Deceased Donation - Why Data? Damon C. Scales MD PhD

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1 Deceased Donation - Why Data? Damon C. Scales MD PhD

2 Deceased Donation Why Data?

3 Deceased Donation Why Data? Describe and explain variation Understand trends Performance measurement and comparisons Evaluate policy decisions Address supply-demand mismatch

4 Deceased Donation Why Data? Canadian organ donation Supply vs. demand Donors Persons transplanted Persons on waitlist sources & limitations - refer to data 4 notes page

5 Donation in Perspective Canada ,643 Deaths XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX

6 Donation in Perspective Canada ,643 Deaths 117,156 Hospital Deaths XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX

7 Donation in Perspective Canada ,643 Deaths 117,156 Hospital Deaths XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 3,711 Potential Donors

8 Donation in Perspective Canada ,643 Deaths 117,156 Hospital Deaths XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 3,711 Potential Donors 542 Actual Donors

9 Measuring Organ Donation Potential Organ donation rate (ODR) Slide courtesy of Karen Hornby

10 Measuring Organ Donation Potential Organ donation rate (ODR) Conversion rate Donors Potential donors Slide courtesy of Karen Hornby

11 Measuring Organ Donation Potential Organ donation rate (ODR) Conversion rate Donors Potential donors Standard definitions Slide courtesy of Karen Hornby

12 Measuring Organ Donation Potential Organ donation rate (ODR) Conversion rate Donors Potential donors Not available at the International level Slide courtesy of Karen Hornby

13 Measuring Organ Donation Potential Organ donation rate (ODR) DPMP Donors Million population Readily available for international comparisons Slide courtesy of Karen Hornby

14 Measuring Organ Donation Potential Organ donation rate (ODR) DPMP Donors Million population Readily available for international comparisons Higher DPMP Slide courtesy of Karen Hornby

15 Measuring Organ Donation Potential Organ donation rate (ODR) DPMP Donors Million population Readily available for international comparisons Higher DPMP Better program? Slide courtesy of Karen Hornby

16 Measuring Organ Donation Potential Organ donation rate (ODR) DPMP Donors Million population Readily available for international comparisons Higher DPMP Larger pool of potential donors? Slide courtesy of Karen Hornby

17 Measuring Organ Donation Potential Organ donation rate (ODR) DPMP Donors Million population Readily available for international comparisons Higher DPMP Factors affecting donation potential Larger pool of potential donors? Slide courtesy of Karen Hornby

18 Measuring Organ Donation Potential Organ donation rate (ODR) DPMP Donors Million population Readily available for international comparisons Higher DPMP Larger pool of potential donors? Slide courtesy of Karen Hornby Factors affecting donation potential Demographics age, ethnicity, religion Mortality patterns CVA, TBI etc. Infrastructure ICUs, transplant & OD programs Public policy speed limits, helmet laws etc.

19 Organ donation rates across countries for different denominators, 22 Countries Countries Countries Countries Countries Countries Slide courtesy of Karen Hornby

20 Organ donation rates across countries for different denominators, 22 Donor per million population Donor per thousand deaths deaths < 65 yrs Donor per thousand eligible deaths Countries Countries Countries Countries eligible deaths < 65 yrs CVA & TBI deaths CVA & TBI deaths < 65 yrs Countries Countries Countries Slide courtesy of Karen Hornby

21 Organ donation rates across countries for different denominators, 22 Donor per million population Donor per thousand deaths deaths < 65 yrs Donor per thousand eligible deaths Countries Countries Countries Countries eligible deaths < 65 yrs CVA & TBI deaths CVA & TBI deaths < 65 yrs Countries Countries Countries Slide courtesy of Karen Hornby

22 Organ donation rates across countries for different denominators, 22 Donor per million population Donor per thousand deaths deaths < 65 yrs Donor per thousand eligible deaths Countries Countries Countries Countries eligible deaths < 65 yrs CVA & TBI deaths CVA & TBI deaths < 65 yrs Countries Countries Countries Slide courtesy of Karen Hornby

23 Organ donation rates across countries for different denominators, 22 Donor per million population Donor per thousand deaths deaths < 65 yrs Donor per thousand eligible deaths Countries Countries Countries Countries eligible deaths < 65 yrs CVA & TBI deaths CVA & TBI deaths < 65 yrs Countries Countries Countries Slide courtesy of Karen Hornby

24 Organ donation rates across countries for different denominators, 22 Donor per million population Donor per thousand deaths deaths < 65 yrs Donor per thousand eligible deaths Countries Countries Countries Countries eligible deaths < 65 yrs CVA & TBI deaths CVA & TBI deaths < 65 yrs Countries Countries Countries Slide courtesy of Karen Hornby

25 Organ donation rates across countries for different denominators, 22 Donor per million population Donor per thousand deaths deaths < 65 yrs Donor per thousand eligible deaths Countries Countries Countries Countries eligible deaths < 65 yrs CVA & TBI deaths CVA & TBI deaths < 65 yrs Countries Countries Countries Slide courtesy of Karen Hornby

