scholarly journals The Multiple Sclerosis Health Resource Utilization Survey (MS-HRS): Development and Validation Study (Preprint)

2020 ◽  
Author(s):  
Nils-Henning Ness ◽  
Rocco Haase ◽  
Raimar Kern ◽  
Dirk Schriefer ◽  
Benjamin Ettle ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Resource Utilization ◽  
Discriminant Validity ◽  
Response Rate ◽  
Health Resource ◽  
Health Resource Utilization ◽  
Retest Reliability ◽  
Study Results ◽  
Patient Reported ◽  
Test Retest Reliability

BACKGROUND Survey-based studies are frequently used to describe the economic impact of multiple sclerosis (MS). However, there is no validated health resource survey available, preventing comparison of study results and meaningful conclusions regarding the efficiency of long-term treatments. OBJECTIVE The aim of this study was to develop and validate a tablet- and paper-based MS health resource utilization survey. METHODS We developed and validated the Multiple Sclerosis Health Resource Utilization Survey (MS-HRS), consisting of 24 cost items for paper and tablet users. Data for validation came from two large German observational studies. Survey practicability was assessed according to the response rate. Reliability was described using test-retest reliability as well as Guttman lambda. Construct validity was assessed as convergent and discriminant validity via correlations with associated patient-reported outcomes and known-group analyses. RESULTS In total, 2207 out of 2388 (response rate: 92.4%) patients completed the survey and were included to determine psychometric properties. The test-retest reliability had an intraclass correlation coefficient of 0.828 over a course of 3 months. Convergent validity analyses showed that total costs correlated positively with increased disability (<i>r</i>=0.411, <i>P</i>&lt;.001). For discriminant validity, correlations of total costs with the Treatment Satisfaction Questionnaire for Medication ranged from −0.006 (convenience) to −0.216 (effectiveness). The mean annual cost was €28,203 (SD €14,808) (US $39,203; SD US $20,583) with disease-modifying therapies. CONCLUSIONS The MS-HRS is a multilingual, reliable, valid, electronically available, and easy-to-administer questionnaire providing a holistic cross-sectional and longitudinal assessment of resource utilization in patients with MS.

scholarly journals The Multiple Sclerosis Health Resource Utilization Survey (MS-HRS): Development and Validation Study

10.2196/17921 ◽  
2020 ◽  
Vol 22 (3) ◽  
pp. e17921 ◽  
Author(s):  
Nils-Henning Ness ◽  
Rocco Haase ◽  
Raimar Kern ◽  
Dirk Schriefer ◽  
Benjamin Ettle ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Resource Utilization ◽  
Discriminant Validity ◽  
Response Rate ◽  
Health Resource ◽  
Health Resource Utilization ◽  
Retest Reliability ◽  
Study Results ◽  
Patient Reported ◽  
Test Retest Reliability

Background Survey-based studies are frequently used to describe the economic impact of multiple sclerosis (MS). However, there is no validated health resource survey available, preventing comparison of study results and meaningful conclusions regarding the efficiency of long-term treatments. Objective The aim of this study was to develop and validate a tablet- and paper-based MS health resource utilization survey. Methods We developed and validated the Multiple Sclerosis Health Resource Utilization Survey (MS-HRS), consisting of 24 cost items for paper and tablet users. Data for validation came from two large German observational studies. Survey practicability was assessed according to the response rate. Reliability was described using test-retest reliability as well as Guttman lambda. Construct validity was assessed as convergent and discriminant validity via correlations with associated patient-reported outcomes and known-group analyses. Results In total, 2207 out of 2388 (response rate: 92.4%) patients completed the survey and were included to determine psychometric properties. The test-retest reliability had an intraclass correlation coefficient of 0.828 over a course of 3 months. Convergent validity analyses showed that total costs correlated positively with increased disability (r=0.411, P<.001). For discriminant validity, correlations of total costs with the Treatment Satisfaction Questionnaire for Medication ranged from −0.006 (convenience) to −0.216 (effectiveness). The mean annual cost was €28,203 (SD €14,808) (US $39,203; SD US $20,583) with disease-modifying therapies. Conclusions The MS-HRS is a multilingual, reliable, valid, electronically available, and easy-to-administer questionnaire providing a holistic cross-sectional and longitudinal assessment of resource utilization in patients with MS.

