "Afebrile men with UTI, two centers, and eligibility or baseline conditions", "role": "Required", "role_reason": "An item prepared to distinguish Afebrile men with UTI, two centers, and eligibility or baseline conditions and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for Afebrile men with UTI, two centers, and eligibility or baseline conditions must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M03 §3.2.1; detailed population conditions are Chamgap's own design", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking Afebrile men with UTI, two centers, and eligibility or baseline conditions as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original study included 272 afebrile men with UTI at two US VA centers. Its existing boundary is preserved: results cannot be directly applied to uncomplicated cystitis in women, febrile UTI, prostatitis or other drugs.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but Exact ages or comorbidities, inclusion and exclusion criteria, infection or culture conditions, and recurrence risk remain unverified. Review of existing content remains incomplete.", "missingness": "Exact ages or comorbidities, inclusion and exclusion criteria, infection or culture conditions, and recurrence risk remain unverified.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for Afebrile men with UTI, two centers, and eligibility or baseline conditions." }, { "item_id": "N12", "question_type": "Efficacy comparison and presentation of stored material", "question": "What historical comparison do 7 versus 14 days and the two antibiotics represent?", "needed": "The study duration and drugs, placebo, and actual exposure or concomitant treatment", "role": "Required", "role_reason": "An item prepared to distinguish The study duration and drugs, placebo, and actual exposure or concomitant treatment and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for The study duration and drugs, placebo, and actual exposure or concomitant treatment must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labels and checking adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking The study duration and drugs, placebo, and actual exposure or concomitant treatment as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The comparison of 7 versus 14 days of ciprofloxacin or TMP-SMX is an original study condition. It does not create instructions on drug selection, treatment duration, prescribing or suitability, and equal recurrence effects of the two drugs are not assumed.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but Drug-specific denominators and recurrence, dose or actual adherence, crossover or retreatment, and concomitant treatment remain unverified. Review of existing content remains incomplete.", "missingness": "Drug-specific denominators and recurrence, dose or actual adherence, crossover or retreatment, and concomitant treatment remain unverified.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for The study duration and drugs, placebo, and actual exposure or concomitant treatment." }, { "item_id": "N13", "question_type": "Efficacy comparison and presentation of stored material", "question": "Has the double-blind, placebo-controlled design been verified through recurrence measurement?", "needed": "Allocation or concealment, recurrence collection or assessors, and awareness of assignment", "role": "Required", "role_reason": "An item prepared to distinguish Allocation or concealment, recurrence collection or assessors, and awareness of assignment and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for Allocation or concealment, recurrence collection or assessors, and awareness of assignment must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking Allocation or concealment, recurrence collection or assessors, and awareness of assignment as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original study is a double-blind, placebo-controlled noninferiority RCT. Recurrence measurement procedures, assessor blinding, participants' actual awareness and the original B1 axis are kept separate.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but Sequence generation or concealment, recurrence instruments or collection timing, assessors and blinding details remain unverified. Review of existing content remains incomplete.", "missingness": "Sequence generation or concealment, recurrence instruments or collection timing, assessors and blinding details remain unverified.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for Allocation or concealment, recurrence collection or assessors, and awareness of assignment." }, { "item_id": "N14", "question_type": "Efficacy comparison and presentation of stored material", "question": "Are reports, populations and the sibling resolution question kept from being counted as new replications?", "needed": "The same Drekonja trial, 272/254 participants, and shared resolution, recurrence and safety results", "role": "Required", "role_reason": "An item prepared to distinguish The same Drekonja trial, 272/254 participants, and shared resolution, recurrence and safety results and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for The same Drekonja trial, 272/254 participants, and shared resolution, recurrence and safety results must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking The same Drekonja trial, 272/254 participants, and shared resolution, recurrence and safety results as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The resolution, recurrence and safety values in one Drekonja2021 report, and the parent or sibling questions, are different endpoints or denominators of the same study. They are not added as independent trials, new participants or total events.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but Unique clinical trial, participant and independent replication totals have not been verified and are not recorded. Review of existing content remains incomplete.", "missingness": "Unique clinical trial, participant and independent replication totals have not been verified and are not recorded.