{ "schema_version": "chamgap-public-criteria-1.0", "title": "High-resistance IMST × diastolic pressure and cardiovascular events: evidence gaps", "language": "en", "translation_date": "2026-10-16", "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": "Preserved methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited" }, { "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": "Preserved methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited" }, { "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": "Preserved methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited" }, { "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": "Preserved methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited" }, { "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": "Preserved methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited" } ], "status_dictionary": { "Partly verified": "Some information is present in the stored source, with detailed original materials still unverified; this does not mean review passed or clinical efficacy certified", "Unverified": "Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety", "Review incomplete": "Awaiting user review", "Met": "Use only within the relevant condition's scope after user review; no automatic display in this preparation", "Not reported": "Distinguish only within materials actually read; do not turn unread external materials into unreported findings", "Inaccessible": "Not applied during this preparation because actual access was not tested", "Not applicable": "Use with a reason for non-applicability based on an explicit question boundary", "Conflicting data": "Judge after actual material comparison; review was not performed during this preparation", "Insufficient evidence for the conditions": "Do not use as a clinical grade encompassing currently unread materials" }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which diastolic-pressure and cardiovascular-event claim is examined?", "needed": "Selected DBP and cardiovascular-event benefit claim", "role": "Required", "role_reason": "This condition connects Selected DBP and cardiovascular-event benefit claim with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.", "application_exception": "Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.", "criterion": "Material for Selected DBP and cardiovascular-event benefit claim must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Materials identifying the direct DBP result and unmeasured cardiovascular events separately, plus content review, are needed. Absent subclaim fields are not filled with parent scores or axes. This records needed materials; no new research was executed." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "What is the direct resting diastolic-pressure test?", "needed": "Resting DBP interaction and separate between-group effects", "role": "Required", "role_reason": "This condition connects Resting DBP interaction and separate between-group effects with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.", "application_exception": "Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.", "criterion": "Material for Resting DBP interaction and separate between-group effects must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: DBP measurement conditions, denominators, original values, models, between-group effects, 95% CIs, contrasts of interest and prespecified hierarchy are needed. This records needed materials; no new research was executed." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Does positive resting SBP establish a DBP effect?", "needed": "Parent SBP versus selected DBP/event endpoints", "role": "Required", "role_reason": "This condition connects Parent SBP versus selected DBP/event endpoints with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.", "application_exception": "Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.", "criterion": "Material for Parent SBP versus selected DBP/event endpoints must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: DBP-specific original tables, denominators, effects, CIs and measurement conditions are needed. Original SBP numbers are not copied to other endpoints or used for new difference calculations. This records needed materials; no new research was executed." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Are resting, ambulatory and 24-hour DBP distinguished?", "needed": "Measurement conditions and SBP/DBP endpoints", "role": "Required", "role_reason": "This condition connects Measurement conditions and SBP/DBP endpoints with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.", "application_exception": "Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.", "criterion": "Material for Measurement conditions and SBP/DBP endpoints must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Resting/ambulatory DBP tables, measurement coverage, valid time, day/night definitions, denominators, models, effects and CIs are needed. Ambulatory SBP P=.07 is not changed into an ambulatory DBP P value. This records needed materials; no new research was executed." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Were cardiovascular events directly tested or measured?", "needed": "Direct clinical events versus nonmeasurement", "role": "Required", "role_reason": "This condition connects Direct clinical events versus nonmeasurement with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.", "application_exception": "Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.", "criterion": "Material for Direct clinical events versus nonmeasurement must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Direct event definitions/adjudication, arm-specific events/risk time, follow-up, missingness and original effects/CIs are needed. No new event analysis or retrieval was executed. This records needed materials; no new research was executed." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Are null DBP and unmeasured events the same state?", "needed": "Tested DBP versus unmeasured-event evidence states", "role": "Required", "role_reason": "This condition connects Tested DBP versus unmeasured-event evidence states with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.", "application_exception": "Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.", "criterion": "Material for Tested DBP versus unmeasured-event evidence states must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: DBP effects/CIs and direct clinical-event material are needed separately. They are distinguished within the existing question without creating new subclaims or revising grades. This records needed materials; no new research was executed." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Does relative FMD improvement establish event prevention?", "needed": "FMD, mechanisms and clinical events", "role": "Required", "role_reason": "This condition connects FMD, mechanisms and clinical events with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.", "application_exception": "Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.", "criterion": "Material for FMD, mechanisms and clinical events must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original FMD/mechanism tables, denominators, CIs and direct event definitions, follow-up and risk data are needed. No new mechanism numbers, risk conversions or hypothetical examples are created. This records needed materials; no new research was executed." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Is six-week exposure the same as long-term event follow-up?", "needed": "Short-term pressure results versus long-term events/follow-up", "role": "Required", "role_reason": "This condition connects Short-term pressure results versus long-term events/follow-up with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.", "application_exception": "Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.", "criterion": "Material for Short-term pressure results versus long-term events/follow-up must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Direct long-term studies, risk time, follow-up loss, maintained exposure, actual denominators and event effects/CIs are needed. Original duration is not transferred to long-term incidence. This records needed materials; no new research was executed." