Re-envisioning autonomy: From consent and cognitive capacity to embodied, relational, and authentic selfhood

With a growing ageing population and increased life expectancy in the UK, oral healthcare professionals will be exposed to a greater number of patients with health conditions which may affect cognitive function, communication and capacity to consent to treatment. This often gives rise to a conundrum which clinicians may face when considering capacity, consent and the legal implications and frameworks surrounding this. Assessing patient capacity is encountered routinely in dental practice and so oral healthcare professionals should be well informed of their responsibilities in this context. This article summarises and introduces readers to key concepts regarding consent and capacity with reference to relevant cross-jurisdictional legislation.

<h3>Background:</h3> The complex environment and technology of intensive care unit (ICU) care may impair the ability of patients to participate in medical decision making or give informed consent. We studied the agreement of the intuitive assessments of residents and nurses of ICU patients' cognition, judgment, and decision-making capacity, and whether those assessments agreed with abbreviated formal mental status testing. <h3>Methods:</h3> Using a prospective survey case study, we assessed 200 English-speaking patients within 24 hours of their ICU admission. Formal assessment of cognition, judgment, and insight was performed by a research assistant. We obtained independent intuitive ratings by nurses and residents of patient cognition, judgment, and ability to participate in medical decision making or give informed consent. <h3>Results:</h3> Residents' and nurses' assessment of cognition and judgment showed a high degree of agreement with weighted κs of greater than 0.76. Assessments of cognition by residents and nurses agreed with Folstein Mini-Mental State Examination in 70% and 73.6% of cases, respectively. Forty percent of the population had an unimpaired Mini-Mental State Examination score of greater than 23, and an additional 12% of the subjects were mildly impaired with scores of 20 to 23. When asked whether they would approach patient or family for consent for an invasive procedure, nurses and physicians said they would request informed consent from 66% and 62% of the patients, respectively. <h3>Conclusions:</h3> Residents and nurses caring for patients newly admitted to the ICU agree in their assessment of cognition, judgment, and capacity to participate in medical decision making, and are not unduly influenced by ventilator status. Their assessments correlate highly with abbreviated formal mental status testing. (Arch Intern Med. 1993;153:2481-2485)

The complex environment and technology of intensive care unit (ICU) care may impair the ability of patients to participate in medical decision making or give informed consent. We studied the agreement of the intuitive assessments of residents and nurses of ICU patients' cognition, judgment, and decision-making capacity, and whether those assessments agreed with abbreviated formal mental status testing. Using a prospective survey case study, we assessed 200 English-speaking patients within 24 hours of their ICU admission. Formal assessment of cognition, judgment, and insight was performed by a research assistant. We obtained independent intuitive ratings by nurses and residents of patient cognition, judgment, and ability to participate in medical decision making or give informed consent. Residents' and nurses' assessment of cognition and judgment showed a high degree of agreement with weighted ks of greater than 0.76. Assessments of cognition by residents and nurses agreed with Folstein Mini-Mental State Examination in 70% and 73.6% of cases, respectively. Forty percent of the population had an unimpaired Mini-Mental State Examination score of greater than 23, and an additional 12% of the subjects were mildly impaired with scores of 20 to 23. When asked whether they would approach patient or family for consent for an invasive procedure, nurses and physicians said they would request informed consent from 66% and 62% of the patients, respectively. Residents and nurses caring for patients newly admitted to the ICU agree in their assessment of cognition, judgment, and capacity to participate in medical decision making, and are not unduly influenced by ventilator status. Their assessments correlate highly with abbreviated formal mental status testing.

We examined the process of obtaining informed consent (IC) for clinical research purposes in long-term care facilities (LTCFs) in Rhode Island (RI), USA. We assessed factors that were associated with resident ability to consent, such as Brief Interview for Mental Status scores. We used a self-administered questionnaire to further understand the effect of LTCF staff evaluation of ability to consent on residents' autonomy and control over their medical decision making.Observational clinical studyLong-term care setting.LTCF personnel provided us with residents' names, as well as their professional assessment of resident ability to consent. We used Brief Interview for Mental Status (BIMS) scores to assess the cognitive capacity of all residents to assess, and compare it to the assessment provided by LTCF personnel. A logistic regression analysis was performed to determine the relationship between LTCF assessment of resident ability to consent and BIMS score or confirmed diagnosis of dementia as seen from residents' medical charts. A self-administered questionnaire was filled out by the personnel of 10 LTCFs across RI, USA.LTCF personnel in 9 out of 10 recruited facilities reported that their assessment of resident ability to consent was based on subjective assessment of the resident as alert and oriented. There was a statistically significant relationship between the LTCF assessment of resident ability to consent and previously diagnosed dementia (OR: 0.211, 95% CI 0.107-0.415). Therefore, as BIMS scores increased, the likelihood that the resident would be deemed able to consent by LTCF personnel also increased. Furthermore, there was a statistically significant relationship between LTCF assessment of resident ability to consent and BIMS scores (OR: 1.430, 95% CI 1.274-1.605).There is no standard on obtaining IC for research studies conducted in LTCFs. We recommend that standardizing the process of obtaining IC in LTCFs can enhance the ability to perform research with LTCF residents.

