Organ donation for transplantation, Improving donor identification and consent rates NICE clinical guideline 135

Disclaimer

NICE clinical guidelines are recommendations about the treatment and care of people with specific diseases and conditions in the NHS in England and Wales.

This guidance represents the view of NICE, which was arrived at after careful consideration of the evidence available. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. However, the guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient.

Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties.

Introduction

A significant proportion of people in England and Wales would wish to donate their organs after death for the purpose of transplantation. This guideline recognises the complexities that arise owing to the majority of potential organ donors lacking the capacity to be directly involved in decision making at the time of their death. This guideline seeks to promote the identification and fulfilment of these wishes through:

• more effective and expedient identification and referral of potential organ donors
• a more informed, considered and timely approach to consent for donation that is based primarily on identifying the wishes of the individual whenever known and however recorded.

The General Medical Council (GMC) guidance ‘Treatment and care towards the end of life: good practice in decision making’1 requires that consultant staff who have clinical responsibility for patients who are potential donors exercise a duty to consider organ donation as part of end-of-life care.

Although donation occurs after death, there are steps that healthcare professionals may need to take before the death of the patient if donation is to take place. This guidance covers such steps, and in the case of clinical triggers for referral, refers to actions that might take place even before the inevitability of death has been recognised. These actions may result in challenges and tensions for the healthcare teams but they can and indeed should be incorporated into local hospital policies in order to better promote donation as part of end-of-life care.

Organ donation for transplantation is a complex area and one to which conventional clinical research methods cannot be easily applied. Consequently, much of the evidence included in this guideline is of a qualitative nature and does not lend itself to conventional use of GRADE assessment. A modified version of the GRADE assessment tool has been used to assess study limitations, indirectness and inconsistency.

Recognising the ethical and legal context in this area, legal advice was sought and incorporated during the development of the guideline.

Person centred care

This guideline offers best practice advice on improving donor identification and consent rates.

Treatment and care should take into account people’s needs and preferences. Where the person at the end of their life has the capacity to make decisions, they should have the opportunity to make informed decisions about their care, in partnership with their healthcare professionals. In many cases parents, families and guardians are an important part of the consent process and, unless the person has expressed otherwise, should be involved in decisions about consent. If potential donors do not have the capacity to make decisions, healthcare professionals should follow the Department of Health’s advice on consent (available from www.dh.gov.uk/en/DH_103643) and the code of practice that accompanies the Mental Capacity Act (summary available from www.dh.gov.uk/en/SocialCare/Deliveringsocialcare/MentalCapacity). In Wales, healthcare professionals should follow advice on consent from the Welsh Government (available from www.wales.nhs.uk/consent).

If the potential donor is under 16, healthcare professionals should follow the guidelines in ‘Seeking consent: working with children’.

The Human Tissue Authority has produced codes of practice for consent and for donation of solid organs for transplantation, and the NHS has produced a code of practice on confidentiality.

Good communication between healthcare professionals and people is essential. It should be supported by evidence-based written information tailored to the person’s needs. The information people are given about their care should be culturally appropriate. It should also be accessible to people with additional needs such as physical, sensory or learning disabilities, and to people who do not speak or read English.

Parents, families and guardians should also be given the information and support they need.

1 Recommendations

1.1 List of all recommendations

1.1.1 Organ donation should be considered as a usual part of ‘end-of-life care’ planning.

1.1.2 Identify all patients who are potentially suitable donors as early as possible, through a systematic approach. While recognising that clinical situations vary identification should be based on either of the following criteria:

• defined clinical trigger factors in patients who have had a catastrophic brain injury, namely:

– the absence of one or more cranial nerve reflexes and
– a Glasgow Coma Scale (GCS) score of 4 or less that is not explained by sedation
unless there is a clear reason why the above clinical triggers are not met (for example because of sedation) and/or a decision has been made to perform brainstem death tests, whichever is the earlier

• the intention to withdraw life-sustaining treatment in patients with a life-threatening or life-limiting condition which will, or is expected to, result in circulatory death.

1.1.3 The healthcare team caring for the patient should initiate discussions about potential organ donation with the specialist nurse for organ donation at the time the criteria in recommendation 1.1.2 are met.

Patients who have capacity

1.1.4 In circumstances where a patient has the capacity to make their own decisions, obtain their views on, and consent to, organ donation.

Assessing best interests

1.1.5 If a patient lacks capacity to make decisions about their end-of life-care, seek to establish whether taking steps, before death, to facilitate organ donation would be in the best interests of the patient.

1.1.6 While assessing the patient’s best interests clinically stabilise the patient in an appropriate critical care setting while the assessment for donation is performed – for example, an adult intensive care unit or in discussion with a regional paediatric intensive care unit (see recommendation 1.1.8).

1.1.7 Provided that delay is in the patient’s overall best interests, life-sustaining treatments should not be withdrawn or limited until the patient’s wishes around organ donation have been explored and the clinical potential for the patient to donate has been assessed in accordance with legal7 and professional guidance.

1.1.8 In assessing a patient’s best interests, consider:

• the patient’s known wishes and feelings, in particular any advance statement or registration on the NHS organ donor register10 but also any views expressed by the patient to those close to the patient
• the beliefs or values that would be likely to influence the patient’s decision if they had the capacity to make it
• any other factors they would be likely to consider if they were able to do so
• the views of the patient’s family, friends and anyone involved in their care as appropriate as to what would be in the patient’s best interests; and
• anyone named by the patient to be consulted about such decisions.

Seeking consent to organ donation

1.1.9 If a patient lacks the capacity to consent to organ donation seek to establish the patient’s prior consent by:

• referring to an advance statement if available
• establishing whether the patient has registered and recorded their consent to donate on the NHS organ donor register and
• exploring with those close to the patient whether the patient had expressed any views about organ donation.

1.1.10 If the patient’s prior consent has not already been ascertained, and in the absence of a person or persons having been appointed as nominated representative(s), consent for organ donation should be sought from those in a qualifying relationship with the patient. Where a nominated representative has been appointed and the person had not already made a decision about donation prior to their death, then consent should be sought after death from the said nominated representative(s).

Approach to those close to the patient

The multidisciplinary team
1.1.11 A multidisciplinary team (MDT) should be responsible for planning the approach and discussing organ donation with those close to the patient.

1.1.12 The MDT should include:

• the medical and nursing staff involved in the care of the patient, led throughout the process by an identifiable consultant
• the specialist nurse for organ donation
• local faith representative(s) where relevant.

1.1.13 Whenever possible, continuity of care should be provided by team members who have been directly involved in caring for the patient.

1.1.14 The MDT involved in the initial approach should have the necessary skills and knowledge to provide to those close to the patient appropriate support and accurate information about organ donation (see recommendations 1.1.30 and 1.1.31).

Discussions in all cases

1.1.15 Before approaching those close to the patient:

• identify a patient’s potential for donation in consultation with the specialist nurse for organ donation
• check the NHS organ donor register and any advance statements or Lasting Power of Attorney for health and welfare
• clarify coronial, legal and safeguarding issues.

1.1.16 Before approaching those close to the patient, try to seek information on all of the following:

• knowledge of the clinical history of the patient who is a potential donor
• identification of key family members
• assessment of whether family support is required – for example faith representative, family liaison officer, bereavement service, trained interpreter, advocate
• identification of other key family issues
• identification of cultural and religious issues that may have an impact on consent.

