{ "schema_version": "chamgap-public-criteria-1.0", "title": "Buteyko for Adult Asthma × FEV1, PEF and Airway Responsiveness — Improvement Unproven · Evidence and Gaps Sheet", "language": "en", "translation_date": "2026-10-19", "criteria_version": "1.0", "criteria_date": "2026-10-06", "condition_origin": "Chamgap's own application conditions", "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." }, "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." } ] }