Search

Background and objective: Radical prostatectomy (RP) is an established treatment for localised prostate cancer that can have a significant impact on urinary and sexual function, with recovery over time. Our aim was to describe functional recovery in the first year after RP, reporting descriptive outcomes alongside validated patient-reported outcome measure scores (Expanded Prostate Cancer Index Composite, EPIC-26). Methods: Men undergoing RP between September 2015 and November 2019 completed EPIC-26 at baseline and 1, 3, 6, and 12 mo. Key findings and limitations: Overall, 2030 men consented to participation, underwent RP, and completed EPIC-26. At baseline, 97% were pad-free (1928/1996; 95% confidence interval [CI] 96–97%) and 77% were leak-free and pad-free (1529/1996; 95% CI 75–78), with a median EPIC-26 incontinence domain score of 100 (interquartile range [IQR] 86–100). At 12 mo, 65% were pad-free (904/1388; 95% CI 63–68%) and 42% were leak-free and pad-free (583/1388; 95% CI 39–45%), with a median EPIC-26 score of 76 (IQR 61–100). While one in three men reported wearing a pad at 12 mo, fewer than one in ten men needed more than 1 pad/d. At baseline, 1.9% reported a “moderate or big problem” with urine leakage, which increased to 9.7% at 12 mo. At baseline, the median sexual domain score among 1880 men was 74 (IQR 43–92) and 52% had erections sufficient for intercourse without medication (975/1880; 95% CI 50–54%). Among these 975 men, 630 responded at 12 mo, of whom 17% reported sufficient erections for intercourse (105/630; 95% CI 14–20%), without medication in 6% (37/630; 95% CI 4–8%) and needing medication in 11% (68/630; 95% CI 9–13%); the median EPIC-26 domain score was 26 (IQR 13–57). Conclusions and clinical implications: Reporting of functional outcomes after RP in terms of easily understood concepts such as pad-free and leak-free status, and erections with and with medication, alongside the classical report using EPIC-26 domain scores, increases the understanding of RP recovery patterns over the first year. Patient summary: At 12 months after surgery for prostate cancer, one in ten men reported a moderate or big problem with urine leakage and one in five men reported sufficient erections.

Abstract Background The National Health Service in England pledged >£365 million to improve access to mental healthcare services via Community Perinatal Mental Health Teams (CPMHTs) and reduce the rate of perinatal relapse in women with severe mental illness. This study aimed to explore changes in service use patterns following the implementation of CPMHTs in pregnant women with a history of specialist mental healthcare in England, and conduct a cost-analysis on these changes. Methods This study used a longitudinal cohort design based on existing routine administrative data. The study population was all women residing in England with an onset of pregnancy on or after 1st April 2016 and who gave birth on or before 31st March 2018 with pre-existing mental illness (N = 70,323). Resource use and costs were compared before and after the implementation of CPMHTs. The economic perspective was limited to secondary mental health services, and the time horizon was the perinatal period (from the start of pregnancy to 1-year post-birth, ~ 21 months). Results The percentage of women using community mental healthcare services over the perinatal period was higher for areas with CPMHTs (30.96%, n=9,653) compared to areas without CPMHTs (24.72%, n=9,615). The overall percentage of women using acute care services (inpatient and crisis resolution teams) over the perinatal period was lower for areas with CPMHTs (4.94%, n=1,540 vs. 5.58%, n=2,171), comprising reduced crisis resolution team contacts (4.41%, n=1,375 vs. 5.23%, n=2,035) but increased psychiatric admissions (1.43%, n=445 vs. 1.13%, n=441). Total mental healthcare costs over the perinatal period were significantly higher for areas with CPMHTs (fully adjusted incremental cost £111, 95% CI £29 to £192, p-value 0.008). Conclusions Following implementation of CPMHTs, the percentage of women using acute care decreased while the percentage of women using community care increased. However, the greater use of inpatient admissions alongside greater use of community care resulted in a significantly higher mean cost of secondary mental health service use for women in the CPMHT group compared with no CPMHT. Increased costs must be considered with caution as no data was available on relevant outcomes such as quality of life or satisfaction with services.

