The integration of quantitative-Evidence Based Medicine and qualitative-narrative methods in observational studies
Interview with the Janssen team of the DIAMANTE study
The clinical study DIAMANTE is an observational study, carried out by the Janssen Company with the collaboration of the Healthcare Area of ISTUD Foundation, and integrates a narrative investigation on illness living to quantitative surveys, typical of clinical studies. In particular, it is directed at people with one of the most stigmatized diagnoses in the modern world: HIV.
Concerning the narrative approach, integrating qualitative and quantitative methodology, we have the pleasure today to present to our readers an interview with not only one of the referents of the DIAMANTE project but the entire Janssen team involved in this study.
1) As the first question, I’ll ask you briefly present you to our readers, from your role in the Company to your interest in narrative medicine
Roberta Termini, Therapeutic Area Medical Manager di Janssen Italia.
Daniela Mancusi, Medical Affairs Manager HIV, Janssen.
Alessia Uglietti, Medical Affair Manager Infectivology, Janssen.
Maria Palma, Medical Affair Manager, Janssen.
Roberta Termini: The first time I heard about narrative medicine was through the participation in a Conference organized by Maria Giulia Marini some years ago. Listening experts that were speaking about this items and were reporting the patients’ perceptions, I discovered that a narrative medicine project is not only possible but has already be done in HIV, sponsored by another Company. On the base of this experience, we began to search for information about this methodology to understand whether it could be applied to a clinical study.
Daniela Mancusi, Alessia Uglietti, Maria Palma: We discovered narrative medicine thanks to our colleague Roberta who told us about a Conference she had participated where she had known this new approach. So, we began to think about the possible application of it into our therapeutic area and our studies.
2) Could you describe us how the idea of integrating a narrative investigation into a clinical study?
Maria Palma: The idea of applying narrative medicine into a clinical study made us enthusiastic; in the past, we experienced the use of surveys in observational studies to collect the patients’ point of view. The idea of patients’ writing narrative plots on their experiences could be considered deepening these items and putting the patient at the center of the study.
Roberta Termini: Janssen has, indeed, several activities directed to patient centricity since it is considered a real company value.
3) What are the expectations of such an innovative project? What are the benefits of the narrative in this study, in your opinion?
Alessia Uglietti: Patients, as said by Roberta, are the focus of all our activities nowadays, in all the phases of a clinical study. Consequently, we try to give more space to their perceptions and their feelings, especially when, as in this case, we have to face up to such a stigmatized pathology as HIV, which is already considered the “black swan”. Some patients, indeed, have still problems to line up and never speak about it. With the use of narrative medicine they could vent, so they could describe themselves, describe their perceptions, their feelings, their episodes of living with such a secret they’re carrying.
Roberta Termini: The DIAMANTE study is an “observational” study, of clinical practice; consequently, it is not an interventionist-pivotal one. From this point of view, narrative medicine actually adds a new piece in the clinical practice, a piece that is, of course, part of the clinical practice too, but that until now has been too often considered as neglected. Actually, few researchers probably had focused their attention on what the patient really think, and anyone until now has focused on the patient’s perception in a clinical study. In some cases, the patient has even been “ignored”: for example, tenting to convince the patient to do something considered the best for them, they could not play the appropriate attention to their doubts. The narrative approach may represent a step forward, and also clinicians who have participated to the present study until now, without knowing the study results at the moment, have already expressed their positive comments on the addition of narrative medicine.
4) How was the news of qualitative investigation perceived from your colleagues, clinicians and patients involved, who probably used to work in an evidence-based medicine world?
Daniela Mancusi: Concerning clinicians, at the beginning of the study they reacted in two different ways: some of them, who had just known the methodology, approved it enthusiastically; others were more skeptic since they were afraid on the patients’ participation, essaying it is not easy to convince them filling a simple survey, so it will be more difficult to convince to write narratives, probably more complex. However, focusing on the progression of the study, we have 93 enlisted patients, of whom beyond 40% has already sent also the first form of the narrative part; the other 40%, more or less, has already had the possibility to bring the narrative plot at home in order to write with privacy and calmness. Those who refused to participate in this narrative part of the study were actually a minority: they are extra-Community people in the majority of cases, who don’t know the Italian language or poorly alphabetized people who, in consequence of this, don’t think they will be able to complete that part. At the moment, the initial clinicians’ doubts on the lack of patients’ acceptance didn’t occur, and the majority of patients have accepted the narrative part, even willingly! From the first narratives collected, indeed, many participants have had markedly positive reactions: at the question “How did you feel when writing your narrative?” the answers were similar to “I’m happy to have the possibility to vent and to tell my experience”. From these preliminary results, we are very happy about the progression of the project, that integrates qualitative and quantitative methods. We hope it will continue in this way.
Maria Palma: Concerning our collaborators, we presented this project, including the narrative medicine in a clinical study, to the medical direction and to other therapeutic areas, as immunology and hematology. Also, that other teams decided to better understand the narrative approach since narrative medicine could break down barriers, especially for diseases as HIV, but also psoriasis, where the social stigma still exists. This is the main reason that leads to design a future project to listen to patients with multiple myeloma, involving the immunology and the hematology areas. There are initiatives still at a design phase, but it will be a pleasure for us to pursue the project in the future.
Alessia Uglietti: The integration of results from the narrative part and those from the clinical study can help us to design new initiatives, as initiatives for patients, that will be programmed and structured specifically according to the results of the project. To diffuse the results, that is fundamental for our team, it will be important to make the methodology known but also to diffuse the data to clinicians who didn’t have the possibility to apprehend narrative medicine since they didn’t participate to this study.
Roberta Termini: Finally, we are going to present first results of the collected data, on the base-time phase, to the next National Congress of Infective Diseases, the next June, in Milan.