This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Blood Pressure Checks for Diagnosing Hypertension (BP-CHECK) (NCT03130257), a randomized na study. The primary outcome is Comparative Performance of Clinic, Home, and Kiosk.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03130257 |
| Phase | NA |
| Condition | Blood Pressure |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 510 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Kaiser Permanente |
| Results posted | Yes |
2. Clinical Question
Population
Adults ages 18 to 85 with high blood pressure at a screening visit after high blood pressure at their last clinic visit. The primary analysis population was narrower: participants who completed 14 or more daytime 24-hour blood pressure measurements and at least one measurement according to their randomization group.
Intervention
One of three blood pressure measurement approaches: a clinic measurement, measurements taken at home, or measurements taken at a kiosk. The home and kiosk schedules extended over three weeks.
Comparator
Twenty-four-hour ambulatory blood pressure monitoring, designated as the reference standard. The monitor takes measurements during both daytime and nighttime periods.
Primary question
How do mean systolic and diastolic blood pressure measurements from clinic, home, and kiosk approaches compare with measurements from 24-hour ambulatory monitoring for evaluating new hypertension diagnoses?
This is a diagnostic-method comparison, not a trial of a blood pressure treatment. Its focus is how blood pressure values from different measurement settings relate to the reference-standard measurements. The registry describes comparison of mean systolic and diastolic blood pressure; it does not state that the primary question is whether one measurement strategy changes health outcomes.
The clinical context is that high clinic readings may not reflect blood pressure outside the clinic. The registry summary describes this as white-coat hypertension and notes that home and kiosk measurements may offer alternatives to clinic measurements. The study's central question is therefore whether the measurement setting is associated with differences in recorded blood pressure when assessed against ambulatory monitoring.
Although the study was designed around possible new hypertension diagnoses, the registered primary outcome is differences in mean blood pressure, in millimeters of mercury. The registry record does not report the resulting means or differences, so it does not establish how closely any of the three approaches matched the reference standard in the observed participants.
3. Trial Design
BP-CHECK is a randomized, parallel-group diagnostic study listed as completed. The registry record reports enrollment of 510 participants and identifies three randomized measurement groups: clinic, home, and kiosk blood pressure measurement. The study was unmasked. The listed phase is not applicable.
Participants assigned to clinic measurement were asked to have their blood pressure checked at their clinic once within the subsequent three weeks. The home group received a validated upper-arm monitor and was asked to take two measurements in the morning and two in the evening for at least 5 days over three weeks. The kiosk group was asked to use a validated kiosk at a clinic or local pharmacy, measuring blood pressure three times on three separate days over three weeks.
Twenty-four-hour ambulatory blood pressure monitoring was designated as the reference standard. The registry summary describes an arm cuff and monitor worn for 24 hours, with measurements every 30 minutes during the day and every 60 minutes at night. The primary outcome timeframe is randomization to three weeks.
Random allocation can help balance participant characteristics across groups on average, supporting comparisons between assigned measurement approaches. In a parallel design, participants are assigned to a group rather than cycling through the randomized groups. The registry record does not report the randomization procedure, allocation concealment, or additional details about how the monitoring measurements were scheduled alongside each assigned approach.
