Measuring Cognitive Changes in HIV Infection: Size Really ......Measuring Cognitive Changes in HIV...
Transcript of Measuring Cognitive Changes in HIV Infection: Size Really ......Measuring Cognitive Changes in HIV...
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Measuring Cognitive Changes
in HIV Infection:
Size Really Matters
Jose A. Muñoz-Moreno, Ph.D. Lluita contra la SIDA Foundation
Germans Trias i Pujol University Hospital Badalona, Barcelona
Catalonia, Spain
26-27 May 2017 Barcelona, Catalonia, Spain
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Happy Birthday!
Muñoz-Moreno / Barcelona / May 2017
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Initial Examples
Raw score: 53 T score: 49 Z score: -0.1
Information Processing Speed SDMT (TEA Ediciones, 2002)
Muñoz-Moreno / Barcelona / May 2017
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Initial Examples
Raw score: 53 T score: 49 Z score: -0.1
Information Processing Speed SDMT (TEA Ediciones, 2002)
Raw score: 71 T score: 65 Z score: 1.5
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Initial Examples
Executive Functioning TMT-B (Periáñez JA, et al, 2007)
Raw score: 60 T score: 46 Z score: -0.4
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Initial Examples
Executive Functioning TMT-B (Periáñez JA, et al, 2007)
Raw score: 60 T score: 46 Z score: -0.4
Raw score: 86 T score: 32 Z score: -1.8
Muñoz-Moreno / Barcelona / May 2017
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Initial Examples
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Verbal Fluency COWAT/PMR (Casals-Coll M, et al, 2013)
Raw score: 19 T score: 60 Z score: 1.0
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Initial Examples
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Verbal Fluency COWAT/PMR (Casals-Coll M, et al, 2013)
Raw score: 19 T score: 60 Z score: 1.0
Raw score: 8 T score: 43 Z score: -0.7
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Information Processing Speed?
YES
Right Answers
NO
Executive Functioning?
YES NO
Verbal Fluency?
YES NO
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Information Processing Speed
YES
Right Answers
NO
Executive Functioning
YES NO
Verbal Fluency
YES NO
Muñoz-Moreno / Barcelona / May 2017
Source: Clipartpanda.com
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Disclosure
Dr. Jose A. Muñoz-Moreno
May 2017
• Dr. Muñoz-Moreno has received research funding from AbbVie and ViiV Healthcare.
• Dr. Muñoz-Moreno has received speaker honoraria from Gilead Sciences, Merck Sharp & Dohme, and ViiV Healthcare.
• Dr. Muñoz-Moreno has received consulting fees
from AlbaJuna Therapeutics, SL.
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Learning Objectives
1. To summarize the recommendations made to measure cognition in HIV infection, and to point out the instruments and scores most commonly used. 2. To emphasize the relevance of the definition of change for HIV-related cognitive functioning, and to show the factors most importantly related to that definition.
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Outline
1. Measuring Cognition: A. Non-HIV Populations: Recommendations B. HIV Population: Recommendations C. Measures of Change 2. Defining Change: A. Setting & Design B. Statistical Approach C. Relevance of Time D. Representative Examples
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Outline
1. Measuring Cognition: A. Non-HIV Populations: Recommendations
Muñoz-Moreno / Barcelona / May 2017
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Measuring Cognitive Change in Non-HIV Populations
• Neuropsychologists are uniquely equipped by training and expertise to assess changes in cognitive functioning and to distinguish normal changes from early signs of pathology.
• Neuropsychological evaluation remains the most effective differential
diagnostic method in discriminating dementia from age-related cognitive decline, symptoms that are depression related, and other related disorders.
• Despite of reliable biomarkers discovered, cognitive testing will still be
necessary to determine cognitive changes, the rate of decline, the functional capacities of the individual, and hopefully, response to therapies.
