Measuring Health-Related Quality of Life in Neurology Clinical ...

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  • Static questionnaire are either not precise enough or their measurement range is to narrow … ceiling and floor effects …
  • Purpose of this slide is to walk the audience through the CAT process using an example …and thereby transmit the message of narrower measurement range and higher precision with each question …
    I typically ese e.g. an example for depression, or any other topic I want to focus on … like first question “do you feel depressed”, answer “some of the time” … than we would like to know how depressed and the CAT might choose a question asking about self worth, and if the patient indicates that this is diminished also, a third question asking about thoughts of suicide might be appropriate … in this case the answer would be no, never …
    And maybe compare it with another scenario like the participant would have answered the first question, no I am not at all depressed, asking about suicide would not make sense, instead the CAT might have chosen a question asking about happiness … bla bla
    The conclusion is, we can make precise test over the entire range …
  • At this point in the process, our preliminary domain structure looked like this.
  • At this point in the process, our preliminary domain structure looked like this.
  • Measuring Health-Related Quality of Life in Neurology Clinical ...

    1. 1. Measuring Health-Related Quality of Life in Neurology Clinical Research: Neuro-QOL Item Banks and Disease Targeted Scales David Cella, Claudia Scala-Moy, Deborah Miller, Amy Peterman, Richard Gershon, David Victorson, Cindy Nowinski, Seung Choi, Jin-Shei Lai, Rita Bode, and Anthony Reder
    2. 2. Neuro-QOL Primary Sites ●UNC –Charlotte ● Westat ●Cleveland Clinic ●Boston U ENH/NU/RIC ♥ ● NIHNIH U. Chicago –NINDS (Project Officer: Claudia Scala-Moy, Ph.D) –Principal Investigator: David Cella, PhD
    3. 3. Objectives of Neuro-QOL RFP-NIH-NINDS-03-04  Develop a core set of QOL questions that cut across chronic neurologic disorders  Develop supplemental questions that address concerns specific to targeted diseases or subgroups of patients  Create a publicly available, adaptable and sustainable system allowing clinical researchers access to a common item repository and computerized adaptive testing (“CAT”)
    4. 4. What's wrong with today's static measurements ? 0123-1-2-3 Questionnaire with a wide range - but low precision 12 Questionnaire with a high precision - but small range
    5. 5. Computerized Adaptive Tests 0123-1-2-3 high depression low depression 012 2. Question 12 3. Question Questionnaire with a high precision - AND a wide range
    6. 6. “Item Bank” • A large collection of items measuring a single domain • Basis for tailored/adaptive testing – Items in the same bank are linked on a common metric. – Items are selected to maximize precision and retain clinical relevance
    7. 7. Target Disorders • Adult conditions – Stroke – Multiple Sclerosis – Parkinson’s disease – Epilepsy – ALS • Pediatric conditions – Epilepsy – Muscular dystrophies
    8. 8. Psycho- metric Testing Item Bank (IRT-calibrated items) 0.0 0.5 1.0 1.5 2.0 2.5 -3 -2 -1 0 1 2 3 Theta Information 0.0 0.2 0.4 0.6 0.8 1.0 -3 -2 -1 0 1 2 3 Theta ProbabilityofResponse Short Form Instruments CAT Literature Review Item Pool Patient Focus Groups Expert Input and Consensus Existing Items (PROMIS; AMPAC)  Questionnaire administered to large representative sample            Secondary Data Analysis Cognitive Testing Translation Expert Review Newly Written Items
    9. 9. Neuro-QOL Testing Samples • WAVE Ia: Online clinical samples (511 adults; 59 children – Complete • WAVE Ib: Online general population calibration testing for adults (3000 adults; 1500 children): English and Spanish – Complete • WAVE II: Clinical validation testing of IRT-calibrated short forms (n=800 baseline; n=400 7 day; n=400 180 day) – In progress • Today’s results are for WAVE I (a and b) calibration field testing
    10. 10. Analysis Plan • If N > 500 – PROMIS analysis plan • Reeve et al, 2007; or – Evaluation of unidimensionality • Descriptive statistics • Factor analysis – Estimation of Item Parameter using 2-PL IRT • If N < 500 (Wave 1a Pediatric) – Descriptive statistics and Rasch analysis
    11. 11. Wave 1b: Adult Item Bank Information Functions Positive Psychological Function T-score rel.=.90 rel.=.95 0 20 40 60 80 100 10 20 30 40 50 60 70 80 90 Depression T-score rel.=.90 rel.=.95 0 20 40 60 80 100 10 20 30 40 50 60 70 80 90 Anxiety T-score rel.=.90 rel.=.95 0 10 20 30 40 50 60 10 20 30 40 50 60 70 80 90 Perceived Cognitive Deficiency T-score rel.=.90 rel.=.95 0 50 100 150 10 20 30 40 50 60 70 80 90 Applied Cognitive Function T-score rel.=.90 rel.=.95 0 20 40 60 80 100 120 140 10 20 30 40 50 60 70 80 90 Stigma T-score rel.=.90 rel.=.95 0 20 40 60 80 100 10 20 30 40 50 60 70 80 90 Mobility Ambulation T-score rel.=.90 rel.=.95 0 50 100 150 10 20 30 40 50 60 70 80 90 Upper Extremity ADL T-score rel.=.90rel.=.95 0 100 200 300 400 500 600 10 20 30 40 50 60 70 80 90 Social Role Ability T-score rel.=.90 rel.=.95 0 50 100 150 200 250 10 20 30 40 50 60 70 80 90 Social Role Satisfaction T-score rel.=.90 rel.=.95 0 50 100 150 200 250 300 10 20 30 40 50 60 70 80 90 The shaded areas represent the effective measurement ranges where a reliability of roughly .95 is attainable.
