Responsiveness and minimal important change of the Family Reported Outcome Measure (FROM-16)

Journal of Patient-Reported Outcomes

Table 3 Testing results of the hypotheses for evaluation of responsiveness of FROM-16 to change over time

Hypotheses to be tested	Family member/partner				Patient			Hypotheses Confirmed
Hypotheses to be tested	Mean FROM-16 change score (SD)	CC	ES	SRM	Mean EQ-5D¹ change score (SD)	ES	SRM	Hypotheses Confirmed
1. An improvement/deterioration in family member/partner QoL (measured by FROM-16) was hypothesised in relation to changes in:
(a) Patient’s HRQoL on EQ-5D-3 L (n = 83)	1. 43 (5.01)*		0.21	0.29	−0.059 (0.14)**	−0.26	−0.41	Yes
(b) Patient’s disease severity (Improved) on GSQ (n = 42)	2.53 (4.82)**		0.39	0.56	−0.10 (0.14)**	−0.44	−0.73	Yes
(c) Patient’s disease severity (worsened) on GS scale (n = 27)	0.41(5.27)		0.06	0.08	−0.014 (0.17)	−0.06	−0.086	Yes
2. Moderate to high positive correlation between FROM-16 change score and the GRC score		r = 0.39**						Yes (moderate)
3. Low to moderate positive correlation FROM-16 and DS change score		r = 0.37**						Yes (moderate)
4. Low to moderate negative correlation FROM-16 and EQ-5D change score		r = -0.24**						Yes (Low)
5. Mean change improved^a is positive (n = 9)	6.89 (8.22)*		0.83	0.85				Yes
6. Mean change worsened^b is negative (n = 8)	− 1.38 (2.26)		−0.17	−0.61				Yes
7. Mean change unchanged (n = 6)	1.03 (4.2)		0.17	0.25				Yes, (6.9 > 1.0 > −1.4)
Mean change improved > unchanged > worsened								Yes, (6.9 > 1.0 > −1.4)
8. FROM-16 change score (Improvement)^c, AUC ≥ 7								Yes, AUC = 0.76*
9. FROM-16 change score (deterioration)^d, AUC ≥ 7								Yes, AUC = 0.78*

¹EQ-5D improvement/deterioration runs in the opposite direction to FROM-16; GRC Gobal rating of change; GS scale Global severity scale; AUC area under the receiver operating characteristics curve; CC Correlation Coefficient; ES Effect size; SRM Standardized response mean; DS Disease severity; Correlation was interpreted as high (>0.5), moderate (0.3–0.5) or low (<0.3)
** Correlation is significant at < 0.001 level (2-tailed); * Correlation is significant at < 0.05 level (2-tailed)
^aThe mean change score of the family members indicating improvement on the associated GRC scale; ^bThe mean change score of the family members indicating worsening on the associated GRC scale; ^cbased on the anchor perceived improvement; ^dbased on the anchor perceived deterioration