scholarly journals Adapting Social Neuroscience Measures for Schizophrenia Clinical Trials, Part 2: Trolling the Depths of Psychometric Properties

2013 ◽  
Vol 39 (6) ◽  
pp. 1201-1210 ◽  
Author(s):  
Robert S. Kern ◽  
David L. Penn ◽  
Junghee Lee ◽  
William P. Horan ◽  
Steven P. Reise ◽  
...  
2019 ◽  
Author(s):  
Toni Saari ◽  
Anne Koivisto ◽  
Taina Hintsa ◽  
Tuomo Hänninen ◽  
Ilona Hallikainen

Neuropsychiatric symptoms (NPSs) cause a significant burden to individuals with memory disorders and their families. Insights into the clinical associations, neurobiology, and treatment of NPSs are largely dependent on informant questionnaires, such as the commonly used Neuropsychiatric Inventory (NPI). Like any scale, the utility of the NPI relies on its psychometric properties, but unlike many scales, the NPI faces unique challenges related to its skip-question and scoring formats.We examined and reviewed the psychometric properties of the NPI in a framework including psychometric properties pertinent for construct validation, and health-related outcome measurement in general. We found that aspects such as test-retest and inter-rater reliability are major strengths of the NPI in addition to its flexible and relatively quick administration. These properties are desired in clinical trials. However, it seems that the reported properties cover only some of the generally examined psychometric properties, representing perhaps necessary but not sufficient reliability and validity evidence for the NPI. There appear to be significant gaps in psychometric data, at least partially owing to small sample sizes in the studies that preclude more comprehensive analyses. Regarding construct validity, only one study examined structural validity with the NPI subquestions. Measurement error was not assessed in the reviewed studies. For future validation, we recommend using data from all subquestions, collecting larger samples, paying specific attention to construct validity and formulating hypotheses a priori. As the NPI is an outcome measure of interest in clinical trials, examining measurement error could be of practical importance.


RMD Open ◽  
2020 ◽  
Vol 6 (1) ◽  
pp. e000928 ◽  
Author(s):  
Dafna Gladman ◽  
Peter Nash ◽  
Hitoshi Goto ◽  
Julie A Birt ◽  
Chen-Yen Lin ◽  
...  

ObjectivesThis study assessed the psychometric properties of the fatigue numeric rating scale (NRS) and sought to establish values for clinically meaningful change (responder definition).MethodsUsing disease-specific clinician-reported and patient-reported data from two randomised clinical trials of patients with psoriatic arthritis (PsA), the fatigue NRS was evaluated for test–retest reliability, construct validity and responsiveness. A responder definition was also explored using anchor-based and distribution-based methods.ResultsTest–retest reliability analyses supported the reproducibility of the fatigue NRS in patients with PsA (intraclass correlation coefficient=0.829). Mean (SD) values at baseline and week 2 were 5.7 (2.2) and 5.7 (2.4), respectively. Supporting construct validity of the fatigue NRS, moderate-to-large correlations with other assessments measuring similar concepts as measured by Sackett’s conventions were demonstrated. Fatigue severity was reduced when the underlying disease activity was improved and reductions remained consistent at week 12 and 24. A 3-point improvement was identified as being optimal for demonstrating a level of clinically meaningful improvement in fatigue NRS after 12–24 weeks of treatment.ConclusionsFatigue NRS is a valid and responsive patient-reported outcome instrument for use in patients with PsA. The established psychometric properties from this study support the use of fatigue NRS in clinical trials and in routine clinical practice. Robust validation of reliability for use in routine clinical practice in treating patients with active PsA in less active disease states and other more diverse ethnic groups is needed.


2013 ◽  
Vol 18 (3) ◽  
pp. 142-152 ◽  
Author(s):  
Jennifer N Stinson ◽  
Anna Huguet ◽  
Patrick McGrath ◽  
Brittany Rosenbloom ◽  
Charlene Soobiah ◽  
...  

BACKGROUND: While paper headache pain diaries have been used to determine the effectiveness of headache treatments in clinical trials, recent advances in information and communication technologies have resulted in the burgeoning use of electronic diaries (e-diaries) for headache pain.OBJECTIVE: To qualitatively review headache e-diaries, assess their measurement properties, examine measurement components and compare these components with recommended reporting guidelines.METHODS: The databases Medline, the Cumulative Index to Nursing and Allied Health Literature, Embase, PsychInfo, the Education Resources Information Centre and ISI Web of Science were searched for self-report headache e-diaries for children and adults. A total of 21 publications that involved e-diaries were found; five articles reported on the development of an e-diary and 16 used an e-diary as an outcome measure in randomized controlled trials or observational studies. The diary measures’ components, features and psychometric properties, as well as the quality of evidence of their psychometric properties, were evaluated.RESULTS: Five headache e-diaries met the a priori criteria and were included in the final analysis. None of these e-diaries had well-developed evidence of reliability and validity. Three e-diaries showed evidence of feasibility. E-diaries with ad hoc measures developed by the study investigators were most common, with little to no supportive evidence of reliability and/or validity. Compliance with the reporting guidelines was variable, with only one-half of the e-diaries measuring the recommended primary outcome of headache frequency.CONCLUSIONS: Specific recommendations regarding the development (including essential components) and testing of headache e-diaries are discussed. Further research is needed to strengthen the measurement of headache pain in clinical trials using headache e-diaries.


2003 ◽  
Vol 9 (4) ◽  
pp. 411-419 ◽  
Author(s):  
A Riazi ◽  
J C Hobart ◽  
D L Lamping ◽  
R Fitzpatrick ◽  
A J Thompson

The selection of measures of quality of life used in clinical trials of multiple sclerosis (MS) should be evidence-based. Head-to -head comparison of measures facilitates the selection of measures. The aim of the study was to compare the psychometric properties of the physical and psychological dimensions in three measures of quality of life to aid choice of the most appropriate scale for use in clinical trials of MS. O ne hundred and twenty-one people with MS (rehabilitation =57; steroids =64) completed a selection of health measures before and after treatment. The psychometric properties of three measures of physical function (MSIS-29 physical, SF-36 physical functioning, FA MS mobility) and three measures of psychological function (MSIS-29 psychological, SF-36 mental health, FA MS emotional well-being) were compared by examining data quality, scaling assumptions, acceptability, reliability, validity and responsiveness. Physical (0.63- 0.71) and psychological (0.70-0.75) scales were substantially correlated indicating they measure related constructs. The MSIS-29 physical and psychological scales satisfied all criteria for internal consistency reliability (physical =0.91; psychological =0.89) and validity. The SF-36 physical scale had a notable floor effect (20%). The FA MS mobility scale had lower reliability (a=0.78) compared to other measures. The MSIS-29 physical (effect size=0.91) and psychological (effect size =0.62) scales were the most responsive. In these three samples, the MSIS-29 had better measurement properties for combined physical and psychological health than the SF-36 and the FA MS.


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