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 Intelligent Pain Management System for Assessing Pain in Cancer Patients (NCT02765269), a randomized na study. The primary outcome is Feasibility of Mobile Application Assessed by Observing the Number of Daily Pain Assessments Recorded Among Patients.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02765269 |
| Phase | NA |
| Condition | Pain, Neoplasms |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 46 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Xinhua Translational Institute for Cancer Pain, Shanghai |
| Results posted | Yes |
2. Clinical Question
Population
Chinese patients with cancer who have pain. The registry describes a study population asked to record pain assessments and gives an enrollment of 46, but the primary endpoint result is reported for 25 patients in the IPMS group only.
Intervention
The Intelligent Pain Management System (IPMS), a device-based mobile application. Patients were asked to use it as much as possible to record pain degree and location at least once every day. Physicians could use the recorded assessments to provide advice.
Comparator
Conventional communication, such as telephone calls or door-to-door visits, to collect pain assessments and guide physicians' therapy. A control-group result is not reported for the primary endpoint.
Primary question
Is the IPMS feasible for recording daily pain assessments among patients with cancer and pain? The registered primary measure is the mean number of daily pain assessments recorded per patient over 2 weeks. Although the trial is randomized, the posted primary result does not permit a comparison with the control group.
3. Trial Design
The registry describes a randomized, unmasked, parallel-group study comparing the Intelligent Pain Management System with conventional pain-assessment communication. The study is listed as completed. Its start and primary-completion dates are both recorded as 2016-05. The listed enrollment is 46. The sponsor is Xinhua Translational Institute for Cancer Pain, Shanghai.
In the IPMS group, patients were asked to use the system as much as possible to enter pain degree and location at least once daily. Physicians could consider those assessments when giving advice. The control group was contacted through conventional methods, including telephone calls or door-to-door visits, to collect pain assessments that could guide physicians' therapy.
The primary outcome concerns the number of daily pain assessments recorded over 2 weeks. The registry reports a mean and standard deviation for 25 patients in the IPMS group. It gives no control-group value for this outcome: the control group is listed with zero participants and no estimable mean or standard deviation for the primary measure. The random allocation therefore cannot be evaluated using the posted primary-endpoint results.
Two secondary outcome results include group summaries and unadjusted comparisons. User satisfaction is also listed among the secondary outcomes, but a corresponding numerical result is not reported in the registry record. The registry record does not report a statistical analysis plan or an account of how the groups were analyzed.
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 | IPMS Group | Control Group |
|---|---|---|
| STARTED | 25 | 21 |
| COMPLETED | 25 | 21 |
| NOT COMPLETED | 0 | 0 |
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 | IPMS Group | Control Group | Total |
|---|---|---|---|---|
| Participants analysed | 25 | 21 | 46 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 10 | 6 | 16 |
| Age, Categorical: >=65 years | Participants | 15 | 15 | 30 |
| Gender: Female | Participants | 6 | 8 | 14 |
| Gender: Male | Participants | 19 | 13 | 32 |
| Region of Enrollment: China | participants | 25 | 21 | 46 |
6. Primary Endpoint
The registry lists the primary outcome as Feasibility of Mobile Application Assessed by Observing the Number of Daily Pain Assessments Recorded Among Patients, measured over 2 weeks.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | pain assessments per day |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the mean number of daily pain assessments recorded per patient during 2 weeks. It is a measure of recording activity: it captures how often patients entered an assessment, rather than the degree of pain itself or a clinical response to treatment. The registry describes the endpoint as a way to assess whether the mobile application is feasible.
For the IPMS group, the posted mean is 2.37 pain assessments per day, with a standard deviation of 0.53, based on 25 patients. The mean describes the group's average recording frequency; the standard deviation describes variation among the recorded patient-level values. The registry record does not report a control-group value for this outcome, so the posted primary result cannot show whether recording frequency differed from conventional communication.
