High-resistance IMST × six-week resting systolic blood pressure: evidence gaps

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Evidence conditionWhich resting systolic-pressure claim is examined?Required	The selected subclaim's original grade is C; its note records group-by-time P=.02 and an unverified adjusted between-group CI. Subclaim score, status and axes are absent and distinguished from parent C54, Caution and axes. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Selected lower resting systolic-pressure claim	Material needed: The selected SBP definition, population, time, comparator, original denominators and content review are needed. Absent subclaim fields are not filled with parent scores or axes. This records needed materials; no new research was executed.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionWhat are the original six-week resting-pressure values?Required	High-resistance IMST was 135±2 to 126±3 and low-resistance sham 134±2 to 131±3 mmHg, with group-by-time P=.02. The statistical definition of ± and exact adjusted between-group effect/CI are separately unverified. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Baseline and six-week resting SBP by arm	Material needed: Analysis denominators, baseline/follow-up values, measurement conditions, model, definition of ±, adjusted between-group estimate and 95% CI are needed. No new differences or CIs were calculated. This records needed materials; no new research was executed.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionAre 9 mmHg and 6 mmHg adjusted between-group effects?Required	The original distinguishes the high-resistance arm's 9 mmHg within-arm fall, a 6 mmHg crude difference in changes after subtracting sham, and an adjusted between-group effect. These two numbers are existing statements, not recalculated or converted into adjusted effects/CIs. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Within-arm fall, crude difference in changes and adjusted effect	Material needed: The effect of interest, model, adjustment variables, exact estimate, CI and original result table are needed. The crude difference is not promoted to independent confirmation of efficacy. This records needed materials; no new research was executed.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionDoes group-by-time P=.02 provide an exact effect and CI?Required	The resting-SBP group-by-time test is recorded as positive. P=.02 alone does not establish the exact adjusted between-group effect, 95% CI, direct contrast at an individual time point or clinical importance. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Distinguishing tests, effect estimates and precision	Material needed: The test model, interaction/direct contrast, adjusted estimate, CI, prespecified importance threshold and original denominators are needed. This records needed materials; no new research was executed.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionIs diastolic P=.17 the same result?Required	The stored summary separately records DBP interaction P=.17. Resting SBP P=.02 is not transferred to DBP success, and the null DBP finding is not converted into absence of all blood-pressure effects. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Separate resting SBP and DBP endpoints	Material needed: DBP measurement conditions, original arm values, denominators, effects, CIs, prespecified hierarchy and original analysis tables are needed. This records needed materials; no new research was executed.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionAre ambulatory and 24-hour pressure equally established?Required	The original records ambulatory SBP interaction P=.07 and states that DBP/24-hour pressure were not equally established. Resting-SBP values and P values are not copied to ambulatory, 24-hour, daytime or nighttime values. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Resting versus ambulatory measurement conditions	Material needed: Ambulatory measurement/valid time, 24-hour/day-night definitions, denominators, between-group values, CIs and detailed DBP tables are needed. P=.07 does not establish zero effect or equivalence. This records needed materials; no new research was executed.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionWas the actual control low-resistance sham?Required	The preserved study is a randomized trial against 15% low-resistance sham. It is not changed into no treatment, no breathing training or a direct comparison with blood-pressure medication. Actual control exposure, sensations, attention and masking details are unverified. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	High resistance versus 15% low-resistance sham	Material needed: Actual resistance/exposure, device, masking, concurrent care, denominators and direct contrasts by arm are needed. The effect of low resistance versus no intervention is not established. This records needed materials; no new research was executed.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionWhich middle-aged and older adults were studied?Required	The original records ages 50–79 and the bibliography describes adults with above-normal pressure. Exact eligibility, baseline medication, treatment status and comorbidity details are unverified. This is not generalized to everyone with hypertension or cardiopulmonary disease. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Ages 50–79 and above-normal blood-pressure eligibility	Material needed: Original eligibility, screening, baseline SBP, medication, sex, disease, arm baselines and subgroup denominators are needed. This records needed materials; no new research was executed.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionWhat do 38 randomized, 36 analyzed and 18 per arm mean?Required	The original records 38 randomized, 36 analyzed and 18 analyzed per arm. Completer-analysis boundaries, actual exclusion reasons and endpoint-specific denominators are separately unverified. No dropout counts or rates were newly calculated. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Allocation, analysis populations, completers and original denominators	Material needed: Arm-specific allocation, completion/analysis flow, exclusions, missingness, ITT/effect of interest and valid blood-pressure/FMD denominators are needed. This records needed materials; no new research was executed.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionWhat do the six-week training numbers identify?Required	The original records six days weekly, 30 breaths daily, six weeks, 55% maximal inspiratory pressure in week 1, 65% in week 2 and 75% thereafter, five sets of six breaths, and 15% sham. These identify the study; no new breathing methods, device settings, procedures or total exposures were created. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Study-exposure duration, frequency and resistance	Material needed: Original methods, device/resistance measurement, actual adherence/exposure, comparator and denominators are needed. Exposure numbers are preserved without becoming medication-replacement or training instructions. This records needed materials; no new research was executed.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionAre adherence and persistence after six weeks verified?Required	The original describes high adherence and results in 36 people over six weeks. Exact adherence rates/denominators and SBP persistence, maintenance or discontinuation outcomes after six weeks are not established in this summary. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Adherence statements and follow-up/persistence boundaries	Material needed: Adherence records, actual exposure, attrition, post-training follow-up duration/denominators, between-group effects and CIs are needed. No new maintenance methods or sustained effects are created. This records needed materials; no new research was executed.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionIs approximately 45% FMD an SBP or event effect?Required	The original records approximately 45% relative FMD improvement and explicitly distinguishes it from a 45-percentage-point gain. FMD is a surrogate separate from SBP and is not converted into cardiovascular-event prevention. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Relative FMD change and a separate surrogate	Material needed: Original FMD values, measurement, denominators, between-group effects, CIs, timing and actual clinical-event data are needed. No new percentage-point or risk-reduction calculations are made. This records needed materials; no new research was executed.
