{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2973-s0", "verdict_number": "2973", "title": "Low-dose penicillin × Reduced first recurrence during 12 months of treatment", "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. Original PATCH I: 28 hospitals, 274 participants, 136/138. Detailed eligibility/baseline risk, time-specific observation/risk denominators and withdrawal/missingness remain unverified. PATCH I conditions are not automatically applied to the separate 123-person PATCH II cohort.", "intervention": "Only original PATCH I study exposure is preserved: penicillin V 250 mg twice daily for 12 months. Actual adherence/discontinuation and product/formulation remain unverified; no intake/prevention/cellulitis-management or other-drug/dose/route instructions.", "dose": "Separate 12 months during treatment from off-treatment follow-up afterwards. Actual intake/duration, discontinuation/re-exposure and post-treatment windows remain unverified; no new dose/frequency/duration conversion.", "comparator": "Multicentre double-blind randomized placebo comparison. Central-pharmacy dispensing, ITT and pre-recruitment registration/matching-endpoint descriptions are preserved history, not current original-text/procedural verification. Actual placebo/contact, concurrent treatment and masking/allocation details remain unread/unverified.", "endpoint": "Time to first clinician-confirmed recurrence; during treatment 30/136 (22%) versus 51/138 (37%), HR 0.55 (95% CI 0.35–0.86)/P=.01, original absolute difference −15 percentage points and NNT 5 (4–9) are preserved as separate original estimands. People/first events/all repeated events/time are not combined; no new arithmetic/effects/CI. Post-treatment 27% in both arms is a separate-period result.", "duration": "Distinguish original PATCH I first recurrence during 12 months from lost protection after stopping. PATCH II HR 0.53 (0.26–1.07)/P=.08, 123 participants, concerns a separate cohort in the same network; exact exposure/duration/eligibility remain unverified.", "excluded_extensions": [ "Calculating new effects/CI, proportions/events, observation time or repeated totals from 30/136, 51/138 or 22%/37%", "Recalculating/correcting original absolute difference −15 percentage points, NNT 5 (4–9) or HR 0.55, or transferring them to other periods/populations", "Turning post-treatment 27% in both arms into new proof of during-treatment effects, permanent protection or exactly zero effect/equivalence", "Adding/mixing first-recurrence time, recurrent people within a period and all repeated events/people/time", "Applying PATCH I eligibility, 12-month exposure, registration/denominators/plans to PATCH II’s 123 participants/HR 0.53/CI/P=.08", "Turning original PATCH I/II relationships into independent replication, new pooled effects or clinical-participant/trial totals", "Repurposing adverse-event reporters 37/48/P=.50 as total related events, no harm, resistance measurements or equivalent safety", "Inheriting original parent values/axes and historical cross-checking/registration/allocation/masking/analysis descriptions as subclaim scores or current clinical-content review/full-text reading", "New arithmetic, invented quantities, effects/CI, grades/independence certification or antibiotic-use/prevention/cellulitis-management/treatment-replacement instructions" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Selected first recurrence during treatment and original grade", "needed": "Original wording/grade/note versus parent values and post-treatment results", "role": "Required", "role_reason": "An application item distinguishing Original wording/grade/note versus parent values and post-treatment results to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant originals and analysis scope for Original wording/grade/note versus parent values and post-treatment results should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up comparative research specifying first-recurrence endpoints by period; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Selected subclaim: reduced first recurrence during 12 months, grade B, with the original 22% versus 37%/NNT 5 note. Subclaim score/status/axes are absent; parent B with 76 points does not fill the subclaim score.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Subclaim score/status/axes are absent; distinguish protection after stopping from first recurrence. Existing content review remains incomplete.", "missingness": "Subclaim score/status/axes are absent; distinguish protection after stopping from first recurrence.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original selected-subclaim/parent records and user correction comments" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Recurrence risk, eligibility and population", "needed": "Recent recurrence, age/eligibility, baseline risk and applicability", "role": "Required", "role_reason": "An application item distinguishing Recent recurrence, age/eligibility, baseline risk and applicability to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant originals and analysis scope for Recent recurrence, age/eligibility, baseline risk and applicability should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.1; Detailed population conditions are Chamgap design; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details are Chamgap design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research specifying recurrence risk and population scope; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original PATCH I population: adults with at least two leg-cellulitis episodes in the previous three years. Do not extend to prevention after a first episode or other sites/populations.