Tracey Chantler

The Role Familiarity With Science and Medicine Plays in Parents’ Decision Making About Enrolling a Child in Vaccine Research:

Parental consent to children’s participation in vaccine research has resulted in the licensure of essential vaccines. Recruitment to this type of research is typically difficult, however, and many parents decline. In this study, the authors interviewed parents about their decision for or against enrolling their child in a vaccine study. The data analysis suggests that parents’ ability to evaluate a vaccine study depends on how attuned they are with science and medicine, either professionally or as consumers of health services. Familiarity does not predispose parents to enrolling their child in research; rather, it is a predictor of parents’ confidence in their decision making. Many parents were motivated by altruism and trust, which, if uninformed, can leave the parents prone to exploitation. It is vital to ensure that parents are confident in their judgment of a study and its potential benefit to their child and society.

Field Workers at the Interface

This issue of Developing World Bioethics includes a collection of papers on intermediary staff and volunteers working at the interface between research institutions and researchers, and the communities from which research participants are recruited. ‘Field worker’ – a short hand commonly used in many research settings – refers here to those whose main role is face-to-face engagement with participants, who usually speak the participants’ first language, who are from or live in the study areas, and whose work entails moving around the study areas or health facilities. Field workers can be differentiated from medical or scientific staff for whom only part of their duties entail direct interaction with participants, and who are primarily based in the research institution or the clinic. In international research settings field workers are variously called research assistants, community interviewers, data collectors, fieldworkers, field assistants, assessors, follow up staff or defaulter tracers. Although some may hold first degrees or certificates, many are secondary school leavers without higher education opportunity; overall they are formally less qualified than clinical and research staff. Instead, field workers often have extensive informal training and experience from earlier volunteering and jobs in research centres or the NGO sector, which often require similar tasks and expertise.1 Their roles may include communicating about studies and mobilisation and follow-up of participants, conducting interviews, and carrying out relatively simple biomedical data-collection procedures such as taking temperatures and collecting finger prick blood samples.

Ethical challenges that arise at the community interface of health research: village reporters' experiences in Western Kenya.

Community Engagement (CE) has been presented by bio-ethicists and scientists as a straightforward and unequivocal good which can minimize the risks of exploitation and ensure a fair distribution of research benefits in developing countries. By means of ethnographic fieldwork undertaken in Kenya between 2007 and 2009 we explored how CE is understood and enacted in paediatric vaccine trials conducted by the Kenyan Medical Research Institute and the US Centers for Disease Control (KEMRI/CDC). In this paper we focus on the role of paid volunteers who act as an interface between villagers KEMRI/CDC. Village Reporters’ (VRs) position of being both with the community and with KEMRI/CDC is advantageous for the conduct of trials. However it is also problematic in terms of exercising trust, balancing allegiances and representing community views. VRs role is shaped by ambiguities related to their employment status and their dual accountability to researchers and their villages. VRs are understandably careful to stress their commitment to self-less community service since it augments their respectability at community level and opens up opportunities for financial gain and self-development. Simultaneously VRs association with KEMRI/CDC and proximity to trial participants requires them to negotiate implicit and explicit expectations for material and medical assistance in a cultural setting in which much importance is placed on sharing and mutuality. To ensure continuity of productive interactions between VRs, and similar community intermediaries, and researchers, open discussion is needed about the problematic aspects of relational ethics, issues concerning undue influence, power relations and negotiating expectations.

“It’s a complex mesh”- how large-scale health system reorganisation affected the delivery of the immunisation programme in England: a qualitative study

BackgroundThe English health system experienced a large-scale reorganisation in April 2013. A national tri-partite delivery framework involving the Department of Health, NHS England and Public Health England was agreed and a new local operational model applied. Evidence about how health system re-organisations affect constituent public health programmes is sparse and focused on low and middle income countries. We conducted an in-depth analysis of how the English immunisation programme adapted to the April 2013 health system reorganisation, and what facilitated or hindered the delivery of immunisation services in this context.MethodsA qualitative case study methodology involving interviews and observations at national and local level was applied. Three sites were selected to represent different localities, varying levels of immunisation coverage and a range of changes in governance. Study participants included 19 national decision-makers and 56 local implementers. Two rounds of interviews and observations (immunisation board/committee meetings) occurred between December 2014 and June 2015, and September and December 2015. Interviews were audio recorded and transcribed verbatim and written accounts of observed events compiled. Data was imported into NVIVO 10 and analysed thematically.ResultsThe new immunisation programme in the new health system was described as fragmented, and significant effort was expended to regroup. National tripartite arrangements required joint working and accountability; a shift from the simpler hierarchical pre-reform structure, typical of many public health programmes. New local inter-organisational arrangements resulted in ambiguity about organisational responsibilities and hindered data-sharing. Whilst making immunisation managers responsible for larger areas supported equitable resource distribution and strengthened service commissioning, it also reduced their ability to apply clinical expertise, support and evaluate immunisation providers’ performance. Partnership working helped staff adapt, but the complexity of the health system hindered the development of consistent approaches for training and service evaluation.ConclusionThe April 2013 health system reorganisation in England resulted in significant fragmentation in the way the immunisation programme was delivered. Some of this was a temporary by-product of organisational change, other more persistent challenges were intrinsic to the complex architecture of the new health system. Partnership working helped immunisation leaders and implementers reconnect and now the challenge is to assess how inter-agency collaboration can be strengthened.

