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We lead multidisciplinary applied research and training to rethink the way health care is delivered in general practice and across the community.
Gestational age at birth and child special educational needs: a UK representative birth cohort study
<p><strong>Objective:</strong> To examine the association between gestational age at birth across the entire gestational age spectrum and special education needs (SEN) in UK children at 11 years of age.</p> <p><strong>Methods:</strong> The Millennium Cohort Study is a nationally representative longitudinal sample of children born in the UK during 2000-2002. Information about the child’s birth, health and sociodemographic factors was collected when children were 9 months old. Information about presence and reasons for SEN was collected from parents at age 11. Adjusted relative risks (aRR) were estimated using modified Poisson regression, accounting for confounders.</p> <p><strong>Results:</strong> The sample included 12,081 children with data at both time points. The overall prevalence of SEN was 11.2%, and it was inversely associated with gestational age. Among children born <32 weeks of gestation, the prevalence of SEN was 27.4%, three times higher than among those born at 40 weeks (aRR=2.89; 95% CI 2.02, 4.13). Children born early term (37-38 weeks) were also at increased risk for SEN (aRR=1.33; 95% CI 1.11, 1.59); this was the same when the analysis was restricted to births after labour with spontaneous onset. Birth before full term was more strongly associated with having a formal statement of SEN or SEN for multiple reasons.</p> <p><strong>Conclusion:</strong> Children born at earlier gestational ages are more likely to experience SEN, have more complex SEN and require support in multiple facets of learning. This association was observed even among children born early-term and when labour began spontaneously.</p>
Granulocyte-macrophage colony stimulating factor administered as prophylaxis for reduction of sepsis in extremely preterm, small for gestational age neonates (the PROGRAMS trial): a single-blind, multicentre, randomised controlled trial
Background: Systemic sepsis is a major cause of death in preterm neonates. There are compelling theoretical reasons why treatment with haemopoietic colony-stimulating factors might reduce sepsis and improve outcomes, and as a consequence these agents have entered into use in neonatal medicine without adequate evidence. We assessed whether granulocyte-macrophage colony stimulating factor (GM-CSF) administered as prophylaxis to preterm neonates at high risk of neutropenia would reduce sepsis, mortality, and morbidity. Methods: We undertook a single-blind, multicentre, randomised controlled trial in 26 centres between June, 2000, and June, 2006. 280 neonates of below or equal to 31 weeks' gestation and below the 10th centile for birthweight were randomised within 72 h of birth to receive GM-CSF 10 μg/kg per day subcutaneously for 5 days or standard management. From recruitment to day 28 a detailed daily clinical record form was completed by the treating clinicians. Primary outcome was sepsis-free survival to 14 days from trial entry. Analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN42553489. Findings: Neutrophil counts after trial entry rose significantly more rapidly in infants treated with GM-CSF than in control infants during the first 11 days (difference between neutrophil count slopes 0·34×109/L/day; 95% CI 0·12-0·56). There was no significant difference in sepsis-free survival for all infants (93 of 139 treated infants, 105 of 141 control infants; difference -8%, 95% CI -18 to 3). A meta-analysis of this trial and previous published prophylactic trials showed no survival benefit. Interpretation: Early postnatal prophylactic GM-CSF corrects neutropenia but does not reduce sepsis or improve survival and short-term outcomes in extremely preterm neonates. Funding: Action Medical Research. © 2009 Elsevier Ltd. All rights reserved.
