Capacity To Consent To Treatment Instrument Research Articles

Decisional capacity to consent to treatment and research in patients affected by Mild Cognitive Impairment. A systematic review and meta-analysis.

To perform a meta-analysis of clinical studies on the differences in treatment or research decision-making capacity among patients with Mild Cognitive Impairment (MCI), Alzheimer's disease (AD), and healthy comparisons (HCs). A systematic search was conducted on Medline/Pubmed, CINAHL, PsycINFO, Web of Science, and Scopus. Standardized mean differences and random-effects model were used in all cases. The United States, France, Japan, and China. Four hundred and ten patients with MCI, 149 with AD, and 368 HCs were included. The studies we included in the analysis assessed decisional capacity to consent by the MacArthur Competence Assessment Tool for Treatment (MAcCAT-T), MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), Capacity to Consent to Treatment Instrument (CCTI), and University of California Brief Assessment of Capacity to Consent (UBACC). We identified 109 potentially eligible studies from 1672 records, and 7 papers were included in the meta-analysis. The meta-analysis showed that there was significant impairment in a decision-making capacity in MCI patients compared to the HCs group in terms of Understanding (SMD = -1.04, 95% CI: -1.31 to -0.77, P < 0.001; I2 = 52%, P = 0.07), Appreciation (SMD = -0.51, 95% CI: -0.66 to -0.36, P < 0.001; I2 = 0%, P = 0.97), and Reasoning (SMD = -0.62, 95% CI: -0.77, -0.47, P < 0.001; I2=0%, P =0.46). MCI patients scored significantly higher in Understanding (SMD = 1.50, 95% CI: 0.91, 2.09, P = 0.01, I2 = 78%, P = 0.00001) compared to patients affected by AD. Patients affected by MCI are at higher risk of impaired capacity to consent to treatment and research compared to HCs, despite being at lower risk compared to patients affected by AD. Clinicians and researchers need to carefully evaluate decisional capacity in MCI patients providing informed consent.

Reliability of the Capacity to Consent to Treatment Instrument in Metastatic Cancer

Metastatic cancer patients undergo numerous treatment strategies with known cognitive side effects. It is unclear how medical decision-making capacity (MDC) is impacted by cognitive deficits in metastatic cancer. This study examines reliability of an objective measure of MDC compared with self-report. Participants with newly diagnosed metastasis to the brain and other sites were enrolled at the University of Alabama at Birmingham over seven years. At the study visit, participants completed a comprehensive neuropsychological battery including memory and executive functioning, and the Capacity to Consent to Treatment Instrument (CCTI) assessing medico-legal domains of MDC. The CCTI is a reliable and valid instrument containing two vignettes of hypothetical medical situations assessing four standards of consent. We examined reliability between the CCTI and self-reported MDC using Gwet’s AC1 statistic. Participants with brain metastasis with impairment on the CCTI demonstrated significantly lower executive functioning and memory skills than those without impairment (Trails B Raw: 158.20±86.82 vs. 118.90±77.98 p: 0.0248; Digit-Span Raw Forward: 9.13±2.30 vs. 10.12±2.03 p: 0.0254). There were no significant differences between intact and impaired participants with other metastases. Low reliability was observed between self-report and all medico-legal standards on the CCTI across both metastatic groups [Gwet’s AC1 Appreciation: 0.70 (0.58, 0.81); Reasoning: 0.34 (0.16, 0.52); Understanding: 0.44, (0.27, 0.60)]. Self-rating of MDC is unreliable in metastatic cancer patients. Patients with metastases (particularly brain metastases) may lack awareness of deficits in their MDC, so providers must affirm proper autonomy in their decisions.

