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Evaluating more naturalistic outcome measures: A 1-year smartphone study in multiple sclerosis.

Bove R, White CC, Giovannoni G, Glanz B, Golubchikov V, Hujol J, Jennings C, Langdon D, Lee M, Legedza A, Paskavitz J, Prasad S, Richert J, Robbins A, Roberts S, Weiner H, Ramachandran R, Botfield M, De Jager PL - Neurol Neuroimmunol Neuroinflamm (2015)

Bottom Line: Among patients with MS, low scores on PROs relating to mental and visual function were associated with dropout (p < 0.05).Finally, averaging repeated measures over the study yielded the most robust correlation matrix of the different outcome measures.A smartphone platform may therefore enable large-scale naturalistic studies of patients with MS or other neurologic diseases.

View Article: PubMed Central - PubMed

Affiliation: Program in Translational Neuropsychiatric Genomics (R.B., C.C.W., B.G., M.L., S.P., A.R., H.W., P.L.D.J.), Ann Romney Center for Neurologic Diseases, and the Partners Multiple Sclerosis Center, Department of Neurology, Brigham and Women's Hospital, Brookline, MA; Harvard Medical School (R.B., B.G., S.P., H.W., P.L.D.G.), Boston, MA; Blizard Institute (G.G.) and Royal Holloway (D.L.), University College London, London, UK; Vertex Pharmaceuticals Incorporated (V.G., A.L., S.R., R.R., M.B.), Boston MA; Woo Sports (J.H.), Boston, MA; McGovern Institute Neurotechnology Program (C.J.), MIT, Cambridge, MA; and Biogen-Idec (J.P., J.R.), Cambridge, MA.

ABSTRACT

Objective: In this cohort of individuals with and without multiple sclerosis (MS), we illustrate some of the novel approaches that smartphones provide to monitor patients with chronic neurologic disorders in their natural setting.

Methods: Thirty-eight participant pairs (MS and cohabitant) aged 18-55 years participated in the study. Each participant received an Android HTC Sensation 4G smartphone containing a custom application suite of 19 tests capturing participant performance and patient-reported outcomes (PROs). Over 1 year, participants were prompted daily to complete one assigned test.

Results: A total of 22 patients with MS and 17 cohabitants completed the entire study. Among patients with MS, low scores on PROs relating to mental and visual function were associated with dropout (p < 0.05). We illustrate several novel features of a smartphone platform. First, fluctuations in MS outcomes (e.g., fatigue) were assessed against an individual's ambient environment by linking responses to meteorological data. Second, both response accuracy and speed for the Ishihara color vision test were captured, highlighting the benefits of both active and passive data collection. Third, a new trait, a person-specific learning curve in neuropsychological testing, was identified using spline analysis. Finally, averaging repeated measures over the study yielded the most robust correlation matrix of the different outcome measures.

Conclusions: We report the feasibility of, and barriers to, deploying a smartphone platform to gather useful passive and active performance data at high frequency in an unstructured manner in the field. A smartphone platform may therefore enable large-scale naturalistic studies of patients with MS or other neurologic diseases.

No MeSH data available.


Related in: MedlinePlus

Patterns of study retentionThe proportion of individuals actively participating in the study is displayed over the course of the study. (A) The trajectories of the cohabitants and the patients with multiple sclerosis (MS). (B) Patients with MS with subjective cognitive impairment at study entry (defined as an SF-36 Mental Composite Scale [MCS] score in the lowest quartile) were more likely to drop out of the study. (C) Patients with MS with subjective visual impairment at study entry (defined as an Impact of Visual Impairment Scale [IVIS] score >0) were more likely to drop out of the study.
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Figure 1: Patterns of study retentionThe proportion of individuals actively participating in the study is displayed over the course of the study. (A) The trajectories of the cohabitants and the patients with multiple sclerosis (MS). (B) Patients with MS with subjective cognitive impairment at study entry (defined as an SF-36 Mental Composite Scale [MCS] score in the lowest quartile) were more likely to drop out of the study. (C) Patients with MS with subjective visual impairment at study entry (defined as an Impact of Visual Impairment Scale [IVIS] score >0) were more likely to drop out of the study.

Mentions: The likelihood of study discontinuation decreased throughout the year: 50% of participants dropping out did so within 4 months, and 75% did so by 7.25 months (figure 1A). To investigate drivers of dropout rates, we performed a series of Cox proportional hazard regression analyses adjusting for age, sex, and, when appropriate, disease duration. Including all participants, we did not find an association of MS diagnosis with dropout. In patients with MS, we analyzed 18 of the smartphone measurements independently. We found that a low score on the SF-36 Mental Composite Scale (MCS; hazard ratio [HR] = 4.1, p = 0.017) (figure 1B) and a score of 1 or greater on the Impact of Visual Impairment Scale (IVIS; HR = 4.2, p = 0.03) (figure 1C) were nominally related to the likelihood of dropping out. Age, sex, and disease duration did not show an association with dropout in any of these models. IVIS and SF-36 MCS were correlated in patients with MS at the time of first measurement (r = 0.44, p < 0.01), and when they were both included in the model, neither was significant (p > 0.2), indicating that these factors were not independent risk factors for discontinuation.


