The spasticity-related quality of life 6-dimensions instrument in upper-limb spasticity: Part I Development and responsiveness

Lynne Turner-Stokes, Klemens Fheodoroff, Jorge Jacinto, Jeremy Lambert, Christine De La Loge, Françoise Calvi-Gries, John Whalen, Andreas Lysandropoulos, Pascal Maisonobe, Stephen Ashford, Lynne Turner-Stokes, Klemens Fheodoroff, Jorge Jacinto, Jeremy Lambert, Christine De La Loge, Françoise Calvi-Gries, John Whalen, Andreas Lysandropoulos, Pascal Maisonobe, Stephen Ashford

Abstract

Objective: To describe the development of the Spasticity-related Quality of Life 6-Dimensions instrument (SQoL-6D) and its sensitivity to clinical change (responsiveness).

Design: Multicentre, prospective, longitudinal cohort study at 8 UK sites (NCT03442660).

Patients: Adults (n = 104) undergoing focal treatment of upper limb spasticity.

Methods: No condition-specific health-related quality of life tool is available for upper-limb spasticity of any aetiology. The SQoL-6D was developed to fulfil this need, designed to complement the Upper Limb Spasticity Index (which incorporates the Goal Attainment Scaling evaluation of upper limb spasticity [GASeous] tool) with targeted standardised measures. The 6 dimensions of the SQoL-6D (score range 0-4) map onto common treatment goal areas identified in upper-limb spasticity studies. A Total score (0-100) provides overall spasticity-related health status. To assess responsiveness, the SQoL-6D, Global Assessment of Benefit scale and "GASeous" were administered at enrolment and 8 weeks.

Results: Significant differences in mean SQoL-6D Total score change and effect sizes across patients rating "some benefit" (0.51) and "great benefit" (0.88) supported responsiveness.

Conclusion: The SQoL-6D is a promising new measure of health status in upper limb spasticity, that enables systematic assessment of the impact of this condition in relation to patients' priority treatment goals. A psychometric evaluation of SQoL-6D is presented separately.

Figures

Fig. 1
Fig. 1
Context and development of the spasticity-related quality of life 6-dimensions instrument (SQoL-6D). 1. Turner-Stokes et al. J Rehab Med 2010; 42: 81–89; 2. Ashford et al. Phy Res Int 2006; 11: 24–34; 3. Turner-Stokes et al. J Int Soc Phys Rehabil Med 2019; 2: 138–150.
Fig. 2
Fig. 2
Patient disposition. Percentages were calculated based on the enrolled population for the full analysis set (FAS) population, and based on the FAS population for the responsiveness population. SQoL-6D: Spasticity Quality of Life-6 Dimensions instrument.
Fig. 3
Fig. 3
Mean (95% CI) change in Spasticity Quality of Life-6 Dimensions instrument (SQoL-6D) scores by subgroups at follow-up. (a) Clinician Global Assessment of Benefit scale. (b) Patient Global Assessment of Benefit scale. (c) GAS T-scores. Data are derived from the Responsiveness Population (n = 90).*p < 0.05 **p < 0.01. Analysis of variance (ANOVA) was used for the Total score, Kruskal–Wallis for dimension scores and t-tests for GAS T-scores. Note: Parametric and non-parametric tests led to similar p-values. 95% CI: 95% confidence interval; GAS: goal attainment scaling.

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