Date Published: April 3, 2019
Publisher: Public Library of Science
Author(s): Miguel Sola, Carmen Sanchez-Quevedo, Miguel A. Martin-Piedra, Victor Carriel, Ingrid Garzon, Jesus Chato-Astrain, Oscar-Dario Garcia-Garcia, Miguel Alaminos, Fernando Campos, Helena Kuivaniemi.
Advanced therapies are increasingly demanded by patients with the intent of treating some incurable conditions. Because family medicine professionals play an important role as health educators, their residency programs should incorporate new knowledge related to advanced therapies. To successfully implement these programs, how family medicine residents perceive these therapies should be investigated. The main components of perception, i.e. conceptual, procedural and attitudinal, refer to knowledge, skills and feelings, respectively.
We designed a specific questionnaire to assess the components of perceptions of advanced therapies in 300 medical residents enrolled in the Spanish National Family Medicine Residency Program. Each component consisted of 4 or 5 topics and each topic contained 6 items. Respondents scored highest in the procedural component (average 4.12±1.00), followed by the attitudinal (3.94±1.07) and conceptual component (3.04±1.43). Differences among the three components were statistically significant (p<0.00017). Family medicine residents perceived that procedures to implement advanced therapies are well established, especially their application. However, they felt their cognitive background was insufficient to respond efficiently to the expectations generated by these new therapeutic tools, especially in the regulatory framework. High awareness of the risks and limitations of these treatments was reflected by residents’ preference for clinically tested therapies. Although they appropriately situated treatment with these therapies within hospital care, they associated the biofabrication of novel products with research centers, although these therapeutic tools can be produced in different facilities. These results are potentially useful for designing future training programs and health policies for family medicine residents, and suggest the need to implement specific training programs in advanced therapies at the conceptual, procedural and attitudinal level.
In recent decades, genes, cells and tissues have been adapted as new therapeutic tools in medicine. In this new approach, known as advanced therapies, each of these therapeutic agents is termed an advanced therapy medicinal product (ATMP) . As in other medicinal products such as drugs, devices and biological agents, products based on genes, cells and tissues are subject to regulatory requirements that vary widely among countries and product types . The regulatory requirements for ATMPs were established in the European Union by two European Directives (2003/63/EC and 2009/120/EC) and by EC Regulation No. 1394/2007 of the European Parliament and Council. Specific regulations have also been established in different countries, e.g. FDA regulation in the USA . In European countries, marketing authorization must follow a centralized procedure at the European Medicines Agency (EMA), and very precise guidelines must be met for product safety, control of the manufacturing process, and clinical trials .
The results for each component, topic and item are summarized in Tables 2, 3 and 4 and raw data are available in the S1 File.
The increasing relevance of gene-, cell- and tissue-based therapies in medicine and the expectations these novel therapies generate in the population of health care users require specific studies in this field. Incorporating knowledge about advanced therapies in training programs for future family medicine physicians will allow these professionals to contribute effectively to health education in the user population. However, before training activities are developed and implemented for family medicine residents, their conceptual, procedural and attitudinal profiles related to these therapies should be investigated. As indicated by different theoretical frameworks in educational research, a wide range of circumstances can potentially promote or limit the learning process in a particular situation [20–22]. Moreover, studies of medical residents’ perceptions regarding professional practice have demonstrated the importance that residents give to the need to overcome shortcomings in their professional behavior, cognitive ability and procedure skills [23, 24].