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Analysis of outcomes and adverse events of patients undergoing radiation therapy. Quality control using data base of patient records 2000-2025
What are the findings of the systematic recording and analysis of the outcomes and adverse events of radiotherapy, and how do these findings improve radiotherapy for future patients?
The goals of the systematic collection and analysis of patient-related personal data include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Data Base of Patient Records 2000-2025 | Analysis of outcomes and adverse events |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation | Outcomes and adverse events using radiation therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) and progression free survival (PFS) analysis after radiation therapy | Calculation of Overall survival (OS) and progression free survival (PFS). Time-to-event endpoints are summarized as the median and corresponding 95% confidence interval using Kaplan-Meier method | 25 years |
| Analysis of risk factors influencing outcome after radiation therapy | Calculation of log-rank tests. If possible, hazard ratios are calculated via Cox regression. Competing risk analysis is conducted as supportive analysis | 25 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with acute and late adverse events after radiation therapy | Predefined toxicity events are described by type, grade, frequency, and percentage across all time points. Fisher's exact tests are used for comparison (base line and defined time points). Quality of life symptom and function scales are used. Two-tailed tests with a significance level of 0.05 are used for all analyses. Adjustments for multiple testing may be used. Some of the analyses are exploratory and hypothesis generating |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are being treated with radiotherapy at the Department of Radiation Oncology at the Winterthur Cantonal Hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel R Zwahlen, MD, MBA | Contact | +41522662645 | daniel.zwahlen@ksw.ch | |
| Romy Frey | Contact | +41522662645 | romy.frey@ksw.ch |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Zwahlen, MD, MBA | Kantonsspital Winterthur KSW | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Winterthur | Recruiting | Winterthur | Canton of Zurich | 8401 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38310268 | Derived | Windisch P, Becker I, Tang H, Schroder C, Buchali A, Aebersold DM, Zwahlen DR, Forster R, Shelan M. Converting between the International Prostate Symptom Score (IPSS) and the Expanded Prostate Cancer Index Composite (EPIC) urinary subscales: modeling and external validation. BMC Urol. 2024 Feb 3;24(1):28. doi: 10.1186/s12894-024-01421-y. |
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| ID | Term |
|---|---|
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| 25 years |