CORESEARCH staff has a huge experience in the design and analysis of randomized clinical trials and observational studies, as well as in analysis of administrative databases and experimental research.

Regarding project design, main activities include:

  • Development or revision of protocols
  • Preparation of statistical analysis plans (SAP)
  • Writing of paragraphs on statistical methods a/o results of scientific articles.

Through the use and development of advanced programs, data analysis and generation of tables, listings and figures according to the required standards is ensured.

The applied statistical techniques include:

  • Sample size computation (e.g. for observational studies or non-inferiority/equivalence/superiority randomized clinical trials)
  • Prediction models and building of risk engines (for creation/validation/comparison of diagnostic tests a/o “scores” able to quantify the strength of the association with the outcome, in terms of calibration, discrimination and reclassification as well)
  • Hierarchical Generalized Linear Models (valid for the analysis of binomial outcome, linear, rare a/o count)
  • Analysis of longitudinal data (for the study of repeated measurements over time)
  • Survival Analysis (e.g. Cox models, Kaplan-Meier curves)
  • Tree-based classification algorithms and Random Forests (for risk stratification and selection/validation/permutation of the factors associated with the outcome in the study, particularly useful for the implementation in routine clinical practice)
  • Advanced methods of meta-analysis and meta-regression (asymptotic or exact, fixed or random effects, dose-response, network meta-analysis for indirect comparisons)
  • Advanced methods in statistics and bioinformatics for biology and genetics (Microarray Data)
  • Bayesian statistics (based on the use of a priori probabilities for the studied effect)
  • PropensitysScore and marginal structural models methodology in observational studies (for the mimicking of randomized experimental designs)
  • Explorative statistics (principal component analysis, factorial analysis, cluster analysis, path analysis)
  • Psychometric validation of questionnaires on quality of life (factor analysis, item-scale correlation, internal consistency reliability, convergent and discriminant validity, criterion validity, test-retest reliability)
  • Accuracy rating of instruments for measuring blood glucose (consensus error grid analysis, Clark error grid analysis, Bland-Altman bias plot, Passing-Bablok regression, MARD)

Bibliography:

