{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3007-s1", "verdict_number": "3007", "title": "Buteyko for Adult Asthma × FEV1, PEF and Airway Responsiveness — Improvement Unproven · Evidence and Gaps Sheet", "view_version": "1.0", "view_created_date": "2026-10-19", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-09-07", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Existing stored summary and preserved methodology application records. External papers, abstracts, registration, protocols, SAPs, original result tables and support disclosures are unread, and review of existing content remains incomplete.", "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": "These materials concern adjunctive training in adults with asthma. The parent representative population and report-specific overall, assigned and completed populations are not valid denominators for every lung-function test, arm and time. Original materials are needed for diagnosis, severity, baseline FEV1, PEF and PD20, concurrent care and eligibility. Findings are not extended to other populations or acute attacks.", "intervention": "This is the objective lung-function question for Buteyko breathing training added to standard inhaled care. Adjunctive teaching and training are distinguished from arm-specific background care. Detailed teaching, instructors, intensity, frequency, actual adherence, exposure and medication changes are unverified. No new practice, treatment or tapering instructions are created.", "dose": "Only the teaching and program context in the stored summary is transferred. Exact intensity, frequency, actual exposure, arm-specific medication types and changes, and medication effects around testing are unverified. Voluntary control pause or medication figures are not converted into personal breathing amounts, optimal intensity or tapering steps.", "comparator": "Asthma education, sham devices, pranayama, Cowie's active physiotherapist-led breathing education and Vagedes's usual care are distinct comparisons. Arm-specific contact, teaching, exposure, background care and direct contrasts are needed. General breathing-retraining findings or effects against other comparators are not pooled as the same effect on selected measures.", "endpoint": "The selection is improved FEV1, PEF or airway responsiveness, retaining original subclaim D and absent individual score, status and axes. Null FEV1 in Bowler, Cooper and Vagedes, PEF in Bowler and PD20 in Cooper are distinguished. Cowie's asthma control and ICS, voluntary control pause, ACQ, FeNO and symptom or rescue-use signals are not values or denominators for the selected tests. Without exact effects and CIs, null findings do not establish an effect of 0 or equivalence.", "duration": "The parent range spans several weeks to 6 months across trials. Bowler's 3 months and Cowie's 6-month assessment are distinguished; exact measurement windows for other reports and tests remain unverified. The same period is not copied to every measure or harm, and persistence after completion or long-term applicability is not newly established.", "excluded_extensions": [ "Null FEV1, PEF and PD20 findings are distinguished from gaps in exact effects and CIs; they are not converted into an effect of 0, equivalence or a new grade.", "Symptoms, rescue use, ICS, asthma control, voluntary control pause, ACQ and FeNO are not substituted for values or denominators of the selected tests.", "Different education, sham devices, pranayama, active education, usual care and report-specific observation periods are not pooled as the same comparison.", "Assigned and completed populations, medication denominators, reports and subclaims are not summed to create new attrition counts, effects, unique trials, participants or harm counts.", "Registration identifiers, historical funding or COI checks and preserved material dates are not labeled as new external reading or verification of prespecification or independent replication.", "Null objective findings or parent symptom and medication signals are not extended into exacerbation prevention, inhaled-care replacement, cure or effects on acute attacks.", "Study breathing, medication and observation periods are not converted into personal training steps, medication tapering or long-term safety guidance." ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which lung-function question and original verdict are being transferred?", "needed": "Selected claim, existing subclaim verdict and parent-question scope", "role": "Required", "role_reason": "This condition links Selected claim, existing subclaim verdict and parent-question scope with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Selected claim, existing subclaim verdict and parent-question scope must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original records are needed to establish the selected boundary and applicability to each measure. Measures or reports are not counted as new independent claims or trials. This records needed materials; no new research was executed.", "current_reports": [], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "The selection is improvement in FEV1, PEF or airway responsiveness. Each measure is distinguished within the existing subclaim and separated from the parent question about symptoms and rescue use.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Original records are needed to establish the selected boundary and applicability to each measure. Measures or reports are not counted as new independent claims or trials.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original records are needed to establish the selected boundary and applicability to each measure. Measures or reports are not counted as new independent claims or trials." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "What do selected D and parent C50 refer to?", "needed": "Applicability of selected grade and explanation versus parent score and axes", "role": "Required", "role_reason": "This condition links Applicability of selected grade and explanation versus parent score and axes with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Applicability of selected grade and explanation versus parent score and axes must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original fields and authorized change records are needed. Missing selected values are not filled with the parent score or positive-effect axis, and no new grade is created. This records needed materials; no new research was executed.", "current_reports": [], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "The original explanation for selected D is that direct trials repeatedly failed to show improvement. Parent C50 concerns a different question about symptom and rescue-use signals; the selection has no separate score, status or axes.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Original fields and authorized change records are needed. Missing selected values are not filled with the parent score or positive-effect axis, and no new grade is created.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original fields and authorized change records are needed. Missing selected values are not filled with the parent score or positive-effect axis, and no new grade is created." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Which adjunctive Buteyko training was studied?", "needed": "Adjunctive education, actual exposure and standard care in adult asthma", "role": "Required", "role_reason": "This condition links Adjunctive education, actual exposure and standard care in adult asthma with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Adjunctive education, actual exposure and standard care in adult asthma must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Specifications for instructors, teaching, exposure, adherence and arm-specific background care are needed. No new breathing-practice steps or treatment instructions are written. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "The stored intervention is Buteyko breathing training added to standard inhaled care for adult asthma. Detailed teaching, intensity, frequency and actual adherence are unverified.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Specifications for instructors, teaching, exposure, adherence and arm-specific background care are needed. No new breathing-practice steps or treatment instructions are written.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Specifications for instructors, teaching, exposure, adherence and arm-specific background care are needed. No new breathing-practice steps or treatment instructions are written." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Which adults with asthma do the findings apply to?", "needed": "Diagnosis, severity, baseline lung function, medication and eligibility", "role": "Required", "role_reason": "This condition links Diagnosis, severity, baseline lung function, medication and eligibility with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Diagnosis, severity, baseline lung function, medication and eligibility must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original baseline tables are needed for report-specific diagnosis, severity, baseline FEV1, PEF and PD20, medication, comorbidity and eligibility distributions. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "The parent material concerns adult asthma. Overall, assigned and completed populations in each report are not used as valid denominators for every lung-function test and time point.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Original baseline tables are needed for report-specific diagnosis, severity, baseline FEV1, PEF and PD20, medication, comorbidity and eligibility distributions.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original baseline tables are needed for report-specific diagnosis, severity, baseline FEV1, PEF and PD20, medication, comorbidity and eligibility distributions." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Are education, sham devices, pranayama and usual care the same comparison?", "needed": "Placebo and active comparators, contact, background care and direct contrasts", "role": "Required", "role_reason": "This condition links Placebo and active comparators, contact, background care and direct contrasts with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Placebo and active comparators, contact, background care and direct contrasts must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original plans for arm-specific teaching, contact, exposure, background care and lung-function contrasts are needed. General breathing retraining or pranayama is not pooled as Buteyko findings. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "The original summary distinguishes education, sham devices and pranayama. Cowie's active physiotherapist-led breathing education and Vagedes's usual care are also different comparisons.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Original plans for arm-specific teaching, contact, exposure, background care and lung-function contrasts are needed. General breathing retraining or pranayama is not pooled as Buteyko findings.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original plans for arm-specific teaching, contact, exposure, background care and lung-function contrasts are needed. General breathing retraining or pranayama is not pooled as Buteyko findings." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "How are inhaled care and medication changes distinguished from the findings?", "needed": "Background inhaled care, clinical review, arm-specific changes and the effect of interest", "role": "Required", "role_reason": "This condition links Background inhaled care, clinical review, arm-specific changes and the effect of interest with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Background inhaled care, clinical review, arm-specific changes and the effect of interest must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Arm-specific medication types, doses, actual changes, adherence, medication effects around measurement and analysis plans are needed. No personal tapering, withdrawal or replacement instructions are created. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "The original material retains the context of adjunctive studies and medication reduction under clinical review. Symptom or medication changes do not themselves establish improved objective lung function.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Arm-specific medication types, doses, actual changes, adherence, medication effects around measurement and analysis plans are needed. No personal tapering, withdrawal or replacement instructions are created.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific medication types, doses, actual changes, adherence, medication effects around measurement and analysis plans are needed. No personal tapering, withdrawal or replacement instructions are created." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "What do several weeks to 6 months and individual test times mean?", "needed": "Training, visits, testing, follow-up after completion and time-specific denominators", "role": "Required", "role_reason": "This condition links Training, visits, testing, follow-up after completion and time-specific denominators with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Training, visits, testing, follow-up after completion and time-specific denominators must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Report-specific exposure, visit and test schedules, persistence after completion and measure-specific denominators are needed. The same period is not copied to every test or harms follow-up. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "The parent range spans several weeks to 6 months across trials. Bowler's 3 months and Cowie's 6-month assessment are distinguished; measurement windows for other reports are not filled in by assumption.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Report-specific exposure, visit and test schedules, persistence after completion and measure-specific denominators are needed. The same period is not copied to every test or harms follow-up.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report-specific exposure, visit and test schedules, persistence after completion and measure-specific denominators are needed. The same period is not copied to every test or harms follow-up." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "How was FEV1 measured and analyzed?", "needed": "FEV1 units, absolute values, predicted values, change and test denominators", "role": "Required", "role_reason": "This condition links FEV1 units, absolute values, predicted values, change and test denominators with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for FEV1 units, absolute values, predicted values, change and test denominators must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Test procedures, calibration, medication conditions, aggregation, adjustment, arm- and time-specific denominators, and direct effects and CIs are needed. Values from other measures are not substituted. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "The stored Bowler, Cooper and Vagedes summaries record null FEV1 findings. These are distinguished from symptoms, control pause and FeNO.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Test procedures, calibration, medication conditions, aggregation, adjustment, arm- and time-specific denominators, and direct effects and CIs are needed. Values from other measures are not substituted.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Test procedures, calibration, medication conditions, aggregation, adjustment, arm- and time-specific denominators, and direct effects and CIs are needed. Values from other measures are not substituted." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Which report and finding concern PEF?", "needed": "PEF devices, records, units, between-arm comparisons and denominators", "role": "Required", "role_reason": "This condition links PEF devices, records, units, between-arm comparisons and denominators with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for PEF devices, records, units, between-arm comparisons and denominators must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original tables are needed for devices, recording methods, absolute values versus change, measurement windows, denominators and exact estimates, CIs and P values. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "Bowler's original endpoints and results include PEF and describe a null finding. The same test is not assumed to have been performed in other reports.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Original tables are needed for devices, recording methods, absolute values versus change, measurement windows, denominators and exact estimates, CIs and P values.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original tables are needed for devices, recording methods, absolute values versus change, measurement windows, denominators and exact estimates, CIs and P values." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Which test records airway responsiveness?", "needed": "Cooper's PD20 definition, units, testing, contrasts and denominators", "role": "Required", "role_reason": "This condition links Cooper's PD20 definition, units, testing, contrasts and denominators with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Cooper's PD20 definition, units, testing, contrasts and denominators must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Challenge-test definitions, units, transformations, testing conditions, estimates, CIs, denominators and the original endpoint hierarchy are needed. FEV1, PEF, control pause and FeNO are not substitutes. This records needed materials; no new research was executed.", "current_reports": [ "R02" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "The original explanation and Cooper endpoints record null PD20 airway responsiveness. This differs from the symptom co-primary outcome.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Challenge-test definitions, units, transformations, testing conditions, estimates, CIs, denominators and the original endpoint hierarchy are needed. FEV1, PEF, control pause and FeNO are not substitutes.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Challenge-test definitions, units, transformations, testing conditions, estimates, CIs, denominators and the original endpoint hierarchy are needed. FEV1, PEF, control pause and FeNO are not substitutes." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "What are the lung-function findings in the 1998 report of 39 adults?", "needed": "Distinguishing lung-function findings from medication and quality-of-life findings in the early controlled trial", "role": "Required", "role_reason": "This condition links Distinguishing lung-function findings from medication and quality-of-life findings in the early controlled trial with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Distinguishing lung-function findings from medication and quality-of-life findings in the early controlled trial must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original tables are needed for direct effects, CIs and P values for each lung-function measure, baseline, timing, valid denominators and primary versus supporting hierarchy. Medication figures are not reassigned as lung-function effects. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "Bowler records null FEV1 and PEF. Beta2-agonist reductions of 904 versus 57 mcg, P=.002, and ICS P=.06 and QOL P=.09 are preserved as separate parent context.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Original tables are needed for direct effects, CIs and P values for each lung-function measure, baseline, timing, valid denominators and primary versus supporting hierarchy. Medication figures are not reassigned as lung-function effects.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original tables are needed for direct effects, CIs and P values for each lung-function measure, baseline, timing, valid denominators and primary versus supporting hierarchy. Medication figures are not reassigned as lung-function effects." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "What analysis denominator does 39 represent?", "needed": "Overall population versus valid denominators by arm, test and time", "role": "Required", "role_reason": "This condition links Overall population versus valid denominators by arm, test and time with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Overall population versus valid denominators by arm, test and time must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Flow diagrams and denominator tables are needed for allocation and analysis by arm, test failures, exclusions and time-specific observation loss. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "The original population is 39 adults with asthma. Valid denominators for individual FEV1 and PEF tests, medication outcomes and harms have not been separately verified.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Flow diagrams and denominator tables are needed for allocation and analysis by arm, test failures, exclusions and time-specific observation loss.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Flow diagrams and denominator tables are needed for allocation and analysis by arm, test failures, exclusions and time-specific observation loss." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "What are the objective findings in the 2003 report with 3 arms?", "needed": "PD20 and FEV1 versus symptoms and rescue use across Buteyko, pranayama and placebo", "role": "Required", "role_reason": "This condition links PD20 and FEV1 versus symptoms and rescue use across Buteyko, pranayama and placebo with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for PD20 and FEV1 versus symptoms and rescue use across Buteyko, pranayama and placebo must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Arm matching, contrasts, models, direct CIs, P values, denominators and measurement times are needed for each lung-function measure. Symptom and rescue-use test values are not reassigned. This records needed materials; no new research was executed.", "current_reports": [ "R02" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "The original explanation specifies null PD20 and FEV1. Symptom and bronchodilator signals are distinguished from null objective measures, exacerbations and ICS.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Arm matching, contrasts, models, direct CIs, P values, denominators and measurement times are needed for each lung-function measure. Symptom and rescue-use test values are not reassigned.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm matching, contrasts, models, direct CIs, P values, denominators and measurement times are needed for each lung-function measure. Symptom and rescue-use test values are not reassigned." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "What do 90 assigned, 69 completed and the original 23% mean?", "needed": "Assignment, completion, historical attrition wording and test-specific analysis denominators", "role": "Required", "role_reason": "This condition links Assignment, completion, historical attrition wording and test-specific analysis denominators with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Assignment, completion, historical attrition wording and test-specific analysis denominators must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Materials are needed for arm-specific losses and reasons, valid test denominators among completers, missing-data adjustment and sensitivity analyses. This records needed materials; no new research was executed.", "current_reports": [ "R02" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "The original population retains 90 randomized and 69 completed, alongside the parent's 23% attrition wording. No new difference or attrition rate is calculated.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Materials are needed for arm-specific losses and reasons, valid test denominators among completers, missing-data adjustment and sensitivity analyses.