There is precedent in medicine for recognizing and accepting intact decisional capacity and the subsequent ability to provide valid consent in one treatment domain, while simultaneously recognizing that the patient lacks decisional capacity in other domains. As such, obtaining consent for anesthesia for a surgical procedure is a separate entity from obtaining consent for the surgery itself. Anesthesia for surgery and the surgical procedure itself are separate treatment domains and as such require separate consents. Anesthesiologists should understand the independence of these functionally linked consent processes and be vigilant with respect to the informed consent process. The cases reported in this article show that capacity for surgical consent may be inadequate for consent to anesthesia because anesthesia involves more abstract concepts requiring a higher cognitive state than surgery, thus requiring a higher state of cognitive capacity for understanding.

Brain-computer interfaces in end-of-life decision-making

We thank López-Blanco et al1 for their interest in our recent findings on touchscreen skills in patients with Parkinson's disease (PD),2 highlighting the importance of this topic and the increased use of touchscreen devices in current society and in healthcare. In their own study, the authors did not find differences in touchscreen performance between PD patients on medication and healthy control subjects (HC) despite a variety of tasks used. Similar to our findings, timing parameters did not differ between groups when tapping and sliding in a single direction.2 In contrast, we found a significantly slower performance when sliding in multiple directions in PD patients compared to HC even when on medication and increased slowing of specific tasks when off. Moreover, PD patients had a worse tapping accuracy than HC on medication, similar to previous work.3, 4 López-Blanco et al1 ascribed these between-study discrepancies to touchscreen interface settings, disease characteristics, and the number of task repetitions. López-Blanco et al1 questioned the ecological meaning of the multi-direction sliding tests used in our study and the significance of touchscreen performance slowing for daily use. Multi-direction sliding on a touchscreen is a complex manipulation, which we believe is highly relevant for daily life. For instance, a touchscreen unlock trace requires sliding motions in multiple directions5 as do specific search functions on a smartphone. Although slower performance might not necessarily impede the efficient use of mobile devices, we contend that during daily tasks time constraints frequently cause stress and anxiety, for example, when having to find information quickly. As such, slowing is likely to affect patients' smartphone proficiency during functional tasks. Additionally, turning off an alarm requires fast responses, via double tapping or sliding a circle toward a target (test 3-4 of López-Blanco et al).1 Although neither study found between-group differences in inter-tap interval time and single sliding time when on medication, we expect that, particularly when off, PD patients will be hampered when turning off alarm clocks or medication reminders.2 When off medication, Wissel et al4 demonstrated a significantly slower inter-tap interval time than HC in PD patients with worse disease severity than included in our study. This predicts that more affected patients will experience even greater problems. We did not suggest that on the basis of our findings touchscreen technology should be disregarded in PD.2 Instead, we claimed that even basic touchscreen skills cannot be assumed to remain unaffected by the disease and that this needs to be taken into account. As medication only had limited effects, we also recommended developing training programs targeting touchscreen manipulations, which may become even more functionally useful than writing training programs with time. To conclude, we agree with López-Blanco et al1 that in future work laboratory touchscreen tests need to be extended to real life touchscreen manipulation tasks, requiring both motor and cognitive flexibility. Ideally, such study should include larger PD samples with more diverse motor and cognitive capacity. (1) Research Project: A. Conception, B. Organization, C. Execution; (2) Statistical Analysis: A. Design, B. Execution, C. Review and Critique; (3) Manuscript Preparation: A. Writing of the first draft, B. Review and Critique. J.D.V.: 1C, 2A, 2B, 3A A.N.: 1A, 2C, 3B E.N.: 1A, 1B, 1C, 2A, 2C, 3C This study was approved by the local ethics committee UZ/KU Leuven according to the code of Ethics of the World Medical Association (Declaration of Helsinki, version 2013, S61793). Before participation in the study, an informed consent form was signed after explanation of the study protocol. We confirm that we have read the Journal's position on issues involved in ethical publication and affirm that this work is consistent with those guidelines. The work presented in this manuscript was supported by the Research Foundation Flanders—FWO (12F4719N, 1,520,619 N, G0A5619N) and King Baudouin Foundation (J1811020-E003). The authors declare that there are no conflicts of interest relevant to this work. E.N. is a postdoctoral fellow funded by the Research Foundation Flanders—FWO (12F4719N).

