# Contribution of nationwide medico administrative data on congenital anomalies in France: Validation study on congenital diaphragmatic hernia.

Arthur Lauriot Dit Prevost, G. Clement, Xavier Lenne, Dyuti Sharma, D.

Carriere, Jad Atallah, Kevin Le Duc, Laurent Storme, Amelie Bruandet, Sébastien Mur

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## ► To cite this version:

Arthur Lauriot Dit Prevost, G. Clement, Xavier Lenne, Dyuti Sharma, D. Carriere, et al.. Contribution of nationwide medico administrative data on congenital anomalies in France: Validation study on congenital diaphragmatic hernia.. Journal of Epidemiology and Population Health, 2025, Journal of Epidemiology and Population Health, 7 (3), pp.203109. 10.1016/j.jeph.2025.203109. hal-05215645

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Original article

# Contribution of nationwide medico administrative data on congenital anomalies in France: Validation study on congenital diaphragmatic hernia

<figure><img src="image_3.png" /></figure>

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Arthur Lauriot Dit Prevost<sup>a,b,c,*</sup>, Guillaume Clement<sup>d</sup>, Xavier Lenne<sup>e</sup>, Dyuti Sharma<sup>a,b,c</sup>, Diane Carriere<sup>f</sup>, Jad Atallah<sup>b,g</sup>, Kevin Le Duc<sup>b,c,g</sup>, Laurent Storme<sup>b,c,g</sup>, Amélie Bruandet<sup>e</sup>, Sebastien Mur<sup>b,g</sup>

## ARTICLE INFO

**Article History:**
Received 13 October 2024
Accepted 8 April 2025
Available online 17 May 2025

**Keywords:**
Diaphragmatic hernia
Medico administrative data
PMSI
Epidemiology

## ABSTRACT

**Introduction:** In France, medico-administrative data are collected through the Programme de Médicalisation des Systèmes d'Information (PMSI), which includes all discharge reports from public and private hospitals, covering more than 20 million hospital stays per year. In parallel, databases on rare diseases are a national priority but remain difficult to implement and maintain. We aimed to assess the validity of PMSI data to identify patients with congenital rare diseases, using congenital diaphragmatic hernia (CDH) as an example. We also aimed to explore the national epidemiological estimates provided by PMSI.

**Methods:** Using PMSI, we identified CDH patients treated in the neonatal intensive care units (NICU) of two French referral centers between 2010 and 2018 based on ICD-10 diagnostic codes. These centers have maintained a prospective database of CDH patients (CDHdb) for over 10 years. We compared PMSI data with CDHdb to assess the accuracy of PMSI in detecting CDH cases. A nationwide extraction was then performed to estimate the incidence and mortality of CDH in France.

**Results:** PMSI identified all 248 CDH patients listed in the CDHdb. However, 37 additional cases were found in PMSI but not in the CDHdb, including 24 neonatal deaths with confirmed CDH. Encoding errors were found in four cases (omphalocele, diaphragmatic eventration), and eight CDH cases were missing from the CDHdb. The sensitivity and specificity of PMSI were estimated at 100 % (98.5 %; 100 %) and 99.9 % (99.9 %; 100 %), respectively. At the national level, 1680 cases were identified, corresponding to an incidence of 2.33 per 10,000 live births, a male-to-female ratio of 1.40, and a 1-year mortality rate of 30.5 % (28.2 %; 32.9 %).

**Discussion:** PMSI appears to be a valid source for identifying CDH patients at birth, with national epidemiological estimates consistent with the literature. However, medico-administrative data require careful validation before being used for rare disease surveillance.

**Conclusion:** Our findings suggest that PMSI could be a valuable tool for studying and monitoring CDH patients —and potentially other congenital anomalies—on a nationwide scale.

