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      Pilotstudie zu Erfahrungsfokussierter Beratung durch Pflegende bei Menschen, die Stimmen hören : Evaluation der Umsetzung des Studienplans

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          Abstract

          Zusammenfassung: Hintergrund: Stimmenhören wie auch die Behandlung und Unterstützung von Menschen, die unter Stimmenhören leiden, werden in der Psychiatrie unterschiedlich definiert. Entgegen dem medizinischen Ansatz, Stimmen als Symptome einer Erkrankung zu definieren und zu behandeln, setzt die mit Stimmenhörenden entwickelte EFC-Beratung auf Akzeptanz und einen konstruktiven Umgang mit den Stimmen. Zur Verbreitung und Anwendung von alternativen therapeutischen Ansätzen in der Praxis, sind psychiatrische Pflegefachpersonen mit ihrem Alltagsbezug prädestiniert. Ziel: Das Ziel war die Überprüfung der Umsetzung des Studienplans als Teil einer Pilotstudie bezüglich dessen Eignung für eine größere Studie. Methode: Die multizentrische Pilotstudie hatte ein einfach verblindetes, randomisiertes, kontrolliertes Design. Die Intervention bestand aus der EFC-Beratung durch Pflegefachpersonen. Die Eignung des Studienplans wurde bezüglich Rekrutierung, Belastung der Studienteilnehmenden, Eignung der Assessmentinstrumente, Anwendung der EFC-Beratung und des Einsatzes von Study-Nurses evaluiert. Resultate: In den beiden Studienzentren konnten wie geplant innerhalb von 15 Monaten 21 Teilnehmende in die Studie eingeschlossen werden. Die Teilnehmenden bewerteten die Studie insgesamt als wenig belastend und die Intervention als hilfreich. Die Anwendung der EFC-Beratung durch die Pflegenden und der Einsatz von Study-Nurses wurde als gut respektive zielführend eingeschätzt. Diskussion: Die Evaluation des Studienplans zeigt, dass sich dieser für die Durchführung einer größeren Studie mit kleineren Anpassungen am Protokoll eignet.

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          The qualitative content analysis process.

          This paper is a description of inductive and deductive content analysis. Content analysis is a method that may be used with either qualitative or quantitative data and in an inductive or deductive way. Qualitative content analysis is commonly used in nursing studies but little has been published on the analysis process and many research books generally only provide a short description of this method. When using content analysis, the aim was to build a model to describe the phenomenon in a conceptual form. Both inductive and deductive analysis processes are represented as three main phases: preparation, organizing and reporting. The preparation phase is similar in both approaches. The concepts are derived from the data in inductive content analysis. Deductive content analysis is used when the structure of analysis is operationalized on the basis of previous knowledge. Inductive content analysis is used in cases where there are no previous studies dealing with the phenomenon or when it is fragmented. A deductive approach is useful if the general aim was to test a previous theory in a different situation or to compare categories at different time periods.
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            CONSORT 2010 statement: extension to randomised pilot and feasibility trials

            The Consolidated Standards of Reporting Trials (CONSORT) statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials (RCTs). In this article we present an extension to that statement for randomised pilot and feasibility trials conducted in advance of a future definitive RCT. The checklist applies to any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). The extension does not directly apply to internal pilot studies built into the design of a main trial, non-randomised pilot and feasibility studies, or phase II studies, but these studies all have some similarities to randomised pilot and feasibility studies and so many of the principles might also apply. The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct. We followed recommended good practice to develop the extension, including carrying out a Delphi survey, holding a consensus meeting and research team meetings, and piloting the checklist. The aims and objectives of pilot and feasibility randomised studies differ from those of other randomised trials. Consequently, although much of the information to be reported in these trials is similar to those in randomised controlled trials (RCTs) assessing effectiveness and efficacy, there are some key differences in the type of information and in the appropriate interpretation of standard CONSORT reporting items. We have retained some of the original CONSORT statement items, but most have been adapted, some removed, and new items added. The new items cover how participants were identified and consent obtained; if applicable, the prespecified criteria used to judge whether or how to proceed with a future definitive RCT; if relevant, other important unintended consequences; implications for progression from pilot to future definitive RCT, including any proposed amendments; and ethical approval or approval by a research review committee confirmed with a reference number. This article includes the 26 item checklist, a separate checklist for the abstract, a template for a CONSORT flowchart for these studies, and an explanation of the changes made and supporting examples. We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials. Editor’s note: In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites. Electronic supplementary material The online version of this article (doi:10.1186/s40814-016-0105-8) contains supplementary material, which is available to authorized users.
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              A systematic review and meta-analysis of the psychosis continuum: evidence for a psychosis proneness-persistence-impairment model of psychotic disorder.

              A systematic review of all reported incidence and prevalence studies of population rates of subclinical psychotic experiences reveals a median prevalence rate of around 5% and a median incidence rate of around 3%. A meta-analysis of risk factors reveals associations with developmental stage, child and adult social adversity, psychoactive drug use, and also male sex and migrant status. The small difference between prevalence and incidence rates, together with data from follow-up studies, indicates that approximately 75-90% of developmental psychotic experiences are transitory and disappear over time. There is evidence, however, that transitory developmental expression of psychosis (psychosis proneness) may become abnormally persistent (persistence) and subsequently clinically relevant (impairment), depending on the degree of environmental risk the person is additionally exposed to. The psychosis proneness-persistence-impairment model considers genetic background factors impacting on a broadly distributed and transitory population expression of psychosis during development, poor prognosis of which, in terms of persistence and clinical need, is predicted by environmental exposure interacting with genetic risk.
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                Author and article information

                Contributors
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                Journal
                Pflege
                Pflege
                Hogrefe Publishing Group
                1012-5302
                1664-283X
                October 16 2023
                Affiliations
                [1 ] Departement Gesundheit, Berner Fachhochschule, Schweiz
                [2 ] Universitäre Psychiatrische Dienste UPD, Universitätsklinik für Psychiatrie und Psychotherapie, Bern, Schweiz
                [3 ] Vinzenz-Pallotti University, Vallendar, Deutschland
                [4 ] EFC-Institut, Kropp, Deutschland
                [5 ] Universitäre Psychiatrische Dienste UPD, Zentrum Psychiatrische Rehabilitation, Bern, Schweiz
                [6 ] Universität Koblenz, Deutschland
                Article
                10.1024/1012-5302/a000962
                8f4db10f-4c5e-47a5-84a8-9e9f7533b34d
                © 2023
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