Table 3.
Spanish standard set of patient-centered outcomes in LC.
| Patient profile | Variable | Supporting information | Measurement instrument | Timing | Data sources |
|---|---|---|---|---|---|
| Demographic factors | |||||
| All patients | Age | Date of birth | Baseline (before treatment begins) | Clinical | |
| Gender | F: female; M: male | Clinical | |||
| Family support | Degree of family support and degree of patient dependence | Yes/No | Patient-reported | ||
| Educational level | Level of schooling completed | (0) Without studies; (1) primary school level; (2) secondary school level; (3) higher education | Patient-reported | ||
| Baseline clinical factors | |||||
| All patients | Unintentional weight loss | Yes/No/I don't know | Baseline (before treatment begins) | Patient-reported | |
| Smoking status | Smoking status at diagnosis | Pack-year index + smoking status classification: Never-smoker (<100 cigarettes in lifetime), ex-smoker (stopped >1 year before diagnosis), current smoker | Patient-reported | ||
| Performance status | ECOG scale | Clinical | |||
| Patient-reported health status | Tracked via generic questionnaire EQ5D and LC specific questionnaire LCSS | Patient-reported | |||
| Comorbidities | Charlson index | Clinical | |||
| Pulmonary function | FEV1 | NA | Clinical | ||
| Baseline tumor factors | |||||
| All patients | Clinical stage | TNM scale | Baseline (before treatment begin) | Clinical | |
| Pathological stage | TNM scale | Clinical | |||
| Histology | NA | Clinical | |||
| EGFR mutation* | Yes/No/undetermined | Clinical | |||
| ALK translocation* | Yes/No/undetermined | Clinical | |||
| ROS-1 rearrangement * | Yes/No/undetermined | Clinical | |||
| PD-L1 expression* | Yes/No/undetermined | Clinical | |||
| Treatment factors | |||||
| All patients | Treatment intent | (1) curative; (2) palliative | Baseline (before treatment begins) | Physician-reported | |
| Completed treatment | (1) Yes, with dose reduction; (2) No, due to toxicity; (3) No, due to patient's will; (4) No, due to patient's death | At treatment ending | Physician-reported | ||
Case-mix variables.
NA, not applicable; ECOG, Eastern Cooperative Oncology Group; EQ-5D, EuroQol; LCSS, Lung Cancer Symptoms Scale; FEV-1, forced expiratory volume; EGFR, Epidermal growth Factor Receptor; ALK, Anaplastic Lymphoma Kinase; PD-L1, Programmed Death-ligand;
*
List of Biomarkers annually valuated and updated.