Background/objectives The Family Nurse Partnership is an intensive home visiting programme for adolescent mothers. We aimed to evaluate the effectiveness of the Family Nurse Partnership on outcomes up to age 7 using national administrative data. Design We created a linked cohort of all mothers aged 13–19 using data from health, educational and children’s social care and defined mothers enrolled in the Family Nurse Partnership or not using Family Nurse Partnership system data. Propensity scores were used to create matched groups for analysis. Setting One hundred and thirty-six local authorities in England with active Family Nurse Partnership sites between 2010 and 2017. Participants Mothers aged 13–19 at last menstrual period with live births between April 2010 and March 2019, living in a Family Nurse Partnership catchment area and their firstborn child(ren). Interventions The Family Nurse Partnership includes up to 64 home visits by a family nurse from early pregnancy until the child’s second birthday and is combined with usual health and social care. Controls received usual health and social care. Main outcome measures Indicators of child maltreatment (hospital admissions for injury/maltreatment, referral to social care services); child health and development (hospital utilisation and education) outcomes and maternal hospital utilisation and educational outcomes up to 7 years following birth. Data sources Family Nurse Partnership Information System, Hospital Episode Statistics, National Pupil Database. Results Of 110,520 eligible mothers, 25,680 (23.2%) were enrolled in the Family Nurse Partnership. Enrolment rates varied across 122 sites (range: 11–68%). Areas with more eligible mothers had lower enrolment rates. Enrolment was higher among mothers aged 13–15 (52%), than 18–19 year-olds (21%). Indicators of child maltreatment: we found no evidence of an association between the Family Nurse Partnership and indicators of child maltreatment, except for an increased rate of unplanned admissions for maltreatment/injury-related diagnoses up to age 2 for children born to Family Nurse Partnership mothers (6.6% vs. 5.7%, relative risk 1.15; 95% confidence interval 1.07 to 1.24). Child health and developmental outcomes: there was weak evidence that children born to Family Nurse Partnership mothers were more likely to achieve a Good Level of Development at age 5 (57.5% vs. 55.4%, relative risk 1.05; 95% confidence interval 1.00 to 1.09). Maternal outcomes: There was some evidence that Family Nurse Partnership mothers were less likely to have a subsequent delivery within 18 months of the index birth (8.4% vs. 9.3%, relative risk 0.92; 95% confidence interval 0.88 to 0.97). Younger and more vulnerable mothers received higher numbers of visits and were more likely to achieve fidelity targets. Meeting the fidelity targets was associated with some outcomes. Limitations Bias by indication and variation in the intervention and usual care over time and between areas may have limited our ability to detect effects. Multiple testing may have led to spurious, significant results. Conclusions This study supports findings from evaluations of the Family Nurse Partnership showing no evidence of benefit for maltreatment outcomes measured in administrative data. Amongst all the outcomes measured, we found weak evidence that the Family Nurse Partnership was associated with improvements in child development at school entry, a reduction in rapid repeat pregnancies and evidence of increased healthcare-seeking in the mother and child. Future work Future evaluations should capture better measures of Family Nurse Partnership interventions and usual care, more information on maternal risk factors and additional outcomes relating to maternal well-being. Study registration The study is registered as NIHR CRN Portfolio (42900). Funding This award was funded by the National Institute of Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 17/99/19) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 11. See the NIHR Funding and Awards website for further award information. Plain language summary The Family Nurse Partnership is an intensive home visiting service that offers first-time young mothers up to 64 visits with a family nurse from pregnancy to their child’s second birthday. The Family Nurse Partnership aims to improve birth outcomes, child health and development and promote economic self-sufficiency among young mothers. Previous research in England found no differences in birthweight, maternal smoking, repeat pregnancies or accident and emergency attendances between mothers who did or did not take part in the Family Nurse Partnership. However, children in the Family Nurse Partnership group had better measures of development at school age. We aimed to add to the evidence from earlier studies, by using electronic records that are routinely collected as part of health, education and social care services, to compare outcomes for around 26,000 mothers enrolled in the Family Nurse Partnership between 2010 and 2019 with similar mothers who were not enrolled. This study showed that around one in four mothers who were eligible for the programme were enrolled in the Family Nurse Partnership, and family nurses gave priority to mothers who were younger, more deprived or who had other markers of vulnerability (e.g. a history of substance misuse violence, self-harm or mental health conditions). We found no evidence of a difference in indicators of child maltreatment between mothers who were enrolled in the Family Nurse Partnership and those who were not enrolled, but we found weak evidence to suggest that children born to mothers enrolled in the Family Nurse Partnership were more likely to achieve a Good Level of Development at school entry (age 5). We also saw that mothers enrolled in the Family Nurse Partnership were less likely than those who were not enrolled to have their next child within 18 months of their first child. More research is needed to understand which elements of intensive home visiting services work best, for whom and when. This will help inform decisions about whether it is better to offer highly intensive services for a small portion of the target population or to extend and enhance existing universal health visiting services to better support all adolescent mothers. Scientific summary Background The Family Nurse Partnership (FNP) is an intensive home visiting programme supporting young first-time mothers, which has a strong evidence base from several randomised trials in the USA. Mothers enrolled in the FNP receive up to 64 home visits by a dedicated family nurse, from early pregnancy until the child’s second birthday. The FNP aims to improve birth outcomes, child health and development and promote economic self-sufficiency among young mothers. Although a randomised trial of the FNP in England found no evidence of benefit on smoking in pregnancy, birthweight, hospital admissions before age 2 or second pregnancy within 2 years, improved cognitive development outcomes were reported, and there remains strong support for the programme locally. Our population-based study used longitudinal linked observational data between the health, education and social care sectors to evaluate the effects of FNP on outcomes of eligible mothers and their children up to age 7 and generated evidence on the factors that may influence effectiveness and programme engagement (including participant and programme characteristics). We aimed to generate evidence on which groups of mothers and children benefit from the real-world implementation of FNP in England in order to inform the targeting and commissioning of services. Objectives Determine the rate of and characteristics associated with enrolment in FNP among young mothers across local authorities in England. Determine the effect of FNP on maternal and child outcomes, including identifying which families benefit the most from FNP. Identify contextual and programme factors that might influence the effect of FNP. Methods We created a linked cohort of all mothers aged 13–19 using data from health, educational and children’s social care and defined mothers enrolled in FNP or not using FNP system data. Propensity scores based on pre-enrolment maternal characteristics were used to create matched groups for analysis. Setting One hundred and thirty-six local authorities in England with active FNP sites between 2010 and 2019. Participants Mothers aged 13–19 at last menstrual period with their first live birth between April 2010 and March 2019, living in a FNP catchment area and their firstborn child(ren). Interventions The FNP includes up to 64 home visits by a family nurse from early pregnancy until the child’s second birthday and is combined with usual health and social care. Controls received usual health and social care alone. Main outcome measures Indicators of child maltreatment (hospital admissions for injury/maltreatment, referral to social care services); child health and development (hospital utilisation and education) outcomes and maternal hospital utilisation and educational outcomes up to 7 years following birth. Data sources Family Nurse Partnership Information System data on programme participation linked with hospital admissions, outpatient referrals/attendances and accident and emergency (A&E) attendances from Hospital Episode Statistics and information on pupils attending state schools or children in contact with social care services in England from the National Pupil Database. Results Objective 1 Of 110,520 eligible mothers aged 13–19 years who gave birth between April 2010 and March 2017, 25,680 (23.2%) were enrolled in FNP: 14% were aged 13–15 years. Enrolment rates varied across 122 sites (range: 11–68%). Areas with more eligible mothers had lower enrolment rates. Enrolment was higher among mothers aged 13–15 (52%) than 18-19 year-olds (21%). Only 26% of mothers with markers of vulnerability (including living in the most deprived area decile or previous mental health-related hospitalisations) were enrolled. Objective 2 Indicators of child maltreatment: we found no evidence of an association between FNP and indicators of child maltreatment, except for an increased rate of unplanned admissions for maltreatment/injury-related diagnoses up to age 2 for children born to mothers enrolled in FNP [6.6% vs. 5.7%, relative risk (RR) 1.15; 95% confidence interval (CI) 1.07 to 1.24] and weak evidence of a reduction in the percentage of children with a child protection plan for those born to mothers enrolled in FNP (5.1% vs. 6.1%, RR 0.84; 95% CI 0.71 to 1.00). Child health and developmental outcomes: FNP was associated with an increase in the number of children with ≥ 1 unplanned admission for any diagnosis up to age 2 and the number of children with ≥ 1 A&E attendance by age 2 and age 7. There was weak evidence that children born to FNP mothers were more likely to achieve a Good Level of Development (school readiness) at age 5 (57.5% vs. 55.4%, RR 1.05; 95% CI 1.00 to 1.09). There was no evidence of a difference between groups in Special Educational Needs provision or attainment at Key Stage 1, but FNP was associated with an increase in the percentage of children registered for Free School Meals (51.2% vs. 46.7%, RR 1.09; 95% CI 1.04 to 1.14). Maternal outcomes Mothers enrolled in FNP were more likely to have unplanned hospital admissions for any diagnosis (and for adversity and mental health diagnoses) in the 2 years following birth, compared with mothers who were not enrolled. This effect persisted until 7 years following birth, though the size of the effect decreased over time. Mothers enrolled in FNP were less likely to have a subsequent delivery within 18 months of the index birth (8.4% vs. 9.3%, RR 0.92; 95% CI 0.88 to 0.97) compared to those who were not enrolled. Objective 3 Fifty-eight per cent of mothers enrolled in FNP completed the programme (42% left early). Attrition was 8% during pregnancy, 23% in infancy (between birth and 1 year) and 19% in toddlerhood (between 1 and 2 years). Mothers received on average 38 visits and 42 hours of contact time with family nurses during the programme. Younger and more vulnerable mothers received higher numbers of visits and were more likely to achieve fidelity targets for the expected number of visits at each stage of the programme. After adjusting for these characteristics, mothers who met the target for the number of expected visits in pregnancy were less likely to have a subsequent birth within 18 months than those who did not meet the target; children born to mothers who met the target in infancy and toddlerhood were more likely to have an unplanned hospital admission for maltreatment/injury up to age 2 than those who did not meet the targets in these stages. Conclusions Our findings support previous evaluations of FNP in England, which show no evidence of an impact on child maltreatment outcomes but some weak evidence that FNP is associated with improvements in some child development measures. Limitations Mothers enrolled in FNP were more vulnerable than those who were not, but we could only control for maternal characteristics associated with enrolment that were captured in administrative data. Residual confounding could have limited our ability to detect beneficial effects of the programme. The weak evidence for small improvements in school readiness as measured by a Good Level of Development, and reductions in the number of rapid repeat pregnancies may therefore reflect larger positive effects of the programme. As these outcomes were the only ‘positive’ effects amongst the many outcomes that were evaluated, they could be due to chance. There are challenges in interpreting outcomes captured in administrative data: the increased rates of unplanned admissions and A&E attendances in the mother and child associated with FNP may reflect higher rates of health problems or appropriate care seeking when a health problem such as injury occurs as a result of advice and support from family nurses. This finding could therefore be interpreted as demonstrating that family nurses can have a long-term effect on maternal health care-seeking behaviours. This study was not designed to identify effects on a range of other important outcomes, including changes in self-reported maternal mental health, well-being, confidence, behaviour and mother/parent–child engagement and interaction. Implications Despite reductions in teenage pregnancies over recent decades, there remains a significant population of young and vulnerable mothers in England who need intensive support. Currently, the majority of these mothers are not receiving support from FNP, as it is not offered in all areas and is only offered to around one in four mothers in areas in which it is commissioned. Expecting to detect effects of home visiting that starts in pregnancy on birth outcomes and on relatively insensitive child development measures and other child outcomes may be unreasonable in the context of social disadvantage, discrimination and other challenges that adolescent mothers face before, during and after pregnancy. However, there is strong support for FNP locally, and FNP practitioners report that mothers participating in the programme develop more reflective parenting and awareness of their child’s needs. Without better evidence, removing support for young mothers could be harmful, especially in the context of increasing social disadvantage and widespread health visitor shortages. There remains uncertainty about whether it is better to commission highly intensive services like the FNP versus enhanced universal services. Recommendations for research More research is needed to understand which elements of intensive interventions are most effective, for whom and when and to help inform decisions about whether it is better to commission highly intensive services for a small portion of the target population or to extend and enhance universal services to better support all adolescent mothers. More research is needed to understand the effects of the programme on mothers who are not enrolled in FNP: we do not yet know if FNP diverts resources away from the usual care that an adolescent mother should receive or if FNP has a positive effect on mothers not enrolled in the programme through shared learning and practices. Robust evaluation is needed of modifications to FNP, including changes in the Accelerated Design and Programme Testing sites, outcomes for mothers aged 20–24 years, outcomes for fathers and outcomes for subsequent children. Better measures of changes in maternally reported well-being, confidence, mental health, parent–child interaction and child behaviour would improve evidence on whether the programme affects mothers and their children and how. Study registration The study is registered as NIHR CRN Portfolio (42900). Funding This award was funded by the National Institute of Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 17/99/19) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 11. See the NIHR Funding and Awards website for further award information.

