Clinical Platforms

Clinical Epidemiology and Research Center

Clinical Epidemiology and Research Center

Holger Schünemann

CERC Director

Clinical epidemiology drives excellence in clinical research and practice. Effective clinical decision-making hinges on addressing key questions regarding diagnosis, treatment, prevention, and potential risks, alongside achieving accurate and unbiased estimates of prognosis and intervention outcomes. Only robust research methods can deliver these answers. By refining research methodologies, clinical epidemiology ensures that clinical practice is firmly rooted in evidence-based principles

The challenge

The goal of CERC is to conduct and support first-class health research at Humanitas while creating new opportunities for advances in health research methodology. We want to be a leading hub of clinical research methods in Italy embedded in a population health stream at Humanitas that is connected globally and strongly linked with other European and international institutions.

Main research areas

Clinical research: study conduct and methods development

Our group is involved in primary clinical research. This includes the design and conduct of interventional (phase II to phase IV trials) and observational studies to explore the effect of treatments, diagnostic processes, and to make predictions. We conduct research in house and offer support to other researchers as a clinical trial unit. We are committed to use state-of the art methodology and contribute to the development of new health research methods. This includes using innovative study designs (e.g. platform, adaptative, registry-based trials), analysis techniques, and technologies, including artificial intelligence.

Systematic reviews, evidence synthesis, evidence-based decision-making

Systematic reviews are widely used in medical research to understand what is already know about a specific treatment/intervention, to identify existing gaps, to support evidence-based decisions and to plan future research. They provide critical assessment and evaluation of existing evidence applying rigorous and transparent methods. Our group is involved in the development and application of systematic review methods for evidence synthesis and in their implementation for evidence-based decision making.

Clinical practice guideline methods, development and implementation

Clinical practice guidelines are evidence-based statements which allow different stakeholders to make informed decisions about healthcare interventions. They are supported by systematic reviews of the evidence, and their implementation may optimize health and healthcare. Our group has great expertise in planning, development and implementation of clinical practice guidelines and it is leading several projects on the development of innovative methods and approach in this field i.e. use of routinely collected data, quality assurance and improvement integration, artificial intelligence applications.

Occupational and Environmental Health section

Our group has great expertise in both occupational and environmental health, where the same methodology is applied to support evidence-based protocols of monitoring, health promoting and intervention to reduce risk factor exposure, as well as prevent disease and accidents. We are involved in many clinical studies addressing physiological and pathological conditions that are associated with working conditions, environmental risk factors and chronic exposure. Among the topics addressed: Long-Covid and its impact on work ability; sleep disorders associated with irregular (rotating and long-lasting shifts) and other stressful working activities; the effectiveness of Health Promotion Programs and Total Worker Health models; occupational exposure in patients affected by lung cancer.

Collaborations

GRADE Working Group

Italian GRADE network

Cochrane Collaboration

WHO

European Commission Joint Research Centre

American College of Physicians

McMaster University

Charité Berlin

Western University, London, Ontario, CA

European Space Agency, Cologne, Germany

education

🢒 Teaching at Humanitas University in International Medical school, MedTech school, nursing school, biomedical lab technicians and medical radiology technicians schools, physiotherapy school

🢒 Directorship and education for residency program in hygiene and preventive medicine

