Unsettling the treatment imperative? Chemotherapy decision-making in the wake of genomic techniques.

Social scientists have argued that a treatment imperative shapes experiences of biomedicine. This is evident within oncology, where discourses of hope are tempered by persistent fears surrounding cancer. It is within this context that genomic decision-making tools are entering routine care. These may indicate that a treatment is not appropriate for a particular disease profile. We draw on qualitative interviews and observations centred on gene expression profiling to consider the implications of this technique for the treatment imperative in early breast cancer. Influenced by sociological perspectives on medical technologies, we discuss how fallibilities of established tools have forged a space for the introduction of genomic testing into chemotherapy decision-making. We demonstrate how high expectations shaped patients' interpretations of this tool as facilitating the 'right' treatment choice. We then unpick these accounts, highlighting the complex relationship between gene expression profiling and treatment decision-making. We argue that anticipations for genomic testing to provide certainty in treatment choice must account for the sociocultural and organisational contexts in which it is used, including the powerful entwinement of chemotherapy and cancer. Our research has implications for sociological perspectives on treatment decision-making and clinical expectations for genomic medicine to resolve the 'problem' of overtreatment.

Evaluation of the Arabin cervical pessary for prevention of preterm birth in women with a twin pregnancy and short cervix (STOPPIT-2): An open-label randomised trial and updated meta-analysis.

BACKGROUND: Preterm-labour-associated preterm birth is a common cause of perinatal mortality and morbidity in twin pregnancy. We aimed to test the hypothesis that the Arabin pessary would reduce preterm-labour-associated preterm birth by 40% or greater in women with a twin pregnancy and a short cervix. METHODS AND FINDINGS: We conducted an open-label randomised controlled trial in 57 hospital antenatal clinics in the UK and Europe. From 1 April 2015 to 14 February 2019, 2,228 women with a twin pregnancy underwent cervical length screening between 18 weeks 0 days and 20 weeks 6 days of gestation. In total, 503 women with cervical length ≤ 35 mm were randomly assigned to pessary in addition to standard care (n = 250, mean age 32.4 years, mean cervical length 29 mm, with pessary inserted in 230 women [92.0%]) or standard care alone (n = 253, mean age 32.7 years, mean cervical length 30 mm). The pessary was inserted before 21 completed weeks of gestation and removed at between 35 and 36 weeks or before birth if earlier. The primary obstetric outcome, spontaneous onset of labour and birth before 34 weeks 0 days of gestation, was present in 46/250 (18.4%) in the pessary group compared to 52/253 (20.6%) following standard care alone (adjusted odds ratio [aOR] 0.87 [95% CI 0.55-1.38], p = 0.54). The primary neonatal outcome-a composite of any of stillbirth, neonatal death, periventricular leukomalacia, early respiratory morbidity, intraventricular haemorrhage, necrotising enterocolitis, or proven sepsis, from birth to 28 days after the expected date of delivery-was present in 67/500 infants (13.4%) in the pessary group compared to 76/506 (15.0%) following standard care alone (aOR 0.86 [95% CI 0.54-1.36], p = 0.50). The positive and negative likelihood ratios of a short cervix (≤35 mm) to predict preterm birth before 34 weeks were 2.14 and 0.83, respectively. A meta-analysis of data from existing publications (4 studies, 313 women) and from STOPPIT-2 indicated that a cervical pessary does not reduce preterm birth before 34 weeks in women with a short cervix (risk ratio 0.74 [95% CI 0.50-1.11], p = 0.15). No women died in either arm of the study; 4.4% of babies in the Arabin pessary group and 5.5% of babies in the standard treatment group died in utero or in the neonatal period (p = 0.53). Study limitations include lack of power to exclude a smaller than 40% reduction in preterm labour associated preterm birth, and to be conclusive about subgroup analyses. CONCLUSIONS: These results led us to reject our hypothesis that the Arabin pessary would reduce the risk of the primary outcome by 40%. Smaller treatment effects cannot be ruled out. TRIAL REGISTRATION: ISRCTN Registry ISRCTN 02235181. ClinicalTrials.gov NCT02235181.

