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Assessment of the quality, content and perceived utility of local maternity guidelines in hospitals in England implementing the saving babies' lives care bundle to reduce stillbirth.

ABSTRACT: INTRODUCTION:The UK Department of Health have targeted a reduction in stillbirth by 50% by 2025; to achieve this, the first version of the Saving Babies' Lives Care Bundle (SBLCB) was developed by NHS England in 2016 to improve four key areas of antenatal and intrapartum care. Clinical practice guidelines are a key means by which quality improvement initiatives are disseminated to front-line staff. METHODS:Seventy-five clinical practice guidelines covering the four areas of antenatal and intrapartum care in the first version of SBLCB were obtained from 19 maternity providers. The content and quality of guidelines were evaluated using the Appraisal of Guidelines for Research and Evaluation (AGREE II) tool. Maternity health professionals in participating organisations were invited to participate in an anonymous survey to determine perceptions toward and experiences of the use of clinical practice guidelines using a series of Likert scales. RESULTS:Unit guidelines showed considerable variation in quality with median scores of 50%-58%. Only 4 (5.6%) guidelines were recommended for use in clinical practice without modifications, 54 (75.0%) were recommended for use subject to modifications and 12 (16.7%) were not recommended for use. The lowest scoring domains were 'rigour of development', 'stakeholder involvement' and 'applicability'. A significant minority of unit guidelines omitted recommendations from national guidelines. The majority of staff believed that clinical practice guidelines standardised and improved the quality of care but over 30% had insufficient time to use them and 24% stated they were unable to implement recommendations. CONCLUSION:To successfully implement initiatives such as the SBLCB change is needed to local clinical practice guidelines to reduce variation in quality and to ensure they are consistent with national recommendations . In addition, to improve clinical practice, adequate time and resources need to be in place to deliver and evaluate care recommended in the SBLCB.

SUBMITTER: Lau YZ

PROVIDER: S-EPMC7254132 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Assessment of the quality, content and perceived utility of local maternity guidelines in hospitals in England implementing the saving babies' lives care bundle to reduce stillbirth.

Lau Yu Zhen YZ Widdows Kate K Roberts Stephen A SA Khizar Sheher S Stephen Gillian L GL Rauf Saima S Heazell Alexander E P AEP

BMJ open quality 20200401 2

<h4>Introduction</h4>The UK Department of Health have targeted a reduction in stillbirth by 50% by 2025; to achieve this, the first version of the Saving Babies' Lives Care Bundle (SBLCB) was developed by NHS England in 2016 to improve four key areas of antenatal and intrapartum care. Clinical practice guidelines are a key means by which quality improvement initiatives are disseminated to front-line staff.<h4>Methods</h4>Seventy-five clinical practice guidelines covering the four areas of antena ...[more]

PMID: 32327423

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Project description:ObjectiveTo assess implementation of the Saving Babies Lives (SBL) Care Bundle, a collection of practice recommendations in four key areas, to reduce stillbirth in England.DesignA retrospective cohort study of 463,630 births in 19 NHS Trusts in England using routinely collected electronic data supplemented with case note audit (n = 1,658), and surveys of service users (n = 2,085) and health care professionals (n = 1,064). The primary outcome was stillbirth rate. Outcome rates two years before and after the nominal SBL implementation date were derived as a measure of change over the implementation period. Data were collected on secondary outcomes and process outcomes which reflected implementation of the SBL care bundle.ResultsThe total stillbirth rate, declined from 4.2 to 3.4 per 1,000 births between the two time points (adjusted Relative Risk (aRR) 0.80, 95% Confidence Interval (95% CI) 0.70 to 0.91, P<0.001). There was a contemporaneous increase in induction of labour (aRR 1.20 (95%CI 1.18-1.21), p<0.001) and emergency Caesarean section (aRR 1.10 (95%CI 1.07-1.12), p<0.001). The number of ultrasound scans performed (aRR 1.25 (95%CI 1.21-1.28), p<0.001) and the proportion of small for gestational age infants detected (aRR 1.59 (95%CI 1.32-1.92), p<0.001) also increased. Organisations reporting higher levels of implementation had improvements in process measures in all elements of the care bundle. An economic analysis estimated the cost of implementing the care bundle at ~£140 per birth. However, neither the costs nor changes in outcomes could be definitively attributed to implementation of the SBL care bundle.ConclusionsImplementation of the SBL care bundle increased over time in the majority of sites. Implementation was associated with improvements in process outcomes. The reduction in stillbirth rates in participating sites exceeded that reported nationally in the same timeframe. The intervention should be refined to identify women who are most likely to benefit and minimise unwarranted intervention.Trial registrationThe study was registered on (NCT03231007); www.clinicaltrials.gov.

