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Objectives: In October 2020, rapid prenatal exome sequencing (pES) was introduced into routine National Health Service (NHS) care in England. This study aimed to explore parent experiences and their information and support needs from the perspective of parents offered pES and of health professionals involved in its delivery., Methods: In this qualitative study, semi-structured interviews were conducted with 42 women and 6 male partners and 63 fetal medicine and genetic health professionals. Interviews were transcribed verbatim and analysed using thematic analysis., Results: Overall views about pES were positive and parents were grateful to be offered the test. Highlighted benefits of pES included the value of the additional information for pregnancy management and planning for future pregnancies. An anxious wait for results was common, often associated with the need to make decisions near to 24 weeks in pregnancy when there are legal restrictions for late termination. Descriptions of dealing with uncertainty were also common, even when results had been returned. Many parents described pES results as informing decision-making around whether or not to terminate pregnancy. Some professionals were concerned that a non-informative result could be overly reassuring and highlighted that careful counselling was needed to ensure parents have a good understanding of what the result means for their pregnancy. Emotional support from professionals was valued; however, some parents felt that post-test support was lacking., Conclusion: Parents and professionals welcomed the introduction of pES. Results inform parents' decision-making around the termination of pregnancy. When there are no diagnostic findings or uncertain findings from pES, personalised counselling that considers scans and other tests are crucial. Directing parents to reliable online sources of information and providing emotional support throughout could improve their experiences of care., (© 2024 The Authors. Prenatal Diagnosis published by John Wiley & Sons Ltd.)

Background: Health-care organisations in England that are rated as inadequate for leadership and one other domain enter the Special Measures for Quality regime to receive support and oversight. A 'watch list' of challenged providers that are at risk of entering Special Measures for Quality also receive support. Knowledge is limited about whether or not the support interventions drive improvements in quality, the costs of the support interventions and whether or not the support interventions strike the right balance between support and scrutiny., Objective: To analyse the responses of trusts to the implementation of (1) interventions for Special Measures for Quality trusts and (2) interventions for challenged provider trusts to determine their impact on these organisations' capacity to achieve and sustain quality improvements., Design: This was rapid research comprising five interrelated workstreams: (1) a literature review using systematic methods; (2) an analysis of policy documents and interviews at the national level; (3) eight multisite, mixed-methods trust case studies; (4) an analysis of national performance and workforce indicators; and (5) an economic analysis., Results: The Special Measures for Quality/challenged provider regimes were intended to be 'support' programmes. Special Measures for Quality/challenged provider regimes had an emotional impact on staff. Perceptions of NHS Improvement interventions were mixed overall. Senior leadership teams were a key driver of change, with strong clinical input being vital. Local systems have a role in improvement. Trusts focus efforts to improve across multiple domains. Internal and external factors contribute to positive performance trajectories. Nationally, only 15.8% of Special Measures for Quality trusts exited the regime in 24 months. Entry into Special Measures for Quality/challenged provider regimes resulted in changes in quality indicators (such the number of patients waiting in emergency departments for more than 4 hours, mortality and the number of delayed transfers of care) that were more positive than national trends. The trends in staff sickness and absence improved after trusts left Special Measures for Quality/challenged provider regimes. There was some evidence that staff survey results improved. No association was found between Special Measures for Quality/challenged provider regimes and referral to treatment times or cancer treatment waiting times. NHS Improvement spending in case study trusts was mostly directed at interventions addressing 'training on cultural change' (33.6%), 'workforce quality and safety' (21.7%) and 'governance and assurance' (18.4%). The impact of Special Measures for Quality on financial stability was equivocal; most trusts exiting Special Measures for Quality experienced the same financial stability before and after exiting., Limitations: The rapid research design and 1-year time frame precludes longitudinal observations of trusts and local systems. The small number of indicators limited the quantitative analysis of impact. Measurement of workforce effects was limited by data availability., Conclusions: Empirical evidence of positive impacts of Special Measures for Quality/challenged provider regimes were identified; however, perceptions were mixed. Key lessons were that (1) time is needed to implement and embed changes; (2) ways to mitigate emotional costs and stigma are needed; (3) support strategies should be more trust specific; (4) poor organisational performance needs to be addressed within local systems; (5) senior leadership teams with stability, strong clinical input and previous Special Measures for Quality experience helped to enact change; (6) organisation-wide quality improvement strategies and capabilities are needed; (7) staff engagement and an open-listening culture promote continuous learning and a quality improvement 'mindset', which is critical for sustainable improvement; and (8) consideration of the level of sustainable funds required to improve patients' outcomes is needed., Future Work: Future work could include evaluating recent changes to the regimes, the role of local systems and longitudinal approaches., Study Registration: The review protocol is registered with PROSPERO (CRD42019131024)., Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research ; Vol. 11, No. 19. See the NIHR Journals Library website for further project information.