Background We evaluated the effectiveness of the Family Nurse Partnership (FNP), an intensive home visiting programme aiming to improve birth outcomes, child health and development, and to promote economic self-sufficiency among teenage mothers.Methods We created a linked cohort of >130 000 mothers aged 13–19 years with live births between April 2010 and March 2019, using administrative data from health (Hospital Episode Statistics), education and children’s social care (National Pupil Database). Using propensity score matching, we compared indicators of child maltreatment, health and development outcomes, and maternal hospital utilisation and educational outcomes up to 7 years following birth for mothers who did or did not enrol in FNP.Results We found no evidence of an association between FNP and indicators of child maltreatment, except for an increased rate of unplanned admissions for maltreatment/injury-related diagnoses up to age 2 years for children born to FNP mothers (6.6% vs 5.7%, relative risk (RR) 1.15; 95% CI 1.07, 1.24). There was weak evidence that children born to FNP mothers were more likely to achieve a good level of development at age 5 years (57.5% vs 55.4%, RR 1.05; 95% CI 1.00, 1.09). FNP mothers were less likely to have a subsequent delivery within 18 months of the index birth (8.4% vs 9.3%, RR 0.92; 95% CI 0.88, 0.97).Conclusion Our study supports findings from previous evaluations of FNP showing no evidence of benefit for child maltreatment or health outcomes measured in administrative data. Bias by indication, and variation in the intervention and usual care, may have limited our ability to detect effects. Future evaluations should capture more information on maternal risk factors and additional outcomes relating to maternal/child well-being.

Objectives A national survey aimed to measure how men with prostate cancer perceived their involvement in and decisions around their care immediately after diagnosis. This study aimed to describe any differences found by socio-demographic groups.Design Cross-sectional study of men who were diagnosed with and treated for prostate cancer.Setting The National Prostate Cancer Audit patient-reported experience measures (PREMs) survey in England.Participants Men diagnosed in 2014–2016, with non-metastatic prostate cancer, were surveyed. Responses from 32 796 men were individually linked to records from a national clinical audit and to administrative hospital data. Age, ethnicity, deprivation and disease risk classification were used to explore variation in responses to selected questions.Primary and secondary outcome measures Responses to five questions from the PREMs survey: the proportion responding to the highest positive category was compared across the socio-demographic characteristics above.Results When adjusted for other factors, older men were less likely than men under the age of 60 to feel side effects had been explained in a way they could understand (men 80+: relative risk (RR)=0.92, 95% CI 0.84 to 1.00), that their views were considered (RR=0.79, 95% CI 0.73 to 0.87) or that they were involved in decisions (RR=0.92, 95% CI 0.85 to 1.00). The latter was also apparent for men who were not white (black men: RR=0.89, 95% CI 0.82 to 0.98; Asian men: RR=0.85, 95% CI 0.75 to 0.96) and, to a lesser extent, for more deprived men.Conclusions The observed discrepancies highlight the need for more focus on initiatives to improve the experience of ethnic minority patients and those older than 60 years. The findings also argue for further validation of discriminatory instruments to help cancer care providers fully understand the variation in the experience of their patients.

Objectives We assessed how often National Health Service (NHS) hospitals reported that they had specific supportive services for patients with prostate cancer available onsite, including nursing support, sexual function and urinary continence services, psychological and genetic counselling, and oncogeriatric services. We identified groups of hospitals with similar patterns of supportive services.Design/setting We conducted an organisational survey in 2021 of all NHS hospitals providing prostate cancer services in England and Wales. Latent class analysis grouped hospitals with similar patterns of supportive services.Results In 138 hospitals, an advanced prostate cancer nurse was available in 125 hospitals (90.6%), 107 (77.5%) had a clinical nurse specialist (CNS) attending all clinics, 103 (75.7%) had sexual function services, 111 (81.6%) had continence services and 93 (69.4%) psychological counselling. The availability of genetic counselling (41 hospitals, 30.6%) and oncogeriatric services (15 hospitals, 11.0%) was lower. The hospitals could be divided into three groups. The first and largest group of 85 hospitals provided the most comprehensive supportive services onsite: all hospitals had a CNS attending all clinics, 84 (98.8%) sexual function services and 73 (85.9%) continence services. A key characteristic of the second group of 31 hospitals was that none had a CNS attending all clinics. A key characteristic of the third group of 22 hospitals was that none had sexual function services available. The hospitals in the largest group were more likely to run joint clinics (p

Objective To quantify differences in number and timing of first primary cleft lip and palate (CLP) repair procedures during the first year of the COVID-19 pandemic (1 April 2020 to 31 March 2021; 2020/2021) compared with the preceding year (1 April 2019 to 31 March 2020; 2019/2021).Design National observational study of administrative hospital data.Setting National Health Service hospitals in England.Study population Children

Purpose There is debate about the effectiveness and toxicity of pelvic lymph node (PLN) irradiation in addition to prostate bed radiotherapy when used to treat disease recurrence following radical prostatectomy. We compared toxicity from radiation therapy (RT) to the prostate bed and pelvic lymph nodes (PBPLN-RT) with prostatebed only radiation therapy (PBO-RT) following radical prostatectomy. Methods and Materials Patients with prostate cancer who underwent post-prostatectomy RT between 2010 and 2016 were identified by using the National Prostate Cancer Audit (NPCA) database. Follow-up data was available up to December 31, 2018. Validated outcome measures, based on a framework of procedural and diagnostic codes, were used to capture ≥Grade 2 gastrointestinal (GI) and genitourinary (GU) toxicity. An adjusted competing-risks regression analysis estimated subdistribution hazard ratios (sHR). A sHR > 1 indicated a higher incidence of toxicity with PBPLN-RT than with PBO-RT. Results 5-year cumulative incidences in the PBO-RT (n = 5,087) and PBPLNRT (n = 593) groups was 18.2% and 15.9% for GI toxicity, respectively. For GU toxicity it was 19.1% and 20.7%, respectively. There was no evidence of difference in GI or GU toxicity after adjustment between PBO-RT and PBPLN-RT (GI: adjusted sHR, 0.90, 95% CI, 0.67–1.19; P = 0.45); (GU: adjusted sHR, 1.19, 95% CI, 0.99–1.44; P = 0.09). Conclusions This national population-based study found that including PLNs in the radiation field following radical prostatectomy is not associated with a significant increase in rates of ≥Grade 2 GI or GU toxicity at 5 years.

