{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2973-s1", "verdict_number": "2973", "title": "Penicillin V × Protection after stopping — Time intervals, 27% recurrence and gaps", "view_version": "1.0", "view_created_date": "2026-10-14", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "Adults with at least two leg-cellulitis episodes in the previous three years; PATCH I: 274 participants, 136/138, 28 hospitals. Post-treatment risk populations/follow-up denominators remain unverified.", "intervention": "Distinguish penicillin V preventive study exposure from off-treatment follow-up after stopping.", "dose": "Original study exposure: 250 mg twice daily for 12 months. No antibiotic-selection/intake/extension/discontinuation or treatment-replacement instructions.", "comparator": "PATCH I placebo; actual post-treatment concurrent care/re-exposure in both arms and PATCH II comparator details remain unverified.", "endpoint": "Selected persistent protection after stopping and original 27% result in both arms, separated from during-treatment time to first clinician-confirmed recurrence/HR/NNT.", "duration": "12 months during treatment versus off-treatment follow-up; exact post-treatment duration/censoring/denominator details remain unverified.", "excluded_extensions": [ "Transferring during-treatment effects to persistent protection after stopping or effects on other endpoints", "Adding the same reports/people/arms/periods/events/endpoints, citations, related sheets as new independent trials or participants", "Mixing randomized/ITT denominators, endpoint-specific observation/testing, person/time/event denominators and other cohorts", "New effects/CI/invented quantities, equivalence/zero effects, reassessment/grades or independence certification from original numbers", "Antibiotic/product-use, cellulitis-management/infection-prevention and treatment-replacement instructions" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which original post-treatment protection claim is selected?", "needed": "Selected wording/subclaim grade and parent effects during treatment", "role": "Required", "role_reason": "Needed to connect selected wording/subclaim grade and parent effects during treatment with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for selected wording/subclaim grade and parent effects during treatment together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Definitions, start/duration, denominators/estimands for post-treatment follow-up and review of the claim boundary. Parent scores do not fill the subclaim score. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The selected claim concerns persistent protection after stopping; its original subclaim grade is D and the note reports 27% in both arms during off-treatment follow-up. Absent subclaim score/status/axes are distinguished from parent B with 76 points and its axes.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Definitions, start/duration, denominators/estimands for post-treatment follow-up and review of the claim boundary. Parent scores do not fill the subclaim score.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Definitions, start/duration, denominators/estimands for post-treatment follow-up and review of the claim boundary. Parent scores do not fill the subclaim score." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Which recurrence-history population was studied?", "needed": "Adults with at least two leg-cellulitis episodes in the previous three years", "role": "Required", "role_reason": "Needed to connect adults with at least two leg-cellulitis episodes in the previous three years with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for adults with at least two leg-cellulitis episodes in the previous three years together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Eligibility/exclusions, baseline history/severity, oedema/skin/comorbidities, treatment/follow-up and direct comparisons in other populations. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original intervention population comprised adults with at least two recurrent leg-cellulitis episodes in the previous three years. PATCH I involved 28 hospitals and 274 participants. Do not extend to prevention after a first episode, other sites/causes or other antibiotics.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Eligibility/exclusions, baseline history/severity, oedema/skin/comorbidities, treatment/follow-up and direct comparisons in other populations.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Eligibility/exclusions, baseline history/severity, oedema/skin/comorbidities, treatment/follow-up and direct comparisons in other populations." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Are study exposure and the post-treatment interval separated?", "needed": "Penicillin V 250 mg twice daily for 12 months", "role": "Required", "role_reason": "Needed to connect penicillin V 250 mg twice daily for 12 months with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for penicillin V 250 mg twice daily for 12 months together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Original actual-exposure/adherence, discontinuation dates/reasons, concurrent treatment and follow-up time data. No drug/cellulitis-management or treatment-replacement instructions. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Original study exposure was penicillin V 250 mg twice daily for 12 months. Prevention during treatment and off-treatment follow-up are different intervals. No new cumulative dose, intake, extension/discontinuation or antibiotic-selection guidance.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Original actual-exposure/adherence, discontinuation dates/reasons, concurrent treatment and follow-up time data. No drug/cellulitis-management or treatment-replacement instructions.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original actual-exposure/adherence, discontinuation dates/reasons, concurrent treatment and follow-up time data. No drug/cellulitis-management or treatment-replacement instructions." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Is the scope of actual comparison/concurrent care known?", "needed": "Placebo comparison and post-treatment care", "role": "Required", "role_reason": "Needed to connect placebo comparison and post-treatment care with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for placebo comparison and post-treatment care together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Actual placebo/care in both arms, treatment completion/withdrawal, post-treatment care/exposure and observation data. Do not repurpose as comparisons of other doses/injections/procedures. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original design was multicentre, double-blind and randomized with placebo control. Actual concurrent treatment/antibiotics, care after recurrence, exposure changes and adherence after stopping remain unverified. The during-treatment comparator is not represented as identical active exposure afterwards.