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Qualitative research in clinical trials: a review and our experience

In a 2013 article published in the BMJ OpenAlicia O’Cathain and colleagues undertook a review of journal publications on the use of qualitative research in Randomized Control Trials (RCTs). The aim was not so much to summarize the presented results as to classify them in a reference frame.

In this review, authors included articles published in English between 2001 and 2010, reporting the results of qualitative studies undertaken before, during or after a specific RCT. However, the use of qualitative research methods in experimental and clinical research has increased in the years after 2013.

In general, the potential value of qualitative research within RCTs was considerable:

  • The improvement of the external validity of experiments,
  • The facilitation of the interpretation of results,
  • A support to those who carried out the experiments in the relationship with RCT participants,
  • Better targeting of research towards more effective interventions.

As O’Cathain and colleagues point out, it is also true that in many articles there were indications that researchers were not capitalizing on this potential, partly due to a poor articulation of qualitative methods within the scientific articles that made them unclear to other EBM researchers. Another problem raised by the authors of the review is that qualitative research is still difficult to be published in scientific journals because it is considered less rigorous and less “objective”.

The framework can be found in the article. Now, let us add a consideration from our own experience.

As Luigi Reale reports in an article in this online journal, at Fondazione ISTUD we have undertaken an innovative experience, introducing the administration of narrative alongside the more traditional quantitative tools within observational clinical studies, enhancing what is subjective – the individual experience of disease, which is unique – and not only what is objective and quantifiable. So far, the experience is receiving positive feedback, as emerges from this interview.

Moreover, for years we have been trying to publish the results of our narrative medicine projects in scientific journals, to show that researching the use of narrative

it is possible, with rigorous work and compliance with the analysis criteria, and the comparison of two or more researchers independently. This approach allows to obtain numerous qualitative data and, through the construction of patterns on recurrences in the narratives, also quantitative data to record an experience, an emotion, a need.

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