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  • A pilot study was carried out from September 2007 to April 2008. The study sample was extracted from patients, operated by seven general surgeons (one working at a private hospital and six at a state hospital), and one ophthalmologist (working at a private hospital) in association with the Alfa Institute of Biomedical Sciences (AIBS) Athens, Greece. Surgeons asked certain patients to voluntarily participate in this survey. There was no specific protocol or methodology on the selection of the participants of this survey as this was a convenience sample. Written informed consent was taken by the participants and the study was approved by the Ethics Comittee of AIBS in collaboration with Hellenic American University. According to Greek institutional policies, patients signed a legal form that certifies that they have been informed on the nature, risks, and benefits of the surgery and that they consent to all required medical procedures including anaesthesia. Self-report measures are important tools for understanding the IC process[14]. We developed a questionnaire of several items (Appendix S1), organized in four parts: a) questions regarding general demographic information (gender, marital status, age, education level, profession, ethnicity and place of residence) (Appendix S1 - general information questions 1–8); Questions about the number of children, the place of residence and the profession of the respondents were not used in the analysis b) questions regarding the information delivered to the patient through the IC process (substantial elements of information that should be provided by the surgeon and recalled by the patient) (Appendix S1 – part I questions 1,2,4–11); c) questions regarding the perception of significance, the proper application and comprehension of the IC process (Appendix S1 – part II questions 1–9); d) questions regarding the patient-physician relationship (Appendix S1 – part III questions 1–9) and respondents' opinion on the questionnaire itself (Appendix S1 – part III question 10). The questionnaire was developed taking into consideration current literature regarding the goals and requirements for IC. There was only one version that was used in this pilot study. A research assistant was available at all times to assist the participants to complete the questionnaire. The assistant answered questions regarding the comprehension of the questionnaire. To better serve the purposes of this exploratory pilot study we constructed a composite delivered information index. One point was given for every “positive” answer (answer indicating that the certain element of information was successfully delivered to the patient) to the 10 questions presented in Table 1 (Appendix S1 part 1 questions 1–2, 4–11). The delivered information index ranged from 0–10. Furthermore, we constructed a respective patient-physician relationship index using a Likert type scale methodology. Responses to the five questions presented in Table 2 (Appendix S1 part III questions 2–6) were scored and added. The patient-physician relationship index ranged from 0–20. Categories of education were combined; participants were divided into 2 groups; the first had secondary education or higher, and the second group had elementary education or lower. The eight participating surgeons were grouped into those practicing in a private hospital (one general and one ophthalmic surgeon) and those practicing in a state hospital (six general surgeons). Table data removed from full text. Table identifier and caption: 10.1371/journal.pone.0008073.t001 Responses to questions of the composite delivered information index*. *Appendix S1 part 1 questions 1–2, 4–11. Table data removed from full text. Table identifier and caption: 10.1371/journal.pone.0008073.t002 Responses to questions investigating the patient-physician relationship*. *Appendix S1 part III questions 2–6. Mann-Whitney U test was used to detect differences in the patient-physician relationship index and delivered information index (Table 3) when the sample was grouped according to gender, age, and education level (Appendix S1 general information questions 1, 3, and 5), comprehension of the right to IC, delivery of information regarding other therapeutic choice, perception of importance of IC (Appendix S1 part III questions 1,2 and 8), and surgery in state or private hospital (as derived by the grouping of the participating surgeons). Spearman's rank-order was used to measure the correlation between the indexes of delivered information and patient-physician relationship, as well as between delivered information index and age and finally between patient-physician relationship index and age. All reported P-values are based on two-sided tests and compared to a significance level of 5%. SPSS version 15.0 software (SPSS Inc. 2007, Chicago, Illinois, USA) was used for statistical calculations. Table data removed from full text. Table identifier and caption: 10.1371/journal.pone.0008073.t003 Subgroup comparisons. IC: informed consent, SD: standard deviation, all p values<0.05 are presented in bold fonts.
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