Simulation TRaining for Operative vaginal Birth Evaluation: study protocol for an observational stepped-wedge interrupted time-series study (STROBE).

BACKGROUND: Operative vaginal birth is a common procedure used to expedite birth after full cervical dilatation where there is a clinical need to do so (15% of births in the UK in 2016). The acquisition of skills for operative vaginal birth is dependent on the exposure of junior obstetricians to situations in which they can undertake directly supervised learning from senior accouchers. The Royal College of Obstetricians and Gynaecologists has recently introduced the first structured course in operative vaginal birth. To date, there have been no attempts to determine the clinical impact of a structured training package for operative vaginal birth. METHODS: The STROBE study is a quasi-experimental before-after interrupted time-series study of the effect of simulation training in operative vaginal birth for obstetricians on clinical outcomes of women and babies following operative vaginal birth. Similar to a stepped-wedge design, the intervention will be gradually implemented in all participating units but at different time periods. The primary outcome is failed operative vaginal birth with the first intended instrument. Secondary maternal outcomes are; use of second instrument to achieve operative vaginal birth, caesarean section, episiotomy, perineal trauma (1st, 2nd, 3rd, 4th degree tear), cervical tear requiring suturing, general anaesthesia and estimated blood loss. Secondary neonatal outcomes are; Apgar score at one, five, and ten minutes, Umbilical artery pH, shoulder dystocia, admission to Neonatal Intensive Care Unit and death within 28 days of birth. The analysis will be intention-to-treat (per unit) on the primary and secondary outcomes. The STROBE study received approval from the Health Research Authority and is sponsored by North Bristol NHS Trust. Results will be published in an open-access peer-reviewed medical journal within one year of completion of data gathering. DISCUSSION: The STROBE study will help establish our understanding of the effectiveness of locally-delivered simulation training for operative vaginal birth. Robust evidence supporting the effectiveness of such an approach would add weight to the argument supporting regular, local training for junior obstetricians in operative vaginal birth. TRIAL REGISTRATION: ISRCTN11760611 05/03/2018 (retrospectively registered).

Onsite training of doctors, midwives and nurses in obstetric emergencies, Zimbabwe.

PROBLEM: In Zimbabwe, many health facilities are not able to manage serious obstetric complications. Staff most commonly identified inadequate training as the greatest barrier to preventing avoidable maternal deaths. APPROACH: We established an onsite obstetric emergencies training programme for maternity staff in the Mpilo Central Hospital. We trained 12 local staff to become trainers and provided them with the equipment and resources needed for the course. The trainers held one-day courses for 299 staff at the hospital. LOCAL SETTING: Maternal mortality in Zimbabwe has increased from 555 to 960 per 100,000 pregnant women from 2006 to 2011 and 47% of the deaths are believed to be avoidable. Most obstetric emergencies trainings are held off-site, away from the clinical area, for a limited number of staff. RELEVANT CHANGES: Following an in-hospital train-the-trainers course, 90% (138/153) of maternity staff were trained locally within the first year, with 299 hospital staff trained to date. Local system changes included: the introduction of a labour ward board, emergency boxes, colour-coded early warning observation charts and a maternity dashboard. In this hospital, these changes have been associated with a 34% reduction in hospital maternal mortality from 67 maternal deaths per 9078 births (0.74%) in 2011 compared with 48 maternal deaths per 9884 births (0.49%) in 2014. LESSONS LEARNT: Introducing obstetric emergencies training and tools was feasible onsite, improved clinical practice, was sustained by local staff and associated with improved clinical outcomes. Further work to study the implementation and effect of this intervention at scale is required.

The role of manual rotation in avoiding and managing OVD.

Manual rotation (MR) is the most common technique used by accoucheurs who wish to correct malposition of the foetal head to either avoid or facilitate an operative vaginal delivery (OVD). MR can be performed using either a whole-hand or a digital approach. MR should be formally taught and trainees should be assessed for competence, and later, performance should ideally be tracked with statistical control charts. There is paucity of robust evidence evaluating MR relative to the other methods of rotational OVD: rotational forceps (RF) and rotational ventouse (RV). Furthermore, there is little evidence concerning long-term maternal outcomes of rotational OVD. A prospective randomised trial of MR versus either RF or RV is clearly needed, along with a core outcome set for OVD to facilitate comprehensive evaluation programmes that focus on aspects pertaining to women.