Exploring Patient Experience of Chest Pain Before and After Implementation of an Early Rule-Out Pathway for Myocardial Infarction: A Qualitative Study.

STUDY OBJECTIVE: High-sensitivity cardiac troponin assays enable myocardial infarction to be excluded in the emergency department (ED). As part of a prospective clinical trial, we explore how introducing an early rule-out pathway may affect patient experience of chest pain. METHODS: In a qualitative study, participants presenting to the ED with suspected acute coronary syndrome, and for whom the diagnosis of myocardial infarction was excluded, were interviewed before (n=23) or after (n=26) implementation of an early rule-out pathway. Preimplementation, diagnosis of myocardial infarction was excluded on serial troponin testing requiring admission to the hospital. Postimplementation, diagnosis could be excluded in the ED, enabling direct patient discharge. Semistructured interviews exploring the patients' illness experience were conducted approximately 1 week postdischarge, transcribed verbatim, and analyzed thematically. Themes emerging pre- and postimplementation are described. RESULTS: Common themes emerged across both pathways: participants commonly sought health care advice before presenting to the ED; a discordance may exist between the objective interpretation of troponin results by clinicians and the patients' experience of illness; and pretest information, trust in the clinician, and active listening may enhance reassurance gained from negative test results. Other themes related to the care pathway were that routine care procedures appeared to be a source of frustration for participants requiring hospital admission, and patients assessed with the early rule-out pathway appeared less likely to appraise their future health status. CONCLUSION: The early rule-out of myocardial infarction may be enhanced by recognition of patient out-of-hospital experience and improved communication surrounding reassurance and future cardiovascular health goals.

Public involvement in the governance of population-level biomedical research: unresolved questions and future directions.

Population-level biomedical research offers new opportunities to improve population health, but also raises new challenges to traditional systems of research governance and ethical oversight. Partly in response to these challenges, various models of public involvement in research are being introduced. Yet, the ways in which public involvement should meet governance challenges are not well understood. We conducted a qualitative study with 36 experts and stakeholders using the World Café method to identify key governance challenges and explore how public involvement can meet these challenges. This brief report discusses four cross-cutting themes from the study: the need to move beyond individual consent; issues in benefit and data sharing; the challenge of delineating and understanding publics; and the goal of clarifying justifications for public involvement. The report aims to provide a starting point for making sense of the relationship between public involvement and the governance of population-level biomedical research, showing connections, potential solutions and issues arising at their intersection. We suggest that, in population-level biomedical research, there is a pressing need for a shift away from conventional governance frameworks focused on the individual and towards a focus on collectives, as well as to foreground ethical issues around social justice and develop ways to address cultural diversity, value pluralism and competing stakeholder interests. There are many unresolved questions around how this shift could be realised, but these unresolved questions should form the basis for developing justificatory accounts and frameworks for suitable collective models of public involvement in population-level biomedical research governance.

Diagnosing uncertainty, producing neonatal abstinence syndrome.

The use of alcohol and other drugs during pregnancy is understood to be an important public health problem. One way in which this problem is expressed and responded to is via the identification and treatment of neonatal abstinence syndrome (NAS). In this article, we demonstrate how the processes of anticipating, identifying and responding to NAS are characterised by significant uncertainty among parents and health and social care practitioners. We draw on interviews with 16 parents who had recently had a baby at risk of NAS, and multidisciplinary focus groups with 27 health and social care professionals, held in Scotland, UK. NAS, and drug use in pregnancy, is a fraught and complex arena. Parents in the UK who use opioids risk losing custody of children, and must navigate a high degree of surveillance, governance and marginalisation. We suggest that considering NAS as a social diagnosis, further informed by Mol's political ontology of 'multiple' bodies/diseases, may help to produce clinical and social responses to uncertainty which avoid, rather than promote, further marginalisation of parents who use drugs. One such response is to develop a culture of relationship-based care which empowers both service providers and service users to challenge existing practice and decision-making.