Project description:OBJECTIVE:To investigate the mechanisms that link maternal haemoglobin concentration with stillbirth. DESIGN:A retrospective cohort analysis using anonymised maternity data from two hospitals in England. SETTING:The Royal Wolverhampton NHS Trust and Guy's and St Thomas' NHS Foundation Trust. STUDY POPULATION:12?636 women with singleton pregnancies ?24 weeks of gestation giving birth in the two hospitals during 2013-2015. METHOD:A conceptual framework of hypothesised pathways through birth weight-for-gestational age and maternal infection including potential confounders and other risk factors was developed and examined using path-analysis. Path-analysis was performed by fitting a set of regression equations using weighted least squares adjusted for mean and variance. Goodness-of-fit indices were estimated. MAIN OUTCOME MEASURES:Coefficient of association (?) for relationship between each parameter, and direct, indirect and total effects via the postulated pathways. RESULTS:The path-model showed a significant adjusted indirect negative effect of maternal haemoglobin on stillbirth mediated via birth weight-for-gestational age (standardised estimate (SE)=-0.01; 95%?CI=-0.01?to -0.001; P=0.028). The effect through maternal infection was not significant at P<0.05 (SE=0.001; 95%?CI=-0.004?to 0.01; P=0.610). There was a residual direct negative effect of maternal haemoglobin on stillbirth (SE=-0.12; 95%?CI -0.23 to -0.02; P=0.020) after accounting for the two pathways. Total indirect SE=-0.004; 95%?CI -0.01 to 0.003; P=0.267; total direct and indirect SE=-0.13; 95%?CI -0.23 to -0.02; P=0.016. The goodness-of-fit indices showed a good fit between the model and the data. CONCLUSION:While some of the influence on risk of stillbirth acts through low birth weight-for-gestational age, the majority does not. Several new mechanisms have been suggested for how haemoglobin may be exerting its influence on the risk of stillbirth possibly involving genetic, epigenetic and/or alternative obstetric and nutritional pathologies, but much more research is needed.

Project description:Reducing stillbirth and early neonatal death is a national priority in the UK. Current evidence indicates this is potentially achievable through application of four key interventions within routine maternity care delivered as the National Health Service (NHS) England's Saving Babies' Lives care bundle. However, there is significant variation in the degree of implementation of the care bundle between and within maternity units and the effectiveness in reducing stillbirth and improving service delivery has not yet been evaluated. This study aims to evaluate the impact of implementing the care bundle on UK maternity services and perinatal outcomes.The Saving Babies' Lives Project Impact and Results Evaluation (SPiRE) study is a multicentre evaluation of maternity care delivered through the Saving Babies' Lives care bundle using both quantitative and qualitative methodologies. The study will be conducted in twenty NHS Hospital Trusts and will include approximately 100,000 births. It involves participation by both service users and care providers. To determine the impact of the care bundle on pregnancy outcomes, birth data and other clinical measures will be extracted from maternity databases and case-note audit from before and after implementation. Additionally, this study will employ questionnaires with organisational leads and review clinical guidelines to assess how resources, leadership and governance may affect implementation in diverse hospital settings. The cost of implementing the care bundle, and the cost per stillbirth avoided, will also be estimated as part of a health economic analysis. The views and experiences of service users and service providers towards maternity care in relation to the care bundle will be also be sought using questionnaires.This protocol describes a pragmatic study design which is necessarily limited by the availability of data and limitations of timescales and funding. In particular there was no opportunity to prospectively gather pre-intervention data or design a phased implementation such as a stepped-wedge study. Nevertheless this study will provide useful practice-based evidence which will advance knowledge about the processes that underpin successful implementation of the care bundle so that it can be further developed and refined.www.clinicaltrials.gov NCT03231007 (26th July 2017).