The registry record gives an enrollment total, but it does not report the number randomized to each group as part of the trial design information. It also does not report a protocol-based sample-size justification or the planned method for estimating differences. The registry identifies Kaiser Permanente as sponsor. The study start and primary completion dates are recorded as 2017-05-11 and 2019-08-26.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Clinic Blood Pressure Measurement | Home Blood Pressure Measurement | Kiosk Blood Pressure Measurement |
|---|---|---|---|
| STARTED | 172 | 170 | 168 |
| COMPLETED | 171 | 170 | 166 |
| NOT COMPLETED | 1 | 0 | 2 |
Reasons for not completing this period:
| Reason | Clinic Blood Pressure Measurement | Home Blood Pressure Measurement | Kiosk Blood Pressure Measurement |
|---|---|---|---|
| Withdrawal by Subject | 1 | 0 | 2 |
Analysis population for the primary outcome, as defined in the registry: The primary analysis population included all participants who completed 14 or more daytime 24-hour BP measurements, plus one or more measurements according to their randomization group.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Clinic Blood Pressure Measurement | Home Blood Pressure Measurement | Kiosk Blood Pressure Measurement | Total |
|---|---|---|---|---|---|
| Participants analysed | 172 | 170 | 168 | 510 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 103 | 99 | 102 | 304 |
| Age, Categorical: >=65 years | Participants | 69 | 71 | 66 | 206 |
| Age, Continuous | years | 58.1 (SD 14.2) | 59.3 (SD 13.2) | 58.9 (SD 12.9) | 58.8 (SD 13.4) |
| Sex: Female, Male: Female | Participants | 82 | 86 | 79 | 247 |
| Sex: Female, Male: Male | Participants | 90 | 84 | 89 | 263 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 8 | 3 | 8 | 19 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 160 | 165 | 157 | 482 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 4 | 2 | 3 | 9 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 | 0 | 2 | 3 |
| Race (NIH/OMB): Asian | Participants | 9 | 10 | 9 | 28 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 2 | 0 | 2 |
| Race (NIH/OMB): Black or African American | Participants | 13 | 13 | 8 | 34 |
| Race (NIH/OMB): White | Participants | 136 | 137 | 136 | 409 |
| Race (NIH/OMB): More than one race | Participants | 6 | 4 | 6 | 16 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 7 | 4 | 7 | 18 |
| Region of Enrollment: United States | participants | 172 | 170 | 168 | 510 |
| Baseline systolic blood pressure | millimeters of mercury | 149.4 (SD 9.8) | 149.9 (SD 11.0) | 150.1 (SD 9.4) | 149.8 (SD 10.1) |
| Baseline diastolic blood pressure | millimeters of mercury | 88.5 (SD 9.3) | 87.9 (SD 9.2) | 88.0 (SD 9.6) | 88.1 (SD 9.3) |
6. Primary Endpoint
The registry lists the primary outcome as Comparative Performance of Clinic, Home, and Kiosk, measured over Randomization to three weeks.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | millimeters of mercury |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the difference in mean systolic and diastolic blood pressure when clinic, home, and kiosk measurements are compared with 24-hour ambulatory blood pressure measurements. Blood pressure is expressed in millimeters of mercury, and the registry identifies the endpoint as a continuous measure reported with a 95% confidence interval. Its timeframe is randomization to three weeks.
A mean describes the average measurement within a group or measurement approach. Comparing means can indicate whether the values recorded by different approaches tend to be higher or lower than those recorded by ambulatory monitoring. This is relevant because the study concerns measurement performance, and a systematic difference in recorded values could affect how the readings align with the reference standard.
A confidence interval expresses statistical uncertainty around an estimate. It helps readers judge the range of values compatible with the observed data and the analysis method. It is not a guarantee that the true value falls within the interval, and it does not by itself establish that a difference is clinically important.
The registry record describes the endpoint and the intended primary analysis population, but numerical endpoint estimates are not reported in the registry record. Arm-specific means, mean differences, confidence intervals, and statistical test results are therefore not available in the record. The endpoint description alone cannot show which method produced values closest to the reference standard.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clear measurement question: whether mean systolic and diastolic blood pressure values from clinic, home, and kiosk approaches differ from values recorded by 24-hour ambulatory monitoring. However, the record does not report the numerical primary outcome results. No arm-specific means, mean differences, confidence intervals, or p-values are reported in the registry record. As a result, the direction and precision of the observed comparisons cannot be described from the registered results.
The distinction between the study question and its reported results is important. Naming the reference standard and the measurement approaches tells readers what the trial set out to compare. It does not tell readers whether one approach yielded systematically higher or lower readings, how large any difference was, or whether the estimates were precise. Those conclusions require the numerical outcome estimates and their uncertainty.
