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Neonatal outcomes and delivery of care for infants born late preterm or moderately preterm: a prospective population-based study
Objective To describe neonatal outcomes and explore variation in delivery of care for infants born late (34-36 weeks) and moderately (32-33 weeks) preterm (LMPT). Design/setting Prospective population-based study comprising births in four major maternity centres, one midwifery-led unit and at home between September 2009 and December 2010. Data were obtained from maternal and neonatal records. Participants All LMPT infants were eligible. A random sample of term-born infants (>= 37 weeks) acted as controls. Outcome measures Neonatal unit (NNU) admission, respiratory and nutritional support, neonatal morbidities, investigations, length of stay and postnatal ward care were measured. Differences between centres were explored. Results 1146(83%) LMPT and 1258 (79% of eligible) term-born infants were recruited. LMPT infants were significantly more likely to receive resuscitation at birth (17.5% vs 7.4%), respiratory (11.8% vs 0.9%) and nutritional support (3.5% vs 0.3%) and were less likely to be fed breast milk (64.2% vs 72.2%) than term infants. For all interventions and morbidities, a gradient of increasing risk with decreasing gestation was evident. Although 60% of late preterm infants were never admitted to a NNU, 83% required medical input on postnatal wards. Clinical management differed significantly between services. Conclusions LMPT infants place high demands on specialist neonatal services. A substantial amount of previously unreported specialist input is provided in postnatal wards, beyond normal newborn care. Appropriate expertise and planning of early care are essential if such infants are managed away from specialised neonatal settings. Further research is required to clarify optimal and cost-effective postnatal management for LMPT babies.
Neurodevelopmental outcomes following late and moderate prematurity: a population-based cohort study
Objective There is a paucity of data relating to neurodevelopmental outcomes in infants born late and moderately preterm (LMPT; 32(+0)-36(+6) weeks). This paper present the results of a prospective, population-based study of 2-year outcomes following LMPT birth. Design 1130 LMPT and 1255 term-born children were recruited at birth. At 2 years corrected age, parents completed a questionnaire to assess neurosensory (vision, hearing, motor) impairments and the Parent Report of Children's Abilities-Revised to identify cognitive impairment. Relative risks for adverse outcomes were adjusted for sex, socio-economic status and small for gestational age, and weighted to account for over-sampling of term-born multiples. Risk factors for cognitive impairment were explored using multivariable analyses. Results Parents of 638 (57%) LMPT infants and 765 (62%) controls completed questionnaires. Among LMPT infants, 1.6% had neurosensory impairment compared with 0.3% of controls (RR 4.89, 95% CI 1.07 to 22.25). Cognitive impairments were the most common adverse outcome: LMPT 6.3%; controls 2.4% (RR 2.09, 95% CI 1.19 to 3.64). LMPT infants were at twice the risk for neurodevelopmental disability (RR 2.19, 95% CI 1.27 to 3.75). Independent risk factors for cognitive impairment in LMPT infants were male sex, socioeconomic disadvantage, non-white ethnicity, preeclampsia and not receiving breast milk at discharge. Conclusions Compared with term-born peers, LMPT infants are at double the risk for neurodevelopmental disability at 2 years of age, with the majority of impairments observed in the cognitive domain. Male sex, socio-economic disadvantage and preeclampsia are independent predictors of low cognitive scores following LMPT birth.
Preferred Reporting Items for Studies Mapping onto Preference-Based Outcome Measures: The Maps Statement
Background: Mapping onto generic preference-based outcome measures is increasingly being used as a means of generating health utilities for use within health economic evaluations. Despite publication of technical guides for the conduct of mapping research, guidance for the reporting of mapping studies is currently lacking. The MAPS (MApping onto Preference-based measures reporting Standards) statement is a new checklist, which aims to promote complete and transparent reporting of mapping studies. Methods: In the absence of previously published reporting checklists or reporting guidance documents, a de novo list of reporting items was created by a working group comprised of six health economists and one Delphi methodologist. A two-round, modified Delphi survey with representatives from academia, consultancy, health technology assessment agencies, and the biomedical journal editorial community was used to identify a list of essential reporting items from this larger list. Results: From the initial de novo list of twenty-nine candidate items, a set of twenty-three essential reporting items was developed. The items are presented numerically and categorized within six sections, namely: (i) title and abstract, (ii) introduction, (iii) methods, (iv) results, (v) discussion, and (vi) other. The MAPS statement is best applied in conjunction with the accompanying MAPS explanation and elaboration document. Conclusions: It is anticipated that the MAPS statement will improve the clarity, transparency. and completeness of reporting of mapping studies. To facilitate dissemination and uptake, the MAPS statement is being co-published by seven health economics and quality of life journals, and broader endorsement is encouraged. The MAPS working group plans to assess the need for an update of the reporting checklist in five years' time.