NCOG-09. TREATMENT DECISION MAKING IN THE SETTING OF ADVANCED CANCER

Abstract OBJECTIVE To investigate medical decision-making capacity (MDC) in patients with advanced stage cancer. METHODS Participants were 113 newly diagnosed adults with brain metastases and 41 adults with metastatic cancer without brain metastases who were recruited from an academic medical center and 40 demographically-matched healthy controls recruited from the community. We evaluated MDC using the Capacity to Consent to Treatment Instrument (CCTI) Vignette B and its four clinically relevant consent standards (expressing a treatment choice, appreciation, reasoning, and understanding). Capacity impairment ratings (no impairment, mild/moderate impairment, and severe impairment) on the consent standards were also assigned to each participant using cutoff scores derived statistically from the performance of the control group. RESULTS Both of the metastatic cancer groups (with and without brain metastasis) performed significantly below controls on consent standards of understanding and reasoning. The brain metastasis group performed below the non-metastatic cancer group on understanding. Capacity compromise was defined as performance ≤1.5 standard deviations (SD) below the control group mean. Using this definition, approximately 65% of the participants with brain metastases and 51% of participants with metastatic cancer without brain metastases were impaired on at least one MDC standard. CONCLUSION Over half of participants with metastatic cancer regardless of whether they have brain disease have reduced capacity to make treatment decisions. The finding of impaired MDC in patients without brain metastases is surprising and suggests this group likely exhibits cognitive deficits that impact their ability to understand and reason about different treatment options. This finding suggests that clinicians need to carefully consider the patient’s ability to engage in treatment decision making when they are discussing treatment options for metastatic cancer. These results also indicate a need for the development and investigation of interventions to support MDC in this patient population.

OTHR-05. THE ABILITY TO MAKE INFORMED TREATMENT DECISIONS IS COMPROMISED IN ADULTS WITH ADVANCED STAGE CANCER

OBJECTIVE: To investigate medical decision-making capacity (MDC) in patients with advanced stage cancer. METHODS: Participants were 113 newly diagnosed adults with brain metastases and 41 adults with metastatic cancer without brain metastases who were recruited from an academic medical center and 40 demographically-matched healthy controls recruited from the community. We evaluated MDC using the Capacity to Consent to Treatment Instrument (CCTI) Vignette B and its four clinically relevant consent standards (expressing a treatment choice, appreciation, reasoning, and understanding). Capacity impairment ratings (no impairment, mild/moderate impairment, and severe impairment) on the consent standards were also assigned to each participant using cutoff scores derived statistically from the performance of the control group. RESULTS: Both of the metastatic cancer groups (with and without brain metastasis) performed significantly below controls on consent standards of understanding and reasoning. The brain metastasis group performed below the non-metastatic cancer group on understanding. Capacity compromise was defined as performance ≤1.5 standard deviations (SD) below the control group mean. Using this definition, approximately 65% of the participants with brain metastases and 51% of participants with metastatic cancer without brain metastases were impaired on at least one MDC standard. CONCLUSION: Over half of participants with metastatic cancer regardless of whether they have brain disease have reduced capacity to make treatment decisions. The finding of impaired MDC in patients without brain metastases is surprising and suggests this group likely exhibits cognitive deficits that impact their ability to understand and reason about different treatment options. The reasons underlying this impairment will be investigated. This highlights the importance of routine clinical assessment of MDC in all patients with metastatic cancer when important treatment decisions are being discussed. These results also indicate a need for the development and investigation of interventions to support or improve MDC in this patient population.

Twelve-month recovery of medical decision-making capacity following traumatic brain injury.

