Goal analysis in patients with limb spasticity treated with incobotulinumtoxinA in the TOWER study

Abstract

Purpose

To map spasticity-related goals using the International Classification of Functioning, Disability and Health (ICF) linking rules, and review goal syntax to direct future goal setting.

Materials and methods

1633 treatment goals, set during the TOWER study, were linked to the ICF framework and EQ-5D domains. Goals were mapped independently by two investigators with expertise in ICF linking rules.

Results

In total, 1630 (99.8%) goals could be mapped to the ICF (inter-rater agreement on the main ICF category 96.1%). Most goals (80.2%) were mapped to a single ICF category and were related to activities/participation (54.9%). 170 (10.4%) goals were related to general tasks and activities, such as positioning, stretching, and strengthening. In total, 1072 goals (65.6%) mapped to the EQ-5D domains (inter-rater agreement 90.8%). Analysis of the goal syntax highlighted the need to include a verb in patient-centered goals to direct active behavior.

Conclusions

The ICF offers a broad framework for setting patient-centered, easily understandable goals for patients with spasticity, including goals related to (guided) self-management activities. This analysis sheds new light on patient needs and could direct future goal-driven botulinum toxin spasticity treatment focused on enabling patients to better manage activity limitations imposed by their body function impairments.

Trial registration: NCT01603459 registered with ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT01603459).

Implications for Rehabilitation

• The ICF offers a broad framework for setting patient-centered, easily understandable goals for patients with spasticity.

• ICF domains that include general tasks and demands can be used to establish goals relating to (guided) self-management of spasticity.

• An ICF-based goal-setting framework may increase the comparability of clinical data across studies.

Keywords:

• Botulinum toxin
• incobotulinumtoxinA
• spasticity
• goal setting
• International Classification of Functioning
• Disability and Health

Acknowledgments

The authors would like to thank Sylvia Ramusch for her contributions to goal mapping in this study, and the patients and investigators for their participation in the TOWER study; in particular, the Primary Investigators at each study site: Canada, Stephen McNeil, and Lalith Satkunam; France, Djamel Bensmail, Isabelle Laffont, and Frédéric Pellas; Germany, Manuel Dafotakis, Markus Ebke, Martin Hecht, Peter Kossmehl, David Liebetanz, Friedemann Müller, Iris Reuter, Walter Raffauf, and Tobias Wächter; Italy, Sergio Barbieri, Alessio Baricich, Mario Basciani, Giancarlo Ianieri, Franco Molteni, Maurizio Osio, Francesco Sciarrini, Nicola Smania; Norway, Tiina Ader, and Tiina Rekand; Portugal, Joaquim Ferreira, and Luisa Medeiros; Spain, Montserrat Abenoza Guardiola, Josefina Junyent Pares, Lourdes López de Munaín, Susana Moraleda, and Marina Tirado; USA, François Bethoux, William Bockenek, Shashank Davé, John McGuire, Bruce Rubin, and David M Simpson. The authors would also like to thank Merz team members Birgit Flatau-Baqué, Daniel Ropeter, Olivier Simon, and Michael Althaus for their contributions to the TOWER study. Medical writing support, under the direction of the authors, was provided by Eric Comeau, PhD, CMC Connect, McCann Health Medical Communications, in accordance with Good Publication Practice (GPP3).

Disclosure statement

KF: Received research grants from Ipsen and Merz, and has received sponsorship from Ipsen, Merz, and Allergan to attend conferences and advisory board meetings in the EU. JW: Received honorarium for lectures and served as a consultant at advisory board meetings for Allergan, Ipsen, Gedeon-Richter, Medtronic, and Merz. AS: Is an employee of Merz Pharmaceuticals GmbH.

Author contributions

KF, JW contributed in study design. AS, KF, JW contributed in data analysis and interpretation. AS, KF, JW contributed in Critical review of the manuscript. AS, KF, JW contributed in the final version of the manuscript reviewed and approved for submission.

Additional information

Funding

Medical writing support was funded by Merz Pharmaceuticals GmbH.