Enabling Advance Directive Completion: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Enabling Advance Directive Completion (NCT01746368), a randomized na study. The primary outcome is Number of Participants Who Completed an Advance Directive.

2. Clinical Question

The registry describes a prospective, randomized, controlled, unblinded pilot study. Its stated objectives included testing recruitment, randomization, retention, intervention delivery, assessment and data-collection procedures, satisfaction, and preliminary effects. The posted primary outcome therefore addresses one part of a broader feasibility and preliminary-effect evaluation. It does not, by itself, characterize every objective of the pilot.

3. Trial Design

The study was a randomized, controlled, unblinded, parallel-group pilot conducted with Alabama Veterans receiving care through Tuscaloosa VA Medical Center care sites. Fifty participants were recruited as a convenience sample. The brief summary describes allocation in a 2:1 ratio to the Nurse-Supported Advance Care Planning Intervention or Care-as-Usual, respectively. The posted primary-outcome counts are 32 in the nurse-supported arm and 17 in the care-as-usual arm; these outcome counts total 49. The record does not explain the difference between the stated recruitment total and the posted outcome counts.

The nurse-supported intervention was a manualized session delivered by a Registered Nurse, including education, support, guidance, and information about risks, benefits, and alternatives of specific choices. The comparison session was delivered by a social worker and explained the advance directive and its completion process, without information about the risks, benefits, and alternatives of specific choices. Because the study was unblinded, participants and staff were not masked to the allocated session; further masking details are not reported in the registry record.

The primary outcome was assessed up to 1 month after intervention. The registry dates the study start to 2013-04 and primary completion to 2014-01, and lists the study status as completed. The brief summary states that the study lasted one year. The stated objectives emphasize feasibility, satisfaction, assessment procedures, and preliminary effects, which places the results in a pilot-study context. The original target sample-size justification, planned interim analyses, and detailed original statistical plan are not reported in the registry record. The posted results therefore describe what was observed in this pilot; they do not establish that the study was designed as a definitive effectiveness trial.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: intention to treat (ITT)

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.

Population: The number of participants for analysis was 50 - the full sample size.

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants Who Completed an Advance Directive, measured over Up to 1 month after intervention.

The primary endpoint is the number of participants who completed an advance directive, with completion defined as confirmation of a scanned document in the medical record. The timeframe is up to 1 month after intervention, and the registry identifies the population as intention to treat (ITT). This is a binary outcome at the participant level: each person either met the stated completion criterion during the assessment window or did not.

Using a documented completion criterion makes the endpoint more concrete than an outcome based only on a participant's recollection or stated intention. It focuses on whether a document was recorded in the medical record within the specified period. It does not measure the content of the directive, the quality of decision-making, later use of the document, or whether a participant's preferences changed; those outcomes are not reported as the primary endpoint.

In a pilot focused on advance-care-planning procedures, the completion count can describe a preliminary difference between the two assigned approaches and can inform consideration of a later study. It should be interpreted alongside the small posted arm counts, the study's feasibility objectives, and the uncertainty around the estimated difference. The registry record does not report further details about how unconfirmed or unavailable documents were classified, beyond the stated confirmation criterion.

7. Results Posted in the Registry

• Nurse-Supported Advance Care Planning Intervention: 93.8% (30/32) versus 29.4% (5/17) on control; risk difference 64.3 percentage points (95% CI 41.1 to 87.6), risk ratio 3.19 (1.52–6.69); unadjusted two-proportion z-test p = <0.001.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Satisfaction

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Nurse-Supported Advance Care Planning Intervention: mean 31.03 versus 28.00 on control; difference 3.03 (95% CI 0.95 to 5.11), standardized effect d = 1.14; z-test p = 0.004.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Nurse-Supported Advance Care Planning Intervention than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The posted secondary outcome concerns satisfaction, measured as scores on a scale. Its overall pattern favors higher average satisfaction scores in the nurse-supported arm than in the care-as-usual arm. This direction is broadly consistent with the primary outcome's observed contrast, but the outcomes represent different aspects of the study: one records advance-directive completion and the other records participants' satisfaction.

