Decisional capacity to consent to treatment and anaesthesia in patients over the age of 60 undergoing major orthopaedic surgery

2019 ◽  
Vol 59 (4) ◽  
pp. 247-254 ◽  
Author(s):  
Gabriele Mandarelli ◽  
Giovanna Parmigiani ◽  
Felice Carabellese ◽  
Silvia Codella ◽  
Paolo Roma ◽  
...  
Keyword(s):  
Informed Consent ◽  
Orthopaedic Surgery ◽  
Decisional Capacity ◽  
Capacity To Consent ◽  
Capacity Evaluation ◽  
Decision Making Capacity ◽  
Consent To Treatment ◽  
Major Orthopaedic Surgery ◽  
Pain Symptoms ◽  
State Examination

Despite growing attention to the ability of patients to provide informed consent to treatment in different medical settings, few studies have dealt with the issue of informed consent to major orthopaedic surgery in those over the age of 60. This population is at risk of impaired decision-making capacity (DMC) because older age is often associated with a decline in cognitive function, and they often present with anxiety and depressive symptoms, which could also affect their capacity to consent to treatment. Consent to major orthopaedic surgery requires the patient to understand, retain and reason about complex procedures. This study was undertaken to extend the literature on decisional capacity to consent to surgery and anaesthesia of patients over the age of 60 undergoing major orthopaedic surgery. Recruited patients ( N=83) were evaluated using the Aid to Capacity Evaluation, the Beck Depression Inventory, the State–Trait Anxiety Inventory Y, the Mini-Mental State Examination and a visual analogue scale for measuring pain symptomatology. Impairment of medical DMC was common in the overall sample, with about 50% of the recruited patients showing a doubtful ability, or overt inability, to provide informed consent. Poor cognitive functioning was associated with reduced medical DMC, although no association was found between decisional capacity and depressive, anxiety and pain symptoms. These findings underline the need of an in-depth assessment of capacity in older patients undergoing major orthopaedic surgery.

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

2021 ◽  
pp. 1-14
Author(s):  
Giovanna Parmigiani ◽  
Antonio Del Casale ◽  
Gabriele Mandarelli ◽  
Benedetta Barchielli ◽  
Georgios D. Kotzalidis ◽  
...  
Keyword(s):  
Decision Making ◽  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Assessment Tool ◽  
Meta Analysis ◽  
Competence Assessment ◽  
Decisional Capacity ◽  
Capacity To Consent ◽  
Decision Making Capacity ◽  
Consent To Treatment

ABSTRACT Objectives: 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). Design: 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. Setting: The United States, France, Japan, and China. Participants: Four hundred and ten patients with MCI, 149 with AD, and 368 HCs were included. Measurements: 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). Results: 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. Conclusions: 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.

scholarly journals Validation of the French Version of the MacArthur Competence Assessment Tool for Treatment (MacCAT-T) in a French Sample of Individuals with Schizophrenia: Validation de la version française de l’instrument d’évaluation des compétences MacArthur-traitement (MacCAT-T) dans un échantillon français de personnes souffrant de schizophrénie

2020 ◽  
pp. 070674372096644
Author(s):  
Stéphane Raffard ◽  
Cindy Lebrun ◽  
Yasmine Laraki ◽  
Delphine Capdevielle
Keyword(s):  
Decision Making ◽  
Factor Analysis ◽  
Assessment Tool ◽  
Competence Assessment ◽  
Rater Reliability ◽  
French Version ◽  
Capacity To Consent ◽  
Decision Making Capacity ◽  
Consent To Treatment ◽  
High Degree

Background: Assessing an individual’s capacity to consent to treatment is a complex and challenging task for psychiatrists and health-care professionals. Diminished capacity to consent to pharmacological treatment is a common concern in individuals with schizophrenia. The MacArthur Competence Assessment Tool for Treatment (MacCAT-T) is the most common tool used in individuals with schizophrenia to evaluate the decision-making abilities for judgments about competence to consent to treatment. This instrument assesses patients’ competence to make treatment decisions by examining their capacities in 4 areas: understanding information relevant to their condition and the recommended treatment, reasoning about the potential risks and benefits of their choices, appreciating the nature of their situation and the consequences of their choices, and expressing a choice. Despite its importance, there is no French version of this scale. Furthermore, its factor structure has never been explored, although validated measures are strongly needed to further detect deficits in patients’ decision-making abilities. The goal of this study was thus to empirically validate a French version of the MacCAT-T in a French sample of individuals with schizophrenia. Method: In this cross-sectional study, we included 125 inpatients with a diagnosis of schizophrenia from the University Department of Adult Psychiatry in Montpellier. The MacCAT-T was administered to patients by a trained psychologist. Patients were also assessed for severity of symptoms, insight into illness, and depressive and anxiety symptoms. Inter-rater reliability and psychometric properties including internal consistency, construct validity, and discriminant and divergent validity were also investigated. Results: The MacCAT-T’s internal consistency was high (Cronbach α of 0.91). A high degree of inter-rater reliability was found for all the areas of the MacCAT-T (intraclass correlation coefficient range, 0.92 to 0.98). Exploratory factor analysis revealed a 2-factor model. The factor analysis explained 50.03% of the total score variation. Component 1 included all subparts of “understanding.” Component 2 included all subparts of “appreciation” and “reasoning” and was therefore labeled “reflexivity.” After Bonferroni corrections, decision-making capacity was positively associated with insight and the severity of psychotic symptoms but not with sociodemographic variables except for education. Conclusions: The MacCAT-T demonstrated a high degree of inter-rater reliability and strong psychometric properties. The French version of the MacCAT-T is a valid instrument to assess the decision-making capacity to consent to treatment in a French sample of individuals with schizophrenia.

