Early exposure of pregnant women to non-steroidal anti-inflammatory drugs delivered outside hospitals and preterm birth risk: nationwide cohort study.

OBJECTIVE: To assess the risk of preterm birth associated with nonsteroidal anti-inflammatory drugs (NSAIDs), focusing on early exposure in the period from conception to 22 weeks of gestation (WG). DESIGN: National population-based retrospective cohort study. SETTING: The French National Health Insurance Database that includes hospital discharge data and health claims data. POPULATION: Singleton pregnancies (2012-2014) with a live birth occurring after 22WG from women between 15 and 45 years old and insured the year before the first day of gestation and during pregnancy were included. We excluded pregnancies for which anti-inflammatory medications were dispensed after 22WG. METHODS: The association between exposure and risk of preterm birth was evaluated with GEE models, adjusting on a large number of covariables, socio-demographic variables, maternal comorbidities, prescription drugs and pregnancy complications. MAIN OUTCOME MEASURES: Prematurity, defined as a birth that occurred before 37WG. RESULTS: Among our 1 598 330 singleton pregnancies, early exposure to non-selective NSAIDs was associated with a significantly increased risk of preterm birth, regardless of the severity of prematurity: adjusted odds ratio (aOR) = 1.76 (95% CI 1.54-2.00) for extreme prematurity (95% CI 22-27WG), 1.28 (95% CI 1.17-1.40) for moderate prematurity (28-31WG) and 1.08 (95% CI 1.05-1.11) for late prematurity (32-36WG), with non-overlapping confidence intervals. We identified five NSAIDs for which the risk of premature birth was significantly increased: ketoprofen, flurbiprofen, nabumetone, etodolac and indomethacin: for the latter, aOR = 1.92 (95% CI 1.37-2.70) with aOR = 9.33 (95% CI 3.75-23.22) for extreme prematurity. CONCLUSION: Overall, non-selective NSAID use (delivered outside hospitals) during the first 22WG was found to be associated with an increased risk of prematurity. However, the association differs among NSAIDs. TWEETABLE ABSTRACT: French study for which early exposure to non-selective NSAIDs was associated with increased risk of prematurity.

Will applications on smartphones allow a generalization of telemedicine?

BACKGROUND: Telemedicine is one of the healthcare sectors that has developed the most in recent years. Currently, telemedicine is mostly used for patients who have difficulty attending medical consultations because of where they live (teleconsultation) or for specialist referrals when no specialist of a given discipline is locally available (telexpertise). However, the use of specific equipment (with dedicated cameras, screens, and computers) and the need for institutional infrastructure made the deployment and use of these systems expensive and rigid. Although many telemedicine systems have been tested, most have not generally gone beyond local projects. Our hypothesis is that the use of smartphones will allow health care providers to overcome some of the limitations that we have exposed, thus allowing the generalization of telemedicine. MAIN BODY: This paper addresses the problem of telemedicine applications, the market of which is growing fast. Their development may completely transform the organization of healthcare systems, change the way patients are managed and revolutionize prevention. This new organization should facilitate the lives of both patients and doctors. In this paper, we examine why telemedicine has failed for years to take its rightful place in many European healthcare systems although there was a real need. By developing the example of France, this article analyses the reasons most commonly put forth: the administrative and legal difficulties, and the lack of funding. We argue that the real reason telemedicine struggled to find its place was because the technology was not close enough to the patient. CONCLUSION: Finally, we explain how the development of smartphones and their current ubiquitousness should allow the generalization of telemedicine in France and on a global scale.

Intrauterine balloon tamponade for management of severe postpartum haemorrhage in a perinatal network: a prospective cohort study.

