Decisional Capacity to Consent to Clinical Research Involving Placebo in Psychiatric Patients

Parmigiani, Giovanna; Mandarelli, Gabriele; Dacquino, Claudia; Pompili, Pieritalo; Chiesa, Giovanni Lelli; Ferracuti, Stefano

doi:10.1111/1556-4029.13000

Cited by 11 publications

(10 citation statements)

References 43 publications

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“…2014), cognitive dysfunction (Palmer et al , 2004; Palmer & Jeste, 2006; Parmigiani et al . 2016), impaired executive functioning (Mandarelli et al . 2012), impaired metacognition (Koren et al .…”

Section: Introductionmentioning

confidence: 99%

Treatment decision-making capacity in non-consensual psychiatric treatment: a multicentre study

Mandarelli

Carabellese

Parmigiani

et al. 2017

Epidemiol Psychiatr Sci

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Section: Introductionmentioning

confidence: 99%

Treatment decision-making capacity in non-consensual psychiatric treatment: a multicentre study

Mandarelli

Carabellese

Parmigiani

et al. 2017

Epidemiol Psychiatr Sci

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Section: Limitationsmentioning

confidence: 45%

“…Behaviourally disturbed patients who are involuntarily admitted are generally difficult to include in research. They often refuse consent or a lack of decisional capacity to give informed consent is assumed (Lopez‐Jaramillo, Tobler, Gomez, & Triana, ; Parmigiani et al, ). Our results show that, although suffering from a severe mental condition, most such patients are willing and able to participate in a qualitative study.…”

Section: Discussionmentioning

confidence: 99%

“But I did not touch nobody!”—Patients' and nurses' perspectives and recommendations after aggression on psychiatric wards—A qualitative study

Vermeulen

Doedens

Boyette

et al. 2019

Journal of Advanced Nursing

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AimsTo gain a deeper understanding of the differences in patients and staff perspectives in response to aggression and to explore recommendations on prevention.DesignQualitative, grounded theory study.MethodsWe conducted semi‐structured interviews with patients and nurses involved in an aggressive incident. Data collection was performed from May 2016 ‐ March 2017.ResultsThirty‐one interviews were conducted concerning 15 aggressive incidents. Patients and nurses generally showed agreement on the factual course of events, there was variation in agreement on the perceived severity (PS). Patients' recommendations on prevention were mostly personally focussed, while nurses suggested general improvements.ConclusionPatients are often capable to evaluate aggression and give recommendations on prevention shortly after the incident. Patients and nurses differ in the PS of aggression. Recommendations on prevention of patients and nurses are complementary.ImpactWhat problem did the study address? Perspectives of patients and nurses differ with respect to aggression, but how is unclear. What were the main findings? Patients and nurses generally described a similar factual course of events concerning the incident, patients often perceive the severity less than nurses. Patients are capable to give recommendations on prevention of aggressive incidents, shortly after the incident. Where and on whom will the research have impact? Factual course of events can be a common ground to start evaluating aggressive incidents and post‐incident review should address the severity of incidents. Asking recommendations from patients on how to improve safety and de‐escalation can lead to innovative and personal de‐escalation strategies and supports patients autonomy.

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“…[2][3][4] Several tools have been designed to assist clinicians when evaluating patients' decisional capacity to consent to treatment [4][5][6][7] or research. [8][9][10] Patients' incapacity to make medical decisions is common. However, it is often poorly recognised.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2019

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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.

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Decisional Capacity to Consent to Clinical Research Involving Placebo in Psychiatric Patients

Cited by 11 publications

References 43 publications

Treatment decision-making capacity in non-consensual psychiatric treatment: a multicentre study

Treatment decision-making capacity in non-consensual psychiatric treatment: a multicentre study

“But I did not touch nobody!”—Patients' and nurses' perspectives and recommendations after aggression on psychiatric wards—A qualitative study

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

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