Objectives To compare two approaches for linking multiple datasets: using all "pairwise linkages", linking each dataset to every other dataset; versus linking each dataset to a designated "spine dataset", by: considering the differences between these approaches, and illustrating using real-world data on patients undergoing emergency bowel cancer surgery. Approach We linked an administrative hospital dataset (Hospital Episode Statistics; HES) capturing patients admitted to hospitals in England, and two clinical datasets comprising patients undergoing emergency bowel surgery (National Emergency Laparotomy Audit; NELA) and patients diagnosed with bowel cancer (National Bowel Cancer Audit; NBOCA), with study period from 31 October 2013 to 30 April 2018. We compared pairwise linkage to spine linkage, designating HES as the spine dataset, by considering the number of eligible patients linked by each approach, characteristics of linked patients, levels of missing data, and whether analysis results were sensitive to the approach used. Results The spine linkage approach resulted in an analysis cohort of 15,826 patients, equating to 98.3% of the 16,100 patients identified with the pairwise linkage approach. Of 274 additional patients captured in the pairwise approach, approximately two-thirds were only in the emergency surgery dataset (NELA) and one-third were only in the bowel cancer dataset (NBOCA). There were no systematic differences in patient characteristics between these analysis cohorts. Associations of patient and tumour characteristics with mortality, complications, and length of stay were not sensitive to the linkage approach. When eligibility criteria were applied before linkage, spine linkage included 14,509 patients (90.0% compared to pairwise linkage). Conclusion Spine linkage can be an efficient alternative to pairwise linkage, if case ascertainment in the spine dataset and data quality of linkage variables are high. These aspects should be systematically evaluated in the nominated spine dataset before spine linkage. Results are sensitive to order of linkage steps.

Objectives To develop a step-by-step process for probabilistic linkage of national clinical and administrative datasets without personal information, providing guidance on selecting variables for linkage, estimating match weights, and choosing the probabilistic linkage threshold. To validate this process against deterministic linkage using patient identifiers. Approach We undertook probabilistic linkage without personal information using electronic health records from the National Bowel Cancer Audit (NBOCA) and Hospital Episode Statistics (HES) databases for bowel cancer patients undergoing emergency surgery in England. We selected linkage variables based on completeness, and ability to discriminate between matches and non-matches, assessed using a novel score derived from m-probabilities and u-probabilities. Taking deterministic linkage using patient identifiers as the reference-standard, we calculated sensitivity and specificity of probabilistic linkage, plotted a Receiver Operating Characteristic curve across alternative thresholds of match weights, and compared patient characteristics and estimates from fitted regression models between linkage methods. Results When considering the ability to discriminate between matches and non-matches, patient and administrative variables tended to discriminate better than clinical variables. 81.4% of NBOCA records were linked to HES using probabilistic linkage, versus 82.8% using deterministic linkage. Most NBOCA records were linked to HES using both methods (8,427/10,566). Probabilistic linkage had over 96% sensitivity and 90% specificity compared to deterministic linkage using patient identifiers. Patients that linked deterministically, but not probabilistically, were younger and more likely to have emergency admission, but otherwise had similar characteristics. Regression models for mortality and length of hospital stay according to patient and tumour characteristics were not sensitive to the linkage approach. Conclusion Probabilistic linkage without personal information can be used as an alternative to deterministic linkage using patient identifiers, or as a method for enhancing deterministic linkage. It allows analysts outside highly secure data environments to undertake linkage while minimising costs and delays, protecting data security, and maintaining linkage quality.

Objectives We describe the challenges and lessons learned from two studies using linked administrative data from health, education and social care sectors to evaluate the Family Nurse Partnership (FNP), an intervention supporting adolescent mothers in England(E) and Scotland(S). We present recommendations for studies using linked administrative data to evaluate complex interventions. Approach We constructed two cohorts of all mothers aged 13-19 giving birth in NHS hospitals in England and Scotland between 2010-2016/17 using linkage of mothers and babies in hospital admissions data (E:Hospital Episode Statistics/S:Maternity Inpatient and Day Case), and identified FNP participation through linkage to FNP programme data. We additionally linked to health, educational and social care data for mothers and their babies (E:National Pupil Database/S:eDRIS). We used these data to identify key risk factors for enrolment in the FNP, assess the effect of the FNP on maternal and child outcomes, and determine programme characteristics modifying the effect of the FNP. Results Key challenges: characterising the intervention and usual care, understanding quality of multi-sector data linkage, data access delays, constructing appropriate comparator groups and interpreting outcomes captured in administrative data. Lessons learned: evaluations require detailed data on intervention activity (dates/geography), and assessment of usual care, which are rarely readily available and are time-consuming to gather; data linkage quality is variable/not available, making defining denominators challenging; data access delays impeded on data analysis time; unmeasured confounders not captured in administrative data may prevent generation of an appropriate comparator group. Recommendations: Characteristics informing targeting should be explicitly documented, and could be enhanced using linked primary care data and information on household members (e.g. fathers). Process evaluation and qualitative research could help to provide better understanding of mechanisms of effect. Conclusion Linkage of administrative data presents exciting opportunities for efficient evaluation of large-scale, complex public health interventions. However, sufficient information is needed on programme meta-data, targeting and important confounders in order to generate meaningful results. Study findings should help stimulate exploration with practitioners about how programmes can be improved.

Objectives The Family Nurse Partnership (FNP) is an early home visiting service supporting young mothers. A randomised controlled trial of FNP in England found no effect on short-term primary outcomes or maltreatment up to age seven, but positive impacts on educational outcomes by age 7. We report preliminary results of an evaluation of FNP using linked administrative data. Approach We constructed a cohort of all mothers aged 13-19 and their firstborn child(ren) giving birth between 2010 and 2017, using linked administrative data from hospital admissions (Hospital Episode Statistics) and education and social care (National Pupil Database). We evaluated differences in a range of policy relevant child and maternal outcomes, comparing mothers who were enrolled in FNP with those who were not using propensity score matching. Results Of 110,960 mothers in our linked cohort, 26,290 (24%) were enrolled in FNP. FNP mothers were younger, more deprived, and more likely to have adversity or social care histories than mothers not enrolled. Preliminary results suggest that FNP was not associated with fewer unplanned hospital admissions for injury / maltreatment by age two, improved child development at age 4, persistent school absence or children looked after in out-of-home care by age 7, or improved maternal outcomes. Some adverse outcomes appeared to be increased in the FNP group. We will present findings amongst subgroups of younger maternal age (13-15 years), increased deprivation according to quintile of Index of Multiple Deprivation, and adversity and social care history. We also present sensitivity analyses that aim to minimise confounding. Conclusion Our study supports findings from previous trials of FNP showing little benefit for measured child and maternal outcomes. Interpretation of results needs careful consideration of the impact of residual confounding due to unmeasured or undisclosed factors (e.g. family violence) linked to targeting of FNP to higher risk mothers, and surveillance bias.

Abstract 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

Abstract Background Female urinary incontinence is underdiagnosed and undertreated in primary care. There is little evidence on factors that determine whether women with urinary incontinence are referred to specialist services. This study aimed to investigate characteristics associated with referrals from primary to specialist secondary care for urinary incontinence. Methods We carried out a cohort study, using primary care data from over 600 general practices contributing to the Clinical Practice Research Datalink (CPRD) in the United Kingdom. We used multi-level logistic regression to estimate adjusted odds ratios (aOR) that reflect the impact of patient and GP practice-level characteristics on referrals to specialist services in secondary care within 30 days of a urinary incontinence diagnosis. All women aged ≥18 years newly diagnosed with urinary incontinence between 1 April 2004 and 31 March 2013 were included. One-year referral was estimated with death as competing event. Results Of the 104,466 included women (median age: 58 years), 28,476 (27.3%) were referred within 30 days. Referral rates decreased with age (aOR 0.34, 95% CI 0.31–0.37, comparing women aged ≥80 with those aged 40–49 years) and was lower among women who were severely obese (aOR 0.84, 95% CI 0.78–0.90), smokers (aOR 0.94, 95% CI 0.90–0.98), women from a minority-ethnic backgrounds (aOR 0.76, 95% CI 0.65–0.89 comparing Asian with white women), women with pelvic organ prolapse (aOR 0.77, 95% CI 0.68–0.87), and women in Scotland (aOR 0.60, 95% CI 0.46–0.78, comparing women in Scotland and England). One-year referral rate was 34.0% and the pattern of associations with patient characteristics was almost the same as for 30-day referrals. Conclusions About one in four women with urinary incontinence were referred to specialist secondary care services within one month after a UI diagnosis and one in three within one year. Referral rates decreased with age which confirms concerns that older women with UI are less likely to receive care according to existing clinical guidelines. Referral rates were also lower in women from minority-ethnic backgrounds. These finding may reflect clinicians’ beliefs about the appropriateness of referral, differences in women’s preferences for treatment, or other factors leading to inequities in referral for urinary incontinence.