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Actual placebo/care in both arms, treatment completion/withdrawal, post-treatment care/exposure and observation data. Do not repurpose as comparisons of other doses/injections/procedures.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual placebo/care in both arms, treatment completion/withdrawal, post-treatment care/exposure and observation data. Do not repurpose as comparisons of other doses/injections/procedures." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "What is the direct post-treatment protection result?", "needed": "27% in both arms during off-treatment follow-up", "role": "Required", "role_reason": "Needed to connect 27% in both arms during off-treatment follow-up with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for 27% in both arms during off-treatment follow-up together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Arm-specific post-treatment numerators/denominators, estimands/CI, event/follow-up definitions, observation start/end and original tables. Do not back-calculate new event counts/HR/RR from 27%. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The selected note and bilingual text record recurrence in 27% of both arms after stopping and protection did not persist. Preserve this original result and subclaim grade D; do not apply during-treatment HR/NNT afterwards.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Arm-specific post-treatment numerators/denominators, estimands/CI, event/follow-up definitions, observation start/end and original tables. Do not back-calculate new event counts/HR/RR from 27%.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific post-treatment numerators/denominators, estimands/CI, event/follow-up definitions, observation start/end and original tables. Do not back-calculate new event counts/HR/RR from 27%." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Which interval do the during-treatment numbers concern?", "needed": "30/136 versus 51/138, HR/CI/P and NNT", "role": "Required", "role_reason": "Needed to connect 30/136 versus 51/138, HR/CI/P and NNT with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for 30/136 versus 51/138, HR/CI/P and NNT together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Interval-specific estimands, denominators/censoring, models/plans and post-treatment effects/CI. No new absolute difference/RRR/NNT/CI calculations. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "First recurrence during treatment was 30/136 (22%) versus 51/138 (37%), HR 0.55 (CI 0.35–0.86), P=.01, original absolute difference −15 percentage points and NNT 5 (4–9). These concern comparison during 12 months of treatment, not protection after stopping or permanent effects.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Interval-specific estimands, denominators/censoring, models/plans and post-treatment effects/CI. No new absolute difference/RRR/NNT/CI calculations.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Interval-specific estimands, denominators/censoring, models/plans and post-treatment effects/CI. No new absolute difference/RRR/NNT/CI calculations." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Are observation starts and lengths during/after treatment verified?", "needed": "Time intervals and the post-treatment follow-up-duration gap", "role": "Required", "role_reason": "Needed to connect time intervals and the post-treatment follow-up-duration gap with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for time intervals and the post-treatment follow-up-duration gap together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Interval-specific observation plans, treatment end/follow-up start, censoring/withdrawal, actual exposure/event-time originals. Do not mix post-treatment cumulative and time-specific risks. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original separates 12 months during treatment from the off-treatment interval; exact post-treatment length, individual observation/end, follow-up loss/re-exposure are not established by the summary. No new total follow-up years/person-time.", "condition_status": "Unverified", "status_reason": "Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Interval-specific observation plans, treatment end/follow-up start, censoring/withdrawal, actual exposure/event-time originals. Do not mix post-treatment cumulative and time-specific risks.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Interval-specific observation plans, treatment end/follow-up start, censoring/withdrawal, actual exposure/event-time originals. Do not mix post-treatment cumulative and time-specific risks." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "What is the risk population underlying post-treatment 27%?", "needed": "274 randomized participants and interval-specific denominators", "role": "Required", "role_reason": "Needed to connect 274 randomized participants and interval-specific denominators with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for 274 randomized participants and interval-specific denominators together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Interval-specific risk sets/denominators, events/censoring, flow/follow-up loss and analysis data. No new post-treatment events/rates or participant addition. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Original randomization comprised 274 participants, 136/138, and the original post-treatment proportion is 27% in both arms. Arm-specific post-treatment observation/analysis, risk sets after recurrence/among nonrecurring participants, person-time/numerators remain unverified. Do not calculate new post-treatment events from randomized 136/138.", "condition_status": "Unverified", "status_reason": "Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Interval-specific risk sets/denominators, events/censoring, flow/follow-up loss and analysis data. No new post-treatment events/rates or participant addition.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Interval-specific risk sets/denominators, events/censoring, flow/follow-up loss and analysis data. No new post-treatment events/rates or participant addition." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Are first recurrence and all repeated events distinguished?", "needed": "Time to first clinician-confirmed leg recurrence", "role": "Required", "role_reason": "Needed to connect time to first clinician-confirmed leg recurrence with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for time to first clinician-confirmed leg recurrence together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Original interval-specific event definitions, first/repeated aggregation, person/leg identifiers, post-recurrence care and denominators/analysis plans. The same people/legs are not new participants. