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 Telephonic Contact and Subsequent Physical Follow up Treated Lung Cancer Patients (NCT01133067), a registered phase not stated study. The primary outcome is Concurrence Between the Telephonic Interview and the Physician Assessment.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01133067 |
| Phase | Phase not stated |
| Condition | Lung Cancer |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 200 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Tata Memorial Hospital |
| Results posted | Yes |
2. Clinical Question
Population
Radically treated lung cancer patients were the intended population. The registry record lists an enrollment of 200, but does not report further eligibility criteria or participant characteristics. Details such as the disease-status distribution or the clinical settings in which assessments took place are not reported in the registry record.
Intervention
The study examined telephonic contact for follow-up after primary treatment. The primary measure concerns telephonic assessments of each patient's disease status at each follow-up visit. The registry record does not describe the interview format, staff conducting calls, or procedures for handling unsuccessful contact.
Comparator
The relevant comparison is between the telephonic interview and a physician assessment. This is an assessment-agreement question, not a randomized comparison between treatment groups. Allocation is not stated, and the record specifically identifies the study as not a randomized comparison. Details about the timing or independence of the paired assessments are not reported in the registry record.
Primary question
Over a timeframe of 2 years, how closely did the disease-status assessment from a telephonic interview concur with the physician's assessment at each follow-up visit? The registered measure is the prevalence and bias adjusted kappa score, with a 95% Confidence Interval. The registry record does not report the score or its interval, so the amount and precision of observed agreement cannot be described.
3. Trial Design
The registry describes a prospective study of telephonic contact and subsequent physical follow-up among radically treated lung cancer patients. It lists Tata Memorial Hospital as the sponsor, an enrollment of 200, a start date of 2010-07, a primary completion date of 2016-07, and a status of COMPLETED. These registry entries describe the study record; they do not establish what proportion of enrolled participants completed each assessment.
The design is not a randomized comparison. The registry record states that allocation was not stated and that any arms are not a like-for-like control comparison. The primary question instead compares two ways of assessing disease status: a telephonic interview and a physician assessment. The description says concurrence was assessed for each patient at each follow-up visit, over a timeframe of 2 years. The detailed visit schedule and the timing of the two assessments are not reported in the registry record.
The primary outcome is described as a probability with a 95% Confidence Interval, and the registered parameter is NUMBER. The record names the prevalence and bias adjusted kappa score as the measure of concurrence. It also lists Cost Analysis as a secondary outcome. Although 2 outcome measures are recorded, no analysis results are posted in the registry record; the number of analyses recorded is 0. Consequently, there is no reported estimate for agreement or cost to interpret.
Further design details—including eligibility criteria, recruitment methods, interview procedures, physician-assessment procedures, and the method used to select or train assessors—are not reported in the registry record. The record also does not describe how participants were assigned to any follow-up approach, beyond identifying the study as nonrandomized and allocation as not stated. Those omissions limit how fully the conduct and scope of the assessment comparison can be reconstructed from the registry entry.
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 | Total Cohort |
|---|---|
| STARTED | 200 |
| COMPLETED | 61 |
| NOT COMPLETED | 139 |
Reasons for not completing this period:
| Reason | Total Cohort |
|---|---|
| Death | 136 |
| Lost to Follow-up | 3 |
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 | Total Cohort |
|---|---|---|
| Participants analysed | 200 | |
| Age, Continuous | years | 56 (50 to 63) |
| Sex: Female, Male: Female | Participants | 33 |
| Sex: Female, Male: Male | Participants | 167 |
| Region of Enrollment: India | participants | 200 |
| Stage: Stage I | participants | 20 |
| Stage: Stage II | participants | 25 |
| Stage: Stage III | participants | 152 |
| Stage: Stage IV | participants | 3 |
| Histology: Adenocarcinoma | participants | 80 |
| Histology: Squamous Carcinoma | participants | 67 |
| Histology: Other NSCLC | participants | 23 |
| Histology: Small Cell Carcinoma | participants | 30 |
6. Primary Endpoint
The registry lists the primary outcome as Concurrence Between the Telephonic Interview and the Physician Assessment, measured over 2 years.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | probability |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint concerns concurrence between the telephonic interview and physician assessment of disease status. The registry describes assessment at each follow-up visit for each patient, using the prevalence and bias adjusted kappa score (PABAK), with a 95% Confidence Interval. The registered timeframe is 2 years. The outcome is identified as a probability and its parameter as NUMBER, but the registry record does not report a numerical result.