1.1.17 Approach those close to the patient in a setting suitable for private and compassionate discussion.

1.1.18 Every approach to those close to the patient should be planned with the MDT and at a time that suits the family’s circumstances.

1.1.19 In all cases those close to the patient should be approached in a professional, compassionate and caring manner and given sufficient time to consider the information.

1.1.20 Discussions about organ donation with those close to the patient should only take place when it has been clearly established that they understand that death is inevitable or has occurred.

1.1.21 When approaching those close to the patient:

• discuss with them that donation is a usual part of the end-of-life care
• use open-ended questions – for example ‘how do you think your relative would feel about organ donation?’
• use positive ways to describe organ donation, especially when patients are on the NHS organ donor register or they have expressed a wish to donate during their lifetime – for example ‘by becoming a donor your relative has a chance to save and transform the lives of many others’
• avoid the use of apologetic or negative language (for example ‘I am asking you because it is policy’ or ‘I am sorry to have to ask you’).

1.1.22 The healthcare team providing care for the patient should provide those close to the patient who is a potential donor with the following, as appropriate:

• assurance that the primary focus is on the care and dignity of the patient (whether the donation occurs or not)
• explicit confirmation and reassurance that the standard of care received will be the same whether they consider giving consent for organ donation or not
• the rationale behind the decision to withdraw or withhold life-sustaining treatment and how the timing will be coordinated to support organ donation
• a clear explanation of, and information on:

– the process of organ donation and retrieval, including post-retrieval arrangements
– what interventions may be required between consent and organ retrieval
– where and when organ retrieval is likely to occur
– how current legislation applies to their situation, including the status of being on the NHS organ donor register or any advance statement
– how the requirements for coronial referral apply to their situation

• consent documentation
• reasons why organ donation may not take place, even if consent is granted.

1.1.23 Allow sufficient time for those close to the patient to understand the inevitability of the death or anticipated death and to spend time with the patient.

1.1.24 Discuss withdrawal of life-sustaining treatment or neurological death before, and at a different time from, discussing organ donation unless those close to the patient initiate these discussions in the same conversation.

1.1.25 For discussions where circulatory death is anticipated, provide a clear explanation on:

• what end-of-life care involves and where it will take place – for example, theatre, critical care department
• how death is confirmed and what happens next
• what happens if death does not occur within a defined time period.

1.1.26 For discussions where neurological death is anticipated, provide a clear explanation on:

• how death is diagnosed using neurological criteria
• how this is confirmed and what happens next.

Organisation of the identification, referral and consent processes

1.1.27 Each hospital should have a policy and protocol that is consistent with these recommendations for identifying patients who are potential donors and managing the consent process.

1.1.28 Each hospital should identify a clinical team to ensure the development, implementation and regular review of their policies.

1.1.29 Adult and paediatric intensive care units should have a named lead consultant with responsibility for organ donation.

1.1.30 The MDT involved in the identification, referral to a specialist nurse for organ donation, and consent should have the specialist skills and competencies necessary to deliver the recommended process for organ donation outlined in this guideline.

1.1.31 The skills and competencies required of the individual members of the team will depend on their role in the process. However, all healthcare professionals involved in identification, referral to a specialist nurse for organ donation, and consent processes should:

• have knowledge of the basic principles and the relative benefits of, donation after circulatory death (DCD) versus donation after brainstem death (DBD)
• understand the principles of the diagnosis of death using neurological or cardiorespiratory criteria and how this relates to the organ donation process
• be able to explain neurological death clearly to families
• understand the use of clinical triggers to identify patients who may be potential organ donors
• understand the processes, policies and protocols relating to donor management
• adhere to relevant professional standards of practice regarding organ donation and end-of-life care.

1.1.32 Consultant staff should have specific knowledge and skills in:

• the law surrounding organ donation
• medical ethics as applied to organ donation
• the diagnosis and confirmation of death using neurological or cardiorespiratory criteria
• the greater potential for transplantation of organs retrieved from DBD donors compared with organs from DCD donors
• legally and ethically appropriate clinical techniques to secure physiological optimisation in patients who are potential organ donors
• communication skills and knowledge necessary to improve consent ratios for organ donation.

1.2 Overview

1.2.1 Consent for organ donation
Organ transplantation has a major role in the management of organ failure – that is, of a single organ system of the kidneys, small bowel, liver, pancreas, heart, or lung, and of combined organ failure of the heart and lung, the kidney and pancreas, the liver and kidney, or liver and small bowel. Transplants may be needed because of primary organ disease, such as chronic inflammatory disease of the kidneys or cardiomyopathy, or because of secondary effects of a disease – for example, people with diabetes needing kidney, islet cell and/or pancreas transplants, and people with cystic fibrosis needing lung transplants.

There is a shortage of organs for transplant resulting in long waits for transplantation and a significant number of deaths among those awaiting transplantation, and among those not considered for transplantation because of organ scarcity.
UK Transplant commissioned a survey in 2003 that showed a large majority of the public is supportive of organ donation in principle, with 90% of those responding in favour. Over 18 million people (29% of the population) are already on the NHS organ donor register. However, the actual donation rate in the UK remains poor. This may be partly because of bereaved relatives not consenting to organ donation. Many reviews of organ donation have been done, but all failed to resolve the problems that result from the lack of a structured and systematic approach to organ donation.

This guideline focuses on identifying potential donors and obtaining consent for solid organ donation under current legislation. It aims to help address the burden of disease by increasing the availability of organs for transplant. It also addresses current inequalities in approach by helping to make organ donation a usual part of NHS practice, meaning that families of all potential organ donors are approached and supported, irrespective of factors such as ethnicity and religion.

This short clinical guideline aims to improve consent rates by making recommendations based on evidence where it is available, on the structures and processes of identifying potential donors and the approach for consent.

1.3 How this guideline was developed

‘Organ donation for transplantation: improving donor identification and consent rates for deceased organ donation’ (NICE clinical guideline 135 is a NICE short clinical guideline.

For a full explanation of how this type of guideline is developed, see ‘The guidelines manual’ (2009) at www.nice.org.uk/GuidelinesManual.

1.4 Who this guideline is for

This document sets out NICE guidelines for health professionals involved in the process of organ donation, including their interactions with potential donors, and parents, partner, family, carers or guardians.

2 Evidence review and recommendations

2.1 Increasing donation rates through identification, referral and consent

2.1.1 Evidence review
The five review questions were:

• Review question 1:

– What structures and processes including timing for referral and criteria for consideration are appropriate and effective for identifying potential DBD and DCD donors?

• Review question 2:

– What structures and processes are appropriate and effective for obtaining consent from families, relatives and legal guardians of potential DBD and DCD donors?

• Review question 3:

– When is the optimal time for approaching the families, relatives and legal guardians of potential DBD and DCD donors for consent?

• Review question 4:

– How should the care pathway of deceased organ donation be coordinated to improve potential donors giving consent?

• Review question 5:

– What key skills and competencies are important for healthcare professionals to improve the structures and processes for identifying potential DBD and DCD, to improve structures and processes for obtaining consent, and to effectively coordinate the care pathway from identification to obtaining consent?

