思覺失調症病人其正性症狀、負性症狀與臨床試驗知情同意決策能力的關係

Positive and Negative Symptoms and Decision-making Capacity for Research Participation among Patients with Schizophrenia Spectrum Disorders

背景：許多研究曾探討思覺失調症病人其正性或負性症狀，何者較顯著影響參與臨床試 驗的知情同意決策能力，但結論並不一致。本研究運用迴歸方程模式探討此主題。方法：本 研究納入177 位思覺失調症或情感性思覺失調症住院病人，以「麥氏臨床試驗知情同意決策 能力評量表（以下簡稱為MacCAT-CR）」、「正性及負性症狀量表」，以線性迴歸調整其 他共變量，探討精神病症狀與 MacCAT-CR 分數的關係。結果：受試者平均年齡為51.4 年， 平均發病年數為27.9 年，住院年數為15.1 年，68.9% 為男性。負性症狀總分與鑑別度分數 (B = -0.06, t = -2.27, p < 0.05) 及推論分數 (B = -0.09, t = -2.65, p < 0.01) 呈現明顯的負相關。男 性 (p < 0.05)、教育程度 (p < 0.01)、認知功能 (p < 0.01) 與知情能力呈現明顯的正相關，而與 住院年數 (p < 0.05) 呈現明顯的負相關。結論：本研究發現思覺失調症病人，負性症狀嚴重 度與臨床試驗的知情同意決策能力呈現顯著負相關。臨床試驗主持人招募思覺失調症病人進 行研究時，必須篩選出決策能力受損危險因子的個案，並須積極加強個案對於該臨床試驗內 容的理解，以保障其權益。

Objectives: Inconsistent results exist about which domain of psychopathology, i.e, positive or negative symptoms affects the decision-making capacity to consent to clinical research (DMC) most in patients with schizophrenia spectrum disorders (SSD). The current study was to explore this topic using a regression model controlling for related covariates. Methods: All 177 patients with schizophrenia or schizoaffective disorders were assessed with the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), the Positive and Negative Syndrome Scale, and other measures. We used a linear regression model to fi nd the association between psychotic symptoms and MacCAT-CR. Results: The mean age of subjects was 51.4 years. The majority of subjects were male (68.9%). The mean duration of schizophrenia and hospitalization were 27.9 years and 15.1 years, respectively. Negative symptoms were found to be signifi cantly to have negative association with appreciation (B = -0.06, t = -2.27, p < 0.05) and reasoning scores (B = -0.09, t = -2.65, p < 0.01). Some components of MacCAT-CR scores were signifi cantly to have positive association with educational years (p < 0.01), cognitive function (p < 0.01), male sex (p < 0.05), and negative association with the length of stay (p < 0.05). Conclusion: The most central fi nding of this study was that SSD patients with severe negative symptoms performed poorly on DMC. Beside, females, those with longer length of stay, lower educational level, and cognitive defi cit were associated with impaired DMC. Those fi ndings suggest that study investigators and institutional review boards should consider more intensive surveys for SSD patients with risk factors for impaired DMC and administer educational interventions to improve capacities to make decisions in the process of recruitment.