General statistical explanation: an agreement measure is used when the interest is whether two assessments classify or describe the same cases similarly, rather than whether one treatment changes an outcome relative to another. Kappa-type measures account for agreement that could arise by chance under their statistical formulation. PABAK is a prevalence- and bias-adjusted form of kappa; prevalence and systematic differences between assessors can influence how agreement measures behave. The measure therefore gives a different summary from simply counting matching assessments, and its interpretation depends on the assessment categories and the data being compared. Those category details are not reported in the registry record.
A confidence interval communicates uncertainty around an estimate: it indicates a range of values compatible with the data under the interval's assumptions. A 95% Confidence Interval is specified, but its bounds are not reported in the registry record. Without the estimate and interval, the size and precision of concurrence cannot be assessed. The endpoint is an assessment-agreement measure; it does not by itself quantify clinical benefit, survival, or the consequences of using one follow-up method rather than another.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a specific statistical question: whether disease-status assessments made by telephonic interview concurred with physician assessments during follow-up. It identifies PABAK as the primary measure and a 95% Confidence Interval as the accompanying uncertainty summary. However, the registry record does not report the PABAK estimate, its interval, or the underlying assessment counts. There is therefore no posted numerical result from which to judge the observed level of agreement or its precision.
This absence is important for interpretation. The study's enrollment is 200, but enrollment alone does not indicate how many participants contributed paired assessments, how many visits were included, or whether all planned observations were available. Those details are not reported in the registry record. Likewise, the time frame of 2 years describes the registered outcome window; it does not establish that every participant was followed for the full period.
General statistical explanation: agreement can be influenced by the distribution of disease-status categories as well as by whether assessors tend to differ systematically. PABAK is designed to adjust for prevalence and bias considerations, but the adjustment does not remove the need to understand the actual categories, assessment process, or missing observations. Interpretation would ordinarily consider the point estimate alongside its confidence interval and the clinical meaning of the categories being judged. The necessary result and category information are not reported in the registry record.
The record also identifies Cost Analysis as a secondary outcome, but does not report its result, methods, or the resources included. It records 2 outcome measures and 0 analyses. This means the posted registry record does not provide numerical outcome analyses to compare, whether for agreement or cost. No conclusion about comparative cost or the consequences of the follow-up approach can be drawn from the listed outcome titles alone.
The study is explicitly not a randomized comparison, and allocation is not stated. Thus the primary question should be read as a comparison of assessment methods, not as a randomized test of two treatment strategies. Even if an agreement estimate were available, agreement would not establish that either assessment is more accurate, because the registry does not identify an independent reference standard. Nor does the record report whether assessors were blinded to one another's findings. These are material interpretive considerations, not evidence that the assessments were or were not conducted in a particular way.
The registry status is COMPLETED, but completion status does not substitute for posted results. The available record supports describing the study question and its registered measure; it does not support a claim about the observed agreement, its clinical implications, or the cost findings.
9. Statistical Methods Explained
The primary method named in the registry is the prevalence and bias adjusted kappa score, abbreviated PABAK, for concurrence between telephonic interviews and physician assessments of disease status. The description says the score was analysed for each patient at each follow-up visit. A 95% Confidence Interval is specified. The score itself, the interval bounds, and the detailed analytical procedure are not reported in the registry record.
What does an agreement measure address?
General statistical explanation: agreement methods address whether two assessments assign the same result to the same case. This differs from a treatment-effect analysis, which asks whether outcomes differ between treatment groups. Here, the named comparison is between a telephonic interview and a physician assessment. The outcome description does not identify a treatment allocation or a randomized control group, and the registry explicitly says this is not a randomized comparison.
Agreement can be summarized in several ways, and each has a different interpretation. A simple proportion of matching assessments describes the observed match rate. Kappa-type measures go beyond that by incorporating an allowance for agreement expected by chance under a specified framework. The registry names a prevalence- and bias-adjusted version. The precise scoring conventions, assessment categories, and handling of repeated visits are not reported in the registry record, so the specific computational implementation cannot be reconstructed.
Why can prevalence and bias matter?
General statistical explanation: prevalence refers to how common the different assessment categories are in the data. If one category is much more common than others, the chance-agreement component can substantially affect a kappa statistic. Bias in this context concerns systematic differences in how assessors use categories. If one assessor tends to classify cases differently from another, agreement summaries may reflect that pattern as well as the case mix. PABAK is intended to adjust for prevalence and bias effects, but it remains a summary of the observed assessment data and depends on the study's measurement process.
These considerations do not show that prevalence or assessor bias was present in this study. The registry record does not report the category frequencies, cross-classification of assessments, or diagnostics describing assessor tendencies. It is therefore not possible to determine how much any such feature influenced the planned measure.
What does the confidence interval contribute?
General statistical explanation: a confidence interval expresses uncertainty around a point estimate under the method's assumptions. A narrow interval generally indicates more precision than a wide one, while the point estimate describes the central result. Neither feature alone establishes clinical importance. The registry specifies a 95% Confidence Interval, but gives neither the PABAK estimate nor the interval limits. Without those values, no statement about precision or the range of plausible agreement levels can be made.
