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NINDS CDE Notice of Copyright
Neuro-QOL Adult Bank - Fatigue
Availability
Although the Neuro-QOL measures have been tested in two large calibration studies with disease-based and community dwelling samples, the calibrated short forms are currently being administered in a multi-site clinical validation study. Until this study is completed and the Neuro-QOL measures are released into the public domain, investigators or groups wishing to use them in their current or future study may do so only if they agree to provide the Neuro-QOL study team with item-level data derived from their respective study. This data will be used to evaluate the performance of Neuro-QOL items in different neurological conditions and trials.
 
 
For additional information and to obtain Neuro-QOL instruments, see: Quality of Life in Neurological Disorders; and General Page for currently available Neuro-Qol Bank CDE Details.
 
From their website: Neuro-QoL measures are copyrighted. All English and Spanish version of Neuro-QoL are publicly available for use in one’s individual research, clinical practice, educational assessment, or other application without licensing or royalty fees. Commercial users must seek permission to use, reproduce, or distribute measures. Integration into proprietary technology requires written permission.
Classification
Supplemental – Highly Recommended: Congenital Muscular Dystrophy (CMD) (Highly recommended for studies of psychosocial functioning, quality-of-life, outcome, and long-term adjustment studies.) and Epilepsy (quality of life studies)
 
Supplemental: Amyotrophic Lateral Sclerosis (ALS), Chiari I Malformation (CM), Friedreich’s Ataxia (FA), Huntington’s Disease (HD), Mitochondrial Disease (Mito), Multiple Sclerosis (MS), Myasthenia Gravis (MG), Neuromuscular Disease (NMD), Parkinson’s Disease (PD), Spinal Cord Injury (SCI), Spinal Muscular Atrophy (SMA) and Traumatic Brain Injury (TBI)
 
Exploratory: Cerebral Palsy (CP), Duchenne Muscular Dystrophy (DMD), Facioscapulohumeral Muscular Dystrophy (FSHD), Headache, Myalgic encephalomyelitis/Chronic fatigue syndrome (ME/CFS), Myotonic Dystrophy (DM), Sport-Related Concussion (SRC), Stroke, and Unruptured Cerebral Aneurysms and Subarachnoid Hemorrhage (SAH)
Comments
Item Bank Recommendations:
  
Stroke: Adult Mobility, Adult Upper Extremities, Adult Assistive Devices
 
 
 
 
Short Description of Instrument
Neuro-QoL (Quality of Life in Neurological Disorders) is a set of health-related quality of life (HRQoL) measures for use with adults (18+) and children (ages 8-17) who have a neurological condition or disorder.
 
Neuro-QoL development was funded by NINDS with the goal of providing a set of standard measures that could be used across a variety of neurological conditions and in both neurology clinical research and clinical practice. Neuro-QoL is appropriate for both within-disease and cross-disease comparisons. Recent work linking individual Neuro-QoL instruments to generic measures included in the Patient Reported Outcomes Measurement Information System (PROMIS) also allows comparisons to non-neurological conditions.
 
Development utilized state-of-the art qualitative and quantitative methods (including item response theory [IRT]) consistent with FDA guidance regarding Patient Reported Outcomes. Domains (constructs) were selected and items refined based on patient, caregiver, and expert input. Most of the measures were constructed as item banks, which confers several advantages. The item banks enable assessment using either a variety of fixed-length short forms (SFs) or computer adaptive tests (CAT). CATs, computerized tests that select the most informative items to present based on the participant’s previous response, can shorten assessments while maintaining measurement precision. Any or all items within a bank can be used for assessment, with scores comparable no matter which item or subset of items are used. Thus, users can create their own “custom” short forms that best meet their measurement needs.
 
The Neuro-QoL system assesses important domains (symptoms, concerns, and issues) of physical, mental and social health that are relevant across disorders (generic measures) along with instruments that assess areas most relevant for specific patient populations (targeted).
 
Purpose: The Neuro-QOL is a Patient Reported Outcome (PRO) measurement system designed for neurologically impaired populations. Neuro-QOL seeks to incorporate patient reported outcomes of functioning, such as social, psychological, and mental well-being; fatigue is included but is not the main part of the instrument. It may be completed on paper (short forms), computer or with an app.
 
Overview: The Neuro-QOL contains 10 calibrated item banks with Likert-style items and with several banks linked with PROMIS. Item banks cover the following domains: Mobility/Ambulation, ADL/Upper Extremity, Depression, Anxiety, Positive Psychological Functioning, Stigma, Perceived and Applied Cognition (includes communication), Social Role Performance, Social Role Satisfaction, Fatigue, Personality and Behavioral Change and Sleep Disturbances.
 