That consistency should be interpreted cautiously. A group-level pattern across two endpoints does not establish that satisfaction explains document completion, that participants with higher satisfaction were more likely to complete a directive, or that the two outcomes measure the same underlying effect. The registry does not report a participant-level association between satisfaction and completion, nor does it report further secondary analyses. Satisfaction was assessed in participants who received the allocated intervention within the stated timeframe, while the primary endpoint is identified as intention to treat. The populations and assessment conditions therefore should not be assumed to be identical.

The secondary result is unadjusted. General explanation: when several outcomes or comparisons are examined, the chance of finding at least one apparently strong result by chance can increase unless the analysis plan addresses multiplicity. The registry record does not report a multiplicity adjustment or a prespecified hierarchy for interpreting secondary outcomes. The satisfaction finding is consequently best treated as supportive, exploratory information rather than as independent confirmation of the primary result.

The registry lists one secondary outcome and reports no analyses. It does not provide a threshold for an important satisfaction-score difference or describe the scale's range. The statistical direction can be described, but the practical meaning and broader generalizability of a score contrast remain uncertain. As with the primary result, these secondary observations come from a pilot and should be read in that context.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Satisfaction

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is binary: the registry counts participants who met the document-confirmation definition. A basic comparison for this type of outcome is to calculate the proportion meeting the criterion in each arm and then contrast those proportions. The posted counts are 30 of 32 for the nurse-supported intervention and 5 of 17 for care-as-usual. The reported risk difference is an absolute contrast in proportions. General explanation: an absolute difference keeps the scale tied to the outcome itself, while a relative measure compares one arm's proportion with the other's.

What does the confidence interval express?

General explanation: a confidence interval describes the range of estimates that are reasonably compatible with the observed data under the assumptions of the interval procedure. A narrower interval indicates greater precision; a wider interval indicates more uncertainty. The primary risk-difference interval runs from 0.411 to 0.876. It is entirely on the positive side of zero, which is consistent with the observed direction of the contrast. The interval does not say that every value inside it is equally likely, and it is not a range guaranteed to contain the true value in this particular study.

How should the p-value be read?

The primary p-value is unadjusted and reported as <0.001. General explanation: a p-value describes how unusual data at least as inconsistent with a specified null hypothesis would be if that null hypothesis and the test's assumptions were true. It is not the probability that the null hypothesis is true, nor does it measure the size or importance of the observed difference. The p-value complements the effect estimate and confidence interval; it should not replace inspection of the counts or uncertainty.

The registry record lists the primary population as intention to treat (ITT). General explanation: an ITT approach aims to analyze participants according to their randomized allocation, regardless of whether they fully received the assigned intervention. The record does not describe the exact handling of missing outcome information, participant withdrawals, or any departures from allocation. In particular, the total recruited sample is fifty while the posted primary outcome arm counts are 32 and 17. The record does not explain that difference, so its cause should not be inferred.

The posted primary comparison is unadjusted. No reported analyses are listed in the registry, and details of the original planned statistical tests or any covariate adjustments are not reported in the registry record. General explanation: adjustment can account for selected measured characteristics, but an adjusted estimate answers a somewhat different question from a simple unadjusted arm comparison. Without a reported model specification, there is no basis for describing an adjusted result or the rationale for choosing particular covariates.

The secondary satisfaction outcome is a mean score, with standard deviations reported for each arm. The posted mean difference is 3.03, with a 95% confidence interval from 0.947 to 5.113 and an unadjusted p-value of 0.004. General explanation: for a continuous score, a difference in means compares average scores between arms; the standard deviation describes variation among participants within an arm. The confidence interval expresses uncertainty about the difference in average scores, not the range of individual scores. The record does not state the scale's possible range or a threshold for a meaningful difference, so the practical interpretation of the score contrast cannot be determined from the reported statistics alone.

The primary estimate's relative measures are a risk ratio of 3.188 and an odds ratio of 36.0, each with a confidence interval reported in the posted results. General explanation: the risk ratio compares proportions directly, whereas the odds ratio compares odds. They are different scales and need not have the same numerical magnitude. The risk difference, risk ratio, and odds ratio are alternative summaries of the same binary outcome comparison, not independent pieces of evidence.