Mean differences would describe the average separation between measurements, while confidence intervals would convey uncertainty about those estimates. A narrow interval would generally indicate greater precision than a wide interval, though precision does not establish that the measurement difference matters clinically. A result compatible with little or no difference could still be imprecise if its interval were wide. These are general statistical principles; the registry record contains no numerical intervals with which to apply them to BP-CHECK.
The primary analysis population required participants to complete 14 or more daytime ambulatory measurements and at least one measurement in their randomized group. This definition helps clarify which participants were eligible for the stated primary analysis. The registry record does not report how many participants met those criteria, how many were excluded from that population, or how missing measurements were handled in the outcome analysis. The enrollment total should therefore not be treated as the number contributing to every primary estimate.
The record includes adverse-event counts, but these are not the primary endpoint and do not answer the comparative measurement question. Nor do adverse-event counts indicate whether a measurement approach agreed with ambulatory monitoring. The diagnostic focus and the safety information address different aspects of the study.
Overall, the registry record supports a description of the design, measurement schedules, endpoint, analysis population, and listed adverse events. It does not support a numerical conclusion about comparative performance. A judgment about the observed differences would require the posted outcome estimates and their uncertainty; those results are not reported in the registry record.
9. Statistical Methods Explained
BP-CHECK used a randomized, parallel-group design to compare three approaches for measuring blood pressure with 24-hour ambulatory monitoring as the reference standard. Randomization is intended to make assigned groups comparable on average, reducing the likelihood that observed differences arise solely from systematic differences in participant characteristics. It does not guarantee identical groups, and it does not replace the need to report the results and analysis details.
The study was unmasked. For a measurement comparison, the measurement setting and procedures are apparent to participants and study staff, so masking may not be practical. The registry record does not describe whether staff assessing or analyzing the measurements were masked to group assignment. That information is not reported in the registry record.
The primary outcome is continuous: mean systolic and diastolic blood pressure, measured in millimeters of mercury. Continuous outcomes retain information about the measured values rather than reducing each observation to a category. Comparing means can identify average differences, but mean comparisons do not fully describe the spread of individual readings or how well a method classifies each participant. The registry record does not state that classification accuracy is the primary endpoint.
A 95% confidence interval is a way of expressing uncertainty around an estimated quantity. In general, it reflects both the amount of information in the data and the variability in the measurements, under the assumptions of the analysis. An interval that includes values on both sides of no difference may indicate that the data are compatible with a range of possible directions and sizes of difference. A confidence interval is not a measure of the probability that a particular treatment or method is correct. No primary outcome intervals are reported in the registry record, so their width or position cannot be assessed for this trial.
The ambulatory procedure is important to the comparison because it is the designated reference standard. The registry summary describes measurements during the day and night, whereas the randomized approaches involve measurements at a clinic, at home, or at a kiosk. Differences in setting and timing can contribute to variation in recorded blood pressure. That is a general feature of repeated measurement and does not, on its own, indicate that one approach is inaccurate. The trial's numerical comparison would be needed to describe the observed pattern.
Repeated measurements can provide information about variability across readings. The home group was asked to take multiple readings across mornings and evenings, and the kiosk group was asked to obtain readings across separate days. The clinic group was asked to attend once. These different schedules are part of the assigned measurement strategies. They also mean the approaches differ in more than location: the timing and number of requested readings vary. The registry record does not describe how measurements were combined into participant-level values for the primary analysis.
Over-dispersion is a general statistical issue that arises when data vary more than a model's assumptions allow. If a model assumes less variability than the data contain, standard errors and confidence intervals can be too small, making estimates appear more precise than warranted. A suitable analysis may account for the data structure and variability. The registry record does not report whether over-dispersion was assessed or how repeated measurements were modeled, so no specific approach should be attributed to this trial.
The analysis population was defined as participants who completed 14 or more daytime 24-hour measurements and at least one measurement corresponding to their randomized group. This is a completion-based eligibility rule for the primary analysis. In general, analyzing only participants with sufficiently complete measurements can affect interpretation if completion is related to blood pressure or participant characteristics. The registry record does not report how many participants met the rule or whether results were also analyzed in another population.
