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Responsiveness of patient-reported outcome measures in multiple sclerosis relapses: the REMS study
  1. Andrea Giordano
  1. Unit of Neuroepidemiology, Foundation IRCCS Neurological Institute C. Besta, Milan, Italy
    1. Eugenio Pucci
    1. Neurology Department, Macerata Hospital, Macerata, Italy
      1. Paola Naldi
      1. Neurology Clinic, University Hospital “Maggiore della Carità”, Novara, Italy
        1. Laura Mendozzi
        1. MS Unit, Foundation IRCCS Don C. Gnocchi Onlus, Milan, Italy
          1. Clara Milanese
          1. Multiple Sclerosis Unit, Foundation IRCCS Neurological Institute C. Besta, Milan, Italy
            1. Federica Tronci
            1. MS Unit, Foundation IRCCS Don C. Gnocchi Onlus, Milan, Italy
              1. Maurizio Leone
              1. Neurology Clinic, University Hospital “Maggiore della Carità”, Novara, Italy
                1. Nerina Mascoli
                1. Multiple Sclerosis Unit, Foundation IRCCS Neurological Institute C. Besta, Milan, Italy
                  1. Loredana La Mantia
                  1. Multiple Sclerosis Unit, Foundation IRCCS Neurological Institute C. Besta, Milan, Italy
                    1. Giorgio Giuliani
                    1. Neurology Department, Macerata Hospital, Macerata, Italy
                      1. Alessandra Solari (solari{at}istituto-besta.it)
                      1. Unit of Neuroepidemiology, Foundation IRCCS Neurological Institute C. Besta, Milan, Italy

                        Abstract

                        Objectives: To assess the responsiveness of the three most-used patient-reported multiple sclerosis (MS)-specific questionnaires: the Functional Assessment of MS (FAMS), the MS Impact Scale (MSIS-29), and the 54-item MS Quality of Life (MSQOL-54).

                        Design: Prospective multicentre longitudinal study on 104 MS patients treated with i.v. steroids for clinical exacerbation.

                        Methods: Patient-reported data, EDSS score and clinical information were collected at admission and 8 weeks later. ‘Internal’ (distribution-based) responsiveness was assessed by standardized response means (SRM). ‘External’ (anchor-based) responsiveness was assessed by receiver operating characteristic (ROC) curves in relation to corresponding changes in a pre-specified reference measure (anchor). The pre-specified anchor was patients’ self-reported recovery assessed on a five-point Likert scale.

                        Results: SRM was 0.39 for FAMS, 0.58 for MSIS-29 physical scale, 0.45 for MSIS-29 psychological scale, 0.71 for MSQOL-54 physical health composite, and 0.57 for MSQOL-54 mental health composite. Seventy three patients (70%) reported they had improved; physicians agreed substantially with patient assessments (kappa statistic 0.70, 95% CI 0.54-0.85). Areas under ROC curves differed significantly from 0.50 only for the MSIS-29 and MSQOL-54 scales, where areas ranged from 0.65 (95% CI 0.53-0.76) for the MSIS-29 psychological scale, to 0.70 (95% CI 0.58-0.81) for the MSQOL-54 mental health composite. Areas under ROC curves assessed using a physician-based anchor were similar to the patient-based areas.

                        Conclusions: The responsiveness of the MS-specific instruments was less than ideal. The MSIS-29 and the MSQOL-54 were significantly more responsive, using both distribution-based and anchor-based approaches, than FAMS, and should be preferred in longitudinal studies.

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