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[精神病学中随机对照试验的纳入标准和评定量表。定性研究的未来]

[Inclusion criteria and rating scales for RCTs in Psychiatry. The future of qualitative studies].

作者信息

Pringuey D, Pommier R, Pringuey-Criou F, Boyer S, Massoubre C, Fakra E, Adida M, Belzeaux R, Bottai T, Azorin J-M

机构信息

Faculté de Médecine de Nice, UNSA, 28 avenue de Valombrose, 06107 Nice, France.

Service de Psychiatrie Adultes, CHU Saint-Etienne, 5 chemin de la Marendière, 42055 Saint-Etienne Cedex, France.

出版信息

Encephale. 2016 Dec;42(6S):S12-S17. doi: 10.1016/S0013-7006(17)30048-9.

DOI:10.1016/S0013-7006(17)30048-9
PMID:28236986
Abstract

An inventory on the two critical dimensions that structure the Randomized Controlled Trial in Psychiatry, namely the definition of inclusion criteria for eligible patients for testing and the choice of psychometric methods of pathology assessment and its evolution during the experiment, considers the importance of increasingly numerous and precise international recommendations. Taking into account the formal constraints of industrial, questioning the cultural differences of the methodological approach of the tests, meeting the requirements of feasibility and ever increasing security, frequent cumbersome procedure often contrasts with the modest nature of the results. A better definition to include patients in randomized trials is desirable and it asks to return to the clinic studying the expectations of patients and their response to the therapeutic situation. Excessive standardization otherwise required for ensuring the objective nature of the assessment hampers the collection of original and varied clinical features of importance in the further definitions of indications. On the way to a resumption of the single case study, we can expect from qualitative methods applied to small groups of subjects, optimization principles of patient selection for the upcoming randomized trial and greater chance to address the relevant details of clinical response to the therapeutic situation. This is what has led to the discovery of psychotropic drugs and which is involved in the various modalities of the qualitative approach. For example, and beyond the exploration of clinical drug effects, the study of the experience of psychiatric inpatient care in the Healing Garden, conducted on a small group and on the basis of the narrative analysis of their experience, notes several operating thematic dimensions: a reduction in the perception of symptoms of the disease, the impression of regaining a foothold into reality, the interest of a differently perceived doctor-patient relationship, the advantage of renewed power to act and the recognition of the importance of support from others, patients recovering somehow « vitality » of touch with reality. This suggests the possibility to establish an appropriate rating scale for such a specific therapeutic situation and to provide a more accurate and efficient recruitment for a comparative objective demonstration. Moreover, this construction of meaning reinforces the therapeutic benefit of treatment in Healing Garden and offers new dimensions for research.

摘要

一项关于精神病学随机对照试验的两个关键维度的清单,即确定符合测试条件的合格患者的纳入标准,以及选择病理评估的心理测量方法及其在实验过程中的演变,考虑到了越来越多且精确的国际建议的重要性。考虑到行业的形式限制,质疑测试方法学方法的文化差异,满足可行性和不断提高的安全性要求,频繁繁琐的程序往往与结果的有限性形成对比。在随机试验中纳入患者的更好定义是可取的,这要求回到临床,研究患者的期望及其对治疗情况的反应。为确保评估的客观性而要求的过度标准化会阻碍收集在进一步定义适应症时重要的原始和多样的临床特征。在恢复单病例研究的道路上,我们可以期待应用于小群体受试者的定性方法、为即将到来的随机试验优化患者选择原则,以及更有机会处理对治疗情况临床反应的相关细节。这就是导致精神药物发现的原因,也是定性方法的各种模式所涉及的内容。例如,除了探索临床药物效果之外,对康复花园中精神科住院护理体验的研究,基于对一小群患者体验的叙事分析进行,注意到几个操作主题维度:疾病症状感知的减轻、重新回归现实的感觉、以不同方式感知的医患关系的益处、重新获得行动能力的优势以及认识到他人支持的重要性,患者在某种程度上恢复了与现实接触的“活力”。这表明有可能为这种特定的治疗情况建立一个合适的评分量表,并为比较客观的论证提供更准确和有效的招募。此外,这种意义构建加强了康复花园治疗的益处,并为研究提供了新的维度。

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