Vicki Xafis

Ethical language and decision-making for prenatally diagnosed lethal malformations

Summary In clinical practice, and in the medical literature, severe congenital malformations such as trisomy 18, anencephaly, and renal agenesis are frequently referred to as ‘lethal’ or as ‘incompatible with life’. However, there is no agreement about a definition of lethal malformations, nor which conditions should be included in this category. Review of outcomes for malformations commonly designated ‘lethal’ reveals that prolonged survival is possible, even if rare. This article analyses the concept of lethal malformations and compares it to the problematic concept of ‘futility’. We recommend avoiding the term ‘lethal’ and suggest that counseling should focus on salient prognostic features instead. For conditions with a high chance of early death or profound impairment in survivors despite treatment, perinatal and neonatal palliative care would be ethical. However, active obstetric and neonatal management, if desired, may also sometimes be appropriate.

A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: study protocol

BackgroundThe Vaccine Assessment using Linked Data (VALiD) trial compared opt-in and opt-out parental consent for a population-based childhood vaccine safety surveillance program using data linkage. A subsequent telephone interview of all households enrolled in the trial elicited parental intent regarding the return or non-return of reply forms for opt-in and opt-out consent. This paper describes the rationale for the trial and provides an overview of the design and methods.Methods/DesignSingle-centre, single-blind, randomised controlled trial (RCT) stratified by firstborn status. Mothers who gave birth at one tertiary South Australian hospital were randomised at six weeks post-partum to receive an opt-in or opt-out reply form, along with information explaining data linkage. The primary outcome at 10 weeks post-partum was parental participation in each arm, as indicated by the respective return or non-return of a reply form (or via telephone or email response). A subsequent telephone interview at 10 weeks post-partum elicited parental intent regarding the return or non-return of the reply form, and attitudes and knowledge about data linkage, vaccine safety, consent preferences and vaccination practices. Enrolment began in July 2009 and 1,129 households were recruited in a three-month period. Analysis has not yet been undertaken. The participation rate and selection bias for each method of consent will be compared when the data are analysed.DiscussionThe VALiD RCT represents the first trial of opt-in versus opt-out consent for a data linkage study that assesses consent preferences and intent compared with actual opting in or opting out behaviour, and socioeconomic factors. The limitations to generalisability are discussed.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12610000332022

Diversity in collaborative research communities: a multicultural, multidisciplinary thesis writing group in public health

Writing groups for doctoral students are generally agreed to provide valuable learning spaces for Ph.D. candidates. Here an academic developer and the eight members of a writing group formed in a Discipline of Public Health provide an account of their experiences of collaborating in a multicultural, multidisciplinary thesis writing group. We consider the benefits of belonging to such a group for Ph.D. students who are operating in a research climate in which disciplinary boundaries are blurring and where an increasing number of doctoral projects are interdisciplinary in nature; in which both academic staff and students come from enormously diverse cultural and language backgrounds; and in which teamwork, networking and collaboration are prized but not always proactively facilitated. We argue that doctoral writing groups comprising students from diverse cultural and disciplinary backgrounds can be of significant value for postgraduates who wish to collaborate on their own academic development to improve their research writing and communication skills; at the same time, such collaborative work effectively builds an inclusive, dynamic research community.

What information do parents need when facing end-of-life decisions for their child? A meta-synthesis of parental feedback

BackgroundThe information needs of parents facing end-of-life decisions for their child are complex due to the wide-ranging dimensions within which such significant events unfold. While parents acknowledge that healthcare professionals are their main source of information, they also turn to a variety of additional sources of written information in an attempt to source facts, discover solutions, and find hope.Much has been written about the needs of parents faced with end-of-life decisions for their child but little is known about the written information needs such parents have. Research in the adult intensive care context has shown that written resources impact positively on the understanding of medical facts, including diagnoses and prognoses, communication between families and healthcare professionals, and the emotional wellbeing of families after their relative’s death.MethodsA meta-synthesis of predominantly empirical research pertaining to features which assist or impede parental end-of-life decisions was undertaken to provide insight and guidance in our development of written resources (short print and online comprehensive version) for parents.ResultsThe most prominently cited needs in the literature related to numerous aspects of information provision; the quantity, quality, delivery, and timing of information and its provision impacted not only on parents’ ability to make end-of-life decisions but also on their emotional wellbeing. The meta-synthesis supports the value of written materials, as these provide guidance for both parents and healthcare professionals in pertinent content areas.ConclusionsFurther research is required to determine the impact that written resources have on parental end-of-life decision-making and on parents’ wellbeing during and after their experience and time in the hospital environment.