Self-reported health and socio-economic inequalities in England, 1996-2009: Repeated national cross-sectional study
Tackling social inequalities in health has been a priority for recent UK governments. We used repeated national cross-sectional data for 155,311 participants (aged >= 16 years) in the Health Survey of England to examine trends in socio-economic inequalities in self-reported health over a recent period of sustained policy focus by successive UK governments aimed at tackling social inequalities in health. Socioeconomic related inequalities in self-reported health were estimated using the Registrar General's occupational classification (1996-2009), and for sensitivity analyses, the National Statistics Socio-Economic Classification (NS-SEC; 2001-2011). Multi-level regression was used to evaluate time trends in General Health Questionnaire (GHQ-12) scores and bad or very bad self-assessed health (SAH), as well as EQ-5D utility scores. The study found that the probability of reporting GHQ-12 scores >= 4 and >= 1 was higher in those from lower social classes, and decreased for all social classes between 1997 and 2009. For SAH, the probability of reporting bad or very bad health remained relatively constant for social class I (professional) [0.028 (95%CI: 0.026, 0.029) in 1996 compared to 0.028 (95%CI: 0.024, 0.032) in 20091, but increased in lower social classes, with the greatest increase observed amongst those in social class V (unskilled manual) [0.089 (95%CI: 0.085, 0.093) in 1996 compared to 0.155 (95%CI: 0.141, 0.168) in 2009]. EQ-5D utility scores were lower for those in lower social classes, but remained comparable across survey years. In sensitivity analyses using the NS-SEC, health outcomes improved from 2001 to 2011, with no evidence of widening socio-economic inequalities. Our findings suggest that socio-economic inequalities have persisted, with evidence of widening for some adverse self-reported health outcomes. Crown Copyright (C) 2015 Published by Elsevier Ltd.
Many factors affect child and adolescent mortality in high-income countries. These factors can be conceptualised within four domains-intrinsic (biological and psychological) factors, the physical environment, the social environment, and service delivery. The most prominent factors are socioeconomic gradients, although the mechanisms through which they exert their effects are complex, affect all four domains, and are often poorly understood. Although some contributing factors are relatively fixed-including a child's sex, age, ethnic origin, and genetics, some parental characteristics, and environmental conditions-others might be amenable to interventions that could lessen risks and help to prevent future child deaths. We give several examples of health service features that could affect child survival, along with interventions, such as changes to the physical or social environment, which could affect upstream (distal) factors.
Discrete choice experiments (DCEs) are increasingly used in health economics to address a wide range of health policy-related concerns. Broadly adopting the methodology of an earlier systematic review of health-related DCEs, which covered the period 2001-2008, we report whether earlier trends continued during 2009-2012. This paper systematically reviews health-related DCEs published between 2009 and 2012, using the same database as the earlier published review (PubMed) to obtain citations, and the same range of search terms. A total of 179 health-related DCEs for 2009-2012 met the inclusion criteria for the review. We found a continuing trend towards conducting DCEs across a broader range of countries. However, the trend towards including fewer attributes was reversed, whilst the trend towards interview-based DCEs reversed because of increased computer administration. The trend towards using more flexible econometric models, including mixed logit and latent class, has also continued. Reporting of monetary values has fallen compared with earlier periods, but the proportion of studies estimating trade-offs between health outcomes and experience factors, or valuing outcomes in terms of utility scores, has increased, although use of odds ratios and probabilities has declined. The reassuring trend towards the use of more flexible and appropriate DCE designs and econometric methods has been reinforced by the increased use of qualitative methods to inform DCE processes and results. However, qualitative research methods are being used less often to inform attribute selection, which may make DCEs more susceptible to omitted variable bias if the decision framework is not known prior to the research project. The use of DCEs in healthcare continues to grow dramatically, as does the scope of applications across an expanding range of countries. There is increasing evidence that more sophisticated approaches to DCE design and analytical techniques are improving the quality of final outputs. That said, recent evidence that the use of qualitative methods to inform attribute selection has declined is of concern.