Project description:BackgroundThis study aimed to assess the predictive power of three different Sepsis Scoring Systems (SSSs), namely maternity Systematic Inflammatory Response Syndrome (mSIRS), quick Sepsis-related Organ Failure Assessment (qSOFA) and Modified Early Warning System (MEWS) in identifying sepsis by comparing them with positive culture. This study also sought to evaluate compliance with using the Sepsis Six Care Bundle (SSCB) operated in an individual health board.MethodsA retrospective cohort study was conducted in 3 maternity hospitals of a single Scottish health board that admitted 2690 pregnancies in a 12 weeks period in 2016. Data for study was obtained from medical notes, handheld and electronic health records for women who were prescribed antibiotics with a confirmed or suspected diagnosis of sepsis. Data on clinical parameters was used to classify women according to mSIRS, qSOFA and MEWS as having sepsis or not and this was compared to results of positive culture to obtain sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and area under Receiver Operating Characteristic curve (AUROC) along with their 95% confidence intervals. Data was also obtained on SSCB compliance.ResultsA total of 89 women were diagnosed with sepsis, of which 14 had missing data, leaving 75 for final analysis. Sensitivity, specificity, PPV, NPV and AUROC of mSIRS and MEWS were almost similar with AUROC of both being around 50%. Only 33 (37.1%) had identifiable sepsis six sticker displayed on medical notes and only 2 (2.2%) had all elements of SSCB delivered within the recommended one-hour post-diagnosis period. Blood culture and full blood count with other lab tests had been performed for most women (97%) followed by intravenous antibiotics and fluids (93.9%).ConclusionsmSIRS and MEWS were quite similar in detecting sepsis when compared to positive culture, with their ability to detect sepsis being close to chance. This underlines the need for creating a valid SSS with high sensitivity and specificity for clinical use in obstetric settings. Clinical use of SSCB was limited despite it being a health board policy, although there is considerable possibility of improvement following detailed audits and removal of barriers for implementing SSCB.

Project description:BackgroundNeonatal mortality remains unacceptably high. Many studies successful at reducing neonatal mortality have failed to realise similar gains at scale. Effective implementation and scale-up of interventions designed to tackle neonatal mortality is a global health priority. Multifaceted programmes targeting the continuum of neonatal care, with sustainability and scalability built into the design, can provide practical insights to solve this challenge. Cambodia has amongst the highest neonatal mortality rates in South-East Asia, with rural areas particularly affected. The primary objective of this study is the design, implementation, and assessment of the Saving Babies' Lives programme, a package of interventions designed to reduce neonatal mortality in rural Cambodia.MethodsThis study is a five-year stepped-wedge cluster-randomised trial conducted in a rural Cambodian province with an estimated annual delivery rate of 6615. The study is designed to implement and evaluate the Saving Babies' Lives programme, which is the intervention. The Saving Babies' Lives programme is an iterative package of neonatal interventions spanning the continuum of care and integrating into the existing health system. The Saving Babies' Lives programme comprises two major components: participatory learning and action with community health workers, and capacity building of primary care facilities involving facility-based mentorship. Standard government service continues in control arms. Data collection covering the whole study area includes surveillance of all pregnancies, verbal and social autopsies, and quality of care surveys. Mixed methods data collection supports iteration of the complex intervention, and facilitates impact, outcome, process and economic evaluation.DiscussionOur study uses a robust study design to evaluate and develop a holistic, innovative, contextually relevant and sustainable programme that can be scaled-up to reduce neonatal mortality.Trial registrationClinicalTrials.gov: NCT04663620 . Registered on 11th December 2020, retrospectively registered.