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionHow far are registration and prior SBP endpoints verified?Required	The original describes a preregistered trial and the evidence item contains NCT03266510. Registration, protocol and SAP remain unread in this work; exact hierarchy, changes, multiplicity and analysis plans were not newly verified. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	NCT03266510 and historical preregistration statements	Material needed: Initial registration/change dates, original protocol, SAP, SBP/DBP/ambulatory-pressure/FMD hierarchy and analysis populations are needed. Historical preregistration statements and current reading are distinguished. This records needed materials; no new research was executed.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionDoes short-term SBP establish clinical events or medication replacement?Required	The original records that cardiovascular-event prevention was not tested and cautions against extending the result to medication replacement. A six-week resting-SBP signal is not converted into myocardial-infarction/stroke counts or treatment-replacement effects. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Surrogate, cardiovascular-event and medication-replacement boundaries	Material needed: Direct clinical-event definitions, follow-up, denominators, CIs and direct medication comparisons are needed. No new risk effects or treatment-replacement instructions are created. This records needed materials; no new research was executed.
15	Unverified	Full text not readStored summary read	N15 · Evidence conditionAre clinical importance and effects in other settings verified?Required	A relatively large SBP change is the original interpretation. Exact adjusted CIs, clinical importance and equivalent effects in other populations, devices, durations or activity conditions remain unverified. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Between-group CIs, clinical importance and applicability	Material needed: Between-group estimates, CIs, prespecified importance thresholds and direct trials/exposure in the same intervention, comparator and population are needed. No new grades or independent-replication certification are created. This records needed materials; no new research was executed.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionAre the same report, trial and participants counted twice?Required	Parent 2990 and two subclaim sheets share the same Craighead 2021 bibliography/trial context. Sheets, reports, pressure/FMD endpoints and follow-up measurements do not create new independent trials/participants, and 38 randomized/36 analyzed are not added as separate people. Unique-trial and participant totals are unverified. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Shared parent/subclaim sheets and Craighead report	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.
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionWhich materials were actually read?Required	The complete stored parent-verdict summary was read. External abstracts, full text, registration, protocols and SAPs remain unread. URL, PMCID or NCT presence does not establish actual reading, access or condition fulfillment. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Distinguishing the stored summary from external originals	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.
18	Partly verified	Full text not readStored summary read	N18 · Evidence conditionWhere are bibliography and registration identifiers recorded?Required	The citation list contains PMID 34184544, PMCID PMC8403283, DOI 10.1161/JAHA.121.020980 and the original PubMed URL. NCT03266510 is in the evidence item; the citation text itself contains no registration statement. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	PMID, PMCID, DOI and the evidence-item NCT	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.
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionAre historical bilingual checks the current review?Required	Original Korean/English wording and historical statements about checking pressure, FMD, denominators and funding in reports, the primary trial and registration are preserved. Historical verification does not establish current external reading or completed clinical review. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Original bilingual wording and historical verification scope	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.
20	Partly verified	Full text not readStored summary read	N20 · Evidence conditionAre subclaim values separated from parent scores and axes?Required	Original selected grade C/note and absent subclaim score, status and axes are preserved. Parent C54, Caution, B/S/R1/I2/E+/B2 and unrecorded precision remain parent context; they do not fill subclaim scores, axes or independence certification. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Original subclaim grade/note and absent score, status and axes	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.
21	Partly verified	Full text not readStored summary read	N21 · Evidence conditionAre the evidence date and production date distinguished?Required	Original evidence date 2026-09-07, empty corrections array and empty deliberation string are retained. This is not the current production/review date or certification that no external corrections exist. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Original evidence date, correction and deliberation records	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.
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionAre public funding and company-related dimensions separated?Required	Original funding records public/nonprofit support including NIH and the American Heart Association. This does not separately verify device/product support, company-employee authors or company involvement in analysis/reporting. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Funding, product support, employee authors and analysis/reporting roles	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.
23	Unverified	Full text not readStored summary read	N23 · Evidence conditionAre randomization, masking, measurement and selective reporting detailed?Required	The original design is randomized with low-resistance sham control. Allocation concealment, participant/assessor masking, pressure/FMD measurements, missingness and selective-reporting details are separately unverified. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Sham-controlled design, bias and prior plans	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.
24	Partly verified	Full text not readStored summary read	N24 · Evidence conditionAre actual exposure, adherence and concurrent care verified?Required	Original exposure and directional adherence statements remain study-identification context. Actual breathing/resistance exposure, intervention deviations, baseline/follow-up medication, diet/activity changes and detailed denominators are unverified. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Study identification versus actual exposure and cointerventions	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.
25	Unverified	Full text not readStored summary read	N25 · Evidence conditionAre possible harms separated from observed event counts?Supplementary	The original describes possible neck discomfort/dizziness and boundaries for certain cardiopulmonary conditions/symptoms. Possibilities do not all establish observed events; counts, incidence, collection methods, exposure denominators and CIs are unverified. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Original caution statements and actual harm collection/denominators	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.
26	Unverified	Full text not readStored summary read	N26 · Evidence conditionAre long-term, rare harms and applicability verified?Supplementary	A six-week completer pressure study is not extended to rare-harm rates, long-term events or safety of medication replacement. Original boundaries concerning cardiopulmonary disease, chest pain and presyncope are existing statements, not new treatment decisions or procedures. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Six-week selected adults versus long-term harms	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.
27	Partly verified	Full text not readStored summary read	N27 · Evidence conditionWhich materials would trigger an update?Required	This sheet organizes stored material concerning resting SBP. Related observations can be updated after content review of original reports, between-group effects, denominators, prior plans, endpoints, times, follow-up, support and harm data. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Separating originals, applied conditions, observations and verdict changes	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.

