Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT).

OBJECTIVE: To compare the effect of induction of labour with a policy of expectant monitoring for intrauterine growth restriction near term. DESIGN: Multicentre randomised equivalence trial (the Disproportionate Intrauterine Growth Intervention Trial At Term (DIGITAT)). SETTING: Eight academic and 44 non-academic hospitals in the Netherlands between November 2004 and November 2008. PARTICIPANTS: Pregnant women who had a singleton pregnancy beyond 36+0 weeks' gestation with suspected intrauterine growth restriction. INTERVENTIONS: Induction of labour or expectant monitoring. MAIN OUTCOME MEASURES: The primary outcome was a composite measure of adverse neonatal outcome, defined as death before hospital discharge, five minute Apgar score of less than 7, umbilical artery pH of less than 7.05, or admission to the intensive care unit. Operative delivery (vaginal instrumental delivery or caesarean section) was a secondary outcome. Analysis was by intention to treat, with confidence intervals calculated for the differences in percentages or means. RESULTS: 321 pregnant women were randomly allocated to induction and 329 to expectant monitoring. Induction group infants were delivered 10 days earlier (mean difference -9.9 days, 95% CI -11.3 to -8.6) and weighed 130 g less (mean difference -130 g, 95% CI -188 g to -71 g) than babies in the expectant monitoring group. A total of 17 (5.3%) infants in the induction group experienced the composite adverse neonatal outcome, compared with 20 (6.1%) in the expectant monitoring group (difference -0.8%, 95% CI -4.3% to 3.2%). Caesarean sections were performed on 45 (14.0%) mothers in the induction group and 45 (13.7%) in the expectant monitoring group (difference 0.3%, 95% CI -5.0% to 5.6%). CONCLUSIONS: In women with suspected intrauterine growth restriction at term, we found no important differences in adverse outcomes between induction of labour and expectant monitoring. Patients who are keen on non-intervention can safely choose expectant management with intensive maternal and fetal monitoring; however, it is rational to choose induction to prevent possible neonatal morbidity and stillbirth. TRIAL REGISTRATION: International Standard Randomised Controlled Trial number ISRCTN10363217.

An economic analysis of induction of labour and expectant monitoring in women with gestational hypertension or pre-eclampsia at term (HYPITAT trial).

OBJECTIVE: To assess the economic consequences of labour induction compared with expectant monitoring in women with gestational hypertension or pre-eclampsia at term. DESIGN: An economic analysis alongside the Hypertension and Pre-eclampsia Intervention Trial At Term (HYPITAT). SETTING: Obstetric departments of six university and 32 teaching and district hospitals in the Netherlands. POPULATION: Women diagnosed with gestational hypertension or pre-eclampsia between 36(+0) and 41(+0) weeks of gestation, randomly allocated to either induction of labour or expectant monitoring. METHODS: A trial-based cost-effectiveness analysis was performed from a societal perspective during a 1-year time horizon. MAIN OUTCOME MEASURES: One-year costs were estimated and health outcomes were expressed as the prevalence of poor maternal outcome defined as either maternal complications or progression to severe disease. RESULTS: The average costs of induction of labour (n = 377) were €7077 versus €7908 for expectant monitoring (n = 379), with an average difference of -€831 (95% CI -€1561 to -€144). This 11% difference predominantly originated from the antepartum period: per woman costs were €1259 for induction versus €2700 for expectant monitoring. During delivery, more costs were generated following induction (€2190) compared with expectant monitoring (€1210). No substantial differences were found in the postpartum, follow-up and for non-medical costs. CONCLUSION: In women with gestational hypertension or mild pre-eclampsia at term, induction of labour is less costly than expectant monitoring because of differences in resource use in the antepartum period. As the trial already demonstrated that induction of labour results in less progression to severe disease without resulting in a higher caesarean section rate, both clinical and economic consequences are in favour of induction of labour in these women. TRIAL REGISTRATION: The trial has been registered in the clinical trial register as ISRCTN08132825.

Relationship between costs of lifestyle interventions and weight loss in overweight adults.

Lifestyle interventions in a healthcare setting are effective for weight loss, but it is unclear whether more expensive interventions result in more weight loss. Our objective was to explore the relationship between intervention costs and effectiveness in a systematic review of randomized trials. Intervention studies were selected from 14 reviews and from a systematic MEDLINE-search. Studies had to contain a dietary and a physical activity component and report data on measured weight loss in healthy Caucasian overweight adults. Intervention costs were calculated in a standardized way. The association between costs and percentage weight loss after 1 year was assessed using regression analysis. Nineteen original studies describing 31 interventions were selected. The relationship between weight loss and intervention costs was best described by an asymptotic regression model, which explained 47% of the variance in weight loss. A clinically relevant weight loss of 5% was already observed in interventions of approximately euro110. Results were similar in an intention-to-treat analysis. In conclusion, lifestyle interventions in health care for overweight adults are relatively cheap and higher intervention costs are associated with more weight loss, although the effect of costs on weight loss levels off with growing costs.

[Cost-effectiveness of prevention: opportunities for public health policy in the Netherlands]. / Kosteneffectiviteit van preventie: kansen voor het Nederlandse volksgezondheidsbeleid.

OBJECTIVE: To gain insight into the cost-effectiveness of new preventive interventions. DESIGN: Systematic review and interviews. METHOD: Based on literature search, a search of the project database of ZonMw and interviews with experts, the National Institute for Public Health and the Environment drew up a long list of preventive interventions that are potentially cost-effective but are not yet systematically carried out in the Netherlands. From this long list, 21 interventions were selected for each of which, at least 3 economic evaluations were available that indicate favourable cost-effectiveness (< Euro 20,000,--per QALY gained). RESULTS: The majority of the interventions concerned vaccination and screening programmes (7 and 5 respectively). Only a small minority concerned health promotion or health protection (1 respectively 3). There was strong evidence that 5 interventions were both cost-effective, and feasible. These were: screening for Chlamydia, screening for diabetic retinopathy in type 2 diabetes, screening for neonatal group beta streptococcal infections through a combination strategy, prevention of recurrent myocardial infarction through heart habilitation, and prevention of head injuries by wearing of bicycle helmets by children. CONCLUSION: Before implementation of preventive interventions, it is necessary to investigate whether these interventions are also cost-effective in the Dutch context.

Cost-effectiveness analyses of health promotion programs: a case study of smoking prevention and cessation among Dutch students.

Little research has been done to connect health promotion programs to outcomes in terms of life expectancy, health care costs and cost-effectiveness. For a policy maker, economic evaluation may be an important tool to support decisions on how to allocate the health care budget. The aim of this paper was to determine the cost-effectiveness of a Dutch school-based smoking education program. The incremental cost-effectiveness ratio of the school program was estimated at euro19 900 per quality adjusted life year gained. For a complete analysis, not only intervention costs but also savings for smoking-related diseases and differences in total health care costs should be taken into account. As several assumptions had to be made in order to estimate cost-effectiveness, the study outcomes should be interpreted with caution. Main problem in estimating the cost-effectiveness was the lack of proper effectiveness data on daily smokers among adolescents. Absence of specific effectiveness data often is an obstacle in the economic evaluation of public health interventions. While some problems may be the result of insufficient sample size or follow-up, another possible explanation might be the different basic principles of analysis of health promoters and economists.