Abstract W MP7: Predictors and Implications of Capacity to Provide Informed Consent for Acute Ischemic Stroke Treatment Trials

Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Hari Kishan R Indupuru ◽  
Loren Shen ◽  
Amber N Jacobs ◽  
Chunyan Cai ◽  
James C Grotta ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Ischemic Stroke ◽  
Informed Consent ◽  
Acute Ischemic Stroke ◽  
Stroke Patients ◽  
Stroke Treatment ◽  
Capacity To Consent ◽  
Decision Making Capacity ◽  
The Right ◽  
Study Designs

Background and objectives: Enrollment into AIS trials has always been limited by the ability of the patient to give informed consent or the availability of a Legally Authorized Representative (LAR) in decision making capacity on behalf of the patient. In this analysis we try to identify the factors contributing to an acute ischemic stroke (AIS) patient’s inability to give informed consent. We hypothesized that clinical features and demographics would differ between those patients with and without capacity to consent. Methods: This analysis includes patients who enrolled into the coordinating center of the prospective, randomized ARTSS-2 clinical trial (Argatroban + TPA for acute ischemic stroke) and also screen failures due to inability to consent. Data is collected prospectively in the study screening log. The data collected included age, gender, race, NIHSS, lesion location, ER arrival time and mode of consent (self-consent, LAR-consent and unable to consent). Results: Between 12/11 and 06/13, a total of 33 acute ischemic stroke patients received IV-tPA and were eligible for the ARTSS-2 study. While 19 were enrolled, 14/33 (42.4%) were otherwise eligible, but not enrolled due to inability to self-consent and no LAR present. Patients not enrolled due to lack of capacity to consent and without LAR present tended to have higher median NIHSS scores and greater proportions of drowsiness and aphasia compared to the other groups (see table). Conclusion: Approximately 2 in 5 AIS patients are not eligible for AIS clinical trials based solely on their lack of capacity for informed consent. It is remains ethically imperative that current clinical trials as well as future study designs address this disregarded group of patients who deserve the right to be able to participate in research. Addressing this group of patients through exception from informed consent (EFIC) will both extend research to all stroke patients, but also greatly enhance AIS research.

Assessing capacity to consent to treatment with cholinesterase inhibitors in dementia using a specific and standardized version of the MacArthur Competence Assessment Tool (MacCAT-T)

2016 ◽  
Vol 29 (2) ◽  
pp. 333-343 ◽  
Author(s):  
Tanja Mueller ◽  
Julia Haberstroh ◽  
Maren Knebel ◽  
Frank Oswald ◽  
Roman Kaspar ◽  
...  
Keyword(s):  
Informed Consent ◽  
Cholinesterase Inhibitors ◽  
Assessment Tool ◽  
Assessment Tools ◽  
Competence Assessment ◽  
Rater Reliability ◽  
Capacity To Consent ◽  
People With Dementia ◽  
Hypothetical Treatment ◽  
Consent To Treatment

