The capacity of schizophrenia and bipolar disorder individuals to make autonomous decisions about pharmacological treatments for their illness in real life: A scoping review

Abstract Background and aim Having decision making capacity is central to the exercise of autonomy in mental health care. The objective of this scoping review is to summarize the evidence on the capacity of people with schizophrenia or bipolar disorder to make decisions about their treatment in real life to support medical practice. Methods Systematic search of observational studies on the assessment of capacity of patients with schizophrenia, psychosis, or bipolar disorder to make healthcare and treatment‐related decisions, conducted in any clinical setting published up to January 31, 2020 was performed. Free text searches and medical subject headings in English were combined in PubMed, Scopus, CINAHL, and PsycInfo. Publications were selected as per inclusion and exclusion criteria. The Newcastle‐Ottawa Scale for observational studies was used to assess the quality of publications. Results Thirty publications were reviewed. According to the Newcastle‐Ottawa Scale criteria, the publications reviewed were good quality. Findings showed that more than 70% of schizophrenia and schizoaffective disorder outpatients understood treatment options at the point of making decisions about their illness and healthcare. Patients treated voluntarily had considerably better scores for decisional capacity than those treated involuntarily. The burden of psychiatric symptoms could compromise decisional capacity temporarily. Decision‐making capacity improved over time from admission to discharge from hospital, and with treatment among psychiatry inpatients. Schizophrenia and bipolar disorder patients could be as competent as nonpsychiatric individuals in making decisions about their treatments in everyday life. Conclusions This scoping review provides a body of evidence for healthcare professionals in need of assessing the capacity of schizophrenia and bipolar disorder patients for autonomously decide about their treatments. Decisional capacity judgements should consider variations in capacity over time and be based on the type of decision to be made, the severity of symptoms, and the specific phase of the mental disorder.


| INTRODUCTION
Respect for autonomy is a key principle in biomedical ethics. It is, however, a particularly vulnerable principle in everyday mental health care practice. 1 In medical practice, autonomy is usually expressed as the right of competent adults to make informed decisions about their own medical care; it denotes self-government. 2 Autonomy is strongly associated with the idea that patients should be allowed and enabled to make their own decisions about treatments they receive for their diseases, and to make these decisions with purpose, substantial understanding, and freedom from controlling influences. 3 A range of factors such as interactions with health-care providers and symptom management challenge patient autonomy across a variety of diseases. 45 Preserving independence and privacy and dealing successfully with threats to self-identity may enhance patients' autonomous decision making. Policies across the world require that, where possible, equal weight be given to the wishes, feelings, beliefs, and values of patients who have decision-making capacity and of patients who are deemed to lack it. 6 Psychiatry has led major improvements in patient empowerment as part of the development of person-centered care and recovery. 7 However, paternalistic attitudes could prevail despite an awareness of patients' right to autonomy and the practitioners' duty of reciprocity that requires to build up trust with the patient and to involve him or her in the planning and implementation of care. 8 It is important to distinguish between the concepts of capacity and competency. Capacity describes a person's ability to a make a particular decision, whereas competency is a global assessment and a legal determination made by a judge in court. 9 In a medical context, capacity refers to the ability to use information about an illness and proposed treatment options to make a choice that is congruent with one's own values and preferences 10 ; it is the determining element that establishes the role of patient choices in medical decisions. Historically, patients with severe mental illnesses have been regarded as having impaired capacity for making functional decisions with respect to their health, and their agency has been largely disregarded in diagnosis and management. 11 Persons with schizophrenia, for instance, describe a sense of being considered incapable and unmotivated to exercise their autonomy by their care givers, despite the knowledge that being trusted in their abilities and being offered freedom to make their own decisions might help them to respond successfully to a series of situations in daily life. 12 Among bipolar disorder patients, medication schedules and a better understanding of illness and of treatment complications would foster better treatment decision-making and adherence. 13 In both cases, the assessment of capacity is critical for the agreement with the therapists in shared contracts 14 and with the case-manager in joint care planning. 15 Assessing individuals' capacity to consent to or refuse treatment is a demanding task for psychiatrists, psychologists, and other healthcare professionals, particularly when dealing with unrepresented patients. 16 It requires the assessment of the individual's ability to understand their medical situation and its consequences, to form and communicate a choice about the proposed care options, and to process the information in order to reach a rational decision. The evaluation may happen in episodes of acute care during a crisis and it must find a balance between promoting and restoring the patient's health, providing good care and assuming responsibility, while at the same time respecting the patient's integrity, his/her right to selfdetermination and information, and protecting human rights. 8 Professional judgement on these issues is required, but to date the values, beliefs and previous experiences of patients with mental illness have not been explicitly included in structured evaluations in real medical practice. 17 The aim of the present review is to assess the scope of the literature on the capacity of people with schizophrenia or bipolar disorder to make decisions about treatments in the management of their disease in real life. Building up evidence on the capacity of people with schizophrenia and bipolar disorder to make decisions about their illness is a first step on the way to a fuller consideration of their autonomy in usual medical practice.