  1. Conti F, Balducci S, Pugliese L, D’Errico V, Vitale M, Alessi E, Salerno G, Iacobini C, Menini S, Bollanti L, Nicolucci A, Pugliese G. Correlates of Calcaneal Quantitative Ultrasound Parameters in Patients with Diabetes: The Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes. J Diab Research 2017; 2017: 4749619.
  2. Lamartina L, Durante C, Lucisano G, Grani G, Bellantone RA, Lombardi CP, Pontecorvi A, Arvat E, Felicetti F, Zatelli MC, Rossi R, Puxeddu E, Morelli S, Torlontano M, Crocetti U, Montesano T, Giubbini R, Orlandi F, Aimaretti G, Monzani F, Attard M, Francese C, Antonelli A, Limone PP, Rossetto R, Fugazzola L, Meringolo D, Bruno R, Tumino S, Ceresini G, Centanni M, Monti S, Salvatore D, Mian C, Spiazzi G, Persani L, Barbaro D, Nicolucci A, Filetti S. Are evidence-based guidelines reflected in clinical practice? An analysis of prospectively collected data of the Italian Thyroid Cancer Observatory. Thyroid 2017; 27: 1490-1497.
  3. Grani G, Bruno R, Lucisano G, Costante G, Meringolo D, Puxeddu E, Torlontano M, Tumino S, Attard M, Lamartina L, Nicolucci A, Cooper DS, Filetti S, Durante C. Temporal changes in thyroid nodule volume: lack of effect on paranodular thyroid tissue volume. Thyroid 2017; 27: 1378-1384.
  4. Franzago M, Fraticelli F, Nicolucci A, Celentano C, Liberati M, Stuppia L, Vitacolonna E. Molecular Analysis of a Genetic Variants Panel Related to Nutrients and Metabolism: Association with Susceptibility to Gestational Diabetes and Cardiometabolic Risk in Affected Women. J Diabetes Res. 2017;2017:4612623. doi: 10.1155/2017/4612623. Epub 2017 Jan 4.
  5. Ceriello A, De Cosmo S, Rossi MC, Lucisano G, Genovese S, Pontremoli R, Fioretto P, Giorda C, Pacilli A, Viazzi F, Russo G, Nicolucci A; AMD-Annals Study Group. Variability in HbA1c, blood pressure, lipid parameters and serum uric acid, and risk of development of chronic kidney disease in type 2 diabetes. Diabetes Obes Metab. 2017 Nov;19(11):1570-1578. doi: 10.1111/dom.12976. Epub 2017 Jul 10. PubMed PMID: 28432733.
  6. Quaglietta A, Di Saverio M, Lucisano G, Accorsi P, Nicolucci A. Development of the Platelet Efficacy Score (PEscore) to predict the efficacy of platelet transfusion in oncohematologic patients. Transfusion 2017; 57: 905-912.
  7. Marzona I, Avanzini F, Lucisano G, Tettamanti M, Baviera M, Nicolucci A, Roncaglioni MC; Risk & Prevention Collaborative Group. Are all people with diabetes and cardiovascular risk factors or microvascular complications at very high risk? Findings from the Risk and Prevention Study. Acta Diabetol. 2017 Feb;54(2):123-131.
  8. Robusto F, Lepore V, D’Ettorre A, Lucisano G, De Berardis G, Bisceglia L, Tognoni G, Nicolucci A. The Drug Derived Complexity Index (DDCI) Predicts Mortality, Unplanned Hospitalization and Hospital Readmissions at the Population Level. PLoS One. 2016;11:e0149203.
  9. Holt RI, Nicolucci A, Kovacs Burns K, Lucisano G, Skovlund SE, Forbes A, Kalra S, Menéndez Torre E, Munro N, Peyrot M. Correlates of psychological care strategies for people with diabetes in the second Diabetes Attitudes, Wishes and Needs (DAWN2(™) ) study. Diabet Med. 2016 Mar 4.
  10. Durante C, Costante G, Lucisano G, Bruno R, Meringolo D, Paciaroni A, Puxeddu E, Torlontano M, Tumino S, Attard M, Lamartina L, Nicolucci A, Filetti S. The natural history of benign thyroid nodules. JAMA. 2015;313:926-35.
  11. Pintaudi B, Lucisano G, Pellegrini F, D’Ettorre A, Lepore V, De Berardis G, Scardapane M, Di Vieste G, Rossi MC, Sacco M, Tognoni G, Nicolucci A. The long-term effects of stillbirth on women with and without gestational diabetes: a population-based cohort study. Diabetologia. 2015;58:67-74.
  12. Porcu G, Serone E, De Nardis V, Di Giandomenico D, Lucisano G, Scardapane M, Poma A, Ragnini-Wilson A. Clobetasol and Halcinonide Act as Smoothened Agonists to Promote Myelin Gene Expression and RxRγ Receptor Activation. PLoS One. 2015;10:e0144550.
  13. Valentini M, Scardapane M, Bondanini F, Bossi A, Colatrella A, Girelli A, Ciucci A, Leotta S, Minotti E, Pasotti F, Pesenti A, Rocca L, Sciangula L, Vavassori E, Nicolucci A. Efficacy, safety and acceptability of the new pen needle 33G × 4 mm. AGO 01 study. Curr Med Res Opin. 2015;31:487-92.
  14. Pintaudi B, Lucisano G, Gentile S, Bulotta A, Skovlund SE, Vespasiani G, Rossi MC, Nicolucci A; BENCH-D Study Group. Correlates of diabetes-related distress in type 2 diabetes: Findings from the benchmarking network for clinical and humanistic outcomes in diabetes (BENCH-D) study. J Psychosom Res. 2015;79:348-54.
