Home-based Digital Assessments with Applied Sentiment & Emotion AI Capture Improved Quality-of-life in Asthma Patients.

With the rise of digital transformation in the pharmaceutical industry, digital therapeutics are being integrated in drug development clinical trials. In the TWINKLE study, information about asthmatic patients' disease control and quality-of-life (QoL) was measured by daily video recording, in conjunction with daily electronic questionnaires and home-based spirometry. From the video messages, sentiment and emotion AI was applied to detect subtle QoL changes in asthmatic patients after receiving treatments. Sentiment scores, derived from patients' daily messages via natural language processing, correlated strongly with metrics of lung functions and outcomes of electronic questionnaires. However, video-derived emotional analysis exhibited strong interpersonal variations and systematic biases, yet still showed utility in detecting QoL changes after personalized calibration and signal aggregation. Compared to traditional patient-reported outcomes, all three categories of digital measurements were able to detect significantly improved asthma control from patients who responded to treatments. The result provides insights into developing novel digital outcomes through the application of connected digital devices and advanced AI tailored to clinical settings.Clinical relevance- Digital outcomes involving connected digital devices and AI for sentiment/emotion analysis could capture subtle QoL changes reliably and earlier than hospital visits, reducing burden and improving disease management. Integrating digital therapeutics in asthma drug development trials may prove to be feasible and valuable.

Therapeutic misconception: hope, trust and misconception in paediatric research.

Although the therapeutic misconception (TM) has been well described over a period of approximately 20 years, there has been disagreement about its implications for informed consent to research. In this paper we review some of the history and debate over the ethical implications of TM but also bring a new perspective to those debates. Drawing upon our experience of working in the context of translational research for rare childhood diseases such as Duchenne muscular dystrophy, we consider the ethical and legal implications of the TM for parental consent to research. In this situation, it is potentially the parent who is vulnerable to TM. In our analysis we not only consider the context of informed consent for research but also the wider environment in which the value of research is promoted, more broadly through the media but also more specifically through the communication strategies of patient organizations. All dissemination about developments in research for health runs the risk of portraying an overly optimistic view of the promise of biotechnological solutions and has the potential to encourage a 'collective' TM. In this paper we consider the challenge that TM presents to parents as well as explore the ethical and legal responsibilities of researchers to ensure an appropriately informed consent: compatible with a hopeful disposition of parents who consent for the their children whilst avoiding a blind and misleading optimism.

Guidance in social and ethical issues related to clinical, diagnostic care and novel therapies for hereditary neuromuscular rare diseases: "translating" the translational.

Drug trials in children engage with many ethical issues, from drug-related safety concerns to communication with patients and parents, and recruitment and informed consent procedures. This paper addresses the field of neuromuscular disorders where the possibility of genetic, mutation-specific treatments, has added new complexity. Not only must trial design address issues of equity of access, but researchers must also think through the implications of adopting a personalised medicine approach, which requires a precise molecular diagnosis, in addition to other implications of developing orphan drugs. It is against this background of change and complexity that the Project Ethics Council (PEC) was established within the TREAT-NMD EU Network of Excellence. The PEC is a high level advisory group that draws upon the expertise of its interdisciplinary membership which includes clinicians, lawyers, scientists, parents, representatives of patient organisations, social scientists and ethicists. In this paper we describe the establishment and terms of reference of the PEC, give an indication of the range and depth of its work and provide some analysis of the kinds of complex questions encountered. The paper describes how the PEC has responded to substantive ethical issues raised within the TREAT-NMD consortium and how it has provided a wider resource for any concerned parent, patient, or clinician to ask a question of ethical concern. Issues raised range from science related ethical issues, issues related to hereditary neuromuscular diseases and the new therapeutic approaches and questions concerning patients rights in the context of patient registries and bio-banks. We conclude by recommending the PEC as a model for similar research contexts in rare diseases.

Organised assistance to suicide in England?

Guidelines provided by the Director of Public Prosecutions suggest that anyone assisting another to commit suicide in England and Wales, or elsewhere, will not be prosecuted provided there are no self-seeking motives and no active encouragement. This reflects the position in Switzerland. There, however, no difference is made between assistance and inducement. In addition, the Swiss approach makes it possible to establish organisations to assist the suicides of both their citizens and foreign visitors. It should not be assumed that this approach is without controversy in Switzerland. Proposals for reform continue to be debated there, not least because of the concern about some of the actual practices of certain end-of-life organisations. It is likely that a few English citizens will continue to avail themselves of these services in Switzerland if they cannot find the help they require here. This paper explores the legitimacy of the current restrictive position adopted towards assisted suicide in England. It argues that the provisions within the guidelines prohibiting organisations that assist suicides, leaves some without the help they need. While legislative decriminalisation of assisted suicide and the establishment of state-sponsored suicide centres would represent the most permissive regime, this paper proposes that this would be a step too far. The preference here is for decriminalisation but adopting a 'middle way' between the two extremes: the more permissive approach provided by the 'Swiss model' is one that could be employed here, albeit within a more robust regulatory regime.

Autonomy and audit--striking the balance.

The Data Protection Act 1998 purports to implement European legislation which aims to protect the privacy of individuals. There were such concerns about the implications of the Act for certain research and audit that it became necessary to enact further legislation to enable such essential activities to continue. Although this empowers the Secretary of State for Health to approve proposals for these purposes, there should still be a requirement that the use of identifiable personal information without consent must be justified on compelling public interest grounds. It is this that can confound those seeking to rely on such justification. There can either be too cavalier an approach to the issue, and/or there is little sense of what considerations should come into play. This paper attempts to highlight some of the difficulties that are theoretically raised by some audit activities and set out the legal framework within which they must operate. However, the key focus is on how ethical considerations might inform the public interest argument.

Some implications of the Human Rights Act 1998 for the medical treatment of children.

Although the Gillick decision was hailed as an important step in the furtherance of respect for children's autonomy, subsequent judgments seemed to undermine this important principle. While it would be difficult to criticise the outcomes of some of the key cases, the reasoning by which these were achieved is rather more contentious. There have been some interesting discussions suggesting more constructive approaches but there is still a great deal of anecdotal evidence indicating that conservative assessments of children's ability to be involved in decisions about their medical treatment remain the norm. The new Department of Health consent forms should help to create a climate where assessment of a child's competence will become more sophisticated. This paper will argue that the Human Rights Act 1998 offers another opportunity to reassess more traditional approaches to children's capacity; indeed, this could be violation, inter alia, of the right not to be subject to inhuman and degrading treatment under Article 3 in extreme circumstances and the right to private and family life enshrined in Article 8. Clearly, it is not always practicable to carry out assessments rigorously and some health professionals may feel they do not have the expertise to do this, but some basic criteria could assist here; courts are not likely to expect more than a demonstration that best endeavors have been employed in reasoned decision-making. Additionally, other privacy rights may have implications for the medical decision-making process as it affects children and their carers particularly where conflict arises. Disputes may also ensue from the right to manifest religion and other beliefs",' under the Act. This paper will explore how such challenges to those responsible for the medical treatment of children may fare.