26 Organ donation rates across countries for different denominators, 22 Donor per million population Donor per thousand deaths deaths < 65 yrs Donor per thousand eligible deaths Countries Countries Countries Countries eligible deaths < 65 yrs CVA & TBI deaths CVA & TBI deaths < 65 yrs Countries Countries Countries Slide courtesy of Karen Hornby

27 Organ donation rates across countries for different denominators, 22 Donor per million population Donor per thousand deaths deaths < 65 yrs Donor per thousand eligible deaths Countries Countries Countries Countries eligible deaths < 65 yrs CVA & TBI deaths CVA & TBI deaths < 65 yrs Countries Countries Countries Slide courtesy of Karen Hornby

28 Organ donation rates relative to Spain (1%) based on different denominators, 22 Australia Austria Canada Finland % % % % Denominators Denominators Denominators Denominators % France Denominators % Germany Denominators % Netherlands Denominators United Kingdom % Denominators % United States Denominators Denominators: million population 1, deaths 1, deaths < 65 yrs 1, eligible 1, eligible deaths < 65 yrs, 1, CVA & TBI deaths 1, CVA & TBI deaths < 65 yrs Slide courtesy of Karen Hornby

29 Canadian Challenges Deceased Donation Data Canadian Challenges Deceased Donation Data Multiple, incomplete data sources- CORR, OPO, CTR, Tx programs Different data definitions and datasets Different triggers (potential donors) Lack of data prior to consent Lack of timely reporting Difficulty comparing regions/ provinces Lack of performance data in relation to implementation of leading practices

30 Australia: National summary of potential donors and actual donors, transplant recipients Australian OTDT Authority Annual Report 214

31 National Audit of Potential Donors All audited patient deaths in UK Intensive Care Units (ICUs) and emergency departments, excluding wards and patients over 8 years of age

32 Breakdown of audited deaths in ICU s, 1 April March 215 Figure 13.1 Donation after brain death Figure 13.2 Donation after circulatory death Audited Deaths 36,145 Audited Deaths 36,145 Was the patient ever on mechanical ventilation? Was the patient ever on mechanical ventilation? No Yes No Yes 16,9 19,22 16,9 19,22 Were all criteria for neurological testing met? Was death confirmed using neurological criteria? No Yes No Yes 17,487 1,733 17,798 1,422 Were neurological tests to confirm death performed? 1 Was imminent death anticipated? No Yes No Yes 289 1,444 11,73 6,7 Was death confirmed using neurological criteria? Was treatment withdrawn? No Yes No Yes 22 1, ,28 Were there any absolute medical contraindications to solid organ donation? Were there any absolute medical contraindications to solid organ donation? No Yes No Yes 1, ,264 1,764 Were the family formally approached for consent/authorisation for solid organ donation? Were the family formally approached for consent/authorisation for solid organ donation? No Yes No Yes 89 1,283 2,2 2,12 Was consent/authorisation for solid organ donation given by the family? Was consent/authorisation for solid organ donation given by the family? No Yes No Yes ,45 Did solid organ donation occur? Did solid organ donation occur? No Yes No Yes What type of donation happened? What type of donation happened? DBD DCD DCD Patients for whom tests were not performed due to; cardiac arrest despite resuscitation occurred, brainstem reflexes returned, or neonates - less than 2 months post term are excluded from the calculation of the neurological death testing rate Source: Transplant activity in the UK, , NHS Blood and Transplant

33 Breakdown of audited deaths in ICU s, 1 April March 215 Figure 13.1 Donation after brain death Figure 13.2 Donation after circulatory death Audited Deaths 36,145 Audited Deaths 36,145 Was the patient ever on mechanical ventilation? Was the patient ever on mechanical ventilation? No Yes No Yes 16,9 19,22 16,9 19,22 Were all criteria for neurological testing met? Was death confirmed using neurological criteria? No Yes No Yes 17,487 1,733 17,798 1,422 Were neurological tests to confirm death performed? 1 Was imminent death anticipated? No Yes No Yes 289 1,444 11,73 6,7 Was death confirmed using neurological criteria? Was treatment withdrawn? No Yes No Yes 22 1, ,28 Were there any absolute medical contraindications to solid organ donation? Were there any absolute medical contraindications to solid organ donation? No Yes No Yes 1, ,264 1,764 Were the family formally approached for consent/authorisation for solid organ donation? Were the family formally approached for consent/authorisation for solid organ donation? No Yes No Yes 89 1,283 2,2 2,12 Was consent/authorisation for solid organ donation given by the family? Was consent/authorisation for solid organ donation given by the family? No Yes No Yes ,45 Did solid organ donation occur? Did solid organ donation occur? No Yes No Yes What type of donation happened? What type of donation happened? DBD DCD DCD Patients for whom tests were not performed due to; cardiac arrest despite resuscitation occurred, brainstem reflexes returned, or neonates - less than 2 months post term are excluded from the calculation of the neurological death testing rate Source: Transplant activity in the UK, , NHS Blood and Transplant