OBJECTIVE: To evaluate the effectiveness of intrauterine balloon tamponade (IUBT) for management of severe postpartum haemorrhage (PPH). To identify the factors predicting IUBT failure. DESIGN: Prospective cohort study. SETTING: Ten maternity units in a perinatal network. POPULATION: Women treated by IUBT from July 2010 to March 2013. METHODS: The global IUBT success rate was expressed as the number of women with severe PPH who were successfully treated by IUBT divided by the total number treated by IUBT. IUBT failure was defined as the need for arterial embolisation or surgery. Logistic regression analysis was used to estimate factors predicting IUBT failure. MAIN OUTCOME MEASURES: Global IUBT success rate. Factors associated with IUBT failure. RESULTS: Intrauterine balloon tamponade was attempted in 226 women: 171 after vaginal delivery (VD) (75.7%) and 55 during or after caesarean delivery (CD) (24.3%). The global success rate was 83.2% (188/226) and was significantly higher after VD (152/171, 88.9%) than CD (36/55, 65.5%, P < 0.01). The percentage of CD was significantly higher in the failure group (50.0 versus 19.1%, P < 0.01), as was mean (SD) estimated blood loss before IUBT: 1508 ± 675 ml versus 1064 ± 476, P < 0.01. Coagulopathy was significantly more frequent in the failure group (50.0% versus 17.2%, P < 0.01). CD [Odds ratio (OR) 3.5; 95% CI 1.6-7.6], estimated blood loss before IUBT (OR 3.2; 95% CI 1.5-6.8) and coagulopathy (OR 5.6; 95% CI 2.5-13.0) were predictive of IUBT failure. CONCLUSION: Intrauterine balloon tamponade is an effective method for treating severe PPH. Early balloon deployment before the development of coagulopathy increases its success rate. TWEETABLE ABSTRACT: Intrauterine balloon tamponade is effective for achieving haemostasis in intractable postpartum haemorrhages.

A Computer Prescribing Order Entry-Clinical Decision Support system designed for neonatal care: results of the 'preselected prescription' concept at the bedside.

WHAT IS KNOWN: The neonatal intensive care units (NICUs) are at the highest risk of drug dose error of all hospital wards. NICUs also have the most complicated prescription modalities. The computerization of the prescription process is currently recommended to decrease the risk of preventable adverse drug effects (pADEs) in NICUs. However, Computer Prescribing Order Entry-Clinical Decision Support (C.P.O.E./C.D.S.) systems have been poorly studied in NICUs, and their technical compatibility with neonatal specificities has been limited. OBJECTIVES: We set up a performance study of the preselected prescription of drugs for neonates, which limited the role of the prescriber to choosing the drugs and their indications. METHODS: A single 29 bed neonatal ward used this neonatal C.P.O.E./C.D.S. system for all prescriptions of all hospitalized newborns over an 18-month period. The preselected prescription of drugs was based on the indication, gestational age, body weight and post-natal age. The therapeutic protocols were provided by a formulary reference (330 drugs) that had been specifically designed for newborns. The preselected prescription also gave complete information about preparation and administration of drugs by nurses. The prescriber was allowed to modify the preselected prescription but alarms provided warning when the prescription was outside the recommended range. The main clinical characteristics and all items of each line of prescription were stored in a data warehouse, thus enabling this study to take place. RESULTS: Seven hundred and sixty successive newborns (from 24 to 42 weeks' gestation) were prescribed 52 392 lines of prescription corresponding to 65 drugs; About 30·4% of neonates had at least one out of licensed prescription; A prescription out of the recommended range for daily dose was recorded for 1·0% of all drug prescriptions. WHAT IS NEW?: The C.P.O.E./C.D.S. systems can currently provide a complete preselected prescription in NICUs according to dose rules, which are specific to newborns and also comply with local specificities (therapeutic protocols and formulation of drugs). The role of the prescriber is limited to the choice of drugs and their indications. The prescriber still retains the possibility of modifying each item of the prescription, with all other prescription items being calculated by the C.P.O.E. system. In these conditions, the prescribers rarely modified the preselected prescription and the rate of out of range prescription was low. A multicentric study is required to confirm and extend these observations. CONCLUSIONS: This study showed the feasibility of preselected prescription in NICUs and a low rate of out of range prescriptions. The preselected prescription could play a key role in lowering the dose error rate in NICUs.

[The REDSIAM network]. / Le réseau REDSIAM (Réseau données Sniiram) ­ Spécial REDSIAM.

