title: [Inclusion criteria and rating scales for RCTs in Psychiatry. The future of qualitative studies].
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.
authors.affiliation: Faculté de Médecine de Nice, UNSA, 28 avenue de Valombrose, 06107 Nice, France. Electronic address: pringuey@unice.fr.
authors.forename: D
authors.initials: D
authors.lastname: Pringuey
authors.affiliation: Service de Psychiatrie Adultes, CHU Saint-Etienne, 5 chemin de la Marendière, 42055 Saint-Etienne Cedex, France.
authors.forename: R
authors.initials: R
authors.lastname: Pommier
authors.affiliation: Les Jardins de Saint Pons, 06460 Escragnolles, France.
authors.forename: F
authors.initials: F
authors.lastname: Pringuey-Criou
authors.affiliation: Service de Psychiatrie Adultes, CHU Saint-Etienne, 5 chemin de la Marendière, 42055 Saint-Etienne Cedex, France.
authors.forename: S
authors.initials: S
authors.lastname: Boyer
authors.affiliation: Service de Psychiatrie Adultes, CHU Saint-Etienne, 5 chemin de la Marendière, 42055 Saint-Etienne Cedex, France.
authors.forename: C
authors.initials: C
authors.lastname: Massoubre
authors.affiliation: Service de Psychiatrie Adultes, CHU Saint-Etienne, 5 chemin de la Marendière, 42055 Saint-Etienne Cedex, France.
authors.forename: E
authors.initials: E
authors.lastname: Fakra
authors.affiliation: SHU Psychiatrie Adultes, Hôpital Sainte Marguerite, 13274 Marseille Cedex 9, France.
authors.forename: M
authors.initials: M
authors.lastname: Adida
authors.affiliation: SHU Psychiatrie Adultes, Hôpital Sainte Marguerite, 13274 Marseille Cedex 9, France.
authors.forename: R
authors.initials: R
authors.lastname: Belzeaux
authors.affiliation: Service de Psychiatrie, CH Martigues, 13698 Martigues Cedex, France.
authors.forename: T
authors.initials: T
authors.lastname: Bottai
authors.affiliation: SHU Psychiatrie Adultes, Hôpital Sainte Marguerite, 13274 Marseille Cedex 9, France.
authors.forename: J-M
authors.initials: JM
authors.lastname: Azorin
mesh_terms: D006801:Humans; D001523:Mental Disorders / Q000175:diagnosis / Q000628:therapy; D008605:Mental Health Services / Q000458:organization & administration / Q000592:standards; D018579:Patient Selection; D017410:Practice Guidelines as Topic; D011570:Psychiatry / Q000379:methods* / Q000592:standards; D011594:Psychometrics / Q000379:methods* / Q000592:standards; D036301:Qualitative Research; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000592:standards
keywords: Critères d’inclusion; Essai randomisés contrôlés; Healing garden; Inclusion criteria; Psychiatric rating scales; Qualitative studies; Randomized controlled studies; Échelles d’évaluation; Études qualitatives