Background
Methods/Design
Aim
1. Outcomes assessment | 2. Creation of predictive models | 3. Health services evaluation in breast cancer patients in Spain |
To describe and analyse variability in outcomes by mode of detection, hospital, region and surgeon | • To create and validate predictive rules for relapse, mortality and complications | • To estimate the average costs of breast cancer care in Spain |
To describe and analyse variability in the diagnostic process and treatment | • To identify risk factors for poor health-related quality of life 2 years after treatment | • To investigate differences between Spanish regions |
To explore potential inequalities by age, education and socioeconomic level | • To validate our predictive rules for relapse, mortality and complications in a retrospective sample of patients from early detection programs | • To identify the most efficient process and treatments in breast cancer |
To evaluate the impact of first hospital care (urgent or scheduled) and of delays on relapse, metastasis and death |
Design and setting
Region | Hospital | Valid patients |
---|---|---|
Catalonia | Hospital del Mar, Barcelona | 97 |
Basque Country | Hospital Galdakao-Usansolo, Bizkaia | 197 |
Hospital de Cruces, Bizkaia | 246 | |
Hospital de Basurto, Bizkaia | 125 | |
Hospital de Txagorritxu, Araba | 229 | |
H.U. Donostia, San Sebastián, Gipuzkoa | 245 | |
Instituto Oncológico, San Sebastian, Gipuzkoa | 134 | |
Andalusia | Hospital Costa del Sol, Malaga | 80 |
Antequera, Málaga | 6 | |
Canary Islands | Hospital Nuestra Sra de La Candelaria (Tenerife) | 61 |
Hospital Universitario de Canarias (Tenerife) | ||
Complejo Materno-Insular (Gran Canaria) | 36 | |
Clínica San Roque (Gran Canaria) | ||
Total | 1456 |
Study population
Information and data collection
Variables
Safety and ethical considerations
Follow-up
Sample size calculation
Missing data assumptions and recoding of variables
Symptomatology
Complications
Statistical analysis
Quality assurance
Duration of the project
Project management
Discussion
Total N = 1456
| ||
---|---|---|
Surgery
|
No surgery
| |
1432 (98.35%) | 24 (1.65%) | |
Age, yearsa | 57.604 (11.917) | 80.575 (11.257) |
Charlson comorbidity indexa | 0.325 (0.752) | 0.958 (1.197) |
Initial treatment | ||
Conservative | 648 (45.25%) | – |
Simple mastectomy | 203 (14.18%) | – |
Radical mastectomy | 38 (2.65%) | – |
Radical modified mastectomy | 46 (3.21%) | – |
Neoadjuvant therapy | 165 (11.52%) | 22 (91.67%) |
Adjuvant therapy | ||
Chemotherapy1 | 455 (31.77%) | |
ACT | 166 (11.59%) | |
TAC | 80 (5.59%) | |
CMF | 8 (0.56%) | |
FEC | 42 (2.93%) | |
FEC-Taxane | 41 (2.86%) | |
TC | 35 (2.44%) | |
Other | 88 (6.15%) | |
Radiotherapy (yes) | 1126 (78.63%) | |
Hormone therapy | 1146 (80.03%) | |
Tamoxifen | 484 (33.8%) | |
Tamoxifen +GnRH analogues2 | 50 (3.49%) | |
Tamoxifen +Aromatase inhibitors | 12 (0.84%) | |
Aromatase inhibitors | 639 (44.62%) | |
Others | 26 (1.82%) | |
TNM3 | ||
0 | 135 (9.43%) | 0 |
I | 683 (47.7%) | 2 (8.33%) |
II | 453 (31.63%) | 5 (20.83%) |
III | 134 (9.36%) | 4 (16.67%) |
IV | 18 (1.26%) | 11 (45.83%) |