Related Factors To The Evaluation Of Informed Consent Capacity In Psychiatric Patients

Background and Objective: Informed consent is a cornerstone of ethical practice in treatment settings;an adequate process of informed consent thus reflects and promotes the ethical principle of autonomy.This doctrine is based upon the importance of respecting the individual’s human right to self-determination,and it has been gradually regarded as an important principle which must be followed by health professionals.But the practice of informed consent in psychiatry is examined specifically and controversially,for the patients with mental disorders are usually considered subjects who are unable to give their consent.Informed consent of mentally ill patients has been a sensitive issue in recent Chinese mental health practice.The informed consent capability assessment is becoming more and more important but yet under-researched.The current study set out to investigate interior factor(the assessed individual factors)and exterior factors(assessment tools,evaluation procedure and evaluation factors)to the assessment of informed consent capacity in psychiatric patients.Methods: 1.Between April 2015 and August 2015,we distributed a confidential self-report questionnaire to a simple,stratified,random sample of psychiatrists who served aclinical department having 30 or more psychiatrists.Fourteen sites were included.Frequencies and corresponding percentages for dichotomous variables or medians and interquartile ranges for continuous variables were calculated.2.We developed the two instruments(SACC-CR and SACC-CT)as 10-item scales that included questions focusing on understanding and appreciation reasoning and appreciation of the information concerning a research protocol and a treatment situation.In an investigation of reliability and validity,we studied 109 inpatients interrater reliability,and concurrent(criterion)validity(including correlations with an established instrument as well as sensitivity and specificity relative to 2 potential “gold standard” criteria)were measured.3.109 inpatients with schizophrenia were assessed with MCCB,the informed consent were evaluated by SACC-CT,PANSS and CGI-S were used to assess psychosis symptoms,correlations between the informed consent capacity and related factors were discussed.A confidential self-report questionnaire was developed to address the attitudes;the 109 schizophrenia inpatients,their family members and their attending psychiatrists were invited to complete the attitudes questionnaire.Results: 1.The response rate was 47.2 %(398/844);missing data in all the completed questionnaires were less than 5%.Respondents’ time in practice ranged from 1 to 42 years(M = 11.99,median = 10,SD = 9.08);among them,36.7%~58.4% thought the related regulations of the new law were strict.Most of the respondents would like to inform the patients or their guardian of the diagnosis(95.2%);treatment plan(93.5%),treatment goal and potential adverse effects(94.7%),and alternative treatment plan(71.9%).Only 9.6% of psychiatrists thought they would inform the patients themselves,50.5% of psychiatrists wouldsupport the patients’ right to refuse treatment and that psychiatrists who have longer seniority(years working >10 years)were as likely to support the patients’ refusal of psychiatric treatment(57.7% vs 45.2%,p < 0.05).2.The SACC-CR and SACC-CT were found to have good internal consistency,interrater reliability,concurrent validity,high sensitivity,and acceptable specificity.It typically took about 5 minutes to administer,was easy to use and reliably score,and could be used to identify subjects with questionable capacity to consent to the specific research project and treatment situation.The cut-off scores were 9 for SACC-CR and 10 for SACC-CT with sensitivity of 81.9% and 80.6%,specificity of 76.3% and 73% respectively.3.The informed capacity was significantly correlated with education years(t=3.889,p<0.001),admission type(t=-0.231,p<0.05),severity of illness positive symptoms(r=-4.447,p<0.001),negative symptoms(r=-0.552,p<0.001),and correlated with the MCCB scores in all the seven fields(r=0.255~0.633,p<0.01).Logistic regression demonstrated that information processing speed(OR=1.152)was a protective factor of informed consent capacity while negative symptoms(OR=0.927)was a risk factor.Conclusions: 1.The results suggest that the MHL has had a positive impact on the informed consent process in psychiatric practice,particularly with respect to a uniform approach and informed consent contents.Even though the psychiatrists included in this survey worked in the developed area of China,the attitudes towards psychiatric patients’ informed consent rights are worrisome.Efforts should be made to clarify specific aspects of the MHL to promote one of the main goals of the law,which is to protect the rights of persons with mental disorders.2.The SACC-CR and SACC-CT are potentially useful instruments for screening large numbers of subjects to identify those needing more comprehensive decisional capacity assessment and/or remediation efforts.3.The informed consent capacity to treatment is correlated with education,admission type,psychiatric symptoms and cognitive function.Logistic regression demonstrated that information processing speed(OR=0.927,p<0.01)was a protective factor of informed consent capacity to treatment while negative symptom(OR=1.152,p<0.01)was a risk factor.