ANALYSIS OF DATA FROM THE POTENTIAL DONOR AUDIT
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ANALYSIS OF DATA FROM THE POTENTIAL DONOR AUDIT

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POTENTIAL DONOR AUDIT 12-MONTH SUMMARY REPORT 1 APRIL 2003 – 31 MARCH 2004 1 INTRODUCTION 1.1 Fully validated data from the Potential Donor Audit (PDA) for the first financial year are now available. The dataset used to obtain the results for this report comprises data for all audited patient deaths in UK Intensive Care Units (ICUs) over the period 1 April 2003 to 31 March 2004, as recorded on the National Transplant Database (NTxD). It is based on PDA forms received by UK Transplant on or before 6 August 2004, input onto the NTxD and validated. This report summarises the main findings of the PDA over the 12-month period. 1.2 The results described in this report should be regarded with some caution for two reasons. First, some of the subgroup analyses are based on relatively small numbers of individuals and as a consequence some of the percentages quoted suffer from a lack of precision. Second, UK Transplant were still receiving completed PDA forms for the period from January to March 2004 at the time of analysis and so the results summarised in this report are subject to change. Further note that this report refers to potential heartbeating (HB) donors defined as patients for whom death was diagnosed following brain stem tests and who had no absolute medical contraindications to HB solid organ donation. 2 SUMMARY OF KEY POINTS 2.1 In the 12-month period from 1 April 2003 to 31 March 2004, 341 ICUs in 284 different hospitals in the UK ...

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1 1.1
1.2
2 2.1
POTENTIAL DONOR AUDIT 12-MONTH SUMMARY REPORT 1 APRIL 2003 – 31 MARCH 2004
INTRODUCTION
Fully validated data from the Potential Donor Audit (PDA) for the first financial year are now available. The dataset used to obtain the results for this report comprises data for all audited patient deaths in UK Intensive Care Units (ICUs) over the period 1 April 2003 to 31 March 2004, as recorded on the National Transplant Database (NTxD). It is based on PDA forms received by UK Transplant on or before 6 August 2004, input onto the NTxD and validated. This report summarises the main findings of the PDA over the 12-month period.
The results described in this report should be regarded with some caution for two reasons. First, some of the subgroup analyses are based on relatively small numbers of individuals and as a consequence some of the percentages quoted suffer from a lack of precision. Second, UK Transplant were still receiving completed PDA forms for the period from January to March 2004 at the time of analysis and so the results summarised in this report are subject to change. Further note that this report refers to potential heartbeating (HB) donors defined as patients for whom death was diagnosed following brain stem tests and who had no absolute medical contraindications to HB solid organ donation.
SUMMARY OF KEY POINTS
In the 12-month period from 1 April 2003 to 31 March 2004, 341 ICUs in 284 different hospitals in the UK reported at least one patient death. During the period there were a total of 22,667 audited patient deaths. A detailed breakdown of the 22,667 audited patient deaths is given in Figure 1 and Table 1 summarises the key percentages.
Figure 1 A breakdown of the 22,667 audited patient deaths Audited patient deaths 22,667 Was the patient ever on mechanical ventilation? Yes No 20,689 1,978 Was brain stem death a likely diagnosis? Yes No 2,143 18,546 WWererberabirnaistnesmtedmeattehstsesptserpfeorrfomremde?d? Yes No 1,433 710 Was death diagnosed following brain stem tests? Yes No 1,386 47 Were tWhereabnrayinabssteomludteamthetdeisctaslpceornftorraimneddi?cations to HB solid organ donation?* Yes No 7 1,379
Was the subject of HB solid organ donation considered? Yes No 1,270 109 Were the next of kin approached for permission for HB solid organ donation?$ Yes No 1,181 89 Was consent for HB solid organ donation given by the next of kin? Yes No 690 491 Did HB solid organ donation occur? Note: HB Heartbeating Yes No* Absolute medical contraindications – either known or suspected CJD or known HIV positive 621 69$ Includes cases where the next of kin made the approach 1
3 3.1
3.2
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4.1
4.2
Table 1
Summary of key percentages
Patients on mechanical ventilation at some point during their stay in ICU Potential donors No record of discussion/approach regarding HB solid organ donation with the next of kin Consent given for HB solid organ donation Consent not given for HB solid organ donation Actual HB solid organ donors (based on data provided through the PDA)
OVERALL RELATIVE REFUSAL RATE
 N 20,689
1,379
198
690
491
621
% 91% of 22,667 audited patient deaths
7% of 20,689 patients on mechanical ventilation
14% of 1,379 potential donor families
58% of 1,181 families who were approached
42% of 1,181 families who were approached
90% of 690 patients with family consent; 45% of 1,379 potential donors
Relative refusal rate is based on potential donors, for whom HB solid organ donation was considered and the next of kin were approached for permission (or made the approach). The relative refusal rate is the proportion of these families who did not consent to HB solid organ donation.