Neurobiological limits and the somatic significance of love: Caregivers' engagements with neuroscience in Scottish parenting programmes.

While parents have long received guidance on how to raise children, a relatively new element of this involves explicit references to infant brain development, drawing on brain scans and neuroscientific knowledge. Sometimes called 'brain-based parenting', this has been criticised from within sociological and policy circles alike. However, the engagement of parents themselves with neuroscientific concepts is far less researched. Drawing on 22 interviews with parents/carers of children (mostly aged 0-7) living in Scotland, this article examines how they account for their (non-)use of concepts and understandings relating to neuroscience. Three normative tropes were salient: information about children's processing speed, evidence about deprived Romanian orphans in the 1990s, and ideas relating to whether or not children should 'self-settle' when falling asleep. We interrogate how parents reflexively weigh and judge such understandings and ideas. In some cases, neuroscientific knowledge was enrolled by parents in ways that supported biologically reductionist models of childhood agency. This reductionism commonly had generative effects, enjoining new care practices and producing particular parent and infant subjectivities. Notably, parents do not uncritically adopt or accept (sometimes reductionist) neurobiological and/or psychological knowledge; rather, they reflect on whether and when it is applicable to and relevant for raising their children. Thus, our respondents draw on everyday epistemologies of parenting to negotiate brain-based understandings of infant development and behaviour, and invest meaning in these in ways that cannot be fully anticipated (or appreciated) within straightforward celebrations or critiques of the content of parenting programmes drawing on neuropsychological ideas.

Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial.

BACKGROUND: 2·6 million pregnancies were estimated to have ended in stillbirth in 2015. The aim of the AFFIRM study was to test the hypothesis that introduction of a reduced fetal movement (RFM), care package for pregnant women and clinicians that increased women's awareness of the need for prompt reporting of RFM and that standardised management, including timely delivery, would alter the incidence of stillbirth. METHODS: This stepped wedge, cluster-randomised trial was done in the UK and Ireland. Participating maternity hospitals were grouped and randomised, using a computer-generated allocation scheme, to one of nine intervention implementation dates (at 3 month intervals). This date was concealed from clusters and the trial team until 3 months before the implementation date. Each participating hospital had three observation periods: a control period from Jan 1, 2014, until randomised date of intervention initiation; a washout period from the implementation date and for 2 months; and the intervention period from the end of the washout period until Dec 31, 2016. Treatment allocation was not concealed from participating women and caregivers. Data were derived from observational maternity data. The primary outcome was incidence of stillbirth. The primary analysis was done according to the intention-to-treat principle, with births analysed according to whether they took place during the control or intervention periods, irrespective of whether the intervention had been implemented as planned. This study is registered with www.ClinicalTrials.gov, number NCT01777022. FINDINGS: 37 hospitals were enrolled in the study. Four hospitals declined participation, and 33 hospitals were randomly assigned to an intervention implementation date. Between Jan 1, 2014, and Dec, 31, 2016, data were collected from 409 175 pregnancies (157 692 deliveries during the control period, 23 623 deliveries in the washout period, and 227 860 deliveries in the intervention period). The incidence of stillbirth was 4·40 per 1000 births during the control period and 4·06 per 1000 births in the intervention period (adjusted odds ratio [aOR] 0·90, 95% CI 0·75-1·07; p=0·23). INTERPRETATION: The RFM care package did not reduce the risk of stillbirths. The benefits of a policy that promotes awareness of RFM remains unproven. FUNDING: Chief Scientist Office, Scottish Government (CZH/4/882), Tommy's Centre for Maternal and Fetal Health, Sands.

Online accounts of gene expression profiling in early-stage breast cancer: Interpreting genomic testing for chemotherapy decision making.

