{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2971-s0", "verdict_number": "2971", "title": "Surgical-mask recommendation × Infection in the wearer at one month", "view_version": "1.0", "view_created_date": "2026-10-14", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "Adults in 2020 Denmark where community mask use was uncommon. Distinguish 6,024 randomized (3,030/2,994) from 4,862 primary complete cases (2,392/2,470), with 19.3% missingness. Baseline risk/infection, recruitment/testing and missingness/dropout details remain unverified.", "intervention": "Research intervention supplying a surgical-mask recommendation, 50 masks and instructions. Actual supply/wearing, specifications/batches and exposure/contacts remain unverified. It is not relabeled as filtration/product effects alone or mandate effects. No new wearing/testing/infection-prevention instructions.", "dose": "One-month recommendation/follow-up. Preserve self-reported 46% adherence as recommended, 47% predominantly as recommended and 7% nonadherence; do not fill objective wearing time, complete follow-up for all or other-period/long-term exposure.", "comparator": "Unblinded randomized comparison with both groups following prevailing public-health advice. Control is not relabeled as no action/contact or identical conditions. Actual control wearing/concurrent exposure and allocation/adjudication/analysis details remain unverified.", "endpoint": "Primary composite of the wearer’s own SARS-CoV-2 infection at one month by antibody testing, PCR or hospital diagnosis. Preserve separate original estimands: 42/2,392(1.8%) versus 53/2,470(2.1%); absolute difference −0.3 percentage points (95% CI −1.2–0.4)/P=.38; OR 0.82(0.54–1.23)/P=.33. Component counts/tests, overlap, baseline/assessment windows and models remain unverified. No new RR/effects/CI or event/proportion totals.", "duration": "One-month wearer outcome. Individual actual exposure/observations, testing windows/repetition, later follow-up, other epidemics/healthcare settings and long-term effects remain unverified.", "excluded_extensions": [ "New differences/RR/NNT/CI or event/denominator totals from 42/2,392, 53/2,470 or 1.8/2.1%", "Combining the original absolute-difference/OR P values and intervals as one estimand, or converting OR to RR/individual risk", "Replacing recommendation/50 masks/instructions or 46/47/7% reports with objective full wearing or product/filtration effects alone", "Relabeling 4,862 complete cases/19.3% missingness as ITT for all 6,024 or no missing-data effects", "Transferring antibody/PCR/hospital-diagnosis composite infection to PCR alone, self-reported symptoms, transmission to others or mandates", "Generalizing 2020 Danish one-month recommendations to current epidemics, healthcare, long-term use or all masks", "Changing original six-day retrospective registration into prospective registration, fully verified prespecification or definite outcome switching", "Summing people/groups/tests/events/timepoints/bibliographies, registrations or sibling sheets as new independent trials/participants", "Inheriting original parent values/axes or historical verification/registration/allocation/masking/analysis wording as subclaim scores or current content review/full-text reading", "New calculations, invented quantities, effects/CI, grades, independence certification or mask/testing/infection-prevention/respiratory-care/treatment-replacement instructions" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Selected wearer question and original grade", "needed": "Existing question, grade/note, parent values and separate transmission question", "role": "Required", "role_reason": "Applicability item distinguishing existing question, grade/note, parent values and separate transmission question and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for existing question, grade/note, parent values and separate transmission question should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal for later research specifying the wearer endpoint/timepoint; no new investigation, calculation or trial was performed in that production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Absent subclaim score/status/axes are distinguished from transmission-to-others and mandate effects.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original selected-subclaim/parent records and user correction comments" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "2020 Denmark and community setting", "needed": "Time/setting, actual population, recruitment and baseline risk", "role": "Required", "role_reason": "Applicability item distinguishing time/setting, actual population, recruitment and baseline risk and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for time/setting, actual population, recruitment and baseline risk should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M03 §3.2.1; Detailed population conditions are Chamgap design; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details are Chamgap design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal for later comparative research specifying the setting/population; no new investigation, calculation or trial was performed in that production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Age/eligibility, baseline infection/risk, exposure/occupation, recruitment/group balance and test access remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Population/recruitment, baseline-risk and setting tables" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Recommendation, 50 masks and instructions", "needed": "Assigned recommendation/support versus actual wearing and product effects", "role": "Required", "role_reason": "Applicability item distinguishing assigned recommendation/support versus actual wearing and product effects and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for assigned recommendation/support versus actual wearing and product effects should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal for later research distinguishing recommendation/support from actual wearing; no new investigation, calculation or trial was performed in that production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Product specifications/batches, actual supply/instructions, additional contacts and wearing conditions/exposure remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Recommendation/supply/instruction, product and contact records" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Actual wearing and self-reported adherence", "needed": "46/47/7% categories/periods, measurement and exposure", "role": "Required", "role_reason": "Applicability item distinguishing 46/47/7% categories/periods, measurement and exposure and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for 46/47/7% categories/periods, measurement and exposure should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M08 Table 8.2.a, M03 §3.2.4; own application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is independently designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal specifying differences between reported adherence and actual exposure; no new investigation, calculation or trial was performed in that production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Adherence-questionnaire denominators/timing/definitions, objective wearing/use, missingness and group crossover remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Adherence questionnaires/denominators and actual wearing/exposure" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Recommendation effects and adherence-based analysis", "needed": "Assigned recommendation versus actual-wearer/full-adherence effects", "role": "Required", "role_reason": "Applicability item distinguishing