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 Central Venous Access Study (NCT03480542), a registered phase not stated study. The primary outcome is Adherence to Clinical Guidelines for Catheter Interventions and Management.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03480542 |
| Phase | Phase not stated |
| Condition | Central Line Catheters |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 217 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Hackensack Meridian Health |
| Results posted | Yes |
2. Clinical Question
Population
The registry describes a review of eligible patients’ medical charts involving central venous catheters (CVCs), peripherally inserted central catheters (PICCs), and hemodialysis catheters. The listed enrollment is 217. The number of charts included in the outcome analysis is not reported in the registry record. A patient may have received multiple catheters during a hospitalization, so the number of catheters and number of patients need not be the same.
Intervention
This is not a treatment intervention. The study uses a structured retrospective review of the electronic medical record to document clinicians’ practice in relation to the Medical Center’s approved evidence-based practice guidelines, policies, and procedures for catheter care.
Comparator
No randomized comparator or treatment arm is described. The stated reference for the practice review is the institution’s approved guidance. How guideline concordance was defined or assessed is not reported in the registry record.
Primary question
The registry’s primary outcome is titled “Adherence to Clinical Guidelines for Catheter Interventions and Management.” Its description counts medical records documenting mechanical or technical, thrombotic, and other adverse outcomes associated with catheter use during a 1 year timeframe. The record does not report a numerical outcome, a guideline-adherence estimate, or an analysis connecting documented outcomes to guideline concordance.
In practical terms, the study is framed as a description of recorded catheter practice and outcomes, not as a test of whether one treatment is better than another. The key statistical question is what can be learned from the number of eligible charts that document specified catheter-related outcomes, and what information is needed to interpret that count. Without reported denominators, outcome counts, or analyses, the registry entry does not establish the frequency of outcomes or the degree of adherence.
3. Trial Design
The CentrAl VenouS Catheter Access DocumEntation (CASCADE) Study is registered as NCT03480542 and is listed as completed. The registry lists a start date of 2017-04-11, a primary completion date of 2022-04-07, and enrollment of 217. Hackensack Meridian Health is listed as the sponsor. The condition is central line catheters.
The study aim is to document variation in clinicians’ practice compared with the Medical Center’s approved evidence-based practice guidelines, policies, and procedures for CVCs, PICCs, and hemodialysis catheters. The described approach is a structured retrospective review of the electronic medical record. This design uses existing records rather than assigning participants to treatment groups. Randomization and allocation are not stated, and no like-for-like control arm is described.
The primary outcome is a count of medical records with documentation of mechanical or technical, thrombotic, and other adverse outcomes associated with catheter use. The stated timeframe is 1 year. The registry also lists “Number of Documented Catheter Complications” as a secondary outcome. There are 2 outcome measures listed and 0 analyses listed.
The record notes that a single patient may have had multiple catheters placed during hospitalization. Thus, the outcome description concerns medical charts, while catheter exposure may involve more than one device per patient. The precise eligible-patient criteria, record-review procedures, and rules for linking events to individual catheters are not reported in the registry record. Nor is a protocol or statistical analysis plan described in the registry entries. The design should therefore be understood from its stated purpose and outcome definitions, without assuming additional methods.
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 | Number of Hemodialysis Catheters | Number of Peripherally Inserted Central Venous Catheters | Number of Central Venous Catheters |
|---|---|---|---|
| STARTED | 12 | 53 | 152 |
| COMPLETED | 12 | 53 | 152 |
| NOT COMPLETED | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Medical charts of eligible patients were reviewed and the number of patient medical charts with documentation are summarized. Note, a single patient may have received multiple catheters placed during their hospitalization.
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: For this retrospective data collection, 217 medical records were reviewed and met study eligibility criteria, this corresponds to 178 patients who received catheters during hospitalization (note, one patient may receive more than one catheter during hospitalization).
| Characteristic | Unit | Number of Patients Who Received Hemodialysis Catheters | Number of Patients Who Received Peripherally Inserted Peripherally Inserted Central Venous Catheters | Number of Patients Who Received Central Venous Catheters | Total |
|---|---|---|---|---|---|
| Participants analysed | 12 | 39 | 127 | 178 | |
| Age, Continuous | years | 62.6 (24 to 88) | 68 (22 to 99) | 65.6 (21 to 96) | 65.9 (21 to 99) |
| Sex/Gender, Customized: Male | Participants | 7 | 16 | 82 | 105 |
| Sex/Gender, Customized: Female | Participants | 5 | 23 | 45 | 73 |
| Race and Ethnicity Not Collected | Participants | — | — | — | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Adherence to Clinical Guidelines for Catheter Interventions and Management, measured over 1 year.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | # of catheter-related incidents |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is titled “Adherence to Clinical Guidelines for Catheter Interventions and Management,” with the unit described as the number of catheter-related incidents. Operationally, the registry says it counts medical records documenting mechanical or technical, thrombotic, and other adverse outcomes associated with CVCs, PICCs, and hemodialysis catheters. The stated timeframe is 1 year.