The acceptability of conducting data linkage research without obtaining consent: lay people’s views and justifications

BackgroundA key ethical issue arising in data linkage research relates to consent requirements. Patients’ consent preferences in the context of health research have been explored but their consent preferences regarding data linkage specifically have been under-explored. In addition, the views on data linkage are often those of patient groups. As a result, little is known about lay people’s views and their preferences about consent requirements in the context of data linkage. This study explores lay people’s views and justifications regarding the acceptability of conducting data linkage research without obtaining consent.MethodsA qualitative study explored lay people’s views regarding consent requirements in data linkage via four hypothetical data linkage scenarios of increasing complexity. Prior to considering the scenarios, participants were provided with information regarding best practice data linkage processes via discussion and a diagrammatic representation of the process.ResultsLay people were able to understand the intricate processes involved in data linkage and the key protections afforded within a short amount of time. They were supportive of data linkage research and, on the whole, believed it should be conducted without consent provided a data linkage organization de-identifies the data used so that researchers do not handle identifiable data. Many thought that de-identified data holds a different status to identifiable data and should be used without specific consent in research that aims to benefit society. In weighing up conflicting values and interests, participants shifted consent preferences before arriving at their final consent preference for each scenario and provided justifications for their choices. They considered the protection of people’s information, societal benefits, and the nature and constraints of research and recognized that these need to be balanced.ConclusionsWith some exposure to the features of data linkage, lay people have the capacity to understand the processes sufficiently in order to consider ethical issues associated with consent preferences. Shifts in views reveal the complexity of such decisions. While privacy protection remained an important consideration for most participants, adequate protection measures adopted in best practice data linkage were viewed by most as protection enough for data linkage to proceed without specific individual consent.

Decision‐making at the borderline of viability: Who should decide and on what basis?

Parents and medical staff usually agree on the management of preterm labour at borderline viability, when there is a relatively high risk of long‐term neurodevelopmental problems in survivors. If delivery is imminent and parents and staff cannot agree on the best management, however, who should decide what will happen when the baby is delivered? Should the baby be resuscitated? Should intensive care be initiated? Three ethicists, one of whom is also a neonatologist, discuss this complex issue.

Parent perspectives on consent for the linkage of data to evaluate vaccine safety: A randomised trial of opt-in and opt-out consent

Background We examined parents’ consent preferences and understanding of an opt-in or opt-out invitation to participate in data linkage for post-marketing safety surveillance of childhood vaccines. Methods A single-blind parallel-group randomised controlled trial: 1129 families of babies born at a South Australian hospital in 2009 were sent information at 6 weeks post-partum, explaining data linkage of childhood immunisation and hospital records for vaccine safety surveillance, with 4 weeks to opt in or opt out by reply form, telephone, or email. At 10 weeks post-partum, 1026 (91%) parents were followed up by telephone interview. Results In both the opt-in (n = 564) and opt-out arms (n = 565), four-fifths of the parents recalled receiving the information (81% vs. 83%, P = 0.35), three-fifths reported reading it (63% vs. 67%, P = 0.11), but only two-fifths correctly identified the health records to be linked (43% vs. 39%, P = 0.21). Parents who actively consented (opted in) were more likely than those who passively consented (did not opt out) to recall the information (100% vs. 83%, P < 0.001), report reading it (94% vs. 67%, P < 0.001), and correctly identify the data sources (60% vs. 39%, P < 0.001). Most parents supported data linkage for vaccine safety surveillance (94%) and trusted its privacy protections (84%). Most parents wished to have minimal or no direct involvement, preferring either opt-out consent (40%) or no consent (30%). A quarter (24%) of parents indicated opt-in consent should be sought; of these, 8% requested consent prior to every use, 5% preferred to give broad consent just once and 11% preferred periodic renewal. Three-fifths of the parents gave higher priority to rapid vaccine safety surveillance (61%) rather than first seeking parental consent (21%), and one in seven was undecided (15%). Although 91% of parents reported that their babies were fully immunised (76%) or under-immunised (15%), and trusted vaccines as safe (90%), three-fifths (62%) were very or somewhat concerned about serious reactions. Limitations The context of data linkage is limited to vaccine safety surveillance. Only recall and understanding retained at 1 month post enrolment were measured. Conclusions This trial demonstrates that informed consent for a population-based surveillance programme cannot realistically be achieved using mail-based opt-in and opt-out approaches. While recall and understanding of the study’s purpose were better among parents who actively consented (opted in) compared with parents who passively consented (did not opt out), participation was substantially lower (21% vs. 96% respectively). Most parents appeared to have a poor understanding of data linkage for vaccine safety surveillance; nonetheless, they supported data linkage. They preferred a system utilising opt-out consent or no consent to one using opt-in consent.

