Informed consent for ankle fracture surgery: Patient comprehension of verbal and videotaped information
ABSTRACT The purpose of our study was to evaluate the effectiveness of using a videotape to give patients information about the risks, benefits, alternatives, and treatment of a common orthopaedic procedure before they sign consent forms.
During a 9-month period, 48 patients with isolated closed ankle fractures requiring surgical intervention were randomized into two groups that received either videotaped or conventional verbal information regarding consent for surgery. The study group watched a videotape containing information about the risks, benefits, and treatment alternatives, while the control group obtained this information verbally. To determine comprehension and retention, all patients completed a multiple-choice questionnaire immediately after receiving the information, and 37 patients (77%) were available to complete a questionnaire at an average of 10 weeks later.
The videotape group outperformed the verbal consent group by 40.1% on the initial questionnaire (p = .0002) and by 27.2% on the followup questionnaire (p = 0.0139). Patients with educational levels of less than or equal to the 12th grade performed 67.8% better on the initial questionnaire after watching the video than after receiving the information verbally. (p = .0001).
Patients who received information about their surgery on a videotape before giving their consent demonstrated a significant increase in comprehension compared to patients who received this information verbally. The benefit was even greater for patients with lower education levels.
- SourceAvailable from: Jayaprakash Muliyil
[Show abstract] [Hide abstract]
- "In order to improve the participants' understanding of the information provided, researchers have tried different methods to supplement the traditional informed consent process [5,6,11,24,25]. However, these interventions have shown conflicting results. "
ABSTRACT: Studies on different methods to supplement the traditional informed consent process have generated conflicting results. This study was designed to evaluate whether participants who received group counseling prior to administration of informed consent understood the key components of the study and the consent better than those who received individual counseling, based on the hypothesis that group counseling would foster discussion among potential participants and enhance their understanding of the informed consent. Parents of children participating in a trial of nutritional supplementation were randomized to receive either group counseling or individual counseling prior to administration of the informed consent. To assess the participant's comprehension, a structured questionnaire was administered approximately 48-72 hours afterwards by interviewers who were blinded to the allocation group of the respondents. A total of 128 parents were recruited and follow up was established with 118 (90.2%) for the study. All respondents were aware of their child's participation in a research study and the details of sample collection. However, their understanding of study purpose, randomization and withdrawal was poor. There was no difference in comprehension of key elements of the informed consent between the intervention and control arm. The results suggest that the group counseling might not influence the overall comprehension of the informed consent process. Further research is required to devise better ways of improving participants' understanding of randomization in clinical trials.BMC Medical Ethics 05/2010; 11:8. DOI:10.1186/1472-6939-11-8 · 1.60 Impact Factor
[Show abstract] [Hide abstract]
- "Tissue Eng 2007;13:2601-13. (47) L'Heureux N, Dusserre N, Konig G, et al. Human tissue-engineered blood vessels for adult arterial revascularization. "
ABSTRACT: Ex vivo tissue-engineered products are increasingly entered into clinical trials. To allow prospective participants to make a fully informed, autonomous decision on their participation, we have to adapt the informed consent process by taking the specific aspects of tissue engineering into consideration. New elements in ex vivo tissue engineering are the source and manipulation of the cells in the product, the implantation of the product and the additional risks and benefits due to the construction of the product and its activity in the body. They are the result of the delicate nature of some cell types and of the complexity of the tissue engineering process. The process of informing the participant should be designed in such a way that the participant's capacity to understand the intervention and its implications is enhanced. Crucial issues, such as the aim and procedure of the trial, the risks and benefits involved and the role of the investigator, have to be clarified. We suggest that participants' understanding of the trial can be enhanced through the use of audiovisual material, by developing a simple questionnaire to direct the information process further, and by the assistance of informed third parties to help participants in their decision-making processes.Journal of Tissue Engineering and Regenerative Medicine 06/2008; 2(4):236-41. DOI:10.1002/term.82 · 4.43 Impact Factor
- British Journal of Ophthalmology 08/2005; 89(7):928. DOI:10.1136/bjo.2005.072835 · 2.81 Impact Factor