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Detailed eligibility, baseline conditions/recurrence frequency, diagnosis/exclusions, recruitment and arm balance remain unverified. Existing content review remains incomplete.", "missingness": "Detailed eligibility, baseline conditions/recurrence frequency, diagnosis/exclusions, recruitment and arm balance remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Eligibility/recruitment and baseline risk/characteristic tables" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Penicillin V study exposure", "needed": "Original antibiotic, dose/frequency/duration and formulation identity", "role": "Required", "role_reason": "An application item distinguishing Original antibiotic, dose/frequency/duration and formulation identity to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant originals and analysis scope for Original antibiotic, dose/frequency/duration and formulation identity should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research separating drug/duration from applicability; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original study exposure was penicillin V 250 mg twice daily for 12 months. Preserve study exposure only; do not convert it to intake/prevention/cellulitis-management instructions.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Study product/formulation, manufacture/quality, actual exposure and correspondence to other antibiotics/doses/routes remain unverified. Existing content review remains incomplete.", "missingness": "Study product/formulation, manufacture/quality, actual exposure and correspondence to other antibiotics/doses/routes remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Study-drug ingredients/formulation, manufacture and exposure data" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Placebo and comparison specifications", "needed": "Actual placebo composition/sensory features, contact and concurrent treatment matching", "role": "Required", "role_reason": "An application item distinguishing Actual placebo composition/sensory features, contact and concurrent treatment matching to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant originals and analysis scope for Actual placebo composition/sensory features, contact and concurrent treatment matching should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up trial specifying actual comparison conditions; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "S01 was a multicentre double-blind randomized placebo-controlled trial. The placebo name does not verify matching of all composition/contact/concurrent management.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Placebo ingredients/appearance, supply, contact/instructions, concurrent treatment and distinguishability remain unverified. Existing content review remains incomplete.", "missingness": "Placebo ingredients/appearance, supply, contact/instructions, concurrent treatment and distinguishability remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Placebo/contact and concurrent-exposure/masking materials" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Central pharmacy and allocation concealment", "needed": "Original allocation/drug-supply descriptions versus actual original-text verification", "role": "Required", "role_reason": "An application item distinguishing Original allocation/drug-supply descriptions versus actual original-text verification to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant originals and analysis scope for Original allocation/drug-supply descriptions versus actual original-text verification should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 §8.1–8.2.3; internal application; M04 §4.5–4.6 collection/selection principles; access/reading separation and hyperlink specifications are internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up trial disclosing allocation procedures; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original records central-pharmacy dispensing as allocation-concealment evidence. This is not current verification of original text/allocation records or certification of the whole randomization process.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Sequence generation, concealment/implementation, exceptions, baseline balance and original protocol remain unread. Existing content review remains incomplete.", "missingness": "Sequence generation, concealment/implementation, exceptions, baseline balance and original protocol remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original allocation/drug supply, baseline and protocol materials" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Double masking and assessors", "needed": "Actual masking/maintenance of participants, clinicians and analysts", "role": "Required", "role_reason": "An application item distinguishing Actual masking/maintenance of participants, clinicians and analysts to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant originals and analysis scope for Actual masking/maintenance of participants, clinicians and analysts should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M03 §3.2.4; CHAMGAP adaptation; Material collection/selection principles in M04 §4.5–4.6; Separating access from reading and defining hyperlink behavior are designed by CHAMGAP", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research specifying endpoint adjudication and masking; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original double-blind design and clinician-confirmed recurrence are preserved. Maintained masking of every role or exclusion of expectation effects are not treated as newly verified.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Adjudicator/analyst roles, maintained masking/unmasking and assessment procedures remain unread. Existing content review remains incomplete.", "missingness": "Adjudicator/analyst roles, maintained masking/unmasking and assessment procedures remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original masking roles and adjudication/assessment materials" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Clinician-confirmed recurrence definition", "needed": "Reporting, diagnostic confirmation, first/all recurrences and site definitions", "role": "Required", "role_reason": "An application item distinguishing Reporting, diagnostic confirmation, first/all recurrences and site definitions to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant originals and analysis scope for Reporting, diagnostic confirmation, first/all recurrences and site definitions should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a and M03 §3.2.4; Chamgap application; M03 §3.2.4; Chamgap interpretation boundary", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed research specifying first clinical recurrence definitions/adjudication; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original recurrence was clinician-confirmed, not based only on participant reports. It is not treated as the same endpoint as suspected self-reported symptoms, other infections/sites or all repeated events.