The registry identifies the outcome as a probability and the parameter as NUMBER. These descriptors do not supply a result. They also do not disclose the formula, variance estimator, or method used to account for multiple visits from the same patient. Because observations from one person may be related, a statistical analysis of repeated assessments may need to account for that structure. Whether and how the registered analysis did so is not reported in the registry record.
What cannot be inferred from the record?
The presence of a named statistical measure does not establish that all enrolled participants contributed to it, nor does enrollment establish the number of paired assessments. The analysis population, missing-assessment rules, and any exclusions are not reported in the registry record. The record lists 0 analyses, so there are no posted estimates to evaluate. The secondary outcome is Cost Analysis, but its analytical method and result are also not reported.
General statistical explanation: when a study records repeated observations, the choice of unit of analysis matters. Treating each visit as independent when observations from the same participant are related could lead to uncertainty estimates that are inappropriate; methods can instead account for within-person dependence. This is a general methodological consideration, not a description of the study's actual analysis. The registry does not specify whether visits were combined, analyzed separately, or handled through a repeated-measures model.
No sample-size justification or planned power calculation is reported in the registry record. A planning illustration based on an observed effect, when available, is not the study's original design rationale and is not observed power. No such outcome estimate is posted in this record, so the agreement analysis cannot be assessed against a detectable effect from the registry information.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 2 outcome measures: concurrence between telephonic interview and physician assessment as the primary outcome, and Cost Analysis as a secondary outcome. It records 0 analyses. Numerical results, analysis populations, and the results of any secondary outcome are not reported in the registry record. The outcome listing alone does not establish how many statistical tests were performed or how results were selected for reporting.
General statistical explanation: multiplicity arises when several outcomes, comparisons, time points, or analytical choices are examined. If many inferential tests are conducted, the chance of at least one apparently unusual result can increase unless the analysis plan addresses that issue. Possible approaches include prespecifying a primary outcome, adjusting inference, or treating secondary findings as exploratory. Whether any such approach was specified or used in this study is not reported in the registry record. With no posted analyses, multiplicity procedures cannot be evaluated.
Missing-data handling is also not reported in the registry record. The entry does not say how missed telephone contacts, absent physician assessments, incomplete paired observations, or missing follow-up visits were handled. It does not report the number of participants with usable paired assessments or whether analyses included all enrolled participants. Enrollment of 200 is not, by itself, an analysis-population count.
General statistical explanation: missingness can affect an agreement estimate if the cases with complete assessments differ systematically from those without them. The direction and extent of any effect depend on the pattern and reasons for missing data, which cannot be inferred from the absence of a reported count. No assumptions about missingness or sensitivity analyses are described in the registry record.
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 |
|---|---|---|---|
| Total Cohort | 0 | 200 | 0.0% |
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 |
|---|---|
| Total Cohort | 0 of 200 |
The registry's adverse-event figures list 0 serious events among 200 at risk in the Total Cohort, and 0 other events among 200 at risk. The deaths field is null, so deaths are not reported in the registry record. No top serious-event terms are listed.
These entries should be read as registry-recorded counts, not as proof that no adverse events occurred under every definition or that safety was comprehensively assessed. The record does not describe the event-collection period, definitions, surveillance procedures, severity grading, or completeness of reporting. It also does not explain how the listed counts relate to the timing of telephonic and physical follow-up.
General statistical explanation: a zero count is an observed count, not a guarantee that the underlying event risk is zero. Interpretation depends on how events were sought and recorded, the population under observation, and the duration and completeness of follow-up. Those details are not reported in the registry record. The figures therefore describe what the registry lists for the cohort; they do not support a broader conclusion about safety.
12. What the Result Does, and Does Not, Mean
The record establishes that the study was designed to examine concurrence between telephonic interviews and physician assessments of disease status among radically treated lung cancer patients. It identifies PABAK and a 95% Confidence Interval as the primary statistical summary, over a timeframe of 2 years. It also records Cost Analysis as a secondary outcome. These details define the questions of interest, but the registry record does not report the estimates or results.
Without the PABAK value, its confidence interval, assessment-category counts, and number of paired observations, the observed agreement and its precision cannot be judged. Without the cost result and its methods, no conclusion about cost can be drawn. The registry's COMPLETED status and enrollment of 200 do not fill these result gaps.
Even a reported agreement estimate would answer a limited question: how consistently the two assessment approaches concurred in the studied data. Agreement alone would not show which assessment was correct, because the registry does not report an independent reference standard. It would not establish that the follow-up approach improves health outcomes, changes survival, or is preferable in practice. Those are distinct questions and are not answered by the registered primary endpoint.