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original primary endpoint was time to first clinician-confirmed leg-cellulitis recurrence. Exact post-treatment 27% event aggregation, first/repeated/same-leg and time details remain unverified. Do not repurpose as all repeated events or other sites.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Original interval-specific event definitions, first/repeated aggregation, person/leg identifiers, post-recurrence care and denominators/analysis plans. The same people/legs are not new participants.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original interval-specific event definitions, first/repeated aggregation, person/leg identifiers, post-recurrence care and denominators/analysis plans. The same people/legs are not new participants." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Are clinician confirmation and reporting/adjudication details separated?", "needed": "Original confirmation procedures and post-treatment measurement gaps", "role": "Required", "role_reason": "Needed to connect original confirmation procedures and post-treatment measurement gaps with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for original confirmation procedures and post-treatment measurement gaps together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Event diagnosis/reporting, adjudication/masking, confirmation and post-treatment observation/missingness data. No formal RoB assessment in this production. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original study-product description explains that recurrence was clinician-confirmed rather than solely participant-reported. Interval-specific reporting/confirmation, diagnostic criteria, missingness/adjudication/masking details remain unverified. Do not invent post-treatment confirmation/follow-up methods.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Event diagnosis/reporting, adjudication/masking, confirmation and post-treatment observation/missingness data. No formal RoB assessment in this production.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Event diagnosis/reporting, adjudication/masking, confirmation and post-treatment observation/missingness data. No formal RoB assessment in this production." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Are ITT and actual adherence/follow-up/withdrawal distinguished?", "needed": "Analysis as randomized and actual observed denominators", "role": "Required", "role_reason": "Needed to connect analysis as randomized and actual observed denominators with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for analysis as randomized and actual observed denominators together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Original arm-specific flow, actual exposure/adherence, analysis/observation, censoring/withdrawal reasons and sensitivity plans. No new withdrawal counts/rates or adherence-effect calculations. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original study description records ITT principles, central-pharmacy dispensing and double-blinding. Actual adherence/discontinuation, interval-specific completion/withdrawal, missingness/censoring are not established by the summary. ITT is not converted into universal completion/observation across all intervals.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Original arm-specific flow, actual exposure/adherence, analysis/observation, censoring/withdrawal reasons and sensitivity plans. No new withdrawal counts/rates or adherence-effect calculations.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original arm-specific flow, actual exposure/adherence, analysis/observation, censoring/withdrawal reasons and sensitivity plans. No new withdrawal counts/rates or adherence-effect calculations." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Are equal post-treatment proportions newly certified as equivalence/zero effect?", "needed": "Original 27%/lost protection and unverified CI", "role": "Required", "role_reason": "Needed to connect original 27%/lost protection and unverified CI with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for original 27%/lost protection and unverified CI together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Post-treatment comparative effects/CI, interval/model, prespecified clinical thresholds, original denominators and data. Do not extend original grade D through new calculation/reassessment. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Preserve the original verdict of 27% in both arms and loss of persistent protection. Exact post-treatment effects/CI, equivalence/noninferiority/clinical thresholds are absent here; do not newly certify exclusion of all benefit or exactly zero effect.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Post-treatment comparative effects/CI, interval/model, prespecified clinical thresholds, original denominators and data. Do not extend original grade D through new calculation/reassessment.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Post-treatment comparative effects/CI, interval/model, prespecified clinical thresholds, original denominators and data. Do not extend original grade D through new calculation/reassessment." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Does PATCH II concern the same trial/interval?", "needed": "Separate 123-person cohort with HR 0.53", "role": "Required", "role_reason": "Needed to connect separate 123-person cohort with HR 0.53 with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for separate 123-person cohort with HR 0.53 together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Original PATCH II population/intervention/duration/intervals, events/denominators/plans and funding/author relationships. Do not copy PATCH I exposure, post-treatment 27%, funding/registration into it. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01", "R02" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original counterview records PATCH II with 123 participants, HR 0.53 (CI 0.26–1.07), P=.08, individually nonsignificant. Preserve the original description that its interval includes PATCH I’s 0.55 estimate and does not statistically conflict, and that it was a separate cohort in the same network.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Original PATCH II population/intervention/duration/intervals, events/denominators/plans and funding/author relationships. Do not copy PATCH I exposure, post-treatment 27%, funding/registration into it.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original PATCH II population/intervention/duration/intervals, events/denominators/plans and funding/author relationships. Do not copy PATCH I exposure, post-treatment 27%, funding/registration into it." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "What is the hierarchy of during-treatment success and post-treatment analysis?", "needed": "First recurrence as primary and interval-specific plans", "role": "Required", "role_reason": "Needed to connect first recurrence as primary and interval-specific plans with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for first recurrence as primary and interval-specific plans together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Interval-specific endpoints, censoring/analysis, hierarchy/multiplicity and amendments/publication timing in registration/protocol/SAP. Do not newly designate post-treatment analysis as confirmatory/exploratory. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Preserve the original primary time-to-first-recurrence and matching pre-recruitment registration descriptions. Prespecification/secondary hierarchy, all testing, amendments and model details for post-treatment analysis were not established through original-plan reading now.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Interval-specific endpoints, censoring/analysis, hierarchy/multiplicity and amendments/publication timing in registration/protocol/SAP. Do not newly designate post-treatment analysis as confirmatory/exploratory.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Interval-specific endpoints, censoring/analysis, hierarchy/multiplicity and amendments/publication timing in registration/protocol/SAP. Do not newly designate post-treatment analysis as confirmatory/exploratory." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Is permanent protection extended to a single course/other antibiotics?", "needed": "Applicability boundaries of study population/drug/duration", "role": "Required", "role_reason": "Needed to connect applicability boundaries of study population/drug/duration with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for applicability boundaries of study population/drug/duration together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Direct population/drug/route/duration, during/post-treatment effects/CI and harms for each applicability question. No new antibiotic selection, extension/discontinuation or cellulitis-management guidance. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original advertising interpretation excludes extension to prevention after a first episode, other antibiotics/doses/injection routes and continuing protection after one course. During-treatment signals are not converted to long-term-management/treatment-replacement instructions.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Direct population/drug/route/duration, during/post-treatment effects/CI and harms for each applicability question. No new antibiotic selection, extension/discontinuation or cellulitis-management guidance.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct population/drug/route/duration, during/post-treatment effects/CI and harms for each applicability question. No new antibiotic selection, extension/discontinuation or cellulitis-management guidance." }, { "item_id": "N16", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Are adverse-event reporter counts and event counts distinguished?", "needed": "37 versus 48 people, P=.50", "role": "Supplementary", "role_reason": "Needed to connect 37 versus 48 people, P=.50 with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for 37 versus 48 people, P=.50 together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Original AE collection, reporter/event aggregation, arm exposure/harm denominators, intervals/discontinuation/relatedness and types. No new harm rates/effects or management instructions. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original safety description records 37 versus 48 adverse-event reporters, P=.50. People are distinguished from events/severity/types and interval/actual-exposure denominators, which remain unverified. P=.50 is not converted into no harm/equivalence.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Original AE collection, reporter/event aggregation, arm exposure/harm denominators, intervals/discontinuation/relatedness and types. No new harm rates/effects or management instructions.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original AE collection, reporter/event aggregation, arm exposure/harm denominators, intervals/discontinuation/relatedness and types. No new harm rates/effects or management instructions." }, { "item_id": "N17", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Are allergy, gastrointestinal and resistance harm boundaries retained?", "needed": "Long-term antibiotic burdens and interval-specific data", "role": "Supplementary", "role_reason": "Needed to connect long-term antibiotic burdens and interval-specific data with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for long-term antibiotic burdens and interval-specific data together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Harm-specific collection/exposure/denominators, discontinuation/relatedness, resistance measurement and long-term/post-treatment data. No antibiotic/infection-prevention/treatment instructions. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Original counterview/safety descriptions retain allergy, gastrointestinal adverse effects and antimicrobial-resistance burdens. Event counts/causes/duration by type and post-treatment harm/resistance data remain unverified. No new certification of overall study safety/absence of resistance.", "condition_status": "Unverified", "status_reason": "Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Harm-specific collection/exposure/denominators, discontinuation/relatedness, resistance measurement and long-term/post-treatment data. No antibiotic/infection-prevention/treatment instructions.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Harm-specific collection/exposure/denominators, discontinuation/relatedness, resistance measurement and long-term/post-treatment data. No antibiotic/infection-prevention/treatment instructions." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Are during-treatment signals transferred to post-treatment mechanism/protection?", "needed": "Effect timing and direct persistence data", "role": "Required", "role_reason": "Needed to connect effect timing and direct persistence data with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.", "application_exception": "Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for effect timing and direct persistence data together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Direct post-treatment plans, observation/risk populations, re-exposure/concurrent treatment and effects/CI/harms. No invented persistent protection/management instructions. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original crux limits reduced recurrence to treatment and reports protection disappearing after stopping. During-treatment HR/NNT or mechanistic plausibility do not newly prove permanent/post-treatment protection.", "condition_status": "Unverified", "status_reason": "Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Direct post-treatment plans, observation/risk populations, re-exposure/concurrent treatment and effects/CI/harms. No invented persistent protection/management instructions.