scholarly journals Translation, Adaptation And Validation Of The Bulgarian Version Of The SIDAED Questionnaire

2015 ◽  
Vol 8 (1) ◽  
pp. 19-25
Author(s):  
Rumyana N. Kuzmanova ◽  
Irina Z. Stefanova ◽  
Irena V. Velcheva ◽  
Katerina I. Stambolieva
Keyword(s):  
Adverse Effects ◽  
Antiepileptic Drugs ◽  
Internal Consistency ◽  
Discriminant Validity ◽  
Retest Reliability ◽  
Patient Reported ◽  
Convergent Construct Validity ◽  
The Difference ◽  
Patient’S Outcome ◽  
Test Retest Reliability

Summary The aim of the study is the translation, adaptation and validation of Side effects of antiepileptic drugs questionnaire in Bulgarian language (SIDAED-BG) in order to use it for objective monitoring of patients with epilepsy. One hundred and thirty one patients (mean age 40.13±13.37 years) took part in the investigation. The internal consistency and test-retest reliability were tested by Cronbach's α and ICC estimations. The convergent construct validity was evaluated by estimating the correlation of SIDAED-BG with the QOLIE-89 and the discriminant validity - by evaluation of the difference between SIDAED-BG scores and clinical parameters such as type of epilepsy using Kruskal-Wallis ANOVA. The Cronbach's α of the total scale was 0.93. The test-retest reliability was higher and determined the strong positive correlations between the first and second examination. The SIDAED-BG questionnaire showed good internal consistency (Cronbach's alpha ranged from 0.37 to 0.86) and the scores significantly correlated with other questionnaires such as QOLIE-89 and showed a good discriminative validity between groups with different levels of self-assessed adverse effects of antiepileptic drugs. The Bulgarian version of SIDAED is a reliable and valid tool in assessing the patient-reported adverse effects of antiepileptic drugs and their impact on the patient's outcome.

scholarly journals Psychometric Validation of a Novel PRO MEASURE for Assessing Patient-reported Experience of Cognitive Impairment in Schizophrenia (PRECIS)

2020 ◽  
Author(s):  
Raymond C. Rosen ◽  
Jeremiah J. Trudeau ◽  
Steven Silverstein ◽  
David C. Henderson ◽  
Adam Smith ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Convergent Validity ◽  
Discriminant Validity ◽  
Psychometric Validation ◽  
Controlled Study ◽  
Initial Development ◽  
Retest Reliability ◽  
Control Subjects ◽  
Patient Reported ◽  
Test Retest Reliability

Abstract Background Cognitive impairment associated with schizophrenia (CIAS) can be a distressing feature that contributes to the burden of the disorder, as well as being a strong predictor of functional impairment. To fully assess the burden to patients living with this illness, there is a need to develop a specific measure of patient-reported outcomes . Methods Following initial development of the Patient-Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) instrument, the domain structure, reliability (inter-item consistency and test–retest reliability), and validity (discriminant validity, divergent, and convergent validity) of the tool were assessed in patients (aged 18–55 years) with CIAS participating in a 12-week, Phase II, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of BI 409306. Healthy control subjects were recruited separately. The PRECIS instrument was completed at baseline, Week 6, Week 9, and Week 12. Results The questionnaire responses of 410 patients with schizophrenia and 88 control subjects were compared. Of the original 35 items included in the draft PRECIS instrument, 11 were eliminated due to poor performance against pre-defined criteria, resulting in a 24-item questionnaire that loaded well onto 5 domains (Attention, Memory, Executive Function, Communication, and Bother). The revised 24-item PRECIS instrument demonstrated adequate discriminant validity between patient and control groups in each of the 5 domains (p<0.0001), convergent validity as shown by a significant correlation between PRECIS scores and the Schizophrenia Cognition Rating Scale (p<0.0001), good internal consistency (Cronbach’s alpha score: 0.942), and adequate test–retest reliability (intra-class correlation coefficient [ICC]: 0.78). A simplified, user-friendly scoring method was identified, which assigned scores to each of the 5 domains using a five-category Likert scale. PRECIS did not correlate with MATRICS or CANTAB composite scores. Conclusions PRECIS is a novel self-completed sensitive instrument designed to measure the subjective experience of cognitive impairment in patients with schizophrenia. The test development process included patient input, perceptions, and feedback, and strong evidence for the validity and reliability of the instrument was demonstrated. The scale provides a patient-based perspective to complement existing objective measures of cognition and serves to define key patient-based endpoints for use in future clinical studies.

