Dataset Information

The MS Symptom and Impact Diary (MSSID): psychometric evaluation of a new instrument to measure the day to day impact of multiple sclerosis.

ABSTRACT:

Objectives

This study aimed to develop further a diary originally devised to measure the impact of multiple sclerosis (MS) as part of a cost utility study of beta interferon, and to evaluate its reliability, validity, and responsiveness in an outpatient sample of people with MS.

Methods

The original diary was further developed using qualitative and quantitative methods to ensure that it addressed the views of people with MS. The psychometric properties of the MS Symptom and Impact Diary (MSSID) were evaluated in a sample of 77 people who completed the MSSID daily for 12 weeks. Internal and test-retest reliability, discriminant and convergent validity, and responsiveness were assessed using traditional psychometric methods.

Results

The MSSID formed three, internally consistent scales that measured mobility, fatigue, and the overall impact of MS. The test-retest reliability of the mobility scale was adequate for individual comparisons (ICC>0.90) and the fatigue and overall impact scales were adequate for group comparisons (ICC>0.70). The MSSID was able to distinguish between clinical groups depending on clinical course, indoor ambulation status, and relapse status. It demonstrated associations with other single point instruments in the expected direction. Compared with single point instruments, its responsiveness was similar or better, especially in detecting short term improvements in functioning.

Conclusions

The MSSID may provide a useful complement to currently available instruments to measure the outcomes of MS within clinical trials. Further research is needed to explore its feasibility in the context of a randomised controlled trial and its utility for clinicians.

SUBMITTER: Greenhalgh J

PROVIDER: S-EPMC1739024 | biostudies-literature | 2004 Apr

REPOSITORIES: biostudies-literature

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Publications

The MS Symptom and Impact Diary (MSSID): psychometric evaluation of a new instrument to measure the day to day impact of multiple sclerosis.

Greenhalgh J J Ford H H Long A F AF Hurst K K

Journal of neurology, neurosurgery, and psychiatry 20040401 4

<h4>Objectives</h4>This study aimed to develop further a diary originally devised to measure the impact of multiple sclerosis (MS) as part of a cost utility study of beta interferon, and to evaluate its reliability, validity, and responsiveness in an outpatient sample of people with MS.<h4>Methods</h4>The original diary was further developed using qualitative and quantitative methods to ensure that it addressed the views of people with MS. The psychometric properties of the MS Symptom and Impact ...[more]

PMID: 15026500

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Project description:ObjectivesThe Nasal Polyposis Symptom Diary (NPSD) is a novel and short patient-reported outcome (PRO) tool specifically developed to assess important and relevant symptoms reported by patients with chronic rhinosinusitis with nasal polyposis (CRSwNP). We evaluated the psychometric properties of 4 predefined NPSD-derived scores intended to support symptom-improvement assessments of investigational therapies for inclusion in product labeling.MethodsFive hundred eighteen patients with severe CRSwNP from a Phase III clinical trial (NCT03401229) completed the NPSD, comprising 11 items: 8 symptom-specific, 2 symptom-impact, and 1 optional medication-compliance. The psychometric characteristics of 3 single-item symptom scores (Nasal Blockage Score [NBS], Nasal Congestion Score [NCS], and Difficulty with Sense of Smell Score [DSS]) and a Total Symptom Score (TSS, summary of the 8 symptom-specific items) were evaluated for reliability, validity, and ability to detect change. Within-patient meaningful change thresholds (MCTs) were established using anchor- and distribution-based methods. Comparative PROs included the 22-item Sino-Nasal Outcome Test (SNOT-22) and Patient Global Impression of Severity (PGI-S).ResultsThe TSS exhibited strong internal consistency (Cronbach α = .88) and test-retest reliability (intraclass correlation coefficient >.80). Correlation between the TSS and SNOT-22 total score indicated good convergent validity (r = .70). All 4 NPSD scores demonstrated known-groups validity (significant differences among subgroups of patients with predetermined disease severity levels based on PGI-S categories) and were sensitive to detect change in patients' clinical status (significant differences among subgroups of patients with reported changes between 2 time-points in PGI-S and Patient Global Impression of Change scores). MCTs for improvement were established at 1.0 point for NBS, NCS, and DSS, and 4.0 points for TSS.ConclusionThese findings support the reliability, validity, and suitability of the 4 NPSD-derived scores for evaluating treatment effect on CRSwNP symptoms and their use in clinical trials with predetermined MCTs for improvement.

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Dataset Information

The MS Symptom and Impact Diary (MSSID): psychometric evaluation of a new instrument to measure the day to day impact of multiple sclerosis.

Objectives

Methods

Results

Conclusions

Publications

The MS Symptom and Impact Diary (MSSID): psychometric evaluation of a new instrument to measure the day to day impact of multiple sclerosis.

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