Carer administration of as-needed subcutaneous medication for breakthrough symptoms in people dying at home: the CARiAD feasibility RCT.

BACKGROUND: Most people who are dying want to be cared for at home, but only half of them achieve this. The likelihood of a home death often depends on the availability of able and willing lay carers. When people who are dying are unable to take oral medication, injectable medication is used. When top-up medication is required, a health-care professional travels to the dying person's home, which may delay symptom relief. The administration of subcutaneous medication by lay carers, although not widespread UK practice, has proven to be key in achieving better symptom control for those dying at home in other countries. OBJECTIVES: To determine if carer administration of as-needed subcutaneous medication for common breakthrough symptoms in people dying at home is feasible and acceptable in the UK, and if it would be feasible to test this intervention in a future definitive randomised controlled trial. DESIGN: We conducted a two-arm, parallel-group, individually randomised, open pilot trial of the intervention versus usual care, with a 1 : 1 allocation ratio, using convergent mixed methods. SETTING: Home-based care without 24/7 paid care provision, in three UK sites. PARTICIPANTS: Participants were dyads of adult patients and carers: patients in the last weeks of their life who wished to die at home and lay carers who were willing to be trained to give subcutaneous medication. Strict risk assessment criteria needed to be met before approach, including known history of substance abuse or carer ability to be trained to competency. INTERVENTION: Intervention-group carers received training by local nurses using a manualised training package. MAIN OUTCOME MEASURES: Quantitative data were collected at baseline and 6-8 weeks post bereavement and via carer diaries. Interviews with carers and health-care professionals explored attitudes to, experiences of and preferences for giving subcutaneous medication and experience of trial processes. The main outcomes of interest were feasibility, acceptability, recruitment rates, attrition and selection of the most appropriate outcome measures. RESULTS: In total, 40 out of 101 eligible dyads were recruited (39.6%), which met the feasibility criterion of recruiting > 30% of eligible dyads. The expected recruitment target (≈50 dyads) was not reached, as fewer than expected participants were identified. Although the overall retention rate was 55% (22/40), this was substantially unbalanced [30% (6/20) usual care and 80% (16/20) intervention]. The feasibility criterion of > 40% retention was, therefore, considered not met. A total of 12 carers (intervention, n = 10; usual care, n = 2) and 20 health-care professionals were interviewed. The intervention was considered acceptable, feasible and safe in the small study population. The context of the feasibility study was not ideal, as district nurses were seriously overstretched and unfamiliar with research methods. A disparity in readiness to consider the intervention was demonstrated between carers and health-care professionals. Findings showed that there were methodological and ethics issues pertaining to researching last days of life care. CONCLUSION: The success of a future definitive trial is uncertain because of equivocal results in the progression criteria, particularly poor recruitment overall and a low retention rate in the usual-care group. Future work regarding the intervention should include understanding the context of UK areas where this has been adopted, ascertaining wider public views and exploring health-care professional views on burden and risk in the NHS context. There should be consideration of the need for national policy and of the most appropriate quantitative outcome measures to use. This will help to ascertain if there are unanswered questions to be studied in a trial. TRIAL REGISTRATION: Current Controlled Trials ISRCTN11211024. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 25. See the NIHR Journals Library website for further project information.