To investigate recovery of medical decision-making capacity (MDC) over the first year following traumatic brain injury (TBI). A total of 177 participants (111 persons with TBI and 66 healthy controls) were recruited from an inpatient/outpatient TBI rehabilitation unit and outpatient neurology department. Participants with TBI were classified by injury severity into subgroups: mild TBI (mTBI; n = 28), complicated mild TBI (cmTBI; n = 23), and moderate/severe TBI (msevTBI; n = 60). Control and TBI groups were compared at 1 month (t1), 6 months (t2), and 12 months (t3) postinjury using the Capacity to Consent to Treatment Instrument (CCTI), which evaluates MDC using 5 consent standards: expressing choice, reasonable choice, appreciation, reasoning, and understanding. Relative to controls, no TBI group displayed impairment on CCTI expressing choice or reasonable choice at any timepoint. Those with mTBI had reduced appreciation and understanding at t1, which resolved by t2. The cmTBI and msevTBI groups were impaired on all 3 complex consent standards at t1. While patients with cmTBI improved to a level similar to controls by t3, those with msevTBI remained impaired on reasoning and understanding. Across all TBI groups, notable MDC improvement only occurred over the first 6 months postinjury. Over 1 year, most individuals with mTBI or cmTBI regain MDC, while many individuals with msevTBI have lingering deficits in reasoning and comprehension of treatment information. Clinical recovery of MDC occurs primarily during the first 6 months post-TBI regardless of injury severity. Clinicians can therefore identify MDC outcomes in TBI at 6 months postinjury.

Brain Metabolic Correlates of Decision Making in Amnestic Mild Cognitive Impairment

Persons with amnestic mild cognitive impairment (MCI) have subtle impairments in medical decision-making capacity (MDC). We examined the relationship between proton magnetic resonance spectroscopy (MRS) and MDC in MCI. Twenty-nine MCI patients and 42 controls underwent MRS to obtain ratios of N-acetylaspartate (NAA)/Creatine (Cr), Choline (Cho)/Cr, and myo-Inositol (mI)/Cr of the posterior cingulate. They also completed the Capacity to Consent to Treatment Instrument (CCTI), a vignette-based instrument measuring decisional standards of expressing choice, appreciating consequences of choice, providing rational reasons for choice, and understanding treatment choices. Patients showed abnormal MRS ratios of mI/Cr and Cho/Cr compared to controls, and impairments on the CCTI understanding and reasoning Standards. Performance on the reasoning standard of the CCTI was correlated with NAA/Cr (r = .46, p < .05). The relationship of NAA/Cr with decision-making suggests a role for posterior cortical neuronal functioning in performance of complex IADLs in MCI.

Medical decision‐making capacity in cognitively impaired Parkinson's disease patients without dementia

Little is currently known about the higher order functional skills of patients with Parkinson disease and cognitive impairment. Medical decision-making capacity (MDC) was assessed in patients with Parkinson's disease (PD) with cognitive impairment and dementia. Participants were 16 patients with PD and cognitive impairment without dementia (PD-CIND), 16 patients with PD dementia (PDD), and 22 healthy older adults. All participants were administered the Capacity to Consent to Treatment Instrument (CCTI), a standardized capacity instrument assessing MDC under five different consent standards. Parametric and nonparametric statistical analyses were utilized to examine capacity performance on the consent standards. In addition, capacity outcomes (capable, marginally capable, or incapable outcomes) on the standards were identified for the two patient groups. Relative to controls, PD-CIND patients demonstrated significant impairment on the understanding treatment consent standard, clinically the most stringent CCTI standard. Relative to controls and PD-CIND patients, PDD patients were impaired on the three clinical standards of understanding, reasoning, and appreciation. The findings suggest that impairment in decisional capacity is already present in cognitively impaired patients with PD without dementia and increases as these patients develop dementia. Clinicians and researchers should carefully assess decisional capacity in all patients with PD with cognitive impairment.

Cognitive models of medical decision-making capacity in patients with mild cognitive impairment

This study investigated cognitive predictors of medical decision-making capacity (MDC) in patients with amnestic mild cognitive impairment (MCI). A total of 56 healthy controls, 60 patients with MCI, and 31 patients with mild Alzheimer's disease (AD) were administered the Capacity to Consent to Treatment Instrument (CCTI) and a neuropsychological test battery. The CCTI assesses MDC across four established treatment consent standards--S1 (expressing choice), S3 (appreciation), S4 (reasoning), and S5 (understanding)--and one experimental standard [S2] (reasonable choice). Scores on neuropsychological measures were correlated with scores on each CCTI standard. Significant bivariate correlates were subsequently entered into stepwise regression analyses to identity group-specific multivariable predictors of MDC across CCTI standards. Different multivariable cognitive models emerged across groups and consent standards. For the MCI group, measures of short-term verbal memory were key predictors of MDC for each of the three clinically relevant standards (S3, S4, and S5). Secondary predictors were measures of executive function. In contrast, in the mild AD group, measures tapping executive function and processing speed were primary predictors of S3, S4, and S5. MDC in patients with MCI is supported primarily by short-term verbal memory. The findings demonstrate the impact of amnestic deficits on MDC in patients with MCI.