© 2025 The Author(s). Published by Elsevier Masson SAS. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)

## 1. Introduction

Congenital diaphragmatic hernia (CDH), is a rare congenital malformation, resulting in a defect of diaphragmatic dome with varying

degrees of severity [1]. Prenatal diagnosis is available in France, in more than 80 % of cases, indicating a birth in a referral center [2]. Apart from certain cases with a favorable prognosis, this condition is life-threatening at birth, with pulmonary and circulatory consequences that require expert care and resuscitation, up to and including extra-corporeal membrane oxygenation (ECMO). [3]. Surgical

<footnote><sup>a</sup> Department of Pediatric Surgery, CHU Lille, Jeanne de Flandre University Hospital, Lille, France</footnote>

<footnote><sup>b</sup> Reference Center for Rare Disease, CHU Lille, Congenital Diaphragmatic Hernia, Jeanne de Flandre University Hospital, Lille, France</footnote>

<footnote><sup>c</sup> Univ. Lille, CHU Lille, ULR 2694 - METRICS: Evaluation des technologies de santé et des pratiques médicales, Lille, France</footnote>

<footnote><sup>d</sup> Medical Information Department, AP-HP Paris Saclay University, Bicêtre Hospital, Le Kremlin-Bicêtre, Paris, France</footnote>

<footnote><sup>e</sup> Medical Information Department, Univ. Lille, CHU Lille, Lille, France</footnote>

<footnote><sup>f</sup> AP-HP Paris Saclay University, Pediatric and Neonatal Intensive Care, Bicêtre Hospital, Le Kremlin-Bicêtre, Paris, France</footnote>

<footnote><sup>g</sup> Department of Neonatology, CHU Lille, Neonatal Intensive Care and Reanimation, Jeanne de Flandre University Hospital, Lille, France</footnote>

<footnote>* Corresponding author.</footnote>

<footnote>E-mail address: a.lauriotditprevost@chu-lille.fr (A. Lauriot Dit Prevost).</footnote>
correction of CDH is systematic, and one of the most crucial point is
defining the adequate timing for surgery [4,5].

In 2015, EUROCAT network estimated CDH prevalence at 2.3/
10,000 birth, with a 1 week survival of 69.3 % [6]. In 2021, using data
from 25 registries in 19 countries, the *International Clearinghouse for
Birth Defects Surveillance and Research* estimated the prevalence at
2.6/10,000 births, with a mortality of 37.7 % [7].

In France, a national medico-administrative program, the "Pro-
gramme National de Médicalisation des Systèmes d'Information"
(PMSI), is used to monitor and fund every hospitals based on their
activity [8]. Although its original purpose is administrative, both local
(i.e. one hospital) and national databases can be suitable for data
reuse, which is a growing field in medical research in the era of big
data [9]. PMSI database contains data on approximatively 20 million
hospital stays each year in France, with information of potential med-
ical interest such as length of stay, type of unit, declared diagnoses
(ICD-10), declared intervention as detailed by the French "Classifica-
tion Commune des Actes Médicaux" (CCAM) [8]. Since 2010, the French
health authority has made it mandatory to fill the gestational age at
the time of delivery in the PMSI database for birth hospital stay, and
therefore this data can be exploited through data reuse. In 2013,
Quantin et al. showed perinatal data extracted from PMSI seemed
trustworthy, when compared to manually collected data [10].

Since 2004, a national program was led, to create French reference
centers for rare diseases. As for CDH, referral center is hosted by 3
university hospitals (Bicetre for antenatal part, Marseille for surgical
part, and Lille for neonatal care and follow-up part), and the network
is also composed of 28 competence centers. A multicentric database
was set up, under the supervision of our University Hospital, and pro-
gressively filled by each participating center. Unfortunately, this
database is not exhaustive yet on a national level, depending on each
participating center's resource to complete the database. However, at
in referral centers, database is carefully filled.

Our aim is to assess the validity of the PMSI database in the detec-
tion of CDH patients, by comparing data from our multicentric CDH
database. Our secondary objective is to briefly describe preliminary
data extracted from a national query, to ensure that they are consis-
tent with data from the literature.

## 2. Materials and methods

2.1. Data source

We conducted a query on two local PMSI databases from two dis-
tinct University Hospitals (Lille and Paris-Bicetre), each participating
in the referral center for CDH. The number of live births in France
over the study period was extracted from the French "*Institut
National de la Statistique et des Études Économiques*" (INSEE, https://
www.insee.fr). PMSI data was also used to provide the number of
patients without CDH during the same period.

We included every patient from the CDH clinical database
(CDHdb), treated in the first 7 days of life, in the Neonatal Intensive
Care Unit (NICU) of two of the referral centers, between 2010 and
2018. We included data on patient identification in order to compare
each local data base, with the local PMSI databases. Prior to the study,
the clinical database was declared to the French "Commission Natio-
nale de l'Informatique et des Libertés", under the number 2222678 (09/
2021).

