This is a repository copy of International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials: recommendations of the SISAQOL Consortium.

Although patient-reported outcomes (PROs), such as health-related quality of life, are important endpoints in randomised controlled trials (RCTs), there is little consensus about the analysis, interpretation, and reporting of these data. We did a systematic review to assess the variability, quality, and standards of PRO data analyses in advanced breast cancer RCTs. We searched PubMed for English language articles published in peer-reviewed journals between Jan 1, 2001, and Oct 30, 2017. Eligible articles were those that reported PRO results from RCTs of adult patients with advanced breast cancer receiving anti-cancer treatments with reported sample sizes of at least 50 patients-66 RCTs met the selection criteria. Only eight (12%) RCTs reported a specific PRO research hypothesis. Heterogeneity in the statistical methods used to assess PRO data was observed, with a mixture of longitudinal and cross-sectional techniques. Not all articles addressed the problem of multiple testing. Fewer than half of RCTs (28 [42%]) reported the clinical significance of their findings. 48 (73%) did not report how missing data were handled. Our systematic review shows a need to improve standards in the analysis, interpretation, and reporting of PRO data in cancer RCTs. Lack of standardisation makes it difficult to draw robust conclusions and compare findings across trials. The Setting International Standards in the Analyzing Patient-Reported Outcomes and Quality of Life Data Consortium was set up to address this need and develop recommendations on the analysis of PRO data in RCTs.

analyzed. Completion rates across EORTC-QLQ-C30 items were high (92.2%-94.6% overall rate of non-missing values). Large variation across countries have been observed in mean scores on functional scores as well as symptom scales. Eastern vs Western Europe contrasted sharply, with Serbia and Poland reporting lower functional and much higher symptom scores for fatigue, nausea and vomiting, pain and insomnia. Mean mapped utility scores and standard deviations (SD) were 0.72 (0.17) for Eastern Europe, with 0.72 (0.20), 0.81 (0.13), 0.73 (0.16) and 0.66 (0.17) for CY/H/ P/RS respectively and 0.77 (SD=0.17) for Western Europe countries with 0.76 (0.17), 0.83 (0.12), 0.78 (0.17) and 0.78 (0.19) for BE/ES/NL/UK respectively. Conclusions: mCRC has important detrimental effect on HRQoL, and even more so among real-world mCRC patients than those participating in clinical trials. Variations across countries and compared to trials require further analysis.

Multi-agency working (MAW) has increasingly been considered a promising approach to preventing violent radicalisation, allowing early and effective identification of individuals who may be at risk of violent radicalisation, and breaking down historical silos between agencies. This article provides an overview of the MAW approaches in the context of violent radicalisation in three countries: Belgium, the Netherlands and Germany. Although these countries are neighbouring, the MAW approach is very different in each, in terms of legislation (e.g., on information sharing), structure (e.g., level of organisation, key actors), procedures (e.g., case management) and goals (e.g., target groups, role and function). There does not seem to be one general MAW approach in the field. This article identifies the goals, partnership, governance, information sharing, and other issues that can strengthen local MAW approaches. Through the ‘Evaluation and Mentoring of the Multi-Agency approach to violent radicalisation’ (EMMA) project, the question ‘What works under what conditions?’ will be assessed in each country by means of a realist process evaluation. As part of the project, a practical self-evaluation tool is being developed for local officials that will be widely applicable across different MAW approaches in Europe.