A user-centred home monitoring and self-management system for patients with heart failure: a multicentre cohort study

Aims Previous generations of home monitoring systems have had limited usability. We aimed to develop and evaluate a user-centred and adaptive system for health monitoring and self-management support in patients with heart failure. Methods and results Patients with heart failure were recruited from three UK centres and provided with Internet-enabled tablet computers that were wirelessly linked with sensor devices for blood pressure, heart rate, and weight monitoring. Patient observations, interviews, and concurrent analyses of the automatically collected data from their monitoring devices were used to increase the usability of the system. Of the 52 participants (median age 77 years, median follow-up 6 months [interquartile range, IQR, 3.6-9.2]), 24 (46%) had no, or very limited prior, experience with digital technologies. It took participants about 1.5 min to complete the daily monitoring tasks, and the rate of failed attempts in completing tasks was <5%. After 45 weeks of observation, participants still used the system on 4.5 days per week (confidence interval 3.2-5.7 days). Of the 46 patients who could complete the final survey, 93% considered the monitoring system as easy to use and 38% asked to keep the system for self-management support after the study was completed. Conclusion We developed a user-centred home monitoring system that enabled a wide range of heart failure patients, with differing degrees of IT literacy, to monitor their health status regularly. Despite no active medical intervention, patients felt that they benefited from the reassurance and sense of connectivity that the monitoring system provided.

Supporting heart failure patients through personalized mobile health monitoring

Heart failure is a common chronic condition requiring frequent attention and ongoing provision of healthcare services. In this context we present a personalized mobile-based home monitoring system aiming to support heart failure patients in daily self-monitoring of their condition. An Internet-linked tablet computer and various portable and wearable sensing devices are employed in order to monitor the patients physiological parameters and enable healthcare professionals to review patients status remotely. The proposed system supports the activation/deactivation of system functional components by healthcare professionals during run-time operation, the unobtrusive remote upgrade of the mobile system through a private application distribution channel, and the automatic recording of user interactions, in order to meet the patients ongoing individualized preferences and healthcare needs. Preliminary results from an observational cohort study indicate that heart failure patients find the proposed system acceptable and consider it useful for self-monitoring their condition.

International health research monitoring: exploring a scientific and a cooperative approach using participatory action research.

Objectives To evaluate and determine the value of monitoring models developed by the Mahidol Oxford Tropical Research Unit and the East African Consortium for Clinical Research, consider how this can be measured and explore monitors’ and investigators’ experiences of and views about the nature, purpose and practice of monitoring. Research design A case study approach was used within the context of participatory action research because one of the aims was to guide and improve practice. 34 interviews, five focus groups and observations of monitoring practice were conducted. Setting and participants Fieldwork occurred in the places where the monitoring models are coordinated and applied in Thailand, Cambodia, Uganda and Kenya. Participants included those coordinating the monitoring schemes, monitors, senior investigators and research staff. Analysis Transcribed textual data from field notes, interviews and focus groups was imported into a qualitative data software program (NVIVO V. 10) and analysed inductively and thematically by a qualitative researcher. The initial coding framework was reviewed internally and two main categories emerged from the subsequent interrogation of the data. Results The categories that were identified related to the conceptual framing and nature of monitoring, and the practice of monitoring, including relational factors. Particular emphasis was given to the value of a scientific and cooperative style of monitoring as a means of enhancing data quality, trust and transparency. In terms of practice the primary purpose of monitoring was defined as improving the conduct of health research and increasing the capacity of researchers and trial sites. Conclusions The models studied utilise internal and network wide expertise to improve the ethics and quality of clinical research. They demonstrate how monitoring can be a scientific and constructive exercise rather than a threatening process. The value of cooperative relations needs to be given more emphasis in monitoring activities, which seek to ensure that research protects human rights and produces reliable data.