The French national health database (SNIIRAM) proved to be very useful for epidemiology, health economics, evaluation, surveillance or public health. However, it is a complex database requiring important resources and expertise for being used. The REDSIAM network has been set up for promoting the collaboration of teams working on the Sniiram. The main aim of REDSIAM is to develop and validate methods for analyzing the Sniiram database for research, surveillance, evaluation and public health purposes by sharing the knowledge and experience of specialized teams in the fields of diseases identification from the Sniiram data. The work conducted within the network is devoted to the development and the validation of algorithms using Sniiram data for identifying specific diseases. The REDSIAM governance includes the Steering Committee composed of the main organizations in charge of producing and using the Sniiram data, the Bureau and the Technical Committee. The network is organized in thematic working groups focused on specific pathological domains, and a charter defines the rules for participation in the network, the functioning of the thematic working groups, the rules for publishing and making available algorithms. The articles in this special issue of the journal present the first results of some of the thematic working groups.

[Study of algorithms to identify schizophrenia in the SNIIRAM database conducted by the REDSIAM network]. / Étude des algorithmes de repérage de la schizophrénie dans le Sniiram par le réseau REDSIAM.

BACKGROUND: The aim of the REDSIAM network is to foster communication between users of French medico-administrative databases and to validate and promote analysis methods suitable for the data. Within this network, the working group "Mental and behavioral disorders" took an interest in algorithms to identify adult schizophrenia in the SNIIRAM database and inventoried identification criteria for patients with schizophrenia in these databases. METHODS: The methodology was based on interviews with nine experts in schizophrenia concerning the procedures they use to identify patients with schizophrenia disorders in databases. The interviews were based on a questionnaire and conducted by telephone. RESULTS: The synthesis of the interviews showed that the SNIIRAM contains various tables which allow coders to identify patients suffering from schizophrenia: chronic disease status, drugs and hospitalizations. Taken separately, these criteria were not sufficient to recognize patients with schizophrenia, an algorithm should be based on all of them. Apparently, only one-third of people living with schizophrenia benefit from the longstanding disease status. Not all patients are hospitalized, and coding for diagnoses at the hospitalization, notably for short stays in medicine, surgery or obstetrics departments, is not exhaustive. As for treatment with antipsychotics, it is not specific enough as such treatments are also prescribed to patients with bipolar disorders, or even other disorders. It seems appropriate to combine these complementary criteria, while keeping in mind out-patient care (every year 80,000 patients are seen exclusively in an outpatient setting), even if these data are difficult to link with other information. Finally, the experts made three propositions for selection algorithms of patients with schizophrenia. CONCLUSION: Patients with schizophrenia can be relatively accurately identified using SNIIRAM data. Different combinations of the selected criteria must be used depending on the objectives and they must be related to an appropriate length of time.

An Isotopic Exchange Kinetic Model to Assess the Speciation of Metal Available Pool in Soil: The Case of Nickel.

In this study an innovative approach is proposed to predict the relative contribution of each mineral phase to the total metal availability in soils, which, in other words, could be called the available metal fractionation. Through the use of isotopic exchange kinetics (IEK) performed on typical Ni bearing phases (i.e., two types of serpentines, chlorite, smectite, goethite, and hematite) the isotopic exchange and metal-solid interaction processes are connected, considering both the thermodynamic and kinetic aspects. Results of Ni IEK experiments on mineral phases are fitted with a pseudo-first order kinetic model. For each Ni bearing phase, this allows to (i) determine the number and size of exchangeable pools (ENi(i)), (ii) assess their corresponding kinetic constants (k(i)), and (iii) discuss the mechanism of Ni isotopic exchange at mineral surfaces. It is shown that all the phases investigated, with the only exception of hematite, present at least two distinct reactive pools with significantly different k(i) values. Results suggest also that metal involved in outer-sphere complexes would display isotopic exchange between 100 and 1000 times faster than metal involved in inner-sphere complexes, and that the presence of high and low affinity sites may influence the rate of isotopic exchange up to 1 order of magnitude. Moreover, the method developed represents a tool to predict and estimate Ni mobility and availability in natural soil samples on the basis of soil mineral composition, providing information barely obtained with other techniques.

[Comparison of British and French expatriate doctors' characteristics and motivations]. / Comparaison des caractéristiques et des motivations des médecins expatriés français et britanniques.