BACKGROUND: Genomic techniques are being developed within oncology and beginning to be experienced within routine cancer care. Little is known about how these tools feature in patients' experiences of treatment decision making. OBJECTIVE: This research explores the ways in which women interpret and discuss gene expression profiling for breast cancer treatment decision making, as articulated within online accounts. DESIGN: This study used a qualitative approach to analyse written exchanges focusing on gene expression profiling in the UK (Oncotype DX test). Accounts are taken from online forums hosted by two UK cancer charity websites, comprising 132 discussion threads from a total of seven forums. Authors qualitatively analysed the data and developed key themes drawing on existing literature from medical sociology. FINDINGS: Women used online spaces to share and discuss results of gene expression profiling. Women interpreted results in the context of indirect experience of cancer treatment, and sociocultural depictions of cancer and chemotherapy. Users largely represented the test positively, emphasizing its ability to "personalize" treatment pathways, though many also pointed to inherent uncertainties with regards the possibility of cancer recurrence. DISCUSSION AND CONCLUSIONS: We highlight the complex contexts in which genomic techniques are experienced, with these shaped by personal biographies, online environments and pervasive cultural narratives of cancer and its treatment. We highlight tensions between the claims of genomic testing to aid treatment decision making and patient reflections on the capability of these techniques to resolve uncertainties surrounding treatment decisions.

The sociology of cancer: a decade of research.

Biomedicine is often presented as the driving force behind improvements in cancer care, with genomics the latest innovation poised to change the meaning, diagnosis, treatment, prevention and lived experience of cancer. Reviewing sociological analyses of a diversity of patient and practitioner experiences and accounts of cancer during the last decade (2007-17), we explore the experiences of, approaches to and understandings of cancer in this period. We identify three key areas of focus: (i) cancer patient experiences and identities; (ii) cancer risk and responsibilities and (iii) bioclinical collectives. We explore these sociological studies of societal and biomedical developments and how sociologists have sought to influence developments in cancer identities, care and research. We end by suggesting that we extend our understanding of innovations in the fields of cancer research to take better account of these wider social and cultural innovations, together with patients, activists' and sociologists' contributions therein.

Health Care Robotics: Qualitative Exploration of Key Challenges and Future Directions.

BACKGROUND: The emergence of robotics is transforming industries around the world. Robot technologies are evolving exponentially, particularly as they converge with other functionalities such as artificial intelligence to learn from their environment, from each other, and from humans. OBJECTIVE: The goal of the research was to understand the emerging role of robotics in health care and identify existing and likely future challenges to maximize the benefits associated with robotics and related convergent technologies. METHODS: We conducted qualitative semistructured one-to-one interviews exploring the role of robotic applications in health care contexts. Using purposive sampling, we identified a diverse range of stakeholders involved in conceiving, procuring, developing, and using robotics in a range of national and international health care settings. Interviews were digitally recorded, transcribed verbatim, and analyzed thematically, supported by NVivo 10 (QSR International) software. Theoretically, this work was informed by the sociotechnical perspective, where social and technical systems are understood as being interdependent. RESULTS: We conducted 21 interviews and these accounts suggested that there are significant opportunities for improving the safety, quality, and efficiency of health care through robotics, but our analysis identified 4 major barriers that need to be effectively negotiated to realize these: (1) no clear pull from professionals and patients, (2) appearance of robots and associated expectations and concerns, (3) disruption of the way work is organized and distributed, and (4) new ethical and legal challenges requiring flexible liability and ethical frameworks. CONCLUSIONS: Sociotechnical challenges associated with the effective integration of robotic applications in health care settings are likely to be significant, particularly for patient-facing functions. These need to be identified and addressed for effective innovation and adoption.

Hepatitis C in a new therapeutic era: Recontextualising the lived experience.