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Do population and baseline medication fit the event question?", "needed": "Ages 50–79 and above-normal blood-pressure eligibility", "role": "Required", "role_reason": "This condition connects Ages 50–79 and above-normal blood-pressure eligibility with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.", "application_exception": "Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.", "criterion": "Material for Ages 50–79 and above-normal blood-pressure eligibility must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original DBP/event eligibility, baseline medication/disease, baseline DBP/risk, arm values and denominators are needed. No breathing-method, device or medication-change instructions are created. This records needed materials; no new research was executed." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Are original counts valid DBP/event denominators?", "needed": "Allocation/analysis flow versus endpoint denominators and risk time", "role": "Required", "role_reason": "This condition connects Allocation/analysis flow versus endpoint denominators and risk time with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.", "application_exception": "Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.", "criterion": "Material for Allocation/analysis flow versus endpoint denominators and risk time must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original analysis flow, endpoint-specific allocation, valid values, missingness, event risk time and follow-up are needed. No new dropout counts/rates or participant sums are created. This records needed materials; no new research was executed." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Are exact DBP/event effects and CIs available?", "needed": "P values versus endpoint-specific effect sizes and precision", "role": "Required", "role_reason": "This condition connects P values versus endpoint-specific effect sizes and precision with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.", "application_exception": "Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.", "criterion": "Material for P values versus endpoint-specific effect sizes and precision must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original endpoint values, models, denominators, adjusted effects, CIs, clinical importance and direct event material are needed. No hypothetical quantification or new calculations are made. This records needed materials; no new research was executed." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Is low-resistance sham a medication-replacement control?", "needed": "15% low-resistance sham versus direct medication comparisons", "role": "Required", "role_reason": "This condition connects 15% low-resistance sham versus direct medication comparisons with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.", "application_exception": "Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.", "criterion": "Material for 15% low-resistance sham versus direct medication comparisons must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Direct medication/standard-care comparisons, prior margins, analysis populations, clinical endpoints, CIs and concurrent care are needed. No treatment-replacement, dose-reduction, device-setting or procedure instructions are created. This records needed materials; no new research was executed." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Does preregistration wording verify an event endpoint?", "needed": "NCT03266510, historical checks and nonmeasurement", "role": "Required", "role_reason": "This condition connects NCT03266510, historical checks and nonmeasurement with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.", "application_exception": "Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.", "criterion": "Material for NCT03266510, historical checks and nonmeasurement must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Registration/protocol/SAP endpoints, times, change history, DBP hierarchy/analysis plans and event design are needed. Comparison with actual prior plans remains incomplete. This records needed materials; no new research was executed." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Do harm statements establish prevention or incidence?", "needed": "Original caution statements versus actual clinical-event data", "role": "Supplementary", "role_reason": "This condition connects Original caution statements versus actual clinical-event data with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.", "application_exception": "Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.", "criterion": "Material for Original caution statements versus actual clinical-event data must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original harm definitions, collection, exposure, denominators, withdrawal, comparator, severity and long-term clinical-event material are needed. No new incidence, training or treatment instructions are created. This records needed materials; no new research was executed." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "What direct material would fill DBP/event gaps?", "needed": "Direct DBP results and sufficient clinical-event follow-up", "role": "Required", "role_reason": "This condition connects Direct DBP results and sufficient clinical-event follow-up with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.", "application_exception": "Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.", "criterion": "Material for Direct DBP results and sufficient clinical-event follow-up must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original DBP tables, clinical-event definitions, follow-up, denominators, effects, CIs, actual exposure and concurrent care for the same population/intervention/comparator are needed. Needed material is recorded without new research, calculation or regrading. This records needed materials; no new research was executed." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Are the same report, trial and participants counted twice?", "needed": "Shared parent/subclaim sheets and Craighead report", "role": "Required", "role_reason": "This condition connects Shared parent/subclaim sheets and Craighead report with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.", "application_exception": "Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.", "criterion": "Material for Shared parent/subclaim sheets and Craighead report must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Links between original reports, cohorts, analysis populations, endpoints and follow-up measurements are needed. Report/material counts are not quality scores or unique-trial counts. This records needed materials; no new research was executed." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Which materials were actually read?", "needed": "Distinguishing the stored summary from external originals", "role": "Required", "role_reason": "This condition connects Distinguishing the stored summary from external originals with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.", "application_exception": "Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.", "criterion": "Material for Distinguishing the stored summary from external originals must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Actual acquisition/reading records for originals, appendices, registration and plans are needed. No external material was newly retrieved or read here. This records needed materials; no new research was executed." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Where are bibliography and registration identifiers recorded?", "needed": "PMID, PMCID, DOI and the evidence-item NCT", "role": "Required", "role_reason": "This condition connects PMID, PMCID, DOI and the evidence-item NCT with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.", "application_exception": "Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.", "criterion": "Material for PMID, PMCID, DOI and the evidence-item NCT must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original paper-registration links, dates and content are needed. New URLs are not inferred from PMCID/NCT; original identifiers are preserved. This records needed materials; no new research was executed." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Are historical bilingual checks the current review?", "needed": "Original bilingual wording and historical verification scope", "role": "Required", "role_reason": "This condition connects Original bilingual wording and historical verification scope with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.", "application_exception": "Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.", "criterion": "Material for Original bilingual wording and historical verification scope must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Content review of originals, translation, corrections and applicability boundaries is needed. Historical checks are not labeled as current independent clinical validation. This records needed materials; no new research was executed." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Are subclaim values separated from parent scores and axes?", "needed": "Original subclaim grade/note and absent score, status and axes", "role": "Required", "role_reason": "This condition connects Original subclaim grade/note and absent score, status and axes with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.", "application_exception": "Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.", "criterion": "Material for Original subclaim grade/note and absent score, status and axes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Content review of selected-subclaim and parent original values is needed. No new score, axes, efficacy grade or verdict change is created. This records needed materials; no new research was executed." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Are the evidence date and production date distinguished?", "needed": "Original evidence date, correction and deliberation records", "role": "Required", "role_reason": "This condition connects Original evidence date, correction and deliberation records with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.", "application_exception": "Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.", "criterion": "Material for Original evidence date, correction and deliberation records must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Actual new corrections, follow-up material, complete pre-change originals and change history are needed. Existing dates and empty records are not arbitrarily filled. This records needed materials; no new research was executed." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Are public funding and company-related dimensions separated?", "needed": "Funding, product support, employee authors and analysis/reporting roles", "role": "Required", "role_reason": "This condition connects Funding, product support, employee authors and analysis/reporting roles with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.", "application_exception": "Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.", "criterion": "Material for Funding, product support, employee authors and analysis/reporting roles must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original funding, COI, device/product support, author affiliations and analysis/publication roles are needed. Parent I2 is not promoted to new independence certification. This records needed materials; no new research was executed." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Are randomization, masking, measurement and selective reporting detailed?", "needed": "Sham-controlled design, bias and prior plans", "role": "Required", "role_reason": "This condition connects Sham-controlled design, bias and prior plans with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.", "application_exception": "Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.", "criterion": "Material for Sham-controlled design, bias and prior plans must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original methods, registration, protocol, SAP, measurements, denominators and change history are needed. A design label does not certify official RoB/GRADE assessment or passed review. This records needed materials; no new research was executed." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are actual exposure, adherence and concurrent care verified?", "needed": "Study identification versus actual exposure and cointerventions", "role": "Required", "role_reason": "This condition connects Study identification versus actual exposure and cointerventions with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.", "application_exception": "Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.", "criterion": "Material for Study identification versus actual exposure and cointerventions must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original actual exposure, adherence, concurrent care, missingness and intervention deviations are needed. No new total-exposure/frequency calculations, device/breathing-training or medication-change instructions are created. This records needed materials; no new research was executed." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Are possible harms separated from observed event counts?", "needed": "Original caution statements and actual harm collection/denominators", "role": "Supplementary", "role_reason": "This condition connects Original caution statements and actual harm collection/denominators with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.", "application_exception": "Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.", "criterion": "Material for Original caution statements and actual harm collection/denominators must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original adverse-event definitions, active collection, arm-specific exposure/denominators, withdrawal, comparator and severity tables are needed. Caution is not changed into absence of harm or new safety certification. This records needed materials; no new research was executed." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Are long-term, rare harms and applicability verified?", "needed": "Six-week selected adults versus long-term harms", "role": "Supplementary", "role_reason": "This condition connects Six-week selected adults versus long-term harms with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.", "application_exception": "Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.", "criterion": "Material for Six-week selected adults versus long-term harms must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Actual long-term follow-up, diseases, eligibility, harm surveillance, exposure/risk time, arm denominators and CIs are needed. Unverified does not become safe or zero events. This records needed materials; no new research was executed." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Which materials would trigger an update?", "needed": "Separating originals, applied conditions, observations and verdict changes", "role": "Required", "role_reason": "This condition connects Separating originals, applied conditions, observations and verdict changes with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.", "application_exception": "Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.", "criterion": "Material for Separating originals, applied conditions, observations and verdict changes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Complete pre-change preservation, original/condition versions, separate application and content-review records are needed. Material updates and verdict changes are distinguished. This records needed materials; no new research was executed." } ] }