During the 12-month period, the overall relative refusal rate was 42% and the 95% confidence limits for this percentage range from 39% to 45%. TEMPORAL VARIATION IN THE REFUSAL RATE The month-to-month variation in relative refusal rate is illustrated in Figure 2. The refusal rate was highest in April 2003 (56%) and lowest in February 2004 (33%). The differences in the monthly refusal rates over the 12-month period are statistically significant (p=0.05), and remain so (p=0.04) after taking account of age and sex effects. However, the differences cease to be significant (p=0.1) after allowing for ethnicity effects too.
The refusal rates for the four quarters of the financial year were 49%, 39%, 44% and 36% respectively, with these differences being statistically significant (p=0.007) and remaining so (p=0.005) after taking account of differences in the refusal rate due to quarterly variation in all the considered demographic variables (ie age, sex and ethnicity of potential donors).
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5 5.1
5.2
Figure 2
Month-to-month variation in relative refusal rate
EFFECT OF DEMOGRAPHIC VARIABLES ON THE REFUSAL RATE
The relative refusal rates for males and females (for the 1,177 potential donors out of 1,181 for whom sex was recorded) were 42% and 41%, respectively, with no statistically significant difference between them (p=0.66).
Age is represented by a categorical variable with intervals 0 – 17, 18 – 24, 25 – 34, 35 – 49, 50 – 59 and 60+ years. The relative refusal rates for the six age groups (for the 1,179 potential donors out of 1,181 for whom age was recorded) are illustrated in Figure 3. The differences between the six refusal rates are not statistically significant (p=0.48). Although the refusal rate appears lower for the 18 – 24 age group, there is also no evidence of a significant difference when comparing the 34% relative refusal rate with the 42% relative refusal rate for the combined remaining age groups (p=0.16), unlike the significant difference that was observed and reported in the analysis performed on the first six months of data (April to September 2003).
Figure 3
Age variation in relative refusal rate
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5.3
5.4
6 6.1
6.2
To conduct a meaningful analysis, ethnicity has been split into white and known non-white groups. The relative refusal rates (for the 1,115 potential donors out of 1,181 for whom ethnicity was recorded) were 36% for white potential donors and 77% for known non-white potential donors. The 95% confidence limits for these two refusal rates range from 33% to 39% for white potential donors and 68% to 86% for known non-white potential donors. In other words, there is a 95% chance that the interval from 33% to 39% includes the actual white refusal rate and there is a 95% chance that the interval from 68% to 86% includes the actual known non-white refusal rate.
There is very strong statistical evidence (p<0.001) of a difference between the refusal rates for white and known non-white potential donors and the ethnicity effect remains highly significant after allowing for age, sex and temporal effects.
REGIONAL VARIATION IN THE REFUSAL RATE
Relative refusal rates by region of the UK are shown in Figure 4. The refusal rates range from 30% in the South East to 49% in London. The differences in relative refusal rates across the regions are statistically significant (p=0.04), and remain so after allowing for age, sex, ethnicity and refusal rates by quarter of the financial year (p=0.003).
Figure 4
Relative refusal rates for each region
43%
40%
35%
47%
46%
31%
40%
30%
38%
9%
There is evidence of differences in the risk adjusted relative refusal rate (ie adjusted for age, sex, ethnicity and temporal effects) between 22 donor transplant co-ordinator teams. These differences are illustrated in Figure 5. This graph shows the risk adjusted relative refusal rate plotted against the number of potential donors for each of the 22 donor transplant co-ordinator teams. To aid the interpretation of this plot, the national refusal rate is given as a dotted horizontal line, together with 95% confidence limits for this rate, shown as solid lines. Because of the pattern made by these lines, the graph is known as a funnel plot. The confidence limits indicate that rather more variation is to be expected in teams with fewer potential donors. Points that are close to or above the upper limit correspond to teams with unusually high refusal rates, while points close to or below the lower limit correspond to teams who have low rates. This plot suggests that there are
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7 7.1
7.2
three teams that encounter a lower refusal rate than the others. On the other hand, there are no teams with an unusually high refusal rate. Note that the potential donors for whom age, sex or ethnicity were not recorded have been excluded from the analysis.
Figure 5
Donor transplant co-ordinator team variation in relative refusal rate
EFFECT OF STAFF MEMBER ON THE REFUSAL RATE
The relative refusal rates resulting from each particular staff member’s involvement and non-involvement in the approach to the next of kin are displayed in Figure 6. Cases where the staff member’s involvement is not known have been excluded, as have cases where the relatives made the approach. Of all the families who were approached by a particular type of staff member (eg a Transplant Co-ordinator), the refusal rate is the proportion of these who did not consent to HB solid organ donation. Of all the families who were not approached by that particular type of staff member (ie the approach was made by any type of staff member apart from a Transplant Co-ordinator, for example), the refusal rate is the proportion of these who did not consent to HB solid organ donation. Note that it is possible for more than one type of staff member to be involved in the approach to the next of kin.