scholarly journals Psychometric Validation of a Novel PRO Measure for Assessing Patient-reported Experience of Cognitive Impairment in Schizophrenia (PRECIS)

2019 ◽  
Author(s):  
Raymond C. Rosen ◽  
Jeremiah J. Trudeau ◽  
Steven Silverstein ◽  
David C. Henderson ◽  
Adam Smith ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Convergent Validity ◽  
Discriminant Validity ◽  
Psychometric Validation ◽  
Controlled Study ◽  
Initial Development ◽  
Retest Reliability ◽  
Control Subjects ◽  
Patient Reported ◽  
Test Retest Reliability

Abstract Background Cognitive impairment associated with schizophrenia (CIAS) can be a distressing feature that contributes to the burden of the disorder, as well as being a strong predictor of functional impairment. To fully assess the burden to patients living with this illness, there is a need to develop a specific measure of patient-reported outcomes (PROs). Methods Following initial development of the Patient-Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) instrument, the domain structure, reliability (inter-item consistency and test-retest reliability), and validity (discriminant validity, divergent, and convergent validity) of the tool were assessed in patients (aged 18–55 years) with CIAS participating in a 12-week, Phase II, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of BI 409306. Healthy control subjects were recruited separately. The PRECIS instrument was completed at baseline, Week 6, Week 9, and Week 12. Results The questionnaire responses of 410 patients with schizophrenia and 88 control subjects were compared. Of the original 35 items included in the draft PRECIS instrument, 11 were eliminated due to poor performance against pre-defined criteria, resulting in a 24-item questionnaire. In confirmatory factor analysis, the 24 items loaded well onto 5 domains (Attention, Memory, Executive Function, Communication, and Bother). The revised 24-item PRECIS instrument demonstrated adequate discriminant validity between patient and control groups in each of the 5 domains (p<0.0001), convergent validity as shown by a significant correlation between PRECIS scores and the Schizophrenia Cognition Rating Scale (SCoRS; p<0.0001), good internal consistency (Cronbach’s alpha score: 0.942), and adequate test-retest reliability (intra-class correlation coefficient [ICC]: 0.78). A simplified, user-friendly scoring method was identified, which assigned scores to each of the 5 domains using a 5-category Likert scale. Conclusions PRECIS is a novel self-completed sensitive instrument designed to measure the subjective experience of cognitive impairment in patients with schizophrenia. The test development process included patient input, perceptions, and feedback, and strong evidence for the validity and reliability of the instrument was demonstrated. The scale provides a patient-based perspective to complement existing objective measures of cognition and serves to define key patient-based endpoints for use in future clinical studies.

scholarly journals Psychometric Properties of a Clinical Strength Assessment Protocol in People with Multiple Sclerosis

2017 ◽  
Vol 19 (5) ◽  
pp. 253-262 ◽  
Author(s):  
Mark M. Mañago ◽  
Jeffrey R. Hebert ◽  
Margaret Schenkman
Keyword(s):  
Multiple Sclerosis ◽  
Psychometric Properties ◽  
Discriminant Validity ◽  
Intraclass Correlation ◽  
Minimal Detectable Change ◽  
Retest Reliability ◽  
Strength Assessment ◽  
Assessment Protocol ◽  
Flexion Extension ◽  
Test Retest Reliability

Background: Strength training in people with multiple sclerosis (MS) is an important component of rehabilitation, but it can be challenging for clinicians to quantify strength accurately and reliably. This study investigated the psychometric properties of a clinical strength assessment protocol using handheld dynamometry and other objective, quantifiable tests for the lower extremities and trunk in people with MS. Methods: This study determined discriminant validity between 25 participants with MS and 25 controls and between participants with MS who had higher versus lower disability; test-retest reliability across 7 to 10 days; and response stability. The protocol included handheld dynamometry measurements of ankle dorsiflexion, knee flexion and extension; hip flexion, extension, abduction, and adduction; and trunk lateral flexion. Muscular endurance tests were used to measure trunk extension, trunk flexion, and ankle plantarflexion. Results: The protocol discriminated between participants with MS and controls for all muscles tested (P &lt; .001–.003). The protocol also discriminated between low- and moderate-disability groups (P = .001–.046) for 80% of the muscles tested. Test-retest reliability intraclass correlation coefficients were high (0.81–0.97). Minimal detectable change as a percentage of the mean was 13% to 36% for 85% of muscles tested. Conclusions: This study provides evidence for the discriminant validity, test-retest reliability, and response stability of a strength assessment protocol in people with MS. This protocol may be useful for tracking outcomes in people with MS for clinical investigations and practice.

