Surgical-mask recommendation × Transmission to others — Wearer infection and directly unmeasured gaps

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Evidence conditionWhich existing transmission-to-others claim is being transferred?Required	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. R01	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.	Selected wording/subclaim grade versus parent wearer results	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.
2	Unverified	Full text not readStored summary read	N02 · Evidence conditionAre wearer protection and source control directly distinguished?Required	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. R01	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.	Infection acquired by the wearer versus transmission to others	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.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionWas the intervention enforced or verified actual wearing?Required	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. R01	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.	Surgical-mask recommendation, 50 masks and instructions	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.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionWhat were the control and prevailing advice in both groups?Required	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. R01	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.	Recommendation versus control and common public-health advice	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.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionWhich period, setting and population were studied?Required	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. R01	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.	2020 Danish community and uncommon mask use	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.
6	Unverified	Full text not readStored summary read	N06 · Evidence conditionWas one-month follow-up long-term observation of transmission networks?Required	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. R01	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.	One-month wearer follow-up versus contact observation	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.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionAre allocation, complete-case analysis and missingness separated?Required	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. R01	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.	6,024, 4,862 and 19.3%	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.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionWhat ascertainment methods define wearer infection?Required	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. R01	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.	One-month infection by antibody testing, PCR or hospital diagnosis	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.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionWhich outcome do the wearer effects/CI describe?Required	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. R01	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.	42/2392 versus 53/2470, difference and OR	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.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionAre self-reported adherence and actual-wearing effects distinguished?Required	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. R01	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.	46%/47%/7% versus recommendation effects	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.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionAre null/wide-CI wearer results separated from unmeasured transmission?Required	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. R01	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.	Intervals for possible wearer effects versus selected-question gaps	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.
12	Unverified	Full text not readStored summary read	N12 · Evidence conditionAre contact/cluster/network denominators known?Required	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. R01	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.	Direct-transmission populations at risk and event denominators	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.
13	Unverified	Full text not readStored summary read	N13 · Evidence conditionAre indirect source-control indicators used to fill the gap?Required	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. R01	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.	Direct secondary infection versus wearer/mechanistic outcomes	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.
14	Unverified	Full text not readStored summary read	N14 · Evidence conditionAre mandates, healthcare and other epidemics separate questions?Required	Existing advertising interpretation excludes extension to transmission, mandates, healthcare and other variants/epidemics. Recommendation/behavior/cluster-policy effects are not equated without direct materials. R01	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.	Applicability boundaries of a recommendation trial	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.
15	Partly verified	Full text not readStored summary read	N15 · Evidence conditionAre original unblinded, complete-case and missing-data limitations preserved?Required	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. R01	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.	Recommendation-trial design and measurement/analysis gaps	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.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionAre original registration start/posting times preserved?Required	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. R01	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.	NCT04337541 and six-day retrospective registration	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.
17	Unverified	Full text not readStored summary read	N17 · Harm-information gaps supplementing the efficacy tableWere mask harms directly quantified?Supplementary	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. R01	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.	Discomfort/skin irritation and original lack of harms assessment	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.
18	Partly verified	Full text not readStored summary read	N18 · Evidence conditionWhat materials were actually read or acquired?Required	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. R01	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.	Preserved summary versus external materials	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.
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionAre historical registration/prespecification and current reading separated?Required	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. R01	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.	Original registration identifier, timing and plans	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.
20	Unverified	Full text not readStored summary read	N20 · Evidence conditionHave protocol/SAP and analysis/missing-data plans been acquired?Required	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. R01	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.	Separate materials for prespecified plans/changes	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.
21	Partly verified	Full text not readStored summary read	N21 · Evidence conditionAre sponsorship/funding, products, authors and research roles separated?Required	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. R01	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.	Four company-involvement items and institution/foundation support	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.
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionAre directly unmeasured, null and unverified outcomes distinguished?Required	Distinguish null wearer infection/wide CI from directly unmeasured transmission, absent contact denominators and unread details. R01	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.	Question/results versus access gaps	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.
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionAre reports, trials, people, tests/timepoints and sibling sheets separated?Required	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. R01	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.	Linked records versus unique trials/participants	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.
24	Unverified	Full text not readStored summary read	N24 · Evidence conditionAre the original single trial and separate replication distinguished?Supplementary	Preserve parent R1/I2 and the single-trial scope. Timepoints/endpoints in the same people and sibling sheets do not certify new independent replication. R01	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.	Parent R1/I2, follow-up and confirmation	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.
25	Partly verified	Full text not readStored summary read	N25 · Evidence conditionAre the subclaim grade and parent score/axes preserved?Required	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. R01	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.	Selected ? grade, absent subclaim values and parent D34	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.
26	Partly verified	Full text not readStored summary read	N26 · Evidence conditionAre both languages, citations and absent fields preserved?Required	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. R01	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.	Both original languages and absent separate classification information	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.
27	Partly verified	Full text not readStored summary read	N27 · Evidence conditionAre source dates/corrections/history separated from production dates?Required	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. R01	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.	Original 2026-08-26 and new conditions/application	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.
28	Unverified	Full text not readStored summary read	N28 · Evidence conditionWhat direct materials would fill the selected gaps?Supplementary	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. R01	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.	Direct endpoints, estimands/CI and denominators/follow-up	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.
29	Partly verified	Full text not readStored summary read	N29 · Evidence conditionAre applicability records separated from content review and instructions?Supplementary	These are summary-based applicability records. Existing content/question-boundary review remains incomplete; candidate pending/eligible markers are preserved as history. R01	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.	Applicability records, existing candidate history and content review	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.

