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 Evaluation of Patient Satisfaction in Hepatitis C Patients Treated With PegIntron Pen and Rebetol in Romania (Study P04301) (NCT00704717), a registered phase not stated study. The primary outcome is Satisfaction of Patients Receiving PegIntron Pen Plus Rebetol Therapy, Assessed by a Survey..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00704717 |
| Phase | Phase not stated |
| Condition | Hepatitis C, Chronic, Hepatitis C |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 185 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Merck Sharp & Dohme LLC |
| Results posted | Yes |
2. Clinical Question
Population
Patients with hepatitis C who participated in the study and received PegIntron pen plus Rebetol. The registry record reports enrollment of 185, while the safety figures use 183 patients at risk. It does not explain the difference between these counts or provide further detail about the population used for the satisfaction outcome.
Intervention
PegIntron pen, identified as peginterferon alfa-2b, together with Rebetol, identified as ribavirin. The study description focuses on patients’ experience using the pen as part of this treatment regimen, including training, preparation, and administration.
Comparator
No comparator group is described. The registry lists an all-treated-patients group, and its allocation information is not stated. This is not a randomized comparison, so the record does not support a like-for-like treatment contrast.
Primary question
What level of satisfaction did patients report with PegIntron pen plus Rebetol therapy, based on a questionnaire scored from 0 (dissatisfied) to 8 (very satisfied)? The questionnaire covered training from medical staff, ease of preparing and administering medication, and personal experience using the pen. It was administered at a clinic follow-up visit at any point during the 48-week treatment. The registry record does not report the observed mean satisfaction score or its standard deviation.
3. Trial Design
This completed study, NCT00704717, is titled “Evaluation of Patient Satisfaction in Hepatitis C Patients Treated With PegIntron Pen and Rebetol in Romania (Study P04301).” Its stated objective was to evaluate satisfaction among patients receiving PegIntron pen plus Rebetol. The registry lists Merck Sharp & Dohme LLC as the sponsor, enrollment of 185, a start date of 2005-09, and primary completion in 2007-12.
The design information describes one group, “All Treated Patients,” rather than separate treatment arms. Its description says that it includes all patients participating in the study. Allocation is not stated, and the registry record identifies the study as not being a randomized comparison. Consequently, there is no like-for-like control group described from which to estimate a comparative treatment effect.
The satisfaction questionnaire was administered during a clinic follow-up visit at any point during the 48-week treatment. The record does not state a more specific scheduled assessment time or provide individual assessment timing. It identifies one primary outcome measure: satisfaction with PegIntron pen plus Rebetol therapy, expressed as units on a scale.
The registry record does not report the study protocol, a sample-size justification, interim analyses, or a detailed statistical analysis plan. It also does not report a primary-outcome result or an analysis population for that outcome. The available design information therefore supports describing the study’s objective and measurement approach, but not reconstructing how the satisfaction data were collected, handled, or analyzed beyond the details explicitly recorded.
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 | All Treated Patients |
|---|---|
| STARTED | 185 |
| COMPLETED | 185 |
| NOT COMPLETED | 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 | All Treated Patients |
|---|---|---|
| Participants analysed | 185 | |
| Age, Continuous | years | 49.18 (SD 9.94) |
| Sex: Female, Male: Female | Participants | 109 |
| Sex: Female, Male: Male | Participants | 76 |
| Region of Enrollment: Romania | participants | 185 |
6. Primary Endpoint
The registry lists the primary outcome as Satisfaction of Patients Receiving PegIntron Pen Plus Rebetol Therapy, Assessed by a Survey., measured over The survey was administered during a follow-up visit in the clinic, at any point during the 48-week treatment..
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is patient satisfaction with PegIntron pen plus Rebetol therapy. The registry describes a questionnaire scale from 0 (dissatisfied) to 8 (very satisfied), with higher values representing greater satisfaction. Patients evaluated training received from medical staff, ease of medication preparation and administration, and their personal experience using the PegIntron pen. The registry lists the endpoint as a mean measured in units on a scale, with standard deviation as the dispersion measure.
A satisfaction measure captures patients’ reported experience rather than a clinical outcome. In general, this kind of information can describe how patients perceive training and the practical steps involved in using a device. It can complement other types of outcomes, but it does not by itself establish how treatment affects health or adherence. The study’s rationale links ease and accuracy of administration with adherence, but the registry does not report an adherence outcome or an analysis testing that relationship.