The study is described as randomized, which supports a comparison by allocated group, but the registry also describes it as unblinded. General explanation: lack of masking can influence behavior, reporting, and outcome assessment, depending on how an outcome is measured. Here the completion criterion requires confirmation of a scanned document in the medical record, but the registry does not describe who confirmed the document or whether that assessment was masked. The endpoint has a recorded-document criterion; the record does not provide enough detail to assess every possible source of measurement influence.

The registry characterizes this as a pilot and lists feasibility and preliminary-effect objectives. Statistical significance of a posted comparison does not convert a pilot estimate into a definitive estimate. General explanation: small studies can yield uncertain effect estimates, and a large observed difference may be estimated imprecisely or may not generalize. The confidence interval is therefore important in addition to the p-value. The original sample-size justification, test choices, and any interim analyses are not reported in the registry record.

11. Confidence Intervals and Precision

Precision is conveyed chiefly by the confidence intervals around the estimated contrasts. For the primary risk difference, the posted estimate is 0.643, with a 95% confidence interval from 0.411 to 0.876. The interval lies above zero, indicating that the estimates compatible with the interval procedure are all in the direction of a higher completion proportion in the nurse-supported arm. Its width also signals that the data do not pin down a single precise magnitude for that difference.

The relative estimates have appreciable uncertainty as well. The risk ratio is 3.188, with a 95% confidence interval from 1.518 to 6.693. The odds ratio is 36.0, with a 95% confidence interval from 6.125 to 211.6. The interval for the odds ratio spans a particularly broad range of possible values on that scale. This is one reason to keep attention on the underlying counts and the absolute risk difference rather than treating any one relative measure as a complete account.

General explanation: a confidence interval reflects both the estimate and the amount of information in the data, under the method's assumptions. Small samples commonly lead to less precise estimates, especially for outcomes where a small change in the count has a substantial influence on the proportion. A confidence interval is not a prediction interval for the result of a future study and does not incorporate every possible source of bias or differences between settings.

The satisfaction mean difference is 3.03, with a 95% confidence interval from 0.947 to 5.113. That interval is on a score scale and should not be compared directly with the primary endpoint's risk-difference interval. The registry does not report a clinically or practically important threshold for this satisfaction scale. Precision can therefore be discussed statistically, but the meaning of a particular score difference is not established by the interval alone.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are illustrations based on the observed effects, not the trial's original enrollment plan. For the binary completion outcome, the figures give participants per arm. At 100% of the observed effect, the illustration lists 8 participants per arm for 80% power and 10 participants per arm for 90% power. At 75% of the observed effect, it lists 16 and 21 participants per arm, respectively. At 50% of the observed effect, it lists 37 and 49 participants per arm, respectively.

For the satisfaction outcome, the same effect fractions correspond to 13 and 17 participants per arm at 100% of the observed effect; 22 and 29 at 75%; and 49 and 65 at 50%. These are also participants per arm, not total sample sizes and not total event counts. The registry's planning assumptions are a two-sided significance level of 0.05, equal allocation between the arms, and a normal approximation, with the effect to detect set to the stated fraction of the observed effect. The trial's own original design assumptions are not reported in the registry record.

General explanation: the 80% power column describes the planned chance of detecting the specified effect under the planning assumptions if that effect is the true one; the 90% column uses a higher target chance and therefore generally calls for more participants. Planning for a smaller effect requires more participants because a smaller contrast is harder to distinguish from random variation. These figures are planning illustrations, not observed power. They should not be read as evidence that the completed pilot had a particular probability of detecting its result.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.294; treatment proportion p₁ = 0.938; average p̄ = 0.616.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.6879 = 1.3482.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.5160 = 0.4342.
4. n = (1.3482 + 0.4342)² / (0.6434)² = 7.7, rounded up to 8 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
p0 <- 0.294117647058824                          # control proportion
p1 <- 0.9375                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(1746368)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 8 (80% power), 10 (90% power)
 75% of observed effect: n per arm = 16 (80% power), 21 (90% power)
 50% of observed effect: n per arm = 37 (80% power), 49 (90% power)
power.prop.test: 7.7 
Simulated power at n = 8 per arm: 0.869 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary outcome and one secondary outcome, and it lists no reported analyses. It does not report whether the outcomes were assigned a formal testing hierarchy, whether any multiplicity procedure was planned, or whether other outcomes were assessed but not posted. The unadjusted p-values should therefore be understood as individual comparisons, not as results adjusted for testing across a family of outcomes. General explanation: when many hypotheses are tested, an unadjusted threshold can produce more chance-positive findings across the full set than it would for a single test.