No items match your search or filter.

29 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-08-26
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population: 6,024 community adults in 2020 Denmark; wearer denominators are distinguished from unverified direct contact/cluster/network denominators
Ingredient, formulation and route: 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
Measured outcome: 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
Questions outside this scope: 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

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

R01 · 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.

PubMed

Material type: Nationwide unblinded randomized controlled trial
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/plans remain unread
Findings recorded in the stored summary: 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
Record level: Parent-endpoint summary in the original evidence list; directness/scope for selected/other endpoints are distinguished in condition rows/roles
Study overlap and independent replication: 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.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Local preserved copy of the complete parent summary	Stored summary read	Summary read	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.
External abstract	Original identifier/bibliography or required-material entry; public availability/access details remain unverified	Unread; access testing not performed	Not read	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.
External full text	Original identifier/bibliography or required-material entry; public availability/access details remain unverified	Unread; access testing not performed	Not read	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.
Registration material	Original identifier/bibliography or required-material entry; public availability/access details remain unverified	Unread; access testing not performed	Not read	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.
Protocol/SAP	Original identifier/bibliography or required-material entry; public availability/access details remain unverified	Unread; access testing not performed	Not read	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.

Report counts versus independent study counts

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.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Which existing transmission-to-others claim is being transferred?

Required materials and conditions: Selected wording/subclaim grade versus parent wearer results
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N02 · Are wearer protection and source control directly distinguished?

Required materials and conditions: Infection acquired by the wearer versus transmission to others
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N03 · Was the intervention enforced or verified actual wearing?

Required materials and conditions: Surgical-mask recommendation, 50 masks and instructions
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N04 · What were the control and prevailing advice in both groups?

Required materials and conditions: Recommendation versus control and common public-health advice
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N05 · Which period, setting and population were studied?

Required materials and conditions: 2020 Danish community and uncommon mask use
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N06 · Was one-month follow-up long-term observation of transmission networks?

Required materials and conditions: One-month wearer follow-up versus contact observation
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N07 · Are allocation, complete-case analysis and missingness separated?

Required materials and conditions: 6,024, 4,862 and 19.3%
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N08 · What ascertainment methods define wearer infection?

Required materials and conditions: One-month infection by antibody testing, PCR or hospital diagnosis
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N09 · Which outcome do the wearer effects/CI describe?

Required materials and conditions: 42/2392 versus 53/2470, difference and OR
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N10 · Are self-reported adherence and actual-wearing effects distinguished?

Required materials and conditions: 46%/47%/7% versus recommendation effects
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N11 · Are null/wide-CI wearer results separated from unmeasured transmission?

