How to co-design a prototype of a clinical practice tool: a framework with practical guidance and a case study.

Clinical tools for use in practice-such as medicine reconciliation charts, diagnosis support tools and track-and-trigger charts-are endemic in healthcare, but relatively little attention is given to how to optimise their design. User-centred design approaches and co-design principles offer potential for improving usability and acceptability of clinical tools, but limited practical guidance is currently available. We propose a framework (FRamework for co-dESign of Clinical practice tOols or 'FRESCO') offering practical guidance based on user-centred methods and co-design principles, organised in five steps: (1) establish a multidisciplinary advisory group; (2) develop initial drafts of the prototype; (3) conduct think-aloud usability evaluations; (4) test in clinical simulations; (5) generate a final prototype informed by workshops. We applied the framework in a case study to support co-design of a prototype track-and-trigger chart for detecting and responding to possible fetal deterioration during labour. This started with establishing an advisory group of 22 members with varied expertise. Two initial draft prototypes were developed-one based on a version produced by national bodies, and the other with similar content but designed using human factors principles. Think-aloud usability evaluations of these prototypes were conducted with 15 professionals, and the findings used to inform co-design of an improved draft prototype. This was tested with 52 maternity professionals from five maternity units through clinical simulations. Analysis of these simulations and six workshops were used to co-design the final prototype to the point of readiness for large-scale testing. By codifying existing methods and principles into a single framework, FRESCO supported mobilisation of the expertise and ingenuity of diverse stakeholders to co-design a prototype track-and-trigger chart in an area of pressing service need. Subject to further evaluation, the framework has potential for application beyond the area of clinical practice in which it was applied.

Training for managing impacted fetal head at caesarean birth: multimethod evaluation of a pilot.

BACKGROUND: Implementation of national multiprofessional training for managing the obstetric emergency of impacted fetal head (IFH) at caesarean birth has potential to improve quality and safety in maternity care, but is currently lacking in the UK. OBJECTIVES: To evaluate a training package for managing IFH at caesarean birth with multiprofessional maternity teams. METHODS: The training included an evidence-based lecture supported by an animated video showing management of IFH, followed by hands-on workshops and real-time simulations with use of a birth simulation trainer, augmented reality and management algorithms. Guided by the Kirkpatrick framework, we conducted a multimethod evaluation of the training with multiprofessional maternity teams. Participants rated post-training statements about relevance and helpfulness of the training and pre-training and post-training confidence in their knowledge and skills relating to IFH (7-point Likert scales, strongly disagree to strongly agree). An ethnographer recorded sociotechnical observations during the training. Participants provided feedback in post-training focus groups. RESULTS: Participants (N=57) included 21 midwives, 25 obstetricians, 7 anaesthetists and 4 other professionals from five maternity units. Over 95% of participants agreed that the training was relevant and helpful for their clinical practice and improving outcomes following IFH. Confidence in technical and non-technical skills relating to managing IFH was variable before the training (5%-92% agreement with the pre-training statements), but improved in nearly all participants after the training (71%-100% agreement with the post-training statements). Participants and ethnographers reported that the training helped to: (i) better understand the complexity of IFH, (ii) recognise the need for multiprofessional training and management and (iii) optimise communication with those in labour and their birth partners. CONCLUSIONS: The evaluated training package can improve self-reported knowledge, skills and confidence of multiprofessional teams involved in management of IFH at caesarean birth. A larger-scale evaluation is required to validate these findings and establish how best to scale and implement the training.

2. Labour and birth.

This chapter describes the national guidance for care during labour and childbirth in the United Kingdom during the COVID-19 pandemic. The content largely draws attention on the guidance developed by the Royal College of Obstetricians (RCOG) and the Royal College of Midwives (RCM), and specific guidance on infection prevention and control measures from Public Health England. The key areas addressed are as follows: The chapter refers to some of the ways in which the guidance was translated in practice. The guidance was developed using a rapid analysis approach to emerging research and evidence, along with evidence from previous experiences of coronavirus combined with consensus expert opinion from all key professionals providing maternity care in the UK. WHAT IS KNOWN: The UK RCOG/RCM COVID-19 guidance was widely accepted across the UK maternity services and also worldwide as a reliable and credible source of information to shape care during the pandemic. WHAT IS NOT KNOWN: The full impact of the pandemic on the experiences and outcomes for babies and women of pregnancy, childbirth, and early parenting in the UK. The impact of the new approaches to intrapartum care on experiences and outcomes for women, babies, and families. The impact of the changes required to intrapartum care as a result of the pandemic on the professional care provided; in terms of pressure created by rapidly changing approaches to care and restrictions on the ability to provide normal levels of care.