scholarly journals The Patient-Reported Outcomes Thermometer–5-Item Scale (5T-PROs): Validation of a New Tool for the Quick Assessment of Overall Health Status in Painful Rheumatic Diseases

2018 ◽  
Vol 2018 ◽  
pp. 1-16 ◽  
Author(s):  
Fausto Salaffi ◽  
Marco Di Carlo ◽  
Marina Carotti ◽  
Sonia Farah
Keyword(s):  
Internal Consistency ◽  
Discriminant Validity ◽  
Summary Score ◽  
Retest Reliability ◽  
Sf 36 ◽  
Patient Reported ◽  
The Mean ◽  
Test Retest Reliability ◽  
Item Scale ◽  
Overall Health Status

Objective. To investigate the construct validity, reliability (internal consistency and retest reliability), and feasibility of the patient-reported outcomes thermometer–5-item scale (5T-PROs), a new tool to measure overall health status in patients with painful chronic rheumatic diseases such as rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (axialSpA), and fibromyalgia (FM). Methods. Consecutive patients have been involved in this study. The following analyses were performed to establish the validity of the 5T-PROs: (1) principal component factor analysis was used to identify the presence of a relatively small number of underlying latent factors than can be used to represent relations among sets of many variables; (2) Cronbach’s alpha was calculated as an indicator of internal consistency; and (3) Pearson product-moment correlations were conducted to assess the convergent validity. The 5T-PROs was also administered a second time (two weeks after the initial administration) to a subset of sample (n = 426) to allow for calculation of test-retest reliability. We used the intraclass correlation coefficient (ICC) as an estimate of test-retest reliability. Additionally, discriminant validity was tested using analysis of variance (ANOVA) with Bonferroni post hoc multiple comparisons, in different disease conditions. Feasibility was analyzed by the time taken in completing the 5T-PROs and the proportion of patients able to complete the 5 item. Results. 1,199 patients (572 with RA, 251 with axialSpA, 150 with PsA, and 226 with FM) were examined. The mean age was 55.7 (standard deviation: 13.1; range: 20 to 80) years. Factor analysis yielded two factors which accounted for 62.54% of the variance of the 5T-PROs. The first factor “Symptom Summary Score” (35.57% of the variance) revealed a good internal consistency (alpha = 0.88); the internal consistency of the second factor “Psychological Summary Score” (26.97% of the variance) was moderate (alpha = 0.69). The reliability of the whole instrument was good (alpha = 0.82). A very high correlation was obtained between Symptom Summary Score and SF-36 PCS and between pain thermometer intensity and SF-36 bodily pain. For all five items and summary scale scores of the SF-36, there was strong evidence that the mean rank of the scores differs significantly between the groups (Kruskal–Wallis tests, p<0.001). Discriminant validity, assessed by comparing the 5T-PRO dimensions in patients with different states of disease activity, showed that the 5T-PROs show moderate association with the presence of comorbidities. It was also noted that it was inversely correlated (p=0.01) to years of formal education. Conclusion. The 5T-PROs is easily administered, reliable and a valid instrument for evaluating the extensive multidimensional impact associated with chronic painful rheumatic conditions.