A total of 3465 articles were found by systematic searches for review questions 1 to 4. Full text articles were ordered for 311 articles based on the title and abstract. Sixty-one papers met the eligibility criteria (for review protocol and inclusion and exclusion criteria, see appendix C). Although searches were undertaken for review question 5, the technical team and the GDG considered that evidence already reviewed and included for review questions 1 to 4 would adequately inform evidence-based recommendations on the skills and competencies needed by healthcare professionals. For example, where a lack of knowledge or skills was identified for healthcare professionals as part of review question 2, a recommendation was made that healthcare professionals should have those skills and knowledge in order to implement the other recommendations made in the guideline.

Although systematic reviews were undertaken for each of the review questions (except review question 5 as noted above), this evidence review provides a summary of the whole evidence-base used for this guideline. The reviews for each question can be seen separately in appendix D. However, when drafting the evidence statements and recommendations, it became clear that the evidence reviewed often covered more than one area of interest (that is, the search strategies used were not able to be specific enough to separate out the detailed components of the process that were of interest); therefore the process of identifying the evidence and drafting recommendations was iterative and reflective.
GRADE assessment was adapted, and the following variables were considered: limitations, inconsistency, and indirectness. Imprecision was rated as not relevant for some areas because it did not apply to the type of evidence considered (for example, qualitative studies).
Summary GRADE tables are presented below. For full GRADE profiles, see appendix D.

Review question 1

What structures and processes including timing for referral and criteria for consideration are appropriate and effective for identifying potential DBD and DCD donors?

GRADE profile 1: Summary of structures and processes for identifying potential DBD and DCD donors

GRADE profile 2 - Summary of use of clinical triggers

GRADE profile 3 - Summary of use of required referral

Review question 2

What structures and processes are appropriate and effective for obtaining consent from families, relatives and legal guardians of potential DBD and DCD donors?

GRADE profile 4 - Summary of effect of collaborative requesting on consent rate for organ donation

GRADE profile 5 - Summary of views of families of potential adult donors

GRADE profile 6 - Summary of views of families of potential paediatric donors

Review question 3

When is the optimal time for approaching the families, relatives and legal guardians of potential DBD and DCD donors for consent?

GRADE profile 7 - Summary of the optimal time for approaching the families of potential DBD and DCD donors to gain consent

Review question 4

How should the care pathway of deceased organ donation be coordinated to improve potential donors giving consent?

GRADE profile 8: Summary of co-ordination of the pathway for organ donation and consent from families

Review question 5

– What key skills and competencies are important for healthcare professionals to improve the structures and processes for identifying potential DBD and DCD, to improve structures and processes for obtaining consent, and to effectively coordinate the care pathway from identification to obtaining consent?

As noted above, evidence from other questions was used to inform recommendations on skills and competencies needed. Therefore there is not a separate GRADE profile provided for this question.

2.1.2 Evidence statements

Identification and referral of patients who are potential donors

2.1.2.1 Nine studies (Aubrey et al. 2008; Gabel and Edstrom 1993; Gortmaker et al. 1996; Madsen and Bogh 2005; Moller et al. 2009; Opdam and Silvester 2006; Petersen et al. 2009; Thompson et al. 1995; Wood et al. 2003) showed that healthcare professionals do not recognise potential donors (very low-quality evidence).

2.1.2.2 There was a belief that protocols/structures would lead to improved rates; however, no high-quality evidence to support this was found (very low-quality evidence).

2.1.2.3 One study (Pugliese 2003) showed improvement in identification after implementation of a donor action programme (very low-quality evidence).

2.1.2.4 Two studies (Aubrey et al. 2008; Molzahn 1997) recognised that a lack of organ donation protocol or knowledge of the referral process in emergency departments was a cause for non-identification (very low-quality evidence).

2.1.2.5 Two studies (Gortmaker et al. 1996; Opdam and Silvester 2006) showed that healthcare professionals did not consistently approach families about organ donation (very low-quality evidence).

2.1.2.6 One study (Pearson et al. 1995) identified that healthcare staff perceived that families were too distressed to be approached for consent (very low-quality evidence).

2.1.2.7 One study (Aubrey et al. 2008) showed that no contact details for the donor transplant coordinator were available in the emergency department (very low-quality evidence).

2.1.2.8 One study (Aubrey et al. 2008) identified the following key personnel that should be involved in the identification process in the emergency department (very low-quality evidence):

• hospital consultants – A&E, anaesthetists and neurosurgeons
• emergency trauma team
• A&E nursing and medical staff.

2.1.2.9 One study (Aubrey et al. 2008) showed that lack of identification of potential donors in the emergency department was associated with HM coroner’s involvement being seen as too complex (very low-quality evidence).

2.1.2.10 One study (Aubrey et al. 2008) showed that emergency department staff lacked confidence and experience in offering the option of donation to bereaved families (very low-quality evidence).

2.1.2.11 Two studies (Aubrey et al. 2008; Pearson et al. 1995) suggested that a perception among healthcare staff of a lack of resources and shortage of intensive care beds in the hospital may have contributed to non-identification and referral of potential donors (very low-quality evidence).

2.1.2.12 One study (Molzahn 1997) identified that healthcare professionals found it difficult to explain brain death to families (very low-quality evidence).

2.1.2.13 One study (Ploeg et al. 2003) identified the following factors that influenced whether discussions with families regarding donation occur (very low-quality evidence):

• number of potential organs in a potential donor
• physician’s knowledge of contraindications to organ donation
• cause of death (with physicians more likely to ask when there was a natural cause of death)
• sex of the physician (female physicians are more likely to ask than male physicians).

2.1.2.14 Two studies (Gortmaker et al. 1996; Pearson and Zurynsky 1995) identified that African-Americans and people with perceived cultural differences were less likely to donate and the healthcare professionals were less likely to approach them (very low-quality evidence).

2.1.2.15 One study (Gortmaker et al. 1996) identified that rates of organ donation were higher when the cause of death was a motor vehicle accident, a gunshot wound or stabbing or head trauma compared with cerebrovascular, asphyxiation and cardiovascular events (very low-quality evidence).

2.1.2.16 One study (Pearson and Zurynsky 1995) identified threats to staff as a barrier to organ donation (very low-quality evidence).

2.1.2.17 One study (Pearson and Zurynsky 1995) identified language difficulties in explaining about organ donation to families as a barrier to organ donation (very low-quality evidence).

2.1.2.18 One study (Molzahn 1997) identified that healthcare professionals feel that organ donation is emotionally demanding (very low-quality evidence).

2.1.2.19 One study (Molzahn 1997) identified that fear of potential litigation to healthcare professionals is a factor for non-identification and non-donation (very low-quality evidence).

2.1.2.20 One study (Ploeg et al. 2003) identified the following factors for non-identification (very low-quality evidence):

• lack of time
• did not think
• difficult situation.

Use of clinical triggers

2.1.2.21 One study (Bair et al. 2006) showed that the conversion rate statistically significantly increased when clinical triggers were used to screen all ICU patients (very low-quality evidence).

2.1.2.22 One study (Shafer et al. 2008) showed that the number of organ donors increased when centres introduced clinical triggers (GCS 5) compared with centres that did not (very low-quality evidence).

2.1.2.23 Two studies (Shafer et al. 2004; Van et al. 2006) showed that there was an increase in potential donors and effective donors when some form of donation criteria was used to identify patients (very low-quality evidence).

2.1.2.24 One study (Shafer et al. 2004) showed that the total number of referrals increased when clinical triggers were used (very low-quality evidence).