Medical decision-making capacity in patients with mild cognitive impairment

To empirically assess the capacity of patients with amnestic mild cognitive impairment (MCI) to consent to medical treatment under different consent standards (Ss). Participants were 56 healthy controls, 60 patients with MCI, and 31 patients with mild Alzheimer disease (AD). Each participant was administered the Capacity to Consent to Treatment Instrument (CCTI) and a comprehensive neuropsychological battery. Group differences in performance on the CCTI and neuropsychological variables were examined. In addition, the capacity status (capable, marginally capable, or incapable) of each MCI participant on each CCTI standard was examined using cut scores derived from control performance. Patients with MCI performed comparably to controls on minimal consent standards requiring merely expressing a treatment choice (S1) or making the reasonable treatment choice [S2], but significantly below controls on the three clinically relevant standards of appreciation (S3), reasoning (S4), and understanding (S5). In turn, the MCI group performed significantly better than the mild AD group on [S2], S4, and S5. Regarding capacity status, patients with MCI showed a progressive pattern of capacity compromise (marginally capable and incapable outcomes) related to stringency of consent standard. Patients with amnestic mild cognitive impairment (MCI) demonstrate significant impairments on clinically relevant abilities associated with capacity to consent to treatment. In obtaining informed consent, clinicians and researchers working with patients with MCI must consider the likelihood that many of these patients may have impairments in consent capacity related to their amnestic disorder and related cognitive impairments.

Medical decision-making abilities in older adults with chronic partial epilepsy

Little is known about the medical decision-making abilities of older adults with chronic partial epilepsy, although these patients are often faced with medical decisions that impact their health care. Twenty-one older adults with epilepsy and 21 healthy older adults completed the Capacity to Consent to Treatment Instrument (CCTI) and Dementia Rating Scale II (DRS-II). Older adults with epilepsy performed significantly below controls on the CCTI standards Evidencing Choice, Appreciation, and Understanding and the DRS-II Total Score. DRS-II was positively associated with performance on the standards Appreciation and Understanding. Number of antiepileptic drugs, duration of epilepsy, and age at seizure onset were related to performance on Understanding. Older adults with epilepsy demonstrated deficits in their capacity to give informed consent for medical treatment that appear to be associated with cognition and seizure variables. Physicians should consider the decisional abilities of their older adult patients with epilepsy when presenting treatment options.

Declining medical decision‐making capacity in mild AD: a two‐year longitudinal study

This is a report of a two-year longitudinal study comparing healthy older adult subjects (n = 15) and mild Alzheimer's disease (AD) patients (n = 20) using an objective performance measure of medical decision-making capacity (MDC). Capacity to consent to medical treatment was measured using the Capacity to Consent to Treatment Instrument (CCTI). The CCTI is a psychometric measure that tests MDC using a series of four core capacity standards: S1 (evidencing/communicating choice), S3 (appreciating consequences), S4 (providing rational reasons), and S5 (understanding treatment situation), and one experimental standard [S2] (making the reasonable treatment choice). For each standard, mild AD patients were assigned one of three capacity outcomes (capable, marginally capable, or incapable) based on cut-off scores derived from control group performance. At baseline, mild AD patients performed equivalently with controls on simple standards of evidencing a choice (S1) and making the reasonable choice ([S2]), but significantly below controls on complex standards of appreciation, reasoning, and understanding (S3, S4, and S5) (p < 0.02). Control performance was stable over time on all capacity standards. At one-year follow-up, the mild AD group did not show significant decline from baseline on any capacity standard. However, at two-year follow-up the mild AD group showed significant declines from baseline on the three complex standards (S3, S4, and S5) (p < 0.02), and a trend on one of the simple standards (S1). Over the two-year period, the proportion of marginally capable and incapable outcomes in the AD group increased substantially for four of the five standards (S1, S3, S4, and S5). Performance on [S2] remained stable over time in the AD group.We conclude that mild AD patients have impaired MDC at baseline, and demonstrate significant additional decline on complex consent abilities of appreciation, reasoning, and understanding over a two-year period. AD patients also show emerging impairment on the simple consent ability of evidencing choice at two-year follow-up. Capacity outcome data reflect similar declines over time for these four consent standards. The findings suggest the value of early assessment and regular monitoring at two-year intervals of MDC in patients with mild AD.

