This consensus statement reflects the deliberations of an international group of stakeholders with a range of expertise in public involvement and engagement (PI&E) relating to data-intensive health research. It sets out eight key principles to establish a secure role for PI&E in and with the research community internationally and ensure best practice in its execution. Our aim is to promote culture change and societal benefits through ensuring a socially responsible trajectory for innovations in this field. Our key premise is that the public should not be characterised as a problem to be overcome but a key part of the solution to establish socially beneficial data-intensive health research for all.

These issues require careful consideration of the rights and responsibilities of both employees and employers, where strategies for improving communication, trust, and creating an environment conducive to successful return to work need to be investigated.

The digitization of society and academic research endeavours have led to an explosion of interest in the potential uses of population data in research. Alongside this, increasing attention is focussing on the conditions necessary for maintaining a social license for research practices.

IntroductionData-intensive health research is a fast moving field in which public involvement and engagement (PI\&E) is essential for developing socially acceptable and ethically robust processes and ensuring a social license for research practices. Nevertheless while some consensus is emerging around the importance of PI\&E, commitments and practices are varied. Objectives and ApproachOur objective was to identify a set of principles which would underpin international best practice in data-intensive health research. A one-day consensus workshop was held in Manchester, U.K. in April 2017 and attended by 31 international participants from six countries, with a range of expertise relating to PI&E with data-intensive health research. Participants took part in facilitated discussions to identify key principles and a consensus statement was written to reflect the discussions at the workshop, this developed through iterative drafts on which all workshop participants as well as the four Farr Institute public panels were consulted. ResultsThe consensus statement sets out key principles to establish a secure role for PI&E related to data-intensive health research internationally and to ensure best practice in its execution. While methods used may not vary greatly from PI&E with other types of research, or other policy areas, we have identified a number of particular features of data-intensive health research which make PI&E in this area worthy of special consideration. Often using data from multiple sources without explicit consent, PI&E in data-intensive health research is particularly important for raising awareness, for giving people a voice and for enabling people to participate in processes of research and governance. The consensus statement sets out the key principles to guide future best practice in PI&E with data-intensive health research. Conclusion/ImplicationsThe emergence of data intensive health research and the importance of the social contract upon which it relies, demands that we move beyond rhetorical commitments and engage anew with clearly stated principles to build PI\&E into data-intensive health research at all levels.

The Flags system was useful as a conceptual framework in this context for identifying a number of obstacles to working with health problems, many of which were potentially modifiable on worker, workplace, or wider systems levels.

Background: Stillbirth is a poor pregnancy outcome and one that is common worldwide. It mostly occurs during the intrapartum period, which accounts for more than 50% of cases. Estimates suggest that 55% of stillbirths occur in low-to middle-income countries (Lawn et al, 2011). Objective: To establish factors contributing to intrapartum stillbirth in Mansa General Hospital, Lupala Province, Zambia. Methods: In this retrospective audit, the files of 115 women were purposively reviewed in an initial baseline clinical audit and strategies introduced to change practice. A further 31 files were reviewed in a subsequent re-audit. Data were entered and analysed using SPSS version 16.0. Results: The study found that only 36 (33.3%) labouring women in the initial audit and 20 (65%) in the re-audit were managed using a partograph. Obstructed labour was the main cause of intrapartum stillbirths, which was the case for 65 women (55.7%) at baseline and 12 (38.7%) in the re-audit. Antepartum haemorrhage was the cause for 27 (23.5%) stillbirths in the baseline audit and 5 (16.1%) in the re-audit. Suboptimal care was observed in the initial audit, but thanks to intervention strategies, care improved in the subsequent audit. Conclusions: Improving intrapartum care in labour wards by skilled birth attendants and an improved referral system is critical if stillbirths are to be averted.

Further research is required to substantiate and build on these preliminary findings and collaborations between economists and policy makers are needed to develop clear, rigorous and standard guidance relating to economic evaluation, recognizing the diversity of public health strategies.

Background Patient and Public Involvement (PPI) groups are becoming more established as collaborators with academic researchers and institutions to ensure that research is important and relevant to end users, and to identify areas that might have ethical considerations, as well as to advise on solutions. The National Institute for Health and Care Research UK Standards for Public Involvement in Research embody best practice for PPI, including support and learning opportunities that build confidence and skills for members of the public to play an invaluable and mutually productive role in research. However, the pivotal role of research and professional services (management and administrative) staff within academic institutions for sustaining and making this involvement successful is often overlooked. Main body It takes significant effort to develop and sustain effective PPI in research. The six UK Standards for Public Involvement highlight the need for consistent, inclusive, well-governed and mutually respectful working relationships to sustain effective PPI contributions in health research. Productivity across a team of lay and academic members requires organisation and experience of implementing these standards by a dedicated PPI team, yet advice on PPI finances is usually focused on costs for patient panel members, and budgets in funding applications rarely consider the wider PPI team behind this involvement. As an exemplar, we reflect on how the Asthma UK Centre for Applied Research (AUKCAR) has developed a dedicated PPI Platform, with guidance for how PPI should be embedded throughout the research lifecycle, and detailed information to support the costing of PPI in funding applications. AUKCAR’s work with established researchers, as well as Early Career Researchers and PhD students, is at the heart of a campaign to raise awareness of the importance of PPI in effective research planning. Conclusion Focusing attention on the staff behind best practice involvement in health research may stimulate a much-needed discussion to ensure flourishing PPI capacity, with significant patient and public benefit. With adaptation, the PPI expertise within AUKCAR can be translated more widely.