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27 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-09-07
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population: Middle-aged and older adults aged 50–79 with above-normal pressure. The original records 38 randomized, 36 analyzed and 18 analyzed per arm. Exact eligibility, baseline medication, disease, endpoint denominators and missingness are unverified. Allocation and analysis counts are not added as separate people.
Ingredient, formulation and route: High-resistance inspiratory muscle strength training (IMST) in the original study. This identifies preserved exposure without personal procedures, device settings, treatment decisions or medication-replacement advice. Actual exposure, adherence and concurrent-care details are unverified.
Dose: Original six days weekly, 30 breaths daily, six weeks, 55% maximal inspiratory pressure in week 1, 65% in week 2, 75% thereafter and five sets of six breaths are preserved only to identify the study. No new total-exposure, frequency or individual-resistance calculations or training instructions are created.
Comparator: Low-resistance 15% sham. This is not no intervention, no breathing training or a direct medication comparison. Actual control exposure, masking, sensations/attention, concurrent care and direct-contrast details are unverified.
Measured outcome: The selected endpoint is six-week resting SBP. Original 135±2 to 126±3 versus 134±2 to 131±3 mmHg and group-by-time P=.02 are retained. Definition of ±, exact adjusted between-group effect and 95% CI are unverified. DBP P=.17, ambulatory SBP P=.07, approximately 45% relative FMD change and unmeasured cardiovascular events are distinguished.
Duration: Short-term results after six weeks of training and pressure measurement. Post-training persistence, actual long-term follow-up, rare harms, cardiovascular events and medication-replacement effects are unverified. Follow-up details, sustained effects and long-term safety are not newly filled.
Questions outside this scope: Certifying the 9 mmHg within-arm fall, 6 mmHg crude difference or P=.02 as an adjusted between-group effect, 95% CI or clinical importance; Transferring resting-SBP signals to equivalent DBP/ambulatory or 24-hour-pressure effects, FMD percentage points or cardiovascular-event prevention; Converting null DBP, ambulatory P=.07 and unmeasured events together into zero effects, equivalence or safety; Adding 38 randomized, 36 analyzed, 18 per arm, multiple endpoints or two subclaim sheets as new independent trials, participants or replications; Inheriting parent C54, Caution, axes or historical checks as subclaim scores, current clinical review or independence certification; Creating new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training, medication changes or treatment-replacement instructions

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

R01 · Craighead DH, Heinbockel TC, Freeberg KA, et al. Time-Efficient Inspiratory Muscle Strength Training Lowers Blood Pressure and Improves Endothelial Function, NO Bioavailability, and Oxidative Stress in Midlife/Older Adults With Above-Normal Blood Pressure. J Am Heart Assoc. 2021;10:e020980. PMID: 34184544. PMCID: PMC8403283. DOI: 10.1161/JAHA.121.020980.

PubMed

Material type: Low-resistance sham-controlled randomized trial
Materials actually read: Stored summary read; external paper, registration, protocols, SAPs and support disclosures unread
Findings recorded in the stored summary: SBP 135±2 to 126±3 versus 134±2 to 131±3 mmHg; group-by-time P=.02
Record level: Stored-summary six-week resting-SBP results. The 9 mmHg within-arm fall and 6 mmHg crude difference are existing statements; adjusted between-group effects, 95% CIs and definition of ± are unverified. DBP, ambulatory pressure, FMD, unmeasured cardiovascular events and harms remain separate.
Study overlap and independent replication: The single Craighead 2021 report, parent 2990 and two subclaim sheets share the same trial/population context. The 38 randomized, 36 analyzed, 18 per arm, pressure/FMD endpoints and follow-up measurements are not added as new independent trials, participants or replications. Confirmed unique-trial, participant and independent-replication totals remain unrecorded.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
local_summary	Preserved copy of the complete parent-verdict stored summary	Existing stored review summary read	Summary read	Original PubMed URL, PMID 34184544, PMCID PMC8403283, DOI 10.1161/JAHA.121.020980 and evidence-item NCT03266510 are preserved. The citation text itself has no registration statement. Identifiers alone do not certify current reading, acquisition, prior plans or condition fulfillment, and new URLs are not inferred.
abstract	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 34184544, PMCID PMC8403283, DOI 10.1161/JAHA.121.020980 and evidence-item NCT03266510 are preserved. The citation text itself has no registration statement. Identifiers alone do not certify current reading, acquisition, prior plans or condition fulfillment, and new URLs are not inferred.
fulltext	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 34184544, PMCID PMC8403283, DOI 10.1161/JAHA.121.020980 and evidence-item NCT03266510 are preserved. The citation text itself has no registration statement. Identifiers alone do not certify current reading, acquisition, prior plans or condition fulfillment, and new URLs are not inferred.
registration	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 34184544, PMCID PMC8403283, DOI 10.1161/JAHA.121.020980 and evidence-item NCT03266510 are preserved. The citation text itself has no registration statement. Identifiers alone do not certify current reading, acquisition, prior plans or condition fulfillment, and new URLs are not inferred.
protocol	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 34184544, PMCID PMC8403283, DOI 10.1161/JAHA.121.020980 and evidence-item NCT03266510 are preserved. The citation text itself has no registration statement. Identifiers alone do not certify current reading, acquisition, prior plans or condition fulfillment, and new URLs are not inferred.