A count of documented records can describe how often specified outcomes appear in reviewed charts. Counts are useful when the study question concerns the burden or documentation of events rather than a continuous measurement. However, interpreting a count requires knowing the number of eligible records reviewed and the rules for identifying events. Those details and the numerical endpoint result are not reported in the registry record.
The endpoint title refers to adherence, but the operational description is a count of charts with documented outcomes. A count of adverse outcomes alone does not indicate whether care followed a guideline: that interpretation would require a stated adherence definition and information on which practices were guideline-concordant. Those are not reported in the registry record. The registry also notes that one patient may have received multiple catheters, which makes a chart count distinct from a catheter-level event rate. The outcome is therefore best read as a documentation count, not as a direct measure of the risk associated with an individual catheter or the quality of care.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry entry identifies a descriptive question: documenting clinicians’ variation in catheter practice relative to institutional guidance through retrospective review of medical records. It does not report a numerical result for the primary outcome or the secondary outcome. Consequently, the posted record does not establish how many charts contained documented complications, how often particular categories occurred, or how practices compared with the guidelines.
The primary outcome description is important to interpretation. It refers to records documenting mechanical or technical, thrombotic, and other adverse outcomes, while the outcome title refers to adherence to guidelines. These concepts are related only if the study defines and analyzes the connection. The registry record does not state the guideline-concordance criteria, the count of charts meeting those criteria, or a comparison between concordant and non-concordant care. A documentation count cannot, by itself, quantify adherence.
The listed enrollment is 217, but this is not a reported count of records analyzed for the endpoint. The number of eligible charts reviewed and the number with complete outcome information are not reported in the registry record. The record also notes that patients may have received multiple catheters. Without clarity about whether observations are counted by chart, patient, catheter, or event, the count cannot be interpreted as a rate per patient or catheter.
No inferential analyses are listed. There is no reported estimate, confidence interval, p-value, or analysis comparing catheter categories. The adverse-event listing names hemodialysis catheters, PICCs, and CVCs, but the record does not present interpretable outcome estimates for those categories. Absence of a reported estimate is not evidence that an event did not occur.
General statistical interpretation: a count is more informative when accompanied by its denominator, a clear observation unit, and a prespecified definition of what qualifies as an event. If records differ in observation time or exposure, raw counts may not support direct comparisons. Those features are not sufficiently described in the registry entry to evaluate such comparisons. The result that can be stated is therefore limited: the registry describes a retrospective documentation study and its intended outcomes, but does not report the findings needed to quantify catheter-related outcomes or guideline adherence.
9. Statistical Methods Explained
The registry describes a structured retrospective review of electronic medical records. In this design, information already recorded in clinical charts is reviewed after the care has occurred. The intended purpose is to document variation in catheter practice against institutional evidence-based guidelines, policies, and procedures. The registry does not describe random assignment, treatment groups, or a prospective intervention. Allocation is not stated, and the study is not a randomized comparison.
What does a count endpoint represent?
The primary outcome is expressed as a number of medical records with documented mechanical or technical, thrombotic, and other adverse outcomes associated with catheter use. General statistical explanation: a count records how many qualifying observations were identified, rather than measuring a continuous quantity such as length or concentration. To interpret a count as a frequency or rate, readers need a defined observation unit and denominator. For example, a count of charts is not interchangeable with a count of patients, catheters, or distinct events.
The registry says that one patient may have received multiple catheters during hospitalization. This matters because a chart-level count can combine information about more than one catheter, while a catheter-level count would treat each device as an observation. The record does not specify how multiple catheters, repeated events, or events potentially documented in more than one place were handled. It also does not give the number of records reviewed. Therefore, a rate per chart, patient, or catheter cannot be derived from the registry description.
How should the endpoint title and definition be read?
The title names adherence to clinical guidelines, while the endpoint description specifies a count of records with documented adverse outcomes. These are not automatically equivalent measures. General statistical explanation: an adherence outcome usually requires operational rules that define which actions meet a guideline and what denominator represents the opportunities to follow that guideline. An outcome count can be relevant to a quality question, but without the adherence rules and a comparison of observed practice to those rules it does not directly measure compliance. Those rules and analyses are not reported in the registry record.
