title: Randomized clinical trials as reflexive-interpretative process in patients with rheumatoid arthritis: a qualitative study.
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.
authors: Bone and Joint Research Unit, Department of Rheumatology, IIS - Fundacion Jimenez Diaz, Universidad Autonoma, Av. Reyes Catolicos 2, 28048, Madrid, Spain, mdejorge@msssi.es.
authors: Mercedes
authors: M
authors: de Jorge
authors: Sonia
authors: S
authors: Parra
authors: Jenny
authors: J
authors: de la Torre-Aboki
authors: Gabriel
authors: G
authors: Herrero-Beaumont
mesh_terms: D000328:Adult; D000368:Aged; D018501:Antirheumatic Agents / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000188:drug therapy / Q000523:psychology*; D001688:Biological Products / Q000627:therapeutic use; D015331:Cohort Studies; D003299:Cooperative Behavior; D005260:Female; D066296:Grounded Theory; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D008875:Middle Aged; D009042:Motivation; D010353:Patient Education as Topic; D010358:Patient Participation / Q000523:psychology*; D010817:Physician-Patient Relations; D036301:Qualitative Research; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic / Q000523:psychology*; D055815:Young Adult
chemical_list: D018501:Antirheumatic Agents; D001688:Biological Products
references: J Med Ethics. 2008 Nov;34(11):775-9
references: 18974408
references: J Health Psychol. 2012 Jan;17 (1):132-42
references: 21708868
references: Bull NYU Hosp Jt Dis. 2009;67(2):236-42
references: 19583560
references: Patient Educ Couns. 2009 Jan;74(1):61-9
references: 18778909
references: Ann Rheum Dis. 2012 Jan;71(1):13-9
references: 22039168
references: Ann Rheum Dis. 2014 May;73(5):902-5
references: 23921994
references: J Health Organ Manag. 2010;24(2):167-81
references: 20698192
references: Ann Rheum Dis. 2010 Jun;69(6):964-75
references: 20444750
references: Arthritis Rheum. 2011 Mar;63(3):573-86
references: 21294106
references: Ann Rheum Dis. 2011 Nov;70(11):1999-2002
references: 21803747
references: Ned Tijdschr Geneeskd. 2011;155(29):A3501
references: 21791136
references: Clin Trials. 2011 Feb;8(1):85-93
references: 21163854
references: Clin Exp Rheumatol. 2010 Sep-Oct;28(5):734-44
references: 20883639
references: J Rheumatol. 2005 Nov;32(11):2250-6
references: 16265712
references: Ann Intern Med. 1989 Feb 15;110(4):259-66
references: 2913913
references: Rehabilitation (Stuttg). 2011 Oct;50(5):284-91
references: 21976261
references: Arthritis Care Res (Hoboken). 2012 Apr;64(4):589-96
references: 22162301
references: Sociol Health Illn. 2011 May;33(4):618-33
references: 21281314