BACKGROUND: Migration of medical practitioners is rarely studied despite its importance in medical demography: the objective of this study was to analyze the characteristics and motivations of the French doctors settled in the United Kingdom and of the British doctors settled in France. METHODS: This cross-sectional study was conducted using a self-completed questionnaire sent to all French doctors practicing in the United Kingdom (in 2005) and all British medicine doctors practicing in France (in 2009). The doctors were identified with official data from the National Medical Councils: 244 French doctors practicing in the United Kingdom and 86 British doctors practicing in France. The questionnaire was specifically developed to determine the reasons of moving to the other country, and the level of satisfaction after expatriation. RESULTS: A total of 98 French doctors (out of 244) and 40 British doctors (out of 86) returned the questionnaire. Respondents were mainly general practitioners with a professional experience of 8 to 9 years. The sex ratio was near 1 for both groups with a majority of women among physicians under 50 years. The motivations were different between groups: French doctors were attracted by the conditions offered at the National Health Service, whereas British doctors were more interested in opportunities for career advancement, joining husband or wife, or favourable environmental conditions. Overall, the respondents considered expatriation as satisfactory: 84% of French doctors, compared with only 58% of British doctors, were satisfied with their new professional situation. CONCLUSION: This study, the first in its kind, leads to a clearer understanding of the migration of doctors between France and the United Kingdom.

[Evaluation of the metrological quality of the medico-administrative data for perinatal indicators: A pilot study in 3 university hospitals]. / Évaluation de la qualité métrologique des données du programme de médicalisation du système d'information (PMSI) en périnatalité : étude pilote réalisée dans 3 CHU.

BACKGROUND: In order to assess public health policies for the perinatal period, routinely produced indicators are needed for the whole population. In France, these indicators are used to compare the national public health policy with those of other European countries. French administrative and medical data (PMSI) are straightforward and reliable and may be a valuable source of information for research. This study aimed to measure the quality of PMSI data from three university health centers for core indicators in perinatal health. METHOD: PMSI data were compared with medical files in 2012 from 300 live births after 22 weeks of amenorrhea, drawn at random from University Hospitals in Dijon, Paris and Nancy. The variables were chosen based on the Europeristat Project's core and recommended indicators, as well as those of the French National Perinatal survey conducted in 2010. The information gathered blindly from the medical files was compared with the PMSI data positive predictive value (PPV) and the sensitivity was used to assess data quality. RESULTS: Data on maternal age, parity and mode of delivery as well as the rates of premature births were superimposable for the two sources. The PPV for epidural injection was 96.2% and 94.3% for perineal tears. Overall, maternal morbidity was underdocumented in the PMSI, so the PPV was 100.0% for pre-existing diabetes, 88.9% for gestational diabetes and 100.0% for high blood pressure with a rate of 9.0% in PMSI and 6.3% in the medical files. The PPV for bleeding during labor was 89.5%. CONCLUSION: To conclude, PMSI data are apparently becoming more and more reliable for two reasons: on one hand, the importance of these data for budgetary promotion in hospitals; on the other, the increasing use of this information for statistical and epidemiological purposes.

Frequency of dosage prescribing medication errors associated with manual prescriptions for very preterm infants.

WHAT IS KNOWN AND OBJECTIVE: The risk of dosage Prescription Medication Error (PME) among manually written prescriptions within 'mixed' prescribing system (computerized physician order entry (CPOE) + manual prescriptions) has not been previously assessed in neonatology. This study aimed to evaluate the rate of dosage PME related to manual prescriptions in the high-risk population of very preterm infants (GA < 33 weeks) in a mixed prescription system. METHODS: The study was based on a retrospective review of a random sample of manual daily prescriptions in two neonatal intensive care units (NICU) A and B, located in different French University hospitals (Dijon and La Reunion island). Daily prescription was defined as the set of all drugs manually prescribed on a single day for one patient. Dosage error was defined as a deviation of at least ±10% from the weight-appropriate recommended dose. RESULTS AND DISCUSSION: The analyses were based on the assessment of 676 manually prescribed drugs from NICU A (58 different drugs from 93 newborns and 240 daily prescriptions) and 354 manually prescribed drugs from NICU B (73 different drugs from 131 newborns and 241 daily prescriptions). The dosage error rate per 100 manually prescribed drugs was similar in both NICU: 3·8% (95% CI: 2·5-5·6%) in NICU A and 3·1% (95% CI: 1·6-5·5%) in NICU B (P = 0·54). Among all the 37 identified dosage errors, the over-dosing was almost as frequent as the under-dosing (17 and 20 errors, respectively). Potentially severe dosage errors occurred in a total of seven drug prescriptions. None of the dosage PME was recorded in the corresponding medical files and information on clinical outcome was not sufficient to identify clinical conditions related to dosage PME. Overall, 46·8% of manually prescribed drugs were off label or unlicensed, with no significant differences between prescriptions with or without dosage error. The risk of a dosage PME increased significantly if the drug was included in the CPOE system but was manually prescribed (OR = 3·3; 95% CI: 1·6-7·0, P < 0·001). WHAT IS NEW AND CONCLUSION: The presence of dosage PME in the manual prescriptions written within mixed prescription systems suggests that manual prescriptions should be totally avoided in neonatal units.