Recording frequency is relevant to feasibility because the system depends on patients entering assessments. It does not, by itself, establish whether entries were complete, whether physicians acted on them, or whether pain management changed. Those outcomes require separate measurements. The registry record does not report a primary-endpoint comparison or a reported analysis for this measure.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary result is a mean of 2.37 daily pain assessments per patient in the IPMS group, with a standard deviation of 0.53 over 2 weeks. This describes recording activity among the 25 patients represented in that result. It does not provide a randomized comparison: the control group is recorded as having zero participants for the primary outcome, with no result value. Consequently, the primary endpoint cannot establish whether IPMS changed the frequency of recording relative to conventional communication.
The secondary results include comparisons based on posted group summaries. For Pain Management, the mean difference for IPMS versus control is -0.75, with a confidence interval reported as extending from -1.07 to -0.430, and p < 0.001. For Karnofsky Performance Score Evaluation, the mean difference is 12.61, with a confidence interval from 8.362 to 16.86, and p < 0.001. These are unadjusted calculations from the posted summaries, not analyses listed as reported by the registry. The direction and meaning of a score difference depend on the outcome's scale and its scoring interpretation; the registry does not provide further scale details.
The secondary comparisons are distinct from the primary feasibility measure. They cannot fill the missing control result for daily recording, and their statistical results do not demonstrate that the app caused changes in these outcomes. Random allocation is recorded, but the registry does not report an analysis that accounts for allocation or other factors. The registry record also does not report whether the secondary comparisons were prespecified in a statistical analysis plan.
The confidence intervals express uncertainty around the calculated mean differences. Their widths show that the estimates are not exact; the reported intervals for both comparisons lie on one side of zero. The p-values indicate that the unadjusted comparisons are inconsistent with a zero mean difference under the calculation's assumptions. They do not account for the number of outcomes considered, missing data, or possible analytic choices. No multiplicity adjustment or reported sponsor analysis is available in the registry record.
These results should therefore be read as descriptive evidence about the posted measurements, with the primary endpoint limited to the IPMS group and secondary comparisons carrying important qualifications. A registry entry marked completed does not resolve the absence of the primary control result or provide details about how all randomized patients contributed to each outcome.
9. Statistical Methods Explained
Continuous outcomes are summarized with a mean and standard deviation. The mean represents the average outcome in a group; the standard deviation describes how spread out individual observations are around that average. These quantities answer different questions. A similar mean can occur alongside different degrees of variability, and the standard deviation is not a measure of uncertainty in the mean difference by itself.
What does a mean difference represent?
A mean difference compares the group means by subtracting one from the other. Its sign depends on which group is treated as the reference and on the outcome's direction. For the posted secondary comparisons, the registry-derived calculations identify IPMS as the comparison group and control as the reference. The value is expressed in the outcome's units. It is not a standardized effect and does not, without information about the scale, say whether a difference is important to patients.
The posted secondary comparisons are unadjusted calculations from summary statistics. They compare group averages without a reported adjustment for other variables. The calculation uses the observed group means and standard deviations. A pooled standard deviation combines the groups' variability into a common estimate for a standardized difference; it depends on assumptions about how variability is represented across groups. A standardized effect can assist with planning, but it does not replace the original-unit mean difference, which is generally easier to interpret clinically.
How should confidence intervals and p-values be read?
A confidence interval describes uncertainty in an estimate under the calculation's assumptions. It gives a range of values compatible with the observed data and method; it is not a guarantee that the true value falls within that range. A narrower interval indicates greater precision than a wider interval, while the interval's location indicates which directions of difference are compatible with the calculation. The registry does not report the confidence-level specification or a detailed method for these calculations.
A p-value quantifies how unusual the observed result, or a more extreme one, would be under a specified null model. It is not the probability that the null hypothesis is true, nor does it measure the size or importance of an effect. The posted secondary p-values are unadjusted. They do not account for testing multiple outcomes, and the registry record does not describe a prespecified testing hierarchy or multiplicity procedure.
Why is the primary endpoint not comparable between groups?
The primary outcome is a continuous count-like measure summarized as a mean and standard deviation. The IPMS group has a reported mean and standard deviation, but the control group has no estimable value in the record. A group comparison requires information from both groups. Without a control mean and its variability, a primary mean difference, its uncertainty, and a corresponding test cannot be obtained from the posted primary result. Randomized allocation alone cannot supply those missing outcome data.
