Table 3. Variables, measures and methods of analysis.
| Variable/Outcome | Hypothesis* | Outcome | Method of Analysis |
|---|---|---|---|
| PRIMARY | |||
| Patient-reported Health-Related Quality of Life (HRQOL) outcomes | Improved | HRQOL scores, measured by the EQ-5D-5L at 12 weeks | Examine the distributions/ Wilcoxon rank sum test/regression |
| SECONDARY | |||
| Short-Term Clinical Outcomes | |||
| Pathological Staging | Improved | Pathological stage | McNemar’s test |
| Lymph nodes | More | Number of lymph nodes harvested | Independent t-test, Wilcoxon rank sum test/linear regression |
| Duration of chest tube drainage | Shorter | Number of days between surgery and chest tube removal | Kaplan-Meier method, Cox regression |
| Hospital length of stay | Shorter | Number of days between admission and discharge | Kaplan-Meier method, Cox regression |
| Intra-operative blood loss | Less | Volume of Intra-operative blood loss (mL) | Independent t-test/Wilcoxon rank sum test/ linear regression |
| Post-operative analgesia requirements | Less | In-hospital consumption (days, type, amount) | Independent t-test/Wilcoxon rank sum test/linear regression |
| Chronic post-surgical pain | Less | In-hospital pain (daily, scale) | Independent t-test/Wilcoxon rank sum test/ANOVA |
| Patient-reported Health-Related Quality of Life (HRQOL) outcomes | Improved | HRQOL scores, measured by the EQ-5D-5L at 3 and 7 weeks, and 6 and 18 months, and 1,2, 3, 4 and 5 years | Examine the distributions/ regression/ANOVA |
| Resource Utilization and Cost Effectiveness | More | Resource utilization tracking system, EQ-5D-5L, Return to Normal Living Index (RNLI), and employment status at 12 months | Incremental cost per quality-adjusted life year (QALY) gained will be calculated |
| Overall Survival | Improved | 5-year survival difference | Kaplan-Meier method and cox proportional hazard models. Survival curves will be compared using the Log-rank test |
| SENSITIVITY | |||
| Patient-reported Health-Related Quality of Life (HRQOL) outcome | Improved | HRQOL scores, measured by the EQ-5D-5L at 12 weeks | Independent t-test/ linear regression with multiple imputation for missing data |
*Expected that RTS-Lobectomy will improve or be more, less, fewer or shorter than VATS-Lobectomy for each variable/outcome.