Background: There is limited knowledge about interventions used for the improvement of low-performing healthcare organisations and their unintended consequences. Our evaluation sought to understand how healthcare organisations in the National Health Service (NHS) in England responded to a national improvement initiative (the Special Measures for Quality [SMQ] and challenged provider [CP] regimes) and its perceived impact on achieving quality improvements (QIs)., Methods: Our evaluation included national-level interviews with key stakeholders involved in the delivery of SMQ (n=6); documentary analysis (n=20); and a qualitative study based on interviews (n=60), observations (n=8) and documentary analysis (n=291) in eight NHS case study sites. The analysis was informed by literature on failure, turnaround and QI in organisations in the public sector., Results: At the policy level, SMQ/CP regimes were intended to be "support" programmes, but perceptions of the interventions at hospital level were mixed. The SMQ/CP regimes tended to consider failure at an organisational level and turnaround was visualised as a linear process. There was a negative emotional impact reported by staff, especially in the short-term. Key drivers of change included: engaged senior leadership teams, strong clinical input and supportive external partnerships within local health systems. Trusts focused efforts to improve across multiple domains with particular investment in improving overall staff engagement, developing an open, listening organisational culture and better governance to ensure clinical safety and reporting., Conclusion: Organisational improvement in healthcare requires substantial time to embed and requires investment in staff to drive change and cultivate QI capabilities at different tiers. The time this takes may be underestimated by external 'turn-around' interventions and performance regimes designed to improve quality in the short-term and which come at an emotional cost for staff. Shifting an improvement focus to the health system or regional level may promote sustainable improvement across multiple organisations over the long-term., (© 2022 The Author(s); Published by Kerman University of Medical Sciences This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.)

Background: Healthcare organisations in England rated as inadequate in terms of leadership and one other domain enter the Special Measures for Quality (SMQ) regime to receive increased support and oversight. There is also a 'watch list' of challenged National Health Service (NHS) providers at risk of going into SMQ that receive support. There is limited knowledge about whether the interventions used to deliver this support drive improvements in quality, their costs, and whether they strike the right balance between support and scrutiny. The study will seek to determine how provider organisations respond to these interventions, and whether and how these interventions impact organisations' capacity to achieve and sustain quality improvements over time., Methods: This is a multi-site, mixed methods study. We will carry out interviews at national level to understand the programme theory underpinning the interventions. We will conduct 8 NHS case studies to explore the impact and implementation of the interventions that form part of the SMQ and challenged providers programme. We will use a conceptual framework based on models of organisational readiness for change and draw on board maturity research for implementing quality improvement. We will also review the use of quantitative metrics and data for tracking the progress of improvements in quality of care and sustainability upon leaving SMQ, as well as the costs and benefits of the interventions through a cost-consequence analysis (CCA)., Discussion: High-quality interventions that successfully support struggling healthcare organisations are essential and an issue that is an international concern. Our study will allow a greater understanding of the programme theory, impact, and staff views and experiences of the SMQ and challenged providers regime. Formative feedback will be reported to key stakeholders., (© 2020 The Author(s); Published by Kerman University of Medical Sciences. This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/ licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.)