The primary outcome population is identified as intention to treat (ITT), but the record does not give a detailed missing-data plan. It does not state whether all randomized participants had an outcome assessed, how an unconfirmed document was treated when information was unavailable, or whether imputation or sensitivity analyses were used. The primary arm counts are 32 and 17, while the brief summary describes recruitment of fifty participants. The reason for this difference is not reported in the registry record; no cause should be inferred from the counts alone.

For satisfaction, the outcome description specifies participants who received the allocated intervention, with a later assessment timeframe for all others who consented. The posted satisfaction counts are 30 and 16. The record does not explain how participants without a satisfaction score were handled, whether their absence was related to their allocation or outcome, or whether the secondary analysis was intended to include every randomized participant. The secondary outcome population therefore differs in its stated assessment conditions from the primary ITT description.

General explanation: missingness can affect an estimate if the chance of an outcome being observed is related to the outcome itself or to study group. Without a reported missing-data approach and a clear account of observed outcomes by randomized group, the direction or size of any resulting bias cannot be assessed from the registry record. The record also does not report interim analyses, changes to the analysis plan, or detailed methods for handling deviations from the assigned intervention.

15. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: admission to hospital (5.9%), admission to acute psychiatric unit (3.0%).

The registry lists serious adverse events for both arms. In the Nurse-Supported Advance Care Planning Intervention group, 1 participant was affected among 33 at risk. In Care-as-Usual, 1 participant was affected among 17 at risk. The listed counts of participants at risk for other adverse events are 33 and 17, respectively; the affected counts are 1 and 0. These are descriptive counts and do not, on their own, establish whether an event was caused by an intervention.

The serious-event terms listed include Admission to hospital at 5.9% and Admission to acute psychiatric unit at 3.0%. The registry does not identify the arm associated with each listed term in the posted summary. The percentages should therefore not be assigned to a particular arm or interpreted as comparative rates from the information recorded.

The adverse-event denominators differ from the primary outcome arm counts, and the record does not explain the difference. Death counts are not reported in the registry record. These safety figures should be read as the posted event counts within the registry's reporting framework, not as a complete account of all possible harms or a causal comparison.

16. What the Result Does, and Does Not, Mean

The primary result shows that, among the participants counted in this pilot, documented completion of an advance directive was more frequent in the nurse-supported arm than in care-as-usual during the stated follow-up window. The absolute and relative estimates point in the same direction, and the unadjusted p-value is small. The confidence interval indicates that the estimated magnitude remains uncertain despite the clear separation in the observed counts.

This finding is not a medical treatment result and does not show an effect on health, quality of life, or later care. It concerns completion of a document confirmed in the medical record up to 1 month after intervention. The registry does not report whether the documents were later used, whether they reflected stable preferences, or whether participants' care changed as a result. Those outcomes cannot be inferred from the completion count.

The study was a pilot with stated aims that included feasibility, satisfaction, and preliminary effects. Its convenience sample came from Tuscaloosa VA care settings, and the study was unblinded. The pattern therefore describes these participants and this study context; it does not by itself establish that the estimate would generalize to other groups, settings, or ways of delivering advance care planning. The registry's short-term endpoint also does not describe persistence of completion over a longer period.

The satisfaction result adds a different perspective on participants' reported experience, but it is not a substitute for the primary endpoint and does not show that satisfaction caused completion. The registry does not report a participant-level link between these outcomes, a multiplicity strategy, or detailed missing-data methods. The results are best understood as preliminary evidence about the observed comparison, with limitations in precision and reporting that matter when considering what can be concluded.