Objectives: The aim of this study was to estimate the cost-effectiveness of nebulized magnesium sulphate (MgSO4) in acute asthma in children from the perspective of the UK National Health Service and personal social services. Methods: An economic evaluation was conducted based on evidence from a randomized placebo controlled multi-center trial of nebulized MgSO4 in severe acute asthma in children. Participants comprised 508 children aged 2-16 years presenting to an emergency department or a children's assessment unit with severe acute asthma across thirty hospitals in the United Kingdom. Children were randomly allocated to receive nebulized salbutamol and ipratropium bromide mixed with either 2.5 ml of isotonic MgSO4 or 2.5 ml of isotonic saline on three occasions at 20-min intervals. Cost-effectiveness outcomes were constructed around the Yung Asthma Severity Score (ASS) after 60 min of treatment; whilst cost-utility outcomes were constructed around the quality-adjusted life-year (QALY) metric. The nonparametric bootstrap method was used to present cost-effectiveness acceptability curves at alternative cost-effectiveness thresholds for either: (i) a unit reduction in ASS; or (ii) an additional QALY. Results: MgSO4 had a 75.1 percent probability of being cost-effective at a GBP 1,000 (EUR 1,148) per unit decrement in ASS threshold, an 88.0 percent probability of being more effective (in terms of reducing the ASS) and a 36.6 percent probability of being less costly. MgSO4 also had a 67.6 percent probability of being cost-effective at a GBP 20,000 (EUR 22,957) per QALY gained threshold, an 8.5 percent probability of being more effective (in terms of generating increased QALYs) and a 69.1 percent probability of being less costly. Sensitivity analyses showed that the results of the economic evaluation were particularly sensitive to the methods used for QALY estimation. Conclusions: The probability of cost-effectiveness of nebulized isotonic MgSO4, given as an adjuvant to standard treatment of severe acute asthma in children, is less than 70 percent across accepted cost-effectiveness thresholds for an additional QALY.
The effects of designation and volume of neonatal care on mortality and morbidity outcomes of very preterm infants in England: retrospective population-based cohort study
Objective: To examine the effects of designation and volume of neonatal care at the hospital of birth on mortality and morbidity outcomes in very preterm infants in a managed clinical network setting. Design: A retrospective, population-based analysis of operational clinical data using adjusted logistic regression and instrumental variables (IV) analyses. Setting: 165 National Health Service neonatal units in England contributing data to the National Neonatal Research Database at the Neonatal Data Analysis Unit and participating in the Neonatal Economic, Staffing and Clinical Outcomes Project. Participants: 20 554 infants born at <33 weeks completed gestation (17 995 born at 27-32 weeks; 2559 born at <27 weeks), admitted to neonatal care and either discharged or died, over the period 1 January 2009-31 December 2011. Intervention: Tertiary designation or high-volume neonatal care at the hospital of birth. Outcomes: Neonatal mortality, any in-hospital mortality, surgery for necrotising enterocolitis, surgery for retinopathy of prematurity, bronchopulmonary dysplasia and postmenstrual age at discharge. Results: Infants born at <33 weeks gestation and admitted to a high-volume neonatal unit at the hospital of birth were at reduced odds of neonatal mortality (IV regression odds ratio (OR) 0.70, 95% CI 0.53 to 0.92) and any in-hospital mortality (IV regression OR 0.68, 95% CI 0.54 to 0.85). The effect of volume on any in-hospital mortality was most acute among infants born at <27 weeks gestation (IV regression OR 0.51, 95% CI 0.33 to 0.79). A negative association between tertiary-level unit designation and mortality was also observed with adjusted logistic regression for infants born at <27 weeks gestation. Conclusions: High-volume neonatal care provided at the hospital of birth may protect against in-hospital mortality in very preterm infants. Future developments of neonatal services should promote delivery of very preterm infants at hospitals with high-volume neonatal units.
