The BMBF-funded, international Stracyfic research project offers a novel strategy to better classify and monitor patients with cystic fibrosis according to their individual level of disease-causing effect. In the long term, this personalized-medicine approach enables better detection and management of the disease. Subproject 4, which is conducted at the HAW Hamburg under the direction of Prof. Sabine Wöhlke, investigates the sociological as well as empirical-ethical consequences of the implementation of the novel diagnostic strategy. For this purpose, intensive cooperation with the Patient:innenorganisation Mukoviszidose e. V. takes place. Dr. Manuel Nietert of the University Medical Center Göttingen is in charge of the overarching joint project.
Detection of salty sweat has long been used to diagnose cystic fibrosis, a rare disease that occurs in 1 in 2,500 live births and is associated with high morbidity and mortality. Cystic fibrosis is the most common recessive inherited disease and is caused by CFTR mutations, which produces a viscous mucus that obstructs the airways and lumens of the exocrine glands. Stracyfic develops the implementation of a novel measurement method to assess the individual severity of the underlying biological process that causes cystic fibrosis in vivo as a phenotype-defining parameter. The available measurement range can thus be used to assess individual response to therapeutic interventions as well as to stratify patients:in the intermediate activity range. With this novel measurement method, such milder cases can be better diagnosed before intervention is too late, or it can be used to optimize treatment of already diagnosed cases by personalizing drug levels according to the underlying biological mechanism.
In the accompanying ethical project, the attitudes and expectations of both patients and physicians toward the new test procedure will be determined by means of sociological and empirical-ethical research methods. This project focuses on relevant ethical values such as autonomy and trust. However, expectations of patients and physicians regarding the doctor-patient relationship will also be investigated to determine the extent to which communication about the diagnostic test results influences this relationship. The aim of the study is to identify uncertainties, conflicts and problems that may arise in the context of this specific diagnostic field. It is also intended to gain insights into the everyday medical-diagnostic world of patients and physicians when new technological artifacts in the form of a diagnostic instrument are implemented in practice, in order to be able to conduct an ethical discussion on the basis of this, and to identify possible "blind spots".
The innovative potential of this subproject is to better understand medical ethical standards applied in practice, with a special focus on what information promotes trust and autonomy. Furthermore, the transnational context will be used to analyze cultural differences in the everyday relationship between patient and doctor, with a special focus on how the new technology is communicated to the patient. These findings can help to derive best practice examples as training material for patient organizations and for medical education, which will be developed in close cooperation with Mukoviszidose e. V.
With the transnational collaboration between dedicated computer scientists, biologists, nurses, and social scientists, the Stracyfic project brings a novel biomarker to a translational level of application. In this way, test design and analysis will be further improved and standardized at different sites and in different countries. Based on partners from Belgium, France, Germany, and Italy, this also includes the creation and distribution of appropriate training/teaching material. Social and ethical research group as well as patient organizations will be involved to evaluate the impact of the transition and to guide the process.
Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung; BMBF) (funding code: 01KU2310)