Project description:OBJECTIVE:To report perception of fetal movements in women who experienced a stillbirth compared with controls at a similar gestation with a live birth. DESIGN:Case-control study. SETTING:41 maternity units in the UK. PARTICIPANTS:Cases were women who had a late stillbirth ?28 weeks gestation (n=291) and controls were women with an ongoing pregnancy at the time of the interview (n=733). Controls were frequency matched to cases by obstetric unit and gestational age. METHODS:Data were collected using an interviewer-administered questionnaire which included questions on maternal perception of fetal movement (frequency, strength, increased and decreased movements and hiccups) in the 2?weeks before the interview/stillbirth. Five fetal movement patterns were identified incorporating the changes in strength and frequency in the last 2?weeks by combining groups of similar pattern and risk. Multivariable analysis adjusted for known confounders. PRIMARY OUTCOME MEASURE:Association of maternally perceived fetal movements in relation to late stillbirth. RESULTS:In multivariable analyses, women who reported increased strength of movements in the last 2?weeks had decreased risk of late stillbirth compared with those whose movements were unchanged (adjusted OR (aOR) 0.18, 95%?CI 0.13 to 0.26). Women with decreased frequency (without increase in strength) of fetal movements were at increased risk (aOR 4.51, 95%?CI 2.38 to 8.55). Daily perception of fetal hiccups was protective (aOR 0.31, 95%?CI 0.17 to 0.56). CONCLUSIONS:Increased strength of fetal movements and fetal hiccups is associated with decreased risk of stillbirth. Alterations in frequency of fetal movements are important in identifying pregnancies at increased risk of stillbirth, with the greatest risk in women noting a reduction in fetal activity. Clinical guidance should be updated to reflect that increase in strength and frequency of fetal movements is associated with the lowest risk of stillbirth, and that decreased fetal movements are associated with stillbirth. TRIAL REGISTRATION NUMBER:NCT02025530.

Project description:The worldwide burden of stillbirths is large, with an estimated 2.6 million babies stillborn in 2015 including 1.3 million dying during labour. The Every Newborn Action Plan set a stillbirth target of ?12 per 1000 in all countries by 2030. Planning tools will be essential as countries set policy and plan investment to scale up interventions to meet this target. This paper summarises the approach taken for modelling the impact of scaling-up health interventions on stillbirths in the Lives Saved tool (LiST), and potential future refinements.The specific application to stillbirths of the general method for modelling the impact of interventions in LiST is described. The evidence for the effectiveness of potential interventions to reduce stillbirths are reviewed and the assumptions of the affected fraction of stillbirths who could potentially benefit from these interventions are presented. The current assumptions and their effects on stillbirth reduction are described and potential future improvements discussed.High quality evidence are not available for all parameters in the LiST stillbirth model. Cause-specific mortality data is not available for stillbirths, therefore stillbirths are modelled in LiST using an attributable fraction approach by timing of stillbirths (antepartum/ intrapartum). Of 35 potential interventions to reduce stillbirths identified, eight interventions are currently modelled in LiST. These include childbirth care, induction for prolonged pregnancy, multiple micronutrient and balanced energy supplementation, malaria prevention and detection and management of hypertensive disorders of pregnancy, diabetes and syphilis. For three of the interventions, childbirth care, detection and management of hypertensive disorders of pregnancy, and diabetes the estimate of effectiveness is based on expert opinion through a Delphi process. Only for malaria is coverage information available, with coverage estimated using expert opinion for all other interventions. Going forward, potential improvements identified include improving of effectiveness and coverage estimates for included interventions and addition of further interventions.Known effective interventions have the potential to reduce stillbirths and can be modelled using the LiST tool. Data for stillbirths are improving. Going forward the LiST tool should seek, where possible, to incorporate these improving data, and to continually be refined to provide an increasingly reliable tool for policy and programming purposes.

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Assessment of the quality, content and perceived utility of local maternity guidelines in hospitals in England implementing the saving babies' lives care bundle to reduce stillbirth.

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Assessment of the quality, content and perceived utility of local maternity guidelines in hospitals in England implementing the saving babies' lives care bundle to reduce stillbirth.

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