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for The same Drekonja trial, 272/254 participants, and shared resolution, recurrence and safety results." }, { "item_id": "N15", "question_type": "Efficacy comparison and presentation of stored material", "question": "Is the 1793 nitrofurantoin article reference a direct recurrence report?", "needed": "The B70 reference for uncomplicated cystitis in women and differences from men or the two drugs", "role": "Required", "role_reason": "An item prepared to distinguish The B70 reference for uncomplicated cystitis in women and differences from men or the two drugs and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for The B70 reference for uncomplicated cystitis in women and differences from men or the two drugs must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "Question clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are internally designed; distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application; M03 §3.2.1; detailed population conditions are internally designed", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking The B70 reference for uncomplicated cystitis in women and differences from men or the two drugs as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The existing cross-citation of 1793 refers to an article on clinical cure of acute uncomplicated cystitis in women, B70. That article or trial has not been read in this preparation, and is not turned into a direct trial or replication of 28-day recurrence in men.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but The article's actual materials or population and its direct connection to the selected question in men remain unverified. Review of existing content remains incomplete.", "missingness": "The article's actual materials or population and its direct connection to the selected question in men remain unverified.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for The B70 reference for uncomplicated cystitis in women and differences from men or the two drugs." }, { "item_id": "N16", "question_type": "Efficacy comparison and presentation of stored material", "question": "What different question does the 862 fosfomycin article reference concern?", "needed": "The boundary between B62 single-dose treatment in nonpregnant women and 28-day recurrence in men", "role": "Required", "role_reason": "An item prepared to distinguish The boundary between B62 single-dose treatment in nonpregnant women and 28-day recurrence in men and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for The boundary between B62 single-dose treatment in nonpregnant women and 28-day recurrence in men must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "Question clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are internally designed; distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptation are internally designed", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking The boundary between B62 single-dose treatment in nonpregnant women and 28-day recurrence in men as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The existing cross-citation of 862 refers to an article on single-dose fosfomycin for uncomplicated cystitis in women, B62. Only the relative URL and stored-summary wording are preserved; no new clinical evidence list, antibiotic selection or effect in men is created.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but The article's full text or trial and direct materials for the selected recurrence conditions have not been read. Review of existing content remains incomplete.", "missingness": "The article's full text or trial and direct materials for the selected recurrence conditions have not been read.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for The boundary between B62 single-dose treatment in nonpregnant women and 28-day recurrence in men." }, { "item_id": "N17", "question_type": "Efficacy comparison and presentation of stored material", "question": "What is the scope of VA support, products, employees and COI?", "needed": "The US VA Cooperative Studies Program and actual roles or support", "role": "Required", "role_reason": "An item prepared to distinguish The US VA Cooperative Studies Program and actual roles or support and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for The US VA Cooperative Studies Program and actual roles or support must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking The US VA Cooperative Studies Program and actual roles or support as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original VA public funding and the parent's I2 are preserved as historical records. Public funding alone is not taken as evidence about free drugs or placebo, company or employee authors, absence of COI, or an independence certification in this preparation.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but Details of product support, analysis or writing roles, authors or COI, and contracts remain unverified. Review of existing content remains incomplete.", "missingness": "Details of product support, analysis or writing roles, authors or COI, and contracts remain unverified.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for The US VA Cooperative Studies Program and actual roles or support." }, { "item_id": "N18", "question_type": "Efficacy comparison and presentation of stored material", "question": "Have the registration and prespecified recurrence plan actually been read?", "needed": "The NCT01994538 record, recurrence timing, hierarchy and denominator, and SAP", "role": "Required", "role_reason": "An item prepared to distinguish The NCT01994538 record, recurrence timing, hierarchy and denominator, and SAP and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for The NCT01994538 record, recurrence timing, hierarchy and denominator, and SAP must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking The NCT01994538 record, recurrence timing, hierarchy and denominator, and SAP as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original NCT01994538 is preserved. The identifier or description of the parent's prespecified analysis is not inherited as actual reading of the registration, protocol or SAP, or as fulfillment of prespecified recurrence conditions.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but The full registration, change history, recurrence plans or margins, and multiplicity have not been read. Review of existing content remains incomplete.", "missingness": "The full registration, change history, recurrence plans or margins, and multiplicity have not been read.