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Diagnostic/confirmation criteria, assessment timing/committee, same/other leg and event overlap/adjudication details remain unverified. Existing content review remains incomplete.", "missingness": "Diagnostic/confirmation criteria, assessment timing/committee, same/other leg and event overlap/adjudication details remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Recurrence definitions, clinician confirmation and event adjudication data" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Time to first recurrence", "needed": "Prespecified primary time endpoint versus proportions/total events", "role": "Required", "role_reason": "An application item distinguishing Prespecified primary time endpoint versus proportions/total events to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant originals and analysis scope for Prespecified primary time endpoint versus proportions/total events should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 §8.2.2, M15 §15.3.1; our own application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research distinguishing time endpoints from period proportions/repeated events; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The primary endpoint was time to first clinician-confirmed recurrence. HR, proportions of people within a period, all recurrences and total observation time are not combined as the same estimand.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Time origin, events/censoring, repeated recurrence, at-risk population/analysis windows and estimation models remain unverified. Existing content review remains incomplete.", "missingness": "Time origin, events/censoring, repeated recurrence, at-risk population/analysis windows and estimation models remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Time/censoring, first-event and model/at-risk population data" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "During treatment: 30/136 and 51/138", "needed": "Original first-recurrence people/denominators and 22%/37%", "role": "Required", "role_reason": "An application item distinguishing Original first-recurrence people/denominators and 22%/37% to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant originals and analysis scope for Original first-recurrence people/denominators and 22%/37% should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed research reporting people/event/time denominators separately; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "First recurrence during treatment was 30/136 (22%) versus 51/138 (37%). Distinguish recurrent participants, all repeated events, observation time and randomized populations; no new proportions/event totals are calculated.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Visit/observation/risk denominators, first-recurrence confirmation/censoring and individual recurrence times remain unverified. Existing content review remains incomplete.", "missingness": "Visit/observation/risk denominators, first-recurrence confirmation/censoring and individual recurrence times remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original recurrence/at-risk populations and observations/events" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "HR 0.55·CI·P", "needed": "Original first-recurrence time effect/CI versus proportions", "role": "Required", "role_reason": "An application item distinguishing Original first-recurrence time effect/CI versus proportions to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant originals and analysis scope for Original first-recurrence time effect/CI versus proportions should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 §8.2.2, M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap's own design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research reporting time effects and uncertainty; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original HR 0.55 (95% CI 0.35–0.86), P=.01 is preserved. No new RR/OR, HR, CI or individual risks are calculated from 22%/37%.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Exact models/adjustment, time assumptions, censoring/at-risk populations and original sensitivity results remain unread. Existing content review remains incomplete.", "missingness": "Exact models/adjustment, time assumptions, censoring/at-risk populations and original sensitivity results remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Time models, adjustment/CI and assumption/sensitivity data" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Original absolute difference and NNT", "needed": "Original absolute difference/NNT and period/analysis/estimation specifications", "role": "Required", "role_reason": "An application item distinguishing Original absolute difference/NNT and period/analysis/estimation specifications to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant originals and analysis scope for Original absolute difference/NNT and period/analysis/estimation specifications should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M15 §15.3.1–15.3.3; internal application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research separating absolute/time effects and calculation specifications; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original absolute difference −15 percentage points and NNT 5 (4–9) are preserved unchanged. They are not recalculated/corrected through new arithmetic or transferred to other periods/populations/drugs.