The registry identifies one primary outcome measure and one analysis, but the outcome involves systolic and diastolic measurements and comparisons among multiple approaches with a reference standard. Statistical methods for multiple comparisons can be used to control the chance of false-positive findings across a family of tests. The registry record does not report whether a multiplicity adjustment was planned or used. No inference about such a procedure can be made from the endpoint description alone.
The record includes a sample-size planning illustration based on an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. Such an illustration is not the trial's design justification, and it is not observed power. It cannot establish that the original enrollment target was selected on those assumptions. The registry record does not report the protocol's sample-size justification.
The registry record does not report the statistical model, adjustment variables, handling of repeated measurements, or detailed hypothesis-testing procedure for the primary outcome. These omissions limit independent assessment of how the estimates were produced. General explanations of confidence intervals, repeated measurement, and multiplicity describe statistical concepts, not methods confirmed to have been used in BP-CHECK.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome description includes systolic and diastolic blood pressure and comparisons of clinic, home, and kiosk measurement with the ambulatory reference standard. Multiple related estimates can raise a multiplicity question: when several statistical tests are conducted, the chance of at least one apparently unusual result may increase. General approaches include defining a primary comparison in advance, adjusting inference across a family of comparisons, or presenting estimates with an explicit exploratory interpretation. The registry record does not report which approach, if any, was planned or used.
The registry record lists one outcome measure and one analysis, but that does not establish that only one statistical comparison was made. The outcome description itself covers more than one blood pressure component and more than one measurement approach. The record does not report a hierarchy of comparisons, a multiplicity adjustment, or a prespecified strategy for interpreting the set of comparisons. Numerical results are not reported in the registry record.
The stated primary analysis population included participants with 14 or more daytime ambulatory measurements and at least one measurement according to randomization group. The record does not report the number of participants who met these criteria, group-specific completeness, or the amount and pattern of missing data. It also does not describe an imputation method or sensitivity analysis for incomplete measurements. Missingness can matter if participants with unavailable readings differ systematically from those with complete readings; this is a general concern, not a finding established for this study.
The registry record does not specify whether the primary analysis followed an intention-to-treat principle, how deviations from assigned measurement schedules were handled, or whether additional analysis populations were used. The completion-based primary population definition should not be assumed to be equivalent to any particular named analysis population. These unreported details limit assessment of the consequences of incomplete data and the robustness of the primary comparison.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Clinic Blood Pressure Measurement | 5 | 172 | 2.9% |
| Home Blood Pressure Measurement | 2 | 170 | 1.2% |
| Kiosk Blood Pressure Measurement | 3 | 168 | 1.8% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Clinic Blood Pressure Measurement | 0 of 172 |
| Home Blood Pressure Measurement | 0 of 170 |
| Kiosk Blood Pressure Measurement | 0 of 168 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Clinic Blood Pressure Measurement | 38 of 172 |
| Home Blood Pressure Measurement | 38 of 170 |
| Kiosk Blood Pressure Measurement | 35 of 168 |
Most frequent serious adverse event terms
| Event term | Organ system | Clinic Blood Pressure Measurement | Home Blood Pressure Measurement | Kiosk Blood Pressure Measurement |
|---|---|---|---|---|
| Hospitalization: Back operation | Surgical and medical procedures | 1 of 172 | 0 of 170 | 0 of 168 |
| Hospitalization: Surgery for enlarged prostate & bladder stones | Surgical and medical procedures | 1 of 172 | 0 of 170 | 0 of 168 |
| Hospitalization: Surgery for removal appendix, bowel resection | Surgical and medical procedures | 1 of 172 | 0 of 170 | 0 of 168 |