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for The NCT01994538 record, recurrence timing, hierarchy and denominator, and SAP." }, { "item_id": "N19", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Are adverse-event denominators and differences a separate outcome from recurrence?", "needed": "28/136(20.6%), 33/136(24.3%), −3.7%p and the absence of a reported significance test", "role": "Supplementary", "role_reason": "An item prepared to distinguish 28/136(20.6%), 33/136(24.3%), −3.7%p and the absence of a reported significance test and connect the selected question's required materials with the available materials.", "application_exception": "Addresses gaps in harm information for the selected recurrence/additional tuberculosis prevention question. Original efficacy, recurrence or safety wording is not used to judge overall safety or generate harm rates or guidance on antibiotic or vaccine selection, use or suitability.", "criterion": "Relevant original materials and the scope of analysis for 28/136(20.6%), 33/136(24.3%), −3.7%p and the absence of a reported significance test must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Detailed distinctions are Chamgap design; M19 §19.1.2–19.2.4; Chamgap application; Chamgap interpretation boundary. M19 principles are referenced; no official causality tool was run", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking 28/136(20.6%), 33/136(24.3%), −3.7%p and the absence of a reported significance test as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original adverse-event results are 28/136(20.6%) versus 33/136(24.3%), difference −3.7%p; the stored summary historically states that it did not report a significance test. These are not converted to recurrence denominators, a statistical safety benefit or zero harm.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but Original safety collection or definitions, timing or omissions, CI or P values, and relatedness have not been read externally. Review of existing content remains incomplete.", "missingness": "Original safety collection or definitions, timing or omissions, CI or P values, and relatedness have not been read externally.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for 28/136(20.6%), 33/136(24.3%), −3.7%p and the absence of a reported significance test." }, { "item_id": "N20", "question_type": "Efficacy comparison and presentation of stored material", "question": "Does reduced exposure establish reduced individual resistance or long-term recurrence?", "needed": "Distinguishing exposure, resistance or culture, and outcomes beyond 28 days", "role": "Required", "role_reason": "An item prepared to distinguish Distinguishing exposure, resistance or culture, and outcomes beyond 28 days and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for Distinguishing exposure, resistance or culture, and outcomes beyond 28 days must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M03 §3.2.4; our own extension boundary; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are our own design; M19 §19.1.2–19.2.4; our own application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking Distinguishing exposure, resistance or culture, and outcomes beyond 28 days as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The article describes shorter exposure and proof of reduced individual resistance as separate matters. This is not extended to resistant organisms, culture-confirmed recurrence, long-term cure or complete prevention.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but Direct resistance or microbiological data, long-term recurrence, other harms and subgroup materials remain unverified. Review of existing content remains incomplete.", "missingness": "Direct resistance or microbiological data, long-term recurrence, other harms and subgroup materials remain unverified.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for Distinguishing exposure, resistance or culture, and outcomes beyond 28 days." }, { "item_id": "N21", "question_type": "Efficacy comparison and presentation of stored material", "question": "How are fractions, rates, differences and Korean or English article expressions preserved?", "needed": "Existing records, unread external original tables, and no calculation or correction", "role": "Required", "role_reason": "An item prepared to distinguish Existing records, unread external original tables, and no calculation or correction and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for Existing records, unread external original tables, and no calculation or correction must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and our own design", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking Existing records, unread external original tables, and no calculation or correction as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The recurrence fractions, parenthetical rates, difference and CI in the existing Korean article, and the rate or difference wording in the existing English article, are each preserved as recorded. No arithmetic comparison, original-table review, value correction or adjudication of conflicts with new materials is performed.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but Estimation, denominators and rounding in the original table, and detailed correspondence between languages remain unverified. Review of existing content remains incomplete.", "missingness": "Estimation, denominators and rounding in the original table, and detailed correspondence between languages remain unverified.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for Existing records, unread external original tables, and no calculation or correction." }, { "item_id": "N22", "question_type": "Efficacy comparison and presentation of stored material", "question": "At what level have the stored summary and external paper or article URLs been read?", "needed": "The entire stored summary, 1 clinical report and 2 other articles, with external materials unread", "role": "Required", "role_reason": "An item prepared to distinguish The entire stored summary, 1 clinical report and 2 other articles, with external materials unread and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for The entire stored summary, 1 clinical report and 2 other articles, with external materials unread must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking The entire stored summary, 1 clinical report and 2 other articles, with external materials unread as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The entire stored summary was read for preparation and is marked ‘Summary read’. PMID34313686 and the two relative article URLs are preserved; external papers or articles, registration, plans and COI are ‘Unread’. Existing cross-citation verification wording is not inherited as content review in this preparation.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but External access, link or click testing, and comparison with original texts were not performed. Review of existing content remains incomplete.", "missingness": "External access, link or click testing, and comparison with original texts were not performed.