Report counts versus independent study counts

The single Craighead 2021 report, parent 2990 and two subclaim sheets share the same trial/population context. The 38 randomized, 36 analyzed, 18 per arm, pressure/FMD endpoints and follow-up measurements are not added as new independent trials, participants or replications. Confirmed unique-trial, participant and independent-replication totals remain unrecorded.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Which resting systolic-pressure claim is examined?

Required materials and conditions: Selected lower resting systolic-pressure claim
Conditions for verification: Material for Selected lower resting systolic-pressure claim must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Selected lower resting systolic-pressure claim with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N02 · What are the original six-week resting-pressure values?

Required materials and conditions: Baseline and six-week resting SBP by arm
Conditions for verification: Material for Baseline and six-week resting SBP by arm must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Baseline and six-week resting SBP by arm with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N03 · Are 9 mmHg and 6 mmHg adjusted between-group effects?

Required materials and conditions: Within-arm fall, crude difference in changes and adjusted effect
Conditions for verification: Material for Within-arm fall, crude difference in changes and adjusted effect must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Within-arm fall, crude difference in changes and adjusted effect with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N04 · Does group-by-time P=.02 provide an exact effect and CI?

Required materials and conditions: Distinguishing tests, effect estimates and precision
Conditions for verification: Material for Distinguishing tests, effect estimates 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.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Distinguishing tests, effect estimates and precision with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N05 · Is diastolic P=.17 the same result?

Required materials and conditions: Separate resting SBP and DBP endpoints
Conditions for verification: Material for Separate resting SBP and 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.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Separate resting SBP and DBP endpoints with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N06 · Are ambulatory and 24-hour pressure equally established?

Required materials and conditions: Resting versus ambulatory measurement conditions
Conditions for verification: Material for Resting versus ambulatory measurement conditions must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Resting versus ambulatory measurement conditions with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N07 · Was the actual control low-resistance sham?

Required materials and conditions: High resistance versus 15% low-resistance sham
Conditions for verification: Material for High resistance versus 15% low-resistance sham must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects High resistance versus 15% low-resistance sham with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N08 · Which middle-aged and older adults were studied?

Required materials and conditions: Ages 50–79 and above-normal blood-pressure eligibility
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Ages 50–79 and above-normal blood-pressure eligibility with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N09 · What do 38 randomized, 36 analyzed and 18 per arm mean?

Required materials and conditions: Allocation, analysis populations, completers and original denominators
Conditions for verification: Material for Allocation, analysis populations, completers and original denominators must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Allocation, analysis populations, completers and original denominators with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N10 · What do the six-week training numbers identify?

Required materials and conditions: Study-exposure duration, frequency and resistance
Conditions for verification: Material for Study-exposure duration, frequency and resistance must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Study-exposure duration, frequency and resistance with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N11 · Are adherence and persistence after six weeks verified?

Required materials and conditions: Adherence statements and follow-up/persistence boundaries
Conditions for verification: Material for Adherence statements and follow-up/persistence boundaries must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Adherence statements and follow-up/persistence boundaries with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N12 · Is approximately 45% FMD an SBP or event effect?

Required materials and conditions: Relative FMD change and a separate surrogate
Conditions for verification: Material for Relative FMD change and a separate surrogate must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Relative FMD change and a separate surrogate with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N13 · How far are registration and prior SBP endpoints verified?

Required materials and conditions: NCT03266510 and historical preregistration statements
Conditions for verification: Material for NCT03266510 and historical preregistration statements must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects NCT03266510 and historical preregistration statements with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N14 · Does short-term SBP establish clinical events or medication replacement?

Required materials and conditions: Surrogate, cardiovascular-event and medication-replacement boundaries
Conditions for verification: Material for Surrogate, cardiovascular-event and medication-replacement boundaries must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Surrogate, cardiovascular-event and medication-replacement boundaries with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N15 · Are clinical importance and effects in other settings verified?

Required materials and conditions: Between-group CIs, clinical importance and applicability
Conditions for verification: Material for Between-group CIs, clinical importance and applicability must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Between-group CIs, clinical importance and applicability with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N16 · Are the same report, trial and participants counted twice?

Required materials and conditions: Shared parent/subclaim sheets and Craighead report
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Shared parent/subclaim sheets and Craighead report with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N17 · Which materials were actually read?

Required materials and conditions: Distinguishing the stored summary from external originals
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Distinguishing the stored summary from external originals with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N18 · Where are bibliography and registration identifiers recorded?

Required materials and conditions: PMID, PMCID, DOI and the evidence-item NCT
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects PMID, PMCID, DOI and the evidence-item NCT with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N19 · Are historical bilingual checks the current review?

Required materials and conditions: Original bilingual wording and historical verification scope
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Original bilingual wording and historical verification scope with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N20 · Are subclaim values separated from parent scores and axes?

Required materials and conditions: Original subclaim grade/note and absent score, status and axes
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Original subclaim grade/note and absent score, status and axes with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N21 · Are the evidence date and production date distinguished?

Required materials and conditions: Original evidence date, correction and deliberation records
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Original evidence date, correction and deliberation records with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N22 · Are public funding and company-related dimensions separated?

Required materials and conditions: Funding, product support, employee authors and analysis/reporting roles
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Funding, product support, employee authors and analysis/reporting roles with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N23 · Are randomization, masking, measurement and selective reporting detailed?

