Implementation of PROMETHEUS 4‐step approach for evidence use in EFSA scientific assessments: benefits, issues, needs and solutions
Aiassa, Elisa ; Martino, Laura ; Barizzone, Fulvio ; Ciccolallo, Laura ; Garcia, Ana ; Georgiadis, Marios ; Guajardo, Irene Muñoz ; Tomcikova, Daniela ; Alexander, Jan ; Calistri, Paolo ; Gundert‐remy, Ursula ; Hart, Andrew David ; Hoogenboom, Ron Laurentius ; Messean, Antoine ; Naska, Androniki ; Navarro, Maria Navajas ; Noerrung, Birgit ; Ockleford, Colin ; Wallace, Robert John ; Younes, Maged ; Abuntori, Blaize ; Alvarez, Fernando ; Aryeetey, Monica ; Baldinelli, Francesca ; Barrucci, Federica ; Bau, Andrea ; Binaglia, Marco ; Broglia, Alessandro ; Castoldi, Anna Federica ; Christoph, Eugen ; Sesmaisons‐Lecarré, Agnes De; Georgiadis, Nikolaos ; Gervelmeyer, Andrea ; Istace, Frederique ; López‐Gálvez, Gloria ; Manini, Paola ; Maurici, Daniela ; Merten, Caroline ; Messens, Winy ; Mosbach‐Schulz, Olaf ; Putzu, Claudio ; Bordajandi, Luisa Ramos ; Smeraldi, Camilla ; Tiramani, Manuela ; Martínez, Silvia Valtueña ; Sybren, Vos ; Hardy, Anthony Richard ; Hugas, Marta ; Kleiner, Juliane ; Seze, Guilhem De - \ 2018
EFSA Supporting Publications 15 (2018)4. - ISSN 2397-8325
In 2014, the European Food Safety Authority (EFSA) started the PROMETHEUS (PROmoting METHods for Evidence Use in Scientific assessments) project to improve further and increase the consistency of the methods it uses in its scientific assessments. The project defined a set of principles for the scientific assessment process and a 4‐step approach (plan/carry out/verify/report) for their fulfilment, which was tested in ten case studies, one from each EFSA panel. The present report describes the benefits, issues, needs and solutions related to the implementation of the 4‐step approach in EFSA, identified in a dedicated workshop in October 2017. The key benefits of the approach, which was deemed applicable to all types of EFSA scientific assessment including assessments of regulated products, are: 1) increased ‘scientific value’ of EFSA outputs, i.e. the extent of impartiality, methodological rigour, transparency and engagement; 2) guarantee of fitness‐for‐purpose, as it implies tailoring the methods to the specificities of each assessment; 3) efficiency gain, since preparing a protocol for the assessment upfront helps more streamlined processes throughout the implementation phase; 4) innovation, as the approach promotes the pioneering practice of ‘planning before doing’ (well established in primary research) for broad scientific assessments in regulatory science; and 5) increased harmonisation and consistency of EFSA assessments. The 4‐step approach was also considered an effective system for detecting additional methodological and/or expertise needs and a useful basis for further defining a quality management system for EFSA's scientific processes. The identified issues and solutions related to the implementation of the approach are: a) lack of engagement and need for effective communication on benefits and added value; b) need for further advances especially in the field of problem formulation/protocol development, evidence appraisal and evidence integration; c) need for specialised expertise in the previous aspects; and specific needs for d) assessments of regulated products and e) outsourced projects.
Erratum to: Bias in protein and potassium intake collected with 24-h recalls (EPIC-Soft) is rather comparable across European populations
Crispim, Sandra P. ; Geelen, Anouk ; Vries, Jeanne H.M. De; Freisling, Heinz ; Souverein, Olga W. ; Hulshof, Paul J.M. ; Ocke, Marga C. ; Boshuizen, Hendriek ; Andersen, Lene F. ; Ruprich, Jiri ; Keyzer, Willem De; Huybrechts, Inge ; Lafay, Lionel ; Magistris, Maria S. De; Ricceri, Fulvio ; Tumino, Rosario ; Krogh, Vittorio ; Bueno-De-Mesquita, H.B. ; Beulens, Joline W.J. ; Boutron-Ruault, Marie Christine ; Naska, Androniki ; Crowe, Francesca L. ; Boeing, Heiner ; McTaggart, Alison ; Kaaks, Rudolf ; Veer, Pieter van 't; Slimani, Nadia - \ 2013
European Journal of Nutrition 52 (2013)2. - ISSN 1436-6207 - p. 857 - 858.