AIMS AND OBJECTIVES: To explore the experience of adults living with hepatitis C in a new era of interferon-free treatment. BACKGROUND: Hepatitis C is a leading cause of morbidity and mortality worldwide, posing a significant challenge to global public health. Historically, the treatment of hepatitis C was poorly efficacious and highly demanding; however, more effective and tolerable therapies have become available in high-income nations in recent years. This is the first study to explore how these significant developments in the treatment of hepatitis C may have influenced the experience of those living with the virus, and their understanding of the disease. DESIGN: A qualitative study underpinned by social phenomenological theory. METHODS: Data were generated through semi-structured interviews with a purposive sample of 20 hepatitis C positive adults living in a large city in Scotland. RESULTS: Thematic analysis identified three overriding themes. "Positioning hepatitis C" illustrated how the disease was understood within wider sociocultural, medical and politico-economic contexts. "Beyond a physical burden" emphasised the emotional aspect of infection, and "a new uncertainty" revealed participants' cautious response to the advances in hepatitis C therapy. CONCLUSIONS: Interthematic discourse portrayed the new era of hepatitis C treatment as holding little sway over constructions of the illness, as narratives resonated with previous studies. Such unmoving "lay" understandings of hepatitis C may pose potential barriers to the new therapeutic era from reaching its full potential. RELEVANCE TO CLINICAL PRACTICE: How people living with the virus perceive and understand hepatitis C can have an adverse impact on their engagement with care and treatment. Whilst global medical discourse eulogises the arrival of a new era of therapy, there remain significant challenges for nurses engaging those with hepatitis C in therapeutic pathways.

Smokers' and ex-smokers' understanding of electronic cigarettes: a qualitative study.

OBJECTIVE: To explore among a diverse range of smokers and recent ex-smokers, particularly those from disadvantaged groups, how nicotine-containing products, particularly electronic cigarettes (e-cigarettes), are understood and experienced. METHODS: Qualitative study of 64 smokers and ex-smokers in Central Scotland. Twelve focus groups and 11 individual interviews were carried out with a range of purposively selected groups. RESULTS: Nicotine replacement therapies and e-cigarettes were regarded as being very different products. Nicotine replacement therapies were viewed as medical products for smokers who want to quit, while e-cigarettes emerged as an ambiguous product whose meanings are still being negotiated. Participants' attitudes and intentions about smoking and quitting were especially important in shaping their understanding of these products. Four main interpretations of e-cigarettes were identified: a more satisfying replacement for smoking, an ambiguous but potentially useful device, a less desirable cigarette and a threat to smoking cessation. The acceptability of continued nicotine addiction and the similarity of e-cigarettes to conventional cigarettes were central themes on which participants held conflicting views. There was considerable uncertainty among participants around the constituents and safety of e-cigarettes. CONCLUSIONS: Different groups of smokers bring diverse expectations, requirements and concerns to their evaluations and therefore to the potential use of nicotine-containing products. The ambiguity around e-cigarettes in public health debates and medical practice is reflected in the positions and concerns of smokers. There is a need for both clear, up-to-date trustworthy information about their benefits and risks, and stronger regulation.

Public responses to the sharing and linkage of health data for research purposes: a systematic review and thematic synthesis of qualitative studies.

BACKGROUND: The past 10 years have witnessed a significant growth in sharing of health data for secondary uses. Alongside this there has been growing interest in the public acceptability of data sharing and data linkage practices. Public acceptance is recognised as crucial for ensuring the legitimacy of current practices and systems of governance. Given the growing international interest in this area this systematic review and thematic synthesis represents a timely review of current evidence. It highlights the key factors influencing public responses as well as important areas for further research. METHODS: This paper reports a systematic review and thematic synthesis of qualitative studies examining public attitudes towards the sharing or linkage of health data for research purposes. Twenty-five studies were included in the review. The included studies were conducted primarily in the UK and North America, with one study set in Japan, another in Sweden and one in multiple countries. The included studies were conducted between 1999 and 2013 (eight studies selected for inclusion did not report data collection dates). The qualitative methods represented in the studies included focus groups, interviews, deliberative events, dialogue workshops and asynchronous online interviews. RESULTS: Key themes identified across the corpus of studies related to the conditions necessary for public support/acceptability, areas of public concern and implications for future research. The results identify a growing body of evidence pointing towards widespread general-though conditional-support for data linkage and data sharing for research purposes. Whilst a variety of concerns were raised (e.g. relating to confidentiality, individuals' control over their data, uses and abuses of data and potential harms arising) in cases where participants perceived there to be actual or potential public benefits from research and had trust in the individuals or organisations conducting and/or overseeing data linkage/sharing, they were generally supportive. The studies also find current low levels of awareness about existing practices and uses of data. CONCLUSIONS: Whilst the results indicate widespread (conditional) public support for data sharing and linkage for research purposes, a range of concerns exist. In order to ensure public support for future research uses of data greater awareness raising combined with opportunities for public engagement and deliberation are needed. This will be essential for ensuring the legitimacy of future health informatics research and avoiding further public controversy.