Required materials and conditions: Intervals for possible wearer effects versus selected-question gaps
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N12 · Are contact/cluster/network denominators known?

Required materials and conditions: Direct-transmission populations at risk and event denominators
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N13 · Are indirect source-control indicators used to fill the gap?

Required materials and conditions: Direct secondary infection versus wearer/mechanistic outcomes
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N14 · Are mandates, healthcare and other epidemics separate questions?

Required materials and conditions: Applicability boundaries of a recommendation trial
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N15 · Are original unblinded, complete-case and missing-data limitations preserved?

Required materials and conditions: Recommendation-trial design and measurement/analysis gaps
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N16 · Are original registration start/posting times preserved?

Required materials and conditions: NCT04337541 and six-day retrospective registration
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N17 · Were mask harms directly quantified?

Required materials and conditions: Discomfort/skin irritation and original lack of harms assessment
Conditions for verification: 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.
Requirement and applicability: Supplementary
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N18 · What materials were actually read or acquired?

Required materials and conditions: Preserved summary versus external materials
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N19 · Are historical registration/prespecification and current reading separated?

Required materials and conditions: Original registration identifier, timing and plans
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N20 · Have protocol/SAP and analysis/missing-data plans been acquired?

Required materials and conditions: Separate materials for prespecified plans/changes
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N21 · Are sponsorship/funding, products, authors and research roles separated?

Required materials and conditions: Four company-involvement items and institution/foundation support
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N22 · Are directly unmeasured, null and unverified outcomes distinguished?

Required materials and conditions: Question/results versus access gaps
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N23 · Are reports, trials, people, tests/timepoints and sibling sheets separated?

Required materials and conditions: Linked records versus unique trials/participants
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N24 · Are the original single trial and separate replication distinguished?

Required materials and conditions: Parent R1/I2, follow-up and confirmation
Conditions for verification: 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.
Requirement and applicability: Supplementary
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N25 · Are the subclaim grade and parent score/axes preserved?

Required materials and conditions: Selected ? grade, absent subclaim values and parent D34
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N26 · Are both languages, citations and absent fields preserved?

Required materials and conditions: Both original languages and absent separate classification information
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N27 · Are source dates/corrections/history separated from production dates?

Required materials and conditions: Original 2026-08-26 and new conditions/application
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N28 · What direct materials would fill the selected gaps?

Required materials and conditions: Direct endpoints, estimands/CI and denominators/follow-up
Conditions for verification: 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.
Requirement and applicability: Supplementary
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N29 · Are applicability records separated from content review and instructions?

Required materials and conditions: Applicability records, existing candidate history and content review
Conditions for verification: 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.
Requirement and applicability: Supplementary
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

What the statuses mean

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

Change history

2026-10-14 · Public page/material version 1.0

Public pages and materials were created from the existing 29 items. No new clinical search, verification-status change or scoring was performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-08-26) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · Which existing transmission-to-others claim is being transferred?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: 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.
Reason for missing information: Direct transmission population/endpoints, contact/cluster denominators, comparison/period and existing boundary review. Parent scores are not filled into the subclaim.
Required materials and conditions: Selected wording/subclaim grade versus parent wearer results
Materials to obtain first: Direct transmission population/endpoints, contact/cluster denominators, comparison/period and existing boundary review. Parent scores are not filled into the subclaim.
Further 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.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N02 · Are wearer protection and source control directly distinguished?