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct post-treatment plans, observation/risk populations, re-exposure/concurrent treatment and effects/CI/harms. No invented persistent protection/management instructions." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "What materials were actually read or acquired?", "needed": "Preserved summary and external original materials", "role": "Required", "role_reason": "Needed to connect preserved summary and external original materials with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for preserved summary and external original materials together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Records of actual acquisition/reading scope, versions and dates. No external-link/click/access testing. Only material requests/research needs are recorded; no search or research was performed in that production.", "current_reports": [ "R01", "R02" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The complete parent summary was read for production and preserved in its original form. Summary reading concerns preserved materials; external abstracts/full texts/registrations/protocols/SAP remain unread. Original citations/URLs do not establish external reading here.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Records of actual acquisition/reading scope, versions and dates. No external-link/click/access testing.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Records of actual acquisition/reading scope, versions and dates. No external-link/click/access testing." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Are historical registration/plans distinguished from current reading?", "needed": "Original registration identifier and detailed comparison", "role": "Required", "role_reason": "Needed to connect original registration identifier and detailed comparison with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for original registration identifier and detailed comparison together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Actual registration versions/publication, recruitment/start/amendments, endpoints/models/analysis intervals and original report links. Preserve historical descriptions without new certification of plans or prospective specification. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01", "R02" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Original PATCH I evidence records ISRCTN34716921 and EudraCT 2006-000381-36; original bilingual text describes registration before recruitment and primary-endpoint matching. No current comparison of official registration URLs/versions/actual public dates. PATCH II registration information is unidentified here.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Actual registration versions/publication, recruitment/start/amendments, endpoints/models/analysis intervals and original report links. Preserve historical descriptions without new certification of plans or prospective specification.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual registration versions/publication, recruitment/start/amendments, endpoints/models/analysis intervals and original report links. Preserve historical descriptions without new certification of plans or prospective specification." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Have protocol/SAP and analysis/missing-data plans been acquired?", "needed": "Separate materials for prespecified plans/changes", "role": "Required", "role_reason": "Needed to connect separate prespecified-plan and amendment materials with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for separate prespecified-plan and amendment materials together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Protocol, SAP, amendments, estimands/denominators/analyses, all endpoints and publication timing. Unread materials are not assumed absent. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01", "R02" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Original primary-outcome/ITT/registration descriptions and historical cross-checking are preserved. Actual protocol/SAP versions/timing, interval/endpoint-specific models/censoring/missingness and hierarchy/multiplicity were not newly read.", "condition_status": "Unverified", "status_reason": "Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Protocol, SAP, amendments, estimands/denominators/analyses, all endpoints and publication timing. Unread materials are not assumed absent.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Protocol, SAP, amendments, estimands/denominators/analyses, all endpoints and publication timing. Unread materials are not assumed absent." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Are sponsorship, funding, products, authors and research involvement separated?", "needed": "Four company-involvement items and nonprofit/public/academic support", "role": "Required", "role_reason": "Needed to connect four company-involvement items and nonprofit/public/academic support with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for four company-involvement items and nonprofit/public/academic support together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Separate original materials on company cash funding, product support, employee authors/outside relationships, design/analysis/data control and nonprofit/institutional support. Original independence-axis values are not new certification of all items or independence. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01", "R02" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "PATCH I had nonprofit Action Medical Research funding and University of Nottingham sponsorship; the original limitation is that pharmaceutical cash/product/analysis support was not identified. Employee authors/design/writing/publication, individual roles and PATCH II funding details remain separately unverified.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Separate original materials on company cash funding, product support, employee authors/outside relationships, design/analysis/data control and nonprofit/institutional support. Original independence-axis values are not new certification of all items or independence.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate original materials on company cash funding, product support, employee authors/outside relationships, design/analysis/data control and nonprofit/institutional support. Original independence-axis values are not new certification of all items or independence." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Are results by interval/endpoint distinguished from information gaps?", "needed": "Direct results, unverified details and access status", "role": "Required", "role_reason": "Needed to connect direct results, unverified details and access status with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for direct results, unverified details and access status together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Direct measurements, original interval/endpoint tables, plans, observations/denominators and actual access records. Do not substitute unread with unreported or null with exactly zero effect/equivalence. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01", "R02" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Distinguish positive first recurrence during treatment from post-treatment 27% in both arms/original ineffective persistent protection and post-treatment effect/denominator gaps.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Direct measurements, original interval/endpoint tables, plans, observations/denominators and actual access records. Do not substitute unread with unreported or null with exactly zero effect/equivalence.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct measurements, original interval/endpoint tables, plans, observations/denominators and actual access records. Do not substitute unread with unreported or null with exactly zero effect/equivalence." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are reports, trials, people, intervals, events and related sheets separated?", "needed": "Linked records versus unique trials/participants", "role": "Required", "role_reason": "Needed to connect linked records and unique trials/participants with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for linked records and unique trials/participants together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Original reports/registration, cohorts/intervals, events/repetition/observation and overlap relationships. Unique-trial/participant totals remain unrecorded. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01", "R02" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Parent 2973 and its selected s0/s1 claims share the PATCH I report/cohort, during/post-treatment context and PATCH II reference report. Preserve only the original separate-cohort/same-network PATCH II relationship; no new independent-replication count. The same people, legs, periods, events, citations and related sheets are not added as new participants/trials. Linked-report counts are not certified unique trial/participant totals.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Original reports/registration, cohorts/intervals, events/repetition/observation and overlap relationships. Unique-trial/participant totals remain unrecorded.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original reports/registration, cohorts/intervals, events/repetition/observation and overlap relationships. Unique-trial/participant totals remain unrecorded." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Are the original single trial and separate independent replication distinguished?", "needed": "Parent R1, independence axis and direct replication", "role": "Supplementary", "role_reason": "Needed to connect parent R1, independence axis and direct replication with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for parent R1, independence axis and direct replication together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Separate prespecified confirmation matching the question, with direct population/intervention/comparator/endpoint/duration, denominators/effects/CI and funding/author relationships. No new search or independence verdict. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01", "R02" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Preserve parent R1/I2. Intervals/endpoints/related sheets in the same participants are not certified as new independent replication; PATCH II same-network relationships and manufacturer support remain separate.", "condition_status": "Unverified", "status_reason": "Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Separate prespecified confirmation matching the question, with direct population/intervention/comparator/endpoint/duration, denominators/effects/CI and funding/author relationships. No new search or independence verdict.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate prespecified confirmation matching the question, with direct population/intervention/comparator/endpoint/duration, denominators/effects/CI and funding/author relationships. No new search or independence verdict." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Are the subclaim grade and parent score/axes preserved?", "needed": "Selected D, missing score/status/axes and parent context", "role": "Required", "role_reason": "Needed to connect selected D, missing score/status/axes and parent context with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for selected D, missing score/status/axes and parent context together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Existing subclaim/parent-boundary review and actual correction materials. Distinguish absent/original axis values and their history. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Preserve selected grade/note and bilingual claims; absent subclaim score/status/axes remain unrecorded. Parent B with 76 points and safety/axes are parent context. They do not supply selected scores or create new grades/RoB 2/GRADE certification.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Existing subclaim/parent-boundary review and actual correction materials. Distinguish absent/original axis values and their history.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Existing subclaim/parent-boundary review and actual correction materials. Distinguish absent/original axis values and their history." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Are both languages, citations and absent fields preserved?", "needed": "Both original languages and absent separate classification information", "role": "Required", "role_reason": "Needed to connect both original languages and absent classification fields with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for both original languages and absent classification fields together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Materials for reviewing bilingual terminology, time/event/effect units, selected scope and absent fields. Production explanations are distinguished from original records. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Preserve parent Korean/English citations/descriptions, evidence/citation lists, axes and selected-subclaim records in the complete summary. Separate classification information in both languages is absent; originals are not filled with new fields. No external English full-text comparison.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Materials for reviewing bilingual terminology, time/event/effect units, selected scope and absent fields. Production explanations are distinguished from original records.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Materials for reviewing bilingual terminology, time/event/effect units, selected scope and absent fields. Production explanations are distinguished from original records." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Are source dates/corrections/history separated from production dates?", "needed": "Original 2026-08-26 and new conditions/application", "role": "Required", "role_reason": "Needed to connect original 2026-08-26 and new conditions/application with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for original 2026-08-26 and new conditions/application together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Update materials separating originals, events, conditions/observations and verdict decisions when new evidence/corrections arise. Historical wording is not completed clinical content review here. Only material requests/research needs are recorded; no search or research was performed in that production.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Original evidence date 2026-08-26, empty corrections/deliberation and grade-decision cross-checking are preserved. Historical citation/registration descriptions differ from current production, condition freezing/application and completed content review.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Update materials separating originals, events, conditions/observations and verdict decisions when new evidence/corrections arise. Historical wording is not completed clinical content review here.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Update materials separating originals, events, conditions/observations and verdict decisions when new evidence/corrections arise. Historical wording is not completed clinical content review here." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "What direct materials would fill the selected gaps?", "needed": "Direct interval/endpoint effects, denominators/CI and follow-up", "role": "Supplementary", "role_reason": "Needed to connect direct interval/endpoint effects, denominators/CI and follow-up with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for direct interval/endpoint effects, denominators/CI and follow-up together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Original tables/plans, interval/endpoint definitions, estimands/CI, observation/censoring/denominators, exposure/adherence, independent confirmation and long-term harms. Only the need is recorded; no new lookup/research. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01", "R02" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Post-treatment persistent protection requires the risk population/observation and direct effects/CI for that interval; during-treatment signals do not substitute.", "condition_status": "Unverified", "status_reason": "Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Original tables/plans, interval/endpoint definitions, estimands/CI, observation/censoring/denominators, exposure/adherence, independent confirmation and long-term harms. Only the need is recorded; no new lookup/research.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original tables/plans, interval/endpoint definitions, estimands/CI, observation/censoring/denominators, exposure/adherence, independent confirmation and long-term harms. Only the need is recorded; no new lookup/research." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Are applicability records separated from content review and instructions?", "needed": "Applicability records, existing candidate history and content review", "role": "Supplementary", "role_reason": "Needed to connect condition records, historical candidates and content review with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for condition records, historical candidates and content review together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Content review and subsequent actual evidence/correction work. Original content-production scope excludes clinical QA/testing, external-link/access/web/API research, new calculations/grades and antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "These are summary-based applicability records. Existing content/question-boundary review remains incomplete; candidate pending/eligible markers are preserved as history.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Content review and subsequent actual evidence/correction work. Original content-production scope excludes clinical QA/testing, external-link/access/web/API research, new calculations/grades and antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Content review and subsequent actual evidence/correction work. Original content-production scope excludes clinical QA/testing, external-link/access/web/API research, new calculations/grades and antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions." } ], "reports": [ { "report_id": "R01", "title": "Thomas KS, et al. Penicillin to prevent recurrent leg cellulitis. N Engl J Med. 2013;368:1695-1703. PMID: 23635049.", "url": "https://pubmed.ncbi.nlm.nih.gov/23635049/", "report_type": "Multicentre double-blind randomized placebo-controlled trial", "existence": "Report bibliography exists in original citations; external availability/access remain unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/plans remain unread", "study_family": "F01", "independent_replication": "The same report/intervals/endpoints/related sheets are not certified as new independent replication", "observed_result": "30/136 (22%) versus 51/138 (37%); HR 0.55 (0.35–0.86), P=.01; NNT 5 (4–9)", "result_level": "Parent-endpoint summary from original evidence; during/post-treatment intervals and boundaries of other endpoints are distinguished in checklist conditions/roles.", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Local preserved copy of the complete parent summary", "access_status": "Stored summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only original PubMed URL/citation and registration identifier are preserved; absent full-text/registration/plan URLs or registration for other reports are not guessed. No new external reading/access or certification that conditions are met." }, { "material_type": "External abstract", "public_status": "Original identifier/bibliography or required-material entry; public availability/access details remain unverified", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Only original PubMed URL/citation and registration identifier are preserved; absent full-text/registration/plan URLs or registration for other reports are not guessed. No new external reading/access or certification that conditions are met." }, { "material_type": "External full text", "public_status": "Original identifier/bibliography or required-material entry; public availability/access details remain unverified", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Only original PubMed URL/citation and registration identifier are preserved; absent full-text/registration/plan URLs or registration for other reports are not guessed. No new external reading/access or certification that conditions are met." }, { "material_type": "Registration material", "public_status": "Original identifier/bibliography or required-material entry; public availability/access details remain unverified", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Only original PubMed URL/citation and registration identifier are preserved; absent full-text/registration/plan URLs or registration for other reports are not guessed. No new external reading/access or certification that conditions are met." }, { "material_type": "Protocol/SAP", "public_status": "Original identifier/bibliography or required-material entry; public availability/access details remain unverified", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Only original PubMed URL/citation and registration identifier are preserved; absent full-text/registration/plan URLs or registration for other reports are not guessed. No new external reading/access or certification that conditions are met." