Anne Slowther

Prehospital Randomised Assessment of a Mechanical Compression Device In Cardiac arrest (PaRAMeDIC) Trial Protocol

BackgroundSurvival after out-of-hospital cardiac arrest is closely linked to the quality of CPR, but in real life, resuscitation during prehospital care and ambulance transport is often suboptimal. Mechanical chest compression devices deliver consistent chest compressions, are not prone to fatigue and could potentially overcome some of the limitations of manual chest compression. However, there is no high-quality evidence that they improve clinical outcomes, or that they are cost effective. The Prehospital Randomised Assessment of a Mechanical Compression Device In Cardiac Arrest (PARAMEDIC) trial is a pragmatic cluster randomised study of the LUCAS-2 device in adult patients with non-traumatic out-of-hospital cardiac arrest.Methods/designThe primary objective of this trial is to evaluate the effect of chest compression using LUCAS-2 on mortality at 30 days post out-of-hospital cardiac arrest, compared with manual chest compression. Secondary objectives of the study are to evaluate the effects of LUCAS-2 on survival to 12 months, cognitive and quality of life outcomes and cost-effectiveness. Methods: Ambulance service vehicles will be randomised to either manual compression (control) or LUCAS arms. Adult patients in out-of-hospital cardiac arrest, attended by a trial vehicle will be eligible for inclusion. Patients with traumatic cardiac arrest or who are pregnant will be excluded. The trial will recruit approximately 4000 patients from England, Wales and Scotland. A waiver of initial consent has been approved by the Research Ethics Committees. Consent will be sought from survivors for participation in the follow-up phase.ConclusionThe trial will assess the clinical and cost effectiveness of the LUCAS-2 mechanical chest compression device. Trial Registration: The trial is registered on the International Standard Randomised Controlled Trial Number Registry (ISRCTN08233942).

Ethics of evidence based medicine in the primary care setting.

Evidence based medicine has had an increasing impact on primary care over the last few years. In the UK it has influenced the development of guidelines and quality standards for clinical practice and the allocation of resources for drug treatments and other interventions. It has informed the thinking around patient involvement in decision making with the concept of evidence based patient choice. There are, however, concerns among primary care clinicians that evidence based medicine is not always relevant to primary care and that undue emphasis placed on it can lead to conflict with a clinician’s duty of care and respect for patient autonomy. In this paper we consider the impact of evidence based medicine on primary care, and the ethical implications of its increasing prominence for clinicians and managers in primary care.

Experiences of non-UK-qualified doctors working within the UK regulatory framework: a qualitative study

Objective To explore the experience of non-UK-qualified doctors in working within the regulatory framework of the General Medical Council (GMC) document Good Medical Practice. Design Individual interviews and focus groups. Setting United Kingdom. Participants Non-UK-qualified doctors who had registered with the GMC between 1 April 2006 and 31 March 2008, doctors attending training/induction programmes for non-UK-qualified doctors, and key informants involved in training and support for non-UK-qualified doctors. Main outcome measures Themes identified from analysis of interview and focus group transcripts. Results Information and support for non-UK qualified doctors who apply to register to work in the UK has little reference to the ethical and professional standards required of doctors working in the UK. Recognition of the ethical, legal and cultural context of UK healthcare occurs once doctors are working in practice. Non-UK qualified doctors reported clear differences in the ethical and legal framework for practising medicine between the UK and their country of qualification, particularly in the model of the doctor–patient relationship. The degree of support for non-UK-qualified doctors in dealing with ethical concerns is related to the type of post they work in. European doctors describe similar difficulties with working in an unfamiliar regulatory framework to their non-European colleagues. Conclusions Non-UK-qualified doctors experience a number of difficulties related to practising within a different ethical and professional regulatory framework. Provision of information and educational resources before registration, together with in-practice support would help to develop a more effective understanding of GMP and its implications for practice in the UK.

Should ethics consultants help clinicians face scarcity in their practice

In an international survey of rationing we have found that European physicians encounter scarcity-related ethical difficulties, and are dissatified with the resolution of many of these cases. Here we further examine survey results to explore whether ethics support services would be potentially useful in addressing scarcity related ethical dilemmas. Results indicate that while the type of help offered by ethics support services was considered helpful by physicians, they rarely referred difficulties regarding scarcity to ethics consultation. We propose that ethics consultants could assist physicians by making the process less difficult, and by contributing to decisions being more ethically justifiable. Expertise in bringing considerations of justice to bear on real cases could also be useful in recognising an unjust limit, as opposed to a merely frustrating limit. Though these situations are unlikely to be among the most frequently referred to ethics support services, ethics consultants should be prepared to address them.