Required materials and conditions: Sham-controlled design, bias and prior plans
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Sham-controlled design, bias and prior plans with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N24 · Are actual exposure, adherence and concurrent care verified?

Required materials and conditions: Study identification versus actual exposure and cointerventions
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Study identification versus actual exposure and cointerventions with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N25 · Are possible harms separated from observed event counts?

Required materials and conditions: Original caution statements and actual harm collection/denominators
Conditions for verification: 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.
Requirement and applicability: Supplementary
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Original caution statements and actual harm collection/denominators with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N26 · Are long-term, rare harms and applicability verified?

Required materials and conditions: Six-week selected adults versus long-term harms
Conditions for verification: 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.
Requirement and applicability: Supplementary
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Six-week selected adults versus long-term harms with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N27 · Which materials would trigger an update?

Required materials and conditions: Separating originals, applied conditions, observations and verdict changes
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Separating originals, applied conditions, observations and verdict changes with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Preserved methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Preserved methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Preserved methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Preserved methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Preserved methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited

What the statuses mean

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

Change history

2026-10-16 · Public page/material version 1.0

Public pages and materials were prepared from the existing 27 items. No new clinical search, verification-status change or scoring was performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-09-07) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · Which resting systolic-pressure claim is examined?

Current findings: The selected subclaim's original grade is C; its note records group-by-time P=.02 and an unverified adjusted between-group CI. Subclaim score, status and axes are absent and distinguished from parent C54, Caution and axes.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: The selected SBP definition, population, time, comparator, original denominators and content review are needed. Absent subclaim fields are not filled with parent scores or axes.
Required materials and conditions: Selected lower resting systolic-pressure claim
Materials to obtain first: The selected SBP definition, population, time, comparator, original denominators and content review are needed. Absent subclaim fields are not filled with parent scores or axes.
Further research: Material needed: The selected SBP definition, population, time, comparator, original denominators and content review are needed. Absent subclaim fields are not filled with parent scores or axes. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Selected lower resting systolic-pressure claim must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Selected lower resting systolic-pressure claim with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N02 · What are the original six-week resting-pressure values?

Current findings: High-resistance IMST was 135±2 to 126±3 and low-resistance sham 134±2 to 131±3 mmHg, with group-by-time P=.02. The statistical definition of ± and exact adjusted between-group effect/CI are separately unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Analysis denominators, baseline/follow-up values, measurement conditions, model, definition of ±, adjusted between-group estimate and 95% CI are needed. No new differences or CIs were calculated.
Required materials and conditions: Baseline and six-week resting SBP by arm
Materials to obtain first: Analysis denominators, baseline/follow-up values, measurement conditions, model, definition of ±, adjusted between-group estimate and 95% CI are needed. No new differences or CIs were calculated.
Further research: Material needed: Analysis denominators, baseline/follow-up values, measurement conditions, model, definition of ±, adjusted between-group estimate and 95% CI are needed. No new differences or CIs were calculated. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Baseline and six-week resting SBP by arm must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Baseline and six-week resting SBP by arm with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N03 · Are 9 mmHg and 6 mmHg adjusted between-group effects?

Current findings: The original distinguishes the high-resistance arm's 9 mmHg within-arm fall, a 6 mmHg crude difference in changes after subtracting sham, and an adjusted between-group effect. These two numbers are existing statements, not recalculated or converted into adjusted effects/CIs.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: The effect of interest, model, adjustment variables, exact estimate, CI and original result table are needed. The crude difference is not promoted to independent confirmation of efficacy.
Required materials and conditions: Within-arm fall, crude difference in changes and adjusted effect
Materials to obtain first: The effect of interest, model, adjustment variables, exact estimate, CI and original result table are needed. The crude difference is not promoted to independent confirmation of efficacy.
Further research: Material needed: The effect of interest, model, adjustment variables, exact estimate, CI and original result table are needed. The crude difference is not promoted to independent confirmation of efficacy. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Within-arm fall, crude difference in changes and adjusted effect must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Within-arm fall, crude difference in changes and adjusted effect with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N04 · Does group-by-time P=.02 provide an exact effect and CI?

Current findings: The resting-SBP group-by-time test is recorded as positive. P=.02 alone does not establish the exact adjusted between-group effect, 95% CI, direct contrast at an individual time point or clinical importance.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: The test model, interaction/direct contrast, adjusted estimate, CI, prespecified importance threshold and original denominators are needed.
Required materials and conditions: Distinguishing tests, effect estimates and precision
Materials to obtain first: The test model, interaction/direct contrast, adjusted estimate, CI, prespecified importance threshold and original denominators are needed.
Further research: Material needed: The test model, interaction/direct contrast, adjusted estimate, CI, prespecified importance threshold and original denominators are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Distinguishing tests, effect estimates 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.
Why this condition is needed: This condition connects Distinguishing tests, effect estimates and precision with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N05 · Is diastolic P=.17 the same result?

Current findings: The stored summary separately records DBP interaction P=.17. Resting SBP P=.02 is not transferred to DBP success, and the null DBP finding is not converted into absence of all blood-pressure effects.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: DBP measurement conditions, original arm values, denominators, effects, CIs, prespecified hierarchy and original analysis tables are needed.
Required materials and conditions: Separate resting SBP and DBP endpoints
Materials to obtain first: DBP measurement conditions, original arm values, denominators, effects, CIs, prespecified hierarchy and original analysis tables are needed.
Further research: Material needed: DBP measurement conditions, original arm values, denominators, effects, CIs, prespecified hierarchy and original analysis tables are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Separate resting SBP and 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.
Why this condition is needed: This condition connects Separate resting SBP and DBP endpoints with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N06 · Are ambulatory and 24-hour pressure equally established?