    12. 12. Reliability and Item Total Correlation Examples Domain Alpha i-total r Positive Psychological Function .98 .60 - .91 Depression .98 .64 - .90 Anxiety .97 .56 - .87 Perceived Cognitive Dysfunction .98 .57 - .85 Applied Cognitive Function .97 .54 - .78
    13. 13. Depression – 24-item bank Location 50 52 54 56 I felt I had no reason for living I felt like I needed help for my depression I felt hopeless I felt that nothing was interesting I felt unloved I felt that I wanted to give up on everything I felt that nothing could cheer me up I felt that my life was empty I had trouble enjoying things that I used to enjoy I felt worthless I felt helpless I withdrew from other people I felt that I had nothing to look forward to I had trouble keeping my mind on what I was doing I found that things in my life were overwhelming I felt pessimistic I felt depressed I felt emotionally exhausted I felt lonely I felt that everything I did was an effort I felt discouraged about the future I felt unhappy I was critical of myself for my mistakes I felt sad
    14. 14. 2 4 6 8 10 12 0.0 0.2 0.4 0.6 0.8 1.0 Depression Test Length SE T-score=30 T-score=40 T-score=50 T-score=60 T-score=70
    15. 15. Mobility Ambulation – 31-item bank Location 45 50 55 60 running up and down an incline? taking a 20-minute brisk walk, without stopping to rest? getting into and out of a kneeling position? Are you able to jump up and down? Hwalking 45 minutes on an even surface? climbing stairs step over step without a handrail? going up and down three flights of stairs inside, using a handrail? walking on a slippery surface, outdoors? Are you able to get up off the floor from lying on your back without help? Are you able to go for a walk of at least 15 minutes? How difficult is it for you to go for a walk of at least 15 minutes? standing up from a low, soft couch? crossing the road at a 4-lane traffic light with curbs? going up and down a flight of stairs inside, using a handrail? walking in a busy place without losing your balance? Are you able to run errands and shop? sitting down on a low, soft couch? getting into and out of a truck, bus, shuttle van, or sport utility vehicle? Are you able to step up and down curbs? walking on uneven surfaces? opening a window above shoulder height, while standing? walking in a dark room without falling? standing up from an armless straight chair? using an escalator? Are you able to push open a heavy door? Are you able to get out of bed into a chair? moving from lying on your back to sitting on the side of the bed? Are you able to get in and out of a car? sitting down on an armless straight chair? Are you able to get on and off the toilet? moving from sitting at the side of the bed to lying down on your back?
    16. 16. 2 4 6 8 10 12 0.0 0.2 0.4 0.6 0.8 1.0 Mobility Ambulation Test Length SE T-score=30 T-score=40 T-score=50 T-score=60 T-score=70
    17. 17. PHYSICAL Function/Health Symptoms Fatigue Sleep Mobility/Ambulation Sexual Bowel/Bladder ADL’s/UE’s MENTAL Emotional Health Cognitive Health Perceived Applied Depression Stigma Positive Psych Fn Anxiety Personality Change End of Life Concerns SOCIAL Role Participation Role Satisfaction B=Bank T=Targeted Scale TD=Targeted scale developed but not tested Adult Domain Framework for Item Banks and Targeted Scales B - includes communication problems B B TD TD T T B B B B B B B T TD
    18. 18. PHYSICAL Function/Health Symptoms Pain Fatigue Mobility/Ambulation ADL’s/UE’s MENTAL Emotional Health Cognitive Health Depression Stigma Anxiety SOCIAL B=Bank T=Targeted Scale Pediatric Domain Framework for Item Banks and Targeted Scales B B T T B B T T B
    19. 19. Wave II Clinical Validation Testing Assessment I (Baseline) Assessment II (7 days) Assessment III (180days) Stroke 100 X X Multiple Sclerosis 100 X X Parkinson’s Disease 100 X X Adult Epilepsy 100 X X ALS 100 X X Proxies matched to Stroke 100 X X Pediatric Epilepsy 50 X X Proxies matched to above Epilepsy 50 X X Pediatric Muscular Dystrophy 50 X X Proxies matched to above MD 50 X X Maximum Subtotal 800
    20. 20. Wave II Clinical Testing Sites •University of Texas •Dartmouth •Northwestern University •University of Chicago •Rehabilitation Institute of Chicago •Cleveland Clinic Foundation •University of Pennsylvania •NorthShore University HealthSystem •Children’s Memorial Hospital (Chicago) •University of California Davis •University of Puerto Rico N = 150 of 800
    21. 21. Thank You! www.NeuroQOL.org

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