a) Socio-demographic data | |||
Patient code |
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Age |
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Address |
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Marital status |
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Educational level |
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Employment status |
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b) Informed-consent Questions (Modified Dr. Brezis Questionnaire) | |||
1) Nature of the surgery (Pre-operative diagnosis + Surgical procedure) | Known name (3) | Known nature (1) | Unknown (0) |
2) Evaluation of the consent form in the patient’s file by the principal investigator (content and signature) | Present signed (3) | Present unsigned (1) | Absent |
3) Did you have enough time to think, seek advice and consult others before signing the form | Yes, well in advance (2) | No, or on the day of surgery (0) | |
4) Who brought the form to you and asked you to sign it | Treating Ob/Gyn | Resident in Ob/Gyn | Other hospital staff (nurse, anaesthesiologist) |
5) Did you read the consent form before signing it? | Yes | Partially | No |
6) Why did you not read the consent form? (open-ended) |
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7) Who accompanied you when you signed the consent form? | Spouse | Relative or Friend | Nobody |
8) To what degree was the information you received about your procedure sufficient, clear and detailed? | It was sufficient, clear and detailed (3). | It was not sufficient, clear, and detailed (1). | I am not sure, or I received no explanation (0). |
9) Did you receive an Explanation of the treatment risks? | Yes (2) | No (0) | |
10) List any risks you remember as regards your surgery (qualitative) |
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11) Did any risks prompt you to consider refusing surgery? (qualitative) |
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12) Would you have wanted more explanation of these risks? | No | I am not sure | Yes |
13) Did you receive an explanation about alternative options for this treatment? For example, were you told about other forms of therapy available | Yes (2) | No (0) | |
14) From whom did you receive most of the explanations? | Consultant (treating) Ob/Gyn | Resident Ob/Gyn or Other hospital staff | I did not receive explanations |
15) To what degree did you feel comfortable asking questions? | A lot | A little | Not at all |
16) Who do you think made the final decision about the treatment? | Patient (2) | Patient and treating physician together (1) | Physician (0) |
17) Would you have wanted to be more involved in the treatment decision? (qualitative) |
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18) To what degree are you satisfied with the process of deciding on the treatment? | Satisfied | Somewhat satisfied | Not satisfied at all |
19) Were you asked whether you understood the explanation? | Yes | I do not remember | No |
20) Could you repeat the explanation now? | Yes | I cannot remember | Somewhat I did not receive any explanation |
21) Do you know any expected benefits from your surgery? | Known (2) | Unknown (0) | |
22) List these benefits (qualitative) |
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23) Will there have been consequences if you refused surgery? | Known (2) | Unknown (0) | |
24) List these consequences (qualitative) |
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