Background: The objective of this study was to investigate the association between ethnicity and health related quality of life (HRQoL) in patients with type 2 diabetes. Methods: The EuroQol EQ-5D measure was administered to 1,978 patients with type 2 diabetes in the UK Asian Diabetes Study (UKADS): 1,486 of south Asian origin (Indian, Pakistani, Bangladeshi or other south Asian) and 492 of white European origin. Multivariate regression using ordinary least square (OLS), Tobit, fractional logit and Censored Least Absolutes Deviations estimators was used to estimate the impact of ethnicity on both visual analogue scale (VAS) and utility scores for the EuroQol EQ-5D. Results: Mean EQ-5D VAS and utility scores were lower among south Asians with diabetes compared to the white European population; the unadjusted effect on the mean EQ-5D VAS score was -7.82 (Standard error [SE] = 1.06, p < 0.01) and on the EQ-5D utility score was -0.06 (SE = 0.02, p < 0.01) (OLS estimator). After controlling for socio-demographic and clinical confounders, the adjusted effect on the EQ-5D VAS score was -9.35 (SE = 2.46, p < 0.01) and on the EQ-5D utility score was 0.06 (SE = 0.04), although the latter was not statistically significant. Conclusions: There was a large and statistically significant association between south Asian ethnicity and lower EQ-5D VAS scores. In contrast, there was no significant difference in EQ-5D utility scores between the south Asian and white European sub-groups. Further research is needed to explain the differences in effects on subjective EQ-5D VAS scores and population-weighted EQ-5D utility scores in this context.
Methodological and applied concerns surrounding age-related weighting within health economic evaluation
Economic evaluations that measure the benefits of health interventions in terms of units of health gain inevitably require decision-makers to make judgments about the 'value for money' of those health gains. Decision-making bodies have also commonly returned to the position that a unit of health gain, such as an additional quality-adjusted life year, is of equal value regardless of the characteristics of the recipient. This paper focuses on whether and how health gains in economic evaluation should be differentially weighted by age of recipient. The paper presents a structured overview of evidence from the revealed preference and stated preference literature in this area. It discusses a number of methodological issues raised by differential weighting of health gains by age of recipient. These include identifying appropriate samples for the derivation of age-related weights, methodological issues surrounding the application of the quality-adjusted life year measure, the relative merits of alternative valuation techniques for weighting exercises, the impact of context and design effects on derived values and operational concerns surrounding the application of age-related weights within economic evaluation. The paper ends with pointers for potential future research in this area.
Background There is a paucity of evidence on the association between childhood disability and economic outcomes. This study estimates the economic costs and health utilities associated with neurodevelopmental impairment or serious neurodevelopmental disability during the 11th year of life. Methods Standardized tests of cognitive ability and clinical assessments of functional abilities were performed on participants of a whole population study of extremely preterm children and term-born controls (EPICure). Profiles of children's use of health, social and education services, and descriptions of their health status using the Health Utilities Index Mark 2 and Mark 3 health status classification systems, were extracted from detailed questionnaires completed by the main parent. Descriptive and multiple regression techniques were used to explore the association between neurodevelopmental impairment or serious neurodevelopmental disability and two sets of economic outcomes; economic costs and health utilities. Results Mean health and social service costs over the 12-month period were estimated at 577 pound [standard error (SE): 141] pound among children without neurodevelopmental impairment, 831 pound (112) pound among children with a mild neurodevelopmental impairment, 1053 pound (176) pound among children with a moderate neurodevelopmental impairment and 1662 pound (316) pound among children with a severe neurodevelopmental impairment. Mean health and social service costs were estimated at 1223 pound (157) pound and 695 pound (92) pound among children with and without serious neurodevelopmental disability, respectively. After controlling for clinical and sociodemographic confounders, mild, moderate and severe neurodevelopment impairment increased health and social service costs by an average of 397 pound (95% CI: 86 pound, 707; pound P= 0.012), 655 pound (95% CI: 167 pound, 1144; pound P= 0.009) and 1065 pound (95% CI: 113 pound, 2243; pound P= 0.076), respectively. Cost differences were accentuated when broader public sector costs were considered. The mean (SE) Health Utilities Index Mark 3 multi-attribute utility score for the children with neurodevelopmental disability was 0.652 (0.039), compared with 0.923 (0.009) for children without neurodevelopmental disability, generating a mean difference in utility score of 0.272 (95% CI: 0.220, 0.323) that was statistically significant (P < 0.001). Conclusions Our data should act as a significant new resource for economic analysts modelling the overall economic impact of childhood neurodevelopment impairment or disability or the cost-effectiveness of interventions targeted at neurodevelopmentally impaired or disabled children.
