Dataset Information

Measuring the impact of multiple sclerosis: Enhancing the measurement performance of the Multiple Sclerosis Impact Scale (MSIS-29) using Rasch Measurement Theory (RMT).

ABSTRACT: Background:Study objectives were to evaluate the Multiple Sclerosis Impact Scale (MSIS-29) and explore an optimized scoring structure based on empirical post-hoc analyses of data from the Phase III ADVANCE clinical trial. Methods:ADVANCE MSIS-29 data from six time-points were analyzed in a sample of patients with relapsing-remitting multiple sclerosis (RRMS). Rasch Measurement Theory (RMT) analysis was undertaken to examine three broad areas: sample-to-scale targeting, measurement scale properties, and sample measurement validity. Interpretation of results led to an alternative MSIS-29 scoring structure, further evaluated alongside responsiveness of the original and revised scales at Week 48. Results:RMT analysis provided mixed evidence for Physical and Psychological Impact scales that were sub-optimally targeted at the lower functioning end of the scales. Their conceptual basis could also stand to improve based on item fit results. The revised MSIS-29 rescored scales improved but did not resolve the measurement scale properties and targeting of the MSIS-29. In two out of three revised scales, responsiveness analysis indicated strengthened ability to detect change. Conclusion:The revised MSIS-29 provides an initial evidence-based improved patient-reported outcome (PRO) instrument for evaluating the impact of MS. Revised scoring improves conceptual clarity and interpretation of scores by refining scale structure to include Symptoms, Psychological Impact, and General Limitations. Clinical trial:ADVANCE (ClinicalTrials.gov identifier NCT00906399).

SUBMITTER: Cleanthous S

PROVIDER: S-EPMC5562349 | biostudies-literature | 2017 Jul-Sep

REPOSITORIES: biostudies-literature

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Measuring the impact of multiple sclerosis: Enhancing the measurement performance of the Multiple Sclerosis Impact Scale (MSIS-29) using Rasch Measurement Theory (RMT).

Cleanthous Sophie S Cano Stefan S Kinter Elizabeth E Marquis Patrick P Petrillo Jennifer J You Xiaojun X Wakeford Craig C Sabatella Guido G

Multiple sclerosis journal - experimental, translational and clinical 20170701 3

<h4>Background</h4>Study objectives were to evaluate the Multiple Sclerosis Impact Scale (MSIS-29) and explore an optimized scoring structure based on empirical post-hoc analyses of data from the Phase III ADVANCE clinical trial.<h4>Methods</h4>ADVANCE MSIS-29 data from six time-points were analyzed in a sample of patients with relapsing-remitting multiple sclerosis (RRMS). Rasch Measurement Theory (RMT) analysis was undertaken to examine three broad areas: sample-to-scale targeting, measurement ...[more]

PMID: 29104758

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Project description:BackgroundThere is increasing emphasis on using patient-reported outcomes (PROs) to complement traditional clinical outcomes in medical research, including in multiple sclerosis (MS). Research, particularly in oncology and heart failure, has shown that PROs can be prognostic of hard clinical endpoints such as survival time (time from study entry until death). However, unlike in oncology or cardiology, it is unknown whether PROs are associated with survival time in neurological diseases. The Multiple Sclerosis Impact Scale-29 (MSIS-29) is a PRO sensitive to short-term change in MS, with questions covering both physical and psychological quality of life. This study aimed to investigate whether MSIS-29 scores can be prognostic for survival time in MS, using a large observational cohort of people with MS.Methods and findingsFrom 15 July 2004 onwards, MSIS-29 questionnaires were completed by people with MS registered with the MS Society Tissue Bank (n = 2,126, repeated 1 year later with n = 872 of the original respondents). By 2014, 264 participants (12.4%) had died. Higher baseline MSIS-29 physical (MSIS-29-PHYS) score was associated with reduced survival time (subgroup with highest scores versus subgroup with lowest scores: hazard ratio [HR] 5.7, 95% CI 3.1-10.5, p < 0.001). Higher baseline MSIS-29 psychological score was also associated with reduced survival time (subgroup with highest scores versus subgroup with lowest scores: HR 2.8, 95% CI 1.8-4.4, p < 0.001). In those with high baseline MSIS-29 scores, mortality risk was even greater if the MSIS-29 score worsened over 1 year (HR 2.3, 95% CI 1.2-4.4, p = 0.02). MSIS-29-PHYS scores were associated with survival time independent of age, sex, and patient-reported Expanded Disability Status Scale score in a Cox regression analysis (per 1-SD increase in MSIS-29-PHYS score: HR 1.8, 95% CI 1.1-2.9, p = 0.03). A limitation of the study is that this cohort had high baseline age and disability levels; the prognostic value of MSIS-29 for survival time at earlier disease stages requires further investigation.ConclusionsThis study reports that PROs can be prognostic for hard clinical outcomes in neurological disease, and supports PROs as a meaningful clinical outcome for use in research and clinical settings.