ABSTRACTBackground:The use of assessment tools has been shown to improve the inter-rater reliability of capacity assessments. However, instrument-based capacity assessments of people with dementia face challenges. In dementia research, measuring capacity with instruments like the MacArthur Competence Assessment Tool for Treatment (MacCAT-T) mostly employ hypothetical treatment vignettes that can overwhelm the abstraction capabilities of people with dementia and are thus not always suitable for this target group. The primary aim of this study was to provide a standardized real informed consent paradigm that enables the dementia-specific properties of capacity to consent to treatment in people with dementia to be identified in a real informed consent process that is both externally valid and ethically justifiable.Methods:The sample consisted of 53 people with mild to moderate dementia and a group of 133 people without cognitive impairment. Rather than using a hypothetical treatment vignette, we used a standardized version of the MacCAT-T to assess capacity to consent to treatment with cholinesterase inhibitors in people with dementia. Inter-rater reliability, item statistics, and psychometric properties were also investigated.Results:Intraclass correlations (ICCs) (0.951–0.990) indicated high inter-rater reliability of the standardized real informed consent paradigm. In the dementia group, performance on different items of the MacCAT-T varied. Most people with dementia were able to express a treatment choice, and were aware of the need to take a tablet. Further information on the course of the disorder and the benefits and risks of the treatment were less understood, as was comparative reasoning regarding treatment alternatives.Conclusion:The standardized real informed consent paradigm enabled us to detect dementia-specific characteristics of patients’ capacity to consent to treatment with cholinesterase inhibitors. In order to determine suitable enhanced consent procedures for this treatment, we recommend the consideration of MacCAT-T results on an item level. People with dementia seem to understand only basic information. Our data indicate that one useful strategy to enhance capacity to consent is to reduce attention and memory demands as far as possible.

scholarly journals Can the Mini-Mental State Examination Predict Capacity to Consent to Treatment?

GeroPsych ◽  
2014 ◽  
Vol 27 (4) ◽  
pp. 151-159 ◽  
Author(s):  
Julia Haberstroh ◽  
Tanja Müller ◽  
Maren Knebel ◽  
Roman Kaspar ◽  
Frank Oswald ◽  
...  
Keyword(s):  
Mental State ◽  
Mini Mental State Examination ◽  
Assessment Tool ◽  
Equation Modeling ◽  
Modeling Framework ◽  
Capacity To Consent ◽  
People With Dementia ◽  
Consent To Treatment ◽  
The Relationship ◽  
State Examination

This study examines the relationship between capacity to consent to treatment as measured by the MacArthur Competence Assessment Tool for Treatment (MacCAT-T) and severity of cognitive impairment as measured with the Mini-Mental State Examination (MMSE). It also looks at the role of verbal retrieval in this relationship. We hypothesized that the often-quoted correlation between the MacCAT-T and the MMSE lies mainly in the joint dependence on verbal retrieval ability. Potential subjects were recruited from memory clinics, senior citizen meeting places, and a university program for seniors. Data of 149 people over 54 years, 49 of whom had been diagnosed with Alzheimer’s disease or mixed dementia, were used. The relationship between capacity to consent to treatment, verbal retrieval, and MMSE was examined using a structural equation modeling framework. The findings suggest that verbal retrieval is a confounding method factor. In the informed consent process for people with dementia, verbal memory loads should be minimized to provide a more valid measure of their capacity to consent to treatment.

Capacity, Informed Consent, and Guardianship

2017 ◽  
Author(s):  
Stephen L. Read ◽  
James E. Spar
Keyword(s):  
Decision Making ◽  
Informed Consent ◽  
Medical Decision Making ◽  
Case Law ◽  
Fundamental Principle ◽  
Medical Decision ◽  
Decisional Capacity ◽  
Decision Making Capacity ◽  
Management Capacity

Medical decision-making based on informed consent is a fundamental principle of ethical medical practice. When a patient lacks medical decisional capacity and is unable to give truly informed consent, an agent must be sought to act on the behalf of the person. This chapter reviews the principles underlying determination of the capacity to give informed consent regarding healthcare decisions in a clinical setting. Cognitive loss, emotional distress, or disengagement or the perception that the patient is choosing unwisely or as a result of influence may be concerns that lead to consultation. In contrast to the clear standards for medical decision-making capacity, statutory guidance and case law are essentially nonexistent regarding what standard applies to the capacity to create or to change an advance health directive (AHCD) or to change or designate a healthcare agent. In addition to current decision-making capacity, the consultant must address broader issues of functional or management capacity when the patient’s ongoing capacity to manage personal care and health is at issue, as is relevant to the petition for guardianship. A comprehensive forensic geriatric psychiatry consultation will assist with the care of the patient.

The association of specific neuropsychological deficits with capacity to consent to research or treatment

2007 ◽  
Vol 13 (6) ◽  
pp. 1047-1059 ◽  
Author(s):  
BARTON W. PALMER ◽  
GAURI N. SAVLA
Keyword(s):  
Decision Making ◽  
Informed Consent ◽  
Empirical Studies ◽  
A Priori ◽  
Decisional Capacity ◽  
Capacity To Consent ◽  
Significant Relationships ◽  
Decision Making Processes ◽  
Relationship Of ◽  
The Relationship