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Original estimation/period/model, CI methods and risk-reference details for each number remain unread. Existing content review remains incomplete.", "missingness": "Original estimation/period/model, CI methods and risk-reference details for each number remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original absolute difference/NNT and period/method/CI materials" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "27% after stopping and persistence", "needed": "During-treatment versus post-treatment results, denominators/estimation", "role": "Required", "role_reason": "An application item distinguishing During-treatment versus post-treatment results, denominators/estimation to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant originals and analysis scope for During-treatment versus post-treatment results, denominators/estimation should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research distinguishing persistence during/after treatment; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original off-treatment follow-up had 27% recurrence in both arms and no persistent protection. This is not new proof of the during-treatment HR/proportions, permanent prevention or exactly zero effect/equivalence.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Post-treatment follow-up duration, denominators/event counts, effects/CI, re-exposure and censoring remain unverified. Existing content review remains incomplete.", "missingness": "Post-treatment follow-up duration, denominators/event counts, effects/CI, re-exposure and censoring remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Post-treatment results, follow-up/denominators and effects/CI" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "12 months, exposure, adherence/discontinuation", "needed": "Planned treatment duration versus actual exposure/stopping/changes", "role": "Required", "role_reason": "An application item distinguishing Planned treatment duration versus actual exposure/stopping/changes to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant originals and analysis scope for Planned treatment duration versus actual exposure/stopping/changes should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed research distinguishing planned/actual exposure and period-specific effects; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original 12-month study exposure is preserved. It does not establish full-period complete intake/actual exposure in everyone or continued protection afterwards.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Actual intake/adherence, temporary stopping, drug changes and period-specific observation/contact remain unverified. Existing content review remains incomplete.", "missingness": "Actual intake/adherence, temporary stopping, drug changes and period-specific observation/contact remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exposure/adherence, discontinuation/changes and period records" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "274 participants, 28 hospitals and 136/138", "needed": "Recruitment/randomization denominators versus endpoint observation/at-risk populations", "role": "Required", "role_reason": "An application item distinguishing Recruitment/randomization denominators versus endpoint observation/at-risk populations to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant originals and analysis scope for Recruitment/randomization denominators versus endpoint observation/at-risk populations should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design; M08 §8.2.2, M15 §15.3.1; custom application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed research distinguishing recruitment/observation/risk denominators; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "PATCH I assigned 274 participants at 28 hospitals, 136/138. Hospitals, arms, time, events and citations are not added as new independent trials/participants.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Effective/at-risk denominators by endpoint/time, hospital-specific/analysis inclusion and completion/follow-up remain unverified. Existing content review remains incomplete.", "missingness": "Effective/at-risk denominators by endpoint/time, hospital-specific/analysis inclusion and completion/follow-up remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Flow, hospital/arm-specific and endpoint/time denominators" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "ITT principle and actual analysis populations", "needed": "Original ITT versus inclusion/exclusion, estimation populations and censoring specifications", "role": "Required", "role_reason": "An application item distinguishing Original ITT versus inclusion/exclusion, estimation populations and censoring specifications to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant originals and analysis scope for Original ITT versus inclusion/exclusion, estimation populations and censoring specifications should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 §8.2.2, M15 §15.3.1; internal application; M04 §4.5–4.6 collection/selection principles; access/reading separation and hyperlink specifications are internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed research separately disclosing assignment/exposure/observation analyses; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original records historical wording that all analyses followed ITT. This does not newly verify complete observation or detailed denominators/models for every result.