Use of required referral

2.1.2.25 Five studies (Burris and Jacobs 1996; Higashigawa et al. 2002; Higashigawa et al. 2001; Robertson et al. 1998; Shafer et al. 1998) showed that there was an increase in referral rate and the number of potential donors referred to the OPO representative when required referral was used in hospitals (very low-quality evidence).

2.1.2.26 One study (Murphy et al. 2009) showed that there was an increase in referral rate and the number of potential donors referred to the OPO representative when required referral was used in hospitals (low-quality evidence).

2.1.2.27 Six studies (Burris and Jacobs 1996; Dickerson et al. 2002; Graham et al. 2009; Robertson et al. 1998; Shafer et al. 1998; Shafer et al. 2008) showed that there was an increase in the number of organ donors from potential donors when required referral was used in hospitals (very low-quality evidence).

2.1.2.28 One study (Shafer et al. 1998) showed that the number of organs retrieved per donor increased when required referral was used in hospitals (very low-quality evidence).

2.1.2.29 One study (Graham et al. 2009) showed that there was no change in the number of organs retrieved per donor when required referral was used in hospitals (very low-quality evidence).

Process of obtaining consent

Method of approach

2.1.2.30 One RCT (Young et al. 2009) showed that approaching families of potential donors using ‘collaborative requests’ did not result in any increased rates of consent for donation, or increased rates of organ retrieval when compared with routine requests (low-quality evidence).

2.1.2.31 One study (Bellali and Papadatou 2006) found that if family members or friends were approached by healthcare professionals, and they then approached the parents of potential paediatric donors (indirect approach), parental consent was more likely (very low-quality evidence).

Family experience and factors related to consent

2.1.2.32 One study (Jacoby et al. 2005) found that the presence of the nursing staff was valued by both donor and non-donor families and families expressed satisfaction with the nurses’ behaviour and care. Nurses were also a valued source of emotional support (very low-quality evidence).

2.1.2.33 However, one study (Jacoby et al. 2005) showed that families considered that treating physicians tended not to be available to families, provided inadequate continuity of care and information, did not use simple language and did not verify whether the families had understood everything being explained to them (very low-quality evidence).

2.1.2.34 One study (Haddow 2004) showed that donor families reported that because donor coordinators did not wear uniforms, they found it easier to talk to them (very low-quality evidence).

2.1.2.35 One study (Jacoby et al. 2005) showed that there was, however, considerable variation in the experience of all families (very low-quality evidence).

2.1.2.36 One study reported in three papers (Bellali and Papadatou 2007; Bellali and Papadatou 2006; Bellali et al. 2007) showed that parents of potential paediatric donors tended to give consent for donation when they were able to accept their child’s death, to attribute meaning to the donation (for example, the benefits to the recipient) and to believe that consent was consistent with the child’s wishes (very low-quality evidence).

2.1.2.37 One study reported in three papers (Bellali and Papadatou 2007; Bellali and Papadatou 2006; Bellali et al. 2007) showed that parents of potential paediatric donors were more likely to decline consent if they had no previous knowledge about organ donation, wanted to know the recipient, considered that their child had been inappropriately cared for, or were unaware of their church’s position on organ donation (very low-quality evidence).

2.1.2.38 One study reported in three papers (Bellali and Papadatou 2007; Bellali and Papadatou 2006; Bellali et al. 2007) showed that other factors related to the decision for consent of potential paediatric donors were fear of mutilation or disfigurement, subjecting the child to further ‘ordeal’, and a reluctance to assume responsibility for another’s organs (very low-quality evidence).

2.1.2.39 One study reported in two papers (Bellali and Papadatou 2007; Bellali et al. 2007) showed that where consent was granted, some parents of potential paediatric donors reported feeling that their grief was eased through helping others to live or feeling that their child was living on through others (very low-quality evidence).

2.1.2.40 One study (Sanner 2007) showed that physicians reported that clear and consistent use of terminology was related to the families’ decision to consent (very low-quality evidence).

2.1.2.41 One study (Sanner 2007) showed that physicians considered certainty in their decisions and the process important. They also reported finding the process of consent very stressful (very low-quality evidence).

2.1.2.42 A factor associated with decision stability or satisfaction was an understanding of the term brain death (Burroughs et al. 1998) (very low-quality evidence).

2.1.2.43 Factors associated with decision instability or dissatisfaction were:

• a lack of discussion of donation with the deceased
• poor timing of donation discussion
• not being told of the death before the first mention of donation
• not being given enough time to discuss the donation decision with others (Rodrigue et al. 2008) (very low-quality evidence)

2.1.2.44 Factors associated with the decision to grant consent were:

• understanding that transplantation was a proven procedure and had a high success rate, and knowledge of the benefits of organ donation
• an understanding of the term brain death
• acceptance of death, and confidence in the ‘diagnosis of death’
• consideration and knowledge of the deceased’s wishes (through carrying a donor card, or discussion)
• earlier timing of request
• involving more family members with the decision
• the level of comfort with which the healthcare professional requested consent
• good relationships between the family and the healthcare professionals
• satisfaction with treatment (either of the family or the deceased)
• congruence between the views of healthcare professionals and the families at initial approach
• request for donation being initiated by a healthcare professional (not a physician) with further discussion with an organ donation professional
• request by different healthcare professionals
• more time spent with an organ donation professional
• knowledge of the impact of donation on other processes, such as funeral arrangements
• knowledge of the costs of donation
• choice of organs for donation
• families being able to discuss both specific and wider issues and getting answers to questions

(Brown et al. 2010; Burroughs et al. 1998; Cleiren and Van Zoelen 2002; Douglas 1994; Frutos et al. 2002; Martinez et al. 2001; Niles and Mattice 1996; Pearson et al. 1995; Siminoff and Lawrence 2002; Siminoff et al. 2001; Siminoff et al. 2002) (very low-quality evidence).

2.1.2.45 Factors associated with the decision to refuse consent were:

• feelings of pressure to consent
• feeling emotionally overwhelmed
• feeling of surprise on being asked about consent
• fear of causing more ‘suffering’ or disfigurement, and not wanting the deceased to have more medical intervention
• concern that donation may cause more distress to family members
• uncertainty about the deceased’s wishes
• reluctance to accept the death
• social resentment
• lack of understanding and confidence in the concept of brainstem death
• lack of family consensus and the family being ‘upset’
• family reticence
• making the decision before information was provided by a healthcare or organ donation professional
• an absence of key decision makers
• the length of the process
• not liking the hospital or healthcare professionals
• feeling that the medical care was not optimal
• initial approach by a healthcare professional
• perception that the healthcare professional did not care or was not concerned, or the healthcare professional showing a lack of respect
• healthcare professionals stating that the request was required
• lack of knowledge of the impact of donation on other processes, such as funeral arrangements
• lack of detailed information on the process of organ donation, including the timing of retrieval and information on recipients
• initial perception of healthcare professionals that the family were likely to refuse

(Brown et al. 2010; Burroughs et al. 1998; Chapman et al. 1995; Cleiren and Van Zoelen 2002; Douglas 1994; La et al. 1993; Martinez et al. 2001; Noury et al. 1996; Pearson et al. 1995; Siminoff et al. 2001; Siminoff et al. 2002; Siminoff et al. 2001 ; Sotillo et al. 2009; Sque et al. 2008) (very low-quality evidence).

