Catherine Calderwood

Research priorities for stillbirth: process overview and results from UK Stillbirth Priority Setting Partnership.

†Institute of Human Development, Faculty of Medical and Human Sciences, University of Manchester, Manchester, UK; ‡St Mary’s Hospital, Central Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK; §Library Service, Central Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK; ¶Sands (Stillbirth and Neonatal Death Charity), London, UK; **Tommy’s, London, UK; ††NHS Scotland, Edinburgh, UK; ‡‡National Maternity Support Foundation, Jake’s Charity, Hertfordshire, UK; §§British and Irish Paediatric Pathology Association, London, UK; ¶¶Department of Paediatric Pathology, Addenbrooke’s Hospital, Cambridge, UK; ***The Royal College of Midwives, London, UK; †††Holly Martin Stillbirth Research Fund, Powys, UK; ‡‡‡James Lind Alliance, NIHR Evaluation Trials and Studies Coordinating Centre, Southampton, UK *Correspondence. (e-mail: alexander.heazell@manchester.ac.uk)

Can promoting awareness of fetal movements and focusing interventions reduce fetal mortality? A stepped-wedge cluster randomised trial (AFFIRM)

Background In 2013, the stillbirth rate in the UK was 4.2 per 1000 live births, ranking 24th out of 49 high-income countries, with an annual rate of reduction of only 1.4% per year. The majority of stillbirths occur in normally formed infants, with (retrospective) evidence of placental insufficiency the most common clinical finding. Maternal perception of reduced fetal movements (RFM) is associated with placental insufficiency and increased risk of subsequent stillbirth. This study will test the hypothesis that the introduction of a package of care to increase womens awareness of the need for prompt reporting of RFM and standardised management to identify fetal compromise with timely delivery in confirmed cases, will reduce the rate of stillbirth. Following the introduction of a similar intervention in Norway the odds of stillbirth fell by 30%, but the efficacy of this intervention (and possible adverse effects and implications for service delivery) has not been tested in a randomised trial. Methods We describe a stepped-wedge cluster trial design, in which participating hospitals in the UK and Ireland will be randomised to the timing of introduction of the care package. Outcomes (including the primary outcome of stillbirth) will be derived from detailed routinely collected maternity data, allowing us to robustly test our hypothesis. The degree of implementation of the intervention will be assessed in each site. A nested qualitative study will examine the acceptability of the intervention to women and healthcare providers and identify process issues including barriers to implementation. Ethics and dissemination Ethical approval was obtained from the Scotland A Research Ethics Committee (Ref 13/SS/0001) and from Research and Development offices in participating maternity units. The study started in February 2014 and delivery of the intervention completed in December 2016. Results of the study will be submitted for publication in peer-reviewed journals and disseminated to local investigating sites to inform education and care of women presenting with RFM. Trial registration number www.clinicaltrials.gov NCT01777022. Version Protocol Version 4.2, 3 February 2017.

Turning people into couch potatoes is not the cure for sports concussion

In little more than a decade, concussion has become one of the biggest issues taxing modern sport. Incidents of apparently concussed athletes in footballs World Cup and in recent Six Nations’ rugby matches have generated unparalleled column inches in the press, comment on social media and challenging review articles;1 the clear suggestion is that something is wrong in sport, and young brains are at risk. With the Rugby World Cup under way, yet more scrutiny of further high profile incidents is inevitable. In the USA, heightened anxiety over sports concussion has caused participation levels to fall. Similar reactions are likely to follow in other countries. Is this reaction justified? What is the risk of losing the proven benefits of participation in sport compared with the risks of sports concussion? Concussions are common in contact sports. Data in rugby union suggest approximately one player per match at community level will sustain a head injury requiring medical attention,2 with around one concussion in every 2.5 matches at the elite level.3 Symptoms vary, and may include headache, visual disturbance …

Developing middle-ground research to support primary care transformation

Healthcare systems across the world are facing common challenges relating to changing demographics, and in particular ageing populations. In the UK multimorbidity is a key common denominator in frailty in older people, and health inequalities in younger age groups.1,2 There is substantial divergence in how the four nations of the UK are responding to this challenge.3 In this editorial we describe the Scottish approach to primary care transformation and how better evidence to support transformation can be generated in countries undergoing healthcare reforms. The Scottish Government has recently embarked on an ambitious journey to transform the health and social care system, with primary care at the heart of this.4,5 Numerous new models of primary care are currently being piloted, and an evaluation is being undertaken by the Scottish School of Primary Care (a consortium of Scottish universities with a strong track record in academic primary care). Following the abolition of the Quality and Outcomes Framework in Scotland in 2016, a new Scottish GP contract will be rolled out in 2018 and will include a fresh approach to quality improvement with a requirement for GP practices to work in Quality Clusters. The clusters are expected to lead both healthcare quality improvement focused on local needs, and the engagement of GPs in the wider integration agenda.6 These radical changes in Scotland are underpinned …

Scotland's progress in putting policy about physical activity into practice

The need to increase global levels of physical activity to benefit population health is now incontrovertible.1 ,2 Policy that recommends a voluntary target by countries to reduce global inactivity by 10% by the year 2025 has been adopted by the WHO. Given the compelling argument, and clear aim to increase physical activity, what is required are methods and tangible actions to achieve this goal. Global experts reviewed the evidence for the most effective ways to increase population levels of physical activity and produced a guide to investments that work.3 This has provided a north star for many individuals, organisations, communities and countries aiming to increase physical activity levels. However, there is still a need for examples of how these investments have been implemented and evaluated. Here we offer Scotlands experiences. ### Policy In 2003 a long-term, cross-sector and cross-party policy called ‘Lets make Scotland more active’ was endorsed by the Scottish Government.4 This set a 20-year framework and aimed to have 80% of children achieving 60 min of activity every day and …

Physical activity and pregnancy: time for guidance in the UK

Regular physical activity during pregnancy has a positive impact on pregnancy outcomes and fetomaternal health.1–3 Pregnancy also offers the chance to increase physical activity and sustain this healthy behaviour beyond childbirth. Health behaviours established during childhood can last across the life course, so physical activity interventions during pregnancy may provide a powerful opportunity for population change.4 Despite these benefits, national recommendations do not exist in the UK for physical activity during pregnancy. In their 2011 physical activity recommendations, the UK Chief Medical Officers (CMOs) emphasised the importance of achieving an active lifestyle across the life course, producing guidelines for four categories: the under 5s, children and young people, adults, and older adults. Pregnancy, however, was omitted from their reviews of evidence and no specific physical activity recommendations exist for this group of women. This omission is to the detriment of antenatal care as recommendations provide an important benchmark …

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

Summary 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 womens 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), Tommys Centre for Maternal and Fetal Health, Sands.

A new kind of research

General practice is entering a period of rapid change and requires research evidence to guide it. The ‘gold standard’ model of research, based on randomised controlled trials that are expensive, take several years to complete, and even more years to be implemented, is insufficient to inform the rapidly changing primary care landscape. This article will discuss a new kind of research, co-produced by academics, patients, and NHS staff, which offers a more realistic approach to informing policy and service development in a timely manner. We use the example of multimorbidity to discuss the need for such research. Multimorbidity is not the only population challenge that general practice faces, but it is a key one. Given the very limited evidence-base for how best to manage patients with multimorbidity, discussed in more detail below, it is a prime target for a new kind of research.