Background: Non-invasive prenatal testing (NIPT) for aneuploidies is now available through commercial companies in many countries, including through private practice in the United Kingdom (UK). Thorough evaluation of service delivery requirements are needed to facilitate NIPT being offered more widely within state funded healthcare systems such as the UK's National Health Service (NHS). Successful implementation will require the development of laboratory standards, consideration of stakeholder views, an analysis of costs and development of patient and health professional educational materials., Methods/design: NIPT will be offered in an NHS setting as a contingent screening test. Pregnant woman will be recruited through six maternity units in England and Scotland. Women eligible for Down's syndrome screening (DSS) will be informed about the study at the time of booking. Women that choose routine DSS will be offered NIPT if they have a screening risk ≥ 1:1000. NIPT results for trisomy 21, 18, 13 will be reported within 7-10 working days. Data on DSS, NIPT and invasive testing uptake, pregnancy outcomes and test efficacy will be collected. Additional data will be gathered though questionnaires to a) determine acceptability to patients and health professionals, b) evaluate patient and health professional education, c) assess informed choice in women accepting or declining testing and d) gauge family expenses. Qualitative interviews will also be conducted with a sub-set of participating women and health professionals., Discussion: The results of this study will make a significant contribution to policy decisions around the implementation of NIPT for aneuploidies within the UK NHS. The laboratory standards for testing and reporting, education materials and counselling strategies developed as part of the study are likely to underpin the introduction of NIPT into NHS practice., Nihr Portfolio Number: 13865.

Purpose: To compare the preferences of women and health professionals for key attributes of noninvasive prenatal diagnosis for Down syndrome relative to current invasive tests., Methods: A questionnaire incorporating a discrete choice experiment was used to obtain participants' stated preference for diagnostic tests that varied according to four attributes: accuracy, time of test, risk of miscarriage, and provision of information about Down syndrome only or Down syndrome and other conditions. Women and health professionals were recruited from five maternity services in England and a patient support group., Results: Questionnaires from 335 women and 181 health professionals were analyzed. Safe tests, conducted early in pregnancy, with high accuracy and information about Down syndrome and other conditions were preferred. The key attribute affecting women's preferences for testing was no risk of miscarriage, whereas for health professionals it was accuracy., Conclusions: Policies for implementing noninvasive prenatal diagnosis must consider the differences between women's and health professionals' preferences to ensure the needs of all stakeholders are met. Women's strong preference for tests with no risk of miscarriage demonstrates that consideration for safety of the fetus is paramount in decision making. Effective pretest counseling is therefore essential to ensure women understand the possible implications of results.

Objectives: Fetal sex determination is performed for women who carry X-linked conditions, for example Duchenne muscular dystrophy (DMD), or those associated with ambiguous genitalia, for example congenital adrenal hyperplasia (CAH). Non-invasive prenatal diagnosis (NIPD) using cell-free fetal DNA (cffDNA) in maternal plasma is an alternative to invasive prenatal diagnosis (IPD), which carries a 1% risk of miscarriage. This study aimed to evaluate the incremental cost of NIPD compared with IPD of fetal sex., Methods: Diagnostic accuracy, invasive testing rate, and pregnancy outcome following NIPD were ascertained from an audit of all cases referred to two laboratories in 2006 to 2009. Care pathways for DMD and CAH were established and key cost drivers for IPD and NIPD identified using costs derived from published estimates and local laboratory values., Results: The differences in mean costs per pregnancy for NIPD versus IPD were small for DMD [mean difference - £87, 95% confidence interval (CI) - £303 to £131] and CAH (-£193, 95% CI - £301 to - £84). Testing costs associated with NIPD were offset by fewer women requiring invasive testing., Conclusions: The costs of NIPD and IPD of fetal sex are similar. NIPD can provide benefits for many women by avoiding the risks of invasive testing, without incurring additional costs., (Copyright © 2011 John Wiley & Sons, Ltd.)