Abstract Background An increasing number of patients undergoing hip or knee replacement have chronic diseases. It has been suggested that the presence of chronic diseases may affect access to this type of surgery in the English National Health Service (NHS). We examined the access to hip and knee replacement surgery in patients with and without chronic diseases according to preoperative patient-reported pain, functional status and symptom duration. Methods We analysed data of 640,832 patients who had hip or knee surgery between 2009 and 2016 in England. Multivariable regression was used to estimate the impact of 11 chronic diseases on severity of joint problems as measured on a scale from 0 to 48 by Oxford Hip (OHS) and Knee Scores (OKS) just before surgery and on likelihood of long-standing joint problems (> 5 years pre-operatively). Results Patients with chronic diseases reported more severe joint problems than patients without (OHS differences ranged from 1.1 [95% CI 0.93, 1.2] to 2.5 [95% CI 2.3, 2.7] and OKS differences from 0.5 [95% CI 0.3, 0.7] to 2.6 [95% CI 2.4, 2.7] for the 11 chronic diseases) but the differences remain small. When analysed separately, patients with chronic diseases reported both more severe pain and poorer functional status. Six chronic diseases in hip patients and two in knee patients increased the likelihood that they had long-standing joint problems. The severity of joint problems just before surgery increased with the number of chronic diseases (OHS differences; one chronic disease (1.5 [95% CI 1.4, 1.5]) to four or more (5.8 [95% CI 5.6, 6.0])). Conclusions Patients with chronic diseases reported more severe joint problems immediately before hip or knee replacement surgery suggesting they have hip or knee replacement later in the course of their joint disease.

BackgroundThe COVID-19 pandemic has disrupted maternity services worldwide and imposed restrictions on societal behaviours. This national study aimed to compare obstetric intervention and pregnancy outcome rates in England during the pandemic and corresponding pre-pandemic calendar periods, and to assess whether differences in these rates varied according to ethnic and socioeconomic background.Methods and findingsWe conducted a national study of singleton births in English National Health Service hospitals. We compared births during the COVID-19 pandemic period (23 March 2020 to 22 February 2021) with births during the corresponding calendar period 1 year earlier. The Hospital Episode Statistics database provided administrative hospital data about maternal characteristics, obstetric inventions (induction of labour, elective or emergency cesarean section, and instrumental birth), and outcomes (stillbirth, preterm birth, small for gestational age [SGA; birthweight < 10th centile], prolonged maternal length of stay (≥3 days), and maternal 42-day readmission). Multi-level logistic regression models were used to compare intervention and outcome rates between the corresponding pre-pandemic and pandemic calendar periods and to test for interactions between pandemic period and ethnic and socioeconomic background. All models were adjusted for maternal characteristics including age, obstetric history, comorbidities, and COVID-19 status at birth. The study included 948,020 singleton births (maternal characteristics: median age 30 years, 41.6% primiparous, 8.3% with gestational diabetes, 2.4% with preeclampsia, and 1.6% with pre-existing diabetes or hypertension); 451,727 births occurred during the defined pandemic period. Maternal characteristics were similar in the pre-pandemic and pandemic periods. Compared to the pre-pandemic period, stillbirth rates remained similar (0.36% pandemic versus 0.37% pre-pandemic, p = 0.16). Preterm birth and SGA birth rates were slightly lower during the pandemic (6.0% versus 6.1% for preterm births, adjusted odds ratio [aOR] 0.96, 95% CI 0.94-0.97; 5.6% versus 5.8% for SGA births, aOR 0.95, 95% CI 0.93-0.96; both p < 0.001). Slightly higher rates of obstetric intervention were observed during the pandemic (40.4% versus 39.1% for induction of labour, aOR 1.04, 95% CI 1.03-1.05; 13.9% versus 12.9% for elective cesarean section, aOR 1.13, 95% CI 1.11-1.14; 18.4% versus 17.0% for emergency cesarean section, aOR 1.07, 95% CI 1.06-1.08; all p < 0.001). Lower rates of prolonged maternal length of stay (16.7% versus 20.2%, aOR 0.77, 95% CI 0.76-0.78, p < 0.001) and maternal readmission (3.0% versus 3.3%, aOR 0.88, 95% CI 0.86-0.90, p < 0.001) were observed during the pandemic period. There was some evidence that differences in the rates of preterm birth, emergency cesarean section, and unassisted vaginal birth varied according to the mother's ethnic background but not according to her socioeconomic background. A key limitation is that multiple comparisons were made, increasing the chance of false-positive results.ConclusionsIn this study, we found very small decreases in preterm birth and SGA birth rates and very small increases in induction of labour and elective and emergency cesarean section during the COVID-19 pandemic, with some evidence of a slightly different pattern of results in women from ethnic minority backgrounds. These changes in obstetric intervention rates and pregnancy outcomes may be linked to women's behaviour, environmental exposure, changes in maternity practice, or reduced staffing levels.

Background: The COVID-19 pandemic has had a profound impact on healthcare systems globally, with a worrying increase in adverse maternal and foetal outcomes. We aimed to assess the changes in maternity healthcare provision and healthcare-seeking by pregnant women during the COVID-19 pandemic. Methods: We performed a systematic review and meta-analysis of studies of the effects of the pandemic on provision of, access to and attendance at maternity services (CRD42020211753). We searched MEDLINE and Embase in accordance with PRISMA guidelines from January 1st, 2020 to April 17th 2021 for controlled observational studies and research letters reporting primary data comparing maternity healthcare-seeking and healthcare delivery during compared to before the COVID-19 pandemic. Case reports and series, systematic literature reviews, and pre-print studies were excluded. Meta-analysis was performed on comparable outcomes that were reported in two or more studies. Data were combined using random-effects meta-analysis, using risk ratios (RR) or incidence rate ratios (IRR) with 95% confidence intervals (CI). Findings: Of 4743 citations identified, 56 were included in the systematic review, and 21 in the meta-analysis. We identified a significant decrease in the number of antenatal clinic visits (IRR 0614, 95% CI 0486–0776, P

Summary: Background: The COVID-19 pandemic has had a profound impact on health-care systems and potentially on pregnancy outcomes, but no systematic synthesis of evidence of this effect has been undertaken. We aimed to assess the collective evidence on the effects on maternal, fetal, and neonatal outcomes of the pandemic. Methods: We did a systematic review and meta-analysis of studies on the effects of the pandemic on maternal, fetal, and neonatal outcomes. We searched MEDLINE and Embase in accordance with PRISMA guidelines, from Jan 1, 2020, to Jan 8, 2021, for case-control studies, cohort studies, and brief reports comparing maternal and perinatal mortality, maternal morbidity, pregnancy complications, and intrapartum and neonatal outcomes before and during the pandemic. We also planned to record any additional maternal and offspring outcomes identified. Studies of solely SARS-CoV-2-infected pregnant individuals, as well as case reports, studies without comparison groups, narrative or systematic literature reviews, preprints, and studies reporting on overlapping populations were excluded. Quantitative meta-analysis was done for an outcome when more than one study presented relevant data. Random-effects estimate of the pooled odds ratio (OR) of each outcome were generated with use of the Mantel-Haenszel method. This review was registered with PROSPERO (CRD42020211753). Findings: The search identified 3592 citations, of which 40 studies were included. We identified significant increases in stillbirth (pooled OR 1·28 [95% CI 1·07–1·54]; I2=63%; 12 studies, 168 295 pregnancies during and 198 993 before the pandemic) and maternal death (1·37 [1·22–1·53; I2=0%, two studies [both from low-income and middle-income countries], 1 237 018 and 2 224 859 pregnancies) during versus before the pandemic. Preterm births before 37 weeks' gestation were not significantly changed overall (0·94 [0·87–1·02]; I2=75%; 15 studies, 170 640 and 656 423 pregnancies) but were decreased in high-income countries (0·91 [0·84–0·99]; I2=63%; 12 studies, 159 987 and 635 118 pregnancies), where spontaneous preterm birth was also decreased (0·81 [0·67–0·97]; two studies, 4204 and 6818 pregnancies). Mean Edinburgh Postnatal Depression Scale scores were higher, indicating poorer mental health, during versus before the pandemic (pooled mean difference 0·42 [95% CI 0·02–0·81; three studies, 2330 and 6517 pregnancies). Surgically managed ectopic pregnancies were increased during the pandemic (OR 5·81 [2·16–15·6]; I2=26%; three studies, 37 and 272 pregnancies). No overall significant effects were identified for other outcomes included in the quantitative analysis: maternal gestational diabetes; hypertensive disorders of pregnancy; preterm birth before 34 weeks', 32 weeks', or 28 weeks' gestation; iatrogenic preterm birth; labour induction; modes of delivery (spontaneous vaginal delivery, caesarean section, or instrumental delivery); post-partum haemorrhage; neonatal death; low birthweight (