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Analysis-population definitions, inclusion/exclusion, discontinuation/missingness, censoring and PPS/sensitivity originals remain unread. Existing content review remains incomplete.", "missingness": "Analysis-population definitions, inclusion/exclusion, discontinuation/missingness, censoring and PPS/sensitivity originals remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original ITT, censoring/inclusion and sensitivity materials" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Missingness, withdrawals and observation time", "needed": "Deviations/unobserved data, reasons by arm and effects on time/first-recurrence estimation", "role": "Required", "role_reason": "An application item distinguishing Deviations/unobserved data, reasons by arm and effects on time/first-recurrence estimation to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant originals and analysis scope for Deviations/unobserved data, reasons by arm and effects on time/first-recurrence estimation should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is independently designed; M08 §8.2.2, M15 §15.3.1; own application; M08 Table 8.2.a, M03 §3.2.4; own application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed research reporting follow-up and its effects on first-event estimation; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original randomized denominators and ITT descriptions are preserved. No assumption of zero missingness/withdrawal or no effects from infection reporting/confirmation/follow-up differences is filled in.", "condition_status": "Unverified", "status_reason": "Required current information remains unverified in the preserved summary. Deviations/missingness by arm, confirmation delays, observation time/censoring and missing-data handling/sensitivity remain unverified. Existing content review remains incomplete.", "missingness": "Deviations/missingness by arm, confirmation delays, observation time/censoring and missing-data handling/sensitivity remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Flow, observation time/censoring and missingness/sensitivity data" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Two registrations and prespecified plans", "needed": "ISRCTN/EudraCT identifiers and pre-recruitment/matching-endpoint descriptions", "role": "Required", "role_reason": "An application item distinguishing ISRCTN/EudraCT identifiers and pre-recruitment/matching-endpoint descriptions to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant originals and analysis scope for ISRCTN/EudraCT identifiers and pre-recruitment/matching-endpoint descriptions should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; custom application; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed research linking and disclosing prespecified plans and actual period-specific analyses; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original evidence registration identifier: ISRCTN34716921 · EudraCT 2006-000381-36. Pre-recruitment registration and matching first-recurrence endpoint descriptions are preserved; full registration/plans remain unread.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Registration dates/amendments, protocol/SAP and full period/hierarchy/analysis specifications remain unread. Existing content review remains incomplete.", "missingness": "Registration dates/amendments, protocol/SAP and full period/hierarchy/analysis specifications remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Both registration histories, protocol and SAP" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Primary/secondary outcomes, periods and multiple tests", "needed": "First-recurrence primary endpoint versus other events/periods/subgroup hierarchy", "role": "Required", "role_reason": "An application item distinguishing First-recurrence primary endpoint versus other events/periods/subgroup hierarchy to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant originals and analysis scope for First-recurrence primary endpoint versus other events/periods/subgroup hierarchy should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; internal application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed research distinguishing primary from period-specific/secondary results; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original primary endpoint was time to first recurrence. Post-treatment, all-recurrence, safety and other analyses are not upgraded to new primary endpoints or independent confirmation.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. All secondary/period/subgroup analyses, multiplicity, prespecified order and amendment history remain unverified. Existing content review remains incomplete.", "missingness": "All secondary/period/subgroup analyses, multiplicity, prespecified order and amendment history remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "SAP, all results and endpoint/period hierarchies" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Concurrent treatment and recurrence-risk management", "needed": "Concurrent medications/conditions/lifestyle management and contact by arm", "role": "Required", "role_reason": "An application item distinguishing Concurrent medications/conditions/lifestyle management and contact by arm to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant originals and analysis scope for Concurrent medications/conditions/lifestyle management and contact by arm should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are our own design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research distinguishing concurrent management from study-drug effects; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "This was a placebo-controlled trial in adults at risk of recurrent leg cellulitis. The original summary is not extended to confirm identical concurrent treatment/management or no influence on effects.", "condition_status": "Unverified", "status_reason": "Required current information remains unverified in the preserved summary. Concurrent drugs/conditions, recurrence management, other antibiotic exposures, contact and their analyses remain unverified. Existing content review remains incomplete.", "missingness": "Concurrent drugs/conditions, recurrence management, other antibiotic exposures, contact and their analyses remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Concurrent exposure/management, contact and analysis materials" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "PATCH II companion report and directness", "needed": "Separate-cohort results versus PATCH I specifications", "role": "Required", "role_reason": "An application item distinguishing Separate-cohort results versus PATCH I specifications to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant originals and analysis scope for Separate-cohort results versus PATCH I specifications should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application; M03 §3.2.1; detailed population conditions are internally designed; M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research specifying separate cohorts/specifications; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original S02 PATCH II: 123 participants, HR 0.53 (0.26–1.07), P=.08, individually nonsignificant. The same 12-month/recurrence-risk/exposure specifications are not automatically filled in.