Two licensed vaccines are available to prevent RVGE in infants. A worldwide critical review of economic evaluations of these vaccines was conducted. The objective was to describe differences in methodologies, assumptions and inputs and determine the key factors driving differences in conclusions. 68 economic evaluations were reviewed. RV vaccination was found to be cost-effective in developing countries, while conclusions varied between studies in developed countries. Many studies found that vaccination was likely to be cost-effective under some scenarios, such as lower prices scenarios, inclusion of herd protection, and/or adoption of a societal perspective. Other reasons for variability included uncertainty around healthcare visits incidence and lack of consensus on quality of life (QoL) valuation for infants and caregivers. New evidence on the vaccination effectiveness in real-world, new ways of modeling herd protection and assessments of QoL in children could help more precisely define the conditions under which RV vaccination would be cost-effective in developed countries.
Background Major behavioural risk factors, namely obesity, alcohol consumption, smoking, lack of fruit and vegetable intake and physical inactivity negatively impact on self-reported quality of life. However, little is known about their impact on preference-based measures of health-related quality of life commonly used to inform economic evaluations. Methods Preference-based health-related quality of life outcomes associated with major behavioural risk factors were estimated using the EuroQol EQ-5D responses of 14 117 participants, aged >= 16 years, in the 2008 Health Survey for England. Multivariable linear regression was used to model the relationship between the five risk factors and EQ-5D utility scores. In addition, logistic regression was used to model their relationship to dichotomous reports of problems for each of the five EQ-5D dimensions. Results Only one-third of participants had a body mass index within normal range, never drank alcohol, consumed at least five portions of fruit or vegetable/day or exercised regularly, while nearly half of participants were smokers or ex-smokers. In the fully adjusted multivariable analyses, reductions in EQ-5D utility scores (95% CI) of 0.105 (0.072 to 0.137), 0.062 (0.042 to 0.082) and 0.142 (0.129 to 0.155) were estimated for a body mass index >= 40 kg/m(2), heavy smoking (>= 20 cigarettes/day) and physical inactivity, respectively. Hazardous alcohol consumption (men >4 and <= 8 units/day; women >3 and <= 6 units/day) and daily fruit and vegetable intake between three and less than five portions were associated with small positive effects on EQ-5D utility scores (p<0.05). Conclusions The high prevalence and substantial utility loss associated with obesity, smoking and physical inactivity highlight the potential impact that interventions aimed at their prevention or alleviation may have on population health.
Evaluation of the effectiveness and cost-effectiveness of Families for Health V2 for the treatment of childhood obesity: study protocol for a randomized controlled trial
Background: Effective programs to help children manage their weight are required. Families for Health focuses on a parenting approach, designed to help parents develop their parenting skills to support lifestyle change within the family. Families for Health V1 showed sustained reductions in overweight after 2 years in a pilot evaluation, but lacks a randomized controlled trial (RCT) evidence base. Methods/design: This is a multi-center, investigator-blind RCT, with parallel economic evaluation, with a 12-month follow-up. The trial will recruit 120 families with at least one child aged 6 to 11 years who is overweight (>= 91st centile BMI) or obese (>= 98th centile BMI) from three localities and assigned randomly to Families for Health V2 (60 families) or the usual care control (60 families) groups. Randomization will be stratified by locality (Coventry, Warwickshire, Wolverhampton). Families for Health V2 is a family-based intervention run in a community venue. Parents/carers and children attend parallel groups for 2.5 hours weekly for 10 weeks. The usual care arm will be the usual support provided within each NHS locality. A mixed-methods evaluation will be carried out. Child and parent participants will be assessed at home visits at baseline, 3-month (post-treatment) and 12-month follow-up. The primary outcome measure is the change in the children's BMI z-scores at 12 months from the baseline. Secondary outcome measures include changes in the children's waist circumference, percentage body fat, physical activity, fruit/vegetable consumption and quality of life. The parents' BMI and mental well-being, family eating/activity, parent-child relationships and parenting style will also be assessed. Economic components will encompass the measurement and valuation of service utilization, including the costs of running Families for Health and usual care, and the EuroQol EQ-5D health outcomes. Cost-effectiveness will be expressed in terms of incremental cost per quality-adjusted life year gained. A de novo decision-analytic model will estimate the lifetime cost-effectiveness of the Families for Health program. Process evaluation will document recruitment, attendance and drop-out rates, and the fidelity of Families for Health delivery. Interviews with up to 24 parents and children from each arm will investigate perceptions and changes made. Discussion: This paper describes our protocol to assess the effectiveness and cost-effectiveness of a parenting approach for managing childhood obesity and presents challenges to implementation.