Current findings: 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.
Verification status: Unverified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: 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.
Reason for missing information: Infection sources/contacts, transmission direction/ascertainment, direct cluster/network/contact tracing, denominators/effects/CI. Unmeasured is not changed to zero transmission events.
Required materials and conditions: Infection acquired by the wearer versus transmission to others
Materials to obtain first: Infection sources/contacts, transmission direction/ascertainment, direct cluster/network/contact tracing, denominators/effects/CI. Unmeasured is not changed to zero transmission events.
Further 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.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N03 · Was the intervention enforced or verified actual wearing?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: 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.
Reason for missing information: Original recommendation/distribution, actual use/adherence, product identity/masks and concurrent exposure. No new wearer-adherence or transmission effects are calculated.
Required materials and conditions: Surgical-mask recommendation, 50 masks and instructions
Materials to obtain first: Original recommendation/distribution, actual use/adherence, product identity/masks and concurrent exposure. No new wearer-adherence or transmission effects are calculated.
Further 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.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N04 · What were the control and prevailing advice in both groups?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: 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.
Reason for missing information: Actual group masks/contacts/public-health exposure, contamination, expectations/behavior and adherence. Contributions beyond recommendation differences are not newly established.
Required materials and conditions: Recommendation versus control and common public-health advice
Materials to obtain first: Actual group masks/contacts/public-health exposure, contamination, expectations/behavior and adherence. Contributions beyond recommendation differences are not newly established.
Further 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.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N05 · Which period, setting and population were studied?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: 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.
Reason for missing information: Direct transmission materials with eligibility, location/period/epidemic, baseline/contact/concurrent exposure. This is not converted to current mask/infection-prevention guidance.
Required materials and conditions: 2020 Danish community and uncommon mask use
Materials to obtain first: Direct transmission materials with eligibility, location/period/epidemic, baseline/contact/concurrent exposure. This is not converted to current mask/infection-prevention guidance.
Further 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.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N06 · Was one-month follow-up long-term observation of transmission networks?

Current findings: 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.
Verification status: Unverified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: 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.
Reason for missing information: Direct infection-source/contact enrollment, exposure/incubation/follow-up/testing, time denominators and losses. No new time/day calculations.
Required materials and conditions: One-month wearer follow-up versus contact observation
Materials to obtain first: Direct infection-source/contact enrollment, exposure/incubation/follow-up/testing, time denominators and losses. No new time/day calculations.
Further 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.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N07 · Are allocation, complete-case analysis and missingness separated?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: 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.
Reason for missing information: Flow, group completion/missingness/testing, reasons/handling/sensitivity and contact denominators. Complete-case results do not certify ITT for everyone or outcomes in others.
Required materials and conditions: 6,024, 4,862 and 19.3%
Materials to obtain first: Flow, group completion/missingness/testing, reasons/handling/sensitivity and contact denominators. Complete-case results do not certify ITT for everyone or outcomes in others.
Further 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.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N08 · What ascertainment methods define wearer infection?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: 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.
Reason for missing information: Original ascertainment/event definitions, test selection/omissions, baseline/repetition, denominators and infection-source linkage. Endpoint components are not summed as new infections/participants.
Required materials and conditions: One-month infection by antibody testing, PCR or hospital diagnosis
Materials to obtain first: Original ascertainment/event definitions, test selection/omissions, baseline/repetition, denominators and infection-source linkage. Endpoint components are not summed as new infections/participants.
Further 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.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N09 · Which outcome do the wearer effects/CI describe?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: 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.
Reason for missing information: Original estimands, denominators, models/tests, rounding/intervals and direct transmission effects/CI. No RR/risk-difference/CI recalculation.
Required materials and conditions: 42/2392 versus 53/2470, difference and OR
Materials to obtain first: Original estimands, denominators, models/tests, rounding/intervals and direct transmission effects/CI. No RR/risk-difference/CI recalculation.
Further 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.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N10 · Are self-reported adherence and actual-wearing effects distinguished?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: 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.
Reason for missing information: Adherence definitions, measurement/exposure/missingness, actual group use/contacts and prespecified adherence analyses. No new counts/rates/adherence effects.
Required materials and conditions: 46%/47%/7% versus recommendation effects
Materials to obtain first: Adherence definitions, measurement/exposure/missingness, actual group use/contacts and prespecified adherence analyses. No new counts/rates/adherence effects.
Further 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.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N11 · Are null/wide-CI wearer results separated from unmeasured transmission?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: 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.
Reason for missing information: Original wearer denominators/CI/models/importance and separate direct transmission comparisons. Parent D does not overwrite the transmission subclaim as D.
Required materials and conditions: Intervals for possible wearer effects versus selected-question gaps
Materials to obtain first: Original wearer denominators/CI/models/importance and separate direct transmission comparisons. Parent D does not overwrite the transmission subclaim as D.
Further 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.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N12 · Are contact/cluster/network denominators known?

