Ability of Family Members to Predict Patient’s Consent to Critical Care Research
Magali Ciroldi, Alain Cariou, Christophe Adrie, Djilali Annane, Vincent Castelain, Yves Cohen, Arnaud Delahaye, Luc Marie Joly, Richard Galliot, Maité Garrouste-Orgeas, Fabrice Michel, Nancy Kenstish Barnes, Benoit Schlemmer, Frédéric Pochard, and Elie Azoulay
APPENDIX 1
Information letter to require written consent to participate to the FAMIREA study
(Patient’s version)
Madam, Sir,
You have been hospitalized in intensive care unit. You are at present on the day of ICU discharge. We are part of a national study group designed at identifying patients and family needs during and after an ICU stay. This group is supported by the French Society for Critical care. We would like to propose you participation in a national study concerning consent to critical care research. For the purpose of this study, we are submitting two virtual scenarios to you your surrogate and your doctor. Although this study has no real implication in your management, we are asking you to reply like if you were really about to decide for your own health. The scenarios are imaginary and may have concerned you several days ago. However, the information you will provide is extremely important for ICU caregivers and for future ICU-patients. Your answer will be compared with these of your surrogate and of your doctor.
The results of this study are and will remain anonymous. They may be presented at national or international conferences and may be the subject of publications where your identity will never be revealed. The aim of this scientific work is to better understand your expectations, and these of your family members, regarding consent to critical care research.
In case you are not willing to participate to this study, please be ensured that this will not interfere in the relation between you, your surrogates and the medical team. We understand that you may be too tired to participate in a study at this time. In case you are willing to participate, the following survey will take you 15 to 30 minutes to fill in the questionnaires at the bottom of each scenario.
The caregiver’s team is at your disposal during the hospitalisation to reply to additional questions regarding this study or your health’s status. Please feel free to ask your nurse or doctor.
Thank you
The ICU Medical team
Scenario I (patient’s version)
Madam, Sir,
You have been admitted to the intensive care unit and as a part of your management, your doctors have decided to provide you with intravenous fluids to correct a dehydration. At present, we have different fluids available: saline serum or gelatine fluid. Each of these fluids is currently used in intensive care units, and doctors may use either or both. We don’t know if one is superior to the other.
We would like to include you in a study designed to compare the efficiency of these two fluids on correction of dehydration. These treatments don’t present any risk and don’t involve additional tests compared to the procedures usually applied generally in intensive care unit. This study is a comparison between two validated procedures that don’t provide any direct benefit for participants of the study.
If you accepted to participate to the study, you will randomly receive either one or the other fluid during your hospitalisation in the intensive care unit. Study’s consent is voluntary and you can refuse to participate. Moreover you can stop your participation at any time. Your decision to participate or not will never influence your management.
The caregiver’s team is at your disposal during the hospitalisation to reply to additional questions regarding this study or your health’s status. Please feel free to ask your nurse or doctor.
Thank you
The ICU Medical team
Scenario II (patient’s version)
Madam, Sir,
You have been admitted to the intensive care unit and as a part of your management, your doctors needed to provide you with mechanical ventilation to assist your lungs. Mechanical ventilation requires the placement of a tube in the trachea under general anaesthesia. This tube is usually introduced through the mouth. As an alternative, the tube may be placed directly in the trachea through the throat during a procedure named “tracheotomy” that is routinely performed in our ICU. The risk of this procedure is tracheal bleeding, a risk considerably lowered by operator experience and by routine tests that are performed before the procedure. The rational for tracheotomy, if performed before the fifth day, is that the duration of ventilatory support and associated complications may be significantly reduced. However, this benefit remains controversial so far.
The aim of this study is to investigate the potential role of early tracheotomy in reducing the length of ventilatory support and the incidence of ventilator associated pulmonary infection.
If you accepted to participate to the study, you will randomly receive either mechanical ventilation via a mouth tube or tracheotomy. Study’s consent is voluntary and you can refuse to participate. Moreover you can stop your participation at any time. Your decision to participate or not will never influence your management.
The caregiver’s team is at your disposal during the hospitalisation to reply to additional questions regarding this study or your health’s status. Please feel free to ask your nurse or doctor.
Thank you.
The ICU Medical team