Most people in the UK would prefer to die at home, but only half of them achieve this. This usually depends on having able and willing lay carers (family or friends) to help look after them. Once swallowing is not possible, medicine is given continually under the skin (syringe driver). If common problems such as pain, vomiting or agitation break through, health-care professionals attend to give extra doses. The wait for a health-care professional to arrive can be distressing. In the UK, it is legal (but not routine) for lay carers to give needle-free subcutaneous injections themselves. We reworked an Australian carer education package for UK use. The best way to find out if this would work well is to do a randomised controlled trial. This is a test in which, at random, half of the people taking part receive 'usual care' and the other half receive the 'new care' or intervention. A pilot randomised controlled trial (a 'test' trial to see if a larger one is worth doing) was carried out to determine if lay carer injections were possible in the UK. We approached 90 dyads (a dying person and a key carer) and, of these, 40 were willing to take part and 22 completed the follow-up visit, so we could analyse their data. Of these 22 dyads, 16 were in the intervention group (lay carer injects) and six were in the control group (usual care). All carers were asked to keep a diary. Carers and health-care professionals were interviewed (qualitative study) and carer preferences were assessed. This new practice was safe, acceptable and welcomed. Carer confidence increased rapidly, symptom control was quicker and the interviews backed up these findings. Recruitment was low owing to overstretched health-care professionals. Only certain families were picked. Dyads in the usual-care group often wished they were in the intervention group. Carers found it difficult to complete some of the questionnaires that were used to measure the effect of the intervention. Therefore, uncertainty remains as to whether or not a full trial should proceed. Because the practice is already legal, some areas in the UK are already undertaking it. We plan to study what makes this practice possible or less possible to achieve.

Family overrule of registered refusal to donate organs.

It is well known that families frequently overrule the wishes of dying patients who had previously expressed a wish to donate their organs. Various strategies have been suggested to reduce the frequency of these 'family overrules'. However, the possibility of families overruling a patient's registered decision not to donate has not been discussed in the medical literature, although it is legally possible in some countries. In this article, we provide an ethical analysis of family overrule of a relative's refusal to donate, using the different jurisdictions of the UK, Switzerland, Germany and the Netherlands to provide some context. Despite some asymmetries between overruling consent and overruling refusal, there are some cases in which donation should proceed despite a recorded refusal to do so.

CARer-ADministration of as-needed subcutaneous medication for breakthrough symptoms in homebased dying patients (CARiAD): study protocol for a UK-based open randomised pilot trial.

BACKGROUND: While the majority of seriously ill people wish to die at home, only half achieve this. The likelihood of someone dying at home often depends on the availability of able and willing lay carers to support them. Dying people are usually unable to take oral medication. When top-up symptom relief medication is required, a clinician travels to the home to administer injectable medication, with attendant delays. The administration of subcutaneous injections by lay carers, though not widespread practice in the UK, has proven key in achieving home deaths in other countries. Our aim is to determine if carer-administration of as-needed subcutaneous medication for four frequent breakthrough symptoms (pain, nausea, restlessness and noisy breathing) in home-based dying patients is feasible and acceptable in the UK. METHODS: This paper describes a randomised pilot trial across three UK sites, with an embedded qualitative study. Dyads of adult patients/carers are eligible, where patients are in the last weeks of life and wish to die at home, and lay carers who are willing to be trained to give subcutaneous medication. Dyads who do not meet strict risk assessment criteria (including known history of substance abuse or carer ability to be trained to competency) will not be approached. Carers in the intervention arm will receive a manualised training package delivered by their local nursing team. Dyads in the control arm will receive usual care. The main outcomes of interest are feasibility, acceptability, recruitment rates, attrition and selection of the most appropriate outcome measures. Interviews with carers and healthcare professionals will explore attitudes to, experiences of and preferences for giving subcutaneous medication and experience of trial processes. The study has obtained full ethical approval. DISCUSSION: This study will rehearse the procedures and logistics which will be undertaken in a future definitive randomised controlled trial and will inform the design of such a study. Findings will illuminate methodological and ethical issues pertaining to researching last days of life care. The study is funded by the National Institute for Health Research (Health Technology Assessment [HTA] project 15/10/37). TRIAL REGISTRATION: ISRCTN, ISRCTN 11211024 . Registered on 27 September 2016.

Conscientious objection to deceased organ donation by healthcare professionals.

In this article, we analyse the potential benefits and disadvantages of permitting healthcare professionals to invoke conscientious objection to deceased organ donation. There is some evidence that permitting doctors and nurses to register objections can ultimately lead to attitudinal change and acceptance of organ donation. However, while there may be grounds for conscientious objection in other cases such as abortion and euthanasia, the life-saving nature of donation and transplantation renders objection in this context more difficult to justify. In general, dialogue between healthcare professionals is a more appropriate solution, and any objections must be justified with a strong rationale in hospitals where such policies are put in place.