Magnesium sulphate in acute severe asthma in children (MAGNETIC): a randomised, placebo-controlled trial
Background Little evidence is available for the effect of nebulised magnesium sulphate (MgSO4) in acute asthma in children. We assessed the effect of MgSO4 treatment in children with severe acute asthma. Methods In this randomised placebo-controlled, multi-centre, parallel trial, we enrolled children (aged 2-16 years) with severe acute asthma who did not respond to standard inhaled treatment from 30 hospitals in the UK. Children were randomly allocated (1: 1) to receive nebulised salbutamol and ipratropium bromide with either 2.5 mL of isotonic MgSO4 (250 mmol/L; 151 mg per dose; MgSO4 group) or 2.5 mL of isotonic saline (placebo group) on three occasions at 20-min intervals. Randomisation was done with a computer-generated randomisation sequence, with random block sizes of two to four. Both patients and researchers were masked to treatment allocation. The primary outcome measure was the Yung Asthma Severity Score (ASS) at 60 min post-randomisation. We used a statistical significance level of p<0.05 for a between-group difference, but regarded a between-group difference in ASS of 0.5 as the minimal clinically significant treatment effect. Analysis was done by intention to treat. This trial is registered with controlled-trials.com, number ISRCTN81456894. Findings Between Jan 3, 2009, and March 20, 2011, we recruited and randomly assigned 508 children to treatment: 252 to MgSO4 and 256 to placebo. Mean ASS at 60 min was lower in the MgSO4 group (4.72 [SD 1.37]) than it was in the placebo group (4.95 [SD 1.40]; adjusted difference -0.25, 95% CI -0.48 to -0.02; p=0.03). This difference, however, was not clinically significant. The clinical effect was larger in children with more severe asthma exacerbation (p=0.03) and those with symptoms present for less than 6 h (p=0.049). We detected no difference in the occurrence of adverse events between groups. Interpretation Overall, nebulised isotonic MgSO4, given as an adjuvant to standard treatment, did not show a clinically signifi cant improvement in mean ASS in children with acute severe asthma. However, the greatest clinical response was seen in children with more severe attacks (SaO(2)<92%) at presentation and those with preceding symptoms lasting less than 6 h.
An increasing body of literature is exploring whether the age of the recipient of health care should be a criterion in how health care resources are allocated. The existing literature is constrained both by the relatively small number of age comparison groups within preference-elicitation studies, and by a paucity of methodological robustness tests for order and framing effects and the reliability and transitivity of preferences that would strengthen confidence in the results. This paper reports the results of a study aimed at estimating granulated age-related weights for health gains across the age spectrum that can potentially inform health care decision-making. A sample of 2,500 participants recruited from the health care consumer panels of a social research company completed a person trade-off (or 'matching') study designed to estimate age-related weights for 5- and 10-year life extensions. The results are presented in terms of matrices for alternative age comparisons across the age spectrum. The results revealed a general, although not invariable, tendency to give more weight to health gains, expressed in terms of life extensions, in younger age groups. In over 85% of age comparisons, the person trade-off exercises revealed a preference for life extensions by the younger of the two age groups that were compared. This pattern held regardless of the method of aggregating responses across study participants. Moreover, the relative weight placed on life extensions by the younger of the two age groups was generally, although not invariably, found to increase as the age difference between the comparator age groups increased. Further analyses revealed that the highest mean relative weight placed on life extensions was estimated for 30-year-olds when the ratio of means method was used to aggregate person trade-off responses across study participants. The highest mean relative weight placed on life extensions was estimated for 10-year-olds for 5-year life extensions and for 30-year-olds for 10-year life extensions, when the median of individual ratios method was used to aggregate person trade-off responses across study participants. Methodological tests framed around alternative referents in the person trade-off questions and the stability of preferences had no discernible effects on the study results. This study has produced new evidence on age-related weights for health gains that can potentially inform health care decision-making.