What can be inferred from the absence of analyses?
The registry lists 0 analyses. It does not report an estimate of the count, a measure of uncertainty, or a test of a hypothesis. General statistical explanation: a confidence interval describes a range of values compatible with an estimate under a statistical model and its assumptions. It helps show how precisely an outcome is estimated. A p-value, when used in a stated analysis, summarizes how inconsistent the observed data are with a null hypothesis under that model. Neither replaces a description of the design, outcome definition, or denominator. No such inferential results are reported for this study.
For count outcomes, a statistical model may be chosen according to the data structure and question. General statistical explanation: a Poisson model is one possible approach when counts are modeled in relation to exposure, but it relies on assumptions about the relationship between the mean and variability of counts. Over-dispersion occurs when the observed variability exceeds what a simple Poisson model expects; if ignored, standard errors can be too small and uncertainty can appear understated. Other models or descriptive summaries may be appropriate depending on the design. The registry record does not report which, if any, count model was used, nor whether over-dispersion was assessed. No model should be attributed to the study from the endpoint type alone.
The listed categories of catheters do not establish a comparison. General statistical explanation: comparisons need a clear estimand, such as a difference in event rates, a ratio of rates, or another prespecified contrast, together with suitable denominators and uncertainty estimates. Here, no such contrast or analysis is reported. The study aim mentions variation in practice against institutional guidance, but the record does not specify a statistical comparison between catheter types or practice groups.
The record includes a sample-size planning description based on two-sided significance level 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect set as a stated fraction of the observed effect. It also distinguishes participant counts per arm from total event counts for time-to-event planning. This is a planning illustration, not a description of the retrospective review’s design: no two-arm allocation is stated. The observed effect estimate and numerical planning results are not reported in the registry record. Such planning values, where used, are not observed power and do not replace a reported study result or a sample-size justification for this review. The record does not report the study’s own sample-size justification.
Overall, the statistical methods needed to reproduce or assess an analysis are not described. The endpoint definition is available at a broad level, but the registry record does not report the denominator, event adjudication rules, model specification, uncertainty estimates, or analysis results. General statistical principles can clarify what those elements would contribute, but they cannot fill in methods that are not reported.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 2 outcome measures: the primary endpoint concerning guideline adherence and catheter-related incidents, and the secondary outcome “Number of Documented Catheter Complications.” It lists 0 analyses. The record does not report whether multiple outcomes, catheter categories, or other comparisons were tested, or whether any adjustment for multiple testing was planned or used. A multiplicity strategy is not reported in the registry record.
General statistical explanation: when many outcomes or comparisons are analyzed, the chance of at least one apparently unusual result can increase. A prespecified primary outcome and a clear analysis plan help readers distinguish confirmatory analyses from exploratory ones. Since no analyses or statistical plan are reported, it is not possible to assess how multiplicity was handled or whether an outcome was selected after results were known.
The registry describes medical charts of eligible patients but does not report the number of eligible charts reviewed, the number with missing or incomplete documentation, or how missing values were handled. It also does not describe exclusions after chart review, the definition of the analysis population, or whether all enrolled participants contributed to each outcome. Enrollment of 217 should not be treated as the endpoint denominator without that information.
General statistical explanation: missing chart information may reflect absent documentation rather than the absence of a clinical event. Excluding incomplete records, treating them as having no event, or using another missing-data method can lead to different interpretations. The appropriate approach depends on why information is missing and how the outcome is defined. No missing-data method or analysis-population definition is reported in the registry record. The record also notes multiple catheters per patient but does not describe how dependence among observations from the same patient was addressed.
11. What the Result Does, and Does Not, Mean
The study is described as a retrospective effort to document catheter practice and outcomes in relation to institutional guidance. The registry record establishes the intended scope: CVCs, PICCs, and hemodialysis catheters, with review of existing electronic medical records. It does not report numerical results for the primary endpoint or the listed secondary outcome. As a result, the record cannot support a numerical statement about the burden of documented complications or the degree of guideline adherence.
The absence of reported findings must not be interpreted as a count of zero events. The registry’s adverse-event listing does not provide outcome estimates that can be interpreted as observed results. Without the count of charts reviewed, the count with documented outcomes, and the method used to identify events, neither an absolute frequency nor a rate can be established from the record.