Properties of patient-reported outcome measures in individuals following acute whiplash injury
Background: The aim of this study was to assess the acceptability, reliability, validity and responsiveness of the Short-Form Health Survey (SF-12) and its preference-based derivative (SF-6D), the EQ-5D and the Neck Disability Index (NDI) in patients recovering from acute whiplash injury.Methods: Data from the Managing Injuries of the Neck Trial of 3,851 patients with acute whiplash injury formed the basis of this empirical investigation. The EQ-5D and SF-12 were collected at baseline, and all three outcome measures were then collected at 4 months, 8 months and 12 months post-randomisation. The measures were assessed for their acceptability (response rates), internal consistency, validity (known groups validity and discriminant validity) and their internal and external responsiveness.Results: Response rates were broadly similar across the measures, with evidence of a floor effect for the NDI and a ceiling effect for the EQ-5D utility measure. All measures had Cronbach's α statistics of greater than 0.7, indicating acceptable internal consistency. The NDI and EQ-5D utility score correlated more strongly with the physical component scale of the SF-12 than the mental component scale, whilst this was reversed for the SF-6D utility score. The smaller standard deviations in SF-6D utility scores meant there were larger effect sizes for differences in utility score between patients with different injury severity at baseline than for the EQ-5D utility measure. However, the EQ-5D utility measure and NDI were both more responsive to longitudinal changes in health status than the SF-6D.Conclusions: There was no evidence of differences between the EQ-5D utility measure and NDI in terms of their construct validity, discriminant validity or responsiveness in patients with acute whiplash injury. However, both demonstrated superior responsiveness to longitudinal health changes than the SF-6D. © 2014 Pink et al.; licensee BioMed Central Ltd.
Cost-effectiveness of therapeutic hypothermia to treat neonatal encephalopathy
Objective: To estimate the cost-effectiveness (CE) of total body hypothermia plus intensive care versus intensive care alone to treat neonatal encephalopathy. Methods: Decision analytic modeling was used to synthesize mortality and morbidity data from three randomized controlled trials, the Total Body Hypothermia for Neonatal Encephalopathy Trial (TOBY), National Institute of Child Health and Human Development (NICHD), and CoolCap trials. Cost data inputs were informed by TOBY, the sole source of prospectively collected resource utilization data for encephalopathic infants. CE was expressed in terms of incremental cost per disability-free life year (DFLY) gained. Probabilistic sensitivity analysis was performed to generate CE acceptability curves (CEACs). Results: Cooling led to a cost increase of £3787 (95% confidence interval [CI]: -2516, 12,360) (€5115; 95% CI: -3398-16,694; US$5344; 95% CI: -3598, 26,356; using 2006 Organisation for Economic Co-operation and Development (OECD) purchasing power parities) and a DFLY gain of 0.19 (95%CI: 0.07-0.31) over the first 18 months after birth. The incremental cost per DFLY gained was £19,931 (€26,920; US$28,124). The baseline CEAC showed that if decision-makers are willing to pay £30,000 for an additional DFLY, there is a 69% probability that cooling is cost-effective. The probability of CE exceeded 99% at this threshold when the throughput of infants was increased to reflect the national incidence of neonatal encephalopathy or when the time horizon of the economic evaluation was extended to 18 years after birth. Conclusions: The probability that cooling is a cost-effective treatment for neonatal encephalopathy is finely balanced over the first 18 months after birth but increases substantially when national incidence data or an extended time horizon are considered. © 2010, International Society for Pharmacoeconomics and Outcomes Research (ISPOR).
Weight status and health-related quality of life during childhood and adolescence: effects of age and socioeconomic position
© 2020, The Author(s), under exclusive licence to Springer Nature Limited. Background: Overweight and obesity in children is associated with poor health-related quality of life (HRQoL), but the nuances of this relationship across different age and socio-demographic groups are not well-established. The aim of this study is to examine how the association between weight status and HRQoL changes with age and socioeconomic position (SEP) throughout childhood and adolescence. Methods: We used data from the Longitudinal Study of Australian Children (LSAC), a cohort study in which children were interviewed biennially from ages 4 to 17 years over seven waves of data. Measurements of HRQoL (using PedsQLTM), body mass index (BMI), and socio-demographic characteristics were collected at each interview. Of the 4983 children recruited into the study, we included data from 4083 children (a total of 24,446 observations). We used generalised estimating equations to assess whether age and SEP modified the association between weight status and HRQoL, after controlling for sex, long-term medical condition, language spoken to child and maternal smoking status. Results: Age was a significant modifier of the association between weight status and HRQoL, with adjustment for known predictors of HRQoL (P < 0.001). At age 4, children with obesity had, on average, a 0.99 (95% CI 0.02–1.96) point lower PedsQL total score than children at healthy weight. This difference became clinically important by age 9 at 4.50 (95% CI 3.86–5.13) points and increased to 6.69 (95% CI 5.74–7.64) points by age 17. There was no evidence that SEP modified the relationship between weight status and HRQoL (P > 0.05). Conclusions: Our results demonstrate that the relationship between overweight and obesity status and poor HRQoL is strengthened with increasing age through childhood and adolescence, but is not affected by SEP. Paediatricians, researchers and carers of children with obesity should acknowledge HRQoL outcomes, particularly for older children and adolescents.
