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Volume: 15 Issue: 1 February 2017 - Supplement - 1


Difficult Consent Scale: An Assessment Scale for Anticipated Difficulty in Obtaining Consent for Organ Donation

Objectives: Seeking consent for organ procurement from a brain-dead patient’s family is challenging, especially in developing countries. In the Middle East, legislation necessitates an opt-in system that engages all first-degree relatives. To improve our success rate in the Masih Daneshvari Organ Procurement Unit in Tehran, Iran, we invented a scale for the consent process to predict the degree of difficulty of each family interview before venturing into it.

Materials and Methods: We reviewed the records of brain-dead patients treated in our unit over the previous 10 years. Focusing on cases where families refused to donate organs, we searched for determinants that played a role in the final results. We extracted minor and major determinants, then ascribed a 3-level scale to each determinant (from 1, easiest, to 3, most difficult). We thereby obtained a clear assessment of each consent-taking session based on determinants from real encounters.

Results: We analyzed 150 brain-dead patients and extracted 17 determinants: 2 major and 15 minor. We grouped these into 3 distinct categories: A, patient-related; B, family-related; C, hospital-related.

Inspired by the Glasgow Coma Scale, we named our scale the “Difficulty Consent Scale,” in which a score of 15, using the minor determinants, indicates the easiest scenario for obtaining consent and 45 indicates the most difficult scenario. The 2 major factors function as coefficients to either double or halve the degree of difficulty.

Conclusions: This speculative model may help the managers of organ procurement units choose the best-suited person for any family interview, and it may help clinicians attempting to obtain consent to compare their results over time. Our model must be tested in a real context to discover its predictive power.

Key words : Brain dead


Iran has the highest rate among Asian countries of donation after brain death, with a donation rate of 10.3 per million people in 2015. According to Iranian law, consent for donation after brain death must be obtained from the brain-dead patient’s first-degree relatives (the so-called “vali-e dam” which literally means “blood owner”). Even if the brain-dead patient themself previously agreed to donate their organs, the final legal decision rests with their vali-e dam.

This makes the process of obtaining consent in Iran, and in many Islamic-Arabic countries in the Middle East, very different from the Western paradigm, where the individual’s wishes are most important. The consent session in Iran is usually held with several members of the brain-dead patient’s family, sometimes from 3 different generations, and reaching any sort of consensus can be very challenging. Failure to obtain consent from this heterogeneous group can cost the lives of patients on wait lists; for this reason, it is necessary to make this seemingly subjective process more objective.

Materials and Methods

The study was approved by the Ethical Review Committee of the Institute. All of the protocols conformed to the ethical guidelines of the 1975 Helsinki Declaration. Written informed consent was obtained from all participants.


A total of 17 determinants were extracted from the records (Table 1). The 2 major factors were the individual’s wishes (I) and the religious belief (both the individual’s and/or the family members’) involved (R); there were 15 minor factors. All factors were grouped into 3 distinct categories. Category A consisted of patient-related factors: age, duration of brain death, individual’s wishes, and individual’s religious belief. Category B consisted of family-related factors: ethnicity, total number of first-degree relatives, socioeconomic status, financial expec­tations, values and attitudes, previous experience of donation, previous knowledge of brain death, trust in medical system, waiting for a cure or miracle, difficulty in gathering the main relatives, and the family’s religious beliefs (note that the religious belief related to the individual and/or the family members regarding organ donation was considered as one item in the final score.) Category C consisted of hospital-related factors: complaint that family may have from the hospital services, in-charge physician and nurse attitudes, and the time and place of the family approach.


Inspired by the Glasgow Coma Scale, we named our scale the Difficulty Consent Scale. For each minor factor, there are at least 3 levels of difficulty, scored accordingly. We judged the level of difficulty according to the results obtained in each case.

For example, in the age category, we found that if the brain-dead patient is between 20 and 50 years of age, the chance of obtaining consent is less than in the 2 other age groups (< 20 years and > 50 years). Our results confirm that brain-dead patients aged greater than 50 years have the best outcome for obtaining consent for organ donation. We therefore assigned the easiest score of 1 to this age group. We assigned the score of 2 to the age group less than 20 years, and the score of 3 (most difficult) to those patients between 20 and 50 years of age.

In Table 1, we list the determinants and their subcategorization into 3 levels of difficulty. It must be emphasized that the determination of difficulty level is based on our own experience and reflects the context we face in Iran. This may be completely different in another country with different social characteristics. After assigning a score to each determinant and summing all the individual scores, we obtained a total score. A total score of 15 is considered the easiest situation for obtaining consent, and a score of 45 indicates the most difficult scenario.

We listed 2 major factors as coefficients that either double or halve the degree of difficulty in obtaining consent. We used the letters “I” or “R,” as described above, as the numerator or denominator of the equation, depending on their negative or positive effect on the consent process. For example, “15 × 1/IR” indicates the easiest scenario, in which the brain-dead patient’s individual wishes (I) and the religious beliefs involved (R) are compatible with organ donation; “45 × IR” is the most difficult scenario, with both the individual’s wishes and the religious beliefs involved opposing donation.


The DSC model can help Middle-Eastern organ procurement unit managers to choose the best-suited person to give consent in a given family. The model can also quantitatively compare the results, over time, of different clinicians attempting to obtain consent for donation. This model is preliminary and must be tested in all Arabic-Islamic countries to determine its final shape. The next phase will be a prospective study to evaluate the model’s predictive power.

Volume : 15
Issue : 1
Pages : 57 - 59
DOI : 10.6002/ect.mesot2016.O41

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From the Lung Transplantation Research Center, Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Acknowledgements: The authors declare that they have no sources of funding for this study, and they want to thank of all organ procurement coordinators in Masih Daneshvari Hospital.  
Corresponding author: Masoud Mazaheri, No 2032, Golshan St, Golzar St, Nobonyad Sq, Tehran, Iran
Phone: +98 93 5942 7171