🢒 PhD program

Selected publications

Germini F
Ann Emerg Med
Implementation, Clinical Benefit and Safety of a D-Dimer-Focused Pulmonary Embolism Testing Pathway in the Emergency Department.
Higgins JPT
Environ Int
A tool to assess risk of bias in non-randomized follow-up studies of exposure effects (ROBINS-E).
Brozek J
Allergy
Patients’ values and preferences for health states in allergic rhinitis-An artificial intelligence supported systematic review.
Bognanni A
World Allergy Organ J
World Allergy Organization (WAO) Diagnosis and Rationale for Action against Cow’s Milk Allergy (DRACMA) guideline update – XII – Recommendations on milk formula supplements with and without probiotics for infants and toddlers with CMA.
Piggott T
J Clin Epidemiol
GRADE Concept 7: Issues and Insights Linking Guideline Recommendations to Trustworthy Essential Medicine Lists.
Arienti C
Eur J Phys Rehabil Med
The influence of bias in randomized controlled trials on rehabilitation intervention effect estimates: what we have learned from meta-epidemiological studies.
Middeldorp S
Blood Adv
American Society of Hematology 2023 guidelines for management of venous thromboembolism: thrombophilia testing.
Marcucci M
Lancet Neurol
Prevention of perioperative stroke in patients undergoing non-cardiac surgery.
Dewidar O
BMJ Evid Based Med
Good or best practice statements: proposal for the operationalisation and implementation of GRADE guidance.
de Wit K
Ann Emerg Med
Comparison of YEARS and Adjust-Unlikely D-dimer Testing for Pulmonary Embolism in the Emergency Department.
Piggott T
J Clin Epidemiol
The GIN-McMaster guideline tool extension for the integration of quality improvement and quality assurance in guidelines: a description of the methods for its development.
Karam SG
J Clin Epidemiol
Analytical frameworks in colorectal cancer guidelines: development of methods for systematic reviews, their application and practical guidance for their use.
Piovani D
Gastroenterology
Risk of Cancer in Inflammatory Bowel Diseases: Umbrella Review and Reanalysis of Meta-analyses.
Arienti C
Eur J Phys Rehabil Med
A systematic review opens the black box of “usual care” in stroke rehabilitation control groups and finds a black hole.
Germini F
J Thromb Haemost
Risk factors for bleeding in people living with hemophilia A and B treated with regular prophylaxis: A systematic review of the literature.
Devereaux PJ
N Engl J Med
Tranexamic Acid in Patients Undergoing Noncardiac Surgery.
Schünemann HJ
Lancet Public Health
The ecosystem of health decision making: from fragmentation to synergy.
Marcucci M
BMJ
Benefits and harms of direct oral anticoagulation and low molecular weight heparin for thromboprophylaxis in patients undergoing non-cardiac surgery: systematic review and network meta-analysis of randomised trials.
Arienti C
J Clin Epidemiol
The methodology of a “living” COVID-19 registry development in a clinical context.
Germini F
J Med Internet Res
Accuracy and Acceptability of Wrist-Wearable Activity-Tracking Devices: Systematic Review of the Literature.
Arienti C
Arch Phys Med Rehabil
Methodological Issues in Rehabilitation Research: A Scoping Review.
Parmelli E
BMC Health Serv Res
Guideline-based quality assurance: a conceptual framework for the definition of key elements.
Piovani D
J Infect
Effect of early application of social distancing interventions on COVID-19 mortality over the first pandemic wave: An analysis of longitudinal data from 37 countries.
Arienti C
Am J Phys Med Rehabil
The Structure of Research Questions in Randomized Controlled Trials in the Rehabilitation Field: A Methodological Study.
Young PJ
JAMA
Evaluating Non-Statistically Significant Results From Trials in Practice-Reply.
Piovani D
Lancet
Study of critically ill patients with COVID-19 in New York City.
Torres J
J Crohns Colitis
ECCO Guidelines on Therapeutics in Crohn’s Disease: Medical Treatment.
Marcucci M
BMC Med
Interventions to prevent, delay or reverse frailty in older people: a journey towards clinical guidelines.
Iorio A
Ann Intern Med
Establishing the Prevalence and Prevalence at Birth of Hemophilia in Males: A Meta-analytic Approach Using National Registries.
Piovani D
Gastroenterology
Environmental Risk Factors for Inflammatory Bowel Diseases: An Umbrella Review of Meta-analyses.
Bonovas S
Clin Gastroenterol Hepatol
Biologic Therapies and Risk of Infection and Malignancy in Patients With Inflammatory Bowel Disease: A Systematic Review and Network Meta-analysis.

Staff

Clinical Epidemiology and Research Center
Federico Germini

Assistant professor, Humanitas University

Clinical Epidemiology and Research Center
Holger Schünemann

CERC Director

Clinical Epidemiology and Research Center
Chiara Arienti

Research scientist

Clinical Epidemiology and Research Center
Elena Parmelli

Research Project Manager

Clinical Epidemiology and Research Center
Maura Marcucci

Associate professor, Humanitas University

Clinical Epidemiology and Research Center
Stefanos Bonovas

Associate professor, Humanitas University

Clinical Epidemiology and Research Center
Daniele Piovani

Assistant professor, Humanitas University

Clinical Epidemiology and Research Center
Franca Barbic

Associate professor, Humanitas University

Clinical Epidemiology and Research Center
Gisella Figlioli

Postdoc fellow