Development and Validation of the FSIQ-RMS: A New Patient-Reported Questionnaire to Assess Symptoms and Impacts of Fatigue in Relapsing Multiple Sclerosis

Value in Health - Tập 22 - Trang 453-466 - 2019
Stacie Hudgens1, René Schüler2, Jonathan Stokes3, Sonya Eremenco4, Elke Hunsche5, Thomas P. Leist6
1Clinical Outcomes Solutions, Tucson, AZ, USA
2Global Market Access & Pricing, Actelion, Singapore
3Patient-Centered Outcomes, Adelphi Values, Boston, MA, USA
4Outcomes Research, Evidera, Bethesda, MD, USA
5Global Market Access & Pricing, Actelion, Allschwil, Switzerland
6Comprehensive Multiple Sclerosis Center, Thomas Jefferson University, Philadelphia, PA, USA

Tài liệu tham khảo

Patrick, 2009, Longitudinal correlates of fatigue in multiple sclerosis, Mult Scler, 15, 258, 10.1177/1352458508097466 Fisk, 1994, The impact of fatigue on patients with multiple sclerosis, Can J Neurol Sci, 21, 9, 10.1017/S0317167100048691 Williams, 2014, Symptoms and association with health outcomes in relapsing-remitting multiple sclerosis: results of a US patient survey, Mult Scler Int, 2014, 203183 Dendrou, 2015, Immunopathology of multiple sclerosis, Nat Rev Immunol, 15, 545, 10.1038/nri3871 Smith, 2005, Factors related to employment status changes in individuals with multiple sclerosis, Mult Scler, 11, 602, 10.1191/1352458505ms1204oa Glanz, 2012, Work productivity in relapsing multiple sclerosis: associations with disability, depression, fatigue, anxiety, cognition, and health-related quality of life, Value Health, 15, 1029, 10.1016/j.jval.2012.07.010 Flensner, 2013, Work capacity and health-related quality of life among individuals with multiple sclerosis reduced by fatigue: a cross-sectional study, BMC Public Health, 13, 224, 10.1186/1471-2458-13-224 Janardhan, 2002, Quality of life in patients with multiple sclerosis: the impact of fatigue and depression, J Neurol Sci, 205, 51, 10.1016/S0022-510X(02)00312-X Lerdal, 2003, Fatigue and its association with sociodemographic variables among multiple sclerosis patients, Mult Scler, 9, 509, 10.1191/1352458503ms943oa 1998 Rae-Grant, 2015, Quality improvement in neurology: multiple sclerosis quality measures: executive summary, Neurology, 85, 1904, 10.1212/WNL.0000000000001965 Walton, 2015, Clinical outcome assessments: conceptual foundation—report of the ISPOR Clinical Outcomes Assessment—Emerging Good Practices for Outcomes Research Task Force, Value Health, 18, 741, 10.1016/j.jval.2015.08.006 Krupp, 1989, The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus, Arch Neurol, 46, 1121, 10.1001/archneur.1989.00520460115022 Fisk, 1994, Measuring the functional impact of fatigue: initial validation of the fatigue impact scale, Clin Infect Dis, 18, S79, 10.1093/clinids/18.Supplement_1.S79 Meads, 2009, The development and validation of the Unidimensional Fatigue Impact Scale (U-FIS), Mult Scler, 15, 1228, 10.1177/1352458509106714 Penner, 2009, The Fatigue Scale for Motor and Cognitive Functions (FSMC): validation of a new instrument to assess multiple sclerosis-related fatigue, Mult Scler, 15, 1509, 10.1177/1352458509348519 Mills, 2010, Development of a patient reported outcome scale for fatigue in multiple sclerosis: The Neurological Fatigue Index (NFI-MS), Health Qual Life Outcomes, 8, 22, 10.1186/1477-7525-8-22 Barlow, 2016, Clinical evaluation of fatigue in MS using the Brief Fatigue and Associated Symptoms Scale, Br J Neurosci Nurs, 12, 216, 10.12968/bjnn.2016.12.5.216 Mills, 2009, Rasch analysis of the Fatigue Severity Scale in multiple sclerosis, Mult Scler, 15, 81, 10.1177/1352458508096215 Mills, 2010, Rasch analysis of the Modified Fatigue Impact Scale (MFIS) in multiple sclerosis, J Neurol Neurosurg Psychiatry, 81, 1049, 10.1136/jnnp.2008.151340 Lublin, 2014, Defining the clinical course of multiple sclerosis: the 2013 revisions, Neurology, 83, 278, 10.1212/WNL.0000000000000560 Compston, 2008, Multiple sclerosis, Lancet, 372, 1502, 10.1016/S0140-6736(08)61620-7 Tremlett, 2017, Primary and secondary progressive MS have a similar age at onset of progression—NO, Mult Scler, 23, 640, 10.1177/1352458516684559 Doward, 2010, International development of the Unidimensional Fatigue Impact Scale (U-FIS), Value Health, 13, 463, 10.1111/j.1524-4733.2010.00706.x Newland, 2016, Central fatigue in multiple sclerosis: a review of the literature, J Spinal Cord Med, 39, 386, 10.1080/10790268.2016.1168587 Lamoureux, 2015, How many subjects are enough for symptom-focused concept elicitation studies? A retrospective analysis of saturation across twenty-six studies, Value Health, 18, A33, 10.1016/j.jval.2015.03.198 Hays, 1993, The RAND 36-Item Health Survey 1.0, Health Econ, 2, 217, 10.1002/hec.4730020305 Yalcin, 2003, Validation of two global impression questionnaires for incontinence, Am J Obstet Gynecol, 189, 98, 10.1067/mob.2003.379 Kurtzke, 1983, Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS), Neurology, 33, 1444, 10.1212/WNL.33.11.1444 Guy, 1976 Wild, 2005, Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation, Value Health, 8, 94, 10.1111/j.1524-4733.2005.04054.x Polman, 2005, Diagnostic criteria for multiple sclerosis: 2005 revisions to the “McDonald Criteria”, Ann Neurol, 58, 840, 10.1002/ana.20703 Olsson, 1982, The polyserial correlation coefficient, Psychometrika, 47, 337, 10.1007/BF02294164 Ferguson, 1993, Exploratory factor analysis: a users' guide, Int J Select Assess, 1, 84, 10.1111/j.1468-2389.1993.tb00092.x Cronbach, 1951, Coefficient alpha and the internal structure of tests, Psychometrika, 16, 297, 10.1007/BF02310555 Van Zile-Tamsen, 2017, Using Rasch analysis to inform rating scale development, Res High Educ, 58, 922, 10.1007/s11162-017-9448-0 Kaiser, 1960, The application of electronic computers to factor analysis, Educ Psychol Meas, 20, 141, 10.1177/001316446002000116 Linacre, 2003, Data variance: explained, modeled and empirical, Rasch Meas Trans, 17, 942 Litwin, 1995 Nunnally, 1994, The assessment of reliability Nagata, 1996, Choice of response scale for health measurement: comparison of 4, 5, and 7-point scales and visual analog scale, J Epidemiol, 6, 192 Induruwa, 2012, Fatigue in multiple sclerosis—a brief review, J Neurol Sci, 323, 9, 10.1016/j.jns.2012.08.007 Mills, 2008, A medical definition of fatigue in multiple sclerosis, QJM, 101, 49, 10.1093/qjmed/hcm122