| 1 |
Partly verified |
Full text not readStored summary read |
N01 · Evidence conditionSelected wearer question and original gradeRequired |
The selected subclaim is “Reduced infection in the wearer at one month,” grade D with the null OR 0.82(0.54–1.23) note. Subclaim score/status/axes are absent; parent D34 is not used to fill a subclaim score. |
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Absent subclaim score/status/axes are distinguished from transmission-to-others and mandate effects. Existing content review remains incomplete. |
Existing question, grade/note, parent values and separate transmission question |
Proposal for later research specifying the wearer endpoint/timepoint; no new investigation, calculation or trial was performed in that production. |
| 2 |
Partly verified |
Full text not readStored summary read |
N02 · Evidence condition2020 Denmark and community settingRequired |
DANMASK-19 studied adults in 2020 Denmark where community mask use was uncommon. Results are not extended to current/other epidemics, healthcare settings or protection of all populations. |
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Age/eligibility, baseline infection/risk, exposure/occupation, recruitment/group balance and test access remain unverified. Existing content review remains incomplete. |
Time/setting, actual population, recruitment and baseline risk |
Proposal for later comparative research specifying the setting/population; no new investigation, calculation or trial was performed in that production. |
| 3 |
Partly verified |
Full text not readStored summary read |
N03 · Evidence conditionRecommendation, 50 masks and instructionsRequired |
The intervention supplied a surgical-mask recommendation, 50 masks and instructions. It is not relabeled as full actual wearing, filtration/product effects alone or a mandate trial. |
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Product specifications/batches, actual supply/instructions, additional contacts and wearing conditions/exposure remain unverified. Existing content review remains incomplete. |
Assigned recommendation/support versus actual wearing and product effects |
Proposal for later research distinguishing recommendation/support from actual wearing; no new investigation, calculation or trial was performed in that production. |
| 4 |
Partly verified |
Full text not readStored summary read |
N04 · Evidence conditionActual wearing and self-reported adherenceRequired |
Preserve self-reported adherence: 46% as recommended, 47% predominantly as recommended, 7% not as recommended. These do not fill objective wearing-time/precise exposure records for all participants. |
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Adherence-questionnaire denominators/timing/definitions, objective wearing/use, missingness and group crossover remain unverified. Existing content review remains incomplete. |
46/47/7% categories/periods, measurement and exposure |
Proposal specifying differences between reported adherence and actual exposure; no new investigation, calculation or trial was performed in that production. |
| 5 |
Partly verified |
Full text not readStored summary read |
N05 · Evidence conditionRecommendation effects and adherence-based analysisRequired |
The original trial compares assigned recommendations. The original low-full-adherence context is retained without newly estimating actual-wearer/full-adherence effects or certifying benefits. |
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Prespecified adherence-based plans, inclusion/exposure, adjustment/confounding and related sensitivity results remain unverified. Existing content review remains incomplete. |
Assigned recommendation versus actual-wearer/full-adherence effects |
Proposal distinguishing assignment strategies and actual-exposure estimands; no new investigation, calculation or trial was performed in that production. |
| 6 |
Partly verified |
Full text not readStored summary read |
N06 · Evidence conditionControl and concurrent public-health measuresRequired |
Both groups followed prevailing public-health advice. This does not verify a no-action/no-contact control or identical prevention/lifestyle/exposure conditions. |
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Control mask wearing/additional support, concurrent measures, lifestyle/exposure, contacts and differences/analyses remain unverified. Existing content review remains incomplete. |
Actual measures and contact/exposure differences across groups |
Proposal specifying actual comparisons/concurrent conditions; no new investigation, calculation or trial was performed in that production. |
| 7 |
Partly verified |
Full text not readStored summary read |
N07 · Evidence conditionRandomization and lack of maskingRequired |
The original design is a nationwide unblinded randomized controlled trial. The randomization label does not verify all sequence/concealment or test/adjudicator/analyst masking details. |
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original sequence generation/concealment, implementation/exceptions, role-specific masking and baseline balance remain unread. Existing content review remains incomplete. |
Design label and scope of allocation/measurement/analysis procedures |
Proposal disclosing allocation and outcome measurement/adjudication; no new investigation, calculation or trial was performed in that production. |
| 8 |
Partly verified |
Full text not readStored summary read |
N08 · Evidence conditionComposite infection ascertainmentRequired |
The primary endpoint is the wearer’s own SARS-CoV-2 infection at one month, ascertained through antibody testing, PCR or hospital diagnosis. It is not relabeled as PCR alone, self-reported symptoms or transmission to others. |
