Ishii Mio, Okumura Yasuyuki, Sugiyama Naoya, Hasegawa Hana, Noda Toshie, Hirayasu Yoshio, Ito Hiroto
Department of Psychiatry, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.
Research Department, Institute for Health Economics and Policy, Association for Health Economics Research and Social Insurance and Welfare, 1-5-11 Nishishimbashi, Minato-ku, Tokyo, 105-0003, Japan.
BMC Psychiatry. 2017 Feb 6;17(1):52. doi: 10.1186/s12888-017-1218-1.
The feasibility of shared decision making (SDM) for patients with schizophrenia remains controversial due to the assumed inability of patients to cooperate in treatment decision making. This study evaluated the feasibility and efficacy of SDM in patients upon first admission for schizophrenia.
This was a randomized, parallel-group, two-arm, open-label, single-center study conducted in an acute psychiatric ward of Numazu Chuo Hospital, Japan. Patients with the diagnosis of schizophrenia upon their first admission were randomized into a SDM intervention group or a usual treatment group in a 1:1 ratio. The primary outcome was patient satisfaction at discharge. The secondary outcomes were attitudes toward medication at discharge and treatment continuation at 6 months after discharge.
Twenty-four patients were randomly assigned. The trial was prematurely terminated due to slow enrollment. At discharge, the mean score on satisfaction was 23.7 in the SDM group and 22.1 in the usual care group (unadjusted mean difference: 1.6; 95% CI: -5.2 to 2.0). Group differences were not observed in attitude toward medication and treatment continuation. There was no statistically significant difference between the groups for the mean Global Assessment of Functioning score at discharge or length of stay as safety endpoint.
No statistical differences were found between the SDM group and usual care group in the efficacy outcomes and safety endpoints. Large trials are needed to confirm the efficacy of the SDM program upon first admission for schizophrenia.
The study has been registered with ClinicalTrials.gov as NCT01869660 (registered 27 May, 2013).
由于假定精神分裂症患者无法参与治疗决策，因此针对此类患者的共同决策（SDM）的可行性仍存在争议。本研究评估了精神分裂症首次入院患者中实施共同决策的可行性和疗效。
这是一项在日本沼津中央医院急性精神科病房开展的随机、平行组、双臂、开放标签、单中心研究。首次入院诊断为精神分裂症的患者按1:1比例随机分为共同决策干预组或常规治疗组。主要结局是出院时的患者满意度。次要结局是出院时对药物治疗的态度以及出院后6个月的治疗延续情况。
24例患者被随机分配。由于入组缓慢，试验提前终止。出院时，共同决策组的满意度平均得分为23.7，常规治疗组为22.1（未调整的平均差值：1.6；95%置信区间：-5.2至2.0）。在对药物治疗的态度和治疗延续方面未观察到组间差异。两组在出院时的功能总体评定平均得分或作为安全性终点的住院时长方面无统计学显著差异。
共同决策组与常规治疗组在疗效结局和安全性终点方面未发现统计学差异。需要开展大型试验以确认共同决策方案对精神分裂症首次入院患者的疗效。
该研究已在ClinicalTrials.gov注册，注册号为NCT01869660（2013年5月27日注册）。