Current findings: The original records ambulatory SBP interaction P=.07 and states that DBP/24-hour pressure were not equally established. Resting-SBP values and P values are not copied to ambulatory, 24-hour, daytime or nighttime values.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Ambulatory measurement/valid time, 24-hour/day-night definitions, denominators, between-group values, CIs and detailed DBP tables are needed. P=.07 does not establish zero effect or equivalence.
Required materials and conditions: Resting versus ambulatory measurement conditions
Materials to obtain first: Ambulatory measurement/valid time, 24-hour/day-night definitions, denominators, between-group values, CIs and detailed DBP tables are needed. P=.07 does not establish zero effect or equivalence.
Further research: Material needed: Ambulatory measurement/valid time, 24-hour/day-night definitions, denominators, between-group values, CIs and detailed DBP tables are needed. P=.07 does not establish zero effect or equivalence. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Resting versus ambulatory measurement conditions must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Resting versus ambulatory measurement conditions with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N07 · Was the actual control low-resistance sham?

Current findings: The preserved study is a randomized trial against 15% low-resistance sham. It is not changed into no treatment, no breathing training or a direct comparison with blood-pressure medication. Actual control exposure, sensations, attention and masking details are unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Actual resistance/exposure, device, masking, concurrent care, denominators and direct contrasts by arm are needed. The effect of low resistance versus no intervention is not established.
Required materials and conditions: High resistance versus 15% low-resistance sham
Materials to obtain first: Actual resistance/exposure, device, masking, concurrent care, denominators and direct contrasts by arm are needed. The effect of low resistance versus no intervention is not established.
Further research: Material needed: Actual resistance/exposure, device, masking, concurrent care, denominators and direct contrasts by arm are needed. The effect of low resistance versus no intervention is not established. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for High resistance versus 15% low-resistance sham must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects High resistance versus 15% low-resistance sham with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N08 · Which middle-aged and older adults were studied?

Current findings: The original records ages 50–79 and the bibliography describes adults with above-normal pressure. Exact eligibility, baseline medication, treatment status and comorbidity details are unverified. This is not generalized to everyone with hypertension or cardiopulmonary disease.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Original eligibility, screening, baseline SBP, medication, sex, disease, arm baselines and subgroup denominators are needed.
Required materials and conditions: Ages 50–79 and above-normal blood-pressure eligibility
Materials to obtain first: Original eligibility, screening, baseline SBP, medication, sex, disease, arm baselines and subgroup denominators are needed.
Further research: Material needed: Original eligibility, screening, baseline SBP, medication, sex, disease, arm baselines and subgroup denominators are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: 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.
Why this condition is needed: This condition connects Ages 50–79 and above-normal blood-pressure eligibility with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N09 · What do 38 randomized, 36 analyzed and 18 per arm mean?

Current findings: The original records 38 randomized, 36 analyzed and 18 analyzed per arm. Completer-analysis boundaries, actual exclusion reasons and endpoint-specific denominators are separately unverified. No dropout counts or rates were newly calculated.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Arm-specific allocation, completion/analysis flow, exclusions, missingness, ITT/effect of interest and valid blood-pressure/FMD denominators are needed.
Required materials and conditions: Allocation, analysis populations, completers and original denominators
Materials to obtain first: Arm-specific allocation, completion/analysis flow, exclusions, missingness, ITT/effect of interest and valid blood-pressure/FMD denominators are needed.
Further research: Material needed: Arm-specific allocation, completion/analysis flow, exclusions, missingness, ITT/effect of interest and valid blood-pressure/FMD denominators are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Allocation, analysis populations, completers and original denominators must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Allocation, analysis populations, completers and original denominators with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N10 · What do the six-week training numbers identify?

Current findings: The original records six days weekly, 30 breaths daily, six weeks, 55% maximal inspiratory pressure in week 1, 65% in week 2 and 75% thereafter, five sets of six breaths, and 15% sham. These identify the study; no new breathing methods, device settings, procedures or total exposures were created.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Original methods, device/resistance measurement, actual adherence/exposure, comparator and denominators are needed. Exposure numbers are preserved without becoming medication-replacement or training instructions.
Required materials and conditions: Study-exposure duration, frequency and resistance
Materials to obtain first: Original methods, device/resistance measurement, actual adherence/exposure, comparator and denominators are needed. Exposure numbers are preserved without becoming medication-replacement or training instructions.
Further research: Material needed: Original methods, device/resistance measurement, actual adherence/exposure, comparator and denominators are needed. Exposure numbers are preserved without becoming medication-replacement or training instructions. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Study-exposure duration, frequency and resistance must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Study-exposure duration, frequency and resistance with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N11 · Are adherence and persistence after six weeks verified?

Current findings: The original describes high adherence and results in 36 people over six weeks. Exact adherence rates/denominators and SBP persistence, maintenance or discontinuation outcomes after six weeks are not established in this summary.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Adherence records, actual exposure, attrition, post-training follow-up duration/denominators, between-group effects and CIs are needed. No new maintenance methods or sustained effects are created.
Required materials and conditions: Adherence statements and follow-up/persistence boundaries
Materials to obtain first: Adherence records, actual exposure, attrition, post-training follow-up duration/denominators, between-group effects and CIs are needed. No new maintenance methods or sustained effects are created.
Further research: Material needed: Adherence records, actual exposure, attrition, post-training follow-up duration/denominators, between-group effects and CIs are needed. No new maintenance methods or sustained effects are created. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Adherence statements and follow-up/persistence boundaries must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Adherence statements and follow-up/persistence boundaries with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N12 · Is approximately 45% FMD an SBP or event effect?