Impairment and Partial Recovery of Medical Decision-Making Capacity in Traumatic Brain Injury: A 6-Month Longitudinal Study

Marson DC, Dreer LE, Krzywanski S, Huthwaite JS, DeVivo MJ, Novack TA. Impairment and partial recovery of medical decision-making capacity in traumatic brain injury: a 6-month longitudinal study. Objective To investigate empirically change in medical decision-making capacity (MDC) in patients with traumatic brain injury (TBI). Design Longitudinal study comparing control and TBI groups at hospitalization and at 6 months postinjury. Setting Inpatient brain injury rehabilitation unit. Participants Twenty healthy controls and 24 patients with moderate to severe TBI. Interventions Not applicable. Main outcome measures MDC was measured by using the Capacity to Consent to Treatment Instrument (CCTI). The CCTI evaluates performance on a series of 4 accepted consent abilities, or standards: S1 (evidencing/communicating choice), S3 (appreciating consequences), S4 (reasoning about treatment), and S5 (understanding the treatment situation and choices), and 1 experimental standard [S2] (making the reasonable treatment choice when the alternative choice is unreasonable). In addition, TBI patients were assigned 1 of 3 capacity outcomes (capable, marginally capable, incapable) for each standard. Results At hospitalization, TBI patients performed equivalently with controls on standards S1 and [S2] but significantly below controls on S3 ( P<.001), S4 ( P<.02), and S5 ( P<.001). At 6-month follow-up, TBI patients showed significant within-group improvement on these 3 standards (S3, S4, S5) but continued to fall significantly below controls on S3 ( P<.006) and S5 ( P<.001). A group by time interaction emerged on S5 ( P<.02). The TBI group showed increasing proportions of capable outcomes on all standards over the 6 months. Conclusions Patients with TBI showed initial impairment and subsequent partial recovery of MDC over a 6-month period. Complex consent abilities of appreciation, reasoning, and understanding were significantly impaired in hospitalized acute TBI patients. At follow-up, TBI patients showed substantial recovery of reasoning and partial recovery of appreciation and understanding consent abilities. The study suggests the importance in the rehabilitation setting of serial evaluations of MDC in patients with TBI.

Factor Structure of Capacity to Consent to Medical Treatment in Patients with Alzheimer's Disease

Abstract Loss of capacity to consent to medical treatment (hereafter competency) is an inevitable consequence of Alzheimer's disease (AD) and has important legal and ethical implications. However, the medical-legal construct of competency remains poorly understood, particularly in dementia and aging populations. We investigated the construct through a series of exploratory and validation factor analyses of performance by 82 patients with probable or possible AD on the Capacity to Consent to Treatment Instrument (CCTI). In the exploratory phase, principal components analyses revealed that the CCTI is composed of two orthogonal factors: Verbal Conceptualization/Reasoning and Verbal Memory. In the validation phase, principal components analysis of individual factor scores and neuropsychological test performance supported and further elaborated the two factor structure. The findings suggested that consent capacity in an AD population is a multidimensional construct represented by neurocognitive factors of ver...