It has been used in a range of other neurological conditions, including use in stroke, multiple sclerosis, Parkinson’s disease, epilepsy, amyotrophic lateral sclerosis (ALS), traumatic brain injury (TBI), military deployment–related traumatic brain injury (MDR-TBI), spinal cord injury (SCI), and Huntington’s disease (HD). It is considered highly recommended for congenital muscular dystrophy and supplemental or exploratory for other neurological conditions. The lack of evidence for ME/CFS indicates its use in this disease should be exploratory.
 
Time: Administered as short-forms, Computer Adaptive Tests (CATs) or with an App. Administration time is less than 5 minutes per sub domain (total time for short form across all domains is about 30 minutes). The fatigue domain can be completed in one minute.
 
Standard Neuro-QoL Short Forms are generally 8 items long. Neuro-QoL CATs are typically ~6 items. On average, adult respondents are able to answer 5 questions and pediatric respondents able to answer 4 questions per minute. Thus, it takes adults ~1 to 1.5 minutes and children ~1.5 to 2 minutes to complete Neuro-QoL measures, depending on which format administered.
 
Scoring: Likert items. Embedded in several of the Neuro-QOL domains are a significant number of Patient-Reported Outcomes Measurement Information System (PROMIS) items. As a result, a PROMIS equivalency score can be derived for all individuals who complete the Neuro-QOL measures.
 
Neuro-QoL scores are on a T-score metric (mean = 50 and standard deviation = 10) with higher scores indicating more of what is being measured. Short forms can be hand scored using look-up tables. Short forms (standard or custom) and CATs can be automatically scored using one of the available data collection software systems or a free scoring service.
 
Strengths: Neuro-QOL includes multiple banks and short forms that cover a variety of domains. These domains were initially developed for adult patients with ALS, multiple sclerosis, Parkinson’s disease, and stroke and for pediatric patients with epilepsy and muscular dystrophy (e.g., Duchenne Muscular Dystrophy). It is easy to use.
 
Epilepsy specific:
While Neuro-QoL has not been widely used in epilepsy, uptake is increasing.
Neuro-QoL domains that are not typically found in epilepsy-specific HRQoL instruments include Stigma, Sleep Disturbance, Emotional and Behavioral Dyscontrol and Positive Affect & Wellbeing.
 
ME/CFS: If used, Neuro-Qol- item-level data to be shared. The use as a measurement of quality of life worth further exploration, as it provides a good coverage of physical, mental and social aspects of neurological disease but not targeted at ME/CFS. It has not been validated for ME/CFS.
 
Other Important Notes: The Neuro-QOL is designed to be a common outcome variable across NINDS-sponsored clinical trials. It has been tested in large samples of individuals from both general and diverse, neurologically-impaired populations. Validation with stroke patients is underway.
Available translations. Neuro-QoL measures are available in English and Spanish. Individual measures have been translated into other languages. A list of available translations can be found at: http://www.healthmeasures.net/explore-measurement-systems/neuro-qol/intro-to-neuro-qol/available-translations
Psychometric Properties
It is a clinically relevant and psychometrically robust health-related quality of life (HRQL) assessment tool for adults and children that is responsive to the needs of researchers in a variety of neurological disorders and settings and facilitates comparisons of data across clinical trials in different diseases.
 
Weaknesses related to DM: The instruments include CATs, short forms, and scales. These instruments and domains were not developed specifically for myotonic dystrophy or validated in this population.
 
Epilepsy specific:
 
Adult Neuro-QoL Short Forms
 
Reliability – internal consistency of individual instruments ranged from 0.86- 0.96. One week test-retest range = 0.57- 0.89.
 
Validity – Neuro-QoL measures correlated in expected directions (convergent and discriminant validity) with generic and epilepsy-specific (e.g., QOLIE-31) legacy measures. However, while correlated with other measures of self-reported cognition, Neuro-QoL cognition was not significantly associated with performance-based measures of cognitive function. Neuro-QoL measures successfully discriminated between different levels of seizure severity.
 
Responsiveness to Change – Measures showed sensitivity to self-reported change in health status.
 
Weaknesses: Responsiveness has not been evaluated in intervention or other trials designed to produce change. Neuro-QoL measures do not have caregiver-report versions, limiting their use in adults with cognitive or other deficits that prevent self-report.
 
Pediatric Neuro-QoL Short Forms
 
Reliability – internal consistency (ICCs) of individual instruments ranged from 0.44 for Stigma to 0.94 for Upper Extremity Function. Except for Stigma, all measures had ICCs greater than .62. Test-retest reliability (Cronbach’s alpha) ranged from 0.76- 0.87.
 
Validity – Neuro-QoL measures correlated in expected directions with generic and epilepsy-specific measures of similar domains (convergent validity). Anxiety and Cognitive Function discriminated amongst participants with different seizure severity levels. All pediatric Neuro-QoL measures except Cognitive Function and Upper Extremity Function discriminated participants with different levels of quality of life.
 