Current findings: The original records approximately 45% relative FMD improvement and explicitly distinguishes it from a 45-percentage-point gain. FMD is a surrogate separate from SBP and is not converted into cardiovascular-event prevention.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Original FMD values, measurement, denominators, between-group effects, CIs, timing and actual clinical-event data are needed. No new percentage-point or risk-reduction calculations are made.
Required materials and conditions: Relative FMD change and a separate surrogate
Materials to obtain first: Original FMD values, measurement, denominators, between-group effects, CIs, timing and actual clinical-event data are needed. No new percentage-point or risk-reduction calculations are made.
Further research: Material needed: Original FMD values, measurement, denominators, between-group effects, CIs, timing and actual clinical-event data are needed. No new percentage-point or risk-reduction calculations are made. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Relative FMD change and a separate surrogate must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Relative FMD change and a separate surrogate with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N13 · How far are registration and prior SBP endpoints verified?

Current findings: The original describes a preregistered trial and the evidence item contains NCT03266510. Registration, protocol and SAP remain unread in this work; exact hierarchy, changes, multiplicity and analysis plans were not newly verified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Initial registration/change dates, original protocol, SAP, SBP/DBP/ambulatory-pressure/FMD hierarchy and analysis populations are needed. Historical preregistration statements and current reading are distinguished.
Required materials and conditions: NCT03266510 and historical preregistration statements
Materials to obtain first: Initial registration/change dates, original protocol, SAP, SBP/DBP/ambulatory-pressure/FMD hierarchy and analysis populations are needed. Historical preregistration statements and current reading are distinguished.
Further research: Material needed: Initial registration/change dates, original protocol, SAP, SBP/DBP/ambulatory-pressure/FMD hierarchy and analysis populations are needed. Historical preregistration statements and current reading are distinguished. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for NCT03266510 and historical preregistration statements must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects NCT03266510 and historical preregistration statements with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N14 · Does short-term SBP establish clinical events or medication replacement?

Current findings: The original records that cardiovascular-event prevention was not tested and cautions against extending the result to medication replacement. A six-week resting-SBP signal is not converted into myocardial-infarction/stroke counts or treatment-replacement effects.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Direct clinical-event definitions, follow-up, denominators, CIs and direct medication comparisons are needed. No new risk effects or treatment-replacement instructions are created.
Required materials and conditions: Surrogate, cardiovascular-event and medication-replacement boundaries
Materials to obtain first: Direct clinical-event definitions, follow-up, denominators, CIs and direct medication comparisons are needed. No new risk effects or treatment-replacement instructions are created.
Further research: Material needed: Direct clinical-event definitions, follow-up, denominators, CIs and direct medication comparisons are needed. No new risk effects or treatment-replacement instructions are created. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Surrogate, cardiovascular-event and medication-replacement boundaries must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Surrogate, cardiovascular-event and medication-replacement boundaries with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N15 · Are clinical importance and effects in other settings verified?

Current findings: A relatively large SBP change is the original interpretation. Exact adjusted CIs, clinical importance and equivalent effects in other populations, devices, durations or activity conditions remain unverified.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Between-group estimates, CIs, prespecified importance thresholds and direct trials/exposure in the same intervention, comparator and population are needed. No new grades or independent-replication certification are created.
Required materials and conditions: Between-group CIs, clinical importance and applicability
Materials to obtain first: Between-group estimates, CIs, prespecified importance thresholds and direct trials/exposure in the same intervention, comparator and population are needed. No new grades or independent-replication certification are created.
Further research: Material needed: Between-group estimates, CIs, prespecified importance thresholds and direct trials/exposure in the same intervention, comparator and population are needed. No new grades or independent-replication certification are created. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Between-group CIs, clinical importance and applicability must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Between-group CIs, clinical importance and applicability with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N16 · Are the same report, trial and participants counted twice?

Current findings: Parent 2990 and two subclaim sheets share the same Craighead 2021 bibliography/trial context. Sheets, reports, pressure/FMD endpoints and follow-up measurements do not create new independent trials/participants, and 38 randomized/36 analyzed are not added as separate people. Unique-trial and participant totals are unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: 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.
Required materials and conditions: Shared parent/subclaim sheets and Craighead report
Materials to obtain first: 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.
Further 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.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: 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.
Why this condition is needed: This condition connects Shared parent/subclaim sheets and Craighead report with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N17 · Which materials were actually read?

Current findings: The complete stored parent-verdict summary was read. External abstracts, full text, registration, protocols and SAPs remain unread. URL, PMCID or NCT presence does not establish actual reading, access or condition fulfillment.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Actual acquisition/reading records for originals, appendices, registration and plans are needed. No external material was newly retrieved or read here.
Required materials and conditions: Distinguishing the stored summary from external originals
Materials to obtain first: Actual acquisition/reading records for originals, appendices, registration and plans are needed. No external material was newly retrieved or read here.
Further 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.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: 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.
Why this condition is needed: This condition connects Distinguishing the stored summary from external originals with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N18 · Where are bibliography and registration identifiers recorded?

