WiZen: Effectiveness of Care in Certified Cancer Centres in Germany
Study Details
Study Description
Brief Summary
Assessment of the effectiveness of care in certified cancer centres for eight cancer entities via a retrospective cohort study based on secondary data from statutory health insurance funds and population-based clinical cancer registries.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Cancer constitutes the second most frequent cause of death in Germany. To maintain a high quality of treatment, the national cancer plan aims at a unified certification of cancer centres.
The project "Wirksamkeit der Versorgung in onkologischen Zentren" (WiZen) investigates effects of treatments in certified cancer centres across large populations and different cancer entities in comparison to hospitals that do not hold a certificate.
WiZen is a retrospective comparative cohort study that analyzes incident cases of eight types of cancer diagnosed within 2009-2017 based on nationwide health insurance data provided by WIdO (the AOK research institute) and data from regional clinical cancer registries (CCR) for the period 2006-2017. These eight types of cancer are colorectal cancer, pancreatic cancer, breast cancer, gynecologic tumors, lung cancer, prostate cancer, head and neck tumors and neuro-oncological tumors.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Intervention Cancer patients who have undergone substantial parts of inpatient treatment in a certified cancer centre. |
Other: Oncological certification
Oncological certification encompasses a variety of criteria such as treatment according to the clinical guidelines, staffing, technical infrastructure, minimum caseloads, and multidisciplinary care.
|
| Control Cancer patients who have not undergone inpatient treatment in a certified cancer centre. |
Outcome Measures
Primary Outcome Measures
- Overall survival [first hospitalization (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]), up to 31/12/2017]
Survival after first hospitalization due to cancer
- 1- and 5-year survival [first hospitalization (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]) with 1 or 5-year follow-up, respectively]
1- and 5-year survival after first hospitalization due to cancer
- 30-day mortality [first hospitalization (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]) with 30 days follow-up]
30-day mortality after first hospitalization due to cancer
Secondary Outcome Measures
- 2-, 3-, 4-year survival [first hospitalization (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]) with 2,3, or 4-year follow-up, respectively]
2-, 3-, 4-year survival after first hospitalization due to cancer
- Recurrence-free survival [cancer diagnosis (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]), up to 31/12/2017]
Recurrence-free survival after cancer diagnosis
- Cumulative recurrence rate [cancer diagnosis (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]), up to 31/12/2017]
Cumulative recurrence rate after cancer diagnosis
- Complications due to surgery [date of initial cancer surgery with entity-specific follow-up]
Complications due to cancer surgery
- Successive resection [second resection within three months of initial cancer surgery]
Second resection due to cancer
- Entity-specific outcomes defined by clinical experts [2009-2017 [CCR] or 2006-2017 [WIdO]]
Fractions of entity-specific surgery techniques For head-neck-tumours: aspiration pneumonia due to swallowing dysfunctions
- Fraction of patients [2009-2017]
Fraction of patients in certified centres and in non-certified hospitals over time
- Regional differences [2009-2017]
Differences across outcomes in different counties or federal states
- Differences in patient characteristics [2009-2017 [CCR] or 2006-2017 [WIdO]]
Differences in demographic characteristics, disease severity and risk factors across certified centres/non-certified hospitals
- Pathways of treatment [2009-2017]
Patient's treatment pathways among general practitioners, specialists, and hospitals w.r.t. certification
- Severity Levels in insurance data [2009-2017]
Deduction of cancer severity levels through linkage of health insurance and cancer registry data
Eligibility Criteria
Criteria
Inclusion Criteria:
-
first hospitalization due to diagnosis of colorectal cancer, pancreatic cancer, breast cancer, gynecologic tumors, lung cancer, prostate cancer, head and neck tumors, or neuro-oncological tumors 2009-2017 [WIdO]
-
hospitalization due to primary diagnosis of colorectal cancer, pancreatic cancer, breast cancer, gynecologic tumors, lung cancer, prostate cancer, head and neck tumors, or neuro-oncological tumors 2006-2017 [CCR]
Exclusion Criteria:
-
prevalent diagnosis of colorectal cancer, pancreatic cancer, breast cancer, gynecologic tumors, lung cancer, prostate cancer, head and neck tumors, or neuro-oncological tumors 2006-2017
-
exception: outpatient cancer diagnosis up to 12 months prior to first hospitalization is not regarded as prevalent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Technische Universität Dresden | Dresden | Sachsen | Germany | 01307 |
Sponsors and Collaborators
- Technische Universität Dresden
- Tumorzentrum Regensburg, Institut für Qualitätssicherung und Versorgungsforschung, Universität Regensburg
- Arbeitsgemeinschaft Deutscher Tumorzenten e.V., ADT
- Wissenschaftliches Institut der AOK (WIdO)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 01VSF17020