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עמוד בית
Thu, 21.11.24

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May 2021
Naama Bursztyn MD, Tomer Arad MD, Tamar Fink RN, Jonathan Cohen MD, and Michael Stein MD

Background: Consent rates for organ donation remain one of the most important factors determining the number of organs available for transplantation. Trauma casualties constitute a substantial part of the deceased organ donor pool and have unique characteristics that distinguish them from the general donor population. However, this group has not been extensively studied.

Objectives: To identify donor factors associated with positive familial consent for solid organ donation among trauma casualties.

Methods: This retrospective study included all trauma casualties who were admitted to the Rabin Medical Center, Beilinson hospital, during the period from January 2008 to December 2017, who were potential organ donors. Data collected included demographic features, the nature of the injury, surgical interventions, and which organs were donated. Data was collected from the Rabin Medical Center Trauma Registry.

Results: During the study period 24,504 trauma patients were admitted and 556 died over their hospital course. Of these 76 were potential donors, of whom 32 became actual donors and donated their organs. Two factors showed a statistically significant correlation to donation, namely female gender (P = 0.018) and Jewish religion of the deceased (P = 0.032).

Conclusions: Only a small group of in hospital trauma deaths were potential solid organ donors (13.7%) and less than half of these became actual donors. Consent rates were higher when the deceased was female or Jewish

November 2020
Ilona Voskoboynikov-Ugortsev MPH, Yaakov Rosenfeld MD MPH, and Lital Keinan Boker MD PhD MPH

Background: A thorough informed consent (IC) process is required before in vitro fertilization (IVF) treatments can begin because these treatments are by and large elective and they have expectable and preventable complications, such as ovarian hyper-stimulation syndrome and multi-fetal pregnancies.

Objectives: To empirically examine whether patient knowledge and understanding of potential hazards associated with IVF treatment are better after the IC process compared to before. The authors hypothesized that patients' better understanding of potential complications would be translated and expressed as rational choices of treatment alternatives.

Methods: Responses of 48 IVF patients after IC process (study group) from two IVF units in northern Israel were compared to those of 46 patients before IVF (control group).

Only women undergoing IVF for first time who were older than 18 years of age were eligible for the study.

Results: Socio-demographic parameters were found to be quite similar between the study group and the control group. Contrary to our expectations, in the study group 12 women (25.5%) considered delivery of a single baby as their optimal result, compared to 15 (32.6%) in the control group. Furthermore, preferences shifted toward triplets: eight patients (17%) after IC considered this option as their best result, compared to only five patients (11%) before IC.

Conclusions: IC process goals are not achieved under current practices, at least as far as IVF treatment are concerned. New tools and incentives should be implemented to meet the requirements dictated by the laws regarding patient rights.

August 2012
M. Linder, L. Lev Ari, R. Kurs and Y. Melamed

Background: Patient protection requires the provision of informed consent for participation in medical research. The MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) is frequently used for screening the capacity of research subjects to consent to participate in research.

Objectives: To evaluate the utility of the Hebrew translation of the MacCAT-CR for the assessment of capacity of patients with chronic schizophrenia to provide informed consent to participate in clinical trials.

Methods: We evaluated the translated MacCAT-CR by comparing the capacity of patients with chronic schizophrenia to provide informed consent to participate in clinical trials. The following standardized neurocognitive assessment tools were used: Addenbrooke’s Cognitive Examination (ACE) and Frontal Assessment Battery (FAB), as well as the attending doctor’s assessment.

Results: Twenty-one patients participated. Mean MacCAT-CR score was12 ¡À 10.57 (range 0¨C32), mean FAB score was 9.9 ¡À 4.77 (range 1¨C18), mean ACE was 59.14 ¡À 16.6 (range 27¨C86) and mean doctor’s assessment was 5.24 ¡À 1.18 (range 3¨C7).

Conclusions: The Hebrew-version of the MacCAT-CR helped identify patients with the capacity to provide informed consent for participation in research. Patients with FAB scores ¡Ý 12 tended to score higher on the Hebrew-version of the MacCAT-CR, thus confirming the utility of the Hebrew version of the MacCAT-CR. During the screening process for clinical trials it may be practical to administer the concise FAB questionnaire, and then administer the MacCAT-CR only to those who scored ¡Ý 12 on the FAB.

July 2009
Y. Rosenfeld and A. Strulov

Background: The rate in Israel of in vitro fertilization and embryo transfer procedures is the highest among industrialized countries. The procedure has the potential to make treated patients forever happy, should the desired result occur. It also entails, however, numerous potential complications. Patients who are candidates for the procedure should fully understand potential desired and undesired results, and should give their consent based on this understanding. The question whether currently used informed consent forms for these procedures indeed serve this purpose is, however, open.

Objectives: To explore the usefulness of informed consent forms for IVF&ET[1] that are currently used in Israel to represent the potential benefits and risks of the procedures to the patients.

Methods: Informed consent forms for IVF&ET were scrutinized for accuracy, clarity and relevance, by comparison to relevant medical literature. IVF&ET informed consent forms were also assessed whether they fulfill the requirements of the Israeli Law of Patient's Rights.

Results: Currently used "informed" consent forms for IVF&ET were found to be fundamentally inaccurate and outdated. In some cases (number of embryos to be transferred), the information is grossly obscure. In other cases (alternative management) there are glaring omissions.

Conclusions: Informed consent forms for IVF&ET that are currently used in Israel do not adequately serve their stated purpose. Potential risks and benefits are not presented clearly and alternative management strategies are also missing. Thus, they do not fulfill their social, ethical or legal goals. Updating these forms is urgently needed. New versions should clearly distinguish between common (controllable) and uncommon (uncontrollable) complications.






[1] IVF&ET = in vitro fertilization and embryo transfer


December 2001
Shlomo M. Monnickendam MD, Shlomo Vinker MD, Simon Zalewski MD, Orli Cohen MD and Eliezer Kitai MD, and Research Group of the Department of Family Medicine, Tel Aviv University

Background: Patients’ consent to being part of medical education is often taken for granted, both in primary and secondary care. Formal consent procedures are not used routinely during teaching and patients are not always aware of teaching activities.

Objective: To investigate patients’ attitudes and expectations on issues of consent regarding participation in teaching in general practice, and the influence of a student’s presence on the consultation.

Methods: The study took place in 46 teaching practices during the sixth year clinical internship in family medicine. Patients completed questionnaires at the end of 10 consecutive eligible consultations. The questionnaire contained data on the willingness to participate in teaching, the preferred consent procedure and the effects of the student’s presence. The doctors were asked to estimate the sociodemographic level in their clinic area.

Results: A total of 375 questionnaires were returned; the response rate was not affected by the clinic’s sociodemographic level. Overall, 67% of the patients had come into contact with students in the past; 3.2% of the participants objected to the presence of a student during the consultation; 15% would insist on advance notification of the presence of a student, and another 13.9% would request it; 4% stated that the presence of students had a detrimental influence on the physical examination and history; and 33.6% would refuse to be examined by a student without the doctor’s presence.

Conclusion: Most patients agreed to have a student present during the consultation; some would like prior notification; a minority refused the student’s presence. A large minority would refuse to be examined without the tutor’s presence. Our findings need to be taken into account when planning clinical clerkships.

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