| Hospitalization: Bladder surgery | Surgical and medical procedures | 1 of 172 | 0 of 170 | 0 of 168 |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 1 of 172 | 0 of 170 | 0 of 168 |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 172 | 1 of 170 | 0 of 168 |
| Hospitalization: Knee replacement surgery | Surgical and medical procedures | 0 of 172 | 1 of 170 | 0 of 168 |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 172 | 0 of 170 | 1 of 168 |
| Severe allergic reaction | Immune system disorders | 0 of 172 | 0 of 170 | 1 of 168 |
| Hospitalization: Surgery to implant stents | Surgical and medical procedures | 0 of 172 | 0 of 170 | 1 of 168 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Clinic Blood Pressure Measurement | Home Blood Pressure Measurement | Kiosk Blood Pressure Measurement |
|---|---|---|---|---|
| Discomfort, pain, irritation or bruisng from 24-hour monitor | Skin and subcutaneous tissue disorders | 15 of 172 | 5 of 170 | 7 of 168 |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 2 of 172 | 4 of 170 | 6 of 168 |
| Sleep disruption | General disorders | 1 of 172 | 2 of 170 | 2 of 168 |
| Restlessness | General disorders | 2 of 172 | 1 of 170 | 0 of 168 |
| Anxiety | General disorders | 0 of 172 | 3 of 170 | 0 of 168 |
| High cholesterol | Metabolism and nutrition disorders | 0 of 172 | 0 of 170 | 3 of 168 |
| Shingles | Infections and infestations | 1 of 172 | 1 of 170 | 1 of 168 |
| Hernia | Musculoskeletal and connective tissue disorders | 1 of 172 | 1 of 170 | 1 of 168 |
| Respiratory track infection | Respiratory, thoracic and mediastinal disorders | 0 of 172 | 2 of 170 | 1 of 168 |
| Toothache | General disorders | 1 of 172 | 1 of 170 | 0 of 168 |
Serious events with the highest arm-level rate: prostate cancer (0.6%), severe allergic reaction (0.6%), hospitalization: surgery to implant stents (0.6%), colon cancer (0.6%), hospitalization: knee replacement surgery (0.6%).
The registry lists serious and other adverse events separately for the three randomized measurement groups. In the clinic group, 5 serious adverse events were reported among 172 participants at risk, and 38 other adverse events were reported among 172 at risk. In the home group, the corresponding counts were 2 among 170 for serious events and 38 among 170 for other events. In the kiosk group, 3 serious adverse events were reported among 168 at risk, and 35 other adverse events were reported among 168 at risk. No deaths were reported in any group.
These are event counts and group-specific numbers at risk, not estimates of whether the measurement methods caused the events. The registry lists serious-event terms including prostate cancer, severe allergic reaction, hospitalization for surgery to implant stents, colon cancer, hospitalization for knee replacement surgery, and hospitalization for a back operation. Each listed term is recorded as 0.6%. The record does not assign these listed terms to a specific group in the information, so they should not be interpreted as group-specific rates.
Adverse-event counts are distinct from the primary blood pressure comparisons. They do not indicate how well the measurement approaches agreed with ambulatory monitoring. The registry record does not provide additional detail on event timing, relatedness to study procedures, or the basis for attribution. Consequently, the counts should be read as reported safety events during the study, not as proof that a measurement approach caused or prevented an event.
12. What the Result Does, and Does Not, Mean
BP-CHECK addresses a practical measurement question: how clinic, home, and kiosk blood pressure values compare with 24-hour ambulatory monitoring when evaluating new hypertension diagnoses. Its randomized design and specified measurement schedules make the intended comparison clear. The registry record also defines the primary outcome as differences in mean systolic and diastolic blood pressure.
The available record does not report the numerical results for that primary outcome. It therefore cannot show the direction or size of the differences, their precision, or whether any approach produced measurements more similar to the reference standard. The registered design and endpoint should not be mistaken for evidence of a particular comparative result.
Even when numerical comparisons are available, mean differences alone do not necessarily describe every aspect of diagnostic performance. Average agreement can coexist with substantial variation among individual measurements. A broader assessment may consider how readings vary across people and measurement occasions, and whether conclusions hold under different reasonable analytic assumptions. These are general statistical considerations; the registry record does not report such additional analyses for this trial.