As a secondary objective, we processed a query on a nationwide
level, to evaluate the number of patients, and estimate an incidence
rate. Data were extracted from the French National Health prospec-
tive data system (Système National des Données de Santé [SNDS]), a
national medical-administrative claims database covering about 99 %
of the inhabitants of France, containing individual, anonymous and
comprehensive data on all health expenditure reimbursements of the
French National Health Insurance Information System (Système

national d'information Inter-Régime de l'Assurance Maladie
[SNIIRAM]) for patients. The SNDS can be linked to the French hospi-
tal discharge database (Programme de médicalisation des Systèmes
d'Information [PMSI]), which contains all discharge reports from pub-
lic and private hospitals in France.

2.2. Inclusion/exclusion criteria: query

We defined a query, to extract data from the local PMSI databases
in both centers, based on the following criteria:

- Completed hospital stay between 2010 and 2018 (stillborn [i.e. hospital stay characterized with death in labor], birth hospital stays, or regular hospital stay)

- Age ≤ 7 days during the initial hospital stay.

- ICD-10 diagnosis of (Main, related, or associated) CDH: Q790 - Congenital diaphragmatic hernia, K440 - Diaphragmatic hernia, with obstruction, without gangrene, K441 - Diaphragmatic hernia, with gangrene and K449 - Diaphragmatic hernia, (without obstruction or gangrene)

For the secondary nationwide query, we used the same criteria.

We excluded every subsequent hospital stay for each unique
patient identifier (only the first hospital stay was used to determine
each unique patient for CDH, rather than each hospital stay). The
PMSI database features a specific security-filter ("administrative fil-
ter") in the eventuality of incoherence in administrative data, regard-
ing to their unique anonymized identifier. Patients with such
incoherence were excluded.

2.3. Statistics

To assess the validity of the local PMSI query, we compared the
results between PMSI and CDHdb. Patients with CDH detected by a
local PMSI query are referred as "PMSI +", and likewise for "CDHdb
+". Patients that were neither detected by PMSI nor CDHdb (PMSI - /
CDHdb -) correspond to patients with hospital stay between 2010
and 2018, age ≤ 7 days, and no ICD-10 diagnosis of CDH.

To calculate the incidence, we extracted the number of live births,
as extracted from INSEE.

3. Results

3.1. Detection of CDH patients

We identified 248 patients, born between 2010 and 2018,
included in the CDHdb in center A (Lille, n=123) or center B (Paris-
Bicetre, n=125). Data from the PMSI identified 285 patients with an
ICD-10 code of CDH and a hospital stay before the age of 7 days in
Center A (n=141) or Center B (n=144). (Fig. 1).

Each of the 248 “CDHdb +” patients, were detected by the PMSI
query. Furthermore, the PMSI query found 37 patients, with at least
one hospital stay associated with a CDH ICD-10 code, and who were
absent from the CDH database. Of these PMSI+/CDHdb- patients, 24
patients died (or were dead) at day 0, in labor room (some in a con-
text of medical termination of pregnancy). One patient deceased dur-
ing early neonatal resuscitation, before inclusion in the database.
Four patients were incorrectly encoded as CDH in the PMSI database
(diaphragmatic eventration or omphalocele, without concomitant
CDH). And lastly, 8 patients found by the PMSI request were absent
from the CDHdb, when they should have been included, as medical
records confirmed the diagnosis of CDH (i.e. correctly encoded in
PMSI, but missed by the CDHdb) (Fig. 1).

Our query identified 85,108 patients with a hospital stay between
2010 and 2018, before the age of 7 days, without an ICD-10 diagnosis
of CDH. As shown in Table 1, using these results, we calculated a
<figure><img src="image_4.png" /><figcaption>**Fig. 1.** Flow chart: Comparison between CDH database and local PMSI database for patients treated in Center A and B. Note: CDHdb (+) = patient present in the CDH database; PMSI (-) = patient not found in the result of the PMSI query.</figcaption></figure>