Cognitive impairment is a characteristic of schizophrenia. This impairment may affect the retention of information required for ongoing knowledgeable participation in clinical trials. This study monitored retention of study-related knowledge-including assessment of therapeutic misconception-in people with stable, DSM-IV schizophrenia during participation in placebo-controlled clinical trials of adjunctive agents. Stability was defined as being on an antipsychotic with no change in medication or dose over the previous 4 weeks. This longitudinal study assessed retention of clinical trial-related consent information. Individuals enrolling in 1 of 8 clinical trials were approached for participation. Participants came from research clinics and community mental health centers. At baseline, clinical trial consent forms were reviewed and study knowledge assessed. Participants were randomized to follow-up assessments at weeks 1, 4, and 8; weeks 4 and 8; or at week 8 only. Clinical trial consent forms were not rereviewed at any follow-up visit. Fifty-nine participants were enrolled; analysis included 52 participants with at least 1 follow-up visit. Study knowledge did not decrease meaningfully in any group. Therapeutic misconception was not observed in participants during the study. The group assessed most frequently demonstrated significant improvement over baseline (t44 = 3.43, P = .001). Retention of study knowledge was not related to symptoms but had a weak correlation with cognitive capacity (R = 0.28, P = .07). Performance did not differ between participants from research clinics and those from community mental health centers. Clinically stable people with schizophrenia enrolling in a placebo-controlled adjunctive medication study, once determined to have capacity to consent to a clinical trial, retained appropriate study knowledge for at least 8 weeks. In the absence of a specific reason to suspect a loss of decisional capacity, there appears to be no need to routinely reevaluate participants during this type of clinical trial.

To examine how cognitive impairment affects Parkinson disease (PD) patients' research consent capacity. A cross-sectional study of 90 patients with PD, divided using Mattis Dementia Rating Scale-2 scores into 3 groups of 30 (normal, borderline, and impaired), and 30 neurologically normal older adults completed 2 capacity interviews (an early-phase randomized and controlled drug trial and a sham-controlled surgical implantation of genetic tissue) using the MacArthur Competence Assessment Tool for Clinical Research. Expert clinicians used the interviews to classify the patients as either capable or not capable of providing their own informed consent. These judgments were compared with performance on the Montreal Cognitive Assessment (MoCA) and the Mini-Mental State Examination (MMSE). Cognitively normal PD patients typically scored well on the capacity measures. In contrast, patients with impaired cognition were not capable of providing their own informed consent: 17% (5/30) on the drug trial and 3% (1/30) on the surgery trial were judged capable. Patients with borderline impairment showed adequate performance on measures of appreciation and reasoning, but impaired performance on understanding the drug trial compared with normal controls and normal PD patients, and on understanding the surgery trial compared with normal controls. Sixty-seven percent (20/30) on the drug trial and 57% (17/30) on the surgery trial were judged capable of consent. Receiver operating characteristic analyses showed that the MMSE and MoCA could detect the likelihood of impaired capacity, with the MoCA demonstrating greater sensitivity. PD patients with borderline cognitive impairment have impairments in their decisional capacity. The MoCA may be useful to identify the patients at risk of impaired capacity.

We examined the association between cognitive domains and research consent capacity in PD. Our hypothesis was that research consent capacity is best predicted by executive function. A cohort of 90 PD patients and 30 healthy older adults were administered the MacArthur Competence Assessment Tool for Clinical Research, Dementia Rating Scale-2, and the MoCA. Experts classified patients as either "capable" or "not capable" of providing informed consent to participate in two clinical trials. MacArthur Competence Assessment Tool for Clinical Research Reasoning scores for both clinical trial types were most associated with executive functions and delayed recall. As scores on these domains improved, the odds of an expert rating of "capable of consent" increased. These results extend our previous findings by demonstrating that memory and executive abilities appear closely associated with capacity when evaluated using either a structured interview or expert judgment of that interview.