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    Item type:Publication,
    Reduced quality of life impacts knowledge and type of informed consent in rheumatoid arthritis patients
    (Clinical and Experimental Rheumatology S.A.S, 2019)
    Pascual-Ramos, Virginia
    ;
    Contreras-Yáñez, Irazú
    ;
    Ruiz, Daniel
    ;
    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. © The authors © Clinical and Experimental Rheumatology ©
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    Item type:Publication,
    Attitudes about principle of autonomy in Hispanic patients from a dynamic early rheumatoid arthritis cohort
    (Clinical and Experimental Rheumatology S.A.S., 2019)
    Pascual-Ramos, Virginia
    ;
    Contreras-Yáñez, Irazú
    ;
    Ruiz, Daniel
    ;
    Objetives: In 2004, we began assembling an incidental cohort of patients with recent-onset rheumatoid arthritis (RA). In February 2018, we performed a cross-sectional study with the objective to investigate patients' attitudes/knowledge regarding the autonomy principle. Methods: Patients currently attending the cohort (n=146) were invited to participate. A 4-dimensional questionnaire was administered, and a rheumatologic evaluation performed in the 143 patients who agreed to participate. Dimension-4 (D-4) included 7 multiple-choice (strongly agree-strongly disagree) sentences, 3 of which were related to patients' rights/obligations about health-related decisions (group-1), and 4 additional sentences challenged physician's recommendations (group-2). The D-4 score was considered a surrogate of knowledge autonomy (KA). Additionally, the surveyor scored KA with a Likert scale (poor, borderline and superior), and a cut-off point for poor KA was set using Borderline methodology. Mann-Whitney U-tests and logistic regression analysis were used. The study received IRB approval. RESULTS: At the time the questionnaire was administered, mean (±SD) patient age was 46.9 (±13.6) years, and median (interquartile range) cohort follow-up time was 8.8 (4.3-11.9) years. Fifty-one patients (35.6%) had poor KA; increased age (OR: 0.97, 95% CI: 1.004-1.063, p=0.023) was associated with better KA. Patients more frequently agreed-strongly agreed with group-1 sentences than they did with group-2 sentences (86.7% vs. 58%, p≤0.001). The results were reproduced in the subpopulations with sufficient KA (98.9% vs. 88%, p=0.007) and poor KA for patients in whom the gap was extreme (64.9% vs. 3.9%, p≤0.001). Conclusions: Hispanic RA patients' sense of autonomy suggests paternalism in the physician-patient relationship. © The authors © Clinical and Experimental Rheumatology
    Scopus© Citations 7  33  1