Der Multiple Sclerosis Health Resource Utilization Survey

2021 ◽  
Author(s):  
Nils-Henning Ness ◽  
Dirk Schriefer ◽  
Rocco Haase ◽  
Tjalf Ziemssen
Keyword(s):  
Multiple Sclerosis ◽  
Resource Utilization ◽  
Health Resource ◽  
Health Resource Utilization ◽  
Indirekte Kosten

Zusammenfassung Hintergrund In gesundheitsökonomischen Studien sind valide und verlässliche Kostendaten essentiell, um belastbare Schlussfolgerungen zu ziehen und eine höchstmögliche Versorgungsqualität der Patienten sicherzustellen. Im Falle der Multiplen Sklerose (MS) basieren solche Studien häufig auf Primärdaten, deren zugrundeliegende Erhebungsinstrumente nicht publiziert sind. Zudem erschweren heterogene Methoden die Vergleichbarkeit und Interpretation solcher Studienergebnisse. Zur Vereinheitlichung gesundheitsökonomischer Studien in der MS wurde der Multiple Sclerosis Health Resource Utilization Survey (MS-HRS) entwickelt, validiert und frei zugänglich publiziert. Fragestellung Fokus dieser Übersichtsarbeit bildet der MS-HRS. Wir berichten methodische Grundlagen zur Krankheitskostenerfassung sowie MS-HRS basierte Ergebnisse zu den Kosten der Krankheitsdynamik bei Personen mit MS. Material/Methodik Dieser Artikel beruht auf einer selektiven Literaturrecherche zum MS-HRS und zu den gesundheitsökonomischen Aspekten der Krankheitskostenerfassung. Ergebnisse Der MS-HRS erfasst patientenberichtet die gesellschaftliche Inanspruchnahme von direkten medizinischen, direkten nicht-medizinischen sowie indirekten Ressourcen. Indirekte Kosten werden weiterhin zwischen Absentismus, sowohl kurzzeitig (Krankheitstage) als auch langfristig (Erwerbs-/Berufsunfähigkeit), und Präsentismus unterschieden. Der Ressourcenverbrauch wird mit den gesellschaftlichen Opportunitätskosten approximiert. Erste MS-HRS basierte Analysen zeigen, dass neben dem stationären Behinderungsgrad und dem klinischen Verlauf auch die Krankheitsdynamik in Form von Schüben und Progression enorme sozioökonomische Auswirkungen hat. Diskussion Valide Krankheitskostendaten bringen Transparenz in die ökonomischen Auswirkungen von Erkrankungen. In Ergänzung zu klinischen Daten kann die Kosteneffektivität festgestellt werden und somit Anhaltspunkte für eine effizientere Patientenversorgung aufgedeckt werden. Im Falle der MS steht zur Kostenerfassung ein frei zugängliches Instrument (MS-HRS) zur Verfügung.

Validation of the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) in the Russian Population

2021 ◽  
pp. 1-8
Author(s):  
Evgeniy Evdoshenko ◽  
Kristina Laskova ◽  
Maria Shumilina ◽  
Ekaterina Nekrashevich ◽  
Maria Andreeva ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Cognitive Assessment ◽  
Verbal Learning ◽  
Cognitive Status ◽  
Russian Population ◽  
Cognitive Domain ◽  
Control Group ◽  
Retest Reliability ◽  
Valid Instrument ◽  
Test Retest Reliability

Abstract Objective: Cognitive dysfunction is common in multiple sclerosis (MS). The Brief International Cognitive Assessment for MS (BICAMS) battery of tests has been suggested as a measure for the evaluation of the cognitive status of MS patients. This study aims to validate the BICAMS battery in the Russian population of MS patients. Methods: Age- and sex-matched MS patients (n = 98) and healthy individuals (n = 86) were included in the study. Symbol Digit Modalities Test (SDMT), California Verbal Learning Test, 2nd edition (CVLT-II) and the Brief Visuospatial Memory Test – Revised (BVMT-R) were administered to all participants. The battery was readministered 1 month later to 44 MS patients to investigate the test–retest reliability. Results: MS patients exhibited a significantly lower performance in testing with BICAMS than the control group in all three neuropsychological tests. Test–retest reliability was good for SDMT and CVLT-II (r = .82 and r = .85, respectively) and adequate for BVMT-R (r = .70). Based on the proposed criterion for impairment as z score below 1.5 SD the mean of the control group, we found that 34/98 (35%) of MS patients were found impaired at least in one cognitive domain. Patients with Expanded Disability Status Scale score ≥3.5 performed significantly worse than controls (SDMT, p < .0001; CVLT–II, p = .03; BVMT-R, p = .0004), while those with ≤3.0 scores did not. Conclusion: This study demonstrates that the BICAMS battery is a valid instrument to identify cognitive impairment in MS patients and it can be recommended for routine use in the Russian Federation.

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