Establishing clinically meaningful within-individual improvement thresholds for eight patient-reported outcome measures in people with relapsing-remitting multiple sclerosis

Greene, Nupur; Quéré, Stéphane; Bury, Denise P.; Mazerolle, Flora; M’Hari, Manal; Loubert, Angély; Regnault, Antoine; Higuchi, Keiko

doi:10.1186/s41687-023-00594-8

Journal of Patient-Reported Outcomes

Table 4 Within-individual estimates from anchor-based and distribution-based methods for MSIS-29 v2, FSMC, MSPS, and MSNQ scores

From: Establishing clinically meaningful within-individual improvement thresholds for eight patient-reported outcome measures in people with relapsing-remitting multiple sclerosis

Score	Anchor-based methods				Distribution-based methods				Triangulation
Score	Anchor	Category	Means^a	ROC^b	SD_BL	0.5 SD_BL	SEM^c	Min detectable change	Step^d	Recommended value^e	Conservative value^f
MSIS-29 v2
Physical impact	PDDS	Improvement of 1 category versus No change	− 6.86	− 3.33	25.37	12.69	4.85	13.45	1.67	− 6.68	− 15.03
		Improvement of 2 categories versus Improvement of 1 category or No change	− 4.09	− 5.00
		Improvement of 1 or 2 categories versus No change	− 6.57	− 3.33
Psychological impact	PDDS	Improvement of 1 category versus No change	− 7.30	− 3.70	24.81	12.40	7.20	19.94	3.70	− 7.40	− 22.20
		Improvement of 2 categories versus Improvement of 1 category or No change	− 5.12	− 7.41
		Improvement of 1 or 2 categories versus No change	− 7.21	− 3.70
FSMC
Physical fatigue	MSPS Fatigue item	Improvement of 1 category versus No change	− 1.96	0.00	11.10	5.55	2.37	6.48	1.00	− 3.00	− 7.00
		Improvement of 2 categories versus Improvement of 1 category or No change	− 2.01	− 3.00
		Improvement of 1 or 2 categories versus No change	− 2.07	− 1.00
Cognitive fatigue	MSPS Fatigue item	Improvement of 1 category versus No change	− 2.00	2.00	11.19	5.60	2.37	6.56	1.00	− 2.00	− 7.00
		Improvement of 2 categories versus Improvement of 1 category or No change	1.24	3.00
		Improvement of 1 or 2 categories versus No change	− 1.56	2.00
Total score	MSPS Fatigue item	Improvement of 1 category versus No change	− 3.96	0.00	21.62	10.81	3.47	9.62	1.00	− 4.00	− 10.00
		Improvement of 2 categories versus Improvement of 1 category or No change	− 0.78	1.00
		Improvement of 1 or 2 categories versus No change	− 3.63	0.00
MSPS
Total	PDDS	Improvement of 1 category versus No change	− 1.77	− 1.00	7.03	3.51	2.78	7.71	1.00	− 2.00	− 8.00
		Improvement of 2 categories versus Improvement of 1 category or No change	− 1.64	− 1.00
		Improvement of 1 or 2 categories versus No change	− 1.86	− 1.00
MSNQ
Total	MSPS Cognition item	Improvement of 1 category versus No change	− 2.28	− 1.00	13.24	6.62	2.75	7.62	1.00	− 3.00	− 8.00
		Improvement of 2 categories versus Improvement of 1 category or No change	− 3.26	− 11.00
		Improvement of 1 or 2 categories versus No change	− 2.47	− 1.00

^aMeans refer to the difference in mean change in PRO score between the two categories of the dichotomized anchor variable. ^bROC refers to the cut-off in the ROC curve, being the change in PRO score that best discriminates the two categories of the anchor (smallest sum of squares of 1-sensitivity and 1-specificity). ^cSEM based on Cronbach's alpha calculated at baseline. ^dStep refers to the distance between two consecutive observable values of the PRO score. ^eThe recommended value for meaningful within-individual improvement was defined from the comparison of mean change in PRO scores between participants showing improvement of one or two categories in the anchor variable and those who did not show any change. ^f “Conservative” value was defined based on distribution-based method results
FSMC Fatigue Scale for Motor and Cognitive Functions; MSIS-29 v2 Multiple Sclerosis Impact Scale 29 items version 2; MSNQ Multiple Sclerosis Neuropsychological Screening Questionnaire; MSPS Multiple Sclerosis Performance Scale; PDDS Patient-Determined Disease Steps; ROC Receiver-operating characteristic; SD_BL Standard deviation at baseline; SEM Standard error of measurement

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