Means can be informative summaries, but counts may sometimes have distributions that are strongly skewed or more variable than a simple model expects. General statistical practice may use methods suited to the data's distribution, including approaches that allow over-dispersion when the variability exceeds a model's expectation. Whether such features occurred in this trial, and which method was planned or used, is not reported in the registry record. It would not be appropriate to infer a model from the summary values alone.
What do the sample-size illustrations mean?
The planning illustrations are based on fractions of the observed secondary effects and assume a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They express participants per arm for stated power targets. They are planning illustrations, not observed power and not evidence that the trial was designed using those assumptions. The trial's own sample-size justification is not reported in the registry record. Since the primary control result is unavailable, the illustrations based on secondary effects should not be treated as a power assessment for the primary feasibility question.
In general, over-dispersion matters when a model assumes less variability than the data contain: uncertainty can then be understated, making apparent precision too optimistic. This is a general statistical point, not a finding about this study. The registry record does not provide enough detail to assess the distribution of individual observations or the adequacy of any model for the recorded counts.
10. Confidence Intervals for Each Arm
No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.
| Arm | Participants | Mean | Standard deviation | 95% CI for the mean |
|---|---|---|---|---|
| IPMS Group | 25 | 2.370 | 0.530 | 2.151 to 2.589 |
R code and output
arm <- c("IPMS Group")
n <- c(25)
m <- c(2.37)
sp <- c(0.53)
sd <- sp # posted standard deviations
for (i in seq_along(n)) {
se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}
CARM IPMS Group 25 2.370 0.530 2.151 2.58911. Multiplicity, Missing Data and Analysis Populations
The registry lists several outcomes, including the primary daily pain-assessment measure and secondary measures of pain management, user satisfaction, and Karnofsky performance. The record does not report a multiplicity adjustment, a hierarchy for testing outcomes, or a plan specifying which comparisons were intended to support confirmatory conclusions. The secondary comparison p-values are unadjusted. When multiple outcomes are examined, the chance of at least one apparently unusual result can increase; a prespecified strategy is needed to interpret a family of tests consistently.
Missing-data methods are not reported in the registry record. It does not explain whether outcome data were missing, how missing observations were handled, or whether any sensitivity analyses were conducted. The primary endpoint has a reported IPMS result but no estimable control result. That is a limitation of the posted primary outcome information; the registry record does not explain why the control value is unavailable. It should not be assumed that the group had no pain assessments or that a particular missing-data procedure was used.
The analysis population is also not reported. The record does not specify whether analyses followed randomized assignment, included only participants with available outcome data, or used another population definition. Although the trial is marked randomized, no participant-flow description or account of exclusions is given in the registry record. The outcome-level group counts cannot be used to infer the handling of every randomized participant.
The statistical analysis plan, interim analyses, and sample-size justification are not reported in the registry record. These omissions limit assessment of prespecification and the interpretation of the posted secondary comparisons. No reported sponsor analyses are listed. Accordingly, the available calculations should not be read as evidence that the statistical methods were fully documented or that missingness and multiplicity were addressed.
12. What the Result Does, and Does Not, Mean
The primary result describes the frequency of pain assessments recorded by patients in the IPMS group during 2 weeks. It gives a summary of use among the patients represented in that result. This is relevant to a feasibility question about recording, but it does not establish how the IPMS group compared with conventional communication because no primary control result is reported.
The secondary comparisons describe differences in group averages for other measures, calculated from posted summaries. They are not a direct measure of recording frequency, and they do not establish that IPMS caused any observed difference. The registry record does not report adjusted analyses, details of the outcome scales beyond their descriptions, or a plan for interpreting multiple secondary outcomes. Their statistical significance should therefore not be equated with clinical importance or certainty about causation.
The registry's description indicates that physicians could use recorded assessments to offer advice. It does not report whether physicians consistently acted on entries, whether recommendations changed, or whether patients' care followed a particular pathway. Nor does the primary result alone establish that the system made pain assessment timely in comparison with the control approach. Those questions require outcome and process information beyond a group mean for recording frequency.