assigned recommendation versus actual-wearer/full-adherence effects and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for assigned recommendation versus actual-wearer/full-adherence effects should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M08 §8.2.2, M15 §15.3.1; own application; M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M08 Table 8.2.a, M04 §4.6.3; own application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal distinguishing assignment strategies and actual-exposure estimands; no new investigation, calculation or trial was performed in that production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Prespecified adherence-based plans, inclusion/exposure, adjustment/confounding and related sensitivity results remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Recommendation/adherence analysis plans, models and original results" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Control and concurrent public-health measures", "needed": "Actual measures and contact/exposure differences across groups", "role": "Required", "role_reason": "Applicability item distinguishing actual measures and contact/exposure differences across groups and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for actual measures and contact/exposure differences across groups should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal specifying actual comparisons/concurrent conditions; no new investigation, calculation or trial was performed in that production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Both groups followed prevailing public-health advice. This does not verify a no-action/no-contact control or identical prevention/lifestyle/exposure conditions.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Control mask wearing/additional support, concurrent measures, lifestyle/exposure, contacts and differences/analyses remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Control/concurrent measures, wearing/exposure and contact records" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Randomization and lack of masking", "needed": "Design label and scope of allocation/measurement/analysis procedures", "role": "Required", "role_reason": "Applicability item distinguishing design label and scope of allocation/measurement/analysis procedures and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for design label and scope of allocation/measurement/analysis procedures should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M08 §§8.1–8.2.3; Chamgap adaptation; M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M04 §§4.5–4.6 material collection/selection principles; access/reading separation and hyperlink rules are Chamgap-designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal disclosing allocation and outcome measurement/adjudication; no new investigation, calculation or trial was performed in that production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original sequence generation/concealment, implementation/exceptions, role-specific masking and baseline balance remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original allocation/concealment, masking roles, baseline and protocol materials" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Composite infection ascertainment", "needed": "Antibody testing, PCR, hospital diagnosis and component/adjudication rules", "role": "Required", "role_reason": "Applicability item distinguishing antibody testing, PCR, hospital diagnosis and component/adjudication rules and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for antibody testing, PCR, hospital diagnosis and component/adjudication rules should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M08 §8.2.2, M15 §15.3.1; internal application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal distinguishing component ascertainment from the composite endpoint; no new investigation, calculation or trial was performed in that production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Component definitions/tests, accepted results, overlap/adjudication and event timing remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Composite-endpoint definitions, testing/adjudication and component/overlap materials" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Testing time, baseline infection and missingness", "needed": "Correspondence of one-month infection with tests/baseline/assessment windows", "role": "Required", "role_reason": "Applicability item distinguishing correspondence of one-month infection with tests/baseline/assessment windows and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for correspondence of one-month infection with tests/baseline/assessment windows should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M03 §3.2.4; own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is independently designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is independently designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal specifying testing/baseline conditions and infection-adjudication timing; no new investigation, calculation or trial was performed in that production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve the original ascertainment methods and one-month period without claiming verified test counts, baseline status, assessment windows or identical ascertainment of all events.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Baseline infection, test/sample timing, implementation/nonimplementation, access, adjudication/errors and confirmation delays remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Testing/baseline/assessment flow and adjudication/missingness materials" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "One month and duration/exposure scope", "needed": "Original period, actual observation/wearing and long-term/other-epidemic boundaries", "role": "Required", "role_reason": "Applicability item distinguishing original period, actual observation/wearing and long-term/other-epidemic boundaries and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for original period, actual observation/wearing and long-term/other-epidemic boundaries should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal distinguishing timepoint/duration and setting-specific applicability; no new investigation, calculation or trial was performed in that production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Individual observation/wearing periods, start/end/censoring and later follow-up/exposure remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Period/visit, actual exposure and long-term follow-up materials" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Original events and complete-case denominators", "needed": "42/2,392 and 53/2,470 versus people/test units", "role": "Required", "role_reason": "Applicability item distinguishing 42/2,392 and 53/2,470 versus people/test units and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for 42/2,392 and 53/2,470 versus people/test units should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal reporting people/events/tests and denominators separately; no new investigation, calculation or trial was performed in that production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Component-specific event counts, test/person overlap, risk/observation denominators and ascertainment-method correspondence remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original events/components, denominators/tests and observations" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Original absolute difference, CI and P", "needed": "Original absolute effect/CI versus rounded proportions and models", "role": "Required", "role_reason": "Applicability item distinguishing original absolute effect/CI versus rounded proportions and models and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for original absolute effect/CI versus rounded proportions and models should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M15 §15.3.1–15.3.