Fruit and vegetable consumption and risk of aggressive and non-aggressive urothelial cell carcinomas in the European prospective investigation into cancer and nutrition
Ros, M. ; Bueno-de-Mesquita, H.B. ; Kampman, E. ; Büchner, F.L. ; Aben, K.K. ; Egevad, L. ; Overvad, K. ; Tjonneland, A. ; Roswall, N. ; Clavel-Chapelon, F. ; Boutron-Ruault, M.C. ; Moiros, S. ; Kaaks, R. ; Teucher, B. ; Weikert, S. ; Ruesten, A.V. ; Trichopoulou, A. ; Naska, A. ; Benetou, V. ; Saieva, C. ; Pala, V. ; Ricceri, F. ; Tumino, R. ; Mattiello, A. ; Peeters, P.H.M. ; Gils, C.H. van; Gram, I.T. ; Engeset, D. ; Chirlaque, M.D. ; Ardanazx, E. ; Rodriguez, L. - \ 2012
European Journal of Cancer 48 (2012)17. - ISSN 0959-8049 - p. 3267 - 3277.
bladder-cancer - vitamin-c - prospective cohort - carotenoids - smoking - diet - carcinogenesis - prevention - nutrient - folate
Background - Many epidemiological studies have examined fruit and vegetable consumption in relation to the risk of urothelial cell carcinoma (UCC) of the bladder, but results are inconsistent. The association between fruit and vegetable consumption and UCC risk may vary by bladder tumour aggressiveness. Therefore, we examined the relation between fruit and vegetable consumption and the risk of aggressive and non-aggressive UCC in the European Prospective Investigation into Cancer and Nutrition (EPIC). Methods - After 8.9 years of follow-up, 947 UCC were diagnosed among 468,656 EPIC participants. Of these, 421 could be classified as aggressive UCC and 433 as non-aggressive UCC cases. At recruitment, fruit and vegetable consumption was assessed by validated dietary questionnaires. Multivariable hazard ratios were estimated using Cox regression stratified by age, sex and center and adjusted for smoking status, duration and intensity of smoking, and energy intake. Results - Total consumption of fruits and vegetables was not associated with aggressive UCC nor with non-aggressive UCC. A 25 g/day increase in leafy vegetables and grapes consumption was associated with a reduced risk of non-aggressive UCC (hazard ratio (HR) 0.88; 95% confidence interval (CI) 0.78–1.00 and HR 0.87; 95% CI 0.77–0.98, respectively), while the intake of root vegetables was inversely associated with risk of aggressive UCC (HR 0.87; 95% CI 0.77–0.98). Conclusion - Our study did not confirm a protective effect of total fruit and/or vegetable consumption on aggressive or non-aggressive UCC. High consumption of certain types of vegetables and of fruits may reduce the risk of aggressive or non-aggressive UCC; however chance findings cannot be excluded.
Bias in protein and potassium intake collected with 24-h recalls (EPIC-Soft) is rather comparable across European populations
Crispim, S.P. ; Geelen, A. ; Freisling, H. ; Souverein, O.W. ; Hulshof, P.J.M. ; Ocke, M.C. ; Boshuizen, H.C. ; Andersen, L.F. ; Ruprich, J. ; Keizer, W. de; Huybrechts, I. ; Lafay, L. ; DeMagistris, M.S. ; Ricceri, F. ; Tumino, R. ; Krogh, V. ; Bueono-de-Mesquita, H.B. ; Beulens, J.W.J. ; Boutron-Ruault, M.C. ; Naska, A. ; Crowe, F.L. ; Boeing, H. ; McTaggart, A.R. ; Kaaks, R. ; Veer, P. van 't; Slimani, N. - \ 2012
European Journal of Nutrition 51 (2012)8. - ISSN 1436-6207 - p. 997 - 1010.
consumption validation efcoval - diet recall - urinary nitrogen - nutrition - cancer - calibration - telephone - countries - biomarker - centers
Purpose: We investigated whether group-level bias of a 24-h recall estimate of protein and potassium intake, as compared to biomarkers, varied across European centers and whether this was influenced by characteristics of individuals or centers. Methods: The combined data from EFCOVAL and EPIC studies included 14 centers from 9 countries (n = 1,841). Dietary data were collected using a computerized 24-h recall (EPIC-Soft). Nitrogen and potassium in 24-h urine collections were used as reference method. Multilevel linear regression analysis was performed, including individual-level (e.g., BMI) and center-level (e.g., food pattern index) variables. Results: For protein intake, no between-center variation in bias was observed in men while it was 5.7% in women. For potassium intake, the between-center variation in bias was 8.9% in men and null in women. BMI was an important factor influencing the biases across centers (p <0.01 in all analyses). In addition, mode of administration (p = 0.06 in women) and day of the week (p = 0.03 in men and p = 0.06 in women) may have influenced the bias in protein intake across centers. After inclusion of these individual variables, between-center variation in bias in protein intake disappeared for women, whereas for potassium, it increased slightly in men (to 9.5%). Center-level variables did not influence the results. Conclusion: The results suggest that group-level bias in protein and potassium (for women) collected with 24-h recalls does not vary across centers and to a certain extent varies for potassium in men. BMI and study design aspects, rather than center-level characteristics, affected the biases across centers