Table 1 Hypotheses for testing responsiveness

1.

An improvement/deterioration in family members’ QoL measured by FROM-16 in relation to a significant improvement/deterioration in patient HRQoL measured by EQ-5D (including when a patient’s health improves or worsens). A higher score of FROM-16 means deterioration while a higher score on EQ-5D-3L means improvement and vice versa)

2.

Moderate to high positive correlation between FROM-16 change scores and the GRC scale measuring a similar construct

3.

Low to moderate positive correlation between the FROM-16 change score and the patient’s disease severity change score measuring dissimilar construct

4.

Low to moderate negative correlation between the FROM-16 change score and the patient’s EQ-5D change score measuring related but dissimilar construct

5.

Family members/informal carers indicating improvement on the associated GRC scale should have a positive mean change score

6.

Family members/informal carers indicating worsening on the associated GRC scale should have a negative mean change score

7.

The mean change score of family members/partners indicating improvement should be higher than the mean change score of unchanged family members/partners, which in turn should be higher than the mean change score of worsened family members/partners

8.

FROM-16 change score (Improvement)^a, AUC ≥ 7

9.

FROM-16 change score (deterioration)^b, AUC ≥ 7