2.1.2.47 Other influences on consent were familial (or consentor) age; ethnicity; level of education; socioeconomic status; marital status; previous examples of belief in or support for organ donation (such as carrying a donor card or donating to relevant charities); religious, cultural or spiritual beliefs; personal experience or knowledge of transplantation; setting of donation or death. However, some associations were not consistent across studies (Brown et al. 2010; Burroughs et al. 1998; Frutos et al. 2002; La et al. 1993; Martinez et al. 2001; Pearson et al. 1995; Siminoff and Lawrence 2002; Siminoff et al. 2002; Siminoff et al. 2001; Yong et al. 2000) (very low-quality evidence).

2.1.2.48 Factors associated with the decision to grant consent of potential paediatric donors were:

• belief in the process of donation, and feeling that it was ‘the right thing to do’
• perception that the child would go on living in others
• good interaction with healthcare professionals involved in organ donation
• type of healthcare professional who asked for consent

(Vane et al. 2001; Weiss et al. 1997) (very low-quality evidence).

2.1.2.49 Factors associated with the decision to refuse consent of potential paediatric donors were:

• perception that the doctors who determined death were not part of the organ donation process
• lack of information
• fear or lack of belief in organ donation
• perception that timing of approach was not optimal
• feeling that the child had been through enough and fear of further trauma
• concern that donation would impact on survival
• consideration of donation was too upsetting
•poor interaction with healthcare professionals involved in organ donation, including a perception of insensitivity

(Frauman and Miles 1987; Weiss et al. 1997) (very low-quality evidence).

2.1.2.50 Another influence on consent of potential paediatric donors was donor ethnicity (Frauman and Miles 1987; Pietz et al. 2004) (very low-quality evidence).

2.1.2.51 Other influences on consent of potential paediatric donors were familial (or consentor) ethnicity, religious beliefs, previous examples of belief in or knowledge of transplantation (Frauman and Miles 1987; Pietz et al. 2004) (very low-quality evidence).

Continuity of care

2.1.2.52 One study (Jacoby et al. 2005) showed that continuity of care was considered important by families, but this was sometimes considered inadequate (very low-quality evidence).

2.1.2.53 One study (Jacoby et al. 2005) showed that families of potential donors preferred to interact with a single physician (very low-quality evidence).

Quality of approach

2.1.2.54 Two studies (Haddow 2004; Jacoby et al. 2005) found that compassionate care of the potential donor and their being treated with dignity and respect was important to both donor and non-donor families (very low-quality evidence).

2.1.2.55 One study (Jacoby et al. 2005) showed that families wanted to be listened to and have staff ‘be there’ for them (very low-quality evidence).

2.1.2.56 One study (Bellali and Papadatou 2007; Bellali and Papadatou 2006; Bellali et al. 2007) found that parents of potential paediatric donors were informed in an inappropriate manner and pressured to make a decision; this tended to result in a refusal for donation (very low-quality evidence).

Provision of information

2.1.2.57 Two studies (Jacoby et al. 2005; Sanner 2007) found that both donor and non-donor families wanted information that was understandable, prompt, accurate, in-depth and consistent (very low-quality evidence).

2.1.2.58 Two studies (Haddow 2004; Jacoby et al. 2005) showed that types of information requested included the meaning of brainstem death, the confirmation of death, the reasons for brainstem testing, other medical information related to the condition of the potential donor, and the whole process of organ donation. The understanding of such information should be verified with the family (Jacoby 2005) (very low-quality evidence).

2.1.2.59 One study (Jacoby et al. 2005) showed that tone and pace of information-giving was considered critical. Both donor and non-donor families reported feeling rushed and pressured, and considered that information had been conveyed insensitively. Families wanted information to be conveyed with empathy, concern, and consideration (very low-quality evidence).

2.1.2.60 Two studies (Haddow 2004; Jacoby et al. 2005) showed that families considered privacy for the discussion of donation as being critically important (very low-quality evidence).

2.1.2.61 One study (Bellali and Papadatou 2007; Bellali et al. 2007) showed that parents of potential paediatric donors requested information on the process of organ retrieval, the outcomes of transplantation, the identity of the recipient, and the possibility of making contact with him or her (very low-quality evidence).

2.1.2.62 One study (Bellali and Papadatou 2007; Bellali et al. 2007) showed that parents of potential paediatric donors experienced more distress when they were not given information on the child’s condition, the chance of survival, and the concept of brain death (very low-quality evidence).

2.1.2.63 One study (Bellali and Papadatou 2007; Bellali et al. 2007) showed that after consenting to donation, parents of potential paediatric donors wanted information on what happened next, including the process of burial. Some parents expressed resentment and anger at healthcare professionals who never expressed concern about their wellbeing during the period following the child’s death. They also felt that their act was not socially recognised and that they were quickly forgotten. A few even believed that they had been exploited (very low-quality evidence).

Sources of support

2.1.2.64 One study (Jacoby et al. 2005) showed that nurses were a valued source of emotional support (very low-quality evidence).

2.1.2.65 One study (Jacoby et al. 2005) showed that donor families reported that faith and spiritual support was important to them. This was reported as being less important to non-donor families (very low-quality evidence).

2.1.2.66 One study (Haddow 2004) found that some donor families found follow-up care allowed them to ask further questions and to make the donation feel more personal and sincere; however, not all donor families thought this would be of any value (very low-quality evidence).

Influence of staff involved in organ donation

2.1.2.67 One study (Bellali and Papadatou 2007; Bellali and Papadatou 2006; Bellali et al. 2007) found that if parents of potential paediatric donors had a good relationship with the ICU personnel, they were more likely to accept the irreversibility of their child’s death and give consent to donation. Where this relationship was poor or when staff did not allow parents to be at the child’s bedside, parents were less likely to consent (very low-quality evidence).

Influence of family members

2.1.2.68 One study (Bellali and Papadatou 2006) showed that although parents of potential paediatric donors tended to make the final decision about consent with their spouse, extended family members played a significant role in the decision-making process. Where spousal or mate support was not available or possible, consent for donation was less likely (Bellali and Papadatou 2007; Bellali et al. 2007) (very low-quality evidence).

Timing of approach for consent

2.1.2.69 Two studies (Niles and Mattice 1996; Siminoff and Lawrence 2002) showed that families who were asked about organ donation before death (decoupling approach) tended to have a higher consent rate for donation than those asked at the time of death, or after death (very low-quality evidence).

2.1.2.70 One study (Cutler et al. 1993) showed that if the request for donation was made following notification of death as opposed to before or simultaneously with notification of death, the family was more likely to grant consent for donation (very low-quality evidence).

2.1.2.71 One study (Vane et al. 2001) showed parental consent of potential paediatric donors was obtained when a mean delay of 15.5 hours from admission to time to initiation of brain death protocol was respected compared with a mean delay of 7.0 hours when consent was sought but denied (very low-quality evidence).

2.1.2.72 One study (Jacoby et al. 2005) found that families in the non-donor group had not been given enough time to prepare them for organ donation and had not been clearly informed that the potential donor was brain dead (very low-quality evidence).

2.1.2.73 Three studies (Haddow 2004; Jacoby et al. 2005; Sanner 2007) showed that time was needed to allow families to recover from shock, to consider the benefits of donation, to allow people to discuss the decision with other family members, and to understand the meaning of brainstem death as this was considered to be a difficult concept (very low-quality evidence).

2.1.2.74 Conversely, one study (Jacoby et al. 2005) identified that donor families described the timing of the approach as ‘as good as could have been’ and had time to spend with the family member and to say goodbye (very low-quality evidence).

