{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2971-s1", "verdict_number": "2971", "title": "Surgical-mask recommendation × Transmission to others — Wearer infection and directly unmeasured gaps", "view_version": "1.0", "view_created_date": "2026-10-14", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "6,024 community adults in 2020 Denmark; wearer denominators are distinguished from unverified direct contact/cluster/network denominators", "intervention": "Surgical-mask recommendation, 50 masks/instructions supplied; distinguished from actual wearing, mandates and source control", "dose": "Original research-intervention identification: 50 masks/instructions and one month; no mask/infection-prevention instructions", "comparator": "Control group and prevailing public-health advice in both groups; actual masks/contacts, contamination and exposure details remain unverified", "endpoint": "Selected transmission/source control was directly unmeasured; separate from parent wearer infection at one month by antibody/PCR/hospital diagnosis", "duration": "One-month wearer follow-up in 2020 Denmark; direct contact/cluster/transmission-timing/observation materials are absent", "excluded_extensions": [ "Transferring wearer outcomes to transmission/source control or recommendations to full-wearing/mandate effects", "Combining outcomes in different populations as the same effect", "Summing the same report/people/tests/groups/events/timepoints/bibliographies and sibling sheets as new independent trials/participants", "New effects/CI/invented quantities, equivalence/zero effects, reassessment/grades or independence certification from original numbers", "Mask/infection-prevention/treatment-replacement instructions" ] }, "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The selected claim is reduced transmission to other people, with original subclaim grade ? and the note that this was not measured by the trial. Absent subclaim score/status/axes are separated from parent D34 and axes.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Direct transmission population/endpoints, contact/cluster denominators, comparison/period and existing boundary review. Parent scores are not filled into the subclaim.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct transmission population/endpoints, contact/cluster denominators, comparison/period and existing boundary review. Parent scores are not filled into the subclaim." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Existing Korean/English reader answers explicitly state that transmission/source control and mandates were not tested. Null wearer infection is not transferred to zero/null or positive transmission effects.", "condition_status": "Unverified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Infection sources/contacts, transmission direction/ascertainment, direct cluster/network/contact tracing, denominators/effects/CI. Unmeasured is not changed to zero transmission events.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Infection sources/contacts, transmission direction/ascertainment, direct cluster/network/contact tracing, denominators/effects/CI. Unmeasured is not changed to zero transmission events." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original intervention recommended masks to community adults and supplied 50 surgical masks/instructions. This differs from full actual wearing, mandates or effects of all mask types. Research intervention identification does not provide use/infection-prevention instructions.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Original recommendation/distribution, actual use/adherence, product identity/masks and concurrent exposure. No new wearer-adherence or transmission effects are calculated.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original recommendation/distribution, actual use/adherence, product identity/masks and concurrent exposure. No new wearer-adherence or transmission effects are calculated." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Original materials record 3,030 assigned to recommendations, 2,994 to control, with both groups following prevailing advice. Actual control mask use/contact/behavior/exposure details remain unverified. This is not relabeled as comparison with no preventive exposure.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Actual group masks/contacts/public-health exposure, contamination, expectations/behavior and adherence. Contributions beyond recommendation differences are not newly established.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual group masks/contacts/public-health exposure, contamination, expectations/behavior and adherence. Contributions beyond recommendation differences are not newly established." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original trial involved community adults in 2020 Denmark, where mask use was uncommon. It is not extended to healthcare, other variants/epidemics, mandates or other populations. Eligibility/infection history/baseline/exposure details remain unverified.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Direct transmission materials with eligibility, location/period/epidemic, baseline/contact/concurrent exposure. This is not converted to current mask/infection-prevention guidance.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct transmission materials with eligibility, location/period/epidemic, baseline/contact/concurrent exposure. This is not converted to current mask/infection-prevention guidance." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Original follow-up was one month. Direct contact/cluster, infection-source/secondary-transmission timing/observation materials are absent. Wearer duration does not fill valid transmission follow-up or long-term effects.", "condition_status": "Unverified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Direct infection-source/contact enrollment, exposure/incubation/follow-up/testing, time denominators and losses. No new time/day calculations.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct infection-source/contact enrollment, exposure/incubation/follow-up/testing, time denominators and losses. No new time/day calculations." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Preserve 6,024 allocated (3,030/2,994), 4,862 primary complete cases (2,392/2,470) and 19.3% missingness. Allocation/observation/analysis and other-person/contact denominators differ. No new dropout counts/group missingness rates.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Flow, group completion/missingness/testing, reasons/handling/sensitivity and contact denominators. Complete-case results do not certify ITT for everyone or outcomes in others.