Preventing cerebral palsy in preterm labour: a multiorganisational quality improvement approach to the adoption and spread of magnesium sulphate for neuroprotection.

Magnesium sulphate has been demonstrated to be an effective neuroprotectant for babies delivered prematurely (under 37 weeks' gestational age). Antenatal administration reduces infant mortality and cerebral palsy (CP); however, uptake in the UK has been significantly lower than other countries. A quality improvement (QI) project (PReventing Cerebral palsy in Pre Term labour (PReCePT)) was carried out in the West of England, UK, to raise awareness of evidence and to improve the uptake of magnesium sulphate as neuroprotectant in preterm deliveries. Five National Health Service (NHS) Trusts and the West of England Academic Health Science Network participated in the QI project. The project was underpinned by a multifaceted QI approach that included: patient and clinical coproduction of resources; recruitment of clinical champions to support the local microsystems and create a stimulating/supporting environment for change; Plan, Do, Study, Act cycles; training for over 600 NHS staff and awareness raising and strategic influencing of key leaders. A baseline audit and regular measurement of the number of eligible women receiving magnesium sulphate was undertaken at each hospital site, and the overall programme was evaluated using data from an international benchmarking organisation for neonatal care outcomes-the Vermont Oxford Network. During the project 664 staff received magnesium sulphate training. The use of magnesium sulphate increased across the West of England from an average baseline of 21% over the 2 years preceding the project to 88% by the conclusion of the project. The project was also able to influence the development of a national data collection process for benchmarking the use of magnesium sulphate for neuroprotection in preterm deliveries in the U.K. PReCePT appears to have had a favourable effect on the uptake of magnesium sulphate across the West of England. The project has also provided learning about how to stimulate adoption and spread of evidence using a QI approach across a network.

Functional movement training for recurrent low back pain: lessons from a pilot randomized controlled trial.

OBJECTIVE: Despite considerable effort to reduce low back pain (LBP), approximately 60% of patients have recurrence after their first episode. The high rate of recurrence suggests that more effective intervention approaches are needed. This randomized, controlled feasibility trial was designed to compare disability, physical functional capacity, and pain outcomes at 2, 6, and 12 months for 2 conventional and 1 novel physical therapy (functional movement training) intervention for recurrent LBP. DESIGN: Randomized, controlled feasibility trial. SETTING: University hospital outpatient physical therapy clinic. PARTICIPANTS: Sixty-one participants (60% female) with recurrent LBP. INTERVENTIONS: Subjects were randomized to 1 of 3 intervention groups: group 1 had a single session consisting of standard back pain education; group 2 had 6 sessions in 8 weeks of conventional physical therapy; and group 3 had 6 sessions in 8 weeks of a novel method of functional movement training. Change from baseline was used to determine within-group changes and between-group differences for participants who finished each time point (2, 6, and 12 months). Changes were evaluated using analysis of variance and Newman-Keuls post hoc analysis. MAIN OUTCOME MEASURES: The primary outcome measure was the novel Continuous Scale Physical Functional Performance test (CS-PFP), a measure of actual physical functional capacity. Secondary measures included the revised Oswestry Disability Index, a measure of pain-related disability, the Roland Morris Disability Questionnaire, and a standard visual analogue pain scale. RESULTS: Of the participants, 67% provided data at 2 months and 44% provided information at 12 months. Raw change scores were evaluated at 2, 6, and 12 months. While no statistical significance was reached with any outcome measure, the trends suggested little change for group 1 (education) and suggested that greatest improvement in function may occur in group 3 (functional movement training). In particular, at 2 months, the CS-PFP change scores revealed a trend (P=.072) toward greater improvement in groups 2 (conventional physical therapy) and 3 (functional movement training) compared with group 1. At 12 months, Oswestry Disability Index and CS-PFP scores also trended toward significance for groups 2 and 3 (P=.7 and .9, respectively). Mean change scores were also calculated and revealed groups 2 and 3 had improved by 2 months and this improvement remained stable at the 1-year mark. Trends in the direction of best improvement occurred for those in the functional movement training group. CONCLUSION: A large-scale randomized, controlled trial is warranted to determine whether an intervention based on functional movement training is superior to conventional, impairment-based intervention for individuals with recurrent LBP.