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. PATCH II eligibility, exposure/duration, denominators/events, registration/hierarchy and exact analysis correspondence remain unverified. Existing content review remains incomplete.", "missingness": "PATCH II eligibility, exposure/duration, denominators/events, registration/hierarchy and exact analysis correspondence remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "PATCH II original text/plans and correspondence between both trials" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Two estimates, nonsignificance and conflict scope", "needed": "PATCH II CI and the original verdict’s relationship interpretation", "role": "Required", "role_reason": "An application item distinguishing PATCH II CI and the original verdict’s relationship interpretation to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant originals and analysis scope for PATCH II CI and the original verdict’s relationship interpretation should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M15 §15.3.1–15.3.3; internal application; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed research distinguishing matching specifications from result relationships; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original interpretation that PATCH II’s CI includes PATCH I’s 0.55 and is not statistically conflicting is preserved. No new pooled effects, CI, significance or equivalence/conflict verdicts are calculated.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Matching analysis/population specifications, between-study comparison/pooling models and full independence remain unverified. Existing content review remains incomplete.", "missingness": "Matching analysis/population specifications, between-study comparison/pooling models and full independence remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Both results/specifications and comparison/pooling methods" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Reports, cohorts, network and independence", "needed": "PATCH I/II separate cohorts versus the same network", "role": "Required", "role_reason": "An application item distinguishing PATCH I/II separate cohorts versus the same network to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant originals and analysis scope for PATCH I/II separate cohorts versus the same network should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal for later independent comparative research on the same selected question; no new investigation, calculation or trial was performed in that production.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "PATCH I/II were separate cohorts in the same network, so the original verdict did not count independent replication. 274/123, hospitals, arms, time points, citations/related sheets are not added as new participant/trial totals.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. No new unique-clinical-trial/participant or independent-replication totals are established. Existing content review remains incomplete.", "missingness": "No new unique-clinical-trial/participant or independent-replication totals are established.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Cohort/network and report/registration relationships, plus separate research materials" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Action Medical Research funding", "needed": "Nonprofit funding versus support roles/other relationships", "role": "Required", "role_reason": "An application item distinguishing Nonprofit funding versus support roles/other relationships to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant originals and analysis scope for Nonprofit funding versus support roles/other relationships should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research disclosing support roles; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original PATCH I funding was nonprofit support from Action Medical Research. This does not become new certification of no support/COI or independence.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Funder roles, contracts, other support and original data/publication authority remain unread. Existing content review remains incomplete.", "missingness": "Funder roles, contracts, other support and original data/publication authority remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original funding, support/authority and COI materials" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Nottingham sponsorship and pharmaceutical support", "needed": "Research sponsor and verification of cash/product/analysis support", "role": "Required", "role_reason": "An application item distinguishing Research sponsor and verification of cash/product/analysis support to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant originals and analysis scope for Research sponsor and verification of cash/product/analysis support should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed research separately disclosing research roles and item-specific support; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original records University of Nottingham as sponsor and pharmaceutical cash/product/analysis support as not identified. Unverified does not mean actually absent or no author relationships.