Decisional Capacity for Informed Consent in Schizophrenia Research

Carpenter, William T.; Gold, James M.; Lahti, Adrienne C.; Queern, Caleb A.; Conley, Robert R.; Bartko, John J.; Kovnick, Jeffrey A.; Appelbaum, Paul S.

doi:10.1001/archpsyc.57.6.533

Cited by 438 publications

(407 citation statements)

References 10 publications

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“…1) (Weinstock et al 1984;Veliz & James, 1987;Norko et al 1990;Bean et al 1994;Grisso et al , 1997Carpenter et al 2000;Moser et al 2002Moser et al , 2005Moser et al , 2006Valletto et al 2002;Wong et al 2000Wong et al , 2005Bellhouse et al 2003;Kovnick et al 2003;Vollmann et al 2003;Cohen et al 2004;Palmer et al 2004Palmer et al , 2005Srebnik et al 2004;Cairns et al 2005;Eyler et al 2005Eyler et al , 2007Koren et al 2005;Stroup et al 2005;Candilis et al 2006Candilis et al , 2008Dunn et al 2007;Moye et al 2008;Kavanagh et al 2008;Jeste et al 2009;Owen et al 2009aOwen et al , 2011De Marco et al 2010;Capdevielle et al 2009;Linder et al 2012;Di & Cheng, 2013;Fischer et al 2013;Kumar et al 2013;Lan et al 2013;Raffard et al 2013;Skipworth et al 2013;Chiu et al 2014). A clinician with expertise in the field [G Shields (GS)] ...…”

Section: Resultsmentioning

confidence: 99%

Diversity or disarray? A systematic review of decision-making capacity for treatment and research in schizophrenia and other non-affective psychoses

et al. 2017

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Background. Valid consent for treatment or research participation requires that an individual has decision-making capacity (DMC), which is the ability to make a specific decision. There is evidence that the psychopathology of schizophrenia can compromise DMC. The objective of this review was to examine the presence or absence of DMC in schizophrenia and the socio-demographic/psychopathological factors associated.Methods. We searched three databases Embase, Ovid MEDLINE(R), and PsycINFO for studies reporting data on the proportion of DMC for treatment and research (DMC-T and DMC-R), and/or socio-demographic/psychopathological associations with ability to make such decisions, in people with schizophrenia and related illnesses.Results. A total of 40 studies were identified. While high levels of heterogeneity limited direct comparison, meta-analysis of inpatient data showed that DMC-T was present in 48% of people. Insight was strongly associated with DMC-T. Neurocognitive deficits were strongly associated with lack of DMC-R and to a lesser extent DMC-T. With the exception of years of education, there was no evidence for an association with socio-demographic factors.Conclusions. Insight and neurocognitive deficits are most closely associated with DMC in schizophrenia. The lack of an association with socio-demographic factors dispels common misperceptions regarding DMC and characteristics such as age. Although our results reveal a wide spectrum of DMC-T and DMC-R in schizophrenia, this could be partly due to the complexity of the DMC construct and the heterogeneity of existing studies. To facilitate systematic review research, there is a need for improvement within research study design and increased consistency of concepts and tools.

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Section: Resultsmentioning

confidence: 99%

Diversity or disarray? A systematic review of decision-making capacity for treatment and research in schizophrenia and other non-affective psychoses

et al. 2017

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“…In a prior study, one of the authors (MIL) and colleagues found that implementing an educational intervention improved decisional capacity in severely depressed patients [26]. Similarly, Carpenter and colleagues [24] showed that patients with schizophrenia improved understanding and capacity as measured by a study-specific version of the MacCAT-T following education. Other investigations also showed that education can assist psychiatric patients in achieving capacity to consent [32,33].…”

Section: Influencing a Patient's Decisionmentioning

confidence: 92%

“…Diagnostic categories alone (i.e., Alzheimer's, depression, schizophrenia) do not equate with presence or absence of decision-making capacity [1]. For example, in schizophrenia, capacity is correlated only modestly with psychotic symptoms but more strongly with cognitive dysfunction [24].…”

Section: Influence Of Psychiatric History and Current Diagnosismentioning

confidence: 99%

Influence of Psychiatric Symptoms on Decisional Capacity in Treatment Refusal

2017

AMA Journal of Ethics

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How psychiatric symptoms affect patients' decision making in practice can inform how we think-theoretically and conceptually-about what it means for those patients to have decision-making capacity. Assessment of a patient's decisional capacity allows those with adequate capacity to make choices regarding treatment and protects those who lack capacity from potential harm caused by impaired decision making. In analyzing a case in which a patient with stage II breast cancer refuses further treatment, we review the conceptual model of informed consent and approaches to assessing decision-making capacity that are in accordance with the American Medical Association Code of Medical Ethics as well as tools to assess decisional capacity.

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“…The consent procedure has been specially designed to provide adequate information about the trial in a manner that is matched to the literacy levels of the participant and caregiver and to minimize the cognitive difficulties that persons with schizophrenia commonly face in processing information for making an informed decision[13]. After the procedure, the participant and the caregivers make an informed choice to participate or not.…”

Section: Methodsmentioning

confidence: 99%

Collaborative community based care for people and their families living with schizophrenia in India: protocol for a randomised controlled trial

Chatterjee

Leese

Koschorke

et al. 2011

Trials

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BackgroundThere is a large treatment gap with few community services for people with schizophrenia in low income countries largely due to the shortage of specialist mental healthcare human resources. Community based rehabilitation (CBR), involving lay health workers, has been shown to be feasible, acceptable and more effective than routine care for people with schizophrenia in observational studies. The aim of this study is to evaluate whether a lay health worker led, Collaborative Community Based Care (CCBC) intervention, combined with usual Facility Based Care (FBC), is superior to FBC alone in improving outcomes for people with schizophrenia and their caregivers in India.Methods/DesignThis trial is a multi-site, parallel group randomised controlled trial design in India.The trial will be conducted concurrently at three sites in India where persons with schizophrenia will be screened for eligibility and recruited after providing informed consent. Trial participants will be randomly allocated in a 2:1 ratio to the CCBC+FBC and FBC arms respectively using an allocation sequence pre-prepared through the use of permuted blocks, stratified within site. The structured CCBC intervention will be delivered by trained lay community health workers (CHWs) working together with the treating Psychiatrist. We aim to recruit 282 persons with schizophrenia. The primary outcomes are reduction in severity of symptoms of schizophrenia and disability at 12 months. The study will be conducted according to good ethical practice, data analysis and reporting guidelines.DiscussionIf the additional CCBC intervention delivered by front line CHWs is demonstrated to be effective and cost-effective in comparison to usually available care, this intervention can be scaled up to expand coverage and improve outcomes for persons with schizophrenia and their caregivers in low income countries.Trial registrationThe trial is registered with the International Society for the Registration of Clinical Trials and the allocated unique ID number is ISRCTN 56877013.

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Decisional Capacity for Informed Consent in Schizophrenia Research

Abstract: Many persons with schizophrenia may be challenged by the cognitive demands of an informed consent process for research participation. In many cases, their reduced capacity can be compensated by a more intensive educational intervention as part of the informed consent process.

Cited by 438 publications

References 10 publications

Diversity or disarray? A systematic review of decision-making capacity for treatment and research in schizophrenia and other non-affective psychoses

Diversity or disarray? A systematic review of decision-making capacity for treatment and research in schizophrenia and other non-affective psychoses

Influence of Psychiatric Symptoms on Decisional Capacity in Treatment Refusal

Collaborative community based care for people and their families living with schizophrenia in India: protocol for a randomised controlled trial

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