Current findings: The citation list contains PMID 34184544, PMCID PMC8403283, DOI 10.1161/JAHA.121.020980 and the original PubMed URL. NCT03266510 is in the evidence item; the citation text itself contains no registration statement.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Original paper-registration links, dates and content are needed. New URLs are not inferred from PMCID/NCT; original identifiers are preserved.
Required materials and conditions: PMID, PMCID, DOI and the evidence-item NCT
Materials to obtain first: Original paper-registration links, dates and content are needed. New URLs are not inferred from PMCID/NCT; original identifiers are preserved.
Further 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.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: 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.
Why this condition is needed: This condition connects PMID, PMCID, DOI and the evidence-item NCT with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N19 · Are historical bilingual checks the current review?

Current findings: Original Korean/English wording and historical statements about checking pressure, FMD, denominators and funding in reports, the primary trial and registration are preserved. Historical verification does not establish current external reading or completed clinical review.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Content review of originals, translation, corrections and applicability boundaries is needed. Historical checks are not labeled as current independent clinical validation.
Required materials and conditions: Original bilingual wording and historical verification scope
Materials to obtain first: Content review of originals, translation, corrections and applicability boundaries is needed. Historical checks are not labeled as current independent clinical validation.
Further 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.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: 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.
Why this condition is needed: This condition connects Original bilingual wording and historical verification scope with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N20 · Are subclaim values separated from parent scores and axes?

Current findings: Original selected grade C/note and absent subclaim score, status and axes are preserved. Parent C54, Caution, B/S/R1/I2/E+/B2 and unrecorded precision remain parent context; they do not fill subclaim scores, axes or independence certification.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Content review of selected-subclaim and parent original values is needed. No new score, axes, efficacy grade or verdict change is created.
Required materials and conditions: Original subclaim grade/note and absent score, status and axes
Materials to obtain first: Content review of selected-subclaim and parent original values is needed. No new score, axes, efficacy grade or verdict change is created.
Further 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.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: 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.
Why this condition is needed: This condition connects Original subclaim grade/note and absent score, status and axes with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N21 · Are the evidence date and production date distinguished?

Current findings: Original evidence date 2026-09-07, empty corrections array and empty deliberation string are retained. This is not the current production/review date or certification that no external corrections exist.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Actual new corrections, follow-up material, complete pre-change originals and change history are needed. Existing dates and empty records are not arbitrarily filled.
Required materials and conditions: Original evidence date, correction and deliberation records
Materials to obtain first: Actual new corrections, follow-up material, complete pre-change originals and change history are needed. Existing dates and empty records are not arbitrarily filled.
Further 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.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: 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.
Why this condition is needed: This condition connects Original evidence date, correction and deliberation records with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N22 · Are public funding and company-related dimensions separated?

Current findings: Original funding records public/nonprofit support including NIH and the American Heart Association. This does not separately verify device/product support, company-employee authors or company involvement in analysis/reporting.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Original funding, COI, device/product support, author affiliations and analysis/publication roles are needed. Parent I2 is not promoted to new independence certification.
Required materials and conditions: Funding, product support, employee authors and analysis/reporting roles
Materials to obtain first: Original funding, COI, device/product support, author affiliations and analysis/publication roles are needed. Parent I2 is not promoted to new independence certification.
Further 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.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: 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.
Why this condition is needed: This condition connects Funding, product support, employee authors and analysis/reporting roles with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N23 · Are randomization, masking, measurement and selective reporting detailed?

Current findings: The original design is randomized with low-resistance sham control. Allocation concealment, participant/assessor masking, pressure/FMD measurements, missingness and selective-reporting details are separately unverified.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: 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.
Required materials and conditions: Sham-controlled design, bias and prior plans
Materials to obtain first: 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.
Further 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.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: 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.
Why this condition is needed: This condition connects Sham-controlled design, bias and prior plans with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N24 · Are actual exposure, adherence and concurrent care verified?

Current findings: Original exposure and directional adherence statements remain study-identification context. Actual breathing/resistance exposure, intervention deviations, baseline/follow-up medication, diet/activity changes and detailed denominators are unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: 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.
Required materials and conditions: Study identification versus actual exposure and cointerventions
Materials to obtain first: 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.
Further 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.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: 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.
Why this condition is needed: This condition connects Study identification versus actual exposure and cointerventions with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N25 · Are possible harms separated from observed event counts?

Current findings: The original describes possible neck discomfort/dizziness and boundaries for certain cardiopulmonary conditions/symptoms. Possibilities do not all establish observed events; counts, incidence, collection methods, exposure denominators and CIs are unverified.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: 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.
Required materials and conditions: Original caution statements and actual harm collection/denominators
Materials to obtain first: 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.
Further 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.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: 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.
Why this condition is needed: This condition connects Original caution statements and actual harm collection/denominators with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N26 · Are long-term, rare harms and applicability verified?

Current findings: A six-week completer pressure study is not extended to rare-harm rates, long-term events or safety of medication replacement. Original boundaries concerning cardiopulmonary disease, chest pain and presyncope are existing statements, not new treatment decisions or procedures.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: 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.
Required materials and conditions: Six-week selected adults versus long-term harms
Materials to obtain first: 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.
Further 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.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: 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.
Why this condition is needed: This condition connects Six-week selected adults versus long-term harms with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N27 · Which materials would trigger an update?

Current findings: This sheet organizes stored material concerning resting SBP. Related observations can be updated after content review of original reports, between-group effects, denominators, prior plans, endpoints, times, follow-up, support and harm data.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Complete pre-change preservation, original/condition versions, separate application and content-review records are needed. Material updates and verdict changes are distinguished.
Required materials and conditions: Separating originals, applied conditions, observations and verdict changes
Materials to obtain first: Complete pre-change preservation, original/condition versions, separate application and content-review records are needed. Material updates and verdict changes are distinguished.
Further 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.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: 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.
Why this condition is needed: This condition connects Separating originals, applied conditions, observations and verdict changes with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01