Economic evaluation of computerised interpretation of fetal heart rate during labour: a cost-consequence analysis alongside the INFANT study.

OBJECTIVE: Economic evaluation of computerised decision-support software intended to assist in the interpretation of a cardiotocography (CTG) during birth. DESIGN: Individual patient level data from the INFANT study (an unmasked randomised controlled trial). SETTING: Maternity units in the UK and Ireland. POPULATION: Singleton or twin pregnancy women of 35 weeks' gestation or more and receiving continuous electronic fetal monitoring during labour. INTERVENTION: Computerised decision-support software. METHODS: Cost-consequence analysis presenting costs and outcomes with a time horizon of 2 years from a government healthcare perspective. Unit cost data collected from a combination of primary and secondary sources. MAIN OUTCOME MEASURES: Primary clinical outcomes were (i) composite 'poor neonatal outcome' and (ii) developmental assessment at age 2 years in a subset of surviving children. Mean cost per mother and infant dyad from birth to hospital discharge, and from hospital discharge to 24 months follow-up. Maternal health-related quality of life was assessed at 12 and 24 months follow-up using the EuroQol three-level health-related quality of life instrument (EQ-5D-3L). RESULTS: Data were analysed for 46 042 women and 46 614 infants. No statistically significant differences were detected between trial arms in any of the primary clinical outcomes or maternal quality of life. No statistically significant differences in costs were detected in maternal or infant costs from trial entry to hospital discharge or overall from hospital discharge to 2-year follow-up. CONCLUSIONS: Decision-support software during labour is not associated with additional maternal or infant benefits and over a 2-year period the software did not lead to additional costs or savings to the National Health Service. TRIAL REGISTRATION NUMBER: ISRCTN98680152.

HOspital care versus TELemonitoring in high-risk pregnancy (HOTEL): study protocol for a multicentre non-inferiority randomised controlled trial.

INTRODUCTION: Pregnant women faced with complications of pregnancy often require long-term hospital admission for maternal and/or fetal monitoring. Antenatal admissions cause a burden to patients as well as hospital resources and costs. A telemonitoring platform connected to wireless cardiotocography (CTG) and automated blood pressure (BP) devices can be used for telemonitoring in pregnancy. Home telemonitoring might improve autonomy and reduce admissions and thus costs. The aim of this study is to compare the effects on patient safety, satisfaction and cost-effectiveness of hospital care versus telemonitoring (HOTEL) as an obstetric care strategy in high-risk pregnancies requiring daily monitoring. METHODS AND ANALYSIS: The HOTEL trial is an ongoing multicentre randomised controlled clinical trial with a non-inferiority design. Eligible pregnant women are >26+0 weeks of singleton gestation requiring monitoring because of pre-eclampsia (hypertension with proteinuria), fetal growth restriction, preterm rupture of membranes without contractions, recurrent reduced fetal movements or an intrauterine fetal death in a previous pregnancy.Randomisation takes place between traditional hospitalisation (planned n=208) versus telemonitoring (planned n=208) until delivery. Telemonitoring at home is facilitated with Sense4Baby CTG devices, Microlife BP monitor and daily telephone calls with an obstetric healthcare professional as well as weekly hospital visits.Primary outcome is a composite of adverse perinatal outcome, defined as perinatal mortality, 5 min Apgar <7 or arterial cord blood pH <7.05, maternal morbidity (eclampsia, HELLP (hemolysis, elevated liver enzymes, and low platelets) syndrome, thromboembolic event), neonatal intensive care admission and caesarean section rate. Patient satisfaction and preference of care will be assessed using validated questionnaires. We will perform an economic analysis. Outcomes will be analysed according to the intention to treat principle. ETHICS AND DISSEMINATION: The study protocol was approved by the Ethics Committee of the Utrecht University Medical Center and the boards of all six participating centres. Trial results will be submitted to peer-reviewed journals. TRIAL REGISTRATION NUMBER: NTR6076.

ST-analysis in electronic foetal monitoring is cost-effective from both the maternal and neonatal perspective.