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Materials are needed for arm-specific losses and reasons, valid test denominators among completers, missing-data adjustment and sensitivity analyses." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "How are symptom co-primary findings distinguished from null PD20?", "needed": "Co-primary outcomes, prespecified hierarchy, multiplicity and change history", "role": "Required", "role_reason": "This condition links Co-primary outcomes, prespecified hierarchy, multiplicity and change history with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Co-primary outcomes, prespecified hierarchy, multiplicity and change history must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original protocols, analysis plans and result tables are needed, including exact endpoints, testing hierarchy, multiplicity and change times. This records needed materials; no new research was executed.", "current_reports": [ "R02" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "The parent summary records symptom co-primary signals alongside null airway responsiveness. The parent's split co-primary flag does not certify prespecification of all selected tests.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Original protocols, analysis plans and result tables are needed, including exact endpoints, testing hierarchy, multiplicity and change times.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original protocols, analysis plans and result tables are needed, including exact endpoints, testing hierarchy, multiplicity and change times." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Does the active-education comparison directly report the selected lung-function measures?", "needed": "Links between asthma control, ICS and the selected test results", "role": "Required", "role_reason": "This condition links Links between asthma control, ICS and the selected test results with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Links between asthma control, ICS and the selected test results must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Full results, protocols and tables for the selected tests are needed. A measure absent from the stored summary is not declared absent from all external materials. This records needed materials; no new research was executed.", "current_reports": [ "R03" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "Cowie's stored endpoints and results concern primary asthma control at 6 months and secondary ICS reduction. They are not used as direct FEV1, PEF or PD20 values or denominators.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Full results, protocols and tables for the selected tests are needed. A measure absent from the stored summary is not declared absent from all external materials.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Full results, protocols and tables for the selected tests are needed. A measure absent from the stored summary is not declared absent from all external materials." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "What do 129 assigned, 119 assessed and the medication denominators mean?", "needed": "The distinct scopes of assignment, assessment, asthma control, ICS and sensitivity findings", "role": "Required", "role_reason": "This condition links The distinct scopes of assignment, assessment, asthma control, ICS and sensitivity findings with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for The distinct scopes of assignment, assessment, asthma control, ICS and sensitivity findings must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Mappings between measures and populations, arm-specific losses, and denominators and estimates for selected lung-function outcomes are needed. Assignment-assessment differences or new effects are not calculated. This records needed materials; no new research was executed.", "current_reports": [ "R03" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "The original 129 assigned and 119 assessed, control of 79% versus 72% P=.4, missing-as-failure results of 68% versus 70% P=.7, and ICS 23/56 versus 13/63 P=.02 are retained in their respective contexts.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Mappings between measures and populations, arm-specific losses, and denominators and estimates for selected lung-function outcomes are needed. Assignment-assessment differences or new effects are not calculated.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Mappings between measures and populations, arm-specific losses, and denominators and estimates for selected lung-function outcomes are needed. Assignment-assessment differences or new effects are not calculated." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "What does FEV1 show in the 2024 report of 60 adults?", "needed": "FEV1 versus other physiological and symptom outcomes against usual care", "role": "Required", "role_reason": "This condition links FEV1 versus other physiological and symptom outcomes against usual care with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for FEV1 versus other physiological and symptom outcomes against usual care must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Exact test-specific effects, CIs, P values, denominators, timing, medication conditions and original plans are needed. Observation periods from other reports are not copied. This records needed materials; no new research was executed.", "current_reports": [ "R04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "Vagedes's original summary distinguishes null FEV1 and FeNO from primary and some secondary signals and registration after recruitment. FEV1 and FeNO are separate measures.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Exact test-specific effects, CIs, P values, denominators, timing, medication conditions and original plans are needed. Observation periods from other reports are not copied.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact test-specific effects, CIs, P values, denominators, timing, medication conditions and original plans are needed. Observation periods from other reports are not copied." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Are control pause, ACQ and FeNO the same measures?", "needed": "Distinguishing control pause, ACQ and FeNO from FEV1, PEF and PD20", "role": "Required", "role_reason": "This condition links Distinguishing control pause, ACQ and FeNO from FEV1, PEF and PD20 with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Distinguishing control pause, ACQ and FeNO from FEV1, PEF and PD20 must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Full materials are needed for definitions, hierarchy and timing of each endpoint and for whether selected PEF and PD20 measurements and results exist. This records needed materials; no new research was executed.", "current_reports": [ "R04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "The original primary voluntary control pause and secondary ACQ and medication outcomes, FEV1 and FeNO are different endpoints. They are not treated as the same scale across all selected tests.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Full materials are needed for definitions, hierarchy and timing of each endpoint and for whether selected PEF and PD20 measurements and results exist.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Full materials are needed for definitions, hierarchy and timing of each endpoint and for whether selected PEF and PD20 measurements and results exist." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "What do 60 adults and post-recruitment registration establish?", "needed": "Overall population, arm-specific test denominators and registration and planning times", "role": "Required", "role_reason": "This condition links Overall population, arm-specific test denominators and registration and planning times with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Overall population, arm-specific test denominators and registration and planning times must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Arm-specific allocation and analysis, valid test denominators, registration change history, protocols, analysis plans and mappings to measurements are needed. This records needed materials; no new research was executed.", "current_reports": [ "R04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "The original population is 60 adults and the account describes registration after recruitment. Preserving the NCT03098849 identifier is distinguished from verifying registration content.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Arm-specific allocation and analysis, valid test denominators, registration change history, protocols, analysis plans and mappings to measurements are needed.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific allocation and analysis, valid test denominators, registration change history, protocols, analysis plans and mappings to measurements are needed." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Have device, testing-condition and medication-effect differences been verified?", "needed": "Devices, aggregation, medication effects and assessor masking for FEV1, PEF and PD20", "role": "Required", "role_reason": "This condition links Devices, aggregation, medication effects and assessor masking for FEV1, PEF and PD20 with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Devices, aggregation, medication effects and assessor masking for FEV1, PEF and PD20 must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Materials are needed for calibration, valid-test criteria, repetition, aggregation, timing, assessors, recording differences and exclusions. Objective measurement alone does not establish absence of measurement bias. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "The stored material records null test findings without supplying detailed testing procedures.", "condition_status": "Unverified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Materials are needed for calibration, valid-test criteria, repetition, aggregation, timing, assessors, recording differences and exclusions. Objective measurement alone does not establish absence of measurement bias.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Materials are needed for calibration, valid-test criteria, repetition, aggregation, timing, assessors, recording differences and exclusions. Objective measurement alone does not establish absence of measurement bias." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Which estimates are within-arm, between-arm or adjusted?", "needed": "Effect of interest, analysis populations, repeated measurements, models and direct contrasts", "role": "Required", "role_reason": "This condition links Effect of interest, analysis populations, repeated measurements, models and direct contrasts with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Effect of interest, analysis populations, repeated measurements, models and direct contrasts must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Analysis populations, adjustment, transformations, contrasts, raw values, models, intervals and analysis plans are needed for each test. Within-arm change is not made into a direct between-arm effect. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "The selected explanation of repeated null findings in direct trials is retained. Symptom or medication signals are not converted into objective between-arm effects.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Analysis populations, adjustment, transformations, contrasts, raw values, models, intervals and analysis plans are needed for each test. Within-arm change is not made into a direct between-arm effect.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Analysis populations, adjustment, transformations, contrasts, raw values, models, intervals and analysis plans are needed for each test. Within-arm change is not made into a direct between-arm effect." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "How were missing tests and follow-up handled?", "needed": "Losses, exclusions, adjustment and sensitivity by arm, test and time", "role": "Required", "role_reason": "This condition links Losses, exclusions, adjustment and sensitivity by arm, test and time with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Losses, exclusions, adjustment and sensitivity by arm, test and time must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Valid denominators, arm-specific missingness, exclusion reasons, adjustment and sensitivity are needed for each selected test. Sensitivity analyses of other outcomes are not reassigned as lung-function missing-data handling. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "Assigned and completed populations, the parent's 23% attrition and Cowie's missing-as-failure sensitivity are preserved only in their relevant contexts.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Valid denominators, arm-specific missingness, exclusion reasons, adjustment and sensitivity are needed for each selected test. Sensitivity analyses of other outcomes are not reassigned as lung-function missing-data handling.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Valid denominators, arm-specific missingness, exclusion reasons, adjustment and sensitivity are needed for each selected test. Sensitivity analyses of other outcomes are not reassigned as lung-function missing-data handling." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Do null findings establish an effect of 0 or equivalence?", "needed": "Direct estimates, CIs, variation, denominators and clinical importance for each test", "role": "Required", "role_reason": "This condition links Direct estimates, CIs, variation, denominators and clinical importance for each test with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Direct estimates, CIs, variation, denominators and clinical importance for each test must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Contrasts, estimates, CIs, P values, variation, valid denominators and original footnotes are needed for FEV1, PEF and PD20 separately. No new effect or grade is calculated. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "Original D and its explanation record that direct trials did not show improvement. Absolute absence of effect or equivalence is not newly established without exact effects and CIs.", "condition_status": "Unverified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Contrasts, estimates, CIs, P values, variation, valid denominators and original footnotes are needed for FEV1, PEF and PD20 separately. No new effect or grade is calculated.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Contrasts, estimates, CIs, P values, variation, valid denominators and original footnotes are needed for FEV1, PEF and PD20 separately. No new effect or grade is calculated." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Are lung function, symptoms and exacerbations the same outcomes?", "needed": "Physiological measures, symptoms, medication, exacerbations and clinical importance", "role": "Required", "role_reason": "This condition links Physiological measures, symptoms, medication, exacerbations and clinical importance with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Physiological measures, symptoms, medication, exacerbations and clinical importance must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Measure-specific clinical thresholds, patient importance, links to events, exact effects and intervals are needed. Measurement findings are not extended into personal treatment effects. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "The original summary distinguishes symptoms and rescue use from airway obstruction, airway responsiveness and exacerbations as different questions.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Measure-specific clinical thresholds, patient importance, links to events, exact effects and intervals are needed. Measurement findings are not extended into personal treatment effects.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Measure-specific clinical thresholds, patient importance, links to events, exact effects and intervals are needed. Measurement findings are not extended into personal treatment effects." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Are parent signals and selected null findings retained together?", "needed": "Positive findings, no differences, full results and endpoint lists", "role": "Required", "role_reason": "This condition links Positive findings, no differences, full results and endpoint lists with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Positive findings, no differences, full results and endpoint lists must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Full inclusion and result lists, estimates and CIs for each selection, and original plans for evaluating omissions and selective reporting are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "Report-specific symptom and medication signals, null FEV1, PEF and PD20, and null control against active education are preserved together.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Full inclusion and result lists, estimates and CIs for each selection, and original plans for evaluating omissions and selective reporting are needed.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Full inclusion and result lists, estimates and CIs for each selection, and original plans for evaluating omissions and selective reporting are needed." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "How do populations, comparators, periods and teaching differ?", "needed": "Baseline disease, background care, exposure, measurement and direct comparisons", "role": "Required", "role_reason": "This condition links Baseline disease, background care, exposure, measurement and direct comparisons with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Baseline disease, background care, exposure, measurement and direct comparisons must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Condition-specific direct results, heterogeneity, prespecified subgroups and full eligibility, program and comparator specifications are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "Small trials from different periods, with different comparators and observation times, are not pooled as the same effect. General breathing training, pranayama and Buteyko are distinguished.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Condition-specific direct results, heterogeneity, prespecified subgroups and full eligibility, program and comparator specifications are needed.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Condition-specific direct results, heterogeneity, prespecified subgroups and full eligibility, program and comparator specifications are needed." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Do several weeks to 6 months answer long-term or other-population questions?", "needed": "Follow-up after completion, baseline status, exposure and prespecified subgroups", "role": "Required", "role_reason": "This condition links Follow-up after completion, baseline status, exposure and prespecified subgroups with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Follow-up after completion, baseline status, exposure and prespecified subgroups must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Follow-up after completion and over the long term, other populations, and prespecified medication- or exposure-related differences, interactions and direct intervals are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "The original material concerns adjunctive training in adult asthma over limited periods. Selected lung-function effects over the long term or in other populations are not newly established.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Follow-up after completion and over the long term, other populations, and prespecified medication- or exposure-related differences, interactions and direct intervals are needed.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Follow-up after completion and over the long term, other populations, and prespecified medication- or exposure-related differences, interactions and direct intervals are needed." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Are 4 reports counted as new independent trials or populations?", "needed": "Reports, registration and cohorts shared with the parent and other subclaims", "role": "Required", "role_reason": "This condition links Reports, registration and cohorts shared with the parent and other subclaims with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Reports, registration and cohorts shared with the parent and other subclaims must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Links between recruitment, registration, related reports, populations and each test are needed. Reports, measures and subclaims are not double-counted, and unique trials or participant totals are not newly certified. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "The 4 reports in the original evidence and bibliography are shared by the parent and its subclaims. Parent replication and independence flags are not new verification of independence.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Links between recruitment, registration, related reports, populations and each test are needed. Reports, measures and subclaims are not double-counted, and unique trials or participant totals are not newly certified.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Links between recruitment, registration, related reports, populations and each test are needed. Reports, measures and subclaims are not double-counted, and unique trials or participant totals are not newly certified." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Does original registration wording establish new content verification?", "needed": "Historical registration wording, original identifiers, content and change times", "role": "Required", "role_reason": "This condition links Historical registration wording, original identifiers, content and change times with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Historical registration wording, original identifiers, content and change times must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Actual registration, protocol and analysis-plan content and histories are needed. Identifiers and historical statements of absence are not labeled as new reading or verification of prespecification. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "Bowler and Cooper's preregistry-era wording, Cowie's unverified registration and Vagedes's NCT03098849 are preserved as original records.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Actual registration, protocol and analysis-plan content and histories are needed. Identifiers and historical statements of absence are not labeled as new reading or verification of prespecification.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual registration, protocol and analysis-plan content and histories are needed. Identifiers and historical statements of absence are not labeled as new reading or verification of prespecification." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "How much is known about funding and interests?", "needed": "Specific funding, anonymous donations, institutional support, roles and historical checks", "role": "Required", "role_reason": "This condition links Specific funding, anonymous donations, institutional support, roles and historical checks with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Specific funding, anonymous donations, institutional support, roles and historical checks must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Contracts, product, teaching, analysis and publication involvement, and original funding and COI disclosures are needed. Historical-check wording is not converted into current verification or certification of independently funded replication. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "Bowler and Cooper's unverified details, Cowie's anonymous donation and unverified independence, and Vagedes's public or institutional support and historical COI-check wording are preserved.