Is Protocolised Weaning that Includes Early Extubation Onto Non-Invasive Ventilation More Cost Effective Than Protocolised Weaning Without Non-Invasive Ventilation? Findings from the Breathe Study
© 2020, The Author(s). Background: Optimising techniques to wean patients from invasive mechanical ventilation (IMV) remains a key goal of intensive care practice. The use of non-invasive ventilation (NIV) as a weaning strategy (transitioning patients who are difficult to wean to early NIV) may reduce mortality, ventilator-associated pneumonia and intensive care unit (ICU) length of stay. Objectives: Our objectives were to determine the cost effectiveness of protocolised weaning, including early extubation onto NIV, compared with weaning without NIV in a UK National Health Service setting. Methods: We conducted an economic evaluation alongside a multicentre randomised controlled trial. Patients were randomised to either protocol-directed weaning from mechanical ventilation or ongoing IMV with daily spontaneous breathing trials. The primary efficacy outcome was time to liberation from ventilation. Bivariate regression of costs and quality-adjusted life-years (QALYs) provided estimates of the incremental cost per QALY and incremental net monetary benefit (INMB) overall and for subgroups [presence/absence of chronic obstructive pulmonary disease (COPD) and operative status]. Long-term cost effectiveness was determined through extrapolation of survival curves using flexible parametric modelling. Results: NIV was associated with a mean INMB of £620 ($US885) (cost-effectiveness threshold of £20,000 per QALY) with a corresponding probability of 58% that NIV is cost effective. The probability that NIV is cost effective was higher for those with COPD (84%). NIV was cost effective over 5 years, with an estimated incremental cost-effectiveness ratio of £4618 ($US6594 per QALY gained). Conclusions: The probability of NIV being cost effective relative to weaning without NIV ranged between 57 and 59% overall and between 82 and 87% for the COPD subgroup.
Cost effectiveness of alternative planned places of birth in woman at low risk of complications: evidence from the Birthplace in England national prospective cohort study.
To estimate the cost effectiveness of alternative planned places of birth. Economic evaluation with individual level data from the Birthplace national prospective cohort study. 142 of 147 trusts providing home birth services, 53 of 56 freestanding midwifery units, 43 of 51 alongside midwifery units, and a random sample of 36 of 180 obstetric units, stratified by unit size and geographical region, in England, over varying periods of time within the study period 1 April 2008 to 30 April 2010. 64,538 women at low risk of complications before the onset of labour. Planned birth in four alternative settings: at home, in freestanding midwifery units, in alongside midwifery units, and in obstetric units. Incremental cost per adverse perinatal outcome avoided, adverse maternal morbidity avoided, and additional normal birth. The non-parametric bootstrap method was used to generate net monetary benefits and construct cost effectiveness acceptability curves at alternative thresholds for cost effectiveness. The total unadjusted mean costs were £1066, £1435, £1461, and £1631 for births planned at home, in freestanding midwifery units, in alongside midwifery units, and in obstetric units, respectively (equivalent to about €1274, $1701; €1715, $2290; €1747, $2332; and €1950, $2603). Overall, and for multiparous women, planned birth at home generated the greatest mean net benefit with a 100% probability of being the optimal setting across all thresholds of cost effectiveness when perinatal outcomes were considered. There was, however, an increased incidence of adverse perinatal outcome associated with planned birth at home in nulliparous low risk women, resulting in the probability of it being the most cost effective option at a cost effectiveness threshold of £20 000 declining to 0.63. With regards to maternal outcomes in nulliparous and multiparous women, planned birth at home generated the greatest mean net benefit with a 100% probability of being the optimal setting across all thresholds of cost effectiveness. For multiparous women at low risk of complications, planned birth at home was the most cost effective option. For nulliparous low risk women, planned birth at home is still likely to be the most cost effective option but is associated with an increase in adverse perinatal outcomes.