34 UK Potential deceased organ donor population, 1 April March 215 UK population 1 ~64,, UK deaths 2 ~576, Deaths in hospitals 3 ~ 287, Potential donors 4,5 7,45 Eligible donors 4,6 5,636 Donation requests 4 3,295 Consented donors 7 1,923 Actual donors 7 1,282 Transplants 7,8 3,322 Organs transplanted 7,8 3,736 1 Mid 213 estimates: data: England & Wales Scotland Northern Ireland data: England & Wales Scotland Northern Ireland /215 data: NHSBT, Potential Donor Audit 5 Potential donor - patients for whom death was confirmed following neurological tests or patients who had treatment withdrawn and death was anticipated within four hours 6 Eligible donor - Potential donor with no absolute medical contraindications to solid organ donation 7 214/215 deceased donor data: NHSBT, UK Transplant Registry 8 Using organs from actual donors in the UK Source: Transplant activity in the UK, , NHS Blood and Transplant

35 Consent/authorisation rates by Organ Donation Services Team, 1 April March 215 DBD Consent/authorisation rates DCD 4 - <45% 45 - <5% 69% 5 - <55% 55 - <6% 43% 6 - <65% 65 - <7% 67% 67% 7% 7 - <75% >=75% 54% 55% 51% 63% 66% 53% 48% 73% 7% 44% 56% 8% 55% 73% 72% 56% 52% 45% 64% Source: Transplant activity in the UK, , NHS Blood and Transplant

36 Stages at which potential organ donors lost the opportunity to become actual donors, 1 April March 215 Figure 13.3 Stages at which potential organ donors lose the opportunity to become actual donors, Figure April 214 to 31 March % of potential donors % 2% 4% 29% 7% 53% 33% 9% 2 48% 1 Potential donors 1 DBD, 779 donated (45% of potential donors) DCD, 494 donated (8% of potential donors, 12% of those not contraindicated) Neurological death tests performed (DBD only) Neurological death confirmed (DBD only) Contraindications Family approach Consent/ authorisation 53% Donation 1 1 Potential DBD donor - A patient who meets all four criteria for neurological death testing excluding those for which cardiac arrest occurred despite resuscitation, 1 brain stem reflexes returned, and neonates less than 2 months post term 1 Potential DCD donor - A patient who had treatment withdrawn and death was anticipated within four hours Source: Transplant activity in the UK, , NHS Blood and Transplant

37

38

39 Conversion Rates and Potential Donors per Million

40 DCD as percentage of total deceased donors

41 DECEASED DONATION DATA WORKING GROUP Organized by CBS Tasked with making recommendations for a Minimum Data Set using standard definitions Coordinates activities with other transplant data working groups

42 Canadian Data Capabilities

43 POPULATION - 34,754,312 DEATHS 243,643 HOSPITAL DEATHS 117,156 National, aggregate, data VENTILATED DEATHS - 4,79* BRAIN-INJURED VENTILATED DEATHS POTENTIAL DONORS (PD) 3,711 CBS D3WG Working copy Individual data REFERRED PD 3, ELIGIBLE DONORS (ED) APPROACHED ED data based on local standards CONSENTED data based on DONORS national standards ACTUAL DONORS 542 DRAFT DATA FOR 212

44 Identifying Potential Donors in Canada Brain Injury + Ventilated ON: Ventilated and any of the following: Grave prognosis or GCS = 3 OR Injured brain or non-recoverable injury/illness OR Family-initiated discussion of donation or withdrawal of lifesustaining therapy (WLST) OR Therapy-limited, de-escalation of treatment, or WLST discussion planned QC: Severe neuro insult + mechanical ventilation Brain Injury + Ventilated + EOL Care/Discussions Death Declared (NDD) AB (EDM) - ventilated with severe/devastating illness or injury, neuro consult ruling out recovery. Indicators include, but are not limited to: GCS 3 OR 3 or + absent brain stem reflexes OR Plans for WLST OR Family initiated donation discussion BC - GCS < 5, Injury to brain, Ventilated, EOL care SASK - GCS 5 OR Injured brain OR Ventilated (no respiratory effort) OR EOL discussion of WLST MAN - GCS 5 + Severe neuro insult/injury + Ventilator dependent + Grave prognosis/eol discussion NS - GCS < 5, Irreversible Brain Injury, Ventilated, End of life discussion AB (CAL): Patient who is brain dead Actual Donor

45 Deceased Donation Why Data? Currently available Canadian data lack information to estimate potential donors Standardized definitions and clinical triggers are needed to facilitate meaningful comparisons More data needed to inform strategies to address donation-transplant gap

46

47 Donor definitions Variation in Donor Definitions Country Australia Austria Canada Finland France Germany Netherlands Spain U.K. U.S.A. Definition Donor retrieval operation commenced for purpose of transplantation reported to ODO but no transplant realized + actual donors donation criteria met, no transplant realized + actual donors transferred to operating room, at least 1 solid organ retrieved subjects from whom organs were taken (preleve) reported to ODO but no transplant realized + actual donors reported to ODO but no transplant realized + actual donors transferred to operating room, at least 1 solid organ retrieved At least one solid organ retrieved with the intention to transplant At least one organ recovered for the purpose of transplantation

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