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal for later research disclosing effect measures and precision; no new investigation, calculation or trial was performed in that production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Exact contrasts/models, adjustment, CI methods and original plans/sensitivity remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original absolute effects/models, CI and prespecified plans" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "OR, CI and separate P", "needed": "Original OR/CI versus the different absolute-difference estimand", "role": "Required", "role_reason": "Applicability item distinguishing original OR/CI versus the different absolute-difference estimand and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for original OR/CI versus the different absolute-difference estimand should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M15 §15.3.1–15.3.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal reporting effect measures/tests separately; no new investigation, calculation or trial was performed in that production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "OR models/adjustment, precise contrasts, tests/CI methods and correspondence to absolute effects remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "OR/absolute-effect models/tests and original results" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Nonsignificance, wide CI and importance", "needed": "Null verdict versus possible benefit/harm, exactly zero and equivalence", "role": "Required", "role_reason": "Applicability item distinguishing null verdict versus possible benefit/harm, exactly zero and equivalence and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for null verdict versus possible benefit/harm, exactly zero and equivalence should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M15 §15.3.1–15.3.3; in-house application; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is in-house design; M03 §3.2.4; in-house extension boundaries", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal specifying effects/precision and question scope; no new investigation, calculation or trial was performed in that production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Prespecified importance/success/equivalence criteria and sufficient precision for exact effects remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Prespecified criteria, models/CI and estimand materials" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "6,024 randomized and 4,862 complete cases", "needed": "Randomized/complete-case populations and group denominators", "role": "Required", "role_reason": "Applicability item distinguishing randomized/complete-case populations and group denominators and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for randomized/complete-case populations and group denominators should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal distinguishing allocated/observed/analyzed denominators; no new investigation, calculation or trial was performed in that production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Complete-case inclusion/exclusion, test/component-specific valid denominators and baseline/visit correspondence remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Flow, analysis-population definitions and endpoint/test denominators" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "19.3% missingness and dropout", "needed": "Group missingness/deviations, testing/reporting and outcome effects", "role": "Required", "role_reason": "Applicability item distinguishing group missingness/deviations, testing/reporting and outcome effects and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for group missingness/deviations, testing/reporting and outcome effects should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is independently designed; M08 §8.2.2, M15 §15.3.1; own application; M08 Table 8.2.a, M03 §3.2.4; own application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal reporting effects of missingness and observation selection; no new investigation, calculation or trial was performed in that production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original group missingness/dropout reasons, baseline risk, test/contact differences and handling/sensitivity remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group flow, missingness/contact, missing-data handling and sensitivity" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Complete-case estimands and within/between-group comparisons", "needed": "Analysis populations/models, assigned effects and observation selection", "role": "Required", "role_reason": "Applicability item distinguishing analysis populations/models, assigned effects and observation selection and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for analysis populations/models, assigned effects and observation selection should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M08 §8.2.2, M15 §15.3.1; own application; M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is independently designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal distinguishing assignment, observation and actual-exposure estimands; no new investigation, calculation or trial was performed in that production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Complete-case models/adjustment, observation selection, missingness/adherence sensitivity and other analyses remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Analysis populations, models/contrasts and missingness/adherence sensitivity" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Registration, retrospective dates and plans", "needed": "Preserved NCT/dates and prespecified endpoint/analysis contracts", "role": "Required", "role_reason": "Applicability item distinguishing preserved NCT/dates and prespecified endpoint/analysis contracts and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for preserved NCT/dates and prespecified endpoint/analysis contracts should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; custom application; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal linking and disclosing plan/registration timing and actual analyses; no new investigation, calculation or trial was performed in that production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Registration history, prerecruitment protocols/SAP, changes and complete endpoint/analysis contracts remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration history, protocol, and SAP" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Primary/secondary outcomes and multiplicity", "needed": "Wearer primary endpoint, test components and effect-measure/other-outcome hierarchy", "role": "Required", "role_reason": "Applicability item distinguishing wearer primary endpoint, test components and effect-measure/other-outcome hierarchy and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for wearer primary endpoint, test components and effect-measure/other-outcome hierarchy should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; own application; M04 §4.6.1–4.6.2 on distinguishing studies from reports; cohort/outcome linkage is independently applied; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is independently designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal separating primary, component and secondary outcomes; no new investigation, calculation or trial was performed in that