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      How do dementia researchers view support tools for informed consent procedures of persons with dementia? Translated title: Wie bewerten Demenzforscher:innen Entscheidungsassistenz für die informierte Einwilligung zur Forschungsteilnahme von Menschen mit Demenz?


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          The study aimed to assess how dementia researchers view eight support tools that have been defined to enhance informed consent (IC) procedures for people with dementia (PwD). In an online survey, 19 dementia researchers from Germany and Portugal evaluated the tools in terms of 4 implementation criteria. Overall, they all had a very positive attitude towards the support tools, whereby the tools person-centered attitude of the researcher and elaborated plain language were the most highly rated of the eight tools. Our findings also indicated that familiar support tools were assessed more favorably than those that were previously unknown. Overall, the results of this study showed that the participating dementia researchers were open to the use of decision support measures in PwD and were willing to apply the support tools in practice.

          Translated abstract

          Diese Studie zielte darauf ab, die Meinungen von Demenzforscher:innen zu 8 Entscheidungsassistenz-Tools zu erfragen, die zur Verbesserung der informierten Einwilligung für Menschen mit Demenz (MmD) definiert wurden. In einer Onlineumfrage bewerteten 19 Demenzforscher:innen aus Deutschland und Portugal die Tools hinsichtlich 4 Implementationskriterien. Insgesamt zeigten alle Befragten eine sehr positive Einstellung gegenüber den Entscheidungsassistenz-Tools. Die Tools „person-centered attitude of the researcher“ und „elaborated plain language“ wurden am positivsten bewertet. Die Ergebnisse deuten darauf hin, dass bereits bekannte Entscheidungsassistenz-Tools positiver bewertet werden als solche, die bislang unbekannt waren. Insgesamt zeigten die Ergebnisse dieser Studie, dass die teilnehmenden Demenzforscher:innen offen waren für die Nutzung von Entscheidungsassistenz-Tools und bereit waren, diese in ihrer eigenen Forschungspraxis einzusetzen.

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          Outcomes for Implementation Research: Conceptual Distinctions, Measurement Challenges, and Research Agenda

          An unresolved issue in the field of implementation research is how to conceptualize and evaluate successful implementation. This paper advances the concept of “implementation outcomes” distinct from service system and clinical treatment outcomes. This paper proposes a heuristic, working “taxonomy” of eight conceptually distinct implementation outcomes—acceptability, adoption, appropriateness, feasibility, fidelity, implementation cost, penetration, and sustainability—along with their nominal definitions. We propose a two-pronged agenda for research on implementation outcomes. Conceptualizing and measuring implementation outcomes will advance understanding of implementation processes, enhance efficiency in implementation research, and pave the way for studies of the comparative effectiveness of implementation strategies.
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            Psychometric assessment of three newly developed implementation outcome measures

            Background Implementation outcome measures are essential for monitoring and evaluating the success of implementation efforts. Yet, currently available measures lack conceptual clarity and have largely unknown reliability and validity. This study developed and psychometrically assessed three new measures: the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). Methods Thirty-six implementation scientists and 27 mental health professionals assigned 31 items to the constructs and rated their confidence in their assignments. The Wilcoxon one-sample signed rank test was used to assess substantive and discriminant content validity. Exploratory and confirmatory factor analysis (EFA and CFA) and Cronbach alphas were used to assess the validity of the conceptual model. Three hundred twenty-six mental health counselors read one of six randomly assigned vignettes depicting a therapist contemplating adopting an evidence-based practice (EBP). Participants used 15 items to rate the therapist’s perceptions of the acceptability, appropriateness, and feasibility of adopting the EBP. CFA and Cronbach alphas were used to refine the scales, assess structural validity, and assess reliability. Analysis of variance (ANOVA) was used to assess known-groups validity. Finally, half of the counselors were randomly assigned to receive the same vignette and the other half the opposite vignette; and all were asked to re-rate acceptability, appropriateness, and feasibility. Pearson correlation coefficients were used to assess test-retest reliability and linear regression to assess sensitivity to change. Results All but five items exhibited substantive and discriminant content validity. A trimmed CFA with five items per construct exhibited acceptable model fit (CFI = 0.98, RMSEA = 0.08) and high factor loadings (0.79 to 0.94). The alphas for 5-item scales were between 0.87 and 0.89. Scale refinement based on measure-specific CFAs and Cronbach alphas using vignette data produced 4-item scales (α’s from 0.85 to 0.91). A three-factor CFA exhibited acceptable fit (CFI = 0.96, RMSEA = 0.08) and high factor loadings (0.75 to 0.89), indicating structural validity. ANOVA showed significant main effects, indicating known-groups validity. Test-retest reliability coefficients ranged from 0.73 to 0.88. Regression analysis indicated each measure was sensitive to change in both directions. Conclusions The AIM, IAM, and FIM demonstrate promising psychometric properties. Predictive validity assessment is planned. Electronic supplementary material The online version of this article (doi:10.1186/s13012-017-0635-3) contains supplementary material, which is available to authorized users.
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              Comparison of two enhanced consent procedures for patients with mild Alzheimer disease or mild cognitive impairment.

              The objective of this study was to evaluate the feasibility, acceptability, and preliminary efficacy of two enhanced consent procedures provided to patients with Alzheimer disease or mild cognitive impairment that used either a PowerPoint presentation or an enhanced printed consent form. Patients randomly assigned to an enhanced written consent procedure or slideshow presentation were assessed with the MacArthur Competence Assessment Tool for Clinical Research. Verbal reexplanation was associated with improved understanding in both conditions. Level of understanding did not significantly differ between the two consent groups, but administration time for slideshow presentation was less than that for an enhanced written consent procedure. Enhanced consent procedures are feasible and useful for consent to research among patients with mild cognitive impairment or mild Alzheimer disease.

                Author and article information

                Z Gerontol Geriatr
                Z Gerontol Geriatr
                Zeitschrift Fur Gerontologie Und Geriatrie
                Springer Medizin (Heidelberg )
                19 September 2020
                19 September 2020
                : 54
                : 7
                : 667-675
                [1 ]GRID grid.5836.8, ISNI 0000 0001 2242 8751, Psychological Aging Research (PAR), Faculty II—Education, Architecture, Arts, , University of Siegen, ; Adolf-Reichwein-Str. 2a, 57068 Siegen, Germany
                [2 ]GRID grid.7839.5, ISNI 0000 0004 1936 9721, Interdisciplinary Ageing Research (IAW), , Goethe University Frankfurt, ; Frankfurt, Germany
                [3 ]GRID grid.7839.5, ISNI 0000 0004 1936 9721, Institute of General Practice in Frankfurt am Main, , Goethe University Frankfurt, ; Frankfurt, Germany
                © The Author(s) 2020

                Open Access. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

                : 30 May 2020
                : 19 August 2020
                Funded by: Universität Siegen (3162)
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                © Springer Medizin Verlag GmbH, ein Teil von Springer Nature 2021

                dementia research,informed consent,mental capacity,supported decision-making,demenzforschung,informierte einwilligung,geistige leistungsfähigkeit,entscheidungsassistenz


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