Family Over Rules? An Ethical Analysis of Allowing Families to Overrule Donation Intentions.

Millions of people want to donate their organs after they die for transplantation, and many of them have registered their wish to do so or told their family and friends about their decision. For most of them, however, this wish is unlikely to be fulfilled, as only a small number of deaths (1% in the United Kingdom) occur in circumstances where the opportunity to donate organs is possible. Even for those who do die in the "right" way and have recorded their wishes or live in a jurisdiction with a "presumed consent" system, donation often does not go ahead because of another issue: their families refuse to allow donation to proceed. In some jurisdictions, the rate of "family overrule" is over 10%. In this article, we provide a systematic ethical analysis of the family overrule of donation of solid organs by deceased patients, and examine arguments both in favor of and against allowing relatives to "veto" the potential donor's intentions. First, we provide a brief review of the different consent systems in various European countries, and the ramifications for family overrule. Next, we describe and discuss the arguments in favor of permitting donation intentions to be overruled, and then the arguments against doing so. The "pro" arguments are: overrule minimises family distress and staff stress; families need to cooperate for donation to take place; families might have evidence regarding refusal; and failure to permit overrules could weaken trust in the donation system. The "con" arguments are: overrule violates the patient's wishes; the family is too distressed and will regret the decision; overruling harms other patients; and regulations prohibit overrule. We conclude with a general discussion and recommendations for dealing with families who wish to overrule donation. Overall, overrule should only rarely be permitted.

Ethical, legal, and societal issues and recommendations for controlled and uncontrolled DCD.

This report deals with organ retrieval procedures in both controlled and uncontrolled DCD, looking at the ethical, legal, and psychosocial aspects during the different phases of the process. A recently published report by the UK Donation Ethics Committee (UKDEC) has served as an important reference document to outline the steps in the controlled DCD patient-donor pathway (Academy of Medical Royal Colleges. UK Donation Ethics Committee. An ethical framework for controlled donation after circulatory death. December 2011). For uncontrolled DCD, the UKDEC pathway description was adapted. At the 6th International Conference in Organ Donation held in Paris in 2013, an established expert European Working Group reviewed the UKDEC reports, which were then considered along with the available published literature. Along this pathway, the crucial ethical, legal, and psychosocial aspects have been flagged, and relevant recommendations have been formulated based on a consensus of the working group.

MORECare research methods guidance development: recommendations for ethical issues in palliative and end-of-life care research.

BACKGROUND: There is little guidance on the particular ethical concerns that research raises with a palliative care population. AIM: To present the process and outcomes of a workshop and consensus exercise on agreed best practice to accommodate ethical issues in research on palliative care. DESIGN: Consultation workshop using the MORECare Transparent Expert Consultation approach. Prior to workshops, participants were sent overviews of ethical issues in palliative care. Following the workshop, nominal group techniques were used to produce candidate recommendations. These were rated online by participating experts. Descriptive statistics were used to analyse agreement and consensus. Narrative comments were collated. SETTING/PARTICIPANTS: Experts in ethical issues and palliative care research were invited to the Cicely Saunders Institute in London. They included senior researchers, service providers, commissioners, researchers, members of ethics committees and policy makers. RESULTS: The workshop comprised 28 participants. A total of 16 recommendations were developed. There was high agreement on the issue of research participation and high to moderate agreement on applications to research ethics committees. The recommendations on obtaining and maintaining consent from patients and families were the most contentious. Nine recommendations were refined on the basis of the comments from the online consultation. CONCLUSIONS: The culture surrounding palliative care research needs to change by fostering collaborative approaches between all those involved in the research process. Changes to the legal framework governing the research process are required to enhance the ethical conduct of research in palliative care. The recommendations are relevant to all areas of research involving vulnerable adults.

Evaluating complex interventions in end of life care: the MORECare statement on good practice generated by a synthesis of transparent expert consultations and systematic reviews.