  15. Rossi MC, Lucisano G, Funnell M, Pintaudi B, Bulotta A, Gentile S, Scardapane M, Skovlund SE, Vespasiani G, Nicolucci A; BENCH-D Study Group. Interplay among patient empowerment and clinical and person-centered outcomes in type 2 diabetes. The BENCH-D study. Patient Educ Couns. 2015;98:1142-9.
  16. Rossi MC, Candido R, Ceriello A, Cimino A, Di Bartolo P, Giorda C, Esposito K, Lucisano G, Maggini M, Mannucci E, Meloncelli I, Nicolucci A, Pellegrini F, Scardapane M, Vespasiani G. Trends over 8 years in quality of diabetes care: results of the AMD Annals continuous quality improvement initiative. Acta Diabetol. 2015;52:557-71.
  17. Forte G, Grossi V, Celestini V, Lucisano G, Scardapane M, Varvara D, Patruno M, Bagnulo R, Loconte D, Giunti L, Petracca A, Giglio S, Genuardi M, Pellegrini F, Resta N, Simone C. Characterization of the rs2802292 SNP identifies FOXO3A as a modifier locus predicting cancer risk in patients with PJS and PHTS hamartomatous polyposis syndromes. BMC Cancer. 2014;14:661.
  18. Porcu G, Parsons AB, Di Giandomenico D, Lucisano G, Mosca MG, Boone C, Ragnini-Wilson A. Combined p21-activated kinase and farnesyltransferase inhibitor treatment exhibits enhanced anti-proliferative activity on melanoma, colon and lung cancer cell lines. Mol Cancer. 2013 Aug 6;
  19. Rossi MC, Cristofaro MR, Gentile S, Lucisano G, Manicardi V, Mulas MF, Napoli A, Nicolucci A, Pellegrini F, Suraci C, Giorda C; on behalf of the AMD Annals Study Group. Sex Disparities in the Quality of Diabetes Care: Biological and Cultural Factors May Play a Different Role for Different Outcomes: A cross-sectional observational study from the AMD Annals initiative. Diabetes Care. Diabetes Care. 2013;36:3162-8.
  20. Rossi MC, Nicolucci A, Lucisano G, Pellegrini F, Di Bartolo P, Miselli V, Anichini R, Vespasiani G; DID Study Group. Impact of the “Diabetes Interactive Diary” telemedicine system on metabolic control, risk of hypoglycemia, and quality of life: a randomized clinical trial in type 1 diabetes. Diabetes Technol Ther. 2013;15:670-9.
  21. Buscemi S, Nicolucci A, Mattina A, Rosafio G, Massenti FM, Lucisano G, Galvano F, Amodio E, Pellegrini F, Barile AM, Maniaci V, Grosso G, Verga S, Sprini D, Rini GB. Association of dietary patterns with insulin resistance and clinically silent carotid atherosclerosis in apparently healthy people. Eur J Clin Nutr. 2013;67:1284-90.
  22. Copetti M, Fontana A, Graziano G, Veneziani F, Siena F, Scardapane M, Lucisano G, Pellegrini F. Advances in meta-analysis: examples from internal medicine to neurology. Neuroepidemiology. 2014;42:59-67.
  23. Franciosi M, Lucisano G, Lapice E, Strippoli GF, Pellegrini F, Nicolucci A. Metformin therapy and risk of cancer in patients with type 2 diabetes: systematic review. PLoS One. 2013;8:e71583.
  24. De Berardis G, Lucisano G, D’Ettorre A, Pellegrini F, Lepore V, Tognoni G, Nicolucci A. Association of aspirin use with major bleeding in patients with and without diabetes. JAMA. 2012;307:2286-94.
  25. De Berardis G, D’Ettorre A, Graziano G, Lucisano G, Pellegrini F, Cammarota S, Citarella A, Germinario CA, Lepore V, Menditto E, Nicolosi A, Vitullo F, Nicolucci A; DADA (Diabetes Administrative Data Analysis) Study Group. The burden of hospitalization related to diabetes mellitus: a population-based study. Nutr Metab Cardiovasc Dis. 2012;22:605-12.
  26. Rossi MC, Lucisano G, Comaschi M, Coscelli C, Cucinotta D, Di Blasi P, Bader G, Pellegrini F, Valentini U, Vespasiani G, Nicolucci A; AMD-QUASAR Study Group. Quality of diabetes care predicts the development of cardiovascular events: results of the AMD-QUASAR study. Diabetes Care. 2011;34:347-52.
  27. Franciosi M, Lucisano G, Pellegrini F, Cantarello A, Consoli A, Cucco L, Ghidelli R, Sartore G, Sciangula L, Nicolucci A; ROSES Study Group. ROSES: role of self-monitoring of blood glucose and intensive education in patients with Type 2 diabetes not receiving insulin. A pilot randomized clinical trial. Diabet Med. 2011;28:789-96.
  28. Modica S, Gofflot F, Murzilli S, D’Orazio A, Salvatore L, Pellegrini F, Nicolucci A, Tognoni G, Copetti M, Valanzano R, Veschi S, Mariani-Costantini R, Palasciano G, Schoonjans K, Auwerx J, Moschetta A. The intestinal nuclear receptor signature with epithelial localization patterns and expression modulation in tumors. Gastroenterology. 2010 138:636-48, 648.e1-12.