Perinatal and maternal outcomes by planned place of birth for healthy women with low risk pregnancies: the Birthplace in England national prospective cohort study.
To compare perinatal outcomes, maternal outcomes, and interventions in labour by planned place of birth at the start of care in labour for women with low risk pregnancies. Prospective cohort study. England: all NHS trusts providing intrapartum care at home, all freestanding midwifery units, all alongside midwifery units (midwife led units on a hospital site with an obstetric unit), and a stratified random sample of obstetric units. 64,538 eligible women with a singleton, term (≥37 weeks gestation), and "booked" pregnancy who gave birth between April 2008 and April 2010. Planned caesarean sections and caesarean sections before the onset of labour and unplanned home births were excluded. A composite primary outcome of perinatal mortality and intrapartum related neonatal morbidities (stillbirth after start of care in labour, early neonatal death, neonatal encephalopathy, meconium aspiration syndrome, brachial plexus injury, fractured humerus, or fractured clavicle) was used to compare outcomes by planned place of birth at the start of care in labour (at home, freestanding midwifery units, alongside midwifery units, and obstetric units). There were 250 primary outcome events and an overall weighted incidence of 4.3 per 1000 births (95% CI 3.3 to 5.5). Overall, there were no significant differences in the adjusted odds of the primary outcome for any of the non-obstetric unit settings compared with obstetric units. For nulliparous women, the odds of the primary outcome were higher for planned home births (adjusted odds ratio 1.75, 95% CI 1.07 to 2.86) but not for either midwifery unit setting. For multiparous women, there were no significant differences in the incidence of the primary outcome by planned place of birth. Interventions during labour were substantially lower in all non-obstetric unit settings. Transfers from non-obstetric unit settings were more frequent for nulliparous women (36% to 45%) than for multiparous women (9% to 13%). The results support a policy of offering healthy women with low risk pregnancies a choice of birth setting. Women planning birth in a midwifery unit and multiparous women planning birth at home experience fewer interventions than those planning birth in an obstetric unit with no impact on perinatal outcomes. For nulliparous women, planned home births also have fewer interventions but have poorer perinatal outcomes.
The lived experience of chronic headache: a systematic review and synthesis of the qualitative literature
<jats:sec><jats:title>Objective</jats:title><jats:p>To systematically review the qualitative literature of the lived experience of people with a chronic headache disorder.</jats:p></jats:sec><jats:sec><jats:title>Background</jats:title><jats:p>Chronic headaches affect 3%–4% of the population. The most common chronic headache disorders are chronic migraine, chronic tension-type headache and medication overuse headache. We present a systematic review and meta-ethnographic synthesis of the lived experience of people with chronic headache.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>We searched seven electronic databases, hand-searched nine journals and used a modified Critical Appraisal Skills Programme checklist to appraise study quality. Following thematic analysis we synthesised the data using a meta-ethnographic approach.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>We identified 3586 unique citations; full texts were examined for 86 studies and 4 were included in the review. Included studies differed in their foci: exploring, patient-centred outcomes, chronic headache as a socially invisible disease, psychological processes mediating impaired quality of life, and the process of medication overuse. Initial thematic analysis and subsequent synthesis gave three overarching themes: ‘headache as a driver of behaviour’ (directly and indirectly), ‘the spectre of headache’ and ‘strained relationships’.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>This meta-synthesis of published qualitative evidence demonstrates that chronic headaches have a profound effect on people’s lives, showing similarities with other pain conditions. There were insufficient data to explore the similarities and differences between different chronic headache disorders.</jats:p></jats:sec>