| METHODS
A systematic search of the literature was conducted observing the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) Checklist 18 to achieve the aim of the review. Free text searches and medical subject headings were combined to identify articles published in English and indexed in PubMed, Scopus, the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and PsycInfo since the date of their indexation up to January 31, 2020. The search strategy is summarized in Appendix S1. Lists of references in the key papers retrieved were further checked to identify other relevant articles.
Inclusion criteria were any observational, real world study on schizophrenia, schizophrenic disorder, bipolar disorder, or psychosis individuals reporting a qualitative and/or quantitative assessment of patients' capacity to make treatment related decisions, including to consent and to make advance directives, and to express preferences for their psychiatric medications. Publications referring to multiple mental illnesses were included if the largest proportion of participants in the study were schizophrenia, bipolar disorder, or psychosis patients. The inclusion and exclusion criteria are shown in Table 1.
Potentially relevant abstracts were assessed by two expert reviewers Full text copies were requested of all papers initially considered suitable for inclusion in the review. Publications which were deemed pertinent after mutual agreement were reviewed and data were extracted. A third reviewer was involved in the selection process to resolve any disagreements. Data extraction was carried out by one researcher. A data extraction form that covered author, year of publication, country, study design, research tool, study objective, population and setting was designed and applied to summarize the key characteristics of publications ( Table 2).
The appraisal of publications was based on the Newcastle Ottawa Scale for observational studies, developed to assess their quality and risk of bias (Table 3). 47 The Newcastle Ottawa Scale evaluates three quality parameters (selection, comparability, and outcome) divided across eight specific items. Each item on the scale is scored either 0 or 1, except for comparability, which can be adapted to the specific topic of interest and may score up to 2 points. Thus, the maximum score for each study is 9: studies with scores below five are considered to represent a high risk of bias. The Newcastle Ottawa Scale is one of the most used worldwide, above all for observational studies. 47

| RESULTS
Searches identified a total of 268 hits. After reading titles and abstracts and removing irrelevant and duplicates, 49 potentially relevant papers were retained. Of these, 19 were excluded after assessing the full texts and 30 publications were finally reviewed for data extraction ( Figure 1).
Most studies (23 out of 30) were carried out in European coun-  These findings imply that less symptomatic patients as well as those with a higher level of comprehension of the mental disorder and its consequences would have greater decisional capacity. An important correlation between the competence to consent to treatment and insight was reported in this population. 23 Raffard et al 42    Note: A study can be awarded a maximum of one star for each numbered item within the selection (five items) and outcome (two items) categories. A maximum of two stars can be given for comparability. The review also shows that, in mental health research, the capacity for decision making is usually assessed according to the four traditional criteria of understanding, appreciation, reasoning, and expressing a choice 9 and that each of these elements contributes in different ways to the person's decisional capacity. The effects of impairments in schizophrenia and bipolar disorder on patients' decision-making and functional capacity may vary in intensity depending on the individual, the phase of the illness, the prevailing psychotic symptoms, cognitive function, the moment in time, and the type of decision to be made. 55 The understanding of the disease-and treatment-related information is commonly impaired in schizophrenia and bipolar disorder patients, but this does not mean that these individuals are incapable of making their own decisions or that they are unable to adequately perform treatment-related tasks. 56 The level of understanding can be easily improved by adopting measures such as repeating and redisclosing the missed information or using enhanced information procedures. 57 Research into functional capacity shows that schizophrenia patients can normally manage medications and keep prescription refills over time. 58 These findings reinforce the notion that capacity is a complex, dynamic, and multifactorial neurocognitive concept that should be properly assessed and re-assessed by the clinician familiar with the patient or with the nature of the disease. They also show that, when present, the loss of the capacity for decision making is temporary and the ability recovers over time in the vast majority of patients with schizophrenia or bipolar disorder. 59 Therefore, capacity assessments should primarily be undertaken not to judge whether people are capable or not to decide autonomously, but rather to assess what kind of support people with decision-making impairments need in order to be involved in decision making, and thus to promote their autonomy. 60 The psychiatrist's clinical judgment is fundamental in assessing the decision-making capacity of mentally disordered patients 21 . 22 The currently available scales are very limited and are poorly suited for evaluating this capacity. In this context, a specific assessment of capacity should be conducted together with the standard routine medical and psychopathological evaluation in any patient in a crisis episode and when preparing a shared contract or a joint care plan.
Healthcare practitioners should remember that the limitation of capacity is temporary, and a reassessment should therefore be per-

CONFLICT OF INTEREST
The authors declare that they have no conflict of interest. Alfredo Calcedo-Barba had full access to all of the data in this study and takes complete responsibility for the integrity of the data and the accuracy of the data analysis.

TRANSPARENCY STATEMENT
Alfredo Calcedo-Barba affirms that this manuscriptis an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.

DATA AVAILABILITY STATEMENT
The data that support the findings of this study are available from the corresponding author upon reasonable request.