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10 The Impact of Performance and Symptom Invalidity on Relationships Between Subjective and Objective Cognitive Functioning
- Daniel S Weitzner, Brian I Miller, Troy A Webber, Michael E. DeBakey
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- Journal:
- Journal of the International Neuropsychological Society / Volume 29 / Issue s1 / November 2023
- Published online by Cambridge University Press:
- 21 December 2023, pp. 694-695
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Objective:
Inconsistent relationships between subjective and objective performance have been found across various clinical groups. Discrepancies in these relationships across studies have been attributed to various factors such as patient characteristics (e.g., level of insight associated with cognitive impairment) and test characteristics (e.g., using too few measures to assess different cognitive domains). Although performance and symptom invalidity are common in clinical and research settings and have the potential to impact responding on testing, previous studies have not explored the role of performance and symptom invalidity on relationships between objective and subjective performance. Therefore, the current study examined the impact of invalidity on performance and symptom validity tests (PVTs and SVTs, respectively) on the relationship between subjective and objective cognitive functioning.
Participants and Methods:Data were obtained from 299 Veterans (77.6% male, mean age of 48.8 years (SD = 13.5)) assessed in a VA medical center epilepsy monitoring unit from 2008-2018. Participants completed a measure of subjective functioning (i.e., the Patient Competency Rating Scale), PVTs (i.e., Word Memory Test, Test of Memory Malingering, Reliable Digit Span), SVTs (i.e., Minnesota Multiphasic Personality Inventory-2-Restructured Form Response Bias Scale, Structured Inventory of Malingered Symptomatology), and neuropsychological measures assessing objective cognitive performance (e.g., Trail Making Test parts A and B). Pearson correlations were conducted between subjective functioning and objective cognitive performance in the following groups: 1.) PVT and SVT valid, 2.) PVT and SVT invalid, 3.) PVT-only invalid, 4.) SVT-only invalid. Using Fisher’s r-to-z transformation, tests for the differences between correlation coefficients were then conducted between the PVT and SVT valid vs. PVT and SVT invalid groups, and the PVT-only invalid vs. SVT-only invalid groups.
Results:Participants with fully valid PVT and SVT performances demonstrated generally stronger relationships between subjective and objective scores (r’s = .058 - .310) compared to participants with both invalid PVT and SVT scores (r’s = -.033 - .132). However, the only significant difference in the strengths of correlations between the groups was found on Trail Making Test Part B (p = .034). In separate exploratory analyses due to low group size, those with invalid PVT scores only (fully valid SVT) demonstrated generally stronger relationships between subjective and objective scores (r’s = -.101 - .741) compared to participants with invalid SVT scores only (fully valid PVT; r’s = -.088 - .024). However, the only significant difference in the strengths of correlations between the groups was found on Trail Making Test Part A (p = .028).
Conclusions:The present study suggests that at least some of the discrepancies in previous studies between subjective and objective cognitive performance may be related to performance and symptom validity. Specifically, very weak relationships between objective and subjective performance were found in participants who only failed SVTs, whereas relationships were stronger in those who only failed PVTs. Therefore, findings suggest that including measures of PVTs and SVTs in future studies investigating relationships between subjective and objective cognitive performance is critical to ensuring accuracy of conclusions that are drawn.
426 Datathon Revisited: Implementation of Lesson Learned
- Part of
- Andrew J. Zimolzak, Katherine Sippel, Jessica A. Davila, Michael E. DeBakey, Vamshi Punugoti, Paul E. Klotman, Laura A. Petersen, Michael E. DeBakey, Gloria Liao, Lee Leiber, Christopher I. Amos
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- Journal:
- Journal of Clinical and Translational Science / Volume 7 / Issue s1 / April 2023
- Published online by Cambridge University Press:
- 24 April 2023, pp. 127-128
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OBJECTIVES/GOALS: In 2020, Baylor College of Medicine held a datathon to introduce a data warehouse, identify its capabilities/limitations, foster collaborations, and engage trainees. The event was held again in 2022, and lessons learned (e.g., tools for data self-service or team communication) were applied. METHODS/STUDY POPULATION: Senior faculty reviewed proposals with an emphasis on feasibility, impact, and relevance to quality improvement or population health. Selected teams worked with Information Technology (IT) for 2 months and presented findings at a 1-day event. Surveys were administered to participants before and after the event to evaluate their background, team characteristics, collaborations, knowledge before and after the datathon, perceived value of the datathon, and plans for future work. Descriptive statistics of respondents’ self-reports were tabulated. RESULTS/ANTICIPATED RESULTS: In 2022, 19 of 36 projects were accepted (13/33 in 2020). At both events, most projects studied quality improvement or clinical outcomes. Of 82 participants in 2022, 54 completed surveys. In 2022, 72% had no datathon experience (48% in 2020). Median effort was 10 person-hours; median IT time was 20% (20 and 10%, in 2020). Seven respondents finished and 21 partially finished their projects (1 and 11, in 2020); 92% made new collaborations (91% in 2020). Respondents strongly agreed that: the experience was valuable (n=28), they would participate in future datathons (n=30), and they would use the warehouse for future work (n=25). Twenty-seven have planned abstracts; 25 have planned manuscripts. DISCUSSION/SIGNIFICANCE: The 2022 datathon had more participants with less experience, potentially due to improved promotion and training opportunities. Fewer person-hours and a higher percentage of IT time were required as compared to 2020, and more projects were completed, possibly due to increased IT efficiency.