17. Why This Trial Matters Statistically

This trial illustrates how a pilot study can report both feasibility-oriented aims and a preliminary comparison of outcomes. The primary endpoint is operationalized through confirmation of a scanned advance directive in the medical record, making the outcome a documented event rather than a subjective report of intention. That distinction is useful statistically because it defines what was counted, while also narrowing the interpretation to recorded completion during the specified period.

The comparison also demonstrates why a single p-value is not enough. The arm counts, absolute risk difference, relative measures, and confidence intervals describe different aspects of the same binary outcome. The absolute difference is tied to the proportion completing a directive, while the ratio measures use relative scales. Considering these estimates together helps prevent a striking relative contrast from being separated from the number of participants and the uncertainty in the estimate.

The pilot context matters for the interpretation of the observed magnitude. A result that is statistically distinct from zero can still be imprecise, and an estimate from a convenience sample at particular care sites does not automatically represent other populations. The posted planning illustrations also show how assumptions about the effect to detect can change the sample size needed for a future study; they do not describe the design rationale for this completed trial.

Finally, the registry record highlights questions that statistical interpretation depends on: how outcomes were missing or unavailable, how the ITT population was applied, whether multiple outcomes were planned for formal testing, and how adverse-event terms map to study arms. Those details are not reported. Recognizing the boundaries of the record is part of interpreting the observed statistics responsibly, especially when the goal is to use a pilot result to frame further research.

18. 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.

Several limitations specific to this trial affect the interpretation of the posted estimates. The study recruited a convenience sample from Tuscaloosa VA outpatient clinics and other care settings, so the participants were not described as a population-based sample. The results therefore characterize the recruited group and may not represent Veterans in other settings. Current Hospice or Palliative Care was excluded according to the study description, which also limits the population to which the result directly pertains.

The study was unblinded. The primary endpoint uses a medical-record confirmation criterion, but the registry does not report who verified the scanned document or whether that verification was masked. The record also does not provide sufficient detail to assess how the intervention sessions were monitored for consistency beyond describing one as manualized. Possible variation in delivery or assessment cannot be quantified from the posted information.

The recruited sample was fifty, while the primary-outcome counts are 32 and 17. Satisfaction counts are 30 and 16, and adverse-event denominators are also reported separately. The registry does not reconcile these totals or describe missingness, withdrawals, or exclusions in enough detail to determine why the populations differ. This limits assessment of how fully the stated ITT population was represented in the primary comparison.

The original sample-size justification, detailed statistical plan, multiplicity approach, and interim-analysis procedures are not reported in the registry record. No reported analyses are listed. The pilot's preliminary-effect objective and the width of the confidence intervals counsel against treating the observed effect magnitude as a settled estimate. The registry also does not report longer-term follow-up for directive use or a measure of whether the recorded documents reflected participants' preferences. These are boundaries on the interpretation of the outcome, not evidence that any particular unreported outcome occurred.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Enabling Advance Directive Completion — NCT01746368.
• Registry record last updated 2015-06-12; status last verified 2015-05.
• Results first posted 2015-06-12.
• 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.

22. Record Summary

NCT01746368, titled Enabling Advance Directive Completion, is listed as a completed, randomized, unblinded, parallel-group pilot study sponsored by the US Department of Veterans Affairs. It recruited a convenience sample of fifty Alabama Veterans receiving care through Tuscaloosa VA Medical Center sites, with allocation described as 2:1 to the Nurse-Supported Advance Care Planning Intervention or Care-as-Usual.

The primary endpoint counted participants with an advance directive confirmed by a scanned document in the medical record up to 1 month after intervention. The posted counts were 30 of 32 in the nurse-supported group and 5 of 17 in care-as-usual. The record also reports satisfaction as a secondary outcome and descriptive adverse-event counts. It identifies feasibility and preliminary effects among the study objectives. Detailed original design assumptions, missing-data methods, multiplicity procedures, and reported analyses are not reported in the registry record.