Informed consent is key to ethical clinical research and treatment, but partially rests on the ability of individual patients or research participants to use disclosed information to make a meaningful choice. Although the construct of decisional capacity emerged from legal and philosophical traditions, several investigators have begun examining the relationship of specific neuropsychological abilities to decisional capacity. This line of research may foster development of better consent procedures, as well as aid in refining the construct of decisional capacity toward a form that better reflects the underlying neurocognitive processes. We conducted a systematic search of the published literature and thereby identified and reviewed 16 published reports of empirical studies that examined the relationship between specific neuropsychological abilities and capacity to consent to research or treatment. Significant relationships between neuropsychological scores and decisional capacity were present across all the reviewed studies. The degree to which specific neuropsychological abilities have particular relevance to decisional capacity remains uncertain, but the existing studies provide a solid basis for a priori hypotheses for future investigations. These ongoing efforts represent an important conceptual and empirical bridge between bioethical, legal, and neuropsychological approaches to understanding meaningful decision-making processes. (JINS, 2007, 13, 1047–1059.)

scholarly journals The recovery of factors associated with decision-making capacity in individuals with psychosis

BJPsych Open ◽  
2017 ◽  
Vol 3 (3) ◽  
pp. 113-119 ◽  
Author(s):  
Colin Fernandez ◽  
Harry G. Kennedy ◽  
Miriam Kennedy
Keyword(s):  
Symptom Severity ◽  
Assessment Tool ◽  
Global Assessment Of Functioning ◽  
Symptom Scale ◽  
Global Functioning ◽  
Capacity To Consent ◽  
Factors Associated ◽  
Decision Making Capacity ◽  
Consent To Treatment ◽  
The Relationship

BackgroundThere is limited data on the recovery of factors associated with decisional capacity in patients with psychosis.AimsTo study the relationship between changes in mental capacity, symptoms and global functioning using structured measures during treatment for psychosis.MethodFifty-six patients with psychosis were assessed for capacity to consent to treatment on admission and at 6 and 12 weeks following treatment. The MacArthur Competence Assessment Tool – Treatment, the Positive and Negative Symptom Scale and the Global Assessment of Functioning Scale were used to measure mental capacities, symptom severity and global functioning respectively. Treating consultants rated capacity to consent, masked to these measures.ResultsGreater impairments on all measures were found in patients assessed as lacking capacity. These improved with treatment over 12 weeks with significant effect sizes (0.5 to 0.6). Stronger correlations between mental capacities, positive symptoms (-0.47) and global functioning (0.56) were noted in the first 6 weeks.ConclusionsImpairments in capacity in acute stages of psychosis are related to symptom severity and functional impairment. They improve during treatment, particularly in the first 6 weeks.

Post Discharge Clinically Overt Venous Thromboembolism in Orthopaedic Surgery Patients with Negative Venography -an Overview Analysis

1996 ◽  
Vol 76 (06) ◽  
pp. 0887-0892 ◽  
Author(s):  
Serena Ricotta ◽  
Alfonso lorio ◽  
Pasquale Parise ◽  
Giuseppe G Nenci ◽  
Giancarlo Agnelli
Keyword(s):  
Venous Thromboembolism ◽  
Orthopaedic Surgery ◽  
Diagnostic Methods ◽  
Future Research ◽  
Post Discharge ◽  
Pharmacological Prophylaxis ◽  
Vein Thrombosis ◽  
Overview Analysis ◽  
Major Orthopaedic Surgery

SummaryA high incidence of post-discharge venous thromboembolism in orthopaedic surgery patients has been recently reported drawing further attention to the unresolved issue of the optimal duration of the pharmacological prophylaxis. We performed an overview analysis in order to evaluate the incidence of late occurring clinically overt venous thromboembolism in major orthopaedic surgery patients discharged from the hospital with a negative venography and without further pharmacological prophylaxis. We selected the studies published from January 1974 to December 1995 on the prophylaxis of venous thromboembolism after major orthopaedic surgery fulfilling the following criteria: 1) adoption of pharmacological prophylaxis, 2) performing of a bilateral venography before discharge, 3) interruption of pharmacological prophylaxis at discharge in patients with negative venography, and 4) post-discharge follow-up of the patients for at least four weeks. Out of 31 identified studies, 13 fulfilled the overview criteria. The total number of evaluated patients was 4120. An adequate venography was obtained in 3469 patients (84.1%). In the 2361 patients with negative venography (68.1%), 30 episodes of symptomatic venous thromboembolism after hospital discharge were reported with a resulting cumulative incidence of 1.27% (95% C.I. 0.82-1.72) and a weighted mean incidence of 1.52% (95% C.I. 1.05-1.95). Six cases of pulmonary embolism were reported. Our overview showed a low incidence of clinically overt venous thromboembolism at follow-up in major orthopaedic surgery patients discharged with negative venography. Extending pharmacological prophylaxis in these patients does not appear to be justified. Venous thrombi leading to hospital re-admission are likely to be present but asymptomatic at the time of discharge. Future research should be directed toward improving the accuracy of non invasive diagnostic methods in order to replace venography in the screening of asymptomatic post-operative deep vein thrombosis.

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