Evaluating more naturalistic outcome measures: A 1-year smartphone study in multiple sclerosis.

Bove R, White CC, Giovannoni G, Glanz B, Golubchikov V, Hujol J, Jennings C, Langdon D, Lee M, Legedza A, Paskavitz J, Prasad S, Richert J, Robbins A, Roberts S, Weiner H, Ramachandran R, Botfield M, De Jager PL - Neurol Neuroimmunol Neuroinflamm (2015)

Patterns of study retentionThe proportion of individuals actively participating in the study is displayed over the course of the study. (A) The trajectories of the cohabitants and the patients with multiple sclerosis (MS). (B) Patients with MS with subjective cognitive impairment at study entry (defined as an SF-36 Mental Composite Scale [MCS] score in the lowest quartile) were more likely to drop out of the study. (C) Patients with MS with subjective visual impairment at study entry (defined as an Impact of Visual Impairment Scale [IVIS] score >0) were more likely to drop out of the study.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4608760&req=5

Figure 1: Patterns of study retentionThe proportion of individuals actively participating in the study is displayed over the course of the study. (A) The trajectories of the cohabitants and the patients with multiple sclerosis (MS). (B) Patients with MS with subjective cognitive impairment at study entry (defined as an SF-36 Mental Composite Scale [MCS] score in the lowest quartile) were more likely to drop out of the study. (C) Patients with MS with subjective visual impairment at study entry (defined as an Impact of Visual Impairment Scale [IVIS] score >0) were more likely to drop out of the study.
Mentions: The likelihood of study discontinuation decreased throughout the year: 50% of participants dropping out did so within 4 months, and 75% did so by 7.25 months (figure 1A). To investigate drivers of dropout rates, we performed a series of Cox proportional hazard regression analyses adjusting for age, sex, and, when appropriate, disease duration. Including all participants, we did not find an association of MS diagnosis with dropout. In patients with MS, we analyzed 18 of the smartphone measurements independently. We found that a low score on the SF-36 Mental Composite Scale (MCS; hazard ratio [HR] = 4.1, p = 0.017) (figure 1B) and a score of 1 or greater on the Impact of Visual Impairment Scale (IVIS; HR = 4.2, p = 0.03) (figure 1C) were nominally related to the likelihood of dropping out. Age, sex, and disease duration did not show an association with dropout in any of these models. IVIS and SF-36 MCS were correlated in patients with MS at the time of first measurement (r = 0.44, p < 0.01), and when they were both included in the model, neither was significant (p > 0.2), indicating that these factors were not independent risk factors for discontinuation.

Bottom Line: Among patients with MS, low scores on PROs relating to mental and visual function were associated with dropout (p < 0.05).Finally, averaging repeated measures over the study yielded the most robust correlation matrix of the different outcome measures.A smartphone platform may therefore enable large-scale naturalistic studies of patients with MS or other neurologic diseases.

View Article: PubMed Central - PubMed

Affiliation: Program in Translational Neuropsychiatric Genomics (R.B., C.C.W., B.G., M.L., S.P., A.R., H.W., P.L.D.J.), Ann Romney Center for Neurologic Diseases, and the Partners Multiple Sclerosis Center, Department of Neurology, Brigham and Women's Hospital, Brookline, MA; Harvard Medical School (R.B., B.G., S.P., H.W., P.L.D.G.), Boston, MA; Blizard Institute (G.G.) and Royal Holloway (D.L.), University College London, London, UK; Vertex Pharmaceuticals Incorporated (V.G., A.L., S.R., R.R., M.B.), Boston MA; Woo Sports (J.H.), Boston, MA; McGovern Institute Neurotechnology Program (C.J.), MIT, Cambridge, MA; and Biogen-Idec (J.P., J.R.), Cambridge, MA.

ABSTRACT

Objective: In this cohort of individuals with and without multiple sclerosis (MS), we illustrate some of the novel approaches that smartphones provide to monitor patients with chronic neurologic disorders in their natural setting.

Methods: Thirty-eight participant pairs (MS and cohabitant) aged 18-55 years participated in the study. Each participant received an Android HTC Sensation 4G smartphone containing a custom application suite of 19 tests capturing participant performance and patient-reported outcomes (PROs). Over 1 year, participants were prompted daily to complete one assigned test.

Results: A total of 22 patients with MS and 17 cohabitants completed the entire study. Among patients with MS, low scores on PROs relating to mental and visual function were associated with dropout (p < 0.05). We illustrate several novel features of a smartphone platform. First, fluctuations in MS outcomes (e.g., fatigue) were assessed against an individual's ambient environment by linking responses to meteorological data. Second, both response accuracy and speed for the Ishihara color vision test were captured, highlighting the benefits of both active and passive data collection. Third, a new trait, a person-specific learning curve in neuropsychological testing, was identified using spline analysis. Finally, averaging repeated measures over the study yielded the most robust correlation matrix of the different outcome measures.

Conclusions: We report the feasibility of, and barriers to, deploying a smartphone platform to gather useful passive and active performance data at high frequency in an unstructured manner in the field. A smartphone platform may therefore enable large-scale naturalistic studies of patients with MS or other neurologic diseases.

No MeSH data available.


Related in: MedlinePlus