Responsiveness to Change – Neuro-QoL did not show sensitivity to self-reported change over time. This finding may have been due to lack of change in the sample, as the primary legacy measure (PedsQL) also failed to demonstrate responsiveness.
 
      Weaknesses: The measures do not have parent-report versions and therefore are not appropriate for use with children      
      younger than 8 years of age. Responsiveness to change has yet to be evaluated in studies where change is to be   
      expected.  
 
 
References
Cella D, Lai JS, Nowinski CJ et al. Neuro-QOL: brief measures of health-related quality of life for clinical research in neurology. Neurology. 2012;78(23):1860-1867. doi: 10.1212/WNL.0b013e318258f744. Epub 2012 May 9.
 
Gershon RC, Lai JS Bode R et al. Neuro-QOL: quality of life item banks for adults with neurological disorders: item development and calibrations based upon clinical and general population testing. Qual Life Res. 2012;21(3):475-486. doi: 10.1007/s11136-011-9958-8. Epub 2011.
 
Lai J-S, Nowinski C, Victorson D, et al. Quality-of-Life Measures in Children With Neurological Conditions: Pediatric Neuro-QOL. Neurorehabilitation and neural repair. 2012;26(1):36-47. doi:10.1177/1545968311412054.
 
TBI CDE Working Group (2010). CDE Recommendations – Listing of the Core, Supplemental and Emerging Measures for each Outcome Domain.
 
 
Neuro-QOL Bank Development and Construction.Quality of Life in Neurological Disorders (accessed March 10, 2010).
 
HD:
Cella D, Nowinski C, Peterman A, Victorson D, Miller D, Lai JS, Moy C. The neurology quality-of-life measurement initiative. Arch Phys Med Rehabil. 2011;92(10 Suppl):S28–S36.
 
Carlozzi, N. E. (2010), Examining health-related quality of life in Huntington’s disease. In A. W. Heinemann (Chair), Advances in Outcome Measures for Neurologic Disorders. Symposia presented at the ACRM-ASNR Joint Educational Conference, Montreal, Quebec, Canada.
 
Carlozzi NE & Tulsky DS. Health-related quality of life in Huntington disease.Published Abstract from the Huntington’s Disease World Congress 2011, Melbourne, Australia. Clin Genetics, 2011;80 (Suppl 1):37–38.
 
Carlozzi NE, McGowan H, Tulsky DS. (2010). Extending the Neuro-QOL to Huntington’s Disease (HD): The development of the HD-HRQOL. Poster presented at the International Society for Quality of Life Research 17th Annual Conference, London, England.
 
Carlozzi NE & Ready RE. (2011). Health-related quality of life in Huntington’s Disease. In: C. Jenkinson, M. Peters, & M. B. Bromberg (Eds.), Quality of Life and Neurodegenerative Disease. Cambridge, UK: Cambridge University Press, pp. 71–81.
 
Carlozzi NE. (2012). Adaptations of the PROMIS and Neuro-QOL to traumatic brain injury (TBI) and Huntington disease (HD). In: DS Tulsky & NE Carlozzi (Co-Chairs), Common data elements in neurological research. Symposia submitted for presentation at the 40th Annual International Neuropsychological Society Meeting, Montreal, Canada.
 
Carlozzi NE & Tulsky DS. Identification of health-related quality of life (HRQOL) issues relevant to individuals with Huntington disease. J Health Psychol. 2013;18(2):212–225.
 
Additional Epilepsy:
Lai JS, Nowinski C, Victorson D, Bode R, Podrabsky T, et al. Quality-of-life measures in children with neurological conditions: pediatric Neuro-QOL. Neurorehabilitation and neural repair. 2012; 26(1):36-47.
 
Victorson D, Cavazos JE, Holmes GL, Reder AT, Wojna V, et al. Validity of the Neurology Quality-of-Life (Neuro-QoL) measurement system in adult epilepsy. Epilepsy & Behavior: E&B. 2014; 31:77-84.
 
Lai JS, Nowinski CJ, Zelko F, Wortman K, Burns J, Nordli DR, Cella D. Validation of the Neuro-QoL measurement system in children with epilepsy. Epilepsy & Behavior. 2015;46:209–214.
 
Correia H, Pérez B, Arnold B, Wong AWK, Lai JS, Kallen M, Cella D. Spanish Translation and Linguistic Validation of the Quality of Life in Neurological Disorders (Neuro-Qol) Measurement System. Quality of Life Research. 2014;24(3):753-756.
 
Recommended Instrument for
ALS, CP, CM, CMD, DM, DMD, Epilepsy, FA, FSHD, HD, Headache, MG, Mito, MS, ME/CFS, NMD, PD, SAH, SCI, SMA, SRC, Stroke, and TBI
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