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Component definitions/tests, accepted results, overlap/adjudication and event timing remain unverified. Existing content review remains incomplete. |
Antibody testing, PCR, hospital diagnosis and component/adjudication rules |
Proposal distinguishing component ascertainment from the composite endpoint; no new investigation, calculation or trial was performed in that production. |
| 9 |
Partly verified |
Full text not readStored summary read |
N09 · Evidence conditionTesting time, baseline infection and missingnessRequired |
Preserve the original ascertainment methods and one-month period without claiming verified test counts, baseline status, assessment windows or identical ascertainment of all events. |
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Baseline infection, test/sample timing, implementation/nonimplementation, access, adjudication/errors and confirmation delays remain unverified. Existing content review remains incomplete. |
Correspondence of one-month infection with tests/baseline/assessment windows |
Proposal specifying testing/baseline conditions and infection-adjudication timing; no new investigation, calculation or trial was performed in that production. |
| 10 |
Partly verified |
Full text not readStored summary read |
N10 · Evidence conditionOne month and duration/exposure scopeRequired |
Follow-up was one month. The same recommendation is not expanded to sustained long-term/other-epidemic/healthcare/other-mask effects, and no use/testing instructions are produced. |
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Individual observation/wearing periods, start/end/censoring and later follow-up/exposure remain unverified. Existing content review remains incomplete. |
Original period, actual observation/wearing and long-term/other-epidemic boundaries |
Proposal distinguishing timepoint/duration and setting-specific applicability; no new investigation, calculation or trial was performed in that production. |
| 11 |
Partly verified |
Full text not readStored summary read |
N11 · Evidence conditionOriginal events and complete-case denominatorsRequired |
Primary results were 42/2,392(1.8%) versus 53/2,470(2.1%). They are not relabeled with all-randomized denominators, test counts or total repeated infections; no new proportions/event totals are calculated. |
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Component-specific event counts, test/person overlap, risk/observation denominators and ascertainment-method correspondence remain unverified. Existing content review remains incomplete. |
42/2,392 and 53/2,470 versus people/test units |
Proposal reporting people/events/tests and denominators separately; no new investigation, calculation or trial was performed in that production. |
| 12 |
Partly verified |
Full text not readStored summary read |
N12 · Evidence conditionOriginal absolute difference, CI and PRequired |
Preserve absolute difference −0.3 percentage points (95% CI −1.2–0.4), P=.38. Do not newly subtract 1.8%/2.1% or calculate a new effect, CI or NNT. |
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Exact contrasts/models, adjustment, CI methods and original plans/sensitivity remain unread. Existing content review remains incomplete. |
Original absolute effect/CI versus rounded proportions and models |
Proposal for later research disclosing effect measures and precision; no new investigation, calculation or trial was performed in that production. |
| 13 |
Partly verified |
Full text not readStored summary read |
N13 · Evidence conditionOR, CI and separate PRequired |
OR 0.82(0.54–1.23), P=.33 is the original result. It is retained separately from absolute-difference P=.38; OR is not converted to RR, individual risk or a new relative reduction. |
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. OR models/adjustment, precise contrasts, tests/CI methods and correspondence to absolute effects remain unread. Existing content review remains incomplete. |
Original OR/CI versus the different absolute-difference estimand |
Proposal reporting effect measures/tests separately; no new investigation, calculation or trial was performed in that production. |
| 14 |
Partly verified |
Full text not readStored summary read |
N14 · Evidence conditionNonsignificance, wide CI and importanceRequired |
The original manuscript records no established primary benefit and a CI retaining substantial benefit/harm possibilities. It is not changed to zero effect, equivalence or confirmed general mask ineffectiveness/harm. |
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Prespecified importance/success/equivalence criteria and sufficient precision for exact effects remain unverified. Existing content review remains incomplete. |
Null verdict versus possible benefit/harm, exactly zero and equivalence |
Proposal specifying effects/precision and question scope; no new investigation, calculation or trial was performed in that production. |
| 15 |
Partly verified |
Full text not readStored summary read |
N15 · Evidence condition6,024 randomized and 4,862 complete casesRequired |
Preserve 6,024 randomized (3,030/2,994) and 4,862 primary complete cases (2,392/2,470). These populations/group counts are not combined or filled as complete observation/ITT for everyone. |
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Complete-case inclusion/exclusion, test/component-specific valid denominators and baseline/visit correspondence remain unverified. Existing content review remains incomplete. |
