Clinical correlates of the ability to consent to research participation in brain metastasis

Abstract

Objective: Impairment in the ability to provide informed consent is common in persons with brain metastasis. However, little is known about what factors contribute to this impairment in the patient group. Our objective is to determine if the associations between demographic, cognitive, and clinical variables correlate with the ability to provide informed consent in persons with brain metastasis. Methods: We administered a comprehensive neuropsychological battery to a group of 61 persons with brain metastasis. Demographic and clinical information was also collected. All diagnoses were made by board-certified oncologists and were verified histologically. Statistical analyses included Pearson's product-moment correlations, point biserial correlations, and linear regression. Results: Results indicated that combinations of education, verbal memory, executive function, whole brain radiation therapy, and chemotherapy affected various aspects of the ability to provide informed consent. Subsequent regression models demonstrated that these variables contributed a significant amount of shared variance to the ability to provide informed consent. Conclusion: We found that the ability of persons with brain metastasis to provide informed consent is a cognitively complex ability that is also affected by education and treatment variables. This information can help clinical researchers in identifying persons with brain metastasis at risk of an impaired ability to provide informed consent and aid in the consenting process.

The Relationship Between Cognitive Performance Assessments and the Mental Capacity Functional Test: A Systematic Review

“…Publications spanned 8 countries, although most were carried out in the USA ( = 20) 17,[19][20][21][23][24][25][26]29,30,32,34,36,38,[40][41][42][47][48][49] , followed by China 27,[44][45][46] and the UK 16,22,28,35 ( = 4, respectively), and Italy (n = 2) 18,37 ; Canada, Germany, Sweden and Brazil hosted one study each. All but three inpatient samples 17,28,34 recruited outpatients or those living in the community.…”

“…Study samples included participants with dementia ( = 13) 19,[22][23][24]26,27,32,35,[37][38][39]46,47 , mild cognitive impairment (MCI; = 1) 25 , Parkinson's disease (PD; = 2) 29,40 , relapsing-remitting multiple sclerosis (RRMS; = 1) 16 , progressive MS ( = 1) 42 , progressive supranuclear palsy (PSP, = 1) 41 , amyotrophic lateral sclerosis (ALS, = 1) 18 , stroke ( = 1) 28 , malignant glioma (MG; n = 2) 48,49 , brain metastasis (BM; = 2) 21,36 , and traumatic or acquired brain injury (TBI/ABI; = 2) 17,31 . Study samples with mixed neurological populations included those with either dementia or MCI 30,33,[43][44][45] , dementia or ABI 31 , BM or MG 20 , or varying degrees of TBI 34 . The findings of these mixed populations were pooled 20,33,43 or reported separately 30,31,34,44,45 within each of these studies.…”

“…Study samples with mixed neurological populations included those with either dementia or MCI 30,33,[43][44][45] , dementia or ABI 31 , BM or MG 20 , or varying degrees of TBI 34 . The findings of these mixed populations were pooled 20,33,43 or reported separately 30,31,34,44,45 within each of these studies.…”

“…Twenty-one studies assessed capacity to consent to treatment [16][17][18][19][20][21]24,27,30,33,34,[38][39][40][41][42][43][44]46,47,49 . Of these, all but two studies 16,38 used standardised capacity tools.…”

“…Of these, all but two studies 16,38 used standardised capacity tools. The most frequently used capacity tool was the Capacity to Consent to Treatment Instrument (CCTI) 17,20,21,24,30,34,38,[40][41][42]47,49,50 . Other tools used include the Mac-CAT-T 11, 18,24,27,39,43,46 , Linguistic Instrument for Medical Decision-Making (LIMD) 33,51 , Assessment of Capacity for Everyday Decision-Making (ACED) 44,52 , and Hopkins Competency Assessment Test (HCAT) 19,53 .…”