Pharmacoeconomic Evaluation of the Cost/effectiveness Ratio of Physical Exercise on Non-alcoholic Fatty Liver Disease

Retrospective and Prospective Study Aimed At the Pharmacoeconomic Evaluation of the Cost/effectiveness Ratio of Physical Exercise on the Prognosis of Non-alcoholic Fatty Liver Disease (NAFLD)

Physical inactivity and poor dietary habits are associated with an increased risk of obesity and chronic disease (World Health Organization, 2019; Glanz and Bishop, 2010). Conversely, higher levels of total physical activity result in a reduced risk of cardiovascular disease, breast and colon cancer, and diabetes (Kyu et al., 2016). Similarly, consumption of the minimum recommended level (600 g per day) of fruit and vegetables is associated with a lower risk of cardiovascular disease and cancer (Ezzati et al., 2004). However, despite these recognized benefits, unhealthy diet and physical inactivity are still major contributors to poor health and rising health care costs. Worldwide, physical inactivity accounted for 13.4 million disability-adjusted life years (DALYs) in 2013 and cost $53.8 billion to health systems and an additional $13.7 billion in productivity due to deaths attributable to physical inactivity (Ding et al., 2016).

Pharmacoeconomics, or the economic evaluation of treatments aimed at maintaining the health of the population, is a set of evaluation models used to identify the value (convenience) and the overall economic impact of a possible treatment.

The results of economic evaluations help decision makers inform their choice. Their advantage is that the result is obtained by applying known and validated models, and everyone can know the basis of the decision (evidence-based decision making). The clinical-economic value and the overall financial impact must be compared with the willingness to pay the related costs.

Economic evaluations are a tool for defining the value of a medicine in terms of cost-opportunity, from the point of view of the patient, the NHS and society as a whole.

The definition of "value" is very broad, multidimensional and includes concepts from many disciplines, beyond economics. Specifically, economic evaluations that take into consideration new medicines, innovative or not, the value is given by the marginal utility that the patient, the NHS and/or society can obtain from its acquisition. In this regard, the measurement of years of life gained in full quality of life (QALY - quality-adjusted life years) is widely applied to medicines in various regulatory contexts, albeit with the awareness that it is not able to capture all the elements that contribute to value (Carletto, A et al.; Drummond, M. F)

Study Overview

• Status: Completed
• Conditions: Non-Alcoholic Fatty Liver Disease

• Study Type: Observational
• Enrollment (Actual): 58

Contacts and Locations

Study Locations

• Italy
  • Bari
    • Castellana Grotte, Bari, Italy, 70013
      • Irccs Saverio de Bellis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The population was affected by NAFLD in the observation period (2018-2020), participating in health promotion activities by performing physical exercise under the supervision of the institution's kinesiologists

Description

Inclusion Criteria:

• Being affected by NAFLD in the observation period (2018-2020)
• Participating in health promotion activities by performing physical exercise under the supervision of the institution's kinesiologists

Exclusion Criteria:

• Patient deceased
• Patient who does not agree to participate in the study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
subjects that participates to a previous clinical trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost/effectiveness Ratio	to define the economic value in terms of CER (Cost/Effectiveness Ratio) and ICER (Incremental Cost/Effectivness Ratio) of physical exercise in the treatment of NAFLD in patients who already have comorbidities for metabolic/cardiometabolic diseases.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
long term foresight of an healthy policy	identify the potential savings in terms of costs (direct and indirect) of physical exercise on patients suffering from NAFLD through the use of a predictive scenario developed through the use of the MAFEIP (Monitoring and Assessment Framework for the European Innovation Partnership on Active and Healthy Aging).	3 years

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
• Collaborators: Antonella Bianco; Pietro Trisolini; Giuseppe Dalfino
• Investigators: Principal Investigator: Maurizio Gaetano Polignano, IRCCS "Saverio De Bellis"

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2023
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): October 2, 2024

Study Registration Dates

• First Submitted: August 30, 2023
• First Submitted That Met QC Criteria: September 6, 2023
• First Posted (Actual): September 7, 2023

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 5, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Physical activity; Non-alcoholic fatty liver desease; Cost/effectivness
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: CER_study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No