<table><caption>**Table 1**
Diagnostic tests for CDH detection using PMSI data.</caption><thead><tr><th></th><th>CDHdb +</th><th>CDHdb -</th><th>Total</th><th>Tests</th></tr></thead><tbody><tr><td>PMSI +</td><td>248</td><td>37</td><td><strong>285</strong></td><td>PPV = 0.8702<br/>[0.8255; 0.9069]</td></tr><tr><td>PMSI -</td><td>0</td><td>85 108</td><td><strong>85 108</strong></td><td>NPV = 1.0000<br/>[1.0000; 1.0000]</td></tr><tr><td>Total</td><td><strong>248</strong></td><td><strong>85 145</strong></td><td></td><td></td></tr><tr><td>Tests</td><td><strong>Se = 1.0000</strong><br/>[0.9852; 1.0000]</td><td><strong>Sp = 0.9996</strong><br/>[0.9994; 0.9997]</td><td></td><td></td></tr></tbody></table>

sensitivity of 100 % (98.5 %; 100 %) and a specificity of 99.9 % (99.9 %; 100 %), for PMSI to detect CDH patients.

## 3.2. CDH patients in France 2010–218

The national PMSI query found 1 680 patients (including still-born), over the 9-year period, of which 205 “stillborn stay” (Fig. 2).

Over the study period, the number of live births in France was 7,218,046 (source: INSEE). Hence, we estimated the incidence of CDH as 2.33/10,000 births (i.e. 1680 CDH patients/7,218,046 births).

## 3.3. Detailed description of the identified population

We first looked at mortality data for live-born patients with CDH, and the distribution of mortality over time. Results are described in Table 2 and Fig. 3. One-year mortality for live birth CDH was 30.5 % [28.2 %; 32.9 %].

As for sex ratio, incident CDH cases represented 699 girls for 981 boys, determining a sex ratio of 1.4.

# 4. Discussion

Our results show that data extracted from the French national PMSI database is reliable to detect CDH patients with precision, using ICD-10 codes: Every patient from the “manually-completed” clinical

<figure><img src="image_5.png" /><figcaption>**Fig. 2.** Flow chart for national query on PMSI data. PMSI data on CDH patients on the left, INSEE data on live birth in France.</figcaption></figure>
<table><caption>**Table 2**
Time repartition of 1-year mortality for CDH patients.</caption><thead><tr><th>Post-natal day</th><th>0</th><th>1</th><th>7</th><th>30</th><th>90</th><th>180</th><th>365</th></tr></thead><tbody><tr><td>Cumulative mortality</td><td>4,81 %</td><td>11,32 %</td><td>19,12 %</td><td>25,22 %</td><td>27,66 %</td><td>29,56 %</td><td>30,51 %</td></tr><tr><td>Repartition of mortality over the first year</td><td>15,78 %</td><td>37,11 %</td><td>62,67 %</td><td>82,67 %</td><td>90,67 %</td><td>96,89 %</td><td>100,00 %</td></tr></tbody></table>

Se, Sensitivity; Sp, Specificity; PPV, Positive predictive value; NPV, negative predictive value; with 95 % confidence interval.

<figure><img src="image_6.png" /><figcaption>**Fig. 3.** Survival probability of CDH patients, in France, 2010–2018, using data extracted from PMSI.</figcaption></figure>

database was detected. We estimated a sensibility of 100 % and a specificity of 99 % for PMSI to detect CDH patients.

Moreover, the national query on PMSI allowed to find an incidence of 2.33/10,000 live births, a sex ratio of 1.44, and a one-year survival of 69.4 %.

Studies on medico administrative databases are at risk of duplication or identification of irrelevant patients [11]. Although each patient is theoretically unique in the PMSI database, extraction over a long period may increase the risk of duplicate (for instance identification error in the healthcare center, or more specifically in pediatric population, affiliation to a different social security number, or change in the family name). To control this risk, we applied an “administrative filter” to get rid of non-unique patients, and anonymous identifier anomalies [12].

The prevalence calculated using PMSI data (and INSEE) is comparable to the literature: Using data from 25 centers members of the “International Clearinghouse for Birth Defects Surveillance,” Politis et al. calculated a prevalence of 2.6/10,000 births [7], and using data from EUROCAT Registry, McGivern estimated a global prevalence of 2.3/10,000 births in Europe, and French data estimated a prevalence of 3.1/10,000 births [6].

To continue our comparison with the literature, we compared the sex ratio obtained from the PMSI which was coherent with the findings of McGivern (1.44) and Sferra et al (42 % girls representing a sex ratio of 1.4) [6,13].

Congenital diaphragmatic hernia may associate to other congenital anomalies [14]. We did not explore these associations in our work. We might focus on this parameter in further work.

