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- Witjes, J. Alfred, et al.
(författare)
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EAU-ESMO Consensus Statements on the Management of Advanced and Variant Bladder Cancer – An International Collaborative Multistakeholder Effort : Under the Auspices of the EAU-ESMO Guidelines Committees
- 2020
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Ingår i: European Urology. - : Elsevier. - 0302-2838 .- 1873-7560. ; 77:2, s. 223-250
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Although guidelines exist for advanced and variant bladder cancer management, evidence is limited/conflicting in some areas and the optimal approach remains controversial.OBJECTIVE: To bring together a large multidisciplinary group of experts to develop consensus statements on controversial topics in bladder cancer management.DESIGN: A steering committee compiled proposed statements regarding advanced and variant bladder cancer management which were assessed by 113 experts in a Delphi survey. Statements not reaching consensus were reviewed; those prioritised were revised by a panel of 45 experts prior to voting during a consensus conference.SETTING: Online Delphi survey and consensus conference.PARTICIPANTS: The European Association of Urology (EAU), the European Society for Medical Oncology (ESMO), experts in bladder cancer management.OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Statements were ranked by experts according to their level of agreement: 1-3 (disagree), 4-6 (equivocal), and 7-9 (agree). A priori (level 1) consensus was defined as ≥70% agreement and ≤15% disagreement, or vice versa. In the Delphi survey, a second analysis was restricted to stakeholder group(s) considered to have adequate expertise relating to each statement (to achieve level 2 consensus).RESULTS AND LIMITATIONS: Overall, 116 statements were included in the Delphi survey. Of these statements, 33 (28%) achieved level 1 consensus and 49 (42%) achieved level 1 or 2 consensus. At the consensus conference, 22 of 27 (81%) statements achieved consensus. These consensus statements provide further guidance across a broad range of topics, including the management of variant histologies, the role/limitations of prognostic biomarkers in clinical decision making, bladder preservation strategies, modern radiotherapy techniques, the management of oligometastatic disease, and the evolving role of checkpoint inhibitor therapy in metastatic disease.CONCLUSIONS: These consensus statements provide further guidance on controversial topics in advanced and variant bladder cancer management until a time when further evidence is available to guide our approach.PATIENT SUMMARY: This report summarises findings from an international, multistakeholder project organised by the EAU and ESMO. In this project, a steering committee identified areas of bladder cancer management where there is currently no good-quality evidence to guide treatment decisions. From this, they developed a series of proposed statements, 71 of which achieved consensus by a large group of experts in the field of bladder cancer. It is anticipated that these statements will provide further guidance to health care professionals and could help improve patient outcomes until a time when good-quality evidence is available.
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| 2. |
- Elinder, Liselotte Schäfer, et al.
(författare)
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IMplementation and evaluation of the school-based family support PRogram a Healthy School Start to promote child health and prevent OVErweight and obesity (IMPROVE) - study protocol for a cluster-randomized trial.
- 2021
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Ingår i: BMC Public Health. - : BioMed Central (BMC). - 1471-2458. ; 21:1
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: IMPROVE aims to conduct a hybrid type 3 evaluation design to test the effectiveness of bundled implementation strategies on intervention fidelity of the Healthy School Start (HSS) program, while simultaneously monitoring effects on health outcomes of children and parents. The HSS is a 4-component family support program for children starting school (5-7 years of age) promoting healthy dietary habits and physical activity in the home environment to prevent childhood obesity and parents' risk of developing type 2 diabetes.METHODS: IMPROVE is a cluster-randomized controlled trial with two arms to evaluate and compare the effects of two different bundles of implementation strategies on intervention fidelity expressed as adherence and responsiveness at 12 and 24 months (primary outcomes). Thirty schools in two municipalities will participate in the study reaching about 1400 families per school year. In stakeholder workshops, key implementation determinants were identified according to the domains of the Consolidated Framework for Implementation Research. Through a consensus process with stakeholders, two bundles of implementation strategies were tailored to address context-specific determinants. Schools randomly assigned to group 1 will receive bundle 1 (Basic) and group 2 will receive bundle 1 + 2 (Enhanced). Bundle 2 consists of external facilitation, fidelity monitoring and feedback strategies. Secondary outcomes will include change in acceptability, appropriateness, feasibility, and organisational readiness as perceived by school staff. In addition, child weight status and diet, and parents' feeding practices and risk of type 2 diabetes will be monitored. Linear and ordinal regression analysis will be used to test the effect on the primary and secondary outcomes, taking clustering and covariates into consideration where needed. Process evaluation will be conducted through key stakeholder interviews to investigate experiences of the program and perceptions on sustainability.DISCUSSION: This systematic approach to investigating the effectiveness of two different bundles of implementation strategies tailored to context-specific determinants on the fidelity of the HSS intervention will provide new insight into feasible implementation strategies and external support needed for the HSS to be effective and sustainable. Results will help inform how to bridge the gap between the research on school-based health programs and routine practice in schools.TRIAL REGISTRATION: Registered prospectively at ClinicalTrials.gov ID: NCT04984421 , registered July 30, 2021.
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