Current findings: 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.
Verification status: Unverified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: 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.
Reason for missing information: Direct-transmission design clusters/contacts, enrollment/testing/exposure/ascertainment, secondary events/denominators and correlation/censoring. No new transmission rates, person counts or network values.
Required materials and conditions: Direct-transmission populations at risk and event denominators
Materials to obtain first: Direct-transmission design clusters/contacts, enrollment/testing/exposure/ascertainment, secondary events/denominators and correlation/censoring. No new transmission rates, person counts or network values.
Further 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.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N13 · Are indirect source-control indicators used to fill the gap?

Current findings: 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.
Verification status: Unverified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: 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.
Reason for missing information: Infection-source/contact ascertainment, transmission direction/timing/exposure and direct secondary infection/effects/CI. Materials distinguishing viral shedding/mechanisms from clinical transmission.
Required materials and conditions: Direct secondary infection versus wearer/mechanistic outcomes
Materials to obtain first: Infection-source/contact ascertainment, transmission direction/timing/exposure and direct secondary infection/effects/CI. Materials distinguishing viral shedding/mechanisms from clinical transmission.
Further 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.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N14 · Are mandates, healthcare and other epidemics separate questions?

Current findings: Existing advertising interpretation excludes extension to transmission, mandates, healthcare and other variants/epidemics. Recommendation/behavior/cluster-policy effects are not equated without direct materials.
Verification status: Unverified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: 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.
Reason for missing information: Direct setting/policy populations, interventions/comparators, transmission/infection, cluster/time denominators and effects/CI. No recommendation/mandate/infection-prevention instructions.
Required materials and conditions: Applicability boundaries of a recommendation trial
Materials to obtain first: Direct setting/policy populations, interventions/comparators, transmission/infection, cluster/time denominators and effects/CI. No recommendation/mandate/infection-prevention instructions.
Further 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.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N15 · Are original unblinded, complete-case and missing-data limitations preserved?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: 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.
Reason for missing information: Allocation/behavior/expectations, tests/omissions, missingness/sensitivity and analyses. Original B2 is parent context, not certified transmission review.
Required materials and conditions: Recommendation-trial design and measurement/analysis gaps
Materials to obtain first: Allocation/behavior/expectations, tests/omissions, missingness/sensitivity and analyses. Original B2 is parent context, not certified transmission review.
Further 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.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N16 · Are original registration start/posting times preserved?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: 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.
Reason for missing information: Actual registration/protocol/SAP versions, availability/changes, primary/secondary outcomes and denominators/analyses. Original six days is not a new calculation or certification.
Required materials and conditions: NCT04337541 and six-day retrospective registration
Materials to obtain first: Actual registration/protocol/SAP versions, availability/changes, primary/secondary outcomes and denominators/analyses. Original six days is not a new calculation or certification.
Further 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.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N17 · Were mask harms directly quantified?

Current findings: 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.
Verification status: Unverified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: 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.
Reason for missing information: Actual group wearing/exposure, harms collection/denominators, discomfort/skin reactions/discontinuation, relatedness and long-term materials. No mask-use/infection-prevention-care instructions.
Required materials and conditions: Discomfort/skin irritation and original lack of harms assessment
Materials to obtain first: Actual group wearing/exposure, harms collection/denominators, discomfort/skin reactions/discontinuation, relatedness and long-term materials. No mask-use/infection-prevention-care instructions.
Further 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.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N18 · What materials were actually read or acquired?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: 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.
Reason for missing information: Records of actual acquisition/reading scope, versions and dates. No external-link/click/access testing.
Required materials and conditions: Preserved summary versus external materials
Materials to obtain first: Records of actual acquisition/reading scope, versions and dates. No external-link/click/access testing.
Further 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.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N19 · Are historical registration/prespecification and current reading separated?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: 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.
Reason for missing information: Actual registration versions/availability, recruitment/start/changes, endpoints/models/analyses and original-report linkage. Only history is preserved, with no current plan/prespecification certification.
Required materials and conditions: Original registration identifier, timing and plans
Materials to obtain first: Actual registration versions/availability, recruitment/start/changes, endpoints/models/analyses and original-report linkage. Only history is preserved, with no current plan/prespecification certification.
Further 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.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N20 · Have protocol/SAP and analysis/missing-data plans been acquired?

