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The administration of the paper and electronic versions of the Manual Ability Measure-36 (MAM-36) and Fatigue Severity Scale (FSS) is equivalent in people with multiple sclerosis

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Abstract

Background

The mobile device diffusion has increasingly highlighted the opportunity to collect patient-reported outcomes (PROs) through electronic patient-reported outcomes measurements (ePROMs) during the clinical routine. Despite the ePROMs promises and advantages, the equivalence when a PRO measure is moved from the original paper-and-pencil to the electronic version is still little investigated. This study aims at evaluating equivalence between PROMs and ePROMs self-administration in people with multiple sclerosis (PwMS); in addition, preference of self-administration type was evaluated.

Methods

The Manual Ability Measure-36 (MAM-36) and Fatigue Severity Scale (FSS) were selected for the equivalence test. The app ABOUTCOME was developed through a user-centered design approach to administer the questionnaires on tablet. Both paper-and-pencil and electronic versions were randomly self-administered. Intrarater reliability between both versions was evaluated through the intraclass correlation coefficient (ICC, excellent for values ≥ 0.75).

Results

Fifty PwMS (35 females) participated to the study (mean age: 54.7±11.0 years, disease course: 27 relapsing-remitting and 23 progressive; mean EDSS: 4.7±1.9; mean disease duration: 13.3±9.5 years). No statistically significant differences were found for the means total scores of MAM-36 (p = 0.61) and FSS (p = 0.78). The ICC value for MAM-36 and FSS was excellent (0.98 and 0.94, respectively). Most of participants preferred the tablet version (84%).

Conclusion

The results of the study provide evidence about the equivalence between the paper-and-pencil and electronic versions of PROs administration. In addition, PwMS prefer electronic methods rather than paper because the information can be provided more efficiently and accurately. The results could be easily extended to other MS PROs.

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Data availability

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

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Acknowledgements

We would like to acknowledge the significant contribution of Maria Madera and Giulia Bignone (secretariat) to the implementation of this protocol.

Funding

This work was supported by the Italian Multiple Sclerosis Foundation (FISM) (grant number 2014/20).

Author information

Authors and Affiliations

  1. Italian Multiple Sclerosis Foundation (FISM), Scientific Research Area, Via Operai, 40, 16149, Genoa, Italy

    Andrea Tacchino, Erica Grange, Maria Marcella Spirito, Michela Ponzio & Giampaolo Brichetto

  2. CRRF “Mons. L. Novarese”, Moncrivello (VC), Italy

    Rachele Di Giovanni & Claudio Marcello Solaro

  3. University of Siena, Department of Life Science, Siena, Italy

    Mario Alberto Battaglia

  4. Italian Multiple Sclerosis Society (AISM) Rehabilitation Service of Liguria, Genoa, Italy

    Giampaolo Brichetto

  5. Galliera Hospital, Neurology Unit, Genoa, Italy

    Claudio Marcello Solaro

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  1. Andrea Tacchino
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Contributions

All the authors approved the submitted version (and any substantially modified version that involves the author’s contribution to the study) and agreed both to be personally accountable for the author’s own contributions and to ensure that questions related to the accuracy or integrity of any part of the work, even ones in which the author was not personally involved, are appropriately investigated, resolved, and the resolution documented in the literature. In addition, each of the authors made specific contributions as outlined below. AT substantially contributed to the conception and design of the work; and to the acquisition, analysis, and interpretation of data; he drafted the work. RDG substantially contributed to the conception of the work; and to the acquisition, and analysis of data; she revised the work critically for important intellectual content. EG substantially contributed to the conception of the work; and to the acquisition, and analysis of data; she revised the work critically for important intellectual content. MMS substantially contributed to the conception of the work; she revised the work critically for important intellectual content. MP substantially contributed to the analysis and interpretation of data; she revised the work critically for important intellectual content. MAB substantially contributed to the conception and design of the work. He revised the work critically for important intellectual content. GB substantially contributed to the conception and design of the work; he revised the work critically for important intellectual content. CS substantially contributed to the conception and design of the work; and to the acquisition, analysis, and interpretation of data; he revised the work critically for important intellectual content.

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Correspondence to Andrea Tacchino.

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The project was approved by the local Ethics Committee of San Martino Hospital (P.R.196REG2015) and performed in accordance with the ethical standards as laid down in the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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Tacchino, ., Di Giovanni, R., Grange, E. et al. The administration of the paper and electronic versions of the Manual Ability Measure-36 (MAM-36) and Fatigue Severity Scale (FSS) is equivalent in people with multiple sclerosis. Neurol Sci 45, 1155–1162 (2024). https://doi.org/10.1007/s10072-023-07103-1

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