OBJECTIVE: Electronic foetal monitoring (EFM) together with non-invasive ST-analysis (STAN) has been suggested as a superior technique to EFM alone for foetal surveillance to prevent metabolic acidosis. This study aims to compare the cost-effectiveness of these two techniques from both maternal (short term) as neonatal (long term) perspective to guide clinical decision-making. METHODS: We created two models: a maternal model, focused on the difference in mode of delivery as most important outcome, and a neonatal Markov model focused on the differences in metabolic acidosis - and its relationship to cerebral palsy (CP) - as the most relevant outcome to estimate the long-term cost-effectiveness. The cost to prevent one instrumental delivery was estimated in the maternal model. The costs to prevent one metabolic acidosis and the costs per quality adjusted life years were calculated in the neonatal model. RESULTS: The average costs of STAN are only €34 higher when compared to EFM alone. From maternal perspective the cost of preventing one instrumental delivery was estimated at €2602. From neonatal perspective the cost to prevent one case of metabolic acidosis was €14 509. Over the long term, STAN becomes a dominant (cost saving) strategy if >1% of the patients exposed to metabolic acidosis acquire CP. CONCLUSIONS: Our study suggests that STAN, when compared to EFM alone, can be a cost-effective strategy from both a maternal and neonatal perspective.

Antenatal cardiotocogram quality and interpretation using computers.

OBJECTIVE: To test the application in practice of computerized fetal heart rate (FHR) analysis in pregnancy. DESIGN: Randomized distribution of subjects with computerized analysis automatically revealed or concealed. SETTING: A district general hospital and a teaching hospital outside London. SUBJECTS: 2869 pregnant women studied within a year. OUTCOME MEASURES: Quality and duration of the cardiotocogram; quantitative measurement of FHR variation; number of stillbirths. RESULTS: With interactive advice to the operator, records were of improved quality (up to 28% without signal loss) with potentially much reduced recording time. The short-term FHR variation measured in the last records before intervention is reported for the first time. CONCLUSION: The benefits of using the computers include improvement in record quality and saving of time. In addition, where interpretation depended on estimation of FHR variation there was prima facie evidence of observer misinterpretation; visual analysis was unreliable. A larger trial is now required with more rigorous constraints on intervention.

Impact of the introduction of fetal central monitoring on hospital expenses with cardiotocographic paper.

Digital storage of cardiotocographic (CTG) tracings by fetal central monitoring systems (fCMS) obviates the need for printing, or alternatively, the tracings can be printed in regular paper instead of CTG thermal paper. We aimed at evaluating the impact of the introduction of the Omniview-SisPorto(®) system on CTG paper costs in a large university hospital. After introduction of the fCMS, there was an 87% reduction in median annual expenses with CTG paper in the labour ward (p = 0.011) and a 78% decrease in the prenatal clinic (p = 0.017), despite a more than 40% increase in the median number of observed women. Routine use of fCMS may provide an important reduction in hospital expenses associated with the use of thermal CTG paper, thus reducing the investment made in their acquisition and maintenance.

Cost-effectiveness of cardiotocography plus ST analysis of the fetal electrocardiogram compared with cardiotocography only.

OBJECTIVE: To assess the cost-effectiveness of addition of ST analysis of the fetal electrocardiogram (ECG; STAN) to cardiotocography (CTG) for fetal surveillance during labor compared with CTG only. DESIGN: Cost-effectiveness analysis based on a randomized clinical trial on ST analysis of the fetal ECG. SETTING: Obstetric departments of three academic and six general hospitals in The Netherlands. Population. Laboring women with a singleton high-risk pregnancy, a fetus in cephalic presentation, a gestational age >36 weeks and an indication for internal electronic fetal monitoring. METHODS: A trial-based cost-effectiveness analysis was performed from a health-care provider perspective. MAIN OUTCOME MEASURES: Primary health outcome was the incidence of metabolic acidosis measured in the umbilical artery. Direct medical costs were estimated from start of labor to childbirth. Cost-effectiveness was expressed as costs to prevent one case of metabolic acidosis. RESULTS: The incidence of metabolic acidosis was 0.7% in the ST-analysis group and 1.0% in the CTG-only group (relative risk 0.70; 95% confidence interval 0.38-1.28). Per delivery, the mean costs per patient of CTG plus ST analysis (n= 2 827) were €1,345 vs. €1,316 for CTG only (n= 2 840), with a mean difference of €29 (95% confidence interval -€9 to €77) until childbirth. The incremental costs of ST analysis to prevent one case of metabolic acidosis were €9 667. CONCLUSIONS: The additional costs of monitoring by ST analysis of the fetal ECG are very limited when compared with monitoring by CTG only and very low compared with the total costs of delivery.