Randomized/complete-case populations and group denominators |
Proposal distinguishing allocated/observed/analyzed denominators; no new investigation, calculation or trial was performed in that production. |
| 16 |
Partly verified |
Full text not readStored summary read |
N16 · Evidence condition19.3% missingness and dropoutRequired |
Primary missingness 19.3% is the original record. No new missing counts/rates or best/worst effects are calculated, and absence of missing-data effects is not certified. |
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original group missingness/dropout reasons, baseline risk, test/contact differences and handling/sensitivity remain unverified. Existing content review remains incomplete. |
Group missingness/deviations, testing/reporting and outcome effects |
Proposal reporting effects of missingness and observation selection; no new investigation, calculation or trial was performed in that production. |
| 17 |
Partly verified |
Full text not readStored summary read |
N17 · Evidence conditionComplete-case estimands and within/between-group comparisonsRequired |
The original primary analysis is complete-case. It is not relabeled as ITT for all randomized participants or actual full-wearing effects, and within-group improvements are not made into new between-group benefits. |
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Complete-case models/adjustment, observation selection, missingness/adherence sensitivity and other analyses remain unverified. Existing content review remains incomplete. |
Analysis populations/models, assigned effects and observation selection |
Proposal distinguishing assignment, observation and actual-exposure estimands; no new investigation, calculation or trial was performed in that production. |
| 18 |
Partly verified |
Full text not readStored summary read |
N18 · Evidence conditionRegistration, retrospective dates and plansRequired |
Original wording records NCT04337541 first posted 2020-04-08 after the 2020-04-02 start, six-day retrospective registration. It is not changed to prospective registration, verified complete prespecification or definite outcome switching. |
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Registration history, prerecruitment protocols/SAP, changes and complete endpoint/analysis contracts remain unread. Existing content review remains incomplete. |
Preserved NCT/dates and prespecified endpoint/analysis contracts |
Proposal linking and disclosing plan/registration timing and actual analyses; no new investigation, calculation or trial was performed in that production. |
| 19 |
Partly verified |
Full text not readStored summary read |
N19 · Evidence conditionPrimary/secondary outcomes and multiplicityRequired |
The selected result is the wearer’s own one-month infection primary endpoint. Multiple tests, effect measures, adherence groups or other outcomes are not counted as independent trials or new primary successes. |
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Complete secondary/timepoint, multiplicity, testing-order, prespecified hierarchy and reporting changes remain unverified. Existing content review remains incomplete. |
Wearer primary endpoint, test components and effect-measure/other-outcome hierarchy |
Proposal separating primary, component and secondary outcomes; no new investigation, calculation or trial was performed in that production. |
| 20 |
Partly verified |
Full text not readStored summary read |
N20 · Evidence conditionTransmission to others and mandates were unmeasuredRequired |
The original manuscript records that transmission prevention to others and mask-mandate effects were not tested. The selected wearer result is not transferred to their effects/null results or policy/procedural guidance. |
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Direct transmission-to-others, mandate, healthcare/other-epidemic results are not connected by this trial. Existing content review remains incomplete. |
Wearer protection versus source control, policy and setting |
Proposal for later research separating wearer/others/policy questions; no new investigation, calculation or trial was performed in that production. |
| 21 |
Unverified |
Full text not readStored summary read |
N21 · Evidence conditionConcurrent measures, exposure and lifestyleRequired |
Preserve the original prevailing-public-health-advice record for both groups without filling in identical/no-effect exposure, lifestyle/prevention or disease/medication conditions. |
Information currently required is unverified in the preserved summary. Concurrent measures, outside contacts/exposures, other masks/products, diseases/medications and group differences/analyses remain unverified. Existing content review remains incomplete. |
Group concurrent prevention/exposure, diseases/medications and contacts |
Proposal distinguishing concurrent conditions from recommendation/wearing effects; no new investigation, calculation or trial was performed in that production. |
| 22 |
Partly verified |
Full text not readStored summary read |
N22 · Evidence conditionSalling funding and RigshospitaletRequired |
Salling Foundations funding and Rigshospitalet leadership are original records. Institution/leadership names are not changed to absence of all support/relationships or new independence certification. |
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original support/leadership roles, contracts, data/analysis/publication control and author COI remain unread. Existing content review remains incomplete. |
Support/sponsorship, roles and independence |
Proposal for later research disclosing support/research roles; no new investigation, calculation or trial was performed in that production. |