Objective:. To compare the management and outcomes of colorectal cancer (CRC) patients during the first 2 months of the COVID-19 pandemic with the preceding 6 months. Background:. The pandemic has affected the diagnosis and treatment of CRC patients worldwide. Little is known about the safety of major resection and whether creating “cold” sites (COVID-free hospitals) is effective. Methods:. A national study in England used administrative hospital data for 14,930 CRC patients undergoing surgery between October 1, 2019, and May 31, 2020. Mortality of CRC resection was compared before and after March 23, 2020 (“lockdown” start). Results:. The number of elective CRC procedures dropped sharply during the pandemic (from average 386 to 214 per week), whereas emergency procedures were hardly affected (from 88 to 84 per week). There was little change in characteristics of surgical patients during the pandemic. Laparoscopic surgery decreased from 62.5% to 35.9% for elective and from 17.7% to 9.7% for emergency resections. Surgical mortality increased slightly (from 0.9% to 1.2%, P = 0.06) after elective and markedly (from 5.6% to 8.9%, P = 0.003) after emergency resections. The observed increase in mortality during the first phase of the pandemic was similar in “cold” and “hot” sites (P > 0.5 elective and emergency procedures). Conclusions:. The pandemic resulted in a 50% reduction in elective CRC procedures during the initial surge and a substantial increase in mortality after emergency resection. There was no evidence that surgery in COVID-free “cold” sites led to better outcomes in the first 2 months.

Abstract Background This study examined the agreement between patient-reported chronic diseases and hospital administrative records in hip or knee arthroplasty patients in England. Methods Survey data reported by 676,428 patients for the English Patient Reported Outcome Measures (PROMs) programme was linked to hospital administrative data. Sensitivity and specificity of 11 patient-reported chronic diseases were estimated with hospital administrative data as reference standard. Results Specificity was high (> 90%) for all 11 chronic diseases. However, sensitivity varied by disease with the highest found for ‘diabetes’ (87.5%) and ‘high blood pressure’ (74.3%) and lowest for ‘kidney disease’ (18.8%) and ‘leg pain due to poor circulation’ (26.1%). Sensitivity was increased for diseases that were given as specific examples in the questionnaire (e.g. ‘parkinson’s disease’ (65.6%) and ‘multiple sclerosis’ (69.5%), compared to ‘diseases of the nervous system’ (20.9%)). Conclusions Patients can give information about the presence of chronic diseases that is consistent with chronic diseases derived from hospital administrative data if the description in the patient questionnaire is precise and if the disease is familiar to most patients and has significant impact on their life. Such patient questionnaires need to be validated before they are used for research and service evaluation projects.

Background: Urinary incontinence affects between 25% and 45% of women. The availability and quality of services is variable and inequitable, but our understanding of the drivers is incomplete. Objectives: The objectives of the study were to model patient, specialist clinician, primary and secondary care, and geographical factors associated with referral and surgery for urinary incontinence, and to explore women’s experiences of urinary incontinence and expectations of treatments. Design: This was a mixed-methods study. Setting: The setting was NHS England. Participants: Data were collected from all women with a urinary incontinence diagnosis in primary care data, and all women undergoing mid-urethral mesh tape surgery for stress urinary incontinence were included. Interviews were also carried out with 28 women from four urogynaecology clinics who were deciding whether or not to have surgery, and surveys were completed by 245 members of the Royal College of Obstetricians and Gynaecologists with a specialist interest in urinary incontinence. Data sources: The sources were patient-level data from Hospital Episode Statistics, the Clinical Practice Research Datalink and the Office for National Statistics mortality data linked to Hospital Episode Statistics. Interviews were conducted with women. An online vignette survey was conducted with members of the Royal College of Obstetricians and Gynaecologists. Main outcome measures: The main outcome measures were the rates of referral from primary to secondary care and surgery after referral, the rates of stress urinary incontinence surgery by geographical area, the risk of mid-urethral mesh tape removal and reoperation after mid-urethral mesh tape insertion. Results: Almost half (45.8%) of women with a new urinary incontinence diagnosis in primary care were referred to a urinary incontinence specialist: 59.5% of these referrals were within 30 days of diagnosis. In total, 14.2% of women referred to a specialist underwent a urinary incontinence procedure (94.5% of women underwent a stress urinary incontinence procedure and 5.5% underwent an urgency urinary incontinence procedure) during a follow-up period of up to 10 years. Not all women were equally likely to be referred or receive surgery. Both referral and surgery were less likely for older women, those who were obese and those from minority ethnic backgrounds. The stress urinary incontinence surgery rate was 40 procedures per 100,000 women per year, with substantial geographical variation. Among women undergoing mid-urethral mesh tape insertion for stress urinary incontinence, the 9-year mesh tape removal rate was 3.3%. Women’s decision-making about urinary incontinence surgery centred on perceptions of their urinary incontinence severity and the seriousness/risk of surgery. Women judged urinary incontinence severity in relation to their daily lives and other women’s experiences, rather than frequency or quantity of leakage, as is often recorded and used by clinicians. Five groups of UK gynaecologists could be distinguished who differed mainly in their average inclination to recommend surgery to hypothetical urinary incontinence patients. The gynaecologists’ recommendations were also influenced by urinary incontinence subtype and the patient’s history of previous surgery. Limitations: The primary and secondary care data lacked information on the severity of urinary incontinence. Conclusions: There was substantial variation in rates of referrals, surgery, and mesh tape removals, both geographically and between women of different ages and women from different ethnic backgrounds. The variation persisted after adjustment for factors that were likely to affect women’s preferences. Growing safety concerns over mid-urethral mesh tape surgery for stress urinary incontinence during the period from which the data are drawn are likely to have introduced more uncertainty to women’s and clinicians’ treatment decision-making. Future work: Future work should capture outcomes relevant to women, including ongoing urinary incontinence and pain that is reported by women themselves, both before and after mesh and non-mesh procedures, as well as following conservative treatments. Future research should examine long-term patient-reported outcomes of treatment, including for women who do not seek further health care or surgery, and the extent to which urinary incontinence severity explains observed variation in referrals and surgery. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 9, No. 7. See the NIHR Journals Library website for further project information.

Summary: Background: Existing studies evaluating the association between maternal risk factors and specific infant outcomes such as birthweight, injury admissions, and mortality have mostly focused on single risk factors. We aimed to identify routinely recorded psychosocial characteristics of pregnant women most at risk of adverse infant outcomes to inform targeting of early intervention. Methods: We created a cohort using administrative hospital data (Hospital Episode Statistics) for all births to mothers aged 15–44 years in England, UK, who gave birth on or after April 1, 2010, and who were discharged before or on March 31, 2015. We used generalised linear models to evaluate associations between psychosocial risk factors recorded in hospital records in the 2 years before the 20th week of pregnancy (ie, teenage motherhood, deprivation, pre-pregnancy hospital admissions for mental health or behavioural conditions, and pre-pregnancy hospital admissions for adversity, including drug or alcohol abuse, violence, and self-harm) and infant outcomes (ie, birthweight, unplanned admission for injury, or death from any cause, within 12 months from postnatal discharge). Findings: Of 2 520 501 births initially assessed, 2 137 103 were eligible and were included in the birth outcome analysis. Among the eligible births, 93 279 (4·4%) were births to teenage mothers (age

