ABSTRACT
Although many new interventions including changes in diagnostic policies are performed to increase the rates of diagnosis of brain death (BD) and organ donation in recent years in Turkey, data about the longitudinal effects are limited. The aim of this study was to understand the current status of organ donation in İzmir and to find out whether new regulations have any effect on the diagnosis of BD and organ donation rates.
All patients diagnosed with BD between January 2001 and December 2016 in a tertiary university hospital were included, and patient data and organ donation status were collected from medical records.
There were 303 patients diagnosed with BD during the study period. The most common reason in the pediatric group (n=42) was traumatic brain injury (42.9%) and 12 of these patients (28.6%) became organ donors. In the adult patient group (n=261), the most common reason was intracranial hemorrhage (39.8%) and 97 patients (37.2%) became organ donors. The rate of BD diagnosis increased over the years (from 0.59% to 0.67% after legal regulation), but there was no increase in organ donation rate (39.5 vs 26.5%). The most common cause of ineligibility for donation was refusal by patient’s relatives in both pediatric and adult patients (83.3% and 86.6% respectively).
This study shows that although the diagnosis of BD has increased over the years, organ donation rates are still low in İzmir. New strategies aiming to increase awareness and change the perception of organ donation should be planned as soon as possible.
Keywords: Organ donation, brain death, refusal
Introduction
Although treatment options and technology in healthcare are growing exponentially, transplantation is still the main solution for organ failures. The disparity between the number of required organs for transplantation and the number of donor organs continues to be an important problem in many countries. Some countries such as Spain made comprehensive approaches with successful results and optimized performance in deceased donation, leading the country to an activity of 32-35 donors per million population (1,2). But these programs are still very limited to few countries in Europe.
Turkey is one of the countries with serious problems in organ donation. In 2017, around 25000 patients are in the waiting list for organ donation. However, amongst 12,000 patients diagnosed between 2011-2017 years as brain death (BD) only 25% had organ donation (3). The current legal regulation for BD and organ donation in Turkey was published in February 2012 and revised in January 2014 (4,5). The revision consisted of decreasing the need of four physicians (anesthesiologist, neurologist, neurosurgeon and cardiologist) to two (a neurologist or a neurosurgeon, and an anesthesiologist or an intensivist) to prevent delays in the diagnosis of BD. In addition to that, the Ministry of Health in Turkey started a project together with European Union (EU) which is aimed to develop quality and safety standards for human organ donation and transplantation, to harmonize of the EU acquis communautaire in the area cadaveric organ donation, to strengthen database structure and to increase donation rates (6). Other than those, Ministry of Health initiated an awareness campaign throughout the country in order to increase organ donation (7). The campaign consisted of information for not only the importance of organ donation but also religious perspective through media (television, radio and other social media channels) and in-hospital transplantation team services.
Although the aim of all these policies is to increase awareness and therefore the rates of diagnosis of BD and organ donation, the longitudinal effects are not very well known. The objective of this study is to understand the current status of organ donation at a University Hospital in İzmir and find out whether these new regulations have any impact on BD diagnosis and organ donation rates.
Materials and Methods
Study population: The study was approved by Dokuz Eylul University Local Ethics Committee (protocol number: 2017/04-19) and conducted in a tertiary reference university hospital with 73 intensive care unit (ICU) beds. All adult and pediatric patients diagnosed with BD between January 2001 and December 2016 were included into the study. Data from medical records and hospital database were collected retrospectively. Patient demographics (age, gender), reasons for hospitalization, physical examination findings, tests performed for confirmation of BD transcranial doppler (TCD), computed tomographic angiography (CTA), electroencephalography (EEG), single photon emission computed tomography (SPECT), cerebral scintigraphy, the final status for organ donation, reasons for ineligibility for organ donation (medical problems, patients relatives refusal and other reasons) were recorded. Patients were grouped according to age: pediatric group (<18 years) and adult group (≥18 years).
