Table 1 Primary and Secondary outcomes of the FURTHER-trial, a trial looking at the impact of treatment with MR-HIFU with or without radiotherapy on patients with painful bone metastases

Primary outcomes

1.1. Pain response 14 days after completion of treatment

Assessed using the BPI and patient pain diary. Used to assess the short-term effectiveness of treatment

1.2. Pain response at 14 days after inclusion

Assessed using the BPI and patient pain diary. Used to assess the effectiveness of treatment taking hospital logistics and planning into account

Secondary outcomes

2.1. Patient-reported pain scores

Assessed using the BPI and patient pain diary during the first 21 days, at 4 and 6 weeks and 3 and 6 months following treatment

2.2. Physician reported toxicity

Assessed by telephone call at 3 days; 1, 4, and 6 weeks; and 3 and 6 months following completion of treatment according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

2.3. Patient-reported quality of life

Assessed using the EORTC QLQ BM22, C15-PAL, EQ-5D-5L, and PGIC at baseline; 1, 2, and 4 weeks; and 3 and 6 months following completion of treatment

2.4. Local tumor control

Assessed using CT and/or MRI imaging at patient discretion at 3 and/or 6 months after completion of treatment

2.5. Levels of anxiety and depression

Assessed among patients, patients’ partners, and caregivers by the Hospital Anxiety and Depression Scale (HADS) and EDIZ-list at baseline; 1, 2, 4, and 6 weeks; and 3 and 6 months following completion of treatment

2.6. Cost-effectiveness of the treatment

Assessed as cost per responder and cost per quality-adjusted life years (QALY), from a payer perspective, at 6 months of follow-up