The changing brain: Neuroscience and the enduring import of everyday experience.

Discourses of 'neuroplasticity' have become increasingly apparent in the neurosciences and wider society. These connect with broader narratives about the 'changing brain' throughout the life-course. Here, we explore their presence in the talk of a range of publics. Their presence is indicative of how novel neuroscience is accepted, or not, by our participants. In particular, we suggest that any acceptance of the science relates to their personal and/or professional experiences of change (to their own or others' subjectivities) rather than to some intrinsic and widely-held significance of scientific concepts per se. Accordingly, we also submit that it is in part through the congruence of some neuroscientific claims to everyday experiences and perspectives that the former are rendered legible and salient. In this respect, 'lay' knowledge has considerable import for the wider cultural authorisation of that of 'experts'.

Children's perspectives on how parents protect them from secondhand smoke in their homes and cars in socioeconomically contrasting communities: a qualitative study.

INTRODUCTION: Children are particularly vulnerable to the health effects of secondhand smoke (SHS) and are mainly exposed in the home and the car. Reducing children's SHS exposure is a tobacco control goal, yet few studies have explored children's perspectives on SHS. This study examines children's accounts of the strategies family members employ to protect them from SHS and is the first to examine how these may be constrained or facilitated in communities with contrasting smoking prevalence rates. METHODS: Individual, paired, and group interviews using topic guides and visual stimulus methods were conducted with 38 children aged 10-15 years who lived in 2 Scottish communities of contrasting socioeconomic status and had a close family member who smoked. Transcripts were analyzed thematically. RESULTS: Parents were reported to employ spatial and dispersal measures to reduce children's SHS exposure in homes and cars. Smoking was restricted to certain rooms and to times when those considered more vulnerable were absent. Less distance between smokers and children and more smoking in the home were reported in the disadvantaged community, reflecting less space within homes and greater parental smoking. Participants expressed strong negative views about smoking in cars and the perceived ineffectiveness of dispersal measures in this context. CONCLUSIONS: Although there was general awareness that SHS exposure was potentially harmful, SHS in the home was considered safe by some participants if certain conditions were met, particularly by those from the disadvantaged area. The implications of these findings for tobacco control programs and media campaigns, particularly those targeted at disadvantaged groups, are discussed.

Mother's little helper? Contrasting accounts of benzodiazepine and methadone use among drug-dependent parents in the UK.

AIMS: To explore the ways in which opioid-dependent parents accounted for their use of opioids and benzodiazepines during and after pregnancy. METHODS: Longitudinal qualitative interviews [n = 45] with 19 opioid-dependent adults recruited in Scotland, UK, were held during the antenatal and post-natal period. Interviews focused on parenting and parenting support within the context of problem drug use and were analysed using a narrative informed, thematic analysis. FINDINGS: The majority of participants described using benzodiazepines in addition to opioids. Almost all indicated a desire to stop or reduce opioid use, whereas cessation or reduction of benzodiazepines was rarely prioritised. In stark contrast to opioid dependence, benzodiazepine dependence was portrayed as unproblematic, therapeutic and acceptable in the context of family life. Whereas opioid dependence was framed as stigmatising, benzodiazepine use and dependence was normalised. An exception was benzodiazepine use by men which was occasionally associated with aggression and domestic abuse. CONCLUSIONS: Drug-dependent parents attach different meanings to opioid and benzodiazepine use and dependence in the context of parenthood. Divergent meanings, and stigma, may impact on stated commitment to stability or recovery from dependent drug-use. Attention should be paid to the way in which policy and practice regarding OST and benzodiazepines reflects this divergence.