The survey was administered during a follow-up visit in the clinic at any point during the 48-week treatment. Because the assessment could occur at different points within that period, the record does not establish one uniform assessment time. Most importantly, it does not report the observed mean satisfaction score or its standard deviation. The questionnaire’s stated range and content can therefore be described, but the level and precision of the observed satisfaction result cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a patient-satisfaction outcome and describes its scale and content, but it does not report the observed mean or standard deviation. It also lists no analyses for the outcome. As a result, the posted information does not establish the average satisfaction score, how much individual scores varied, or how precisely an average was estimated. No conclusion about the level of satisfaction in the study group can be drawn from the endpoint description alone.
The scale runs from 0 (dissatisfied) to 8 (very satisfied). Those anchors explain the intended direction and range of the measure, but they are not a result. The description of the questionnaire’s topics likewise indicates what patients were asked to evaluate; it does not show how patients answered. Without the outcome summary or participant-level responses, it is not possible to characterize the distribution, identify whether responses clustered near one end of the scale, or assess whether any score should be considered meaningfully high or low.
The study has no comparator group described in the registry, and allocation is not stated. It is therefore not a randomized comparison and cannot provide a like-for-like estimate of how satisfaction differs between treatment approaches. Even if an average score were available, a single-group satisfaction result would describe the reported experience of that group; it would not isolate the effect of the pen or establish that satisfaction was caused by any one aspect of treatment.
The timeframe also matters. The survey could be given at any point during the 48-week treatment, rather than at one specific time recorded in the endpoint description. Without details on the actual assessment timing, the posted record cannot show whether timing varied among participants or whether experience changed over treatment. These uncertainties limit interpretation independently of the missing numerical outcome.
The enrollment count is 185, whereas the safety figures list 183 patients at risk. The registry does not explain this difference, and it does not state whether the satisfaction outcome used the full enrolled group, the safety group, or another analysis population. These counts should not be treated as interchangeable. Overall, the registry provides enough information to identify the question and measurement method, but not enough to estimate or interpret the primary outcome numerically.
9. Statistical Methods Explained
What does a mean and standard deviation describe?
General statistical explanation: for a continuous measure, the mean describes the arithmetic average of the observed scores. The standard deviation describes how dispersed individual scores are around that average. Together, these statistics can summarize a group’s responses, but they do not show the full distribution or the experiences of every participant. For a bounded questionnaire scale, interpretation also depends on the scale anchors and on how responses are distributed across the available values.
In this study, the registry specifies a mean and standard deviation for the satisfaction outcome and gives the scale anchors as 0 (dissatisfied) and 8 (very satisfied). It does not report either statistic. The mean therefore cannot be interpreted, and the amount of variability among respondents is unknown. The questionnaire’s range alone cannot substitute for the observed results.
What would a confidence interval add?
General statistical explanation: a confidence interval gives a range of values compatible with the data under a specified statistical procedure. It conveys uncertainty in an estimate; it is not a range containing a fixed proportion of individual participants’ scores. The width of an interval depends on factors such as sample size and variability, along with the method used to calculate it.
The registry record does not report a confidence interval for the satisfaction mean or enough outcome information to assess its precision. No interval should be inferred from enrollment alone: the number of participants enrolled does not tell us how many contributed an outcome score, what their scores were, or how variable those scores were.
What can be learned from the study structure?
The registry describes an all-treated-patients group and no comparator. Allocation is not stated, and the record identifies the study as not a randomized comparison. This structure does not supply a treatment contrast. General statistical explanation: a single-group descriptive estimate can characterize observations in that group, but a comparison between treatment strategies requires comparable groups and an analysis designed to estimate the contrast. The registry does not describe such a comparison for this study.
The survey could be administered at any point during the 48-week treatment. General statistical explanation: when measurements are taken at different times, timing can affect interpretation if experience changes over time. A clearly defined assessment schedule or information about actual assessment dates can help readers understand whether participants were measured at comparable points. The registry’s timeframe description does not report individual timing or a single fixed visit for the primary outcome.
What do the planning assumptions mean?
The registry’s planning description refers to an illustration based on an observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; it also describes the effect to detect as a stated fraction of the observed effect. These are planning assumptions, not evidence that the study itself used a two-arm randomized design. The registry describes one all-treated-patients group and no like-for-like control comparison.
General statistical explanation: sample-size planning asks how many participants might be needed under stated assumptions to detect a specified effect with a chosen statistical procedure. The resulting number is an illustration conditional on those assumptions. It is not the number of participants actually observed in an arm, and it is not “observed power.” The registry does not report a study-specific sample-size justification or a numerical observed effect for this endpoint. No planning value can therefore be interpreted as a design target or as evidence about the study’s ability to detect an effect.
