Résumé
Introduction: Pharmacoepidemiology is defined as "the science that investigates the use and action of drugs on a large population scale” according to the World Health Organization. The aim of this review is to highlight the important role of pharmacoepidemiology and its research standing in Greece. Methodology: For this literature review, articles and relative information was extracted using the academic search engines and databases Google Scholar, PubMed, Scopus and Science Direct. The review includes literature content from 1972 to 2021 and the keywords that were used for the literature search are "Pharmacoepidemiology”, "clinical research”, "clinical studies”, and "Pharmacovigilance”. Results-Discussion: Fundamental aims of Pharmacoepidemiology are: a) the enhancement of clinical research with the collection and analysis of Real-World Data, b) the detection of potential side effects of pharmaceutical products and c) the study/investigation of new therapeutic actions of pharmaceutical products for their beneficial use beyond their main known action. Additional reasons that make it crucial to conduct pharmacoepidemiologic studies nowadays are related to regulatory, legal, marketing, and clinical research evolvement factors. The main tools of Pharmacoepidemiology are: (i) advanced epidemiological methods which are applied to clinical research data and (ii) databases that have been developed significantly in recent years due to the progress of computer science and big data analytics. Some of the main resources of real-world data used in pharmacoepidemiologic science are drug prescription-cost related data, health insurance databases, and government related resources. The types of the studies that are used to conduct a pharmacoepidemiologic research are: i) descriptive studies (reports/case series and ecological or cross-sectional studies) aiming to enhance drug safety and pharmaceutical risk assessment and ii) analytical studies (case control and cohort studies) aiming to highlight the cause-effect relationships and detect risk-disease factors. However, despite the excellent design of a pharmacoepidemiologic research study, there are limitations related to the quality of data (primary/secondary) obtained and analyzed but also the population group size studied. There are also further limitations such as bias and recall bias, confounding factors, lack of organized valid large databases for research purposes that may pose an important burden to the proper design of a study. Finally, the reliability of a pharmacoepidemiologic study is very crucial based on its statistical power as defined by the confidence intervals and the large and well-defined/represented population sample. It is worth mentioning that the contribution of pharmacoepidemiology was highlighted significantly during the Covid-19 pandemic as a key pharmacovigilance tool that has identified and recorded serious and rare side effects of the new, innovative vaccines against the coronavirus disease. Conclusion: Pharmacoepidemiology studies are truly valuable since they can also act as a complementary assessment tool to the formation and updates of clinical guidelines. In Greece, the scientific field of pharmacoepidemiology is still in very early foundation stage, although there are groups of Greek scientists-researchers in recent decades that they have been trying through their work to develop and evolve this fascinating scientific field. © 2023, Zita Medical Managent. All rights reserved.
Résumé
Background: As cancer treatments improve, patients' quality of life becomes even more important. In parallel, supportive care delivery is increasingly challenging, also due to resource pressures and COVID19. The effectiveness of digital and remote patient support tools as a complementary approach to improve patients' quality of life is under evaluation. Fatigue is considered among the most prevalent and persistent side effects regardless of tumour type;also, despite ongoing research, there is no single approach established. We compare the effectiveness of different self-care interventions delivered by online platforms to cancer patients in several countries. Methods: Patients report side effects (including Fatigue) on the CareAcross online platforms and receive tailored support to help them improve their quality of life. The supportive material encompasses many topics, and patients may receive several combinations. For Fatigue, different topics (nutrition, hydration, rest etc) were analysed to evaluate effectiveness based on prospectively collected patient reported outcomes. Results: 1456 breast, lung, colorectal or prostate cancer patients from 8 countries (mainly UK, Germany, France, Spain, Italy) reported Fatigue at least once. This analysis focuses on persistent fatigue: 1215 patients reported Fatigue more than once, receiving up to 7 permutations of topics (F1-F7;F4-7 consist of F1-3 combinations). All permutations include the “Physical Activity” topic (see Table). Overall, the “Hydration” topic stands out as consistently linked with the most effective material (all except F3). Comparative analysis between similar combinations shows that those with “Anemia warnings” and “Rest” tend to be more effective (F7>F6). Ambiguously, the “Physical activity before & after treatment”, “Relaxation exercises” and “Fatigue diary” topics contribute to effectiveness (F5>F1), but do not counterbalance absence of the previous 3 (F1>F3). Food-related topics have unclear impact, too: “Food types” is absent from the top combination (F2) where “Food timing” is used;however, that topic is linked with a slightly inferior combination (F7>F5). Conclusions: Fatigue is a complex, multifactorial challenge;digitally delivered interventions can lower its incidence. Hydration appears effective, but the nature of these interventions complicates their thorough evaluation. Randomised studies may enhance these findings and enable additional personalisation towards further quality of life improvements. (Table Presented).