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for The entire stored summary, 1 clinical report and 2 other articles, with external materials unread." }, { "item_id": "N23", "question_type": "Efficacy comparison and presentation of stored material", "question": "Are dates, axes, null or false values, empty correction records and absent scores preserved?", "needed": "The parent's B70, subclaim D, 2026-08-26, existing Korean and English articles, and empty values", "role": "Required", "role_reason": "An item prepared to distinguish The parent's B70, subclaim D, 2026-08-26, existing Korean and English articles, and empty values and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for The parent's B70, subclaim D, 2026-08-26, existing Korean and English articles, and empty values must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. 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The questions in 1793 nitrofurantoin and 862 fosfomycin concern acute uncomplicated cystitis in women. UTI in men has traditionally been classified as a complicated infection; these results must not be combined with uncomplicated cystitis in women. The original recurrence fractions, rates, −3.0 difference and CI are each recorded unchanged. Parenthetical rates or differences are not recalculated from fractions, and the original table or observation window is not corrected. The women's articles 1793/862 provide other article context and are not direct trials of the selected recurrence question.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/34313686/" } ] }, { "report_id": "S02", "title": "1793 nitrofurantoin × clinical cure of acute uncomplicated cystitis (B 70)", "url": "https://chamgap.com/verdicts/womens/nitrofurantoin-acute-uncomplicated-cystitis-clinical-cure/", "report_type": "Citation-only report; no row in the original review summary's evidence list", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "REF2930-VERDICT1793", "independent_replication": null, "observed_result": "Uncomplicated cystitis in women and UTI in men are different questions. Existing cross-citation verification wording and bibliography are preserved historically; clinical content, judgments or numbers are not transferred as direct values for the selected question.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review." }, { "material_type": "External manuscript", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "Official source", "url": "https://chamgap.com/verdicts/womens/nitrofurantoin-acute-uncomplicated-cystitis-clinical-cure/" } ] }, { "report_id": "S03", "title": "862 single-dose fosfomycin 3 g × acute uncomplicated cystitis in nonpregnant women (B 62)", "url": "https://chamgap.com/verdicts/womens/fosfomycin-single-dose-uncomplicated-cystitis-women/", "report_type": "Citation-only report; no row in the original review summary's evidence list", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "REF2930-VERDICT862", "independent_replication": null, "observed_result": "Evidence for single-dose treatment in women is not repurposed for men. Existing cross-citation verification wording and bibliography are preserved historically; clinical content, judgments or numbers are not transferred as direct values for the selected question.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review." }, { "material_type": "External manuscript", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "Official source", "url": "https://chamgap.com/verdicts/womens/fosfomycin-single-dose-uncomplicated-cystitis-women/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" } ], "status_dictionary": { "Met": "A state used when required evidence is confirmed after user review. This production does not declare that review complete.", "Partly verified": "Some information in the stored summary is linked into the table. External comparison/content review is not complete.", "Unverified": "The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.", "Review incomplete": "User review pending.", "Not reported": "Not reported within the stored material actually read; not extended to the entire primary paper.", "Inaccessible": "Means an actual access failure. Access not attempted here is not assigned this state.", "Not applicable": "Not used as a substitute for an evidence gap.", "Conflicting data": "Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.", "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "S01 Drekonja2021/PMID34313686 is the same resolution, recurrence and safety report from 272 randomized afebrile men with UTI and 254 in the adherent primary analysis (131/123). The original parent's resolution noninferiority is distinguished from 28-day recurrence and safety denominators 136/136. Original recurrence fractions, parenthetical rates, differences and intervals are preserved as separate records without arithmetic checks, calculation or correction. The same report or population, sibling questions, groups, time points, denominators and article references are not added as new independent trials or participants. Report or material slots are not unique clinical totals; independent totals are null. S02 is an existing cross-citation reference to article 1793 on nitrofurantoin and clinical cure of acute uncomplicated cystitis in women, B70. The linked article or trial has not been read in this preparation; its population, exposure and endpoint differ from 28-day recurrence in afebrile men. The same report or population, sibling questions, groups, time points, denominators and article references are not added as new independent trials or participants. Report or material slots are not unique clinical totals; independent totals are null. S03 is an existing cross-citation reference to article 862 on single-dose fosfomycin for uncomplicated cystitis in nonpregnant women, B62. The linked article or trial has not been read in this preparation; its population, exposure and endpoint differ from 28-day recurrence in afebrile men. The same report or population, sibling questions, groups, time points, denominators and article references are not added as new independent trials or participants. Report or material slots are not unique clinical totals; independent totals are null." }, "history": [ { "date": "2026-10-10", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public pages and materials were prepared from the existing 24 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-10" }