Validity of neurodevelopmental outcomes of children born very preterm assessed during routine clinical follow-up in England
<jats:sec><jats:title>Objective</jats:title><jats:p>To determine the validity of assessing and recording the neurodevelopmental outcome of very preterm infants during routine clinical follow-up in England.</jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p>Children born <30 weeks gestation, attending routine clinical follow-up at post-term ages 20–28 months, were recruited. Data on neurodevelopmental outcomes were recorded by the reviewing clinician in a standardised format in the child’s electronic patient record, based on a set of key questions designed to be used without formal training or developmental testing. Using a predefined algorithm, each participant was classified as having ‘no’, ‘mild/moderate’ or ‘severe’ impairment in cognitive, communication and motor domains. All participants also received a research assessment by a single assessor using the Bayley Scales of Infant Development, third edition (Bayley-III). The sensitivity and specificity of routine data in capturing impairment (any Bayley-III score <85) or severe impairment (any Bayley-III score <70) was calculated.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>190 children participated. The validity of routine assessments in identifying children with no impairment and no severe impairment was high across all domains (specificities 83.9%–100.0% and 96.6%–100.0%, respectively). However, identification of impairments, particularly in the cognitive (sensitivity 69.7% (55.1%–84.3%)) and communication (sensitivity (53.2% (42.0%–64.5%)) domains, was poor.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Neurodevelopmental status determined during routine clinical assessment lacks adequate sensitivity in cognitive and communication domains. It is uncertain whether this reflects the assessment or/and the recording of findings. As early intervention may improve education and social outcomes, this is an important area for healthcare quality improvement research.</jats:p></jats:sec>
Survival of very preterm infants admitted to neonatal care in England 2008–2014: time trends and regional variation
<jats:sec><jats:title>Objective</jats:title><jats:p>To analyse survival trends and regional variation for very preterm infants admitted to neonatal care.</jats:p></jats:sec><jats:sec><jats:title>Setting</jats:title><jats:p>All neonatal units in England.</jats:p></jats:sec><jats:sec><jats:title>Patients</jats:title><jats:p>Infants born at 22<jats:sup>+0</jats:sup>–31<jats:sup>+6</jats:sup> weeks<jats:sup>+days</jats:sup>gestational age (GA) over 2008–2014 and admitted to neonatal care; published data for admitted infants 22<jats:sup>+0</jats:sup>–25<jats:sup>+6</jats:sup> weeks<jats:sup>+days</jats:sup> GA in 1995 and 2006, and for live births at 22<jats:sup>+0</jats:sup>–31<jats:sup>+6</jats:sup> weeks<jats:sup>+days</jats:sup> GA in 2013.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>We obtained data from the National Neonatal Research Database. We used logistic regression to model survival probability with birth weight, GA, sex, antenatal steroid exposure and multiple birth included in the risk adjustment model and calculated annualpercentage change (APC) for trends using joinpoint regression. We evaluated survival over a 20-year period for infants <26 weeks’ GA using additional published data from the EPICure studies.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>We identified 50 112 eligible infants. There was an increase in survival over 2008–2014 (2008: 88.0%; 2014: 91.3%; adjusted APC 0.46% (95% CI 0.30 to 0.62) p<0.001). The greatest improvement was at 22<jats:sup>+0</jats:sup>–23<jats:sup>+6</jats:sup> weeks (APC 6.03% (95% CI 2.47 to 3.53) p=0.002). Improvement largely occurred in London and South of England (APC: London 1.26% (95% CI 0.60 to 1.96); South of England 1.09% (95% CI 0.36 to 1.82); Midlands and East of England 0.15% (95% CI −0.56 to 0.86); and North of England 0.26% (95% CI −0.54 to 1.07)). Survival at the earliest gestations improved at a similar rate over 1995–2014 (22<jats:sup>+0</jats:sup>–25<jats:sup>+6</jats:sup> weeks, APC 2.73% (95% CI 2.35 to 3.12), p value for change=0.25).</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Continued national improvement in the survival of very preterm admissions masks important regional variation. Timely assessment of preterm survival is feasible using electronic records.</jats:p></jats:sec>