production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Complete secondary/timepoint, multiplicity, testing-order, prespecified hierarchy and reporting changes remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "SAP, complete outcomes and testing/hierarchy materials" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Transmission to others and mandates were unmeasured", "needed": "Wearer protection versus source control, policy and setting", "role": "Required", "role_reason": "Applicability item distinguishing wearer protection versus source control, policy and setting and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for wearer protection versus source control, policy and setting should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M03 §3.1, §3.2.1–3.2.4 on clarifying questions; detailed separation rules are independently designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is independently designed; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are independently designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal for later research separating wearer/others/policy questions; no new investigation, calculation or trial was performed in that production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Direct transmission-to-others, mandate, healthcare/other-epidemic results are not connected by this trial.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate materials directly measuring those questions/settings" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Concurrent measures, exposure and lifestyle", "needed": "Group concurrent prevention/exposure, diseases/medications and contacts", "role": "Required", "role_reason": "Applicability item distinguishing group concurrent prevention/exposure, diseases/medications and contacts and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for group concurrent prevention/exposure, diseases/medications and contacts should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are our own design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal distinguishing concurrent conditions from recommendation/wearing effects; no new investigation, calculation or trial was performed in that production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve the original prevailing-public-health-advice record for both groups without filling in identical/no-effect exposure, lifestyle/prevention or disease/medication conditions.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Concurrent measures, outside contacts/exposures, other masks/products, diseases/medications and group differences/analyses remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Concurrent conditions, exposures/contacts and analyses" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Salling funding and Rigshospitalet", "needed": "Support/sponsorship, roles and independence", "role": "Required", "role_reason": "Applicability item distinguishing support/sponsorship, roles and independence and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for support/sponsorship, roles and independence should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal for later research disclosing support/research roles; no new investigation, calculation or trial was performed in that production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original support/leadership roles, contracts, data/analysis/publication control and author COI remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original funding, investigator/author roles and COI" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Study mask supply and donated support", "needed": "Study supply versus manufacturer support/products and actual receipt", "role": "Required", "role_reason": "Applicability item distinguishing study supply versus manufacturer support/products and actual receipt and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for study supply versus manufacturer support/products and actual receipt should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "Chamgap’s own independence/attribution conditions; the official method sections used in the pilot do not validate every detailed item; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptation are independently designed; M03 §3.2.3, M08 §8.2.2–8.2.3; own application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal separating study supply from manufacturer support; no new investigation, calculation or trial was performed in that production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Manufacture/specifications, actual distribution, purchase/supply contracts and support scope/roles remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Product/distribution, purchase/supply contracts and support disclosures" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Medical writing, publication costs and author relationships", "needed": "Unverified support items and author/analysis roles", "role": "Required", "role_reason": "Applicability item distinguishing unverified support items and author/analysis roles and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for unverified support items and author/analysis roles should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal disclosing support items separately; no new investigation, calculation or trial was performed in that production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Complete original writing/publication, outside analysis, author relationships/contributions and support remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Writing/publication/analysis, author-contribution and COI disclosures" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "One trial, bibliographic years and sibling sheets", "needed": "Evidence-list 2020, citation-list 2021 and the same DANMASK relationship", "role": "Required", "role_reason": "Applicability item distinguishing evidence-list 2020, citation-list 2021 and the same DANMASK relationship and connecting materials needed for the selected question with current materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for evidence-list 2020, citation-list 2021 and the same DANMASK relationship should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.", "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application; M04 §4.6.1–4.6.2, M15 §15.3.1; custom application; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal for later independent comparative research on the same selected question; no new investigation, calculation or trial was performed in that production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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. 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URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. 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Self-reported wearing 46/47/7%, one-month wearer infection by antibody/PCR/hospital diagnosis, 42/2,392 versus 53/2,470, original absolute difference −0.3 percentage points/CI −1.2–0.4/P=.38 and OR 0.82/CI 0.54–1.23/P=.33 are separate exposures/endpoints/estimands. Transmission to others/mandates were unmeasured. Complete-case results are not relabeled as ITT for all, full wearing, generally zero effects or safety. Evidence-list 2020 and citation-list 2021 concern the same report identity. People/groups/tests/events/timepoints, bibliographies/registrations and sibling sheets are not summed as new independent trials/participants. Report entries are not unique clinical totals; no new calculations, independence certification or procedural guidance." }, "history": [ { "date": "2026-10-14", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public pages and materials were created from the existing 29 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-14" }