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Sponsor roles, in-kind/product supply, analysis, author/writing/publication support and original COI remain unread. Existing content review remains incomplete.", "missingness": "Sponsor roles, in-kind/product supply, analysis, author/writing/publication support and original COI remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Sponsor, cash/product/analysis and author/writing support disclosures" }, { "item_id": "N25", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Adverse-event reporters and P", "needed": "People versus event counts/denominators and nonsignificance versus safety", "role": "Supplementary", "role_reason": "An application item distinguishing People versus event counts/denominators and nonsignificance versus safety to connect materials needed for the selected question with available materials.", "application_exception": "Supplements safety-information gaps for the selected subclaim. First-recurrence/post-treatment results or parent safety wording do not yield safety verdicts, harm incidence or new use instructions.", "criterion": "Relevant originals and analysis scope for People versus event counts/denominators and nonsignificance versus safety should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M19 §19.1.2–19.2.4; detailed discrimination is internally designed; M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M19 §19.1.2–19.2.4; internal application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed harm research distinguishing people/events and uncertainty; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original adverse-event reporters numbered 37 versus 48, P=.50. Person counts are not converted to total events, related reactions, no harm or equivalent safety.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Arm-specific safety-analysis denominators, event types/counts, causality/severity, collection/adjudication and CI remain unverified. Existing content review remains incomplete.", "missingness": "Arm-specific safety-analysis denominators, event types/counts, causality/severity, collection/adjudication and CI remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Adverse-event tables, denominators/collection and causality/severity data" }, { "item_id": "N26", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Allergy, gastrointestinal and resistance gaps", "needed": "Parent caution wording versus actual harm/resistance measurement", "role": "Supplementary", "role_reason": "An application item distinguishing Parent caution wording versus actual harm/resistance measurement to connect materials needed for the selected question with available materials.", "application_exception": "Supplements safety-information gaps for the selected subclaim. First-recurrence/post-treatment results or parent safety wording do not yield safety verdicts, harm incidence or new use instructions.", "criterion": "Relevant originals and analysis scope for Parent caution wording versus actual harm/resistance measurement should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP; M19 §19.1.2–19.2.4; CHAMGAP adaptation; CHAMGAP’s interpretation boundary, informed by M19 principles; no official causality tool was run; M19 §19.1.2–19.2.4; CHAMGAP adaptation", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research specifying harm/resistance collection scope; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original parent caution and allergy/gastrointestinal/antimicrobial-resistance burdens are preserved. Warnings are not made into actual event rates/resistance measurements or intake/prevention instructions.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Each harm’s measurement/frequencies/denominators, microbiology/resistance and long-term/vulnerable-population follow-up remain unverified. Existing content review remains incomplete.", "missingness": "Each harm’s measurement/frequencies/denominators, microbiology/resistance and long-term/vulnerable-population follow-up remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Harm-specific collection and resistance/long-term follow-up data" }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Other drugs/populations and persistent application", "needed": "Original recurrence risk, drug/route/duration versus long-term generalization", "role": "Required", "role_reason": "An application item distinguishing Original recurrence risk, drug/route/duration versus long-term generalization to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant originals and analysis scope for Original recurrence risk, drug/route/duration versus long-term generalization should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.1–3.2.4; dose/duration/effect-modification details are internally designed; M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research distinguishing specifications/period from persistent protection; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original excludes extension to prevention after a first episode, other antibiotics/doses/injection routes and permanent protection. Preserve research results only; no management/treatment-replacement instructions.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Direct comparisons for other conditions, exposure/persistence beyond 12 months and long-term harms remain unverified. Existing content review remains incomplete.", "missingness": "Direct comparisons for other conditions, exposure/persistence beyond 12 months and long-term harms remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct population/drug/duration-specific trials and follow-up data" }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Parent/subclaim, bilingual text and history", "needed": "Separate original score/axes, evidence date, corrections and verification descriptions", "role": "Required", "role_reason": "An application item distinguishing Separate original score/axes, evidence date, corrections and verification descriptions to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant originals and analysis scope for Separate original score/axes, evidence date, corrections and verification descriptions should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed research distinguishing original values/history from new-update scope; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Parent B with 76 points, B/H/R1/I2/E+/B0, unrecorded precision, true large-hard-endpoint-RCT and two false indicators, empty grade-override reasons and subclaim B/note are preserved. Bilingual text, 2026-08-26, empty corrections/deliberation and cross-checking are not completed clinical review now or subclaim scores.