2.1.2.75 One study (Bellali and Papadatou 2006) reported that where the approach to consent was indirect, parents of potential paediatric donors felt they had had more time to consider the request before discussion with the physician (very low-quality evidence).

2.1.2.76 One study (Bellali and Papadatou 2007; Bellali et al. 2007) reported that parents of potential paediatric donors experienced more distress when they were not given the chance to see their child and to say goodbye (very low-quality evidence).

Co-ordination of the care pathway

2.1.2.77 Two studies (Roth et al. 2003; Shafer et al. 1998) showed that there was an increase in the number of organ donor referrals when hospitals had in-house coordinators coordinating the process in hospitals (very low-quality evidence).

2.1.2.78 One study (Shafer et al. 2004) showed that hospitals with in-house coordinators had a higher consent rate than hospitals without in-house coordinators (very low-quality evidence).

2.1.2.79 Four studies (Al-Sebayel et al. 2004; Roth et al. 2003; Shafer et al. 2004; Shafer et al. 1998) showed that there was an increase in conversion rates and number of organ donors when hospitals had in-house coordinators coordinating the process in hospitals (very low-quality evidence).

2.1.2.80 Two studies (Roth et al. 2003; Shafer et al. 1998) showed there was an increase in the number of organs recovered when hospitals had in-house coordinators coordinating the process in hospitals (very low-quality evidence).

2.1.3 Health economic modelling

The decision problem for this guideline is to examine the value of increasing consent and conversion rates. It is not to examine the value of transplantation. A search for literature did not find any relevant papers that addressed this particular economic issue. Papers were identified that examined the cost effectiveness of different allocation processes and the cost effectiveness of certain transplantations.

The approach taken therefore is based on the assumption that increases in conversion and consent rates would lead to a reduction in waiting lists for organs and, therefore, increased transplantation rates.

The analysis will therefore examine the effect of reducing the waiting time for organ transplantation. It is not possible to conduct an analysis that includes all transplantations because of the lack of readily available data on all solid organ transplants. However, analysis can be done examining the effect of reduced waiting times on kidney transplantation. This is made possible because of the significant amount of data available on kidney transplantation including graft and overall survival estimates, costs of alternatives to transplantations (dialysis), waiting times and the ability to use a model developed for another short clinical guideline on peritoneal dialysis.

The appendix on health economics for peritoneal dialysis contains data on the clinical and cost effectiveness for other renal replacement therapies. Data on transplantation came from the NHS Blood and Transplant (NHSBT) report 2009, the health technology assessment on kidney perfusion machines and NHS reference costs. A sensitivity analysis was conducted where the waiting time for kidney transplantation was varied from the current waiting time of 3.04 years to 6 months, which was achieved in Spain and is often considered to represent an optimum situation. Table 1 outlines the results of various waiting times for kidney transplants and the corresponding cost-effectiveness results.

Table 1 Health economics – cost-effectiveness results associated with average waiting times for kidney transplantation

The analysis indicates that reducing the waiting time for kidney transplant is cost effective. As waiting times fall, this reduction in waiting time becomes even more cost effective. This is the case even when factoring in the cost of more transplantations.

A limitation of this analysis is that it only considers kidney transplantations. However, kidney transplants are the most common transplant undertaken by the NHS and approximately 2% of NHS resources are spent on renal replacement therapies. In addition, the recommendations in this guideline are not limited to only one type of organ and therefore, the benefits realised for kidneys could be applied more widely. Improving transplant rates and organ availability for transplant would not be associated with significant costs and therefore their implementation would present a cost-effective use of NHS resources. A costing template and report that estimates the national cost impact of implementing the guideline, including the potential cost impact of increasing the number of organs available for transplantation, has been produced (see www.nice.org.uk/guidance/CG135).

2.1.4 Evidence to recommendations

Overall, the GDG considered the quality of evidence to be low to very low. There are two main reasons for this. First, most studies were observational (rather than experimental), and second, many studies were from countries other than the UK that have different legislative systems relating to organ donation, and different healthcare systems. However, the evidence and recommendations are consistent with the considerable experience that the NHSBT and patient groups have in using interventions and strategies to increase rates of consent for organ donation.

No direct evidence on how to increase rates of consent in black and minority ethnic groups or in people with religious beliefs was identified and no recommendations specific to these groups have been made. However, the guideline includes recommendations on the need to understand the beliefs and needs of the families, and to tailor practice appropriately.

The tables that follow outline the five criteria that the GDG considered when translating the evidence into recommendations.

Identifying patients who are potential donors

Recommendation 1.1.1

Recommendation 1.1.2

Recommendation 1.1.3

For recommendation 1.1.6

Recommendation 1.1.4

In circumstances where a patient has the capacity to make their own decisions, obtain their views on, and consent to, organ donation.

Recommendation 1.1.5

If a patient lacks capacity to make decisions about their end-of life-care, seek to establish whether taking steps, before death, to facilitate organ donation would be in the best interests of the patient.

Recommendation 1.1.6

While assessing the patient’s best interests clinically stabilise the patient in an appropriate critical care setting while the assessment for donation is performed – for example, an adult intensive care unit or in discussion with a regional paediatric intensive care unit (see recommendation 1.1.8).

Recommendation 1.1.7

Provided that delay is in the patient’s overall best interests, life-sustaining treatments should not be withdrawn or limited until the patient’s wishes around organ donation have been explored and the clinical potential for the patient to donate has been assessed in accordance with legal19 and professional guidance.

Recommendation 1.1.8

In assessing a patient’s best interests, consider:

• the patient’s known wishes and feelings, in particular any advance statement or registration on the NHS organ donor register but also any views expressed by the patient to those close to the patient
• the beliefs or values that would be likely to influence the patient’s decision if they had the capacity to make it
• any other factors they would be likely to consider if they were able to do so
• the views of the patient’s family, friends and anyone involved in their care as appropriate as to what would be in the patient’s best interests; and
• anyone named by the patient to be consulted about such decisions.

Seeking consent to organ donation

Recommendation 1.1.9

If a patient lacks the capacity to consent to organ donation seek to establish the patient’s prior consent by:

• referring to an advance statement if available
• establishing whether the patient has registered and recorded their consent to donate on the NHS organ donor register and
• exploring with those close to the patient whether the patient had expressed any views about organ donation.

Recommendation 1.1.10

If the patient’s prior consent has not already been ascertained, and in the absence of a person or persons having been appointed as nominated representative(s), consent for organ donation should be sought from those in a qualifying relationship with the patient. Where a nominated representative has been appointed and the person had not already made a decision about donation prior to their death, then consent should be sought after death from the said nominated representative(s).

Approach to those close to the patient

Recommendation 1.1.11

A multidisciplinary team (MDT) should be responsible for planning the approach and discussing organ donation with those close to the patient.

Recommendation 1.1.12

The MDT should include:

• the medical and nursing staff involved in the care of the patient, led throughout the process by an identifiable consultant
• the specialist nurse for organ donation
• local faith representative(s) where relevant.

Recommendation 1.1.13

Whenever possible, continuity of care should be provided by team members who have been directly involved in caring for the patient.

Recommendation 1.1.14

The MDT involved in the initial approach should have the necessary skills and knowledge to provide to those close to the patient appropriate support and accurate information about organ donation (see recommendations 1.1.30 and 1.1.31).