Introduction Almost 20 000 babies are born to teenage mothers each year in England, with poorer outcomes for mothers and babies than among older mothers. A nurse home visitation programme in the USA was found to improve a wide range of outcomes for young mothers and their children. However, a randomised controlled trial in England found no effect on short-term primary outcomes, although cognitive development up to age 2 showed improvement. Our study will use linked routinely collected health, education and social care data to evaluate the real-world effects of the Family Nurse Partnership (FNP) on child outcomes up to age 7, with a focus on identifying whether the FNP works better for particular groups of families, thereby informing programme targeting and resource allocation.Methods and analysis We will construct a retrospective cohort of all women aged 13–24 years giving birth in English NHS hospitals between 2010 and 2017, linking information on mothers and children from FNP programme data, Hospital Episodes Statistics and the National Pupil Database. To assess the effectiveness of FNP, we will compare outcomes for eligible mothers ever and never enrolled in FNP, and their children, using two analysis strategies to adjust for measured confounding: propensity score matching and analyses adjusting for maternal characteristics up to enrolment/28 weeks gestation. Outcomes of interest include early childhood development, childhood unplanned hospital admissions for injury or maltreatment-related diagnoses and children in care. Subgroup analyses will determine whether the effect of FNP varied according to maternal characteristics (eg, age and education).Ethics and dissemination The Nottingham Research Ethics Committee approved this study. Mothers participating in FNP were supportive of our planned research. Results will inform policy-makers for targeting home visiting programmes. Methodological findings on the accuracy and reliability of cross-sectoral data linkage will be of interest to researchers.

Abstract Background Variation in access to joint replacement surgery has been widely reported but less attention has been given to the impact of comorbidities on the patient journey to joint replacement surgery. There is a lack of consensus amongst healthcare professionals and commissioners about how patients with comorbidities should be referred or selected for joint replacement surgery. It is therefore important to understand the views of healthcare professionals on the management, referral and selection of patients with comorbidities for joint replacement surgery. Methods An exploratory qualitative study involving semi-structured interviews with 20 healthcare professionals in England across the referral pathway to joint replacement surgery. They were asked to talk about their experiences of referring and selecting patients with comorbidities for joint replacement surgery. The interviews were audio-recorded and transcribed verbatim. Data analysis followed a thematic analysis approach based on the principles of grounded theory. Results In general, the presence of comorbidities was not seen as a barrier to being referred or selected for joint replacement but was seen as a challenge to manage the patients’ journey across the referral pathway. Each professional group, concentrated on different aspects of the patients’ condition which appeared to affect how they managed patients with comorbidities. This implied there was a disagreement about roles and responsibilities in the management of patients with comorbidities. None of the professionals believed it was their responsibility to address comorbidities in preparation for surgery. This disagreement was identified as a reason why some patients seem to ‘get lost’ in the referral system when they were considered to be unprepared for surgery. Patients were then potentially left to manage their own comorbidities before being reconsidered for joint replacement. Conclusions At the clinician-level, comorbidities were not perceived as a barrier to accessing joint replacement surgery but at the pathway-level, it may create an implicit barrier such that patients with comorbidities may get ‘lost’ to the system. Further study is needed to explore the roles and responsibilities of professionals across the current orthopaedic referral pathway which may be less suitable for patients with comorbidities.

Abstract Background Third and fourth degree perineal tears, or obstetric anal sphincter injuries (OASI), sustained during childbirth can result in anal incontinence and psychosocial problems which require ongoing treatment. Within the English National Health System (NHS) reported rates of OASI have gradually increased. In response, a care bundle was developed incorporating four elements: 1) antenatal information to women, 2) manual perineal protection during all vaginal births, 3) episiotomy to be performed with a 60° mediolateral angle at crowning (when clinically indicated) and 4) perineal examination (including per rectum) after childbirth. Implementation of the OASI Care Bundle is aided by a skills development module and an awareness campaign. The project is a collaboration between two national professional bodies, an NHS hospital trust and an academic institution. Methods Implementation of the OASI Care Bundle will be evaluated using a stepped-wedge design. From January 2017 sixteen maternity units across England, Wales and Scotland will participate in the study over a 15-month period, with sequential roll-out of the intervention in four blocks (regions) of four units. The primary clinical outcome is OASI rate. Regression analysis will adjust for differences in organisational characteristics and obstetric risk factors in women who gave birth before and after implementation of the care bundle. Focus group discussions and in-depth interviews with clinicians will evaluate the feasibility of integrating the care bundle into routine practice. Interviews with women will explore the acceptability of the intervention. Discussion This protocol outlines the evaluation of our quality improvement project which aims to prevent OASI using a bundle of evidence-based interventions that are each widely used in practice. The OASI project aims to 1) standardise practice to prevent OASI in a way that is acceptable to clinicians and women and 2) identify the barriers and enablers associated with upscaling interventions within maternity units. If found to be effective, feasible and acceptable, the OASI Care Bundle will be shared with a range of audiences using the communication channels available to the professional bodies. Trial registration The OASI Project was retrospectively registered on the ISCTRN12143325 database date assigned 03/10/2017.

ObjectivesTo identify ways of using routine hospital data to improve the efficiency of retrospective reviews of case records for identifying avoidable severe harmDesignDevelopment and testing of thresholds and criteria for two indirect indicators of healthcare-related harm (long length of stay (LOS) and emergency readmission) to determine the yield of specified harms coded in Hospital Episode Statistics (HES).SettingAcute National Health Service hospitals in England.ParticipantsHES for acute myocardial infarction (AMI), bowel cancer surgery and hip replacement admissions from 2014 to 2015.InterventionsCase-mix-adjusted linear regression models were used to determine expected LOS. Different thresholds were examined to determine the association with harm. Screening criteria for readmission included time to readmission, length of readmission and diagnoses in initial admission and readmission. The association with harm was examined for each criterion.ResultsThe proportions of AMI cases with a harm code increased from 14% among all cases to 47% if a threshold of three times the expected LOS was used. For hip replacement the respective increase was from 10% to 51%. However as the number of patients at these higher thresholds was small, the overall proportion of harm identified is relatively small (15%, 19%, 9% and 8% among AMI, urgent bowel surgery, elective bowel surgery and hip replacement cohorts, respectively). Selection of the time to readmission had an effect on the yield of harms but this varied with condition. At least 50% of surgical patients had a harm code if readmitted within 7 days compared with 21% of patients with AMI.ConclusionsOur approach would select a substantial number of patients for case record review. Many of these cases would contain no evidence of healthcare-related harm. In practice, Trusts may choose how many reviews it is feasible to do in advance and then select random samples of cases that satisfy the screening criteria.

Introduction Children born to teenage mothers have greater healthcare needs than those born to mothers in their 20s and older, including higher rates of childhood hospitalisations. We performed a direct cross-country comparison of maternal age-related inequalities in infant outcomes in England, Scotland, Sweden, New South Wales (NSW; Australia) and Ontario (Canada). Objectives and Approach We used administrative hospital data capturing 3,002,749 singleton births surviving to discharge between 2010-2014 (2008-2012 for Sweden). We derived risk ratios and risk differences to compare rates of preterm birth (24-37 weeks of gestation), unplanned hospital admissions, emergency department (ED) visits, and mortality within 12 months of postnatal discharge, for infants born to mothers aged 15-19, 20-24, 25-29 and 30-34 years. Results Infants born to teenage mothers experienced higher rates of preterm birth, unplanned admissions, ED visits, and mortality compared with older mothers in all countries. Despite variation in the distribution of maternal characteristics between countries, inequalities according to maternal age were similar. Infants of teenage mothers were between 1.37 (95% CI for risk ratio 1.28-1.47, Sweden) and 1.56 (95% CI 1.49-1.64, NSW) times more likely to have ≥1 unplanned hospital admission and between 2.25 (95% CI 1.92-2.64, England) and 3.87 (95% CI 2.07-7.36, Sweden) times more likely to die, compared with those born to mothers aged 30-34. Conclusion/Implications A similar excess of adverse outcomes was observed for teenage mothers in all five countries, despite different prevalence rates and support for young families. Public health strategies are needed to address these inequalities, which may be due to social risk factors associated with both young motherhood and adverse infant outcomes.