Project description:BackgroundMobile health (mHealth) apps offer great opportunities to deliver large-scale, cost-efficient digital solutions for implementing lifestyle changes. Furthermore, many mHealth apps act as medical devices. Yet, there is little research on how to assess user satisfaction with an mHealth solution.ObjectiveThis study presents the development of the mHealth Satisfaction Questionnaire and evaluates its measurement properties.MethodsRespondents who took part in the Health Integrator Study and were randomized to use the Health Integrator smartphone app for lifestyle changes (n=112), with and without additional telephone coaching, rated their satisfaction with the app using the new 14-item mHealth Satisfaction Questionnaire. The ratings were given on a 5-point Likert scale and measurement properties were evaluated using Rasch measurement theory (RMT).ResultsOptimal scoring was reached when response options 2, 3, and 4 were collapsed, giving three response categories. After omitting two items that did not fit into the scale, fit residuals were within, or close to, the recommended range of ±2.5. There was no differential item functioning between intervention group, age group, or sex. The Person Separation Index was 0.79, indicating that the scale's ability to discriminate correctly between person leniency was acceptable for group comparisons but not for individual evaluations. The scale did not meet the criterion of unidimensionality; 16.1% (18/112) of the respondents were outside the desired range of -1.96 to 1.96. In addition, several items showed local dependency and three underlying dimensions emerged: negative experiences, positive experiences, and lifestyle consequences of using the mHealth solution.ConclusionsIn times where mHealth apps and digital solutions are given more attention, the mHealth Satisfaction Questionnaire provides a new possibility to measure user satisfaction to ensure usability and improve development of new apps. Our study is one of only a few cases where RMT has been used to evaluate the usability of such an instrument. There is, though, a need for further development of the mHealth Satisfaction Questionnaire, including the addition of more items and consideration of further response options. The mHealth Satisfaction Questionnaire should also be evaluated in a larger sample and with other mHealth apps and in other contexts.Trial registrationClinicalTrials.gov NCT03579342; http://clinicaltrials.gov/ct2/show/NCT03579342.

Project description:Background Meaningfully interpreting patient-reported outcomes (PRO) results from randomized clinical trials requires that the PRO scores obtained in the trial have the same meaning across patients and previous applications of the PRO instrument. Calibration of PRO instruments warrants this property. In the Rasch measurement theory (RMT) framework, calibration is performed by fixing the item parameter estimates when measuring the targeted concept for each individual of the trial. The item parameter estimates used for this purpose are typically obtained from a previous “calibration” study. But imposing this constraint on item parameters, instead of freely estimating them directly in the specific sample of the trial, may hamper the ability to detect a treatment effect. The objective of this simulation study was to explore the potential negative impact of calibration of PRO instruments that were developed using RMT on the comparison of results between treatment groups, using different analysis methods. Methods PRO results were simulated following a polytomous Rasch model, for a calibration and a trial sample. Scenarios included varying sample sizes, with instrument of varying number of items and modalities, and varying item parameters distributions. Different treatment effect sizes and distributions of the two patient samples were also explored. Cross-sectional comparison of treatment groups was performed using different methods based on a random effect Rasch model. Calibrated and non-calibrated approaches were compared based on type-I error, power, bias, and variance of the estimates for the difference between groups. Results There was no impact of the calibration approach on type-I error, power, bias, and dispersion of the estimates. Among other findings, mistargeting between the PRO instrument and patients from the trial sample (regarding the level of measured concept) resulted in a lower power and higher position bias than appropriate targeting. Conclusions Calibration does not compromise the ability to accurately assess a treatment effect using a PRO instrument developed within the RMT paradigm in randomized clinical trials. Thus, given its essential role in producing interpretable results, calibration should always be performed when using a PRO instrument developed using RMT as an endpoint in a randomized clinical trial. Supplementary Information The online version contains supplementary material available at 10.1186/s12874-022-01680-z.

Dataset Information

Measuring the impact of multiple sclerosis: Enhancing the measurement performance of the Multiple Sclerosis Impact Scale (MSIS-29) using Rasch Measurement Theory (RMT).

Publications

Measuring the impact of multiple sclerosis: Enhancing the measurement performance of the Multiple Sclerosis Impact Scale (MSIS-29) using Rasch Measurement Theory (RMT).

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