Discussions in all cases

Recommendation 1.1.15

Before approaching those close to the patient:

• identify a patient’s potential for donation in consultation with the specialist nurse for organ donation
• check the NHS organ donor register and any advance statements or Lasting Power of Attorney for health and welfare
• clarify coronial, legal and safeguarding issues.

Recommendation 1.1.16

Before approaching those close to the patient, try to seek information on all of the following:

• knowledge of the clinical history of the patient who is a potential donor
• identification of key family members
• assessment of whether family support is required – for example faith representative, family liaison officer, bereavement service, trained interpreter, advocate
• identification of other key family issues
• identification of cultural and religious issues that may have an impact on consent.

Recommendation 1.1.17

Approach those close to the patient in a setting suitable for private and compassionate discussion.

Recommendation 1.1.18

Every approach to those close to the patient should be planned with the MDT and at a time that suits the family’s circumstances.

Recommendation 1.1.19

In all cases those close to the patient should be approached in a professional, compassionate and caring manner and given sufficient time to consider the information.

Recommendation 1.1.20

Discussions about organ donation with those close to the patient should only take place when it has been clearly established that they understand that death is inevitable or has occurred.

Recommendation 1.1.21

When approaching those close to the patient:

• discuss with them that donation is a usual part of the end-of-life care
• use open-ended questions – for example ‘how do you think your relative would feel about organ donation?’
• use positive ways to describe organ donation, especially when patients are on the NHS organ donor register or they have expressed a wish to donate during their lifetime – for example ‘by becoming a donor your relative has a chance to save and transform the lives of many others’
• avoid the use of apologetic or negative language (for example ‘I am asking you because it is policy’ or ‘I am sorry to have to ask you’).

Recommendation 1.1.22

The healthcare team providing care for the patient should provide those close to the patient who is a potential donor with the following, as appropriate:

• assurance that the primary focus is on the care and dignity of the patient (whether the donation occurs or not)
• explicit confirmation and reassurance that the standard of care received will be the same whether they consider giving consent for organ donation or not
• the rationale behind the decision to withdraw or withhold life-sustaining treatment and how the timing will be coordinated to support organ donation
• a clear explanation of, and information on:
– the process of organ donation and retrieval, including post-retrieval arrangements
– what interventions may be required between consent and organ retrieval
– where and when organ retrieval is likely to occur
– how current legislation applies to their situation, including the status of being on the NHS organ donor register or any advance statement
– how the requirements for coronial referral apply to their situation
• consent documentation
• reasons why organ donation may not take place, even if consent is granted.

Recommendation 1.1.23

Allow sufficient time for those close to the patient to understand the inevitability of the death or anticipated death and to spend time with the patient.

Recommendation 1.1.24

Discuss withdrawal of life-sustaining treatment or neurological death before, and at a different time from, discussing organ donation unless those close to the patient initiate these discussions in the same conversation.

Recommendation 1.1.25

For discussions where circulatory death is anticipated, provide a clear explanation on:

• what end-of-life care involves and where it will take place – for example, theatre, critical care department
• how death is confirmed and what happens next
• what happens if death does not occur within a defined time period.

Recommendation 1.1.26

For discussions where neurological death is anticipated, provide a clear explanation on:

• how death is diagnosed using neurological criteria
• how this is confirmed and what happens next.

Recommendation 1.1.27

Each hospital should have a policy and protocol that is consistent with these recommendations for identifying patients who are potential donors and managing the consent process.

Recommendation 1.1.28

Each hospital should identify a clinical team to ensure the development, implementation and regular review of their policies.

Recommendation 1.1.29

Adult and paediatric intensive care units should have a named lead consultant with responsibility for organ donation.

Recommendation 1.1.30

The MDT involved in the identification, referral to a specialist nurse for organ donation, and consent should have the specialist skills and competencies necessary to deliver the recommended process for organ donation outlined in this guideline.

Recommendation 1.1.31

The skills and competencies required of the individual members of the team will depend on their role in the process. However, all healthcare professionals involved in identification, referral to a specialist nurse for organ donation, and consent processes should:

• have knowledge of the basic principles and the relative benefits of donation after circulatory death (DCD) versus donation after brainstem death (DBD)
• understand the principles of the diagnosis of death using neurological or cardiorespiratory criteria and how this relates to the organ donation process
• be able to explain neurological death clearly to families
• understand the use of clinical triggers to identify patients who may be potential organ donors
• understand the processes, policies and protocols relating to donor management
• adhere to relevant professional standards of practice regarding organ donation and end-of-life care.

Recommendation 1.1.32

Consultant staff should have specific knowledge and skills in:

• the law surrounding organ donation
• medical ethics as applied to organ donation
• the diagnosis and confirmation of death using neurological or cardiorespiratory criteria
• the greater potential for transplantation of organs retrieved from DBD donors compared with organs from DCD donors
• legally and ethically appropriate clinical techniques to secure physiological optimisation in patients who are potential organ donors
• communication skills and knowledge necessary to improve consent ratios for organ donation.

3 Research recommendations

We have made the following recommendations for research, based on our review of evidence, to improve NICE guidance and patient care in the future.

3.1 Joining the NHS organ donation register

What are the factors and processes that would encourage the general public to sign up on the UK NHS organ donor register (ODR)?
Why this is important
Ninety percent of the UK general public approve of organ donation, but only 28% have registered on the ODR. Research is urgently needed to find out what factors would encourage people to register, and what processes could increase registration. If these factors could be identified and processes implemented, the number of people on the ODR could be significantly increased. Therefore the supply of donor organs should be improved given that evidence shows that families are more likely to consent if the potential donor is known to be on the ODR.

3.2 Reasons for refusal for consent

Why do families refuse to give permission for organ donation?

Why this is important
High-quality research using mixed methodology is needed to identify the reasons behind family refusal to see if there are factors that are changeable (for example, poor understanding of the process, medical mistrust, ‘knee-jerk’ response that is later regretted). The study could be, for example, a multi-centre observational study where all family members (those that did and those that did not give permission for their deceased loved one’s organ donation) are followed up 6 months later.

Such research could determine whether those participants who gave permission for donation have higher perceived benefits scores, lower prolonged grief scores and higher quality-of-life scores than those who did not.

3.3 Improving rates of identification and referral of potential donors

What are the key components of an intervention to improve identification and referral rates?

Why this is important
Currently, the evidence for improving identification and referral rates consists mainly of observational reports of complex interventions, with most studies being of limited follow-up. Further research is needed to identify the components, or combinations of components, of the interventions that are effective in increasing identification and referral rates. These studies should have an appropriate length of follow-up to ensure a sustained impact in the longer term.

3.4 Improving consent rates

What are the key components of an intervention to improve consent rates?

Why this is important
Currently, the evidence for improving consent rates consists mainly of observational reports of complex interventions, with most studies being of limited follow-up. Further research is needed to identify the components, or combinations of components, of the identified interventions that are effective in increasing consent rates. These studies should have an appropriate length of follow-up to ensure a sustained impact in the longer term.

3.5 The experience of consenting for organ donation

Does a positive experience of approach and process of consent for families increase consent rates?

Why this is important
It is generally accepted that if families have a more positive experience of the approach and process of consenting, then rates of consent will increase. However, no high-quality evidence was identified to support this perception. Further research is needed to confirm this assumption and, if true, to identify those components of the approach and process that are key to improving the experience, and hence the consent rate.