Why is the analysis information important?
The registry lists one outcome measure and zero analyses. It does not report a statistical model, a confidence interval, a hypothesis test, or details of how missing questionnaire responses were handled. General statistical explanation: an analysis method should match the question, the outcome’s distribution, and the data available. A mean may be a useful summary, but it does not replace information on the analysis population, missingness, and uncertainty. Without those details and the actual result, readers cannot independently assess the statistical analysis or its precision.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome measure: satisfaction with PegIntron pen plus Rebetol therapy. It reports zero analyses, and the record does not describe a statistical analysis plan. The number of planned hypotheses, any hierarchy among outcomes, and any adjustment for multiple testing are not reported in the registry record. Since no outcome analysis is posted, there is no reported primary-outcome test or inferential result to assess for multiplicity.
The registry does not report how many participants completed the satisfaction questionnaire, how many scores were available for analysis, or whether any questionnaire items or whole surveys were incomplete. It also does not describe a missing-data method, such as whether incomplete responses were excluded or otherwise handled. These details matter because the participants with observed scores may not represent everyone enrolled if outcome availability is related to satisfaction or other factors. That is a general concern, not a claim about what happened in this study.
The record reports enrollment of 185 but does not specify the population contributing to the primary outcome. The safety figures use 183 patients at risk; the registry does not state why this count differs or whether it applies to the satisfaction analysis. It would be inappropriate to assume that all enrolled participants provided a usable questionnaire or that the safety population was the outcome population.
The registry record does not report inclusion or exclusion rules for the satisfaction analysis, a per-protocol or other analysis population, or a method for dealing with the survey’s variable assessment timing. These omissions limit assessment of selection, missingness, and the exact population represented by any mean. Because the numerical endpoint result is also absent, neither the amount of missing data nor its possible effect on the estimate can be evaluated.
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 |
|---|---|---|---|
| All Treated Patients | 0 | 183 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| All Treated Patients | 14 of 183 |
Most frequent non-serious adverse event terms
| Event term | Organ system | All Treated Patients |
|---|---|---|
| Pyrexia | General disorders | 14 of 183 |
The registry reports serious adverse events for the all-treated-patients group: 0 affected among 183 patients at risk. It also reports other adverse events for that group: 14 affected among 183 patients at risk. These are separate categories in the record and should not be combined or interpreted as a comparison between treatment groups, because no comparator group is described.
The figures describe counts in the listed safety population. They do not provide event-level detail, timing, severity beyond the serious-event classification, or a causal assessment for the other adverse events. The list of top serious-event terms is empty. Deaths are recorded as null, so the registry record does not report a death count; null should not be read as a reported count of zero.
General statistical explanation: a count of affected participants is a descriptive safety summary. It does not by itself determine whether an event was caused by treatment or how safety compares with another regimen. Here, the record gives no randomized comparator and no comparative safety analysis. The enrollment count is 185, while the safety count at risk is 183; the registry does not explain that difference. The safety figures should therefore be read as reported for the stated safety group, without assuming they cover every enrolled participant.
12. What the Result Does, and Does Not, Mean
The record establishes that a study was conducted to evaluate patient satisfaction among people receiving PegIntron pen plus Rebetol for hepatitis C. It describes a questionnaire with scores from 0 (dissatisfied) to 8 (very satisfied), covering staff training, medication preparation and administration, and personal experience with the pen. It also states that the survey was administered during a clinic follow-up visit at any point during the 48-week treatment. These details explain the intended measurement, not the outcome patients reported.
The registry does not report the primary endpoint’s mean or standard deviation, and it lists zero analyses. The posted information therefore does not establish whether average satisfaction was high or low, how responses varied, or how precisely an average was estimated. No score, uncertainty interval, or inferential conclusion should be inferred from the study’s objective, scale, or enrollment count.
The study description also does not establish that satisfaction caused adherence or that any aspect of the device changed adherence. The rationale discusses a relationship between treatment effectiveness, adherence, ease of use, and accuracy of administration, but the record does not report an adherence outcome or an analysis of that relationship. A stated rationale is not evidence that the proposed relationship was tested or demonstrated.
Because no comparator is described and allocation is not stated, the study cannot be read as a randomized comparison of treatment options. The available record does not estimate how satisfaction would differ under another device or regimen. Nor does the satisfaction measure, by itself, establish clinical effectiveness or safety. The safety summary is descriptive and does not include a comparison group or a causal assessment.