The findings also do not establish broader effectiveness or safety. The adverse-event record lists zero patients at risk and zero affected for serious and other adverse events in each group, while deaths are not reported. With no patients recorded as at risk in those fields, the entries cannot be interpreted as a complete safety assessment. More generally, the registry does not provide the detail needed to judge how representative the analyzed patients were or how broadly the results apply.
In short, the posted information supports a descriptive account of recorded assessments in the IPMS group and unadjusted secondary comparisons. It does not support a primary between-group conclusion, a causal claim, or a conclusion about outcomes not reported in the registry record.
13. Why This Trial Matters Statistically
This trial raises a useful statistical distinction between measuring whether a system is used and measuring whether its use changes patient outcomes. Daily assessment frequency is a process measure: it can describe how often information is entered. It is not interchangeable with pain severity, clinical response, or patient satisfaction. Keeping those questions separate helps prevent a feasibility indicator from being interpreted as evidence about broader clinical effects.
The randomized, parallel-group design makes the missing primary control result especially important. Randomization can support a between-group comparison when outcome information is available and analyzed appropriately, but the design label alone does not create a comparison. In this record, the IPMS mean is reported while the control primary value is not estimable. The main feasibility question therefore remains unresolved by the posted primary results.
The record also illustrates why numerical precision and analytic transparency matter. Group summaries can be used to calculate secondary comparisons, but unadjusted calculations do not replace a reported analysis plan. Clear reporting of the analysis population, missing-data handling, outcome scales, and multiplicity approach would help readers judge how robust the secondary findings are. Those details are not reported in the registry record.
For clinical researchers and statisticians, the study underscores the value of reporting every randomized group's primary outcome, along with participant flow and methods for handling incomplete outcomes. Such reporting allows readers to distinguish descriptive usage data from comparative evidence and to understand what the data can support without overinterpreting the results.
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.
A central trial-specific limitation is that the primary endpoint is reported for the IPMS group but not for the control group. The study is described as randomized, yet the posted primary information cannot answer whether daily recording differed between groups. The record does not explain why a control result is unavailable.
The primary measure reflects frequency of entries, not necessarily completeness, accuracy, timeliness of physician response, or changes in pain management. The registry does not report these links or provide a numerical user-satisfaction result. Although the intervention instructions asked patients to record at least once every day, the record does not describe adherence to that instruction or how the frequency measure was constructed at the patient level.
The registry record provides limited information about the outcomes and their analysis. It does not report a statistical analysis plan, analysis populations, missing-data methods, multiplicity procedures, or reported sponsor analyses. The secondary comparisons are unadjusted calculations based on group summaries, which limits their role as confirmatory evidence. Details needed to interpret the scales, including a fuller description of score direction and clinical meaning, are not reported.
The record lists 46 for enrollment, but does not provide a participant-flow account that would explain how enrollment relates to the outcome-level group counts. The adverse-event fields list zero at risk and zero affected in both groups, and deaths are not reported; these entries do not establish a comprehensive safety assessment. The registry record also does not provide further population characteristics that would support judgments about generalizability.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Intelligent Pain Management System for Assessing Pain in Cancer Patients — NCT02765269.
- Registry record last updated 2016-12-05; status last verified 2016-07.
- Results first posted 2016-10-21.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT02765269 is a completed, randomized, unmasked, parallel-group study of the Intelligent Pain Management System for Chinese patients with cancer and pain. The registry lists an enrollment of 46 and records the start and primary-completion dates as 2016-05.
The primary endpoint measures mean daily pain assessments recorded over 2 weeks. The IPMS group result is 2.37 assessments per day, with a standard deviation of 0.53, among 25 patients. No control-group value is reported for this primary outcome, preventing a primary between-group comparison.
Numerical results are reported for Pain Management and Karnofsky Performance Score Evaluation, with unadjusted comparisons calculated from posted group summaries. User satisfaction is listed as a secondary outcome, but a numerical result is not reported. Details of the analysis plan, missing-data handling, analysis population, and multiplicity procedures are not reported in the registry record.