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Measuring Cognitive Change in Non-HIV Populations
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Measuring Cognitive Change in Non-HIV Populations
Muñoz-Moreno / Barcelona / May 2017
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Measuring Cognitive Change in Non-HIV Populations
Muñoz-Moreno / Barcelona / May 2017
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Outline
1. Measuring Cognition: A. Non-HIV Populations: Recommendations B. HIV Population: Recommendations
Muñoz-Moreno / Barcelona / May 2017
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Measuring Cognitive Change in HIV Population
Muñoz-Moreno / Barcelona / May 2017
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Measuring Cognitive Change in HIV Population
• HIV has measurable consequences for performance on NP tests. The majority of asymptomatic individuals, however, do not manifest significant impairment.
• The diagnosis of HIV-related cognitive impairment based on NP tests has various limitations, based on the comprehensiveness of the batteries, characteristics of the individuals, and settings where the tests are administered, including cultural contexts, and availability of appropriate normative standards.
• The preferred method to assess cognitive changes is using NP tests over time.
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Measuring Cognitive Change in HIV Population
Muñoz-Moreno / Barcelona / May 2017
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Measuring Cognitive Change in Non-HIV Population
Muñoz-Moreno / Barcelona / May 2017
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Measuring Cognitive Change in HIV Population
Muñoz-Moreno / Barcelona / May 2017
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Measuring Cognitive Change in Non-HIV Population
Muñoz-Moreno / Barcelona / May 2017
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Measuring Cognitive Change in Non-HIV Population
Muñoz-Moreno / Barcelona / May 2017
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Outline
1. Measuring Cognition: A. Non-HIV Populations: Recommendations B. HIV Population: Recommendations C. Measures of Change
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Specific Cognitive Scores vs Global Scores
Multiple comparisons Global representation
RCI vs NPZ vs GDS:
Reliable Change Index NeuroPsychological Z Global Deficit Score
Type of Measures
Muñoz-Moreno / Barcelona / May 2017
Source: Alvinalexander.com
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Cognitive Composite Scores
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Definition Formula Recommendation # Studies (longitudinal) PROs CONs
RCI Reliable Change Index
RCI = (Post - Pre) / Sdiff*
*Sdiff = √2(SE)2
5
1. Sensitivity / specificity 2. Integrative / change
1. Calculation
NPZ Neuro
Psychological Z Score
NPZ = (z1 + z2 + ...) / #z >30 1. Integrative
2. Calculation 1. No consensus selection
GDS Global Deficit Score
GDS = x adapted T scores to deficit
scores (0-5) 7 1. Interpretation
2. Calculation
1. Limited range 2. Real benefits unconsidered
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Outline
1. Measuring Cognition: A. Non-HIV Populations: Recommendations B. HIV Population: Recommendations C. Measures of Change 2. Defining Change: A. Setting & Design
Muñoz-Moreno / Barcelona / May 2017
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Setting & Design Approach
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1. Clinical vs Research: Number of measures considered Range of change 2. Research: Study design (prospective, randomized, controlled, ...) Endpoints established (primary vs secondary) Nº study arms Control group required Appropriate local normative data
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Source: Ourcommunitymedia.com
Source: Wakehealth.edu
Setting & Design Approach
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Outline
1. Measuring Cognition: A. Non-HIV Populations: Recommendations B. HIV Population: Recommendations C. Measures of Change 2. Defining Change: A. Setting & Design B. Statistical Approach
Muñoz-Moreno / Barcelona / May 2017
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Relevance of Statistics
Source: Pinterest.com/jillthompsong
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Relevance of Statistics
Source: Slideshare.net
Source: finanz.com.mx
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Relevance of Change Size, but also of Effect Size
What is it really significant?
Source: Linkedin.com
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Muñoz-Moreno / Barcelona / May 2017
Relevance of Change Size, but also of Effect Size
What is it really significant?
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Muñoz-Moreno / Barcelona / May 2017
Relevance of Change Size, but also of Effect Size
What is it really significant?
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Muñoz-Moreno / Barcelona / May 2017
Relevance of Change Size, but also of Effect Size
What is it really significant?