The development of an early complex gut microbiota may play an important role in the protection against intestinal dysbiosis later in life. The significance of the developed microbiota for gut barrier functionality upon interaction with pathogenic or beneficial bacteria is largely unknown. The transcriptome of differently perfused jejunal loops of 12 caesarian-derived pigs, neonatally associated with microbiota of different complexity, was studied. Piglets received pasteurized sow colostrum at birth (d0), a starter microbiota (Lactobacillus amylovorus (LAM), Clostridium glycolicum, and Parabacteroides) on d1-d3, and a placebo inoculant (simple association, SA) or an inoculant consisting of sow's diluted feces (complex association, CA) on d3-d4. On d 26-37, jejunal loops were perfused for 8 h with either enterotoxigenic Escherichia coli F4 (ETEC), purified F4 fimbriae, LAM or saline control (CTRL). Gene expression of each intestinal loop was analyzed by Affymetrix Porcine Gene 1.1_ST array strips. Gene Set Enrichment Analysis was performed on expression values. Compared to CTRL, 184 and 74; 2 and 139; 2 and 48 gene sets, were up- and down-regulated by ETEC, F4 and LAM, respectively. ETEC up-regulated networks related to inflammatory and immune responses, RNA processing, and mitosis. There was a limited overlap in up-regulated gene sets between ETEC and F4 fimbriae. LAM down-regulated genes related to inflammatory and immune responses, as well as to cellular compound metabolism. In CA pigs, 57 gene sets were up-regulated by CA, while 73 were down-regulated compared to SA. CA up-regulated gene sets related to lymphocyte modulation and to cellular defense in all loop perfusions. In CA pigs, compared to SA pigs, genes for chemokine and cytokine activity and for response to external stimuli were down-regulated in ETEC-perfused loops and up-regulated in CTRL. The results highlight the importance of the nature of neonatal microbial colonization in the response to microbial stimuli later in life.

ABSTRACT Background Babies born late preterm (34-36 weeks gestation) or early term (37-38 weeks) are at increased risk of unplanned readmissions compared with full-term babies. We examined differences in neonatal and infant outcomes in England and Ontario. Methods Linked maternity-baby hospitalisation data were extracted from two universal healthcare systems, Ontario (n=702,565; 2005-2013) and England (n=1,165,375; 2011-2013). We modelled rates of unplanned readmissions within 30-days post-discharge of delivery, and readmissions, emergency department (ED) visits, deaths and total inpatient days within 12-months post-discharge, adjusting for neonatal, maternal and delivery factors. Results The median newborn length of stay was 4 and 5 days in Ontario and England respectively for late preterm babies, and 2 days in both countries for early term babies. Early neonatal readmissions were lower in Ontario: 4.8% of early term and 7.2% of late preterm babies compared with 8.3% and 11.4% respectively in England (p

Human intestinal tissue samples are barely accessible to study potential health benefits of nutritional compounds. Numbers of animals used in animal trials, however, need to be minimalized. Therefore, we explored the applicability of in vitro (human Caco-2 cells) and ex vivo intestine models (rat precision cut intestine slices and the pig in-situ small intestinal segment perfusion (SISP) technique) to study the effect of food compounds. In vitro digested yellow (YOd) and white onion extracts (WOd) were used as model food compounds and transcriptomics was applied to obtain more insight into which extent mode of actions depend on the model. The three intestine models shared 9,140 genes which were used to compare the responses to digested onions between the models. Unsupervised clustering analysis showed that genes up- or down-regulated by WOd in human Caco-2 cells and rat intestine slices were similarly regulated by YOd, indicating comparable modes of action for the two onion species. Highly variable responses to onion were found in the pig SISP model. By focussing only on genes with significant differential expression, in combination with a fold change > 1.5, 15 genes showed similar onion-induced expression in human Caco-2 cells and rat intestine slices and 2 overlapping genes were found between the human Caco-2 and pig SISP model. Pathway analyses revealed that mainly processes related to oxidative stress, and especially the Keap1-Nrf2 pathway, were affected by onions in all three models. Our data fit with previous in vivo studies showing that the beneficial effects of onions are mostly linked to their antioxidant properties. Taken together, our data indicate that each of the in vitro and ex vivo intestine models used in this study, taking into account their limitations, can be used to determine modes of action of nutritional compounds and can thereby reduce the number of animals used in conventional nutritional intervention studies.

Linkage of longitudinal administrative data for mothers and babies supports research and service evaluation in several populations around the world. We established a linked mother-baby cohort using pseudonymised, population-level data for England.Retrospective linkage study using electronic hospital records of mothers and babies admitted to NHS hospitals in England, captured in Hospital Episode Statistics between April 2001 and March 2013.Of 672,955 baby records in 2012/13, 280,470 (42%) linked deterministically to a maternal record using hospital, GP practice, maternal age, birthweight, gestation, birth order and sex. A further 380,164 (56%) records linked using probabilistic methods incorporating additional variables that could differ between mother/baby records (admission dates, ethnicity, 3/4-character postcode district) or that include missing values (delivery variables). The false-match rate was estimated at 0.15% using synthetic data. Data quality improved over time: for 2001/02, 91% of baby records were linked (holding the estimated false-match rate at 0.15%). The linked cohort was representative of national distributions of gender, gestation, birth weight and maternal age, and captured approximately 97% of births in England.Probabilistic linkage of maternal and baby healthcare characteristics offers an efficient way to enrich maternity data, improve data quality, and create longitudinal cohorts for research and service evaluation. This approach could be extended to linkage of other datasets that have non-disclosive characteristics in common.

Intestinal chemosensory receptors and transporters are able to detect food-derived molecules and are involved in the modulation of gut hormone release. Gut hormones play an important role in the regulation of food intake and the control of gastrointestinal functioning. This mechanism is often referred to as "nutrient sensing". Knowledge of the distribution of chemosensors along the intestinal tract is important to gain insight in nutrient detection and sensing, both pivotal processes for the regulation of food intake. However, most knowledge is derived from rodents, whereas studies in man and pig are limited, and cross-species comparisons are lacking.To characterize and compare intestinal expression patterns of genes related to nutrient sensing in mice, pigs and humans.Mucosal biopsy samples taken at six locations in human intestine (n = 40) were analyzed by qPCR. Intestinal scrapings from 14 locations in pigs (n = 6) and from 10 locations in mice (n = 4) were analyzed by qPCR and microarray, respectively. The gene expression of glucagon, cholecystokinin, peptide YY, glucagon-like peptide-1 receptor, taste receptor T1R3, sodium/glucose cotransporter, peptide transporter-1, GPR120, taste receptor T1R1, GPR119 and GPR93 was investigated. Partial least squares (PLS) modeling was used to compare the intestinal expression pattern between the three species.The studied genes were found to display specific expression patterns along the intestinal tract. PLS analysis showed a high similarity between human, pig and mouse in the expression of genes related to nutrient sensing in the distal ileum, and between human and pig in the colon. The gene expression pattern was most deviating between the species in the proximal intestine. Our results give new insights in interspecies similarities and provide new leads for translational research and models aiming to modulate food intake processes in man.

Enterotoxigenic Escherichia coli (ETEC) strains that produce heat-stable (ST) and/or heat-labile (LT) enterotoxins are cause of post-weaning diarrhea in piglets. However, the relative importance of the different enterotoxins in host immune responses against ETEC infection has been poorly defined. In the present study, several isogenic mutant strains of an O149:F4ac(+), LT(+) STa(+) STb(+) ETEC strain were constructed that lack the expression of LT in combination with one or both types of ST enterotoxins (STa and/or STb). The small intestinal segment perfusion (SISP) technique and microarray analysis were used to study host early immune responses induced by these mutant strains 4 h after infection in comparison to the wild type strain and a PBS control. Simultaneously, net fluid absorption of pig small intestinal mucosa was measured 4 h after infection, allowing us to correlate enterotoxin secretion with gene regulation. Microarray analysis showed on the one hand a non-toxin related general antibacterial response comprising genes such as PAP, MMP1 and IL8. On the other hand, results suggest a dominant role for STb in small intestinal secretion early after post-weaning infection, as well as in the induced innate immune response through differential regulation of immune mediators like interleukin 1 and interleukin 17.