The long-term cost-effectiveness of fetal monitoring during labour: a comparison of cardiotocography complemented with ST analysis versus cardiotocography alone.

OBJECTIVE: To assess the cost-effectiveness of the use of cardiotocography (CTG) complemented with fetal electrocardiography and ST analysis compared with the use of CTG alone in term deliveries when a decision has been made to use fetal monitoring with a scalp electrode. DESIGN: A cost-effectiveness analysis based on a probabilistic decision model incorporating relevant strategies and lifelong outcomes. SETTING: Maternity wards in Sweden. POPULATION: Women with term fetuses after a clinical decision had been made to apply a fetal scalp electrode for internal CTG. METHODS: A decision model was used to compare the costs and effects of two different treatment strategies. Baseline estimates were derived from the literature. Discounted costs and quality-adjusted life years (QALYs) were simulated over a lifetime horizon using a probabilistic model. MAIN OUTCOME MEASURES: QALYs, incremental costs, and cost per QALY gained expressed as incremental cost-effectiveness ratio (ICER). RESULTS: The analysis found an incremental effect of 0.005 QALYs for ST analysis compared with CTG; the ST analysis strategy was also moreover associated with a euro56 decrease in costs, thus dominating the CTG strategy. The probability that ST analysis is cost-effective in comparison with CTG is high, irrespective of the willingness-to-pay value for a QALY. CONCLUSIONS: Compared with CTG alone, ST analysis is cost-effective when used in term high-risk deliveries in which there is a need for internal fetal monitoring.

A randomised clinical trial on cardiotocography plus fetal blood sampling versus cardiotocography plus ST-analysis of the fetal electrocardiogram (STAN) for intrapartum monitoring.

BACKGROUND: Cardiotocography (CTG) is worldwide the method for fetal surveillance during labour. However, CTG alone shows many false positive test results and without fetal blood sampling (FBS), it results in an increase in operative deliveries without improvement of fetal outcome. FBS requires additional expertise, is invasive and has often to be repeated during labour. Two clinical trials have shown that a combination of CTG and ST-analysis of the fetal electrocardiogram (ECG) reduces the rates of metabolic acidosis and instrumental delivery. However, in both trials FBS was still performed in the ST-analysis arm, and it is therefore still unknown if the observed results were indeed due to the ST-analysis or to the use of FBS in combination with ST-analysis. METHODS/DESIGN: We aim to evaluate the effectiveness of non-invasive monitoring (CTG + ST-analysis) as compared to normal care (CTG + FBS), in a multicentre randomised clinical trial setting. Secondary aims are: 1) to judge whether ST-analysis of fetal electrocardiogram can significantly decrease frequency of performance of FBS or even replace it; 2) perform a cost analysis to establish the economic impact of the two treatment options. Women in labour with a gestational age > or = 36 weeks and an indication for CTG-monitoring can be included in the trial. Eligible women will be randomised for fetal surveillance with CTG and, if necessary, FBS or CTG combined with ST-analysis of the fetal ECG. The primary outcome of the study is the incidence of serious metabolic acidosis (defined as pH < 7.05 and Bdecf > 12 mmol/L in the umbilical cord artery). Secondary outcome measures are: instrumental delivery, neonatal outcome (Apgar score, admission to a neonatal ward), incidence of performance of FBS in both arms and cost-effectiveness of both monitoring strategies across hospitals. The analysis will follow the intention to treat principle. The incidence of metabolic acidosis will be compared across both groups. Assuming a reduction of metabolic acidosis from 3.5% to 2.1 %, using a two-sided test with an alpha of 0.05 and a power of 0.80, in favour of CTG plus ST-analysis, about 5100 women have to be randomised. Furthermore, the cost-effectiveness of CTG and ST-analysis as compared to CTG and FBS will be studied. DISCUSSION: This study will provide data about the use of intrapartum ST-analysis with a strict protocol for performance of FBS to limit its incidence. We aim to clarify to what extent intrapartum ST-analysis can be used without the performance of FBS and in which cases FBS is still needed. TRIAL REGISTRATION NUMBER: ISRCTN95732366.

