Achieving valid patient-reported outcomes measurement: a lesson from fatigue in multiple sclerosis

被引:32
|
作者
Hobart, Jeremy [1 ,6 ,7 ]
Cano, Stefan [1 ,6 ,7 ]
Baron, Rachel [1 ,6 ,7 ]
Thompson, Alan [2 ,8 ]
Schwid, Steven [3 ,5 ,9 ]
Zajicek, John [1 ,6 ,7 ]
Andrich, David [4 ,10 ]
机构
[1] Dept Clin Neuroscience, Plymouth, Devon, England
[2] Univ Coll London, Fac Brain Sci, UK, Plymouth, Devon, England
[3] Dept Neurol, University of Rochester, NY USA
[4] Univ Western Australia, Sch Educ, Perth, WA, Australia
[5] Deceased, Plymouth, Devon, England
[6] Univ Plymouth, Peninsula Sch Med, Dept Clin Neurosci, Plymouth PL6 8BX, Devon, England
[7] Univ Plymouth, Peninsula Sch Dent, Dept Clin Neurosci, Plymouth PL6 8BX, Devon, England
[8] UCL, Fac Brain Sci, London WC1E 6BT, England
[9] Univ Rochester, Dept Neurol, Rochester, NY 14627 USA
[10] Univ Western Australia, Sch Educ, Perth, WA 6009, Australia
关键词
Patient-reported outcome measurement instruments; fatigue; multiple sclerosis; rating scales; psychometric methods; Rasch measurement theory; PRO INSTRUMENTS; IMPACT; MS;
D O I
10.1177/1352458513483378
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
Background: The increasing influence of patient-reported outcome (PRO) measurement instruments indicates their scrutiny has never been more crucial. Above all, PRO instruments should be valid: shown to assess what they purport to assess. Objectives: To evaluate a widely used fatigue PRO instrument, highlight key issues in understanding PRO instrument validity, demonstrate limitations of those approaches and justify notable changes in the validation process. Methods: A two-phase evaluation of the 40-item Fatigue Impact scale (FIS): a qualitative evaluation of content and face validity using expert opinion (n=30) and a modified Delphi technique; a quantitative psychometric evaluation of internal and external construct validity of data from 333 people with multiple sclerosis using traditional and modern methods. Results: Qualitative evaluation did not support content or face validity of the FIS. Expert opinion agreed with the subscale placement of 23 items (58%), and classified all 40 items as being non-specific to fatigue impact. Nevertheless, standard quantitative psychometric evaluations implied, largely, FIS subscales were reliable and valid. Conclusions: Standard quantitative psychometric' evaluations of PRO instrument validity can be misleading. Evaluation of existing PRO instruments requires both qualitative and statistical methods. Development of new PRO instruments requires stronger conceptual underpinning, clearer definitions of the substantive variables for measurement and hypothesis-testing experimental designs.
引用
收藏
页码:1773 / 1783
页数:11
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