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Flow, group completion/missingness/testing, reasons/handling/sensitivity and contact denominators. Complete-case results do not certify ITT for everyone or outcomes in others." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original endpoint is the wearer’s own one-month SARS-CoV-2 infection by antibody testing, PCR or hospital diagnosis. It is not substituted with PCR alone, test counts, repeated events in the same person or confirmed transmission to others.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Original ascertainment/event definitions, test selection/omissions, baseline/repetition, denominators and infection-source linkage. Endpoint components are not summed as new infections/participants.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original ascertainment/event definitions, test selection/omissions, baseline/repetition, denominators and infection-source linkage. Endpoint components are not summed as new infections/participants." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Original primary results: 42/2,392(1.8%) versus 53/2,470(2.1%); absolute difference −0.3 percentage points (CI −1.2–0.4), P=.38; OR 0.82 (CI 0.54–1.23), P=.33. Keep effects/P separate without copying them as transmission values.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Original estimands, denominators, models/tests, rounding/intervals and direct transmission effects/CI. No RR/risk-difference/CI recalculation.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original estimands, denominators, models/tests, rounding/intervals and direct transmission effects/CI. No RR/risk-difference/CI recalculation." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Original self-reports were 46% as recommended, 47% predominantly and 7% not as recommended. Adherence-group denominators/effects and actual exposure details remain unverified. Recommendations are not relabeled as full-wearing/transmission effects, and low adherence is not newly established as the cause of null results.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Adherence definitions, measurement/exposure/missingness, actual group use/contacts and prespecified adherence analyses. No new counts/rates/adherence effects.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Adherence definitions, measurement/exposure/missingness, actual group use/contacts and prespecified adherence analyses. No new counts/rates/adherence effects." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Existing reasons state that the CI retains substantial benefit/harm and does not establish no effect. This concerns wearer uncertainty; transmission was directly unmeasured. No new zero/equivalence or transmission-harms verdict.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Original wearer denominators/CI/models/importance and separate direct transmission comparisons. Parent D does not overwrite the transmission subclaim as D.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original wearer denominators/CI/models/importance and separate direct transmission comparisons. Parent D does not overwrite the transmission subclaim as D." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Because transmission was not measured, direct infection-source/contact/household/cluster/network event/exposure denominators are not provided. The 6,024-person wearer allocation count is not used as a contact/transmission-event denominator.", "condition_status": "Unverified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Direct-transmission design clusters/contacts, enrollment/testing/exposure/ascertainment, secondary events/denominators and correlation/censoring. No new transmission rates, person counts or network values.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct-transmission design clusters/contacts, enrollment/testing/exposure/ascertainment, secondary events/denominators and correlation/censoring. No new transmission rates, person counts or network values." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original trial concerns wearer infection and does not answer source control/transmission. Wearer OR/adherence, instructions or mechanistic plausibility do not establish direct transmission effects.", "condition_status": "Unverified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Infection-source/contact ascertainment, transmission direction/timing/exposure and direct secondary infection/effects/CI. Materials distinguishing viral shedding/mechanisms from clinical transmission.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Infection-source/contact ascertainment, transmission direction/timing/exposure and direct secondary infection/effects/CI. Materials distinguishing viral shedding/mechanisms from clinical transmission." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Existing advertising interpretation excludes extension to transmission, mandates, healthcare and other variants/epidemics. Recommendation/behavior/cluster-policy effects are not equated without direct materials.", "condition_status": "Unverified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Direct setting/policy populations, interventions/comparators, transmission/infection, cluster/time denominators and effects/CI. No recommendation/mandate/infection-prevention instructions.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct setting/policy populations, interventions/comparators, transmission/infection, cluster/time denominators and effects/CI. No recommendation/mandate/infection-prevention instructions." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original design is a nationwide unblinded RCT; the parent records complete-case analysis, 19.3% missingness and one-month follow-up limitations. Concealment/exposure changes, measurement/selection/missing-data handling remain unverified. No official RoB review or new bias grade.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Allocation/behavior/expectations, tests/omissions, missingness/sensitivity and analyses. Original B2 is parent context, not certified transmission review.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation/behavior/expectations, tests/omissions, missingness/sensitivity and analyses. Original B2 is parent context, not certified transmission review." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Existing research wording records start 2020-04-02, first posting 2020-04-08 and six-day retrospective registration. Only original dates/wording are retained; current registration versions/endpoints/plans were not externally compared.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Actual registration/protocol/SAP versions, availability/changes, primary/secondary outcomes and denominators/analyses. Original six days is not a new calculation or certification.