Objectives To test whether health-related quality of life (HRQL) based on societal standards differs between very low birth weight/very preterm (VLBW/VP) and full-term (FT) adolescents using self and parent proxy reports. Also, to examine whether self and parent reported HRQL is explained by indicators of objective functioning in childhood. Study design This prospective cohort study followed 260 VLBW/VP adolescents, 12 VLBW/VP adolescents with disability, and 282 FT adolescents. Objective functioning was assessed at 8.5 years; HRQL was assessed at 13 years with the Health Utilities Index Mark 3 (HUI3). Results Adolescents reported more functional impairment than their parents especially in the psychological aspects of health. The mean difference in HUI3 multi-attribute utility scores between FT and VLBW/VP adolescents was small (parents: 0.91 [95% CI, 0.90, 0.92] vs 0.88 [95% CI, 0.86, 0.90]; adolescents: 0.87 [95% CI, 0.85, 0.89] vs 0.84 [95% CI, 0.82, 0.86]), but high for VLBW/VP adolescents with disabilities (0.18, 95% CI, -0.04, 0.40). Objective function did not predict HRQL in FT adolescents but contributed to prediction of HRQL in VLBW/VP adolescents without disabilities. Different indicators of objective functioning were important for adolescent vs parent reports. More variation in HUI3 scores was explained by objective function in VLBW/VP parent reports compared with adolescent reports (25% vs 18%). Conclusions VLBW/VP adolescents reported poorer HRQL than their FT peers in early adolescence. Improvement in HRQL as VLBW/VP children grow up is, at least partly, explained by exclusion of the most disabled in self reports by VLBW/VP adolescents and the use of different reference points by adolescents compared with parents.
Standard- or high-dose oxytocin for nulliparous women with confirmed delay in labour: quantitative and qualitative results from a pilot randomised controlled trial
ObjectiveEvidence suggests that a high dose of oxytocin for nulliparous women at 37-42weeks of gestation with confirmed delay in labour increases spontaneous vaginal birth. We undertook a pilot study to test the feasibility of this treatment. DesignPilot double-blind randomised controlled trial. SettingThree teaching hospitals in the UK. PopulationA total of 94 consenting nulliparous women at term with confirmed delay in labour were recruited, and 18 were interviewed. MethodsWomen were assigned to either a standard (2mU/min, increasing every 30minutes to 32mU/minute) or a high-dose regimen (4mU/minute, increasing every 30minutes to 64mU/minutes) oxytocin by computer-generated randomisation. Simple descriptive statistics were used, as the sample size was insufficient to evaluate clinical outcomes. The constant comparative method was used to analyse the interviews. Main outcomes measuresThe main outcome measures: number of women eligible; maternal and neonatal birth; safety; maternal psychological outcomes and experiences; health-related quality of life outcomes using validated tools and data on health service resource use; incidence of suspected delay of labour (cervical dilatation of <2cm after 4hours, once labour is established); and incidence of confirmed delay of labour (progress of <1cm on repeat vaginal examination after a period of 2hours). ResultsWe successfully developed systems to recruit eligible women in labour and to collect data. Rates of spontaneous vaginal birth (10/47 versus 12/47, RR 1.2, 95%CI 0.6-2.5) and caesarean section (15/47 versus 17/47, RR 1.1, 95%CI 0.6-2.0) were increased, and rates of instrumental birth were reduced (21/47 versus 17/47, RR 0.8, 95% CI 0.5-1.3). No evidence of increased harm for either mother or baby was found. The incidences of suspected delay (14%) and confirmed delay (11%) in labour were less than anticipated. Of those who did not go on to have delayed labour confirmed, all except one woman gave birth vaginally. ConclusionsA pilot trial assessing the efficacy of high-dose oxytocin was feasible, but uncertainty remains, highlighting the need for a large definitive trial. The implementation of national guidance of suspected and confirmed delay in labour is likely to reduce intervention.