Over the 12-month period, relatives were less likely to refuse consent to HB solid organ donation if a Consultant was involved in the approach, than if they were not involved, with refusal rates of 44% and 53%, respectively. If a Transplant Co-ordinator was involved in the approach, relatives were less likely to refuse consent than if the Transplant Co-ordinator was not involved. Indeed, a Transplant Co-ordinators’ involvement and non-involvement causes the largest difference in refusal rates, with refusal rates of 26% and 48%, respectively. However, if a Staff Nurse was involved in the approach, relatives were more likely to refuse consent than if the Staff Nurse was not involved, with refusal rates of 50% and 41%, respectively. More detailed analyses of this aspect of the study will be reported later.
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Figure 6
Staff member variation in relative refusal rate
EFFECT OF TIMING OF APPROACH ON THE REFUSAL RATE
The relative refusal rates for the five timings of approach are displayed in Figure 7. Cases where the relatives made the approach and cases where the timing was not recorded or the timing was recorded as ‘other’ have been excluded. There is strong statistical evidence of differences in the relative refusal rates (p=0.005), with rates ranging from 37% when the approach was made before the first set of brain stem (BS) tests to 53% when the approach was made between the first and second BS tests in a separate interview from the explanation of the outcome of the first BS tests.
Figure 7
Timing of approach variation in relative refusal rate
OVERALL RELATIVE APPROACH RATE
Relative approach rate is based on potential donors for whom HB solid organ donation was considered. The approach rate is the proportion of this group of potential donors
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9.2
10 10.1
10.2
11 11.1
11.2
whose relatives were approached for permission for donation, or whose relatives made the approach.
During the 12-month period, the overall approach rate was 93% and the 95% confidence limits for this percentage range from 92% to 94%.
TEMPORAL VARIATION IN THE APPROACH RATE
The month-to-month variation in relative approach rate is illustrated in Figure 8. The approach rates range from 87% (October 2003) to 98% (April 2003 and December 2003). The differences in the monthly approach rates (p=0.01) over the 12-month period are statistically significant and remain so (p=0.005) after taking account of differences due to monthly variation in all the considered demographic variables (ie age, sex and ethnicity of potential donors).
Figure 8
Month-to-month variation in relative approach rate
The approach rates for the four quarters of the financial year were 96%, 92%, 92% and 93% respectively, with no evidence of significant differences between them (p=0.14).
EFFECT OF DEMOGRAPHIC VARIABLES ON THE APPROACH RATE
The relative approach rates for males and females (for the 1,266 potential donors out of 1,270 for whom sex was recorded) were both 93%.
The relative approach rates for the six age groups (for the 1,267 potential donors out of 1,270 for whom age was recorded) are illustrated in Figure 9. The approach rates range from 87% in the 0 – 17 age group to 96% in the 50 – 59 age group. The differences between the six approach rates are highly significant (p=0.001), but the differences become less significant (p=0.05) after allowing for sex, ethnicity and quarterly approach rates. It is interesting to see that fewer families in the 18 – 24 age group were approached, although the refusal rate was lowest for potential donors in this age group.
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12 12.1
Figure 9
Age variation in relative approach rate
The approach rates for families of white and known non-white potential donors (for the 1,191 potential donors out of 1,270 for whom ethnicity was recorded) were 94% and 87%, respectively. There is strong statistical evidence (p=0.003) of a difference between the relative approach rates for the two ethnic groups, and the significance level is unaffected by adjustment for sex, age and monthly effects (p=0.006). It is worth noting that the relative approach rates for those ethnic minority groups with sufficiently large numbers of potential HB donors for a meaningful interpretation, namely Asian/ Asian British and Black / Black British were 92% and 82%, respectively.
REGIONAL VARIATION IN THE APPROACH RATE
Relative approach rates by region of the UK are shown in Figure 10. The approach rates range from 89% in the Eastern region to 98% in Northern Ireland. The differences in approach rates across the regions are not statistically significant (p=0.26).
Figure 10
Relative approach rates for each region
98%
91%
97%
91%
95%
94%
93%
96%
89%
2%
13 REFUSAL RATE SUMMARY 13.1 The overall relative refusal rate from 1 April 2003 to 31 March 2004 was 42%, although there is evidence of variation in this rate over the 12 months and the four quarters of the financial year. 13.2 There is a clear difference in the relative refusal rates for white and known non-white potential HB donors, but no differences due to sex or age group. 13.3 The differences in relative refusal rates across the regions of the UK are significant. 13.4 The decrease in refusal rates when a Transplant Co-ordinator is involved in the approach to the next of kin is highly significant. 13.5 The differences in refusal rates for the five next of kin approach timings are also very significant, with the lowest rate obtained when an approach is made before the first brain stem test. 14 APPROACH RATE SUMMARY 14.1 The overall relative approach rate from 1 April 2003 to 31 March 2004 was 93%, although there is evidence of variation in this rate over the 12-month period. 14.2 There are clear differences in the relative approach rates across the age groups and a difference in the approach rates for white and known non-white potential HB donors. There is no difference between males and females. 14.3 There are no differences in relative approach rates across the regions of the UK. Miss Joanne Allen, Mrs Kerri Barber and Dr Dave Collett UK Transplant November 2004
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