The diagnosis of BD: The diagnostic criteria for BD was same throughout the study period: Clinical evaluation of BD was performed in the presence of a severe structural brain lesion, a Glasgow Coma Scale score of 3/15, and absence of brainstem reflexes in normothermic patients according to current legal regulations made by Ministry of Healt in Turkey (8). Ancillary methods were used in some patients for confirmation of BD according to neurological evaluation. The study period was divided into two parts because of change in the criteria for the diagnosis of BD. According to regulatory laws for BD and organ donation in Turkey, the diagnosis of BD was made by a team of four physicians (anesthesiologist, neurologist, cardiologist and neurosurgeon) between January 2001 to December 2013 (Period 1). From January 2014, the diagnosis of BD was made by a team of two physicians (neurologist/neurosurgeon and anesthesiologist/intensivist) (Period 2). In order to understand the impact of regulatory change, we compared the rates of BD and organ donation for both periods.
Statistical Analysis
We conducted a retrospective cohort study and reported its results in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology guidelines (9). The primary outcome of the study was whether the rate of BD diagnosis changed within years and new regulations made any impact on the diagnosis and organ donation. All categorical variables are expressed as numbers and percentages and continuous variables are expressed as mean and standard deviation (SD).
Chi-square or Fisher’s exact tests were used to compare categorical variables between groups; Student’s t-test or Mann-Whitney U test were used to campare continuous variables. A two-tailed p value of <0.05 was considered statistically significant. SPSS was used for statistical analysis (SPSS Version 20; IBM Corporation, Armonk, NY, USA) program.
Results
During study period, 303 patients were diagnosed with BD; 42 (13.9%) of them were in pediatric group, whereas 261 (86.1%) patients were in adult group (Figure 1).
Pediatric patients: The mean ± SD age was 9.7±6.1 years and 26 (61.9%) were male. The most common reason for BD was traumatic brain injury (42.9%) followed by anoxic brain injury (14.3%) (Table 1). The apnea test was positive in 38 patients (90.5%) and 4 patients’ data is unavailable (9.5%). Eighteen patients had the diagnosis of BD with clinical evaluation only. An ancillary test was performed in the rest of patients (n=24, 57.9%) and the most commonly used ancillary method in this age group was EEG (41.7%) (Table 2).
Twelve patients (28.6%) were organ donors and the rest of patients (n=30, 71.4%) were not eligible for organ donation. The most common cause of ineligibility for donation was refusal of parents/patient’s relatives (n=25; 83.3%) (Table 3).
Adult patients: In adult patients the mean ± SD age was 47.6±18.3 years and 169 (64.8%) were male. The most common reason for BD was intracranial hemorrhage (39.8%) followed by traumatic brain injury (19.2%) and ischemic stroke (15.3%) (Table 1). The apnea test was positive in 217 patients (83.1%) and couldn’t be completed in 44 patients (16.8%) (in these patients, TCD was used in 8, CTA was used in 9 as an ancillary method. Other 27 patients’ data is unavailable). TCD and CTA were the most commonly used ancillary method (44.6 and 39.3% respectively), followed by SPECT (8.9%) (Table 2).
Ninety-seven patients (37.2%) were organ donors and 164 patients (62.8%) were not eligible to organ donation. The most common cause for ineligibility for organ donation was refusal of patients’ relatives (86.6%) (Table 3).
The rate of BD diagnosis and organ donation within study years: The rate of diagnosis of BD is increased throughout the study period but this increase was not accompanied by organ donation rates (Figure 2). During Period 1 (2001-2013), amongst patients admitted to ICU, the rates for BD diagnosis and organ donation were 0.59% (220/36866) and 39.5% (86/220) respectively. During Period 2 (2014-2016), which is after the change in diagnostic approach, the rate of diagnosis for BD was increased to 0.67% (83/12447) but organ donation rate was 26.5% (22/83) (Figure 3).
Discussion
The present study has two important results: First, the diagnosis of BD is increasing within years in our center, however this was not accompanied by organ donation rates. Second, the main reason for ineligibility for organ donation was refusal from patient relatives in both pediatric and adult age groups.
Recently, Ministry of Health in Turkey declared important regulatory changes in order to increase organ transplantation rates. First, the reimbursements for the diagnosis of BD and organ transplantation procedures are increased in order to encourage physicians. Second, the certification of BD was performed with two physicians after policy changes in 2014. These regulatory changes were expected to facilitate the rate of diagnosis of BD. In our study, although there is a huge variation between years, the number of diagnosis of BD is slowly increasing within time in our center. This finding is consistent with Ministry of Health data in which the number of BD diagnosis was increased from 1313 in 2011 to 2042 in 2017. Harmanci Seren and Yavuz (10) also reported that the number of the diagnosis of BD increased nearly 5 times between 2005 and 2015 in İstanbul province and they commented that the increase is mainly due to increase in the number of transplant centers. Overall, the rate of BD diagnosis is increasing but it still is very low than expected as Turkey’s population is more than 80 million. Currently, similar to Spanish model, transplant coordinators are actively working in many tertiary reference hospitals in Turkey however we think that further improvements are needed to have successful networking between transplant team and ICU physicians which is definitely a key step to enhance BD diagnosis. In addition interventions which aim to educate physicians and other health care personnel for assessment and determination of BD should continuously be reinforced.