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Missing subclaim score/status/axes are not filled with parent values. No new efficacy/method certification. Existing content review remains incomplete.", "missingness": "Missing subclaim score/status/axes are not filled with parent values. No new efficacy/method certification.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original corrections, versions and user correction comments" }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Actual summary reading and material links", "needed": "Reading preserved summaries versus external papers/two registrations/plans", "role": "Required", "role_reason": "An application item distinguishing Reading preserved summaries versus external papers/two registrations/plans to connect materials needed for the selected question with available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant originals and analysis scope for Reading preserved summaries versus external papers/two registrations/plans should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal for updating while distinguishing actual acquisition/timing/scope; no new investigation, calculation or trial was performed in that production.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The entire preserved summary/citations were used for production and PATCH I/II links retained. Original papers/registration/protocol/SAP/support/COI remain unread, access unattempted and external links untested.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. External original content, exact denominators/duration/models and accessibility remain unverified. Existing content review remains incomplete.", "missingness": "External original content, exact denominators/duration/models and accessibility remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original paper, registration, protocol, SAP and support materials or user comments" } ], "reports": [ { "report_id": "S01", "title": "Thomas KS et al. 2013 PATCH I", "url": "https://pubmed.ncbi.nlm.nih.gov/23635049/", "report_type": "Multicentre double-blind randomized placebo-controlled trial", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2973-PATCH-I", "independent_replication": null, "observed_result": "30/136 (22%) vs 51/138 (37%); HR 0.55 (0.35–0.86), P=.01; NNT 5 (4–9). Grade B. PATCH I first recurrence during treatment was 30/136 (22%) versus 51/138 (37%), HR 0.55 (95% CI 0.35–0.86), P=.01, absolute difference −15 percentage points and NNT 5 (4–9). After stopping, 27% in both arms recurred and protection did not persist.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only stored-summary and bibliographic content was used for production. External material verification/review is not complete." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/23635049/" } ] }, { "report_id": "S02", "title": "UK Dermatology Clinical Trials Network. PATCH II. Br J Dermatol. 2012. PMID: 21910701.", "url": "https://pubmed.ncbi.nlm.nih.gov/21910701/", "report_type": "Citation-only PATCH II companion report of a separate cohort; no original evidence-list row", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2973-PATCH-II", "independent_replication": null, "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": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only stored-summary and bibliographic content was used for production. External material verification/review is not complete." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/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": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" } ], "status_dictionary": { "Met": "Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.", "Partly verified": "Some information in the stored summary is linked into the table. External comparison/content review is not complete.", "Unverified": "The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.", "Review incomplete": "Existing content review remains incomplete.", "Not reported": "Not reported within the stored material actually read; not extended to the entire primary paper.", "Inaccessible": "Means an actual access failure. Access not attempted here is not assigned this state.", "Not applicable": "Not used as a substitute for an evidence gap.", "Conflicting data": "Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.", "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "PATCH I and PATCH II are separate cohorts in the same network. PATCH I reports time to first clinician-confirmed recurrence at 28 hospitals, 274 participants, 136/138, comparing penicillin V 250 mg twice daily for 12 months with placebo. Original 30/136 (22%) versus 51/138 (37%), HR 0.55 (0.35–0.86)/P=.01 and absolute difference −15 percentage points/NNT 5 (4–9) are preserved. Post-treatment 27% in both arms concerns a separate period. PATCH II is a companion report of 123 participants, HR 0.53 (0.26–1.07)/P=.08; eligibility, exposure/duration, registration/denominators/models are not filled from PATCH I. The original same-network relationship and decision not to count independent replication are preserved; no new clinical totals, pooled effects or independence certification. Reports/cohorts, people, arms, events, time and related sheets are not summed." }, "history": [ { "date": "2026-10-14", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public pages and materials were created from the existing 29 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-14" }