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Contracts, product, teaching, analysis and publication involvement, and original funding and COI disclosures are needed. Historical-check wording is not converted into current verification or certification of independently funded replication.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Contracts, product, teaching, analysis and publication involvement, and original funding and COI disclosures are needed. Historical-check wording is not converted into current verification or certification of independently funded replication." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "What was read in this work, and what materials are needed?", "needed": "Distinguishing stored summaries from external abstracts, full texts and registration", "role": "Required", "role_reason": "This condition links Distinguishing stored summaries from external abstracts, full texts and registration with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Distinguishing stored summaries from external abstracts, full texts and registration must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Acquisition and reading of external originals, full results for each test, measurement procedures and analysis plans are needed. A link does not establish that material was read. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "The stored parent-review summary and selected lung-function question were used for production. External abstracts, full texts and registration were unread, with no access attempted.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Acquisition and reading of external originals, full results for each test, measurement procedures and analysis plans are needed. A link does not establish that material was read.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Acquisition and reading of external originals, full results for each test, measurement procedures and analysis plans are needed. A link does not establish that material was read." }, { "item_id": "N33", "question_type": "Evidence condition", "question": "What do 2026-09-07 and historical checks mean?", "needed": "Original evidence date, correction history, historical access and production date", "role": "Required", "role_reason": "This condition links Original evidence date, correction history, historical access and production date with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Original evidence date, correction history, historical access and production date must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original search scope, actual historical access locations and times, and authorized correction materials are needed. Original dates are not changed into new search or completed-content-review dates. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "The original evidence date is 2026-09-07 and the correction list is empty. Historical cross-check and COI-check wording is not a record of new external reading.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Original search scope, actual historical access locations and times, and authorized correction materials are needed. Original dates are not changed into new search or completed-content-review dates.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original search scope, actual historical access locations and times, and authorized correction materials are needed. Original dates are not changed into new search or completed-content-review dates." }, { "item_id": "N34", "question_type": "Evidence condition", "question": "How are selected Korean and English wording and the parent explanation retained?", "needed": "Selected claim, D and explanation versus both language versions of the parent account", "role": "Required", "role_reason": "This condition links Selected claim, D and explanation versus both language versions of the parent account with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Selected claim, D and explanation versus both language versions of the parent account must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original wording, translations and authorized correction records are needed. Translation does not assign a new status, score or positive efficacy conclusion. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "The selection is improvement in FEV1, PEF or airway responsiveness, with an original explanation of repeated null direct-trial findings. Its applicability is distinguished from the parent's symptom and rescue-use account.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Original wording, translations and authorized correction records are needed. Translation does not assign a new status, score or positive efficacy conclusion.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original wording, translations and authorized correction records are needed. Translation does not assign a new status, score or positive efficacy conclusion." }, { "item_id": "N35", "question_type": "Evidence condition", "question": "Do parent axes and primary-secondary flags certify the selection?", "needed": "Original axes, booleans, empty values and applicability to the selected question", "role": "Required", "role_reason": "This condition links Original axes, booleans, empty values and applicability to the selected question with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Original axes, booleans, empty values and applicability to the selected question must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original fields and question-specific applicability records are needed. The parent's positive-effect axis is not inherited as objective lung-function improvement or new certification of prespecification or independence. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "Parent split co-primary and failed-primary-positive-secondary flags, the absence of a no-human-study flag and empty reasons are preserved in the original. No new axes, score or status are created for selected D.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Original fields and question-specific applicability records are needed. The parent's positive-effect axis is not inherited as objective lung-function improvement or new certification of prespecification or independence.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original fields and question-specific applicability records are needed. The parent's positive-effect axis is not inherited as objective lung-function improvement or new certification of prespecification or independence." }, { "item_id": "N36", "question_type": "Evidence condition", "question": "How were harms of adjunctive training collected?", "needed": "Event definitions, severity, collection methods and arm-specific exposure", "role": "Required", "role_reason": "This condition links Event definitions, severity, collection methods and arm-specific exposure with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Event definitions, severity, collection methods and arm-specific exposure must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Materials are needed for event types, event and participant counts, diagnosis, active or spontaneous collection, arm-specific exposure and missingness. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "The original safety account retains limits on replacing inhaled care or acute-attack management. Stored summaries alone do not establish arm-specific adverse-event tables or collection methods.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Materials are needed for event types, event and participant counts, diagnosis, active or spontaneous collection, arm-specific exposure and missingness.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Materials are needed for event types, event and participant counts, diagnosis, active or spontaneous collection, arm-specific exposure and missingness." }, { "item_id": "N37", "question_type": "Evidence condition", "question": "Are exposure, event, discontinuation and recovery times known?", "needed": "Timelines of exposure, observation, onset, recovery, discontinuation and re-exposure", "role": "Required", "role_reason": "This condition links Timelines of exposure, observation, onset, recovery, discontinuation and re-exposure with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Timelines of exposure, observation, onset, recovery, discontinuation and re-exposure must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Existing records are needed for actual arm-specific exposure, onset, recovery, discontinuation, re-exposure and harms follow-up periods. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "Effect observation over several weeks to 6 months is not converted into a timeline of harm onset or recovery.", "condition_status": "Unverified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Existing records are needed for actual arm-specific exposure, onset, recovery, discontinuation, re-exposure and harms follow-up periods.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Existing records are needed for actual arm-specific exposure, onset, recovery, discontinuation, re-exposure and harms follow-up periods." }, { "item_id": "N38", "question_type": "Evidence condition", "question": "Can harm frequency or comparative risk be stated?", "needed": "Arm-specific events, participants, denominators, observation time and direct comparisons", "role": "Required", "role_reason": "This condition links Arm-specific events, participants, denominators, observation time and direct comparisons with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Arm-specific events, participants, denominators, observation time and direct comparisons must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Arm-specific exposure, events, duplicates, observation times, denominators, direct comparisons, CIs and collection methods are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "Overall assigned and completed populations, ICS denominators and null objective findings do not establish harms denominators or absence of events. General caution wording is not used to calculate incidence.", "condition_status": "Unverified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Arm-specific exposure, events, duplicates, observation times, denominators, direct comparisons, CIs and collection methods are needed.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific exposure, events, duplicates, observation times, denominators, direct comparisons, CIs and collection methods are needed." }, { "item_id": "N39", "question_type": "Evidence condition", "question": "How are baseline asthma, medication changes and events distinguished?", "needed": "Baseline status, concurrent care, actual changes and alternative causes", "role": "Required", "role_reason": "This condition links Baseline status, concurrent care, actual changes and alternative causes with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Baseline status, concurrent care, actual changes and alternative causes must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Materials are needed for baseline and arm-specific medication, actual changes, exacerbations, concurrent exposures, alternative causes and adjustment. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "The original study and safety accounts concern adjunctive standard care and medication changes under clinical review. No new tapering or replacement guidance is written.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Materials are needed for baseline and arm-specific medication, actual changes, exacerbations, concurrent exposures, alternative causes and adjustment.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Materials are needed for baseline and arm-specific medication, actual changes, exacerbations, concurrent exposures, alternative causes and adjustment." }, { "item_id": "N40", "question_type": "Evidence condition", "question": "Are missing harms or repeated citations counted as independent events?", "needed": "Collection, detection, follow-up losses, related reports and unique events", "role": "Required", "role_reason": "This condition links Collection, detection, follow-up losses, related reports and unique events with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Collection, detection, follow-up losses, related reports and unique events must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original materials are needed for harms collection, selection, detection differences, unique events, study relationships and the scope of all reports. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "Korean and English wording and reports shared by parent and subclaims are not new independent events. Completion and follow-up counts alone do not establish complete harms reporting.", "condition_status": "Unverified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Original materials are needed for harms collection, selection, detection differences, unique events, study relationships and the scope of all reports.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original materials are needed for harms collection, selection, detection differences, unique events, study relationships and the scope of all reports." }, { "item_id": "N41", "question_type": "Evidence condition", "question": "Can safety be extended to the long term or other populations?", "needed": "Long-term and rare events, baseline populations, concurrent care and exposure", "role": "Required", "role_reason": "This condition links Long-term and rare events, baseline populations, concurrent care and exposure with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Long-term and rare events, baseline populations, concurrent care and exposure must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Direct event and follow-up materials are needed for long-term and rare harms and for other populations, medications and exposures. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "Limited adjunctive-training material in adult asthma is not extended into guaranteed safety across all populations or over the long term.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Direct event and follow-up materials are needed for long-term and rare harms and for other populations, medications and exposures.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct event and follow-up materials are needed for long-term and rare harms and for other populations, medications and exposures." }, { "item_id": "N42", "question_type": "Evidence condition", "question": "How far do selected null findings and parent signals support conclusions?", "needed": "Boundaries between objective measures, symptoms, rescue use, exacerbations and precision", "role": "Required", "role_reason": "This condition links Boundaries between objective measures, symptoms, rescue use, exacerbations and precision with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Boundaries between objective measures, symptoms, rescue use, exacerbations and precision must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Direct effects, CIs, denominators, prespecified plans and long-term, harms and causal materials are needed for each test. Null findings and uncertainty are distinguished. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "Original D and its explanation retain failure to show improvement in the selected measures. Symptom or medication signals are not promoted into airway improvement, exacerbation prevention or inhaled-care replacement.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Direct effects, CIs, denominators, prespecified plans and long-term, harms and causal materials are needed for each test. Null findings and uncertainty are distinguished.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct effects, CIs, denominators, prespecified plans and long-term, harms and causal materials are needed for each test. Null findings and uncertainty are distinguished." }, { "item_id": "N43", "question_type": "Evidence condition", "question": "Do preserved methods and criteria links establish completed review?", "needed": "Distinguishing existing methodological materials and application conditions from content review", "role": "Required", "role_reason": "This condition links Distinguishing existing methodological materials and application conditions from content review with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Distinguishing existing methodological materials and application conditions from content review must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Individual content review and authorized existing materials are needed. Creation, freezing and application of conditions are distinguished from content review. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "The 5 methodological materials and existing criteria and contract are preserved production materials. Linking or authoring them is not labeled as completed new clinical or methodological content review.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Individual content review and authorized existing materials are needed. Creation, freezing and application of conditions are distinguished from content review.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Individual content review and authorized existing materials are needed. Creation, freezing and application of conditions are distinguished from content review." }, { "item_id": "N44", "question_type": "Evidence condition", "question": "What materials would allow lung-function gaps to be updated?", "needed": "Tests, contrasts, denominators, CIs, original plans, timing and study relationships", "role": "Required", "role_reason": "This condition links Tests, contrasts, denominators, CIs, original plans, timing and study relationships with tests, units, populations, interventions, comparators, denominators, timing, analyses, precision, support and harms for the selected lung-function question.", "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent C50 or positive-effect axes. FEV1, PEF and PD20, other physiological, symptom and medication outcomes, comparisons, denominators and times are distinguished. Unread originals and registration or historical funding and COI checks are not promoted into current verification; no new effects, CIs, independent totals or breathing, medication or treatment instructions are created.", "criterion": "Original material and analysis scope for Tests, contrasts, denominators, CIs, original plans, timing and study relationships must be linked to each test, between-arm contrast, denominator and time, distinguishing stored summaries, unverified details and the parent symptom and medication findings.", "basis": "Preserved application conditions concerning questions, comparisons, reports versus trials, outcomes, denominators, errata and harms were referenced.", "condition_origin": "These are in-house application conditions preserved for the existing subclaim. They do not establish clinical preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original materials are needed for effects, CIs, testing procedures, denominators, missingness, prespecified hierarchy, registration, shared studies, exposure and harms. Originals are preserved before change, distinguishing revised conditions from added evidence. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Stored-summary and bibliographic statements were used; identity, exact content, acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, analysis plans, test procedures, harms and support materials unread", "observation": "Currently stored null findings, gaps and parent context are distinguished. Recording needed materials does not establish new clinical verification or completed review.", "condition_status": "Partly verified", "status_reason": "Information was transferred from the stored summary while distinguishing the existing selected question from parent material. Detailed originals are unverified and review of existing content remains incomplete. This does not establish clinical certification or a passed content review.", "missingness": "Original materials are needed for effects, CIs, testing procedures, denominators, missingness, prespecified hierarchy, registration, shared studies, exposure and harms. Originals are preserved before change, distinguishing revised conditions from added evidence.", "uncertainty": "External originals are unread and review of existing content remains incomplete. Original selected D and report-specific null findings are retained alongside gaps in exact testing, contrasts, denominators, effects, CIs, prespecified hierarchy, exposure, harms and independence. Historical checks, registration identifiers and blinding labels do not establish current reading of originals or clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original materials are needed for effects, CIs, testing procedures, denominators, missingness, prespecified hierarchy, registration, shared studies, exposure and harms. Originals are preserved before change, distinguishing revised conditions from added evidence." } ], "reports": [ { "report_id": "R01", "title": "Bowler SD, Green A, Mitchell CA. Buteyko breathing techniques in asthma: a blinded randomised controlled trial. Med J Aust. 1998;169:575-578. PMID: 9887897. DOI: 10.5694/j.1326-5377.1998.tb123422.x.", "url": "https://pubmed.ncbi.nlm.nih.gov/9887897/", "report_type": "Stored controlled asthma report; selected lung-function measures distinguished from related outcomes", "existence": "The stored summary contains a bibliography; acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external materials unread", "study_family": "Reports shared by the parent and subclaims; unique counts and independence unverified", "independent_replication": "The stored reports are shared with the parent and other subclaims. Report-specific links and the overall shared group are distinguished; original repeated null findings and parent replication or independence wording are not converted into new certification of independence. Exact registration, recruitment, cohort and test links are unverified, and unique trial and participant totals remain empty.", "observed_result": "Median beta2-agonist reduction 904 versus 57 mcg, P=.002; FEV1 and PEF null; ICS P=.06 and QOL P=.09", "result_level": "This is the 3-month context in 39 adults with asthma in 1998. Null FEV1 and PEF are distinguished from beta2-agonist reductions of 904 versus 57 mcg, P=.002, and ICS P=.06 and QOL P=.09. Medication and quality-of-life figures are not lung-function effects, units or denominators; exact lung-function estimates and CIs are unverified.", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete parent-verdict stored summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07 (original evidence date; not new external reading)", "qualification": "Preserve original PMID 9887897 and DOI 10.5694/j.1326-5377.1998.tb123422.x. Registration-field wording about the preregistry era is a historical record, not new registry lookup or verification of absent materials. Specific funding, COI, roles and independence are unverified, and originals were not newly read. The material date belongs to the original evidence and is not a new external-reading or completed-review date." }, { "material_type": "External abstract", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07 (original evidence date; not new external reading)", "qualification": "Preserve original PMID 9887897 and DOI 10.5694/j.1326-5377.1998.tb123422.x. Registration-field wording about the preregistry era is a historical record, not new registry lookup or verification of absent materials. Specific funding, COI, roles and independence are unverified, and originals were not newly read. The material date belongs to the original evidence and is not a new external-reading or completed-review date." }, { "material_type": "External full text", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07 (original evidence date; not new external reading)", "qualification": "Preserve original PMID 9887897 and DOI 10.5694/j.1326-5377.1998.tb123422.x. Registration-field wording about the preregistry era is a historical record, not new registry lookup or verification of absent materials. Specific funding, COI, roles and independence are unverified, and originals were not newly read. The material date belongs to the original evidence and is not a new external-reading or completed-review date." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07 (original evidence date; not new external reading)", "qualification": "Preserve original PMID 9887897 and DOI 10.5694/j.1326-5377.1998.tb123422.x. Registration-field wording about the preregistry era is a historical record, not new registry lookup or verification of absent materials. Specific funding, COI, roles and independence are unverified, and originals were not newly read. The material date belongs to the original evidence and is not a new external-reading or completed-review date." }, { "material_type": "Protocol", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07 (original evidence date; not new external reading)", "qualification": "Preserve original PMID 9887897 and DOI 10.5694/j.1326-5377.1998.tb123422.x. Registration-field wording about the preregistry era is a historical record, not new registry lookup or verification of absent materials. Specific funding, COI, roles and independence are unverified, and originals were not newly read. The material date belongs to the original evidence and is not a new external-reading or completed-review date." }, { "material_type": "Analysis plans, test procedures and denominators", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07 (original evidence date; not new external reading)", "qualification": "Preserve original PMID 9887897 and DOI 10.5694/j.1326-5377.1998.tb123422.x. Registration-field wording about the preregistry era is a historical record, not new registry lookup or verification of absent materials. Specific funding, COI, roles and independence are unverified, and originals were not newly read. The material date belongs to the original evidence and is not a new external-reading or completed-review date." }, { "material_type": "Exposure, concurrent care and harms", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07 (original evidence date; not new external reading)", "qualification": "Preserve original PMID 9887897 and DOI 10.5694/j.1326-5377.1998.tb123422.x. Registration-field wording about the preregistry era is a historical record, not new registry lookup or verification of absent materials. Specific funding, COI, roles and independence are unverified, and originals were not newly read. The material date belongs to the original evidence and is not a new external-reading or completed-review date." }, { "material_type": "Funding and interests", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07 (original evidence date; not new external reading)", "qualification": "Preserve original PMID 9887897 and DOI 10.5694/j.1326-5377.1998.tb123422.x. Registration-field wording about the preregistry era is a historical record, not new registry lookup or verification of absent materials. Specific funding, COI, roles and independence are unverified, and originals were not newly read. The material date belongs to the original evidence and is not a new external-reading or completed-review date." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/9887897/" } ] }, { "report_id": "R02", "title": "Cooper S, Oborne J, Newton S, et al. Effect of two breathing exercises (Buteyko and pranayama) in asthma: a randomised controlled trial. Thorax. 2003;58:674-679. PMID: 12885982. PMCID: PMC1746772. DOI: 10.1136/thorax.58.8.674.", "url": "https://pubmed.ncbi.nlm.nih.gov/12885982/", "report_type": "Stored controlled asthma report; selected lung-function measures distinguished from related outcomes", "existence": "The stored summary contains a bibliography; acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external materials unread", "study_family": "Reports shared by the parent and subclaims; unique counts and independence unverified", "independent_replication": "The stored reports are shared with the parent and other subclaims. Report-specific links and the overall shared group are distinguished; original repeated null findings and parent replication or independence wording are not converted into new certification of independence. Exact registration, recruitment, cohort and test links are unverified, and unique trial and participant totals remain empty.", "observed_result": "Median symptom change -3 versus -1 versus 0, P=.003; bronchodilator -2 puffs/day, P=.005; objective outcomes, exacerbations, and ICS null", "result_level": "The 2003 trial retains 3 arms and original wording of 90 assigned, 69 completed and 23% attrition. Null PD20 and FEV1 are distinguished from symptoms of -3 versus -1 versus 0, P=.003, and bronchodilator -2 puffs/day, P=.005. Exact arm- and test-specific contrasts, CIs, denominators and co-primary hierarchy are unverified because external materials are unread.", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete parent-verdict stored summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07 (original evidence date; not new external reading)", "qualification": "Preserve original PMID 12885982, PMCID PMC1746772 and DOI 10.1136/thorax.58.8.674. A PMCID does not establish full-text reading. Preregistry-era wording, completer analysis, lack of masking and split co-primary findings are distinguished; specific funding, COI and direct CIs are unverified. The material date belongs to the original evidence and is not a new external-reading or completed-review date." }, { "material_type": "External abstract", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07 (original evidence date; not new external reading)", "qualification": "Preserve original PMID 12885982, PMCID PMC1746772 and DOI 10.1136/thorax.58.8.674. A PMCID does not establish full-text reading. Preregistry-era wording, completer analysis, lack of masking and split co-primary findings are distinguished; specific funding, COI and direct CIs are unverified. The material date belongs to the original evidence and is not a new external-reading or completed-review date." }, { "material_type": "External full text", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07 (original evidence date; not new external reading)", "qualification": "Preserve original PMID 12885982, PMCID PMC1746772 and DOI 10.1136/thorax.58.8.674. A PMCID does not establish full-text reading. Preregistry-era wording, completer analysis, lack of masking and split co-primary findings are distinguished; specific funding, COI and direct CIs are unverified. The material date belongs to the original evidence and is not a new external-reading or completed-review date." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07 (original evidence date; not new external reading)", "qualification": "Preserve original PMID 12885982, PMCID PMC1746772 and DOI 10.1136/thorax.58.8.674. A PMCID does not establish full-text reading. Preregistry-era wording, completer analysis, lack of masking and split co-primary findings are distinguished; specific funding, COI and direct CIs are unverified. The material date belongs to the original evidence and is not a new external-reading or completed-review date." }, { "material_type": "Protocol", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07 (original evidence date; not new external reading)", "qualification": "Preserve original PMID 12885982, PMCID PMC1746772 and DOI 10.1136/thorax.58.8.674. A PMCID does not establish full-text reading. Preregistry-era wording, completer analysis, lack of masking and split co-primary findings are distinguished; specific funding, COI and direct CIs are unverified. The material date belongs to the original evidence and is not a new external-reading or completed-review date." }, { "material_type": "Analysis plans, test procedures and denominators", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07 (original evidence date; not new external reading)", "qualification": "Preserve original PMID 12885982, PMCID PMC1746772 and DOI 10.1136/thorax.58.8.674. A PMCID does not establish full-text reading. Preregistry-era wording, completer analysis, lack of masking and split co-primary findings are distinguished; specific funding, COI and direct CIs are unverified. The material date belongs to the original evidence and is not a new external-reading or completed-review date." }, { "material_type": "Exposure, concurrent care and harms", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07 (original evidence date; not new external reading)", "qualification": "Preserve original PMID 12885982, PMCID PMC1746772 and DOI 10.1136/thorax.58.8.674. A PMCID does not establish full-text reading. Preregistry-era wording, completer analysis, lack of masking and split co-primary findings are distinguished; specific funding, COI and direct CIs are unverified. The material date belongs to the original evidence and is not a new external-reading or completed-review date." }, { "material_type": "Funding and interests", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07 (original evidence date; not new external reading)", "qualification": "Preserve original PMID 12885982, PMCID PMC1746772 and DOI 10.1136/thorax.58.8.674. A PMCID does not establish full-text reading. Preregistry-era wording, completer analysis, lack of masking and split co-primary findings are distinguished; specific funding, COI and direct CIs are unverified. The material date belongs to the original evidence and is not a new external-reading or completed-review date." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/12885982/" } ] }, { "report_id": "R03", "title": "Cowie RL, Conley DP, Underwood MF, Reader PG. A randomised controlled trial of the Buteyko technique as an adjunct to conventional management of asthma. Respir Med. 2008;102:726-732. PMID: 18249107. DOI: 10.1016/j.rmed.2007.12.012.", "url": "https://pubmed.ncbi.nlm.nih.gov/18249107/", "report_type": "Controlled report on asthma control and ICS; direct selected lung-function values absent from the stored summary", "existence": "The stored summary contains a bibliography; acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external materials unread", "study_family": "Reports shared by the parent and subclaims; unique counts and independence unverified", "independent_replication": "The stored reports are shared with the parent and other subclaims. Report-specific links and the overall shared group are distinguished; original repeated null findings and parent replication or independence wording are not converted into new certification of independence. Exact registration, recruitment, cohort and test links are unverified, and unique trial and participant totals remain empty.", "observed_result": "Control 79% versus 72%, P=.4; missing-as-failure 68% versus 70%, P=.7; ICS reduction 23/56 versus 13/63, P=.02", "result_level": "The 2008 active-breathing-education comparison retains 129 assigned and 119 assessed at 6 months. Control of 79% versus 72%, P=.4, missing-as-failure findings of 68% versus 70%, P=.7, and ICS 23/56 versus 13/63, P=.02, are kept within their respective outcomes. Direct selected FEV1, PEF and PD20 values are absent from the stored summary; this does not establish absence of measurement or findings from all external materials.", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete parent-verdict stored summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07 (original evidence date; not new external reading)", "qualification": "Preserve original PMID 18249107, DOI 10.1016/j.rmed.2007.12.012 and unverified registration. An anonymous donor does not verify independence. Asthma-control and ICS findings and denominators are not reassigned to selected lung-function measures; the existence of tests and findings in full external materials is unverified. The material date belongs to the original evidence and is not a new external-reading or completed-review date." }, { "material_type": "External abstract", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07 (original evidence date; not new external reading)", "qualification": "Preserve original PMID 18249107, DOI 10.1016/j.rmed.2007.12.012 and unverified registration. An anonymous donor does not verify independence. Asthma-control and ICS findings and denominators are not reassigned to selected lung-function measures; the existence of tests and findings in full external materials is unverified. The material date belongs to the original evidence and is not a new external-reading or completed-review date." }, { "material_type": "External full text", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07 (original evidence date; not new external reading)", "qualification": "Preserve original PMID 18249107, DOI 10.1016/j.rmed.2007.12.012 and unverified registration. An anonymous donor does not verify independence. Asthma-control and ICS findings and denominators are not reassigned to selected lung-function measures; the existence of tests and findings in full external materials is unverified. The material date belongs to the original evidence and is not a new external-reading or completed-review date." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07 (original evidence date; not new external reading)", "qualification": "Preserve original PMID 18249107, DOI 10.1016/j.rmed.2007.12.012 and unverified registration. An anonymous donor does not verify independence. Asthma-control and ICS findings and denominators are not reassigned to selected lung-function measures; the existence of tests and findings in full external materials is unverified. The material date belongs to the original evidence and is not a new external-reading or completed-review date." }, { "material_type": "Protocol", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07 (original evidence date; not new external reading)", "qualification": "Preserve original PMID 18249107, DOI 10.1016/j.rmed.2007.12.012 and unverified registration. An anonymous donor does not verify independence. Asthma-control and ICS findings and denominators are not reassigned to selected lung-function measures; the existence of tests and findings in full external materials is unverified. The material date belongs to the original evidence and is not a new external-reading or completed-review date." }, { "material_type": "Analysis plans, test procedures and denominators", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07 (original evidence date; not new external reading)", "qualification": "Preserve original PMID 18249107, DOI 10.1016/j.rmed.2007.12.012 and unverified registration. An anonymous donor does not verify independence. Asthma-control and ICS findings and denominators are not reassigned to selected lung-function measures; the existence of tests and findings in full external materials is unverified. The material date belongs to the original evidence and is not a new external-reading or completed-review date." }, { "material_type": "Exposure, concurrent care and harms", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07 (original evidence date; not new external reading)", "qualification": "Preserve original PMID 18249107, DOI 10.1016/j.rmed.2007.12.012 and unverified registration. An anonymous donor does not verify independence. Asthma-control and ICS findings and denominators are not reassigned to selected lung-function measures; the existence of tests and findings in full external materials is unverified. The material date belongs to the original evidence and is not a new external-reading or completed-review date." }, { "material_type": "Funding and interests", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07 (original evidence date; not new external reading)", "qualification": "Preserve original PMID 18249107, DOI 10.1016/j.rmed.2007.12.012 and unverified registration. An anonymous donor does not verify independence. Asthma-control and ICS findings and denominators are not reassigned to selected lung-function measures; the existence of tests and findings in full external materials is unverified. The material date belongs to the original evidence and is not a new external-reading or completed-review date." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/18249107/" } ] }, { "report_id": "R04", "title": "Vagedes K, et al. Buteyko breathing technique for asthma: an effective intervention. Eur J Med Res. 2024;29:42. PMID: 38212823. PMCID: PMC10782792. DOI: 10.1186/s40001-023-01634-1. NCT03098849.", "url": "https://pubmed.ncbi.nlm.nih.gov/38212823/", "report_type": "Stored controlled asthma report; selected lung-function measures distinguished from related outcomes", "existence": "The stored summary contains a bibliography; acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external materials unread", "study_family": "Reports shared by the parent and subclaims; unique counts and independence unverified", "independent_replication": "The stored reports are shared with the parent and other subclaims. Report-specific links and the overall shared group are distinguished; original repeated null findings and parent replication or independence wording are not converted into new certification of independence. Exact registration, recruitment, cohort and test links are unverified, and unique trial and participant totals remain empty.", "observed_result": "1st and some 2nd outcome signals; FEV1 and FeNO null, registered after recruitment began", "result_level": "The 2024 trial in 60 adults distinguishes null FEV1 and FeNO from the 1st outcome voluntary control pause and some 2nd-outcome ACQ and medication signals. NCT03098849 registration after recruitment is original historical wording. Exact selected-test effects, CIs, denominators and timing, and the existence of PEF and PD20 measurements and results, are unverified.", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete parent-verdict stored summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07 (original evidence date; not new external reading)", "qualification": "Preserve original PMID 38212823, PMCID PMC10782792, DOI 10.1186/s40001-023-01634-1 and NCT03098849. Original post-recruitment registration, public or institutional support and historical full-text COI checks are retained without marking new prespecified-plan, registration, full-text or COI verification complete. The material date belongs to the original evidence and is not a new external-reading or completed-review date." }, { "material_type": "External abstract", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07 (original evidence date; not new external reading)", "qualification": "Preserve original PMID 38212823, PMCID PMC10782792, DOI 10.1186/s40001-023-01634-1 and NCT03098849. Original post-recruitment registration, public or institutional support and historical full-text COI checks are retained without marking new prespecified-plan, registration, full-text or COI verification complete. The material date belongs to the original evidence and is not a new external-reading or completed-review date." }, { "material_type": "External full text", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07 (original evidence date; not new external reading)", "qualification": "Preserve original PMID 38212823, PMCID PMC10782792, DOI 10.1186/s40001-023-01634-1 and NCT03098849. Original post-recruitment registration, public or institutional support and historical full-text COI checks are retained without marking new prespecified-plan, registration, full-text or COI verification complete. The material date belongs to the original evidence and is not a new external-reading or completed-review date." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07 (original evidence date; not new external reading)", "qualification": "Preserve original PMID 38212823, PMCID PMC10782792, DOI 10.1186/s40001-023-01634-1 and NCT03098849. Original post-recruitment registration, public or institutional support and historical full-text COI checks are retained without marking new prespecified-plan, registration, full-text or COI verification complete. The material date belongs to the original evidence and is not a new external-reading or completed-review date." }, { "material_type": "Protocol", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07 (original evidence date; not new external reading)", "qualification": "Preserve original PMID 38212823, PMCID PMC10782792, DOI 10.1186/s40001-023-01634-1 and NCT03098849. Original post-recruitment registration, public or institutional support and historical full-text COI checks are retained without marking new prespecified-plan, registration, full-text or COI verification complete. The material date belongs to the original evidence and is not a new external-reading or completed-review date." }, { "material_type": "Analysis plans, test procedures and denominators", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07 (original evidence date; not new external reading)", "qualification": "Preserve original PMID 38212823, PMCID PMC10782792, DOI 10.1186/s40001-023-01634-1 and NCT03098849. Original post-recruitment registration, public or institutional support and historical full-text COI checks are retained without marking new prespecified-plan, registration, full-text or COI verification complete. The material date belongs to the original evidence and is not a new external-reading or completed-review date." }, { "material_type": "Exposure, concurrent care and harms", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07 (original evidence date; not new external reading)", "qualification": "Preserve original PMID 38212823, PMCID PMC10782792, DOI 10.1186/s40001-023-01634-1 and NCT03098849. Original post-recruitment registration, public or institutional support and historical full-text COI checks are retained without marking new prespecified-plan, registration, full-text or COI verification complete. The material date belongs to the original evidence and is not a new external-reading or completed-review date." }, { "material_type": "Funding and interests", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07 (original evidence date; not new external reading)", "qualification": "Preserve original PMID 38212823, PMCID PMC10782792, DOI 10.1186/s40001-023-01634-1 and NCT03098849. Original post-recruitment registration, public or institutional support and historical full-text COI checks are retained without marking new prespecified-plan, registration, full-text or COI verification complete. The material date belongs to the original evidence and is not a new external-reading or completed-review date." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/38212823/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." } ], "status_dictionary": { "Partly verified": "Partial information from the stored summary is linked; detailed originals and content review remain incomplete.", "Unverified": "Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety.", "Review incomplete": "Review of existing content remains incomplete.", "Met": "This state is used only within the relevant conditions after material verification and content review. It was not automatically assigned in this work.", "Not reported": "Unreported within material actually read. Unread external material is not relabeled as unreported.", "Inaccessible": "This means actual access failure. External access was not attempted in this work, so this state was not assigned.", "Not applicable": "Used only with an application exception and reason based on the question scope.", "Conflicting data": "This requires actual comparison of materials; no new conflict judgment was made in this work.", "Insufficient evidence for the conditions": "This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "The stored reports are shared with the parent and other subclaims. Report-specific links and the overall shared group are distinguished; original repeated null findings and parent replication or independence wording are not converted into new certification of independence. Exact registration, recruitment, cohort and test links are unverified, and unique trial and participant totals remain empty." }, "history": [ { "date": "2026-10-19", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public-facing views and materials were prepared from the existing 44 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-19" }