4 Implementation

NICE has developed tools to help organisations implement this guidance (see www.nice.org.uk/guidance/CG135).

5 Other versions of this guideline

This is the full guideline. It contains details of the methods and evidence used to develop the guideline. It is available from our website (www.nice.org.uk/guidance/CG135/Guidance).

Quick reference guide

A quick reference guide for healthcare professionals is available from www.nice.org.uk/guidance/CG135/QuickRefGuide
For printed copies, phone NICE publications on 0845 003 7783 or email publications@nice.org.uk (quote reference number N2680).

NICE Pathway
The recommendations from this guideline have been incorporated into a NICE pathway, which is available from http://pathways.nice.org.uk (publication expected January 2012)

‘Understanding NICE guidance’
A summary for patients and carers (‘Understanding NICE guidance’) is available from www.nice.org.uk/guidance/CG135/PublicInfo
For printed copies, phone NICE publications on 0845 003 7783 or email publications@nice.org.uk (quote reference number N2681).
We encourage NHS and voluntary sector organisations to use text from this booklet in their own information.

6 Updating the guideline

NICE clinical guidelines are updated so that recommendations take into account important new information. New evidence is checked 3 years after publication, and healthcare professionals and patients are asked for their views; we use this information to decide whether all or part of a guideline needs updating. If important new evidence is published at other times, we may decide to do a more rapid update of some recommendations.

7 References, glossary and abbreviations

7.1 References

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Bellali T, Papadatou D (2006) Parental grief following the brain death of a child: does consent or refusal to organ donation affect their grief? Death Studies 30: 883–917

Bellali T, Papadatou D (2007) The decision-making process of parents regarding organ donation of their brain dead child: A Greek study. Social Science and Medicine 64: 439–50

Bellali T, Papazoglou I, Papadatou D (2007) Empirically based recommendations to support parents facing the dilemma of paediatric cadaver organ donation. Intensive & Critical Care Nursing 23: 216–25

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Burroughs TE, Hong BA, Kappel DF et al. (1998) The stability of family decisions to consent or refuse organ donation: would you do it again? Psychosomatic Medicine 60: 156–62

Chapman JR, Hibberd AD, McCosker C et al. (1995) Obtaining consent for organ donation in nine NSW metropolitan hospitals. Anaesthesia & Intensive Care 23: 81–7

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Cutler JA, David SD, Kress CJ et al. (1993) Increasing the availability of cadaveric organs for transplantation maximizing the consent rate. Transplantation 56: 225–8

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Douglas S (1994) Factors affecting cadaveric organ donation: a national survey of organ procurement coordinators. Journal of Transplant Coordination 4: 96–103

Douglass GE, Daly M (1995) Donor families’ experience of organ donation. Anaesthesia and Intensive Care 23: 96–8

Frauman AC, Miles MS (1987) Parental willingness to donate the organs of a child. Anna Journal 14: 401–4

Frutos MA, Ruiz P, Requena MV et al. (2002) Family refusal in organ donation: Analysis of three patterns. Transplantation Proceedings 34: 2513–4

Gabel H, Edstrom B (1993) Number of potential cadaveric donors: reasons for nonprocurement and suggestions for improvement. Transplantation Proceedings 25: 3136

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Gortmaker SL, Beasley CL, Brigham LE et al. (1996) Organ donor potential and performance: size and nature of the organ donor shortfall. Critical Care Medicine 24: 432–9

Graham JM, Sabeta ME, Cooke JT et al. (2009) A system’s approach to improve organ donation. Progress in Transplantation 19: 216–20

Haddow G (2004) Donor and nondonor families’ accounts of communication and relations with healthcare professionals. Progress in Transplantation 14: 41–8

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Higashigawa KH, Carroll C, Wong LL et al. (2002) Organ donation in Hawaii: impact of the final rule. Clinical Transplantation 16: 180–4

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La SF, Sedda L, Pizzi C et al. (1993) Donor families’ attitude toward organ donation. Transplantation Proceedings 25: 1699-701.

Madsen M, Bogh L (2005) Estimating the organ donor potential in Denmark: a prospective analysis of deaths in intensive care units in northern Denmark. Transplantation Proceedings 37: 3258–9

Martinez JM, Lopez JS, Martin A et al. (2001) Organ donation and family decision-making within the Spanish donation system. Social Science & Medicine 53: 405–21

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Molzahn AE (1997) Knowledge and attitudes of physicians regarding organ donation. Annals of the Royal College of Physicians & Surgeons of Canada 30: 29–32

Murphy F, Cochran D, Thornton S (2009) Impact of a Bereavement and Donation Service incorporating mandatory ‘required referral’ on organ donation rates: a model for the implementation of the Organ Donation Taskforce’s recommendations. Anaesthesia 64: 822–8

NHS Blood and Transplant (2009) Transplant Activity in the UK. Bristol: NHS Blood and Transplant

Niles PA, Mattice BJ (1996) The timing factor in the consent process. Journal of Transplant Coordination 6: 84–7
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7.2 Glossary

Advance statement
A set of instructions given in advance by individuals specifying what actions should be taken for their health in the event that they are no longer able to make decisions due to illness or incapacity. It does not always have to be written down, although most are.

Brainstem death
Death diagnosed after irreversible cessation of brainstem function and confirmed using neurological criteria. The diagnosis of death is made while the body of the person is attached to an artificial ventilator and the heart is still beating.

Circulatory death
Death diagnosed and confirmed following cardiorespiratory arrest.

Clinical triggers
A set of clinical criteria used to indicate a high probability of death, which is used to define a standard point in care when the hospital is expected to initiate referral.

Close to the patient (those)
Family, friends, partners and anyone who knows the patient who can be, but is not necessarily, in a qualifying relationship.

Conversion rate
Depending on the stage of the process for organ donation, this can mean the percentage of potential donors for whom consent is obtained, the percentage of potential donors with consent who then become actual (DBD or DCD) donors, or the percentage of potential donors (before consent) who become actual donors.

Lasting Power of Attorney
A Lasting Power of Attorney (LPA) is a legal document that enables a person who has capacity and is over 18 to choose another person or people (attorney[s]) to make decisions on their behalf. A health and welfare LPA is for decisions about both health and personal welfare, such as where to live, day-to-day care or having medical treatment.

Nominated representative
A nominated representative is a person appointed by the patient to represent the patient after their death in relation to consent for organ donation. The appointment may have been made orally or in writing.

Qualifying relationship
The following are qualifying relationships for the purposes of the Human Tissue Act 2004. Consent should be obtained from the available person ranked highest in the following list:
– spouse or partner (including civil or same sex partner)
– parent or child (in this context a ‘child’ can be any age)
– brother or sister
– grandparent or grandchild
– niece or nephew
– stepfather or stepmother
– half-brother or half-sister
– friend of long standing.

Required referral
A system where all deaths (including anticipated death) are referred to the healthcare professional(s) responsible for organ donation.

7.3 Abbreviations

8  Authorship and citation

Authorship of this document is attributed to the NICE Short Clinical Guidelines Technical Team and members of the Guideline Development Group under group authorship.

The guideline should be cited as:

National Institute for Health and Clinical Excellence (2011) Organ donation for transplantation: improving donor identification and consent rates for deceased organ donation. London: National Institute for Health and Clinical Excellence.

Available from www.nice.org.uk/guidance/CG135