PMID- 30148443
OWN - NLM
STAT- Publisher
LR  - 20180827
IS  - 0392-856X (Print)
IS  - 0392-856X (Linking)
DP  - 2018 Jul 18
TI  - Reduced quality of life impacts knowledge and type of informed consent in
      rheumatoid arthritis patients.
AB  - 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.
FAU - Pascual-Ramos, Virginia
AU  - Pascual-Ramos V
AD  - Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Medicas
      y Nutricion Salvador Zubiran, Mexico City, Mexico. virtichu@gmail.com.
FAU - Contreras-Yanez, Irazu
AU  - Contreras-Yanez I
AD  - Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Medicas
      y Nutricion Salvador Zubiran, Mexico City, Mexico.
FAU - Ruiz, Daniel
AU  - Ruiz D
AD  - Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Medicas
      y Nutricion Salvador Zubiran, Mexico City, Mexico.
FAU - de la Luz Casas-Martinez, Maria
AU  - de la Luz Casas-Martinez M
AD  - Centro de Investigacion en Bioetica, Universidad Panamericana, Mexico City,
      Mexico.
LA  - eng
PT  - Journal Article
DEP - 20180718
PL  - Italy
TA  - Clin Exp Rheumatol
JT  - Clinical and experimental rheumatology
JID - 8308521
EDAT- 2018/08/28 06:00
MHDA- 2018/08/28 06:00
CRDT- 2018/08/28 06:00
PHST- 2018/02/16 00:00 [received]
PHST- 2018/04/24 00:00 [accepted]
PHST- 2018/08/28 06:00 [entrez]
PHST- 2018/08/28 06:00 [pubmed]
PHST- 2018/08/28 06:00 [medline]
AID - 12710 [pii]
PST - aheadofprint
SO  - Clin Exp Rheumatol. 2018 Jul 18. pii: 12710.