Current findings: 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.
Verification status: Unverified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: 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.
Reason for missing information: Original protocol/SAP/revisions, estimands/denominators/analyses, all endpoints and availability timing. Unread is not declared document absence.
Required materials and conditions: Separate materials for prespecified plans/changes
Materials to obtain first: Original protocol/SAP/revisions, estimands/denominators/analyses, all endpoints and availability timing. Unread is not declared document absence.
Further 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.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N21 · Are sponsorship/funding, products, authors and research roles separated?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: 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.
Reason for missing information: 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.
Required materials and conditions: Four company-involvement items and institution/foundation support
Materials to obtain first: 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.
Further 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.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N22 · Are directly unmeasured, null and unverified outcomes distinguished?

Current findings: Distinguish null wearer infection/wide CI from directly unmeasured transmission, absent contact denominators and unread details.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: 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.
Reason for missing information: Original direct-measurement/endpoint tables, estimands/denominators, plans and actual-access records. Unread is not unreported, and null is not exactly zero/equivalence.
Required materials and conditions: Question/results versus access gaps
Materials to obtain first: Original direct-measurement/endpoint tables, estimands/denominators, plans and actual-access records. Unread is not unreported, and null is not exactly zero/equivalence.
Further 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.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N23 · Are reports, trials, people, tests/timepoints and sibling sheets separated?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: 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.
Reason for missing information: Original report/registration, cohort/test/timepoint, event/repetition/observation and overlap relationships. Unique trials/participant totals remain not recorded.
Required materials and conditions: Linked records versus unique trials/participants
Materials to obtain first: Original report/registration, cohort/test/timepoint, event/repetition/observation and overlap relationships. Unique trials/participant totals remain not recorded.
Further 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.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N24 · Are the original single trial and separate replication distinguished?

Current findings: Preserve parent R1/I2 and the single-trial scope. Timepoints/endpoints in the same people and sibling sheets do not certify new independent replication.
Verification status: Unverified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: 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.
Reason for missing information: 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.
Required materials and conditions: Parent R1/I2, follow-up and confirmation
Materials to obtain first: 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.
Further 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.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N25 · Are the subclaim grade and parent score/axes preserved?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: 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.
Reason for missing information: Existing subclaim/parent-boundary review and actual correction materials. No new grade/score or official RoB 2/GRADE certification.
Required materials and conditions: Selected ? grade, absent subclaim values and parent D34
Materials to obtain first: Existing subclaim/parent-boundary review and actual correction materials. No new grade/score or official RoB 2/GRADE certification.
Further 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.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N26 · Are both languages, citations and absent fields preserved?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: 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.
Reason for missing information: Review materials for terminology, endpoints/effects/test units, selected scope and absent fields in both languages. Production explanations are distinguished from original records.
Required materials and conditions: Both original languages and absent separate classification information
Materials to obtain first: Review materials for terminology, endpoints/effects/test units, selected scope and absent fields in both languages. Production explanations are distinguished from original records.
Further 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.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N27 · Are source dates/corrections/history separated from production dates?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: 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.
Reason for missing information: Update materials separating originals, events, conditions/observations and verdict decisions when new evidence/corrections arise. Historical wording is not completed clinical content review here.
Required materials and conditions: Original 2026-08-26 and new conditions/application
Materials to obtain first: Update materials separating originals, events, conditions/observations and verdict decisions when new evidence/corrections arise. Historical wording is not completed clinical content review here.
Further 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.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N28 · What direct materials would fill the selected gaps?

Current findings: 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.
Verification status: Unverified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: 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.
Reason for missing information: 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.
Required materials and conditions: Direct endpoints, estimands/CI and denominators/follow-up
Materials to obtain first: 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.
Further 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.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N29 · Are applicability records separated from content review and instructions?

Current findings: These are summary-based applicability records. Existing content/question-boundary review remains incomplete; candidate pending/eligible markers are preserved as history.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: 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.
Reason for missing information: 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.
Required materials and conditions: Applicability records, existing candidate history and content review
Materials to obtain first: 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.
Further 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.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01