General statistical explanation: a record-review study measures what is available in the records under its definitions. Documentation and clinical occurrence are distinct: an event may occur without being recorded, and a chart entry may not establish the cause of an event. A retrospective association, if reported, would also not by itself establish that a catheter type or care practice caused an outcome. This registry entry reports no such association or causal analysis.
The listed enrollment of 217 is not enough to determine the precision of an outcome estimate because the analyzed denominator and outcome count are not reported. No confidence interval or other uncertainty measure is listed. A planning illustration based on an observed effect is not evidence of an observed effect and is not observed power. The registry record does not provide the results needed to evaluate precision or compare groups.
Accordingly, the result supports a limited conclusion about study intent and design: a structured retrospective chart review was intended to document practice variation and catheter-related outcomes. It does not show whether practice followed guidelines, whether one catheter category had more documented outcomes than another, or whether any care approach changed outcomes. Those conclusions are not reported in the registry record.
12. Why This Trial Matters Statistically
This study raises a useful statistical distinction between a clinical concept and its recorded measure. The title of the primary endpoint invokes adherence to guidelines, but its description counts charts with documented adverse outcomes. A clear operational definition is essential because a count of outcomes and a measure of guideline-concordant practice answer different questions. Making that distinction explicit helps prevent a reader from interpreting a documentation count as a direct measure of care quality.
The stated possibility of multiple catheters per patient also highlights the importance of the unit of analysis. A patient-level chart count, catheter-level count, and event-level count may differ, and observations from one patient may be related. Statistical summaries are only interpretable when the observation unit, denominator, and handling of repeated observations are clear. The registry record identifies the possibility of multiple catheters but does not describe how it was addressed in analysis.
General statistical explanation: retrospective record reviews can inform practice assessment, but their conclusions depend on the completeness and consistency of documentation. Separating event occurrence from event documentation, and defining how guidelines are translated into measurable criteria, are central parts of study design rather than minor reporting details. Counts without denominators can be difficult to compare, and estimates without measures of uncertainty do not convey precision.
For this study, the record lists an enrollment of 217 and the intended outcome framework, yet no analyses are listed and no numerical outcome results are reported. This makes the limits of registry-based interpretation especially clear: a study’s aims and outcome labels do not substitute for its estimates, denominators, and analysis methods. The statistical value of a record-review study depends on reporting those elements so readers can judge what the observed records do and do not establish.
13. 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 entry leaves several trial-specific details unclear. It does not report the criteria used to define an eligible patient or chart, the number of charts actually reviewed, or the number included in each outcome analysis. Although enrollment is listed as 217, the record does not establish that this was the number of charts contributing data to the primary endpoint.
The primary endpoint’s name and description do not fully align: the title refers to guideline adherence, while the description counts charts documenting specified adverse outcomes. The registry record does not define guideline-concordant care, describe how adherence was assessed, or report a direct adherence measure. It is therefore unclear how the stated objective was translated into an outcome that could be analyzed.
Patients may have received multiple catheters during hospitalization, but the record does not say whether outcomes were counted by patient, chart, catheter, or event, or how repeated observations were handled. The relationship between a documented event and a particular catheter is not described. Event ascertainment and chart-review procedures are also not reported in enough detail to assess consistency.
No numerical primary or secondary outcome results, analyses, confidence intervals, or p-values are listed. Missing-data handling, analysis populations, multiplicity procedures, and the study’s own sample-size justification are not reported in the registry record. The study is not described as a randomized comparison, so the record does not support a causal contrast between care approaches or catheter types. These limitations restrict interpretation to the stated purpose and broad outcome definitions; they prevent assessment of the magnitude, precision, or robustness of any result.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Central Venous Access Study — NCT03480542.
- Registry record last updated 2024-06-10; status last verified 2023-12.
- Results first posted 2024-06-10.
- 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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17. Record Summary
NCT03480542, the CentrAl VenouS Catheter Access DocumEntation (CASCADE) Study, is listed as completed and sponsored by Hackensack Meridian Health. The registry lists enrollment of 217, a start date of 2017-04-11, and a primary completion date of 2022-04-07.
The study aim is to use structured retrospective electronic medical record review to document variation in clinician practice relative to institutional guidelines, policies, and procedures for CVCs, PICCs, and hemodialysis catheters. The primary endpoint counts charts documenting specified catheter-related adverse outcomes over 1 year; the secondary outcome is documented catheter complications. A patient may have had multiple catheters.
The registry lists 2 outcome measures and 0 analyses. Numerical outcome findings, the analyzed denominator, statistical methods, and guideline-adherence criteria are not reported in the registry record. The entry describes the study’s intent and broad measurement approach, but does not provide results from which to quantify complications or adherence.