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual registration/protocol/SAP versions, availability/changes, primary/secondary outcomes and denominators/analyses. Original six days is not a new calculation or certification." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Existing safety wording explicitly states that mask harms were not quantified and does not establish absence of discomfort/skin irritation. Unassessed is not confirmed as zero events, harmlessness or transmission-harms effects.", "condition_status": "Unverified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Actual group wearing/exposure, harms collection/denominators, discomfort/skin reactions/discontinuation, relatedness and long-term materials. No mask-use/infection-prevention-care instructions.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual group wearing/exposure, harms collection/denominators, discomfort/skin reactions/discontinuation, relatedness and long-term materials. No mask-use/infection-prevention-care instructions." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The complete parent summary was read for production and preserved in its original form. Summary reading concerns preserved materials; external abstracts/full texts/registrations/protocols/SAP remain unread. Original citations/URLs do not establish external reading here.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Records of actual acquisition/reading scope, versions and dates. No external-link/click/access testing.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Records of actual acquisition/reading scope, versions and dates. No external-link/click/access testing." }, { "item_id": "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Preserve original NCT04337541, start 2020-04-02/first posting 2020-04-08 and six-day retrospective-registration wording. Actual versions/plans/access remain unread here; official URLs are not guessed.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Actual registration versions/availability, recruitment/start/changes, endpoints/models/analyses and original-report linkage. Only history is preserved, with no current plan/prespecification certification.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual registration versions/availability, recruitment/start/changes, endpoints/models/analyses and original-report linkage. Only history is preserved, with no current plan/prespecification certification." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Original primary/analysis/registration wording and historical cross-validation are preserved. Actual protocol/SAP, versions/timing, endpoint-specific models/missingness and hierarchy/multiplicity were not read here.", "condition_status": "Unverified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Original protocol/SAP/revisions, estimands/denominators/analyses, all endpoints and availability timing. Unread is not declared document absence.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original protocol/SAP/revisions, estimands/denominators/analyses, all endpoints and availability timing. Unread is not declared document absence." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Preserve Salling Foundations funding, Rigshospitalet leadership and study-supplied masks. Manufacturer donation/medical-writing/publication-cost support was not verified in the original; company funding, employee authors and design/analysis roles remain separately unverified.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "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.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Distinguish null wearer infection/wide CI from directly unmeasured transmission, absent contact denominators and unread details.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Original direct-measurement/endpoint tables, estimands/denominators, plans and actual-access records. Unread is not unreported, and null is not exactly zero/equivalence.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original direct-measurement/endpoint tables, estimands/denominators, plans and actual-access records. Unread is not unreported, and null is not exactly zero/equivalence." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Parent 2971 and existing s0/s1 share the same DANMASK-19 report, 6,024 allocated and 4,862 complete cases. People/groups/tests/events/timepoints/bibliographies/sibling sheets are not summed as independent trials/participants; wearer denominators do not fill other-person denominators. Linked-report counts do not certify unique totals.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Original report/registration, cohort/test/timepoint, event/repetition/observation and overlap relationships. Unique trials/participant totals remain not recorded.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original report/registration, cohort/test/timepoint, event/repetition/observation and overlap relationships. Unique trials/participant totals remain not recorded." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Preserve parent R1/I2 and the single-trial scope. Timepoints/endpoints in the same people and sibling sheets do not certify new independent replication.", "condition_status": "Unverified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Separate prespecified direct population/intervention/comparator/endpoint/period, denominators/effects/CI and disclosed funding/author relationships for the selected question. No new search/independence judgment.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate prespecified direct population/intervention/comparator/endpoint/period, denominators/effects/CI and disclosed funding/author relationships for the selected question. No new search/independence judgment." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Preserve selected grade/note and both question languages. Absent subclaim score/status/axes remain not recorded. Parent D34, safety and axes are parent context and are not transferred as a selected score.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Existing subclaim/parent-boundary review and actual correction materials. No new grade/score or official RoB 2/GRADE certification.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Existing subclaim/parent-boundary review and actual correction materials. No new grade/score or official RoB 2/GRADE certification." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Preserve parent Korean/English citations/descriptions, evidence/citation lists, axes and selected-subclaim records in the complete summary. Separate classification information in both languages is absent; originals are not filled with new fields. No external English full-text comparison.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Review materials for terminology, endpoints/effects/test units, selected scope and absent fields in both languages. Production explanations are distinguished from original records.