{ "schema_version": "chamgap-public-criteria-1.0", "title": "Surgical-mask recommendation × Transmission to others — Wearer infection and directly unmeasured gaps", "language": "en", "translation_date": "2026-10-14", "criteria_version": "1.0", "criteria_date": "2026-10-06", "condition_origin": "Chamgap's own application conditions", "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." } ], "status_dictionary": { "Partly verified": "Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.", "Unverified": "Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety", "Review incomplete": "Review of existing content incomplete", "Met": "Use only within the relevant conditions after existing content review; no automatic designation in this preparation", "Not reported": "Distinguish only within materials actually read; do not turn unread external materials into unreported findings", "Inaccessible": "Not applied during this preparation because actual access was not tested", "Not applicable": "Use with a reason for non-applicability based on an explicit question boundary", "Conflicting data": "Judge after actual material comparison; review was not performed during this preparation", "Insufficient evidence for the conditions": "Do not use as a clinical grade encompassing currently unread materials" }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which existing transmission-to-others claim is being transferred?", "needed": "Selected wording/subclaim grade versus parent wearer results", "role": "Required", "role_reason": "Needed to connect selected wording/subclaim grade versus parent wearer results with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish recommendation/distribution, actual wearing/adherence, wearer infection, transmission/source control, contact/cluster/network denominators, one month/period, complete cases/missingness, effects/CI and harms. Only original numbers are retained; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or mask/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for selected wording/subclaim grade versus parent wearer results together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Direct transmission population/endpoints, contact/cluster denominators, comparison/period and existing boundary review. Parent scores are not filled into the subclaim. Only material requests/research needs are recorded; no search or research was performed in that production." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Are wearer protection and source control directly distinguished?", "needed": "Infection acquired by the wearer versus transmission to others", "role": "Required", "role_reason": "Needed to connect infection acquired by the wearer versus transmission to others with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish recommendation/distribution, actual wearing/adherence, wearer infection, transmission/source control, contact/cluster/network denominators, one month/period, complete cases/missingness, effects/CI and harms. Only original numbers are retained; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or mask/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for infection acquired by the wearer versus transmission to others together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Infection sources/contacts, transmission direction/ascertainment, direct cluster/network/contact tracing, denominators/effects/CI. Unmeasured is not changed to zero transmission events. Only material requests/research needs are recorded; no search or research was performed in that production." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Was the intervention enforced or verified actual wearing?", "needed": "Surgical-mask recommendation, 50 masks and instructions", "role": "Required", "role_reason": "Needed to connect surgical-mask recommendation, 50 masks and instructions with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish recommendation/distribution, actual wearing/adherence, wearer infection, transmission/source control, contact/cluster/network denominators, one month/period, complete cases/missingness, effects/CI and harms. Only original numbers are retained; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or mask/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for surgical-mask recommendation, 50 masks and instructions together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Original recommendation/distribution, actual use/adherence, product identity/masks and concurrent exposure. No new wearer-adherence or transmission effects are calculated. Only material requests/research needs are recorded; no search or research was performed in that production." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "What were the control and prevailing advice in both groups?", "needed": "Recommendation versus control and common public-health advice", "role": "Required", "role_reason": "Needed to connect recommendation versus control and common public-health advice with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish recommendation/distribution, actual wearing/adherence, wearer infection, transmission/source control, contact/cluster/network denominators, one month/period, complete cases/missingness, effects/CI and harms. Only original numbers are retained; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or mask/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for recommendation versus control and common public-health advice together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Actual group masks/contacts/public-health exposure, contamination, expectations/behavior and adherence. Contributions beyond recommendation differences are not newly established. Only material requests/research needs are recorded; no search or research was performed in that production." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Which period, setting and population were studied?", "needed": "2020 Danish community and uncommon mask use", "role": "Required", "role_reason": "Needed to connect 2020 Danish community and uncommon mask use with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish recommendation/distribution, actual wearing/adherence, wearer infection, transmission/source control, contact/cluster/network denominators, one month/period, complete cases/missingness, effects/CI and harms. Only original numbers are retained; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or mask/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for 2020 Danish community and uncommon mask use together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Direct transmission materials with eligibility, location/period/epidemic, baseline/contact/concurrent exposure. This is not converted to current mask/infection-prevention guidance. Only material requests/research needs are recorded; no search or research was performed in that production." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Was one-month follow-up long-term observation of transmission networks?", "needed": "One-month wearer follow-up versus contact observation", "role": "Required", "role_reason": "Needed to connect one-month wearer follow-up versus contact observation with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish recommendation/distribution, actual wearing/adherence, wearer infection, transmission/source control, contact/cluster/network denominators, one month/period, complete cases/missingness, effects/CI and harms. Only original numbers are retained; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or mask/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for one-month wearer follow-up versus contact observation together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Direct infection-source/contact enrollment, exposure/incubation/follow-up/testing, time denominators and losses. No new time/day calculations. Only material requests/research needs are recorded; no search or research was performed in that production." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Are allocation, complete-case analysis and missingness separated?", "needed": "6,024, 4,862 and 19.3%", "role": "Required", "role_reason": "Needed to connect 6,024, 4,862 and 19.3% with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish recommendation/distribution, actual wearing/adherence, wearer infection, transmission/source control, contact/cluster/network denominators, one month/period, complete cases/missingness, effects/CI and harms. Only original numbers are retained; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or mask/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for 6,024, 4,862 and 19.3% together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Flow, group completion/missingness/testing, reasons/handling/sensitivity and contact denominators. Complete-case results do not certify ITT for everyone or outcomes in others. Only material requests/research needs are recorded; no search or research was performed in that production." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "What ascertainment methods define wearer infection?", "needed": "One-month infection by antibody testing, PCR or hospital diagnosis", "role": "Required", "role_reason": "Needed to connect one-month infection by antibody testing, PCR or hospital diagnosis with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish recommendation/distribution, actual wearing/adherence, wearer infection, transmission/source control, contact/cluster/network denominators, one month/period, complete cases/missingness, effects/CI and harms. Only original numbers are retained; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or mask/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for one-month infection by antibody testing, PCR or hospital diagnosis together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Original ascertainment/event definitions, test selection/omissions, baseline/repetition, denominators and infection-source linkage. Endpoint components are not summed as new infections/participants. Only material requests/research needs are recorded; no search or research was performed in that production." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Which outcome do the wearer effects/CI describe?", "needed": "42/2392 versus 53/2470, difference and OR", "role": "Required", "role_reason": "Needed to connect 42/2392 versus 53/2470, difference and OR with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish recommendation/distribution, actual wearing/adherence, wearer infection, transmission/source control, contact/cluster/network denominators, one month/period, complete cases/missingness, effects/CI and harms. Only original numbers are retained; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or mask/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for 42/2392 versus 53/2470, difference and OR together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Original estimands, denominators, models/tests, rounding/intervals and direct transmission effects/CI. No RR/risk-difference/CI recalculation. Only material requests/research needs are recorded; no search or research was performed in that production." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Are self-reported adherence and actual-wearing effects distinguished?", "needed": "46%/47%/7% versus recommendation effects", "role": "Required", "role_reason": "Needed to connect 46%/47%/7% versus recommendation effects with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish recommendation/distribution, actual wearing/adherence, wearer infection, transmission/source control, contact/cluster/network denominators, one month/period, complete cases/missingness, effects/CI and harms. Only original numbers are retained; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or mask/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for 46%/47%/7% versus recommendation effects together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Adherence definitions, measurement/exposure/missingness, actual group use/contacts and prespecified adherence analyses. No new counts/rates/adherence effects. Only material requests/research needs are recorded; no search or research was performed in that production." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Are null/wide-CI wearer results separated from unmeasured transmission?", "needed": "Intervals for possible wearer effects versus selected-question gaps", "role": "Required", "role_reason": "Needed to connect intervals for possible wearer effects versus selected-question gaps with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish recommendation/distribution, actual wearing/adherence, wearer infection, transmission/source control, contact/cluster/network denominators, one month/period, complete cases/missingness, effects/CI and harms. Only original numbers are retained; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or mask/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for intervals for possible wearer effects versus selected-question gaps together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Original wearer denominators/CI/models/importance and separate direct transmission comparisons. Parent D does not overwrite the transmission subclaim as D. Only material requests/research needs are recorded; no search or research was performed in that production." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Are contact/cluster/network denominators known?", "needed": "Direct-transmission populations at risk and event denominators", "role": "Required", "role_reason": "Needed to connect direct-transmission populations at risk and event denominators with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish recommendation/distribution, actual wearing/adherence, wearer infection, transmission/source control, contact/cluster/network denominators, one month/period, complete cases/missingness, effects/CI and harms. Only original numbers are retained; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or mask/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for direct-transmission populations at risk and event denominators together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Direct-transmission design clusters/contacts, enrollment/testing/exposure/ascertainment, secondary events/denominators and correlation/censoring. No new transmission rates, person counts or network values. Only material requests/research needs are recorded; no search or research was performed in that production." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Are indirect source-control indicators used to fill the gap?", "needed": "Direct secondary infection versus wearer/mechanistic outcomes", "role": "Required", "role_reason": "Needed to connect direct secondary infection versus wearer/mechanistic outcomes with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish recommendation/distribution, actual wearing/adherence, wearer infection, transmission/source control, contact/cluster/network denominators, one month/period, complete cases/missingness, effects/CI and harms. Only original numbers are retained; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or mask/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for direct secondary infection versus wearer/mechanistic outcomes together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Infection-source/contact ascertainment, transmission direction/timing/exposure and direct secondary infection/effects/CI. Materials distinguishing viral shedding/mechanisms from clinical transmission. Only material requests/research needs are recorded; no search or research was performed in that production." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Are mandates, healthcare and other epidemics separate questions?", "needed": "Applicability boundaries of a recommendation trial", "role": "Required", "role_reason": "Needed to connect applicability boundaries of a recommendation trial with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish recommendation/distribution, actual wearing/adherence, wearer infection, transmission/source control, contact/cluster/network denominators, one month/period, complete cases/missingness, effects/CI and harms. Only original numbers are retained; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or mask/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for applicability boundaries of a recommendation trial together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Direct setting/policy populations, interventions/comparators, transmission/infection, cluster/time denominators and effects/CI. No recommendation/mandate/infection-prevention instructions. Only material requests/research needs are recorded; no search or research was performed in that production." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Are original unblinded, complete-case and missing-data limitations preserved?", "needed": "Recommendation-trial design and measurement/analysis gaps", "role": "Required", "role_reason": "Needed to connect recommendation-trial design and measurement/analysis gaps with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish recommendation/distribution, actual wearing/adherence, wearer infection, transmission/source control, contact/cluster/network denominators, one month/period, complete cases/missingness, effects/CI and harms. Only original numbers are retained; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or mask/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for recommendation-trial design and measurement/analysis gaps together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Allocation/behavior/expectations, tests/omissions, missingness/sensitivity and analyses. Original B2 is parent context, not certified transmission review. Only material requests/research needs are recorded; no search or research was performed in that production." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Are original registration start/posting times preserved?", "needed": "NCT04337541 and six-day retrospective registration", "role": "Required", "role_reason": "Needed to connect nCT04337541 and six-day retrospective registration with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish recommendation/distribution, actual wearing/adherence, wearer infection, transmission/source control, contact/cluster/network denominators, one month/period, complete cases/missingness, effects/CI and harms. Only original numbers are retained; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or mask/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for nCT04337541 and six-day retrospective registration together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Actual registration/protocol/SAP versions, availability/changes, primary/secondary outcomes and denominators/analyses. Original six days is not a new calculation or certification. Only material requests/research needs are recorded; no search or research was performed in that production." }, { "item_id": "N17", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Were mask harms directly quantified?", "needed": "Discomfort/skin irritation and original lack of harms assessment", "role": "Supplementary", "role_reason": "Needed to connect discomfort/skin irritation and original lack of harms assessment with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish recommendation/distribution, actual wearing/adherence, wearer infection, transmission/source control, contact/cluster/network denominators, one month/period, complete cases/missingness, effects/CI and harms. Only original numbers are retained; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or mask/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for discomfort/skin irritation and original lack of harms assessment together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Actual group wearing/exposure, harms collection/denominators, discomfort/skin reactions/discontinuation, relatedness and long-term materials. No mask-use/infection-prevention-care instructions. Only material requests/research needs are recorded; no search or research was performed in that production." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "What materials were actually read or acquired?", "needed": "Preserved summary versus external materials", "role": "Required", "role_reason": "Needed to connect preserved summary versus external materials with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish recommendation/distribution, actual wearing/adherence, wearer infection, transmission/source control, contact/cluster/network denominators, one month/period, complete cases/missingness, effects/CI and harms. Only original numbers are retained; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or mask/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for preserved summary versus external materials together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Records of actual acquisition/reading scope, versions and dates. No external-link/click/access testing. Only material requests/research needs are recorded; no search or research was performed in that production." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Are historical registration/prespecification and current reading separated?", "needed": "Original registration identifier, timing and plans", "role": "Required", "role_reason": "Needed to connect original registration identifier, timing and plans with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish recommendation/distribution, actual wearing/adherence, wearer infection, transmission/source control, contact/cluster/network denominators, one month/period, complete cases/missingness, effects/CI and harms. Only original numbers are retained; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or mask/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for original registration identifier, timing and plans together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Actual registration versions/availability, recruitment/start/changes, endpoints/models/analyses and original-report linkage. Only history is preserved, with no current plan/prespecification certification. Only material requests/research needs are recorded; no search or research was performed in that production." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Have protocol/SAP and analysis/missing-data plans been acquired?", "needed": "Separate materials for prespecified plans/changes", "role": "Required", "role_reason": "Needed to connect separate materials for prespecified plans/changes with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish recommendation/distribution, actual wearing/adherence, wearer infection, transmission/source control, contact/cluster/network denominators, one month/period, complete cases/missingness, effects/CI and harms. Only original numbers are retained; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or mask/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for separate materials for prespecified plans/changes together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Original protocol/SAP/revisions, estimands/denominators/analyses, all endpoints and availability timing. Unread is not declared document absence. Only material requests/research needs are recorded; no search or research was performed in that production." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Are sponsorship/funding, products, authors and research roles separated?", "needed": "Four company-involvement items and institution/foundation support", "role": "Required", "role_reason": "Needed to connect four company-involvement items and institution/foundation support with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish recommendation/distribution, actual wearing/adherence, wearer infection, transmission/source control, contact/cluster/network denominators, one month/period, complete cases/missingness, effects/CI and harms. Only original numbers are retained; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or mask/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for four company-involvement items and institution/foundation support together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Individual original company cash funding, product support, employee authors/outside relationships, design/analysis/data control and other institutional support. Original I2 is not new certification of all items/independence. Only material requests/research needs are recorded; no search or research was performed in that production." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Are directly unmeasured, null and unverified outcomes distinguished?", "needed": "Question/results versus access gaps", "role": "Required", "role_reason": "Needed to connect question/results versus access gaps with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish recommendation/distribution, actual wearing/adherence, wearer infection, transmission/source control, contact/cluster/network denominators, one month/period, complete cases/missingness, effects/CI and harms. Only original numbers are retained; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or mask/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for question/results versus access gaps together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Original direct-measurement/endpoint tables, estimands/denominators, plans and actual-access records. Unread is not unreported, and null is not exactly zero/equivalence. Only material requests/research needs are recorded; no search or research was performed in that production." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Are reports, trials, people, tests/timepoints and sibling sheets separated?", "needed": "Linked records versus unique trials/participants", "role": "Required", "role_reason": "Needed to connect linked records versus unique trials/participants with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish recommendation/distribution, actual wearing/adherence, wearer infection, transmission/source control, contact/cluster/network denominators, one month/period, complete cases/missingness, effects/CI and harms. Only original numbers are retained; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or mask/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for linked records versus unique trials/participants together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Original report/registration, cohort/test/timepoint, event/repetition/observation and overlap relationships. Unique trials/participant totals remain not recorded. Only material requests/research needs are recorded; no search or research was performed in that production." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are the original single trial and separate replication distinguished?", "needed": "Parent R1/I2, follow-up and confirmation", "role": "Supplementary", "role_reason": "Needed to connect parent R1/I2, follow-up and confirmation with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish recommendation/distribution, actual wearing/adherence, wearer infection, transmission/source control, contact/cluster/network denominators, one month/period, complete cases/missingness, effects/CI and harms. Only original numbers are retained; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or mask/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for parent R1/I2, follow-up and confirmation together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Separate prespecified direct population/intervention/comparator/endpoint/period, denominators/effects/CI and disclosed funding/author relationships for the selected question. No new search/independence judgment. Only material requests/research needs are recorded; no search or research was performed in that production." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Are the subclaim grade and parent score/axes preserved?", "needed": "Selected ? grade, absent subclaim values and parent D34", "role": "Required", "role_reason": "Needed to connect selected ? grade, absent subclaim values and parent D34 with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish recommendation/distribution, actual wearing/adherence, wearer infection, transmission/source control, contact/cluster/network denominators, one month/period, complete cases/missingness, effects/CI and harms. Only original numbers are retained; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or mask/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for selected ? grade, absent subclaim values and parent D34 together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Existing subclaim/parent-boundary review and actual correction materials. No new grade/score or official RoB 2/GRADE certification. Only material requests/research needs are recorded; no search or research was performed in that production." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Are both languages, citations and absent fields preserved?", "needed": "Both original languages and absent separate classification information", "role": "Required", "role_reason": "Needed to connect both original languages and absent separate classification information with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish recommendation/distribution, actual wearing/adherence, wearer infection, transmission/source control, contact/cluster/network denominators, one month/period, complete cases/missingness, effects/CI and harms. Only original numbers are retained; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or mask/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for both original languages and absent separate classification information together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Review materials for terminology, endpoints/effects/test units, selected scope and absent fields in both languages. Production explanations are distinguished from original records. Only material requests/research needs are recorded; no search or research was performed in that production." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Are source dates/corrections/history separated from production dates?", "needed": "Original 2026-08-26 and new conditions/application", "role": "Required", "role_reason": "Needed to connect original 2026-08-26 and new conditions/application with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish recommendation/distribution, actual wearing/adherence, wearer infection, transmission/source control, contact/cluster/network denominators, one month/period, complete cases/missingness, effects/CI and harms. Only original numbers are retained; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or mask/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for original 2026-08-26 and new conditions/application together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Update materials separating originals, events, conditions/observations and verdict decisions when new evidence/corrections arise. Historical wording is not completed clinical content review here. Only material requests/research needs are recorded; no search or research was performed in that production." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "What direct materials would fill the selected gaps?", "needed": "Direct endpoints, estimands/CI and denominators/follow-up", "role": "Supplementary", "role_reason": "Needed to connect direct endpoints, estimands/CI and denominators/follow-up with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish recommendation/distribution, actual wearing/adherence, wearer infection, transmission/source control, contact/cluster/network denominators, one month/period, complete cases/missingness, effects/CI and harms. Only original numbers are retained; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or mask/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for direct endpoints, estimands/CI and denominators/follow-up together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Original tables/plans, direct populations/comparators/endpoints, estimands/CI, observation/tests/denominators, actual exposure/adherence, separate confirmation and long-term harms. Only needs are recorded; no new search/research. Only material requests/research needs are recorded; no search or research was performed in that production." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Are applicability records separated from content review and instructions?", "needed": "Applicability records, existing candidate history and content review", "role": "Supplementary", "role_reason": "Needed to connect applicability records, existing candidate history and content review with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish recommendation/distribution, actual wearing/adherence, wearer infection, transmission/source control, contact/cluster/network denominators, one month/period, complete cases/missingness, effects/CI and harms. Only original numbers are retained; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or mask/infection-prevention/treatment-replacement instructions.", "criterion": "Show original materials for applicability records, existing candidate history and content review together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Existing content review and later actual-material/correction work. Historical production did not perform clinical original-material comparison, external access, new calculations, grade changes or mask/infection-prevention/treatment-replacement instructions. Only material requests/research needs are recorded; no search or research was performed in that production." } ] }