A tele-obstetric broadband service including ultrasound, videoconferencing and cardiotocogram. A high cost and a low volume of patients.

We established a tele-obstetric service connecting the Department of Obstetrics and Gynaecology at the Nordland Hospital in Bodø to the delivery unit at the Nordland Hospital in Lofoten. The telemedicine service included a videoconferencing link (3 Mbit/s) for transmission of ultrasound scans and a low-speed data link (telephone modem) for transmission of cardiotocograms (CTGs). One hundred and thirty pregnant women entered the antenatal clinic in Lofoten during the eight-month study period. A total of 140 CTGs were recorded. The tele-ultrasound service was used in five cases (4%). The cases were serious malformation, Down's syndrome, breech presentation, vaginal bleeding during pregnancy and triplets. Analysis showed that the cost of patient travel was NOK 2460 per transfer. The variable cost of videoconferencing was NOK 250 per consultation. However, the total investment costs for the telemedicine service, including the broadband infrastructure, was NOK 1.7 million (Euro 212,000). The telemedicine service was not cost saving at annual workloads below 208. We conclude that the installation has to be used by other medical specialities to make it cost-effective.

A cost-effectiveness analysis of the intrapartum fetal pulse oximetry multicentre randomised controlled trial (the FOREMOST trial).

OBJECTIVE: To report an economic analysis of the Australian intrapartum fetal pulse oximetry (FPO) multicentre randomised controlled trial (the FOREMOST trial), which examined whether adding FPO to conventional cardiotocographic (CTG) monitoring (intervention group) was cost-effective in reducing operative delivery rates for non-reassuring fetal status compared with the use of CTG alone (control group). DESIGN: Cost-effectiveness analysis of the FOREMOST trial. SETTING: Four Australian maternity hospitals, each with more than 4000 births/year. POPULATION: Women in labour at > or =36 weeks of gestation, with a non-reassuring CTG. METHODS: Costs were for treatment-related expenses, incorporating diagnosis-related grouping costs and direct costs (including fetal monitoring). Incremental cost-effectiveness ratio (ICER) and cost-effectiveness plane were calculated, and sensitivity analysis was conducted. The primary outcome was that of the clinical trial: operative delivery for non-reassuring fetal status avoided in the intervention group relative to that in the control group. MAIN OUTCOME MEASURES: The ICER. RESULTS: The ICER demonstrated a saving of $A813 for each operative birth for non-reassuring fetal status averted by the addition of FPO to CTG monitoring compared with the use of CTG monitoring alone. CONCLUSION: The addition of FPO to CTG monitoring represented a less costly and more effective use of resources to reduce operative delivery rates for non-reassuring fetal status than the use of conventional CTG monitoring alone.

A cost study of prenatal telemedicine.

We calculated the cost of using a telemedicine system for the cardiotocographic (CTG) recording of fetal heart rate. In a one-year study in the Campania region of Italy, 162 patients were monitored. The total cost of the telemedicine system was euro;344796. A control group was retrospectively drawn from all deliveries at the university hospital in Naples during the year 2000. Patients were retrospectively assigned to a category of high or low risk, and the hospital costs of the high-risk patients were compared. In the intervention group, 11 of the 87 high-risk patients (13%) were admitted to hospital prematurely, and stayed on average 12 days. In the control group, 203 of the 813 women in the high-risk group (25%) were admitted to hospital prematurely, and stayed on average 20 days. If the women in the control group had been monitored, there would have been a notional saving, through avoided bed days, amounting to 358280, which was similar to the cost of the telemedicine system. The study suggests that the use of telemedicine in CTG monitoring improves the quality of prenatal care.

Cost-effectiveness of home telemedical cardiotocography compared with traditional outpatient monitoring.

