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Randomized clinical trials as reflexive–interpretative process in patients with rheumatoid arthritis: a qualitative study

  • Original Article - Food for Thought
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Abstract

Patients in randomized clinical trials have to adapt themselves to a restricted language to capture the necessary information to determine the safety and efficacy of a new treatment. The aim of this study was to explore the experience of patients with rheumatoid arthritis after completing their participation in a biologic therapy randomized clinical trial for a period of 3 years. A qualitative approach was used. The information was collected using 15 semi-structured interviews of patients with rheumatoid arthritis. Data collection was guided by the emergent analysis until no more relevant variations in the categories were found. The data were analysed using the grounded theory method. The objective of the patients when entering the study was to improve their quality of life by initiating the treatment. However, the experience changed the significance of the illness as they acquired skills and practical knowledge related to the management of their disease. The category “Interactional Empowerment” emerged as core category, as it represented the participative experience in a clinical trial. The process integrates the follow categories: “weight of systematisation”, “working together”, and the significance of the experience: “the duties”. Simultaneously these categories evolved. The clinical trial monitoring activities enabled patients to engage in a reflexive–interpretative mechanism that transformed the emotional and symbolic significance of their disease and improved the empowerment of the patient. A better communicative strategy with the health professionals, the relatives of the patients, and the community was also achieved.

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Acknowledgements

The authors thank all who participated in this study, particularly Dr Jover from San Carlos Hospital, University of Madrid, (Spain) and Rosa Muñoz Study coordinator Department of Rheumatology from Foundation Jimenez Diaz and Sandra Cano. The authors extend their appreciation to the patients who participated in this study ethics. The Department of Rheumatology Foundation Jimenez Diaz IDC funded this study.

Conflict of interest

The authors have no conflict of interest to declare.

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Authors and Affiliations

  1. Bone and Joint Research Unit, Department of Rheumatology, IIS - Fundacion Jimenez Diaz, Universidad Autonoma, Av. Reyes Catolicos 2, 28048, Madrid, Spain

    Mercedes de Jorge, Sonia Parra & Gabriel Herrero-Beaumont

  2. Rheumatology Department, Alicante General and University Hospital, Alicante, Spain

    Jenny de la Torre-Aboki

Authors
  1. Mercedes de Jorge
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  2. Sonia Parra
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  3. Jenny de la Torre-Aboki
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  4. Gabriel Herrero-Beaumont
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Correspondence to Mercedes de Jorge.

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de Jorge, M., Parra, S., de la Torre-Aboki, J. et al. Randomized clinical trials as reflexive–interpretative process in patients with rheumatoid arthritis: a qualitative study. Rheumatol Int 35, 1423–1430 (2015). https://doi.org/10.1007/s00296-015-3218-0

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  • DOI: https://doi.org/10.1007/s00296-015-3218-0

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