Background. Fibromyalgia (FMS) is a challenging condition for health care systems worldwide. Only limited trial data is available for FMS for outcomes of complex treatment interventions of complementary and integrative (CIM) approaches. Methods. We conducted a controlled, nonrandomized feasibility study that compared outcomes in 21 patients treated with Ayurveda with those of 11 patients treated with a conventional approach at the end of a two-week inpatient hospital stay. Primary outcome was the impact of fibromyalgia on patients as assessed by the FIQ. Secondary outcomes included scores of pain intensity, pain perception, depression, anxiety, and quality of sleep. Follow-up assessments were done after 6 months. Results. At 2 weeks, there were comparable and significant improvements in the FIQ and for most of secondary outcomes in both groups with no significant in-between-group differences. The beneficial effects for both treatment groups were partly maintained for the main outcome and a number of secondary outcomes at the 6-month followup, again with no significant in-between-group differences. Discussion. The findings of this feasibility study suggest that Ayurvedic therapy is noninferior to conventional treatment in patients with severe FMS. Since Ayurveda was only used as add-on treatment, RCTs on Ayurveda alone are warranted to increase model validity. This trial is registered with NCT01389336.
Abstract. The site selection procedure is participatory and citizens are to be involved as “co-designers of the procedure” (§ 5 (1) 2 StandAG). This is an understanding of participation that goes beyond information and consultation. Although participation is differently defined in participation research, there is agreement that participation – especially in this context – goes beyond formal public participation, as is customary in approval procedures in the context of commenting procedures, and includes forms of informal public participation (cf. Mbah, 2017). Further innovative forms of public participation are needed in which concepts – for participation, for learning, for reversibility, etc. – can be (further) developed. Paragraph 5 (3) stipulates a further development of the participation procedure with the public. On the one hand, this provides framework conditions and, on the other hand, opens up a scope for design, which must be designed together with different groups of actors. This requirement was formulated both before and within the framework of the sub-areas conference (cf. Brohmann et al., 2021; Ewer and Thienel, 2019; Kuhbier, 2020; NBG, 2019, 2021). Therefore, we would like to address the following research questions: What does “learning” mean in the German Site Selection Act (StandAG 2017, § 1 (2)) and how can it be governed and implemented? Who learns and under which conditions? What are the requirements and possibilities of participation and what limitations can be derived in this context? Knowledge and information are the basis of all decision-making processes. Learning is part of a reflexive information exchange and essential for creating, transferring, and readjusting knowledge. In this respect, learning and reflexion means at least a two-way process, often multiple ways and loops. Therefore, we would like to focus on reflexive learning processes, so called double-loop learning processes (Argyris, 1977; Argyris and Schön, 1978) that consider that there should be responsive paths of knowledge transfer to generate learning through reflexion. Such reflexive learning processes may take part at different levels; individual, collective (groups, e.g. departments in an organisation), organisational, and between organisations and indirectly involved or responsible (individual and collective) actors must learn. The reflexive learning processes go beyond strategies and techniques to reach a certain goal but scrutinise certain attitudes and may lead to changes in normative values and belief systems. This is not or if at all, only to a certain extent an automatic process. Rather for systematic learning and reflexion spaces and formats are needed as well as different methods of knowledge and information transfer – mainly if it comes to the requirements of participative formats. These methods and formats as well as spaces need to be adjusted to context and time, which means that e.g. different actors need to be differently addressed and the back-bonding into the organisation and institutional routines must be considered. For this, contextual knowledge and collaboration is crucial. Participatory and transdisciplinary approaches are important key concepts which need to be filled in with actions to initiate and further develop learning processes – as understood and demanded by the StandAG and the selected literature. We give insights into findings based on literature reviews, jurisdictional analysis of the StandAG, several interviews with different actors of the procedure and with experts of different topics (regional planning, place attachment, psychology). In summary, we identified challenges for learning and give insights how to overcome or at least process them.
Abstract. Public participation in the German site selection procedure is not only novel compared to previous sectoral legal regulations, but also significantly more complex. In addition to the usual participation in commenting procedures and discussion meetings (Section 7 of the German Repository Site Selection Act, Standortauswahlgesetz, StandAG), there are new formats for formal participation, such as regional conferences (Section 10 para. 2 sentence 2 StandAG). Informal participation (see Section 5 (3) StandAG) is also planned. In view of the numerous countries neighbouring Germany, the article concentrates on the question of the extent to which the non-German public is also to be involved in this process. The legal regulations are open to interpretation, and their requirements with regard to the non-German public are also largely unresolved in the literature. However, clarification is needed since these are mandatory formats and the German Federal Office for the Safety of Nuclear Waste Management (Bundesamt für die Sicherheit der nuklearen Entsorgung, BASE) is responsible for ensuring compliance with these formats; moreover, complaints can be filed for non-compliance with the mandatory requirements. With regard to participation in commenting procedures and discussion meetings, the relationship between Section 7 StandAG and the requirements for cross-border participation in Sections 54 ff., 61 f. UVPG need to be clarified. This is due to the fact that Section 7 StandAG makes no provision for any restriction on the “public” to be involved, whereas under the German Environmental Impacts Assessment Act (Gesetz über die Umweltverträglichkeitsprüfung, UVPG), participation is in part made dependent on “being affected”. The solution here is to seek that all people (in the world) are allowed in principle to participate. However, the facilitations specifically provided for only in the UVPG (e.g. translations) can be limited to certain states (or languages). For the regional conferences, provision is explicitly made in Section 10 para. 2 sentence 2 StandAG for the participation of the non-German public (“shall be given equal consideration”): If the siting region is in a border area, non-German citizens are to participate in the plenary meeting and are given equal consideration to those of the German regional authorities (bordering the siting region). However, the regional section, the concrete administrative entity, is not defined. Here, according to the researchers, the criterion of equivalence can be taken into account by selecting a geographical section that corresponds in its maximum extent to the largest German territorial community that borders on the siting region. The law also does not specify any further prerequisites for the appointment of the deputizing body and its important tasks. Here again, the requirement of “equal consideration” can be taken into account. The procedural rules must at least allow for the eligibility of non-German citizens for election (if necessary by means of proportional representation). Also of great relevance is the inclusion of non-German citizens in informal forms of participation. Complementary forms of participation are planned in order to further develop “the procedure of public participation”. The principles of public participation do not differentiate between the German and non-German citizens to be involved. Moreover, if the legislature establishes the obligation to involve the non-German public in the case of siting regions in a border area, this must, according to the researchers, also apply to the complementary, informal forms: the principle of equivalence produces a “ripple effect” here. Otherwise, a “gap” in information and participation could arise in a siting region in a border area: “complementarily” integrated citizens, political decision-makers and environmental associations on the German side, as well as their non-German counterparts on the other side, that do not have the same degree of information and integration. The contents of the presentation were developed as part of the research project “Herausforderungen und Erfolgsfaktoren bei grenzüberschreitender Öffentlichkeitsbeteiligung im Standortauswahlverfahren – HErüber” (challenges and success factors in cross-border public participation in the site selection procedure) on behalf of the BASE.
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