Who should donate blood? Policy decisions on donor deferral criteria should protect recipients and be fair to donors

An important element in the development of voluntary blood donation schemes throughout the world has been the attention given to minimising the risk to recipients of donated blood, primarily the risk of transfusion transmitted infections. In response to the appearance of human immunodeficiency virus (HIV) in the 1980s a range of national policies emerged that excluded populations at high risk of contracting HIV from donating blood, with a particular focus on men who have sex with men (MSM), the primary reason being the protection of recipients of donated blood. Recently some countries, including the UK, have revised their policies, informed by advances in screening tests, epidemiological evidence of transmission rates and an increasing concern about unfair discrimination of specific groups in society. Policy makers face a difficult task of balancing safety of recipients; an adequate blood supply for those who require transfusion; and societal/legal obligations to treat everyone fairly. Given that no transfusion is risk free, the question is what degree of risk is acceptable in order to meet the needs of recipients and society. Decisions about acceptance of risk are complex and policy makers who set acceptable risk levels must provide ethically justifiable reasons for their decisions. We suggest it is possible to provide a set of reasons that stakeholders could agree are relevant based on careful evaluation of the evidence of all relevant risks and explicit acknowledgement of other morally relevant values. We describe using such a process in the Safety of Blood Tissue and Organs (SaBTO) review of donor deferral criteria related to sexual behaviour.

Best interests, dementia and the Mental Capacity Act (2005)

The Mental Capacity Act (2005) is an impressive piece of legislation that deserves serious ethical attention, but much of the commentary on the Act has focussed on its legal and practical implications rather than the underlying ethical concepts. This paper examines the approach that the Act takes to best interests. The Act does not provide an account of the underlying concept of best interests. Instead it lists factors that must be considered in determining best interests, and the Code of Practice to the Act states that this list is incomplete. This paper argues that this general approach is correct, contrary to some accounts of best interests. The checklist includes items that are unhelpful. Furthermore, neither the Act nor its Code of Practice provides sufficient guidance to carers faced with difficult decisions concerning best interests. This paper suggests ways in which the checklist can be developed and discusses cases that could be used in an updated Code of Practice.

Regulation of healthcare ethics committees in Europe

In this article, the question is discussed if and how Healthcare Ethics Committees (HECs) should be regulated. The paper consists of two parts. First, authors from eight EC member countries describe the status quo in their respective countries, and give reasons as to the form of regulation they consider most adequate. In the second part, the country reports are analysed. It is suggested that regulation of HECs should be central and weak. Central regulation is argued to be apt to improve HECs’ accountability, relevance and comparability. To facilitate biomedical citizenship and ethical reflection, regulation should at the same time be weak rather than strict. Independence of HECs to deliberate about ethical questions, and to give solicited and unsolicited advice, should be supported and only interfered with by way of exception. One exception is when circumstances become temporary adversarial to ethical deliberation in healthcare institutions. In view of European unification, steps should be taken to develop consistent policies for both Eastern and Western European countries.

Timely digital patient-clinician communication in specialist clinical services for young people: A mixed-methods study (the LYNC study)

Background Young people (aged 16-24 years) with long-term health conditions can disengage from health services, resulting in poor health outcomes, but clinicians in the UK National Health Service (NHS) are using digital communication to try to improve engagement. Evidence of effectiveness of this digital communication is equivocal. There are gaps in evidence as to how it might work, its cost, and ethical and safety issues. Objective Our objective was to understand how the use of digital communication between young people with long-term conditions and their NHS specialist clinicians changes engagement of the young people with their health care; and to identify costs and necessary safeguards. Methods We conducted mixed-methods case studies of 20 NHS specialist clinical teams from across England and Wales and their practice providing care for 13 different long-term physical or mental health conditions. We observed 79 clinical team members and interviewed 165 young people aged 16-24 years with a long-term health condition recruited via case study clinical teams, 173 clinical team members, and 16 information governance specialists from study NHS Trusts. We conducted a thematic analysis of how digital communication works, and analyzed ethics, safety and governance, and annual direct costs. Results Young people and their clinical teams variously used mobile phone calls, text messages, email, and voice over Internet protocol. Length of clinician use of digital communication varied from 1 to 13 years in 17 case studies, and was being considered in 3. Digital communication enables timely access for young people to the right clinician at the time when it can make a difference to how they manage their health condition. This is valued as an addition to traditional clinic appointments and can engage those otherwise disengaged, particularly at times of change for young people. It can enhance patient autonomy, empowerment and activation. It challenges the nature and boundaries of therapeutic relationships but can improve trust. The clinical teams studied had not themselves formally evaluated the impact of their intervention. Staff time is the main cost driver, but offsetting savings are likely elsewhere in the health service. Risks include increased dependence on clinicians, inadvertent disclosure of confidential information, and communication failures, which are mostly mitigated by young people and clinicians using common-sense approaches. Conclusions As NHS policy prompts more widespread use of digital communication to improve the health care experience, our findings suggest that benefit is most likely, and harms are mitigated, when digital communication is used with patients who already have a relationship of trust with the clinical team, and where there is identifiable need for patients to have flexible access, such as when transitioning between services, treatments, or lived context. Clinical teams need a proactive approach to ethics, governance, and patient safety.