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/23635049/" } ] }, { "report_id": "R02", "title": "UK Dermatology Clinical Trials Network. PATCH II. Br J Dermatol. 2012. PMID: 21910701.", "url": "https://pubmed.ncbi.nlm.nih.gov/21910701/", "report_type": "Separate PATCH II cohort; design/population/duration details remain unverified in the preserved summary.", "existence": "Report bibliography exists in original citations; external availability/access remain unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/plans remain unread", "study_family": "F02", "independent_replication": "The separate same-network PATCH II cohort was not counted as independent replication in the original; no additional independence certification.", "observed_result": "PATCH II’s 123 participants had HR 0.53 (0.26–1.07), P=.08, individually nonsignificant. Its interval includes PATCH I’s 0.55 estimate and was described as not statistically conflicting. It was a separate cohort in the same network and was not counted as independent replication.", "result_level": "Original counterview’s individual PATCH II HR/CI/P and cohort relationships, separated from PATCH I results.", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Local preserved copy of the complete parent summary", "access_status": "Stored summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only original PubMed URL/citation and registration identifier are preserved; absent full-text/registration/plan URLs or registration for other reports are not guessed. No new external reading/access or certification that conditions are met." }, { "material_type": "External abstract", "public_status": "Original identifier/bibliography or required-material entry; public availability/access details remain unverified", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Only original PubMed URL/citation and registration identifier are preserved; absent full-text/registration/plan URLs or registration for other reports are not guessed. No new external reading/access or certification that conditions are met." }, { "material_type": "External full text", "public_status": "Original identifier/bibliography or required-material entry; public availability/access details remain unverified", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Only original PubMed URL/citation and registration identifier are preserved; absent full-text/registration/plan URLs or registration for other reports are not guessed. No new external reading/access or certification that conditions are met." }, { "material_type": "Registration material", "public_status": "Original identifier/bibliography or required-material entry; public availability/access details remain unverified", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Only original PubMed URL/citation and registration identifier are preserved; absent full-text/registration/plan URLs or registration for other reports are not guessed. No new external reading/access or certification that conditions are met." }, { "material_type": "Protocol/SAP", "public_status": "Original identifier/bibliography or required-material entry; public availability/access details remain unverified", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Only original PubMed URL/citation and registration identifier are preserved; absent full-text/registration/plan URLs or registration for other reports are not guessed. No new external reading/access or certification that conditions are met." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/21910701/" } ] } ], "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": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "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": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "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": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "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": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "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": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." } ], "status_dictionary": { "Partly verified": "Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.", "Unverified": "Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety", "Review incomplete": "Review of existing content incomplete", "Met": "Use only within the relevant conditions after existing content review; no automatic designation in this preparation", "Not reported": "Distinguish only within materials actually read; do not turn unread external materials into unreported findings", "Inaccessible": "Not applied during this preparation because actual access was not tested", "Not applicable": "Use with a reason for non-applicability based on an explicit question boundary", "Conflicting data": "Judge after actual material comparison; review was not performed during this preparation", "Insufficient evidence for the conditions": "Do not use as a clinical grade encompassing currently unread materials" }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "Separate PATCH I’s primary during-treatment interval from the selected direct post-treatment proportion; no mixing with other cohorts. Parent 2973 and its s0/s1 claims share the PATCH I report/cohort, during/post-treatment context and PATCH II reference report. Preserve the original separate-cohort/same-network PATCH II relationship without newly counting independent replication. The same people, legs, periods, events, citations and related sheets are not added as new participants/trials. These are provisional citation-based links, not certification of unique trials/participants or independence. PATCH II is a separate cohort in the same network, with HR 0.53/CI/P=.08 context; do not copy PATCH I post-treatment 27%, exposure/registration/funding into it. The shared original report/cohort and related-sheet relationships remain as described above, without new participant/trial totals or independence certification." }, "history": [ { "date": "2026-10-14", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public page and data were prepared from the existing 30 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-14" }