Primary RPLND Versus Systemic Chemotherapy in Good-prognosis Metastatic Testicular Cancer

HRQOL after treatment as measured by the EORTC QLQ-C30 with the testicular cancer-specific supplement EORTC QLQ-TC26

Changes across study-groups in global HRQOL after treatment as measured by the EORTC QLQ-C30 with the testicular cancer-specific supplement EORTC QLQ-TC26 The QLQ-C30 comprises both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

Fatigue after RPLND vs. chemotherapy

Differences in fatigue across study-groups as measured by the Fatigue Questionnaire (FQ). The FQ is an established, self-report fatigue questionnaire comprising 14 items that assess the intensity of fatigue-related symptoms. Each item was rated on a 4-point Likert scale (0 'better than usual', 1 'no more than usual', 2 'worse than usual', 3 'much worse than usual'). The FQ score is the sum of all items' scores (range 0-42).

Ejaculation problems

Differences across study-groups in patient-reported prevalence of retrograde ejaculation as assessed by two "supplementary" questions. These questions concern difficulties achieving ejaculation following sexual stimulation and whether the amount of semen is considered a problem. Answers are given on 4-point scales (no sexual stimulation has occurred, big difficulties (achieving ejaculation), small difficulties, no difficulties, and no sexual stimulation has occurred, large problem (amount of semen), small problem, no problem, respectively).

Treatment related complications

Rate of doctor-reported complications related to treatment in the study-groups. Journals are reviewed to gather information regarding the time and type of complication. Surgery group: Surgical complications are classified according to the Clavien-Dindo (CD) system, a standardised, 5-grade system used to grade surgical complications based on the level of therapeutic intervention required to manage them. Chemotherapy group: Complications following chemotherapy are classified according to the Common Terminology Criteria for Adverse Events, using a 1-5 scale to grade the severity of the event.

Healt economy

Differences in quality-adjusted life years across study groups as measured by the EQ-5D-5L tool, consisting of an index varying from 1 (full health) to 0 (dead), with scores below 0 indicating states worse than being dead. The index is evaluated at baseline (before start of treatment) and at 3, 6, 12 and 24 months thereafter.