Realistic Medicine: Changing culture and practice in the delivery of health and social care.

OBJECTIVE: Current models of health and social care services are stretched and do not always suit patients, their carers or the aspirations of the workforce. Realistic Medicine aims to improve patient care by ensuring that people receive appropriate, beneficial, evidence-based care aligned with their personal preferences. This paper builds on a keynote address delivered at ICCH 2018. METHODS: We explore the six core principles of Realistic Medicine: (i) building a personalised approach to patient care; (ii) changing style to shared decision-making; (iii) reducing harm and waste; (iv) tackling unwarranted variation in practice and outcomes; (v) managing risk better; (vi) becoming improvers and innovators in healthcare. RESULTS: Realistic Medicine is being embedded across Scotland, championed by local and national clinical leaders. There is particular focus on engaging patients around shared-decision making and improving value in healthcare. CONCLUSION: Realistic Medicine is the first example of these principles being articulated clearly and collectively as the essential components of a health and care system's national improvement strategy. It reflects the care that most professional staff wish to provide. PRACTICE IMPLICATIONS: To deliver Realistic Medicine, all health and social care professionals must be empowered to work together in teams, networks and in partnership with people.

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.

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 women's 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.

A population-based study of venous thrombosis in pregnancy in Scotland 1980-2005.

OBJECTIVES: Data on time trends in the incidence of pregnancy-related venous thromboembolism (VTE) are sparse. This report charts the incidence of pregnancy-related VTE over the period 1980-2005 in Scotland, and discusses the results in relation to potential risk factors. STUDY DESIGN: 1475301 maternity discharges from Scottish hospitals recorded on the Scottish Morbidity Record 2 (SMR2) were included. Incidences of pregnancy-related VTE, antenatal deep venous thromboembolism (DVT), postnatal DVT and pulmonary embolism (PTE) were derived relative to the number of deliveries, and risk factors were analysed using Poisson regression. RESULTS: Over the period, VTE incidence rose from 13.7 to 18.3 per 10000 deliveries, antenatal DVTs from 8.8 to 12.2 per 10000 deliveries and PTE from 1.5 to 3.0 per 10000 deliveries. Postnatal DVTs, on the other hand, declined from 4.2 to 2.7 per 10000 deliveries. Risk factors were: age over 35 years; three or more previous pregnancies; previous VTE; obstetric haemorrhage; and preeclampsia. Antenatal DVT risk was highest in the most deprived areas, where events started increasing before those in less deprived areas. Postnatal DVT risk was increased following caesarean delivery, especially when unplanned, although after 1996, events following emergency caesarean decreased. CONCLUSION: During the 26-year period, pregnancy-related VTEs increased, with the greatest rise for antenatal DVTs. Postnatal DVTs, on the other hand, declined over the period, particularly following emergency section. Thromboprophylaxis use following emergency delivery may have led to the postpartum reduction. To continue to prevent events, risk assessment and intervention are required, particularly antenatally.