BACKGROUND: Despite being a core business of medicine, end of life care (EoLC) is neglected. It is hampered by research that is difficult to conduct with no common standards. We aimed to develop evidence-based guidance on the best methods for the design and conduct of research on EoLC to further knowledge in the field. METHODS: The Methods Of Researching End of life Care (MORECare) project built on the Medical Research Council guidance on the development and evaluation of complex circumstances. We conducted systematic literature reviews, transparent expert consultations (TEC) involving consensus methods of nominal group and online voting, and stakeholder workshops to identify challenges and best practice in EoLC research, including: participation recruitment, ethics, attrition, integration of mixed methods, complex outcomes and economic evaluation. We synthesised all findings to develop a guidance statement on the best methods to research EoLC. RESULTS: We integrated data from three systematic reviews and five TECs with 133 online responses. We recommend research designs extending beyond randomised trials and encompassing mixed methods. Patients and families value participation in research, and consumer or patient collaboration in developing studies can resolve some ethical concerns. It is ethically desirable to offer patients and families the opportunity to participate in research. Outcome measures should be short, responsive to change and ideally used for both clinical practice and research. Attrition should be anticipated in studies and may affirm inclusion of the relevant population, but careful reporting is necessitated using a new classification. Eventual implementation requires consideration at all stages of the project. CONCLUSIONS: The MORECare statement provides 36 best practice solutions for research evaluating services and treatments in EoLC to improve study quality and set the standard for future research. The statement may be used alongside existing statements and provides a first step in setting common, much needed standards for evaluative research in EoLC. These are relevant to those undertaking research, trainee researchers, research funders, ethical committees and editors.

Adherence to the request criterion in jurisdictions where assisted dying is lawful? A review of the criteria and evidence in the Netherlands, Belgium, Oregon, and Switzerland.

Some form of assisted dying (voluntary euthanasia and/or assisted suicide) is lawful in the Netherlands, Belgium, Oregon, and Switzerland. In order to be lawful in these jurisdictions, a valid request must precede the provision of assistance to die. Non-adherence to the criteria for valid requests for assisted dying may be a trigger for civil and/or criminal liability, as well as disciplinary sanctions where the assistor is a medical professional. In this article, we review the criteria and evidence in respect of requests for assisted dying in the Netherlands, Belgium, Oregon, and Switzerland, with the aim of establishing whether individuals who receive assisted dying do so on the basis of valid requests. We conclude that the evidence suggests that individuals who receive assisted dying in the four jurisdictions examined do so on the basis of valid requests and third parties who assist death do not act unlawfully. However, further research on the elements that may undermine the validity of requests for assisted dying is warranted. More research on the reasons why requests for assisted dying are refused is also desirable.

Euthanasia in Belgium five years after legalisation.

In 2002, Belgium became the second country to legalise euthanasia after the Netherlands. Three biannual reports have been published by the Federal Control and Evaluation Commission, the body which monitors the application of the law. This article explores how the Belgian law works and what is known about Belgian euthanasia practice both before and since legalisation.

The empirical slippery slope from voluntary to non-voluntary euthanasia.

This article examines the evidence for the empirical argument that there is a slippery slope between the legalization of voluntary and non-voluntary euthanasia. The main source of evidence in relation to this argument comes from the Netherlands. The argument is only effective against legalization if it is legalization which causes the slippery slope. Moreover, it is only effective if it is used comparatively-to show that the slope is more slippery in jurisdictions which have legalized voluntary euthanasia than it is in jurisdictions which have not done so. Both of these elements are examined comparatively.

Medical treatment of dementia patients at the end of life: can the law accommodate the personal identity and welfare problems?

This article considers whether two significant philosophical objections to autonomy-based legal approaches to decision-making for incompetent individuals could be accommodated by the law. These philosophical objections are known as the personal identity and welfare problems. The article first sets out the autonomy-based approaches and their objections. Next, the present legal position is briefly canvassed in a comparative vein. Finally, the article suggests how the personal identity and welfare problems might be accommodated were legislators minded to do so, by proposing specific statutory amendments to the recent English legislation on advance decisions and evaluating their viability, particularly in light of the European Convention on Human Rights.