| 23 |
Partly verified |
Full text not readStored summary read |
N23 · Evidence conditionStudy mask supply and donated supportRequired |
Original records state that study masks were supplied within the research and manufacturer donation was not verified. This is not changed to definite manufacturer supply, no support or actual receipt of 50 masks by everyone. |
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Manufacture/specifications, actual distribution, purchase/supply contracts and support scope/roles remain unverified. Existing content review remains incomplete. |
Study supply versus manufacturer support/products and actual receipt |
Proposal separating study supply from manufacturer support; no new investigation, calculation or trial was performed in that production. |
| 24 |
Partly verified |
Full text not readStored summary read |
N24 · Evidence conditionMedical writing, publication costs and author relationshipsRequired |
Original records state that medical-writing/publication-cost support was not verified. Unverified is not changed to absent, and funding/leadership names do not fill all author COI. |
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Complete original writing/publication, outside analysis, author relationships/contributions and support remain unread. Existing content review remains incomplete. |
Unverified support items and author/analysis roles |
Proposal disclosing support items separately; no new investigation, calculation or trial was performed in that production. |
| 25 |
Partly verified |
Full text not readStored summary read |
N25 · Evidence conditionOne trial, bibliographic years and sibling sheetsRequired |
Preserve Bundgaard 2020 DANMASK-19 in the evidence list and 2021 publication bibliography in the citation list. These do not become separate trials/replications or new participant totals across groups/tests/events/timepoints/sibling sheets. |
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Unique clinical-trial/participant totals or independent replication of the same question are not newly established. Existing content review remains incomplete. |
Evidence-list 2020, citation-list 2021 and the same DANMASK relationship |
Proposal for later independent comparative research on the same selected question; no new investigation, calculation or trial was performed in that production. |
| 26 |
Partly verified |
Full text not readStored summary read |
N26 · Evidence conditionGeneralization across duration, setting and productsRequired |
The scope is 2020 Denmark, low community mask use, a surgical-mask recommendation and one month. Effects are not extended to healthcare, other variants/epidemics, long-term use, mandates or other masks/products. |
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Direct comparisons, sustained/discontinued exposure and long-term outcomes in other situations/products remain unverified. Existing content review remains incomplete. |
Original recommendation/setting versus other situations and long-term effects |
Proposal distinguishing question/situation/duration applicability; no new investigation, calculation or trial was performed in that production. |
| 27 |
Partly verified |
Full text not readStored summary read |
N27 · Harm-information gaps supplementing the efficacy tableUnknown safety and unquantified harmsSupplementary |
The original parent safety is Unknown and mask-related harms were not quantified. Infection results/P are not used as evidence of no discomfort/skin irritation or of safety. |
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Adverse-event collection/types/frequency/denominators, discontinuation and long-term/vulnerable-population harms remain unverified. Existing content review remains incomplete. |
Discomfort/skin irritation and harms collection/denominator/follow-up scope |
Proposal for later research specifying harms collection/scope; no new investigation, calculation or trial was performed in that production. |
| 28 |
Partly verified |
Full text not readStored summary read |
N28 · Evidence conditionOriginal values, both languages, dates, corrections and historyRequired |
Preserve parent D34, B/H/R1/I2/E0/B2/C0, the large hard-endpoint RCT true marker, two false markers, empty override reasons and subclaim D/note. Both languages, 2026-08-26, empty corrections/deliberation and cross-validation are not current review or a subclaim score. |
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Absent subclaim score/status/axes are not filled with parent values; no new methodological/efficacy certification. Existing content review remains incomplete. |
Parent/subclaim scores/axes versus historical verification/dates |
Proposal separating original values/history from new-material application; no new investigation, calculation or trial was performed in that production. |
| 29 |
Partly verified |
Full text not readStored summary read |
N29 · Evidence conditionActual summary reading and material linksRequired |
The complete preserved summary/bibliography were used for production and links retained. External paper/registration/protocol/SAP/support/COI originals remain unread/unaccessed; external link testing was not performed. |
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. External original content, exact contracts/denominators/models and access availability remain unverified. Existing content review remains incomplete. |
Preserved-summary reading versus external paper/registration/plan access |
Proposal for updating while distinguishing actual acquisition/timing/scope; no new investigation, calculation or trial was performed in that production. |