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

2015 ◽  
Vol 61 (2) ◽  
pp. 388-393 ◽  
Author(s):  
Giovanna Parmigiani ◽  
Gabriele Mandarelli ◽  
Claudia Dacquino ◽  
Pieritalo Pompili ◽  
Giovanni Lelli Chiesa ◽  
...  
2019 ◽  
Vol 59 (4) ◽  
pp. 247-254 ◽  
Author(s):  
Gabriele Mandarelli ◽  
Giovanna Parmigiani ◽  
Felice Carabellese ◽  
Silvia Codella ◽  
Paolo Roma ◽  
...  

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.


2020 ◽  
Vol 73 (2) ◽  
pp. 431-442
Author(s):  
Rachel K.B. Hamilton ◽  
Cynthia H. Phelan ◽  
Nathaniel A. Chin ◽  
Mary F. Wyman ◽  
Nickolas Lambrou ◽  
...  

CNS Spectrums ◽  
2008 ◽  
Vol 13 (9) ◽  
pp. 757-761 ◽  
Author(s):  
Uriel Halbreich ◽  
Nancy Smail ◽  
Xin Tu ◽  
Judith Halbreich

AbstractIntroduction: This report demonstrates parameters of quality of care and treatment outcome of acute schizophrenia patients who were involved as subjects in a clinical trial of two marketed widely used antipsychotics compared with their fellow patients who received routine clinical hospital care.Methods: Patients were newly admitted severely agitated schizophrenia patients who agreed to participate in a double-blind randomized trial of short-term (5 days) rate of improvement in response to two second-generation oral antipsychotics. Treatment outcomes as measured by the Clinical Global Impression and parameters of quality of care were compared with the general population of inpatients in the same county hospital.Results: Of 145 patients screened, 109 patients did not meet study inclusion and exclusion criteria. It is of note that systematic diagnostic interview did not confirm the clinical diagnosis of schizophrenia in 17 patients (11.7%). Study patients had shorter length of stay (6.75 days vs 15.3 days of total psychiatric patients at the hospital during the study period), no physical restraints (vs 21.9%), no use of antipsychotics as chemical restraints (vs 19.8%), and less recidivism following the trial (28.1%) compared with prior to the trial (64.3%).Conclusion: Patients who participate in structured clinical research with well-delineated procedures, clinical outcome measures, and clear expectations, faired better than their fellow patients in the same non-research hospital wards. Application of some characteristics of clinical research to the diagnosis and treatment of clinical non-research patients may be considered.


1966 ◽  
Vol 19 (3) ◽  
pp. 955-958 ◽  
Author(s):  
Alvin R. Mahrer ◽  
Donald J. Mason ◽  
Elayne Kahn ◽  
Mikhail Projansky

Previous research isolated the amount of symptomatology as a meaningful clinical-research dimension for describing hospitalized psychiatric patients. The purpose of the present study was to investigate the symptoms which are characteristically associated with “high-complainers” and with “low-complainers.” Ss were 248 hospitalized male psychiatric patients, each of whom was administered a symptom checklist. Results indicated that differential symptom patterns are associated with varying amounts of symptomatology.


2007 ◽  
Vol 64 (8) ◽  
pp. 966 ◽  
Author(s):  
Dilip V. Jeste ◽  
Barton W. Palmer ◽  
Paul S. Appelbaum ◽  
Shahrokh Golshan ◽  
Danielle Glorioso ◽  
...  

1967 ◽  
Vol 20 (3) ◽  
pp. 711-714 ◽  
Author(s):  
Alvin R. Mahrer

The Psychological Problem Inventory (PPI) is a clinical-research instrument designed to provide hospitalized male psychiatric patients with a simple, straightforward means of (a) defining the broad scope of their problems-behaviors-symptoms (b) from their own self-reported point of view (c) in concrete, behavioral terminology. The instrument is described in terms of its purposes, characteristics, derivation, sample items, and supplementary-complementary relationship with checklists and rating scales for the evaluation of symptomatic psychopathology.


2006 ◽  
Vol 163 (8) ◽  
pp. 1323-1334 ◽  
Author(s):  
Laura B. Dunn ◽  
Milap A. Nowrangi ◽  
Barton W. Palmer ◽  
Dilip V. Jeste ◽  
Elyn R. Saks

Sign in / Sign up

Export Citation Format

Share Document