Caesarean delivery rates and analgesia effectiveness following injections of sterile water for back pain in labour: A multicentre, randomised placebo controlled trial.

BACKGROUND: About a third of women experience severe back pain during labour. Injecting small volumes of intracutaneous sterile water into the lumbar region can be used to relieve this pain, however the procedure is controversial and previous reviews call for high quality trials to establish efficacy. We evaluated the impact on birth outcomes and analgesic effects of sterile water injections. METHODS: A multicentre, double-blind trial undertaken between December 2012 and December 2017 in one British and 15 Australian maternity units. Women experiencing severe back-pain in labour were assigned (1:1) by an independently generated randomisation schedule stratified by site to injections of either sterile water or saline placebo. Participants and caregivers were blinded to group allocation. The primary outcome was caesarean delivery rate. Main secondary outcomes included at least 30% or 50% reduction in self-reported pain scores at 30, 60 and 90 minutes after treatment. Intention to treat analysis were used and the level of significance for the multiple clinical outcomes was set at p<0.001 with the Bonferroni correction applied. The study is registered with the ACTRN Registry number, ACTRN1261100022195. FINDINGS: Between December 9, 2012, and December 15, 2017, 1166 women were recruited and randomised: 587 women received sterile water injections (SWI) and 579 a saline placebo. Seven women in the SWI group and 12 in the placebo group were excluded as consent was not completed, leaving 580 and 567, respectively, included in the analysis. The proportions of caesarean delivery were 17·1% (82 of 580) in the SWI group and 14·8% (82 of 567) in the placebo (RR 1·16, 95% CI 0·88-1.51; p = 0·293). At 30 min post treatment 60·8% (330 of 543) of women in the SWI group reported a 30% reduction in self-reported pain compared to 31·4% (163 of 520) placebo (RR 1·94, 95% CI 1·68-2·24; p=<0·001) and 43·3% (235 of 534) SWI reported a 50% reduction versus 18·1% (94 of 520) placebo (RR 2·39, 95% CI 1·95-2·94; p=<0·001). The analgesic effect of SWI compared to placebo remained significant at 60 and 90 min post-treatment. There were no significant differences in other maternal or neonatal outcomes. INTERPRETATION: Compared to placebo, injections of sterile water did not reduce rates of caesarean delivery. For the main secondary outcome of pain relief the intervention did result in significantly more women reporting at least 30% and 50% reduction in pain for up to 90 min. Water injections have no effect on birth outcomes though can be an effective treatment for the relief of labour-related back pain.Funded by the National Health and Medical Research Council.

The outcomes of pregnancies with reduced fetal movements: A retrospective cohort study.

INTRODUCTION: The objective of this study was to examine the outcomes and interventions in pregnant women presenting with a perception of reduced fetal movements (RFM), and to determine if repeated episodes of RFM increase the risk of adverse outcomes. MATERIAL AND METHODS: This was a retrospective cohort study conducted in six NHS hospitals within the Thames Valley network region, UK and one neighboring hospital, an area with approximately 31 000 births annually. All women with a primary presentation of perceived RFM after 24 completed weeks of gestation during the month of October 2016 were included in the study. Prospective records in all units were examined and individual case-notes were reviewed. Pregnancy and neonatal outcomes and their relation with recurrent presentations with RFM were examined using relative risks with 95% CI. The main outcome measures are described. Neonatal outcomes measured were perinatal mortality, neonatal unit admission, abnormal cardiotocography at presentation, a composite severe morbidity outcome of Apgar <7 at 5 minutes or arterial pH <7.0 or encephalopathy, and birthweight. Pregnancy outcomes measured were induction of labor, cesarean section, admission and ultrasound usage rates. RESULTS: In all, 591 women presented with RFM during the month; using annual hospital birth figures, the incidence of RFM was estimated at 22.6% (range 14.9%-32.5%). More than 1 presentation of RFM occurred in 273 (46.2%). All 3 deaths (0.5%) were at the first presentation. More than 1 presentation was associated with higher induction rates (56.0% vs 31.9%), but no increase in any adverse outcomes including small-for-gestational-age. CONCLUSIONS: Reduced fetal movements, and recurrent episodes, are common, and lead to considerable resource usage and obstetric intervention. We found no evidence to suggest that recurrent episodes increase pregnancy risk.