Oya Eddama

Effects of Hypothermia for Perinatal Asphyxia on Childhood Outcomes

BACKGROUND In the Total Body Hypothermia for Neonatal Encephalopathy Trial (TOBY), newborns with asphyxial encephalopathy who received hypothermic therapy had improved neurologic outcomes at 18 months of age, but it is uncertain whether such therapy results in longer-term neurocognitive benefits. METHODS We randomly assigned 325 newborns with asphyxial encephalopathy who were born at a gestational age of 36 weeks or more to receive standard care alone (control) or standard care with hypothermia to a rectal temperature of 33 to 34°C for 72 hours within 6 hours after birth. We evaluated the neurocognitive function of these children at 6 to 7 years of age. The primary outcome of this analysis was the frequency of survival with an IQ score of 85 or higher. RESULTS A total of 75 of 145 children (52%) in the hypothermia group versus 52 of 132 (39%) in the control group survived with an IQ score of 85 or more (relative risk, 1.31; P=0.04). The proportions of children who died were similar in the hypothermia group and the control group (29% and 30%, respectively). More children in the hypothermia group than in the control group survived without neurologic abnormalities (65 of 145 [45%] vs. 37 of 132 [28%]; relative risk, 1.60; 95% confidence interval, 1.15 to 2.22). Among survivors, children in the hypothermia group, as compared with those in the control group, had significant reductions in the risk of cerebral palsy (21% vs. 36%, P=0.03) and the risk of moderate or severe disability (22% vs. 37%, P=0.03); they also had significantly better motor-function scores. There was no significant between-group difference in parental assessments of childrens health status and in results on 10 of 11 psychometric tests. CONCLUSIONS Moderate hypothermia after perinatal asphyxia resulted in improved neurocognitive outcomes in middle childhood. (Funded by the United Kingdom Medical Research Council and others; TOBY ClinicalTrials.gov number, NCT01092637.).

A systematic review of the use of economic evaluation in local decision-making

OBJECTIVES In view of resource scarcity, decisions have to be made on the optimal allocation of resources and one possible option in health care is economic evaluation. Little is known, however, about the use of economic evaluation. The objectives of this review were to assimilate the empirical evidence on this topic, discuss the main findings, and explore the possible need for further work needed in this area. METHODS A total of 40 studies were included in the review from a range of countries. A systematic search strategy was used and data from papers were extracted in a systematic way. RESULTS Pharmacists and clinicians in the US are the most frequently sampled group and postal surveys was the most commonly used method. Despite some positive findings, in most cases there appear to be obstacles to the extensive use of economic evaluation in decision-making. Obstacles can be linked to three factors: (1) institutional and political; (2) cultural; (3) methodological factors associated with economic evaluation itself. CONCLUSION There has clearly been an increase in the use of economic evaluation over time, especially in the UK, whereas the US appears to have a deep rooted disfavour of the approach. However, there is still little known about the exact influence of economic evaluation at the local level. Whilst work conducted to date has been valuable in providing information about use and barriers to use, further qualitative work is needed to enrich and explain some of the findings from this review.

A structured review of the recent literature on the economic consequences of preterm birth

Although survival rates for preterm infants have greatly improved over the last three to four decades, these infants remain at risk of developing a broad range of short-term and long-term complications. Despite the large body of work on the clinical sequelae of preterm birth, relatively little is known about its economic consequences. This paper represents a structured review of the recent scientific literature on the economic consequences of preterm birth for the health services, for other sectors of the economy, for families and carers and, more broadly, for society. A total of 2497 studies were identified by a pretested literature search strategy, 52 of which were included in the final review. Of these 52 studies, 19 reported the costs associated with the initial period of hospitalisation, 35 reported costs incurred following the initial hospital discharge (without providing costs for the entire remaining period of childhood), four of which also reported costs associated with the initial period of hospitalisation, while two reported costs incurred throughout childhood. The paper highlights the variable methodological quality of this body of literature. The results of the studies included in the review are summarised and critically appraised. The paper also highlights gaps in our current knowledge of the topic and identifies requirements for further research in this area.

Use of economic evaluation in local health care decision-making in England: A qualitative investigation

OBJECTIVE To explore decision-making and the use of economic evaluation at the local health care decision-making level in England (UK). METHODS Data collection was over a 16-month period (January 2003 to April 2004). Data collection comprised 29 in-depth interviews with a range of decision makers, 13 observations of decision-making meetings, and analysis of documents produced at meetings. A constant comparative approach was used to identify broad themes and sub-themes arising from the data. Data were analysed using Microsoft Word. RESULTS National Institute for Health and Clinical Excellence (NICE) guidance provides the main way in which economic evaluation is used at a local level in the UK, although following NICE guidance is often regarded as detrimental to pursuing local priorities. Other than through NICE, economic evaluation is not considered at the local level; we found no evidence for use at the meeting group (by individuals). Although decision makers appear to understand notions of scarcity, with some also referring to value for money, the process of decision-making departs from these principles in practice. Disinvestment decisions are not made nor are decisions weighted against pre-defined criteria. Options appraisal is conducted, but it does not embody the principles of economic evaluation, since options are not considered in terms of their costs and benefits and opportunity cost is not accounted for. There appear to be two reasons why economic evaluation is not used at the local level: (1) the nature of management decisions concerned with the employment of extra staff and new equipment, rather than the choice of medicines or specific interventions usually assessed in published economic evaluation; (2) lack of awareness of the economic evaluation approach to decision-making. These two factors point to a lack of freedom in decision-making at the local level and a lack of understanding of how priority setting can be achieved in practice. CONCLUSION A more detailed and rigorous approach to prioritisation at the local level is required. Whilst, PCTs have been given greater responsibility for priority setting, they lack the necessary power and understanding of the ways in which long term solutions to problems in health care can be achieved. Economics can be a valuable asset to priority setting and has already filtered into the jargon used by decision makers. Whilst most concepts are understood, the leap to adopting these concepts into the practice of decision-making needs to be made.

Randomised placebo‐controlled trial of outpatient (at home) cervical ripening with isosorbide mononitrate (IMN) prior to induction of labour – clinical trial with analyses of efficacy and acceptability. The IMOP Study

Objective  To determine whether isosorbide mononitrate (IMN), self‐administered vaginally by women at home, improves the process of induction of labour.

The cost-effectiveness of outpatient (at home) cervical ripening with isosorbide mononitrate prior to induction of labour

Objectives  To assess the cost‐effectiveness of outpatient (at home) cervical ripening with isosorbide mononitrate (IMN) prior to induction of labour.

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

Cost-effectiveness analysis of prostaglandin E2 gel for the induction of labour at term.

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

Effect of MRI on preterm infants and their families: a randomised trial with nested diagnostic and economic evaluation.

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.

Study of progesterone for the prevention of preterm birth in twins (STOPPIT): Findings from a trial-based cost-effectiveness analysis

Please cite this paper as: Petrou S, Taher S, Abangma G, Eddama O, Bennett P. Cost‐effectiveness analysis of prostaglandin E2 gel for the induction of labour at term. BJOG 2011;118:726–734.