Reasons for non-vaccination: Parental vaccine hesitancy and the childhood influenza vaccination school pilot programme in England

INTRODUCTION In 2013, the annual influenza immunisation programme in England was extended to children to reduce the burden of influenza, but uptake was sub-optimal at 53.2%. AIM To explore the reasons some parents decided not to vaccinate their child against influenza as part of the pilot programme offered in schools. METHODS Cross-sectional qualitative study conducted between February and July 2015. 913 parents whose children were not vaccinated against influenza in the school pilots in West Yorkshire and Greater Manchester, England, were asked to comment on their reasons for non-vaccination and invited to take part in a semi-structured interview. 138 parents returned response forms, of which 38 were eligible and interested in participating and 25 were interviewed. Interview transcripts were coded by theme in NVivo. RESULTS A third of parents who returned response forms had either vaccinated their child elsewhere, intended to have them vaccinated, or had not vaccinated them due to medical reasons (valid or perceived). Most interviewees were not convinced of the need to vaccinate their child against influenza. Parents expressed concerns about influenza vaccine effectiveness and vaccine side effects. Several parents interviewed declined the vaccine for faith reasons due to the presence of porcine gelatine in the vaccine. CONCLUSIONS To significantly decrease the burden of influenza in England, influenza vaccination coverage in children needs to be >60%. Hence, it is important to understand the reasons why parents are not vaccinating their children, and to tailor the communication and immunisation programme accordingly. Our finding that a third of parents, who did not consent to their child being vaccinated as part of the school programme, had actually vaccinated their child elsewhere, intended to have their child vaccinated, or had not vaccinated them due to medical reasons, illustrates the importance of including additional questions or data sources when investigating under-vaccination.

'We All Work Together to Vaccinate the Child': A Formative Evaluation of a Community-Engagement Strategy Aimed at Closing the Immunization Gap in North-West Ethiopia.

The role of community engagement (CE) in improving demand for immunization merits investigation. The International Rescue Committee developed a CE strategy to implement a vaccine defaulter-tracing tool and a color-coded health calendar aimed at increasing uptake of immunization services in north-west Ethiopia (‘The Fifth Child Project’). We report findings from a formative evaluation of this project. In May/June 2016 we conducted 18 participant observations of project activities, 46 semi-structured interviews and 6 focus groups with caregivers, health workers, community members/leaders. Audio-recordings and fieldnotes were transcribed, anonymized, translated and analyzed thematically using inductive and deductive coding. Additional data was collected in November 2016 to verify findings. The project was suitably integrated within the health extension program and established a practical system for defaulter-tracing. The calendar facilitated personalized interactions between health workers and caregivers and was a catalyst for health discussions within homes. At the community level, a regulation exercise of sanctions was observed, which served as a deterrent against vaccine default. Pre-existing community accountability mechanisms supported the CE, although varying levels of engagement between leaders and health workers were observed. The benefits of shared responsibility for immunization were evident; however, more transparency was required about community self-regulatory measures to ensure health-related discussions remain positive.

The Patient-Healthcare Worker Relationship: How Does it Affect Patient Views towards Vaccination during Pregnancy?

Abstract Relational autonomy proposes that persons are socially embedded, with decisions being made within social relationships. Through this theoretical lens, this article explores how the healthcare professional–patient relationship can affect pregnant women’s decisions to accept pertussis and influenza vaccines. Hackney was chosen as the study site as it has very low vaccine uptake rates. In-depth interviews were conducted with 40 pregnant and recently pregnant women, as well as 10 healthcare professionals. Interviews explored experiences of the UKs National Health Service (NHS) health care and views towards vaccination in pregnancy. An observation of a consultation between a pregnant patient and her General Practitioners (GPs) was also conducted in order to understand how the vaccination discussion takes place. The findings of this study indicate that advice from friends and family can greatly influence a pregnant woman’s vaccination decisions. The patient’s social context, including influences on her decisions, must be understood by healthcare professionals, so that discussions about concerns can take place. If close relationships with patients are formed, healthcare professional advice is more likely to be trusted. With support from healthcare professionals, patients feel competent, empowered to make the right decision for them, and are more likely to vaccinate. This research will help to inform contextualised policies aimed at increasing vaccination acceptance and reducing inequality in access to vaccination during pregnancy in Hackney. To the author’s knowledge, this chapter is the first to apply the theory of relational autonomy to views towards maternal vaccination and decision making. It provides valuable insights into how healthcare professionals’ interactions with their pregnant patients can influence vaccination acceptance. The chapter contains advice on how both healthcare professionals and policy-makers can include mothers in vaccine decision-making processes in more personalised ways, by adopting a dialogue that appreciates and understands the social processes around vaccination concerns.