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Evidence is low regarding the choice of calcineurin inhibitor for immunosuppression after lung transplantation. We aimed to compare the use of tacrolimus once per day with ciclosporin twice per day according to the current definition of chronic lung allograft dysfunction (CLAD) after lung transplantation. ScanCLAD is an investigator-initiated, open-label, multicentre, randomised, controlled trial in Scandinavia evaluating whether an immunosuppressive protocol based on anti-thymocyte globulin induction followed by tacrolimus (once per day), mycophenolate mofetil, and corticosteroids reduces the incidence of CLAD after de novo lung transplantation compared with a protocol using ciclosporin (twice per day), mycophenolate mofetil, and corticosteroids. Patients aged 18–70 years who were scheduled to undergo double lung transplantation were randomly allocated (1:1) to receive either oral ciclosporin (2–3 mg/kg before transplantation and 3 mg/kg [twice per day] from postoperative day 1) or oral tacrolimus (0·05–0·1 mg/kg before transplantation and 0·1–0·2 mg/kg from postoperative day 1). The primary endpoint was CLAD at 36 months post transplantation, determined by repeated lung function tests and adjudicated by an independent committee, and was assessed with a competing-risks analysis with death and re-transplantation as competing events. The primary outcome was assessed in the modified intention-to-treat (mITT) population, defined as those who underwent transplantation and received at least one dose of study drug. This study is registered at ClinicalTrials.gov (NCT02936505) and EudraCT (2015-004137-27). Between Oct 21, 2016, and July 10, 2019, 383 patients were screened for eligibility. 249 patients underwent double lung transplantation and received at least one dose of study drug, and were thus included in the mITT population: 125 (50%) in the ciclosporin group and 124 (50%) in the tacrolimus group. The mITT population consisted of 138 (55%) men and 111 (45%) women, with a mean age of 55·2 years (SD 10·2), and no patients were lost to follow-up. In the mITT population, CLAD occurred in 48 patients (cumulative incidence 39% [95% CI 31–48]) in the ciclosporin group and 16 patients (13% [8–21]) in the tacrolimus group at 36 months post transplantation (hazard ratio [HR] 0·28 [95% CI 0·15–0·52], log-rank p<0·0001). Overall survival did not differ between groups at 3 years in the mITT population (74% [65–81] for ciclosporin vs 79% [70–85] for tacrolimus; HR 0·72 [95% CI 0·41–1·27], log-rank p=0·25). However, in the per protocol CLAD population (those in the mITT population who also had at least one post-baseline lung function test allowing assessment of CLAD), allograft survival was significantly better in the tacrolimus group (HR 0·49 [95% CI 0·26–0·91], log-rank p=0·021). Adverse events totalled 1516 in the ciclosporin group and 1459 in the tacrolimus group. The most frequent adverse events were infection (453 events), acute rejection (165 events), and anaemia (129 events) in the ciclosporin group, and infection (568 events), anaemia (108 events), and acute rejection (98 events) in the tacrolimus group. 112 (90%) patients in the ciclosporin group and 108 (87%) in the tacrolimus group had at least one serious adverse event. Immunosuppression based on use of tacrolimus once per day significantly reduced the incidence of CLAD compared with use of ciclosporin twice per day. These findings support the use of tacrolimus as the first choice of calcineurin inhibitor after lung transplantation. Astellas, the ALF-agreement, Scandiatransplant Organization, and Heart Centre Research Committee, Rigshospitalet, Denmark. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this paper is to examine how students' participation in an integrated school food program was related to the development of components of food and health-related action competence (F & HRAC). These components were understood to be the knowledge, insight, motivation, ownership and social skills that made students able to take action regarding food and health in everyday life. Design/methodology/approach: Research was undertaken as a single case study of the development of an integrated education and health program called LOMA-Local Food (LOMA) in a secondary school in Denmark. Qualitative methods were applied, including an action research component, where researcher and teachers examined how students developed action competence. The program was based on a whole school approach with the aim of improving F & HRAC. As a way to obtain this, students participated in planning, preparing, cooking and serving their own school food as integrated in curriculum. The study applied the Health Promoting Schools' (HPS) conceptual framework and the Investigation, Vision, Action and Change (IVACE) approach. Findings: Students who participated in LOMA educational activities became motivated for developing a food F & HRAC, which included components such as knowledge, insight, motivation, ownership, action experience, commitment, cooperation and critical thinking. Students developed practical skills related to food and health, when they were cooking healthy school food together with professionals and peers. The study also points to the importance of capacity building among teachers. The IVACE matrix is suggested as a relevant tool for monitoring forms of participation that contributes to students' development of F & HRAC. Practical implications: There were indications of how participation in LOMA contributed to students' development of F & HRAC. The practical implication of this is that "setting" is very important for the success of food and health education initiatives. In this integrated approach the production kitchen and the dining hall are indispensable. Also the new organization of the school day and the introduction of a shared daily meal are important practical components for the improvement of the learning environment. The possibility of combining theory and practice seem conducive for students' achievement of action competence. Social implications: The current study is an example of how the IVACE matrix can be applied in order to plan, conduct and evaluate LOMA educational activities, which could be considered as a contribution to the HPS scientific community. It would be useful for other schools that intend to apply the LOMA approach. However, more research is needed, where teachers, students, staff and other stakeholders collaborate in an action research process. This could promote students' health and support other initiatives regarding public health, sustainable development and democracy. Originality/value: This research may have implications for the way that school food programs are developed and implemented if they are to make a contribution to students' development of F & HRAC. Taking the political interest for research-based interventions into account, it is important that future strategies include teachers' capacity building. Research is also needed regarding further development and test of the IVACE matrix as a method in participatory, health education approaches. This should be seen in combination with a renewed focus on integrated curricula models related to the on-going discussion on redesign of western school curricula.