Patients' Perception of Quality of Pre-Operative Informed Consent in Athens, Greece: A Pilot Study

被引:19
作者
Falagas, Matthew E. [1 ,2 ]
Akrivos, Patrick D. [1 ,3 ]
Alexiou, Vangelis G. [1 ]
Saridakis, Vasilios [4 ]
Moutos, Theofanis [1 ,5 ]
Peppas, George [1 ,6 ]
Kondilis, Barbara K. [1 ,3 ]
机构
[1] Alfa Inst Biomed Sci, Athens, Greece
[2] Tufts Univ, Sch Med, Dept Med, Boston, MA 02111 USA
[3] Hellen Amer Univ, Athens, Greece
[4] Agia Barbara Gen Hosp W Attica, Dept Surg, Athens, Greece
[5] Henry Dunant Hosp, Dept Ophthalmol, Athens, Greece
[6] Henry Dunant Hosp, Dept Surg, Athens, Greece
关键词
DECISION-MAKING; CLINICAL-TRIAL; INFORMATION; PARTICIPATION; FORMS;
D O I
10.1371/journal.pone.0008073
中图分类号
O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];
学科分类号
07 ; 0710 ; 09 ;
摘要
Background: We sought to perform a study to record and evaluate patients' views of the way surgeons communicate informed consent (IC) in Greece. Methodology/Principal Findings: A prospective pilot study was carried out in Athens from 9/2007 to 4/2008. The study sample was extracted from patients, operated by eight different surgeons, who volunteered to fill in a post-surgery self-report questionnaire on IC. A composite delivered information index and a patient-physician relationship index were constructed for the purposes of the analysis. In total, 77 patients (42 males) volunteered to respond to the questionnaire. The delivered information index scores ranged from 3 to 10, the mean score was 8, and the standard deviation (SD) was 1.9. All patients were aware of their underlying diagnosis and reason for surgery. However, a considerable proportion of the respondents (14.3%) achieved a score below or equal to 5. The patient-physician relationship scores ranged from 0 to 20, the mean score was 16 and the standard deviation (SD) was 4.3. The better the patient-physician relationship, the more information was finally delivered to the patient from the physician (Spearman's rank-order correlation coefficient was 0.4 and p<0.001). Delivered information index was significantly higher among participants who comprehended the right to informed consent, compared to participants who did not (p<0.001), and among participants who were given information regarding other possible therapeutic options (p = 0.001). 43% of the respondents answered that less than 10 minutes were spent on the consent process, 58.4% of patients stated that they had not been informed about other possible therapeutic choices and 28.6% did not really comprehend their legal rights to IC. Conclusions: Despite the inherent limitations and the small sample size that do not permit to draw any firm conclusions, results indicate that a successful IC process may be associated with specific elements such as the patient-physician relationship, the time spent by the physician to inform the patient, a participant's comprehension of the right to IC and the provision of information regarding other possible therapeutic options.
引用
收藏
页数:6
相关论文
共 23 条
[1]   Residents' ability to identify patients with poor literacy skills [J].
Bass, PF ;
Wilson, JF ;
Griffith, CH ;
Barnett, DR .
ACADEMIC MEDICINE, 2002, 77 (10) :1039-1041
[2]   Hospital informed consent for procedure forms - Facilitating quality patient-physician interaction [J].
Bottrell, MM ;
Alpert, H ;
Fischbach, RL ;
Emanuel, LL .
ARCHIVES OF SURGERY, 2000, 135 (01) :26-33
[3]   INFORMED CONSENT - WHY ARE ITS GOALS IMPERFECTLY REALIZED [J].
CASSILETH, BR ;
ZUPKIS, RV ;
SUTTONSMITH, K ;
MARCH, V .
NEW ENGLAND JOURNAL OF MEDICINE, 1980, 302 (16) :896-900
[4]  
CHRISTOPOULOS P, 1977, WORLD J SURG, V31, P1587
[5]   Informed consent and decision-making: patients' experiences of the process of recruitment to phases I and II anti-cancer drug trials [J].
Cox, K .
PATIENT EDUCATION AND COUNSELING, 2002, 46 (01) :31-38
[6]   Randomized, controlled trial of an easy-to-read informed consent statement for clinical trial participation: A study of the eastern cooperative oncology group [J].
Coyne, CA ;
Xu, RH ;
Raich, P ;
Plomer, K ;
Dignan, M ;
Wenzel, LB ;
Fairclough, D ;
Habermann, T ;
Schnell, L ;
Quella, S ;
Cella, D .
JOURNAL OF CLINICAL ONCOLOGY, 2003, 21 (05) :836-842
[7]   Informed consent for clinical trials: a comparative study of standard versus simplified forms [J].
Davis, TC ;
Holcombe, RF ;
Berkel, HJ ;
Pramanik, S ;
Divers, SG .
JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE, 1998, 90 (09) :668-674
[8]  
DAWES PJD, 1994, J ROY SOC MED, V87, P149
[9]   Development of a measure of informed choice suitable for use in low literacy populations [J].
Dormandy, Elizabeth ;
Tsui, Elaine Y. L. ;
Marteau, Theresa M. .
PATIENT EDUCATION AND COUNSELING, 2007, 66 (03) :278-295
[10]   A brief measure of perceived understanding of informed consent in a clinical trial was validated [J].
Guarino, P ;
Lamping, DL ;
Elbourne, D ;
Carpenter, J ;
Peduzzi, P .
JOURNAL OF CLINICAL EPIDEMIOLOGY, 2006, 59 (06) :608-614