The patient at the center of the HTA evaluation process: research protocol

  • Marta Chiappetta Department of Public Health and Infectious Diseases, Sapienza University of Rome
Keywords: HTA, patient involvement, patient-based evidence (EBP), patient-reported outcomes-PRO


Background: HTA is a multidisciplinary evaluation process that examines the short and long term consequences of using new or existing health technologies.

The subjects directly involved in the evaluation are the patients, the only ones who live with the disease and who know deeply treatments, undesirable effects and benefits of drugs and technologies.  The evidence provided by patients (EBP) is based on direct experience and this makes it essential in the evaluation process, especially when comparing technologies that achieve the same clinical outcomes.

Objectives: several studies have shown that the assessment by regional administrations is more oriented towards a rationalization and management of economic resources than all the introduction of new technologies that meet appropriateness criteria. Furthermore, the research highlighted a lack of interest in the impact of technology and a low level of involvement of patients and, more generally, of stakeholders in the evaluation process. The aim of the project is to develop, through the tools, a plan for involving patients, their associations and health professionals, to build hta reports.

Methods/design: the methodology will mainly focus on the opinions of the patients and will refer to the "outcomes reported by the patient", ie structured questionnaires concerning the effects of a treatment and / or benefits and advantages of drugs and technologies, through targeted questions on the state of greeting, on the quality of life and on more specific aspects such as the perception of pain.

Conclusion: the quantitative investigation of the structured questionnaires will be accompanied by the tools of the qualitative methodology such as interview, focus group and social media analysis which will constitute the completion of the feedback analysis of the three recipients identified for the purposes of the project.