Our results in term of survival are in the expected range compared to others publications. Recently in an international multicentric study, Politis et al. calculated a one-year mortality of 37 % [7]. In Germany, in the absence of a national registry, Wittekindt et al. used data from the main insurance company to study 1-year mortality of CDH patients. With 285 patients, they found a one-year mortality of 41.8 % [15]. Using data from the north American CDH study group, Gupta et al described an in-hospital mortality ranging from 26 % to 28.7 %, which is comparable to our 3 months mortality of 27.6 %. considering that time to first discharge for CDH patients is usually near 3 months [16].

Cumulative mortality for CDH patients admitted in NICU, was 11.3 % at day-1, 19.12 % at day-7, 27.66 % at 3-month. This repartition

over the first weeks of life is comparable with data from international registries published by Politis et al. in 2021, which was 7.4 % at 24 h of life, 26.4 % at one week of life and 31.8 at day 28 [7].

The overall coherence between our results and data from literature is reinforcing the confidence in the reliability of PMSI data to detect accurately CDH patient, and explore epidemiologic data.

It is however important to note the impact of prenatal diagnosis and termination of pregnancies for any epidemiological description of congenital malformation since it may artificially influence mortality. In addition It is not excluded that coding habits related to “still-born hospital stays” may vary between healthcare centers, because it has no impact on “financial valorization” of the hospital stay (for instance, some centers might code a stillborn hospital stay as a live-birth stay, with a death at day-0 of life). Variation on mortality, it must be interpreted with caution, especially regarding centers’ habits on medical termination of pregnancy, and palliative care. Indeed, a team that will tend to limit medical termination of pregnancy in favor of neonatal palliative care will have an artificially higher mortality rate.

Since the main objective of this study was to assess the reliability of PMSI data to explore congenital diaphragmatic hernia, we restricted the number of analyzed parameters. Nonetheless, the PMSI database may provide additional information. Quantin et al. detailed perinatal data that could be exploited with a good reliability [10]. Moreover, as PMSI database comprises maternal medico-administrative data, it may be used to chain data extracted from the mother’s hospital stay, to the infant’s hospital stay, in order to study potential association with maternal comorbidity (provided that it had been previously coded) [10]. Despite those possibilities, every clinical information can’t be estimated with the same precision based on PMSI data. In 2011, Soilly et al. compared data from a dedicated registry on respiratory syncytial virus bronchiolitis, to PMSI data, in pediatric intensive care unit. Some data extracted from PMSI were reliable, such as birth weight, mechanical ventilation, history of bronchopulmonary dysplasia, and intra-hospital death, but others data were not such as particular medical history, or continuous positive airway pressure use [17].

In our study, data extracted from the PMSI detected 37 additional patents, absent from the CDH databases. For 32 (86.4 %) of these patients, the diagnostic was indeed CDH, but they were not included in the database, mostly because they deceased in labor room, before
admission in NICU. Although the CDHdb is focused on studying the neonatal reanimation and follow up of the survivors, we believe these patients should be included in the database, since they are part of the epidemiological description of the disease.

Only 4 patients out of 285 (1.4 %) detected by PMSI query did not have CDH (1 omphalocele, 3 diaphragmatic eventrations). This low false positive rate does not seem to question the reliability of the PMSI.

At a macro level, using data extracted from PMSI to describe at a national level, intra-hospital and inter-hospital pathway of patients is possible, based on successive units visited [18]. In our university hospital, El Amrani et al. used PMSI data to study centralization for pancreatic surgery, allowing them to assess the impact on mortality, especially by describing transfer-analysis to expert center after initial pancreatic surgery [19,20]. Lastly, PMSI can inform on geographic data, through spatial analysis, to explore possible association to environmental factors [21].

The use of PMSI data allowed us to detect 1 680 cases of CDH (of which 1 475 live births), between 2010 and 2018. This gives us hope that we will be able to carry out a virtually exhaustive analysis of the French data on this disease. Once this validation step has been completed, we plan to extend our work using data from the PMSI, by addressing prognostic factors, description of time to surgery, variation between centers, hospital pathway of first days of life (transfer to referral), and first year of life (total length of hospital stays, hospital stay pattern).

This study allows us to hypothesize that the PMSI could also be a reliable source of data for the description of other rare congenital pathologies, either as a complement of preexisting register (e.g oesophageal atresia), or to allow a national overview of a rare disease, in the absence of a register.

## Competing interest

None.

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