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Effectiveness and costs of non-invasive foetal RHD genotyping in rhesus-D negative mothers: a French multicentric two-arm study of 850 women.

ABSTRACT: BACKGROUND:The determination of foetal Rhesus D (RHD) status allows appropriate use of IgRh prophylaxis by restricting its use to cases of RHD feto-maternal incompatibilities. There is a degree of uncertainty about the cost-effectiveness of foetal RHD determination, yet screening programs are being introduced into clinical practice in many countries. This paper evaluates the impact of non-invasive foetal Rhesus D (RHD) status determination on the costs of managing RHD-negative pregnant women and on the appropriate use of anti-D prophylaxis in a large sample of RHD-negative pregnant women using individual prospectively collected clinical and economic data. METHODS:A prospective two-armed trial of RHD negative pregnant women was performed in 11 French Obstetric Departments. Non-invasive foetal RHD genotyping was performed before 26 weeks' gestation in the experimental arm whereas the control arm participants received usual care. The costs associated with patient management in relation to their RHD negative status (biological tests, anti-D prophylaxis and visits) were calculated from inclusion to the end of the postpartum period. The costs of hospital admissions during pregnancy and delivery were also determined. RESULTS:A total of 949 patients were included by 11 centres between 2009 and 2012, and 850 completed follow-up, including medical and biological monitoring. Patients were separated into two groups: the genotyping group (n=515) and the control group (n=335). The cost of the genotyping was estimated at 140 euros per test. The total mean cost per patient was estimated at €3,259 (SD ± 1,120) and €3,004 (SD ± 1,004) in the genotyping and control groups respectively. The cost of delivery represented three quarters of the total cost in both groups. The performance of managing appropriately RHD negative anti-D prophylaxis was 88% in the genotyping group, versus 65% in the control group. Using the costs related to RHD status (biological tests, anti-D immunoglobulin injections and visits) the incremental cost-effectiveness ratio (ICER) was calculated to be €578 for each percentage gain in women receiving appropriate management. CONCLUSION:Early knowledge of the RHD status of the foetus using non-invasive foetal RHD genotyping significantly improved the management of RHD negative pregnancies with a small increase in cost. TRIAL REGISTRATION:Clinical trials registry- NCT00832962 -13 January 2009 - retrospectively registered.

SUBMITTER: Darlington M

PROVIDER: S-EPMC6295078 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Effectiveness and costs of non-invasive foetal RHD genotyping in rhesus-D negative mothers: a French multicentric two-arm study of 850 women.

Darlington Meryl M Carbonne Bruno B Mailloux Agnès A Brossard Yves Y Levy-Mozziconacci Annie A Cortey Anne A Maoulida Hassani H Simon Tabassome T Rousseau Alexandra A Durand-Zaleski Isabelle I

BMC pregnancy and childbirth 20181214 1

<h4>Background</h4>The determination of foetal Rhesus D (RHD) status allows appropriate use of IgRh prophylaxis by restricting its use to cases of RHD feto-maternal incompatibilities. There is a degree of uncertainty about the cost-effectiveness of foetal RHD determination, yet screening programs are being introduced into clinical practice in many countries. This paper evaluates the impact of non-invasive foetal Rhesus D (RHD) status determination on the costs of managing RHD-negative pregnant w ...[more]

PMID: 30547830

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Project description:OBJECTIVES:To evaluate the accuracy of diagnoses of COVID-19 based on chest CT as well as inter-observer agreement between teleradiologists during on-call duty and senior radiologists in suspected COVID-19 patients. MATERIALS AND METHODS:From March 13, 2020, to April 14, 2020, consecutive suspected COVID-19 adult patients who underwent both an RT-PCR test and chest CT from 15 hospitals were included in this prospective study. Chest CTs were immediately interpreted by the on-call teleradiologist and were systematically blind reviewed by a senior radiologist. Readings were categorised using a five-point scale: (1) normal; (2) non-infectious findings; (3) infectious findings but not consistent with COVID-19 infection; (4) consistent with COVID-19 infection; and (5) typical appearance of COVID-19 infection. The diagnostic accuracy of chest CT and inter-observer agreement using the kappa coefficient were evaluated over the study period. RESULTS:In total, 513 patients were enrolled, of whom 244/513 (47.6%) tested positive for RT-PCR. First readings were scored 4 or 5 in 225/244 (92%) RT-PCR+ patients, and between 1 and 3 in 201/269 (74.7%) RT-PCR- patients. The data were highly consistent (weighted kappa = 0.87) and correlated with RT-PCR (p < 0.001, AUC1st-reading = 0.89, AUC2nd-reading = 0.93). The negative predictive value for scores of 4 or 5 was 0.91-0.92, and the PPV for a score of 5 was 0.89-0.96 at the first and second readings, respectively. Diagnostic accuracy was consistent over the study period, irrespective of a variable prevalence rate. CONCLUSION:Chest CT demonstrated high diagnostic accuracy with strong inter-observer agreement between on-call teleradiologists with varying degrees of experience and senior radiologists over the study period. KEY POINTS:• The accuracy of readings by on-call teleradiologists, relative to second readings by senior radiologists, demonstrated a sensitivity of 0.75-0.79, specificity of 0.92-0.97, NPV of 0.80-0.83, and PPV of 0.89-0.96, based on "typical appearance," as predictive of RT-PCR+. • Inter-observer agreement between the first reading in the emergency setting and the second reading by the senior emergency teleradiologist was excellent (weighted kappa = 0.87).

Dataset Information

Effectiveness and costs of non-invasive foetal RHD genotyping in rhesus-D negative mothers: a French multicentric two-arm study of 850 women.

Publications

Effectiveness and costs of non-invasive foetal RHD genotyping in rhesus-D negative mothers: a French multicentric two-arm study of 850 women.

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