We compared the cost of passive sensor telemedical non-stress cardiotocography performed at home and the same test performed by traditional equipment in an outpatient clinic in the Budapest area. The costs were calculated using two years' registered budget data from the home monitoring service in Budapest and the outpatient clinic of the department of obstetrics and gynaecology at the Haynal Imre University of Health Sciences. The traditional test at the university outpatient clinic cost 3652 forint for the health-care and 1000 forint in additional expenses for the patient (travel and time off work). This means that the total cost for each test in the clinic was 4652 forint. The cost of home telemedical cardiotocography was 1500 forint per test, but each test took 2.1 times as long. For a more realistic comparison between the two methods, we adjusted the cost to take account of the extra length of time that home monitoring required. The adjusted cost for home care was 3150 forint, some 32% lower than in the clinic. Passive sensor telemedical non-stress cardiotocography at home was therefore less expensive than the same test performed in the traditional way in an outpatient clinic.

Computerised cardiotocography in a high-risk unit in a developing country--its influence on inter-observer variation and duration of recording.

OBJECTIVE: To determine the role of computer-assisted cardiotocography in an obstetric special care unit and its influence on inter-observer variation in interpretation, proposed management and monitoring time. DESIGN: A prospective comparative study. SETTING: The obstetric special care unit, Tygerberg Hospital, W. Cape. STUDY POPULATION: A group of 10 registrars in obstetrics who have had experience in the interpretation of both standard and computer-assisted cardiotocographs. MAIN OUTCOME MEASURES: The influence of method of cardiotocograph recording on inter-observer variation in respect of suggested management of the patient, as well as the observer's opinion of the duration of the recording. RESULTS: Variation in suggested management decreased significantly after assessment of the computer reports, compared with the standard cardiotocographs. While delivery was regarded to be indicated in 3.5% of patients and an immediate repeat of the cardiotocograph in a further 10%, no such action was proposed after evaluation of the computer reports of the same recordings. Thirty-four per cent of tracings were considered to have been too long and 12.5% too short. However, suggested management in 40% of the latter cases seemed inappropriate for tracings regarded as of too short a duration. CONCLUSION: While computer-assisted cardiotocographs significantly decrease inter-observer variation in the proposed management of patients, its cost-effectiveness in an obstetric special care unit in a developing country should be validated, as it might increase monitoring time.

Predicting prematurity: the mammary stimulation test.

The MST appears to have theoretical rationale, predictive utility, simplicity, safety, and low cost that suggests that its routine use in prematurity prevention may ultimately save significant health care dollars. Presently, the MST should be used as an adjunct to prenatal care until further and more definitive investigation has been conducted; however, it seems promising that the MST will provide some reassurance in patients with negative tests and signify patients that are at significant risk for premature delivery (positive MST). It is hoped that further investigation will validate the MST's use in prematurity prevention in order to help decrease the incidence of preterm delivery.

Home uterine activity monitoring.

Despite tremendous improvements in maternal and neonatal care, preterm delivery remains the leading cause of infant mortality. Widespread use of tocolytics and aggressive preterm labor management have had little effect on reducing the overall neonatal mortality. To improve the success of tocolysis and preterm labor management, it is critical that preterm labor be diagnosed prior to significant cervical change. At present, a combination of several components is indicated for successful preterm birth prevention programs. These should include periodic risk assessment, patient education, cervical assessment, daily contact by highly skilled perinatal nurses, daily home uterine activity monitoring, and aggressive patient management. Studies support that this approach results in early detection of preterm labor, subsequently more effective tocolytic therapy and prevention of preterm birth.

Acoustic stimulation-induced fetal response compared to traditional nonstress testing.

Eighty-eight nonstress tests (NSTs) were obtained on gravid women between 27 and 44 weeks' gestation to compare the results of a three-second acoustic stimulus with a traditional NST. Length of testing time was significantly decreased with the use of acoustic stimulation. Consequently, nursing time and equipment use were also considerably lessened per test. Previous studies indicated that the predictive value of the acoustic stimulation test is comparable or better than the traditional NST.

Assessment of cardiotocographs.

In recent years advances in medical electronic equipment for monitoring, diagnosis and treatment of patients have led to a large increase in the number and variety of instrumentation available to the medical profession. There is a considerable amount of duplication of equipment and in the absence of readily available information buyers are unlikely to make informed decisions about the ideal instrument for their particular circumstances. One method of increasing the users' awareness is a comparative, independent assessment of equipment, with the results disseminated to the interested parties. This paper describes the essential qualities of cardiotocographs: how they are assessed as part of the UK Department of Health's evaluation programme and the measures to inform users of the latest evaluation information.