The study compares diagnostic measurement approaches; it does not test whether a blood pressure treatment prevents health outcomes. Its results, if reported, would need to be interpreted in the context of the tested procedures, the enrolled population, and the reference standard. The registry record does not report enough numerical outcome information to judge the comparative measurement findings.
The proper conclusion from the registry record is therefore limited: it documents a randomized comparison of three measurement strategies against ambulatory monitoring, along with an analysis-population definition and adverse-event counts. It does not provide the primary outcome estimates needed to conclude how the strategies performed in this study. No treatment recommendation or claim of clinical benefit follows from the design description alone.
13. Why This Trial Matters Statistically
Blood pressure varies with context, and measurement setting is part of the diagnostic process. Comparing clinic, home, and kiosk readings with 24-hour ambulatory monitoring raises statistical questions about how repeated measurements should be summarized, how much variability exists within and between people, and how uncertainty should be communicated. These questions matter because a mean difference does not describe the full distribution of readings.
Randomization is a useful feature for comparing assigned measurement strategies because it can reduce systematic differences between groups. At the same time, the strategies use different schedules: clinic measurement is requested once, while home and kiosk readings are collected over multiple occasions. That makes transparent reporting of participant-level summaries, missing measurements, and the analysis model important for judging the comparisons.
The trial also illustrates the distinction between an endpoint definition and a reported result. A precise description of the outcome and reference standard does not substitute for estimates, confidence intervals, and an account of how the data were analyzed. Without the numerical outcome results, readers cannot assess the magnitude, direction, or precision of the differences.
Finally, the diagnostic focus helps keep interpretation aligned with the question. The primary outcome is about blood pressure values, not downstream health outcomes. Safety counts provide separate information and do not measure diagnostic agreement. Clear separation of these questions is a basic part of statistical interpretation in clinical research.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry record does not report numerical results for the primary endpoint. This is the most important limitation for interpreting comparative performance: without arm-specific means, estimated differences, confidence intervals, or test results, the observed measurement contrasts cannot be assessed.
The primary analysis population depends on completion of 14 or more daytime ambulatory measurements and at least one measurement in the assigned group. The record does not state how many participants met these criteria or how many had incomplete measurements. It also does not report how missing readings were handled. The enrollment total should not be treated as the primary analysis sample without those details.
The assigned approaches differ in their measurement schedules as well as their settings. Clinic measurement was requested once; home measurements were requested across mornings and evenings, and kiosk measurements across separate days. The registry record does not report how readings were reduced to participant-level values for comparing means or whether repeated-measure structure was modeled.
The registry record does not report the detailed statistical analysis plan, including any adjustment for multiple comparisons across systolic and diastolic outcomes and measurement approaches. It also does not report the randomization procedure, allocation concealment, masking of outcome assessors or analysts, or sensitivity analyses. These details are relevant to a full assessment of potential bias and analytic robustness but cannot be inferred from the design description.
The registered primary outcome is a comparison of means. The record does not report additional measures that might describe individual-level agreement or classification performance. Therefore, even with the endpoint definition, the registry record does not support a complete assessment of how well each approach performed for individual participants.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Blood Pressure Checks for Diagnosing Hypertension (BP-CHECK) — NCT03130257.
- Registry record last updated 2020-11-16; status last verified 2020-10.
- Results first posted 2020-11-16.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
BP-CHECK is a completed, randomized, unmasked, parallel-group diagnostic study sponsored by Kaiser Permanente, with enrollment of 510. The three assigned approaches were clinic, home, and kiosk blood pressure measurement. Twenty-four-hour ambulatory blood pressure monitoring was designated as the reference standard.
The primary outcome was the difference in mean systolic and diastolic blood pressure, in millimeters of mercury, over randomization to three weeks. The primary analysis population was defined by completion of 14 or more daytime ambulatory measurements and at least one measurement according to randomization group.
The registry record does not report numerical primary outcome estimates or the detailed statistical analysis plan. Serious and other adverse-event counts and zero deaths are listed for the three groups. The record describes the trial's comparison and analysis population, but does not provide the outcome estimates needed to characterize the observed comparative performance.