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

OBJECTIVE: To estimate the cost-effectiveness of prostaglandin E2 (dinoprostone) vaginal gel for the induction of labour at term from the perspective of the UK's National Health Service. DESIGN: Economic evaluation conducted as part of a randomised controlled trial. SETTING: Maternity department at a major teaching hospital in London, UK. POPULATION: A cohort of 165 pregnant women presenting as cephalic between 36(+6) and 41(+6) weeks of gestation, for whom induction of labour was deemed necessary. METHODS: Either 3-mg Prostin E2 vaginal tablets or 1- or 2-mg Prostin E2 vaginal gel were administered at 6-hourly intervals. MAIN OUTCOME MEASURES: Incremental cost per hour prevented between induction and delivery. The nonparametric bootstrap method was used to construct cost-effectiveness acceptability curves and estimate net benefits at alternative cost-effectiveness thresholds. RESULTS: Women receiving the gel accrued nonsignificantly higher costs (incremental cost £630; bootstrap 95% CI -£353, £2320; P = 0.43), and experienced a significantly reduced interval between induction and delivery (median of 1400 versus 1780 minutes; mean of 1711 versus 2765 minutes; P = 0.03). The incremental cost per hour prevented from induction of labour to delivery was estimated at £36. At a cost-effectiveness threshold of £100 per hour of care prevented, the probability that the gel is cost-effective was estimated at 0.83, and the mean net benefit to the health services was estimated at £1121 (bootstrap 95% CI -£1133, £3379). The results were sensitive to the inclusion of neonatal costs in the analysis and the value of the cost-effectiveness threshold. Notably, excluding neonatal costs increased the probability that the gel is cost-effective at a cost-effectiveness threshold of £100 per hour of care prevented to 0.99. CONCLUSIONS: This study suggests that prostaglandin E2 gel is probably more cost-effective than prostaglandin E2 tablets for the induction of labour at term. Given that the results are applicable to the general obstetric population requiring induction of labour at term, decision-makers should consider the likely economic impacts of their implementation.

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. DESIGN: Randomised double blind placebo-controlled trial. SETTING: Large UK maternity hospital. POPULATION OR SAMPLE: Nulliparous women with a singleton pregnancy, cephalic presentation > or = 37 weeks gestation, requiring cervical ripening prior to induction of labour. METHODS: IMN (n = 177) or placebo (n = 173) self-administered vaginally at home at 48, 32 and 16 hours prior to the scheduled time of admission for induction. MAIN OUTCOME MEASURES: Admission to delivery interval and women's experience of induction of labour. RESULTS: IMN did not shorten the admission to delivery interval as compared with placebo [mean difference of -1.6 hours (95% CI -5.1,1.9, P = 0.37)], despite being more effective than placebo in inducing a change in Bishop score [mean difference of 0.65 (95% CI 0.14,1.17, P = 0.013)]. While both groups found the overall experience of home treatment to be positive, (mean score of 3.8/10 +/- 2.3/10 for the IMN group, where 1 = extremely good and 10 = not at all good) women in the placebo group found it marginally more positive than those in the IMN group (just over half a unit on a 10-point scale, P = 0.043). There were no differences between the groups in the pain or anxiety experienced or willingness to take the treatment in a subsequent pregnancy. CONCLUSIONS: IMN self-administered vaginally at home does not shorten admission to delivery interval despite a significant effect on cervical ripeness assessed using the Bishop score. However, women report positive views on cervical ripening at home, and the setting deserves further investigation.

