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Reduced quality of life impacts knowledge and type of informed consent in rheumatoid arthritis patients.
V. Pascual-Ramos1, I. Contreras-Yáñez2, D. Ruiz3, M. De la luz casas-Martínez4
- Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, México City, México. virtichu@gmail.com
- Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
- Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
- Centro de Investigación en Bioética, Universidad Panamericana, México City, México.
CER11183
2019 Vol.37, N°2
PI 0186, PF 0192
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PMID: 30148443 [PubMed]
Received: 16/02/2018
Accepted : 24/04/2018
In Press: 18/07/2018
Published: 19/03/2019
Abstract
OBJECTIVES:
Informed consent (IC) is an ethical process required in human subject research. Primary objective was to determine factors associated to poor knowledge of IC content (PK) in patients from an early rheumatoid arthritis cohort.
METHODS:
The cohort initiated in 2004, had assistant and research purposes (NCT03389711). At inclusion, each patient selected 1 of 4 options of the IC form; options ranged from broad consent (patient’s data could be used for research) to patient denied to have his/her data used. Once enrolled, patients had regular assessments. Up to May 2017, the cohort had 146 patients with (median, range) follow-up of 8.8 years, (4.3-11.9) and 143 agreed to participate in a cross-sectional study; patients had scheduled rheumatic evaluations; additionally, a social worker applied a questionnaire that addressed objective described. PK was established by the borderline performance method. Multiple regression models were applied to investigate factors associated to PK.
RESULTS:
At cohort inclusion, patients were primarily middle-aged (38.3±13.1 years) females (88.9%), with high disease activity (DAS28: 5.8 [4.6-6.8)] and poor quality of life (SF-36: 42 [29-59]). All the patients gave broad IC. At study entry, 35-41.3% of them had PK; longer follow-up and lower SF-36 scores at cohort inclusion, were associated to PK. In addition, 79.7% of the patients had DAS28-remission and 67.1% had SF-36 scores within normal range; interestingly, only 49% of the patients considered broad re-consent and these patients had poorer SF-36 emotional subscore than their counterpart (79±23 vs. 87±1, p=0.02).
CONCLUSIONS:
Poor quality of life impacts the autonomy of RA patients.