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Review materials for terminology, endpoints/effects/test units, selected scope and absent fields in both languages. Production explanations are distinguished from original records." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Preserve original 2026-08-26, empty corrections/deliberation and verdict-decision cross-validation. Original citation/registration wording differs from current production/condition freezing/application or completed content review.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Update materials separating originals, events, conditions/observations and verdict decisions when new evidence/corrections arise. Historical wording is not completed clinical content review here.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Update materials separating originals, events, conditions/observations and verdict decisions when new evidence/corrections arise. Historical wording is not completed clinical content review here." }, { "item_id": "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Transmission gaps require direct infection-source/contact/cluster/network ascertainment/observation and effects/CI. Null one-month wearer results or mechanisms do not substitute for them.", "condition_status": "Unverified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Original tables/plans, 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.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original tables/plans, 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." }, { "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.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "These are summary-based applicability records. Existing content/question-boundary review remains incomplete; candidate pending/eligible markers are preserved as history.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Existing 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.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Existing 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." } ], "reports": [ { "report_id": "R01", "title": "Bundgaard H, et al. Effectiveness of Adding a Mask Recommendation to Other Public Health Measures to Prevent SARS-CoV-2 Infection in Danish Mask Wearers. Ann Intern Med. 2021;174:335-343. PMID: 33205991.", "url": "https://pubmed.ncbi.nlm.nih.gov/33205991/", "report_type": "Nationwide unblinded randomized controlled trial", "existence": "Report bibliography exists in original citations; external availability/access remain unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/plans remain unread", "study_family": "F01", "independent_replication": "Same report/endpoints/timepoints, long-term follow-up or sibling sheets are not certified as new independent replication", "observed_result": "42/2,392(1.8%) versus 53/2,470(2.1%); difference −0.3 percentage points (−1.2–0.4), P=.38; OR 0.82(0.54–1.23), P=.33", "result_level": "Parent-endpoint summary in the original evidence list; directness/scope for selected/other endpoints are distinguished in condition rows/roles", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Local preserved copy of the complete parent summary", "access_status": "Stored summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only original PubMed URL/bibliography and original shared-registration wording are preserved; full-text/registration/plan URLs are not guessed. No new external reading/access or fulfillment certification." }, { "material_type": "External abstract", "public_status": "Original identifier/bibliography or required-material entry; public availability/access details remain unverified", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Only original PubMed URL/bibliography and original shared-registration wording are preserved; full-text/registration/plan URLs are not guessed. No new external reading/access or fulfillment certification." }, { "material_type": "External full text", "public_status": "Original identifier/bibliography or required-material entry; public availability/access details remain unverified", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Only original PubMed URL/bibliography and original shared-registration wording are preserved; full-text/registration/plan URLs are not guessed. No new external reading/access or fulfillment certification." }, { "material_type": "Registration material", "public_status": "Original identifier/bibliography or required-material entry; public availability/access details remain unverified", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Only original PubMed URL/bibliography and original shared-registration wording are preserved; full-text/registration/plan URLs are not guessed. No new external reading/access or fulfillment certification." }, { "material_type": "Protocol/SAP", "public_status": "Original identifier/bibliography or required-material entry; public availability/access details remain unverified", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Only original PubMed URL/bibliography and original shared-registration wording are preserved; full-text/registration/plan URLs are not guessed. No new external reading/access or fulfillment certification." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/33205991/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." } ], "status_dictionary": { "Partly verified": "Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.", "Unverified": "Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety", "Review incomplete": "Review of existing content incomplete", "Met": "Use only within the relevant conditions after existing content review; no automatic designation in this preparation", "Not reported": "Distinguish only within materials actually read; do not turn unread external materials into unreported findings", "Inaccessible": "Not applied during this preparation because actual access was not tested", "Not applicable": "Use with a reason for non-applicability based on an explicit question boundary", "Conflicting data": "Judge after actual material comparison; review was not performed during this preparation", "Insufficient evidence for the conditions": "Do not use as a clinical grade encompassing currently unread materials" }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "Parent 2971 and existing s0/s1 share the same DANMASK-19 report, 6,024 allocated and 4,862 complete cases. People/groups/tests/events/timepoints/bibliographies and sibling sheets are not summed as independent trials/participants; wearer denominators do not fill other-person denominators. Only report/registration/follow-up relationships are linked, without certification of unique trials/participants or independence." }, "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" }