Effectiveness of electroconvulsive therapy (ECT) in patients without capacity to consent

Review Title: Effectiveness of electroconvulsive therapy (ECT) in patients without capacity to consent Background: Although clinical efficacy of ECT has been established in several randomized controlled trials, clear evidence concerning the clinical effectiveness of ECT in patients without capacity to consent is lacking because these patients have been excluded from those clinical trials. Study Aim: To investigate the clinical effectiveness of ECT in patients without capacity to consent compared to those with capacity to consent. Method: The literature search, decisions on inclusion, data extraction will be performed independently by two researchers (A.T. and D.Z-W.). Because potential studies are expected to be observational studies given the target population (i.e., patients who lack capacity to consent), we will follow the Meta-Analysis of Observational Studies in Epidemiology (MOOSE) guidelines. Literature Search PubMed, PsycINFO, Web of Science, and Embase are going to be searched using the following keywords: (Electroconvulsive OR ECT) AND (consent OR involuntary OR incapable OR capacity OR refusal OR autonomy OR coercion). A manual search of reference lists in relevant publications will be conducted to supplement the electronic search. All articles meeting the eligibility criteria are going to be assessed for their quality by two researchers (A.T. and D.Z-W.) in accordance with the Grading of Recommendations, Assessment, Development and Evaluation (GRADE). Risk of bias is going to be assessed by using the Newcastle-Ottawa Scale. Scores will be determined by consensus between the two researchers. Full-text peer-reviewed article written in English, German, Dutch, or Japanese are going to be reviewed for eligibility according to the following criteria. Eligibility criteria Study design: We will not limit the study design and include observational studies, case series, and case report because we do not expect any randomized controlled trial given the target population. Participants: We will include studies which focus on adult patients without capacity to consent. Studies including only children or adolescents will be excluded because they are usually regarded as individuals without capacity to consent regardless of severity of psychiatric symptoms. Studies which do not report consent status will be excluded. We will not limit the diagnoses (e.g., major depressive disorder, bipolar disorder, or schizophrenia) because patients without capacity to consent may present with similar symptoms/conditions regardless of their primary diagnosis (e.g., catatonic stupor, severe psychotic symptoms, or a refusal of food or pharmacological treatment due to delusional thinking). Intervention: Any types of ECT (e.g., bilateral or unilateral) will be included. Comparison: We will compare patients with/without capacity to consent. Outcomes: The primary outcome is the clinical effectiveness (e.g., symptom reduction or response rate). When any numerical rating scales for specific symptoms (e.g., Hamilton Depression Rating Scale: HAM-D, Montgomery Asberg Depression Rating Scale: MADRS, the Positive and Negative Syndrome Scale: PANSS, Brief Psychiatric Rating Scale: BPRS) are not reported, assessments for global symptoms (e.g., Clinical Global Impression: CGI) or functioning (e.g., Global Assessment of Functioning: GAF) will be extracted. When none of the assessment scales are not reported in case series/reports, clinical description will be extracted. The secondary outcomes include tolerability (e.g., incidence of side effects, such as cognitive impairment) and patients' perspective (e.g., satisfaction). Data extraction In addition to the above-mentioned outcomes, we will extract clinical characteristics of the participants (e.g., age, sex, and baseline severity) and ECT parameters (e.g., electrode placement, pulse width, number of ECT sessions). When articles do not provide sufficient information, we will contact corresponding authors to request data. Data analysis In addition to a systematic review, we will conduct a meta-analysis to numerically summarize our findings using relevant articles. First, we will select studies including both patients with/without capacity to consent to compare the clinical effectiveness of ECT between those groups. Second, we will select studies including only patients who lack capacity to consent without any comparison groups to calculate summary statistics. Data analyses are going to be performed using Comprehensive Meta-Analysis version 3.0. For studies which report clinical effectiveness of ECT in patients who lack capacity to consent compared to those who have capacity to consent, the effect size (Hedge's g for continuous outcomes and odds ratio for dichotomous outcomes) will be calculated with 95% confidence intervals, using random effect models. Heterogeneity is going to be reported using τ2, I2, Q, and P values. To investigate the effect of age, diagnosis, ECT parameters, clinical assessment (e.g., response rate or numerical rating scales), and quality of the studies on results, we will conduct a subgroup/meta-regression analysis. Egger’s regression test, followed by Duval & Tweedie’s trim and fill method, are going to be used to assess publication bias. Key Words: electroconvulsive therapy; consent; effectiveness; systematic review; meta-analysis; schizophrenia; bipolar disorder; major depressive disorder; catatonia Conflict of Interest: None

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