Dementia And Physical Activity (DAPA) trial of moderate to high intensity exercise training for people with dementia: randomised controlled trial

Abstract Objective To estimate the effect of a moderate to high intensity aerobic and strength exercise training programme on cognitive impairment and other outcomes in people with mild to moderate dementia. Design Multicentre, pragmatic, investigator masked, randomised controlled trial. Setting National Health Service primary care, community and memory services, dementia research registers, and voluntary sector providers in 15 English regions. Participants 494 people with dementia: 329 were assigned to an aerobic and strength exercise programme and 165 were assigned to usual care. Random allocation was 2:1 in favour of the exercise arm. Interventions Usual care plus four months of supervised exercise and support for ongoing physical activity, or usual care only. Interventions were delivered in community gym facilities and NHS premises. Main outcome measures The primary outcome was score on the Alzheimer’s disease assessment scale-cognitive subscale (ADAS-cog) at 12 months. Secondary outcomes included activities of daily living, neuropsychiatric symptoms, health related quality of life, and carer quality of life and burden. Physical fitness (including the six minute walk test) was measured in the exercise arm during the intervention. Results The average age of participants was 77 (SD 7.9) years and 301/494 (61%) were men. By 12 months the mean ADAS-cog score had increased to 25.2 (SD 12.3) in the exercise arm and 23.8 (SD 10.4) in the usual care arm (adjusted between group difference −1.4, 95% confidence interval −2.6 to −0.2, P=0.03). This indicates greater cognitive impairment in the exercise group, although the average difference is small and clinical relevance uncertain. No differences were found in secondary outcomes or preplanned subgroup analyses by dementia type (Alzheimer’s disease or other), severity of cognitive impairment, sex, and mobility. Compliance with exercise was good. Over 65% of participants (214/329) attended more than three quarters of scheduled sessions. Six minute walking distance improved over six weeks (mean change 18.1 m, 95% confidence interval 11.6 m to 24.6 m). Conclusion A moderate to high intensity aerobic and strength exercise training programme does not slow cognitive impairment in people with mild to moderate dementia. The exercise training programme improved physical fitness, but there were no noticeable improvements in other clinical outcomes. Trial registration Current Controlled Trials ISRCTN10416500.

A Randomized Trial of Epinephrine in Out-of-Hospital Cardiac Arrest

BACKGROUND Concern about the use of epinephrine as a treatment for out‐of‐hospital cardiac arrest led the International Liaison Committee on Resuscitation to call for a placebocontrolled trial to determine whether the use of epinephrine is safe and effective in such patients. METHODS In a randomized, double‐blind trial involving 8014 patients with out‐of‐hospital cardiac arrest in the United Kingdom, paramedics at five National Health Service ambulance services administered either parenteral epinephrine (4015 patients) or saline placebo (3999 patients), along with standard care. The primary outcome was the rate of survival at 30 days. Secondary outcomes included the rate of survival until hospital discharge with a favorable neurologic outcome, as indicated by a score of 3 or less on the modified Rankin scale (which ranges from 0 [no symptoms] to 6 [death]). RESULTS At 30 days, 130 patients (3.2%) in the epinephrine group and 94 (2.4%) in the placebo group were alive (unadjusted odds ratio for survival, 1.39; 95% confidence interval [CI], 1.06 to 1.82; P = 0.02). There was no evidence of a significant difference in the proportion of patients who survived until hospital discharge with a favorable neurologic outcome (87 of 4007 patients [2.2%] vs. 74 of 3994 patients [1.9%]; unadjusted odds ratio, 1.18; 95% CI, 0.86 to 1.61). At the time of hospital discharge, severe neurologic impairment (a score of 4 or 5 on the modified Rankin scale) had occurred in more of the survivors in the epinephrine group than in the placebo group (39 of 126 patients [31.0%] vs. 16 of 90 patients [17.8%]). CONCLUSIONS In adults with out‐of‐hospital cardiac arrest, the use of epinephrine resulted in a significantly higher rate of 30‐day survival than the use of placebo, but there was no significant between‐group difference in the rate of a favorable neurologic outcome because more survivors had severe neurologic impairment in the epinephrine group. (Funded by the U.K. National Institute for Health Research and others; Current Controlled Trials number, ISRCTN73485024.)