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. DESIGN: Economic evaluation was conducted alongside a randomised placebo controlled trial (the IMOP trial). SETTING: Large UK maternity hospital. POPULATION: A total of 350 nulliparous women with a singleton pregnancy, cephalic presentation > or = 37 weeks gestation, requiring cervical ripening prior to induction of labour. INTERVENTIONS: Isosorbide mononitrate (n = 177) or placebo (n = 173) self-administered vaginally at home at 48, 32 and 16 hours prior to the scheduled time of admission for induction. RESULTS: Mean health service costs between the period of randomisation and discharge for mother and infant were 1254.86 pound sterling in the IMN group and 1242.88 pound sterling in the placebo group, generating a mean cost difference of 11.98 pound sterling (bootstrap mean cost difference 12.86 pound sterling; 95%CI: -106.79 pound sterling, 129.39 pound sterling) that was not statistically significant (P = 0.842). The incremental cost per hour prevented from hospital admission to delivery was 7.53 pound sterling. At the notional willingness to pay threshold of 100 pound sterling per hour prevented from hospital admission to delivery, the probability that IMN is cost-effective was estimated at 0.67. This translated into a mean net monetary benefit of 98.13 pound sterling for each woman given IMN. CONCLUSIONS: Although the probability that IMN is cost-effective approaches 0.7 at seemingly low willingness to pay thresholds for an hour prevented from hospital admission to delivery, our results should be viewed in the light of the clinical findings from the IMOP trial.

Patient isolation measures for infants with candida colonization or infection for preventing or reducing transmission of candida in neonatal units.

BACKGROUND: Candida is one of the most common nosocomial infections in the intensive care setting worldwide and is associated with increased healthcare costs. In neonates, candida infection is associated with high mortality and morbidity. Candida is transmitted by direct and indirect contact. Routine infection control measures that include standard precautions are routinely employed to prevent spread of nosocomial infections. Patient isolation measures, i.e. single room isolation or cohorting, are usually recommended for infections spread by contact. OBJECTIVES: To determine the effect of patient isolation measures (single room isolation and/or cohorting) for infants with candida colonization or infection as an adjunct to routine infection control measures on the transmission of candida to other infants in the neonatal unit. SEARCH STRATEGY: Relevant trials in any language were searched in the following databases in Jan 2007: The Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 4, 2006), MEDLINE (1966 - Jan 2007) and PREMEDLINE, EMBASE (1980 - Jan 2007), CINAHL (1982 - Jan 2007). Proceedings of the Pediatric Academic Societies (American Pediatric Society, Society for Pediatric Research) and the European Society for Pediatric Research (1987 - Jan 2007) were also searched in Jan 2007. Authors or other experts were contacted for more information on relevant published or unpublished trials. Additional searches were also made in the reference lists of relevant journal articles and in the reviewer's personal files. SELECTION CRITERIA: Types of studies: Cluster randomized trials (where clusters may be defined by hospital, ward, or other subunits of the hospital). TYPES OF PARTICIPANTS: Neonatal units caring for infants colonized or infected with candida. Types of interventions: A policy of patient isolation measures (single room isolation or cohorting of infants with candida colonization or infection) compared to routine isolation measures. DATA COLLECTION AND ANALYSIS: The standard methods of the Cochrane Neonatal Review Group (CNRG) were to be used to identify studies and to assess the methodological quality of eligible trials. The statistical package (RevMan 4.2) provided by the Cochrane Collaboration was to be used. In cluster-randomized trials, if the unit of analysis of the trial was the cluster (not individuals) and analysis took into account the correlation between clusters, the inverse variance method was to be used for meta-analysis. If this was not the case, a narrative synthesis was to be made without meta-analysis. Infection rates and colonization rates were to be expressed as rate ratios for each trial and if appropriate for meta-analysis, the generic inverse variance method in RevMan was to be used. MAIN RESULTS: No eligible trials were identified. AUTHORS' CONCLUSIONS: The review found no evidence to either support or refute the use of patient isolation measures (single room isolation or cohorting) in neonates with candida colonization or infection. Despite the evidence for transmission of candida by direct or indirect contact and evidence of cross-infection by health care workers, no standard policy of patient isolation measures beyond routine infection control measures exists in the neonatal unit. There is an urgent need to research the role of patient isolation measures for preventing transmission of candida in the neonatal unit. Cluster randomized trials involving multiple units or hospitals with randomized allocation of one type of patient isolation measure or the other (i.e. single room isolation or cohorting) with careful consideration for determining an appropriate sample size and analysis would be the most appropriate method to research this intervention.