The quality of measurement properties of neurocognitive assessment in brain tumor clinical trials over the last 30 years: a COSMIN checklist-based approach

Martino, Maria De; Santini, Barbara; Cappelletti, Giovanna; Mazzotta, Annapina; Rasi, Matteo; Bulgarelli, Giorgia; Annicchiarico, Luciano; Marcocci, Alessandro; Talacchi, Andrea

doi:10.1007/s10072-020-04477-4

Cited by 7 publications

(4 citation statements)

References 50 publications

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“…Neuropsychological test selection for the present study is aligned with recommendations by the International Cognition and Cancer Task Force [ 45 ]. An exhaustive review of neuropsychological assessment in brain tumor clinical trials provides an objective evaluation of the selected neuropsychological tests used in this study, such that all tests demonstrated fair reliability according to the COSMIN (Consensus-based Standards for the selection of health Measurement Instruments) checklist [ 46 ].…”

Section: Methodsmentioning

confidence: 99%

Study protocol for Cognitive Behavioral Therapy for Insomnia in patients with primary brain tumor: A single-arm phase 2a proof-of-concept trial

Loughan¹,

Lanoye²,

Willis³

et al. 2023

Contemporary Clinical Trials Communications

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Section: Methodsmentioning

confidence: 99%

Study protocol for Cognitive Behavioral Therapy for Insomnia in patients with primary brain tumor: A single-arm phase 2a proof-of-concept trial

Loughan¹,

Lanoye²,

Willis³

et al. 2023

Contemporary Clinical Trials Communications

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“…Indeed, NPI-Q in brain tumor patients seems more appropriate than behavioral inventories implemented for psychiatric populations (e.g., Mini-International Neuropsychiatric Interview—M.I.N.I.). Furthermore, administering by-proxy neuropsychiatric tests allows detecting behavioral disturbances in patients with language impairment or anosognosia ( 11 ).…”

Section: Methodsmentioning

confidence: 99%

Levetiracetam Prophylaxis Therapy for Brain Tumor-Related Epilepsy (BTRE) Is Associated With a Higher Psychiatric Burden

et al. 2022

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Purpose: Brain tumor-related epilepsy (BTRE) is a condition characterized by the development of seizures in the context of an undergoing oncological background. Levetiracetam (LEV) is a third-generation anti-seizure medication (ASM) widely used in BTRE prophylaxis. The study evaluated LEV neuropsychiatric side effects (SEs) in BTRE prophylaxis.Method: Twenty-eight patients with brain tumors were retrospectively selected and divided into two groups. In one group, we evaluated patients with a BTRE diagnosis using LEV (BTRE-group). The other group included patients with brain tumors who never had epilepsy and used a prophylactic ASM regimen with LEV (PROPHYLAXIS-group). Neuropsychiatric SEs of LEV were monitored using the Neuropsychiatric Inventory Questionnaire (NPI-Q) at the baseline visit and the 6- and 12-month follow-up.Results: Eighteen patients of the BTRE-group and 10 patients of the PROPHYLAXIS-group were included. Compared to the BTRE-group, the PROPHYLAXIS-group showed a higher severity of neuropsychiatric symptoms. According to Linear Mixed Models (LMM), a multiplicative effect was observed for the interaction between group treatment and time. For the caregiver distress score (CDS), only a time-effect was observed.Conclusion: Prophylactic ASM with LEV is associated with an increased frequency of neuropsychiatric SE. Accurate epileptological evaluations in patients with brain tumors are mandatory to select who would benefit most from ASM.

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“… 16 The Mini-Mental State Examination (MMSE) is the most used screening tool in PBT clinical trials and assesses orientation, attention, memory, language, and visuospatial skills. 17 However, the MMSE has limited value in detecting CD in visuospatial and executive function and has minimal sensitivity in the brain tumor population. 18 , 19 Other validated performance-based measures commonly used in brain tumor research include the Mattis Dementia Rating Scale, Neuropsychiatric Inventory, Hopkins Verbal Learning Test-Revised, Trail Making Test, Controlled Oral Word Association Test, Digit Span, Digit Symbol, Hand Dynamometer, and the Grooved Pegboard Test.…”

mentioning

confidence: 99%

“… 18 , 19 Other validated performance-based measures commonly used in brain tumor research include the Mattis Dementia Rating Scale, Neuropsychiatric Inventory, Hopkins Verbal Learning Test-Revised, Trail Making Test, Controlled Oral Word Association Test, Digit Span, Digit Symbol, Hand Dynamometer, and the Grooved Pegboard Test. 17 Neurocognitive batteries include a combination of these objective tests and provide a comprehensive picture of a patient’s cognitive function across several domains, which can aid in diagnosis. 16 Assessing cognition among PBT patients can be challenging when considering the length and sensitivity of these various tests while also trying to administer an assessment battery that addresses all relevant cognitive domains.…”

mentioning

confidence: 99%

The Montreal Cognitive Assessment (MoCA) in neuro-oncology: A pilot study of feasibility and utility in telehealth and in-person clinical assessments

Jammula

Rogers

Vera

et al. 2022

Neuro-Oncology Practice

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Background Cognitive impairments are a common burden for patients with primary CNS tumors. Neuropsychological assessment batteries can be too lengthy, which limits their use as an objective measure of cognition during routine care. The purpose of this study was to evaluate the feasibility and utility of the brief Montreal Cognitive Assessment (MoCA) in routine in-person and telehealth visits (as a result of the global COVID-19 pandemic) with neuro-oncology patients. Methods 71 adults with primary CNS tumors completed MoCA testing in-person (n=47) and via telehealth (n=24). Patient-reported outcomes (PROs), including symptom burden and interference, perceived cognition, general health status, and anxiety and depression, were and correlation analysis were included in this study. Feasibility was assessed through a provider satisfaction questionnaire. Results Patients were primarily White (83%), college-educated (71%) males (54%) with high grade tumors (66%). The average total score on the MoCA administered in-person was 25 (range: 6-30), with 34% classified as abnormal, and the average total score via telehealth was 26 (range: 12-30), with 29% classified as abnormal. Providers reported satisfaction in using the MoCA during routine clinical care, both in-person and via telehealth. Lower MoCA scores correlated with worse symptom severity, KPS, age, education, and previous treatment. Conclusions The MoCA was feasible in clinical and telehealth settings, and its relationship to clinical characteristics and PROs highlight the need for both objective and patient-reported measures of cognition to understand the overall cognitive profile of a patient with a CNS tumor.

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The quality of measurement properties of neurocognitive assessment in brain tumor clinical trials over the last 30 years: a COSMIN checklist-based approach

Cited by 7 publications

References 50 publications

Study protocol for Cognitive Behavioral Therapy for Insomnia in patients with primary brain tumor: A single-arm phase 2a proof-of-concept trial

Study protocol for Cognitive Behavioral Therapy for Insomnia in patients with primary brain tumor: A single-arm phase 2a proof-of-concept trial

Levetiracetam Prophylaxis Therapy for Brain Tumor-Related Epilepsy (BTRE) Is Associated With a Higher Psychiatric Burden

The Montreal Cognitive Assessment (MoCA) in neuro-oncology: A pilot study of feasibility and utility in telehealth and in-person clinical assessments

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