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Outline
1. Measuring Cognition: A. Non-HIV Populations: Recommendations B. HIV Population: Recommendations C. Measures of Change 2. Defining Change: A. Setting & Design B. Statistical Approach C. Relevance of Time
Muñoz-Moreno / Barcelona / May 2017
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Relevance of Time
BL wk4 wk48
wk12 wk24
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Practice Effect
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Practice Effect
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Outline
1. Measuring Cognition: A. Non-HIV Populations: Recommendations B. HIV Population: Recommendations C. Measures of Change 2. Defining Change: A. Setting & Design B. Statistical Approach C. Relevance of Time D. Representative Examples
Muñoz-Moreno / Barcelona / May 2017
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Examples of Studies (1)
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Schifitto et al, J Neurovirol, 2009
Characteristics
Autor / Year
Schifitto et al / 2009
Design / Sample
Single-arm/ N = 15
Intervention Lithium
Efficacy Endpoint
NPZ10 / 4 domains
Time 10 weeks
Statistical Approach t test, p values
Results No significant improvement
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Examples of Studies (2)
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Sacktor et al, Neurology, 2011
Characteristics
Autor / Year
Sacktor et al / 2011
Design / Sample
Randomized, Double-Blind /
N = 107
Intervention Minocycline / Placebo
Efficacy Endpoint
NPZ8 / 3 domains
Time 24 weeks
Statistical Approach t test, p values
Results No significant improvement
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Examples of Studies (3)
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Characteristics
Autor / Year
Simioni et al / 2013
Design / Sample
Cross-over, Pilot/ N = 17
Intervention Rivastigmine
Efficacy Endpoint
Specific scores / 5 domains
Time 20 weeks
Statistical Approach ANOVA, p values
Results No significant improvement
Simioni et al, Neurology, 2013
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Examples of Studies (4)
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Characteristics
Autor / Year
Ellis et al / 2014
Design / Sample
Randomized, Controlled /
N = 59
Intervention cART: CNS-T vs Non-CNS-T
Efficacy Endpoint
GDS / 7 domains
Time 16 weeks
Statistical Approach
ANCOVA, p values, effect sizes
Results No significant improvement
Ellis et al, CID, 2014
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Examples of Studies (5)
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Winston et al, HIV Medicine, 2012
Characteristics
Autor / Year
Winston et al / 2012
Design / Sample
Randomized, Open-Label /
N = 28
Intervention cART: FTC +
1) EFV, 2) ATV/r, 3) AZT/ABC
Efficacy Endpoint
NPZ9 / 3 domains
Time 24 weeks + 48 weeks
Statistical Approach t test, p values
Results Significant improvements
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Examples of Studies (6)
Muñoz-Moreno / Barcelona / May 2017
Winston et al, Plos ONE, 2015
Characteristics
Autor / Year
Winston et al / 2015
Design / Sample
Randomized, Open-Label /
N = 22
Intervention cART: FTC +
1) EFV, 2) ATV/r, 3) AZT/ABC
Efficacy Endpoint
NPZ9 / 3 domains
Time 48 weeks + 144 weeks
Statistical Approach t test, p values
Results Significant worsening
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Examples of Studies (7)
Muñoz-Moreno / Barcelona / May 2017
Muñoz-Moreno et al, submitted, 2017
Characteristics
Autor / Year
Muñoz-Moreno et al / submitted
Design / Sample
Randomized, Controlled /
N = 29
Intervention Rivastigmine / Lithium / Control
Efficacy Endpoint
NPZ7 / 7 domains
Time 12 weeks + 48 weeks
Statistical Approach
ANOVA, p values, effect sizes
Results No significant improvement
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Conclusions
1. When assessing cognitive change, both the method and specific variables of change, and also the definition of change, are relevant aspects to consider. 2. Neuropsychological testing is the most widely recommended method to assess cognitive changes in HIV infection, and there are different scores that can be selected as measures of change. 3. Several aspects in the definition of change are crucial, in particular the study design, the timepoints, and mainly the statistical tests used. 4. The size of the change is a key point and must be analyzed adequately, preferably including effect sizes. 5. Only few of the multiple studies published in the field incorporate the same scores for change, and effect size tests.
Muñoz-Moreno / Barcelona / May 2017
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Thanks!
Jose A. Muñoz-Moreno, Ph.D.
www.flsida.org