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Background The Obstetric Anal Sphincter Injury (OASI) Care Bundle comprises four primary and secondary prevention practices that target the rising rates of severe perineal tearing during childbirth, which can have severe debilitating consequences for women. The OASI Care Bundle was implemented in 16 maternity units in Britain in the OASI1 project (2017-2018), which demonstrated the care bundle’s effectiveness in reducing OASI rates. In OASI2, the care bundle will be scaled up to 20 additional National Health Service (NHS) maternity units in a hybrid effectiveness-implementation study that will examine the effectiveness of strategies used to introduce, implement and sustain the care bundle. Methods OASI2 is a two-arm cluster-randomised control trial (C-RCT) of maternity units in England, Scotland and Wales, with an additional non-randomised study arm. C-RCT arm 1 (peer support, n = 10 units) will be supported by ‘buddy’ units to implement the OASI Care Bundle. C-RCT arm 2 (lean implementation, n = 10 units) will implement without external support. The additional study arm (sustainability, n = 10 units) will include some original OASI1 units to evaluate the care bundle’s sustainability and OASI rates over time, from before OASI1 and through the end of OASI2. Units in all three study arms will receive an Implementation Toolkit with training resources and implementation support. The C-RCT arms will be compared in terms of OASI rate reduction (primary effectiveness outcome) and clinicians’ adoption of the care bundle (primary implementation outcome). Clinical data will be collated from maternity information systems; implementation data will be collected through validated surveys with women and clinicians, supplemented by qualitative methods. Descriptive statistics and regression modelling will be used for analysis. Emergent themes from the qualitative data will be assessed using framework analysis. Discussion OASI2 will study the impact of various implementation strategies used to introduce and sustain the OASI Care Bundle, and how these strategies affect the bundle’s clinical effectiveness. The study will generate insights into how to effectively scale-up and sustain uptake and coverage of similar interventions in maternity units. A locally adaptable ‘implementation blueprint’ will be produced to inform development of future guidelines to prevent perineal trauma. Trial registration ISRCTN26523605
Background Major surgery accounts for a substantial proportion of health service activity and resource consumption, due not only to the primary procedure, but also the short and long-term implications of perioperative complications. It is likely that both compliance with best practice processes and outcomes from major surgery vary substantially between hospitals and therefore could be targets for quality improvement. Methods The Perioperative Quality Improvement Programme (PQIP) patient study is a multi-centre prospective cohort study which recruits participants undergoing major inpatient non-cardiac surgery with three main aims: to measure and improve processes of care and outcome from major surgery; to implement and evaluate a complex intervention aiming to enhance the use of data for improvement by clinical teams; and to create a national database to support collaborative research and efficient study design. The prospective dataset combines variables for risk adjustment, process measures and both objective and patient reported outcome data. Longer-term outcomes are collected through linkage to national administrative datasets (mortality and readmissions). PQIP deploys a theoretically underpinned improvement methodology to support the use of data for improvement by perioperative clinicians, incorporating action research principles to enable changes to be made in response to user feedback. Dissemination of interim findings (non-inferential) form a part of the improvement methodology and are provided to participating centres at regular intervals, including near-real-time feedback of key process measures. Inferential analyses will be published in the peer-reviewed literature, supported by a multi-modal communications strategy to patients, public, policy makers and academic audiences as well as clinicians. Discussion PQIP is the first national effort in the UK to measure and report risk-adjusted complications, patient-reported outcome and mortality rates for patients undergoing major surgery across multiple surgical specialties in the UK. Its main limitation is the risk of sampling bias due to the requirement for patient consent, and because local resource constraints may lead hospitals to recruit a convenience sample, rather than a truly random sample. We will evaluate this risk by using Hospital Episode Statistics (HES) to identify all patients undergoing PQIP eligible procedures, and undertaking sensitivity analyses comparing common data points in the PQIP sample and the HES population. As the purpose of PQIP is to support quality improvement and research as opposed to quality assurance or institutional comparisons, even if they exist, such sampling biases are unlikely to materially affect the ability of the programme to achieve its aims.
Sir, We would like to thank Scamell and colleagues for their letter in response to our paper describing the results of the Obstetric Anal Sphincter Injury Care Bundle (OASI-CB) evaluation (1,2). We have previously addressed most of the points raised in our response to an earlier critical review of the OASI-CB by two of the signatories of this letter (3). First, Scamell and colleagues indicate that they are disappointed in the quality of the evidence that supports the components of the OASI-CB. We feel that this criticism is misdirected, because the OASI-CB project was initiated in response to this lack of high-quality evidence. We developed a care bundle and we performed a multicentre study, which produced evidence of its positive effect. A second criticism expressed by the authors is that the OASI-CB does not include warm compresses. We have previously acknowledged the evidence that warm compresses reduce the risk of OASI (3). They were not included as a standardised component of the OASI-CB partly because of variation in availability and use (4), and partly because of clinical practicalities such as the feasibility of safely heating/reheating compresses. However, we do encourage the more widespread use of warm compresses because they would further improve the prevention already provided by the OASI-CB. A third concern raised by the authors is that the OASI-CB has only a small effect: a reduction in the OASI rates from 3.3 to 3.0%. As we explained in our article, this reported reduction is very likely to be an underestimate of the true effect of the OASI-CB, given that the OASI-CB also requires a careful check of the perineum following birth for the immediate detection of OASI. Therefore, we emphatically reject the suggestion that our results could be explained by ascertainment bias. Last, the authors suggest that we did not consider women’s experiences and the acceptability of the OASI-CB. Women were–and still are–at the very heart of the development, evaluation and implementation of the care bundle (2). For example, women told us that they experienced a hands-on approach protecting the perineum as very positive and that good communication with the midwife was key to a calm birth (5). We are now performing the OASI2 study that evaluates the sustainability of the OASI-CB and its implementation in a wider group of units (www.rcog.org.uk/oasi2). Based on multi-stakeholder discussions and lessons learned from the original OASI-CB project (6), we updated the OASI-CB manual and antenatal discussion guide and improved our training materials. For example, the antenatal discussion guide now also includes antenatal perineal massage, birth position, importance of a slow birth and the use of warm compresses as discussion points alongside the OASI-CB elements. In OASI2, we will also explore women’s perspectives further via a large-scale survey. We would like to reiterate that women’s health and a positive birth experience are at the centre of the OASI-CB. Our article presents evidence of the effectiveness of the OASI-CB. It is this evidence that, together with our commitment to support women and clinicians, will empower women to make informed choices about whether or not they want the OASI-CB as part of their birth plan.
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consideration of warm compresses and 'hands off' to protect against episiotomy. Even more unsettling is the statement 'MPP should be used unless the woman objects', implying little consideration for autonomy and informed consent.For these reasons we are not only disappointed with the BJOG article but also with the professional stakeholder investment in the intervention, which seems to have been widely and uncritically supported, with some support even being somewhat evangelical, despite the limited evidence in favour.
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