Death talk: Basic linguistic rules and communication in perinatal and paediatric end-of-life discussions.

OBJECTIVE This paper considers clinician/parent communication difficulties noted by parents involved in end-of-life decision-making in the light of linguistic theory. METHODS Grices Cooperative Principle and associated maxims, which enable effective communication, are examined in relation to communication deficiencies that parents have identified when making end-of-life decisions for the child. Examples from the literature are provided to clarify the impact of failing to observe the maxims on parents and on clinician/parent communication. RESULTS Linguistic theory applied to the literature on parental concerns about clinician/parent communication shows that the violation of the maxims of quantity, quality, relation, and manner as well as the stance that some clinicians adopt during discussions with parents impact on clinician/parent communication and lead to distrust, anger, sadness, and long-term difficulties coping with the experience of losing ones child. CONCLUSION Parents have identified communication deficiencies in end-of-life discussions. Relating these communication deficiencies to linguistic theory provides insight into communication difficulties but also solutions. PRACTICE IMPLICATIONS Gaining an understanding of basic linguistic theory that underlies human interactions, gaining insight into the communication deficiencies that parents have identified, and modifying some communication behaviours in light of these with the suggestions made in this article may lead to improved clinician/parent communication.

Why respecting all human beings' privacy matters

There is no single definition of privacy, but Allen proposes that privacy be considered in terms of decisional, physical, informational and proprietary privacy. Equally diverse are accounts of the value of privacy. Because of the emphasis placed on privacy in the context of the World Wide Web and information sharing, the value we assign to privacy is often viewed from a negative perspective, that is, the perspective of harms arising from a lack of privacy protections. In other words, we often only consider the harms that we are protected against by having a level of control over who has access to information about us (including images) and our person. Such harms can impact on numerous critical areas of life and include financial, social, psychological or a combination of such harms. For example, the dissemination of details of a medical history can result in people being stigmatised, marginalised and disadvantaged. Likewise, private details of someone’s intimate relationships can have devastating social and professional repercussions even though one’s private life is, in many ways, separate from one’s social and professional spheres of interaction. What may, however, sometimes be overlooked is the crucial role that privacy plays in our very existence as self-aware individuals who develop a sense not only of our own personhood but also necessarily that of others. Privacy plays an important role in us experiencing a sense of freedom from concerns about being judged and humiliated; this freedom enables us to develop independent thinking as autonomous individuals, which could not be achieved without us experiencing some degree of privacy. In Reiman’s words, ‘...privacy is a condition of the original and continuing creation of “selves” or “persons” and is thus “an ongoing social process” ’. 8 According to Westin, human beings are innately curious not only about their environment but also about each other and are therefore eager to learn details about others, their lives, their thoughts and their actions. If we did not enjoy some privacy, social co-existence would become unbearable, as we would be deprived of any opportunity to escape constant scrutiny from others. Privacy provides the very backdrop against which we develop a series of social relations through controlled and selective expression of facets of our person. It is through this process that we develop a range of connections with those around us choosing, for example, to reveal aspects of ourselves only privy to very few, such as family and romantic partners, or only certain facets of what makes us who we are in more distant relationships. This selective revelation is necessary for us to function appropriately in a professional and social capacity. Even though not always at the forefront of our considerations, privacy is valuable not only for those of us better able to protect and defend ourselves against intrusions but also for those in our society who cannot defend their rights, including children. It is for this reason that the United Nations explicitly articulates the need to protect children’s privacy (amongst other goods) in the Convention on the Rights of the Child.

Balancing obligations: should written information about life-sustaining treatment be neutral?

Parents who are facing decisions about life-sustaining treatment for their seriously ill or dying child are supported by their childs doctors and nurses. They also frequently seek other information sources to help them deal with the medical and ethical questions that arise. This might include written or web-based information. As part of a project involving the development of such a resource to support parents facing difficult decisions, some ethical questions emerged. Should this information be presented in a strictly neutral fashion? Is it problematic if narratives, arguments or perspectives appear to favour stopping over continuing life-sustaining treatment? Similar questions might arise with written materials about decisions for adults, or for other ethically contentious decisions. This paper explores the meaning of ‘balance’ in information provision, focusing particularly on written information about life-sustaining treatment for children. We contrast the norm of non-directiveness in genetic counselling with the shared decision-making model often endorsed in end-of-life care. We review evidence that parents do not find neutrality from medical professionals helpful in discussions. We argue that balance in written information must be understood in the light of the aim of the document, the most common situation in which it will be used, and any existing biases. We conclude with four important strategies for ensuring that non-neutral information is nevertheless ethically appropriate.