5 Clinical Evaluation of the Abuse Potential of Buprenorphine/Samidorphan Combination
- Andrew J. Cutler, Sanjay J. Mathew, Michael E. DeBakey, Beatrice Setnik, Narinder Nangia, Arielle D. Stanford, Sanjeev Pathak
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- Journal:
- CNS Spectrums / Volume 24 / Issue 1 / February 2019
- Published online by Cambridge University Press:
- 12 March 2019, p. 176
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Introduction
Buprenorphine (BUP)/samidorphan (SAM) combination is an opioid system modulator being investigated as an adjunctive treatment for major depressive disorder (MDD). BUP/SAM is a fixed-dose combination of BUP, a partial µ-opioid receptor agonist and κ-opioid receptor antagonist, and SAM, a µ-opioid receptor antagonist added to address the abuse and dependence potential of BUP.1,2
Study ObjectiveWe assessed the effects of SAM on the abuse potential of BUP in the BUP/SAM combination in two ways: (1) a human abuse potential (HAP) study in volunteers; and (2) an evaluation of the clinical experience across studies of patients with MDD.
MethodsStudy 212 (ClinicalTrials.gov ID: NCT02413281) was a HAP study in nondependent, recreational, adult opioid users. Following a qualification period, participants were randomized to 6 treatments in a blinded, crossover design: placebo (PBO), BUP/SAM at the target therapeutic dose (BUP/SAM 2mg/2mg), at 8mg/8mg and 16mg/16mg , and BUP alone (8mg and 16mg). The primary endpoint was maximum effect (Emax) for “At The Moment” Drug Liking Visual Analog Scale (VAS).
The clinical program for BUP/SAM included 4 PBO-controlled studies of patients with MDD (n=961). Pooled safety data were evaluated for adverse events (AEs) that may be associated with abuse, dependence, or withdrawal, as well as for objective signs of withdrawal with the Clinical Opioid Withdrawal Scale (COWS).
ResultsIn Study 212 (n=38), Emax Drug Liking VAS scores for the BUP/SAM 2mg/2mg dose were similar to those for PBO (median within-subject difference [90% CI]: 2.5 [0.0–9.0]). Emax Drug Liking VAS scores for all BUP/SAM dose groups, including supratherapeutic doses, were significantly lower than those observed for either of the BUP doses. The supratherapeutic doses of BUP/SAM (8mg/8mg and 16mg/16mg) had higher Emax Drug Liking VAS scores than PBO, but the differences were small.
In the MDD controlled studies, the incidence of euphoria-related AEs was low for BUP/SAM 2mg/2mg and PBO (1.6% vs 0.2%, respectively) and there was no evidence of abuse or dependence behavior. Euphoria-related events typically occurred with treatment initiation and resolved with continued treatment. There was minimal evidence of withdrawal by reported AEs or COWS assessment.
ConclusionsThese findings indicate that SAM mitigates the abuse potential of BUP in the BUP/SAM combination.
Funding Acknowledgements: Alkermes, Inc.
2121 Quantitative structural knee measurements improve classification of accelerated knee osteoarthritis: Data from the osteoarthritis initiative
- Lori L. Price, Timothy E. McAlindon, Mamta Amin, Charles B. Eaton, Julie E. Davis, Bing Lu, Grace H. Lo, Michael E. DeBakey, Jeffrey Duryea, Mary F. Barbe, Jeffrey B. Driban
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- Journal:
- Journal of Clinical and Translational Science / Volume 2 / Issue S1 / June 2018
- Published online by Cambridge University Press:
- 21 November 2018, p. 25
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OBJECTIVES/SPECIFIC AIMS: The aim of this study is to determine whether quantitative measures of knee structures including effusion, bone marrow lesions, cartilage, and meniscal damage can improve upon an existing model of demographic and clinical characteristics to classify accelerated knee osteoarthritis (AKOA). METHODS/STUDY POPULATION: We conducted a case-control study using data from baseline and four annual follow-up visits from the osteoarthritis initiative. Participants had no radiographic knee osteoarthritis (KOA) at baseline. AKOA is defined as progressing from no KOA to advance-stage KOA in at least 1 knee within 48 months. AKOA knees were matched 1:1 based on sex to (1) participants who did not develop KOA within 48 months and (2) participants who developed KOA but not AKOA. Analyses were person based. Classification and regression tree analysis was used to determine the important variables and percent of variance explained. RESULTS/ANTICIPATED RESULTS: A previous classification and regression tree analysis found that age, BMI, serum glucose, and femorotibial angle explained 31% of the variability between those who did and did not develop AKOA. Including structural measurements as candidate variables yielded a model that included effusion, BMI, serum glucose, cruciate ligament degeneration and coronal slope and explained 39% of the variability. DISCUSSION/SIGNIFICANCE OF IMPACT: Knee structural measurements improve classification of participants who developed AKOA Versus those who did not. Further research is needed to better classify patients at risk for AKOA.