In short, the registry record identifies the study question, the treatment combination, the questionnaire’s content and scale, and limited safety counts. It does not report the primary satisfaction result or enough analysis detail to evaluate it statistically. The supported conclusion is about what was intended to be measured, not about the observed level of satisfaction or a treatment effect.
13. Why This Trial Matters Statistically
This study illustrates an important distinction in clinical research: describing a relevant patient-reported outcome is not the same as reporting its result. The registry gives the satisfaction scale, its anchors, the topics assessed, and a broad assessment timeframe. Those details help define what the measure was intended to capture. Without the observed mean, standard deviation, or analysis, however, readers cannot judge the actual responses or their precision.
It also shows why the design must be considered before interpreting a number. The study describes an all-treated-patients group, with allocation not stated and no like-for-like control comparison. A descriptive satisfaction estimate, if reported, would characterize that group. It would not by itself establish that the pen caused a particular level of satisfaction or that experience would differ with another treatment approach.
The timeframe is another statistical consideration. The survey could be administered at any point during the 48-week treatment. General statistical explanation: when assessment timing is not fixed, readers may need information about when responses were collected to determine how comparable they are and whether timing could shape the observed results. The registry does not give that level of detail.
Finally, the distinction between enrolled participants and the safety population matters for transparent reporting. Enrollment is 185, while 183 patients are listed at risk for the safety summaries. The record does not explain the difference or identify the population used for the satisfaction endpoint. Reporting outcome availability and analysis populations would help readers understand which participants a result represents.
The trial is statistically informative as an example of how much interpretation depends on complete outcome and analysis reporting. Its registry entry states a clear patient-experience objective, but it does not report the primary numerical result needed to assess that objective.
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 central limitation for interpretation is that the registry does not report the primary satisfaction mean or standard deviation, despite listing satisfaction as the primary outcome. It also lists zero analyses. Without a numerical result, readers cannot describe the observed satisfaction level, quantify variability, or assess precision. The scale anchors do not fill this gap.
The study is not described as a randomized comparison. Allocation is not stated, and the registry identifies no like-for-like control group. Accordingly, the record cannot support a comparative estimate of satisfaction between devices, regimens, or treatment strategies. A single all-treated-patients group also cannot separate the contribution of the pen from the other elements of treatment or the care context.
Assessment timing is broad: the survey was administered during a follow-up visit at any point during the 48-week treatment. The registry does not report actual visit timing, whether it differed across participants, or whether responses were assessed at a common time. That limits understanding of the conditions under which responses were collected.
The registry does not report the number of completed questionnaires, missing responses, the analysis population for the endpoint, or how incomplete data were handled. It also does not describe a statistical analysis plan, a sample-size justification, or interim analyses. The record therefore does not permit assessment of those aspects of the study’s methods.
For safety, the registry reports 183 patients at risk, compared with enrollment of 185, without explaining the difference. It reports no serious adverse events in that group and 14 patients with other adverse events, but does not provide a comparator or a causal assessment. Deaths are null rather than reported as a numerical count. These limitations apply to interpretation of the registry record and do not establish what may or may not have been documented elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluation of Patient Satisfaction in Hepatitis C Patients Treated With PegIntron Pen and Rebetol in Romania (Study P04301) — NCT00704717.
- Registry record last updated 2015-04-29; status last verified 2015-04.
- Results first posted 2009-06-02.
- 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
NCT00704717 is a completed study titled “Evaluation of Patient Satisfaction in Hepatitis C Patients Treated With PegIntron Pen and Rebetol in Romania (Study P04301).” The registry lists Merck Sharp & Dohme LLC as sponsor, enrollment of 185, a start date of 2005-09, and primary completion in 2007-12.
The study objective was to evaluate satisfaction among patients receiving PegIntron pen plus Rebetol. The primary outcome was a questionnaire score from 0 (dissatisfied) to 8 (very satisfied), addressing training, preparation and administration, and personal experience with the pen. The survey could be administered at a clinic follow-up visit at any point during the 48-week treatment.
The record describes an all-treated-patients group, no comparator, and allocation not stated. It does not report the primary outcome’s mean or standard deviation and lists zero analyses. Safety figures are 0 serious adverse events among 183 at risk and 14 other adverse events among 183 at risk. The registry does not explain why the safety count differs from enrollment or report a numerical death count.