In Turkey two clinicians with specific departments are required to diagnose BD. There is a huge variability of knowledge and practices for BD declaration among physicians despite there are clear algorithms for the diagnosis (11-13). It was reported that asynchrony between physicians may cause problems not only in the diagnosis of BD but also organ donation. It was previously reported that the difference in attitude of physicians might be an obstacle for BD diagnosis. A study of Kosieradzki et al. (14) showed that in Polish physicians difference in BD diagnosis procedure was considered as an important barrier especially in centers with low rates of organ donation. Varelas et al. (15) reported that BD certified with a single physician is easier, faster and more cost effective when compared to diagnosis with two physicians.
In this study, the overall organ donation rate was 37.2% in adults and 28.6% in the pediatric group, which is relatively lower than expected. Donor problem is still an important obstacle for organ transplantation in Turkey (16,17). Deceased donation rates per million population was 5.1 which is much lower than European Countries (16,17). According to 2017 data of Ministry of Health, only 26% of patients with BD proceeded to organ donation (3). We have found that, family refusal seems to be the main obstacle for organ donation and refusal rate is much higher than previously reported. This finding is contrary to other countries data in which the most common reason for ineligibility for organ donation was medical problems (17-20). Matesanz et al. (2) reported that the donation rate in Spain between 1999 and 2008 was between 50 to 60%, and main obstacle in organ donation was due to medical contraindications whereas refusal from relatives was reported around 10-15%. Similar to that, in a study performed in 42 Spanish centers, Escudero et al. (18) reported overall family refusal rate as 13%. We think that the refusal of patient’s relatives for organ donation needs specific attention, as there was no much change throughout the study years. Although, there are many programs conducted by Ministry of Health, more effective comprehensive interventions for sustainability of deceased donor should be planned according to national needs (21). Moreover, we think that socio-cultural and religious characteristics of the country should be taken into account in order to establish successful organ donation models. Certain profession groups, such as health care professionals, teachers, religion officers, which are role models and have influence for changing the behavior throughout the society should be targeted to achieve a snowball effect for improved attitudes towards donation (22). In a study performed in health care professionals it was shown that only a quarter of them owned a donation card, whereas this rate was found as low as <1% in religion officers (23,24).
When it is considered about family decision, If the family knows that the deceased person wants to be a donor, this affects positively the decision-making process. If the family does not know the deceased’s wishes, this affects negatively the decision-making process. The other important factor is giving to the family sufficient time during the process. The families need time to make a decision. Another important factor is the dissatisfaction with the healt care system and this affects negatively the family during this process. If the family don’t know sufficient information about the BD, this affects negatively the process. Health care professionals should be continuously trained about organ donation process (25).
Patient’s relatives expressed that they did not have enough information about donation process in Turkey. The ratio of organ donation from deceased donor is still low. Sufficient resources, research, and education should be planned increasing organ donation from deceased donor (26).
The study has limitations. First, the study was a retrospective study performed in a tertiary center therefore we think that our results may not be generalizable. Second, because of the retrospective nature of the study, detailed reasons for family refusals for organ donation is unknown. Third, we could not be able to analyze whether new policy for the diagnosis of BD shorten the time needed for the diagnosis. However the present study have important strengths. First it gives a perspective about the trends for the last 16 years of BD and organ donation in our Institution (in Turkey). Second we had the opportunity to better understand the effect of recent change in policy for the diagnosis of BD. Finally we think that our study gives important insights for the main obstacles and possible future solutions for organ donation.
Conclusion
Our study confirms that although changes in policies resulted to a positive impact to rate of BD diagnosis, this was not accompanied by organ donation in İzmir. New strategies which aim to increase population awareness and change in perception for organ donation/transplantation should be planned as soon as possible. In addition, training of health care professionals for good, informative and crystal clear communications with patient relatives should be encouraged.