The study is not a randomized comparison, with allocation not stated. Therefore, the record does not support treating it as a randomized test of follow-up strategies. The information available supports a description of the planned assessment comparison and its statistical measure, but not a claim that one approach outperformed another or produced a particular clinical or economic effect.
General statistical explanation: a study result is most informative when its estimate, uncertainty, population, and measurement procedures can be considered together. A point estimate without uncertainty can be difficult to assess; an agreement statistic without category details or a reference standard has interpretive limits. In this record, the numerical analyses and several design details are not reported, so conclusions must remain confined to the registered question and outcome definitions.
13. Why This Trial Matters Statistically
This study raises a statistical question about measurement, rather than a randomized treatment-effect question: whether disease-status assessments by telephone concur with physician assessments during follow-up. That distinction matters because agreement statistics and treatment comparisons answer different questions. The registry identifies PABAK as its primary measure, giving the record a defined statistical focus even though no estimate is posted.
Agreement measures can be sensitive to the mix of categories being assessed and to systematic differences between assessors. Naming a prevalence- and bias-adjusted kappa indicates that these issues are relevant to the chosen summary. General statistical explanation: the usefulness of such a measure depends not only on its value, but also on the categories, assessment procedures, and distribution of observations. Those details help readers understand what the statistic represents and how broadly it may apply.
The record also illustrates why a completed status and an enrollment count do not replace analysis results. The registry lists an enrollment of 200 and a 2-year primary outcome timeframe, but records 0 analyses. Consequently, the central agreement question remains without a posted numerical answer. The secondary Cost Analysis outcome is likewise listed without a result.
General statistical explanation: transparent reporting of estimates, uncertainty, analysis populations, and missing-data handling allows readers to distinguish a precise finding from an uncertain one and to assess the limits of the evidence. For an agreement study, reporting the paired assessment data and the method for handling repeated visits can be especially informative. These details are not reported in the registry record, so the statistical contribution that can be evaluated is limited to the stated question and measure.
The study matters statistically as an example of a clinically relevant distinction: consistency between methods is not identical to accuracy, and neither is equivalent to a treatment effect. Keeping those concepts separate prevents an agreement endpoint from being read as evidence of clinical benefit or as proof that one assessment is correct.
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 contains no numerical primary-outcome result, despite identifying PABAK and a 95% Confidence Interval. It also records 0 analyses. As a result, the central question about the level and precision of concurrence cannot be answered from the posted record. Cost Analysis is listed as a secondary outcome, but no result or method is reported.
The description says the comparison concerns each patient's disease status at each follow-up visit, but it does not provide the visit schedule, the number of paired assessments, category definitions, or how repeated observations were handled. The analysis population and missing-data procedures are not reported in the registry record. These omissions make it difficult to assess whether the reported enrollment corresponds to the number of observations that would contribute to an agreement analysis.
The record identifies the study as nonrandomized and says allocation was not stated. Its comparison is between assessment methods rather than a like-for-like randomized control comparison. It also does not report whether either assessment was treated as a reference standard, whether assessors were blinded, or how discrepancies were resolved. Accordingly, agreement could not by itself establish accuracy even if an estimate were available.
Eligibility criteria, participant characteristics, interview procedures, and the physician-assessment process are not reported in the registry record. Without those details, the population and assessment context cannot be described more fully. The listed adverse-event counts do not resolve these limitations: event definitions, collection procedures, and death reporting are not described, and deaths are not reported in the registry record.
These are limitations of what can be evaluated from the registry entry. They do not establish that particular methods were absent from the conduct of the study; those methods are simply not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Telephonic Contact and Subsequent Physical Follow up Treated Lung Cancer Patients — NCT01133067.
- Registry record last updated 2018-08-07; status last verified 2017-11.
- Results first posted 2018-08-07.
- 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
The registry record describes a prospective study of telephonic contact and subsequent physical follow-up for radically treated lung cancer patients. Tata Memorial Hospital is listed as sponsor, enrollment is 200, and the status is COMPLETED. The recorded study dates are 2010-07 for start and 2016-07 for primary completion.
The primary outcome is concurrence between telephonic interview and physician assessment of disease status at each follow-up visit, summarized using PABAK with a 95% Confidence Interval over 2 years. Cost Analysis is listed as a secondary outcome. The record identifies 2 outcome measures and 0 analyses; numerical results are not reported in the registry record.
The study is described as nonrandomized, with allocation not stated. Registry adverse-event figures list 0 serious events and 0 other events among 200 at risk in the Total Cohort. Deaths are not reported in the registry record. The entry does not provide enough analysis detail or results to determine the observed agreement, its precision, or the cost findings.