Economic analysis of the costs associated with prematurity from a literature review.

OBJECTIVES: To analyse published cost-of-illness studies that had assessed the cost of prematurity according to gestational age at birth. METHODS: A review of the literature was carried out in March 2011 using the following databases: Medline, ScienceDirect, The Cochrane Library, Econlit and Business Source Premier, and a French Public-Health database. Key-word sequences related to 'prematurity' and 'costs' were considered. Studies that assessed costs according to the gestational age (GA) at the premature birth (<37 weeks of gestation) in industrialized countries and during the last two decades were included. Variations in the reported costs were analysed using a check-list, which allowed the studies to be described according to several methodological and contextual criteria. RESULTS: A total of 18 studies published since 1990 were included. According to these studies, costs were assessed for different follow-up periods (short, medium or long-term), and for different degrees of prematurity (extreme, early, moderate and late). Results showed that whatever the follow-up period, costs correlated inversely with GA. They also showed considerable variability in costs within the same GA group. Differences between studies could be explained by the choices made, concerning i/the study populations, ii/contextual information, iii/and various economic criteria. Despite these variations, a global trend of costs was estimated in the short-term period using mean costs from four American studies that presented similar methodologies. Costs stand at over US$ 100,000 for extreme prematurity, between US$ 40,000 and US$ 100,000 for early prematurity, between US$ 10,000 and US$ 30,000 for moderate prematurity and below US$ 4500 for late prematurity. CONCLUSION: This review underlined not only the clear inverse relationship between costs and GA at birth, but also the difficulty to transfer the results to the French context. It suggests that studies specific to the French health system need to be carried out.

Comparison of the ability of alternative birthweight and fetal weight standards to identify preterm newborns at increased risk of perinatal death.

OBJECTIVE: To compare prediction of perinatal deaths among preterm infants based on fetal weight standards versus a new subpopulation-based birthweight standard. DESIGN: Population-based cohort study. SETTING: France. POPULATION: A total of 9100 preterm singletons, born between 24 and 36 weeks of gestation in 2000-09, in Burgundy (France). METHODS: We first classified all newborns as either small for gestational age (SGA) or not, based on alternative fetal weight or birthweight standards, including a new birthweight standard that excludes infants born to mothers with disease related to the weight of a fetus. Based on discrepancies between the different classifications, we then divided the newborns into four groups, and compared their risks of stillbirth and in-hospital death, using a generalised linear model with relative risks (RR). MAIN OUTCOME MEASURES: Perinatal deaths, including, in separate analyses, stillbirths and in-hospital deaths. RESULTS: The preterm infants classified as SGA by our new subpopulation-based birthweight standard but not by the conventional birthweight standard had a significantly higher risk of both stillbirth (RR = 2.6; 95% confidence interval [95% CI] = 1.9-3.6) and in-hospital death (RR = 2.8; 95% CI = 1.8-4.5). In contrast, no risk increase was found for infants classified as SGA by the fetal standard only (RR = 1.1; 95% CI = 0.7-1.7 for stillbirths, and RR = 0.5; 95% CI = 0.3-1.3 for in-hospital deaths). CONCLUSIONS: Our subpopulation-based birthweight standard identified a subgroup of preterm newborns who have significantly increased risks of perinatal death but are not classified as SGA by the conventional birthweight standard. In contrast, the subgroup classified as SGA by the fetal standards only, but not by our subpopulation-based birthweight standard, had no increased risk of mortality, compared with non-SGA infants.

Advantages and limitations of using national administrative data on obstetric blood transfusions to estimate the frequency of obstetric hemorrhages.

BACKGROUND: Obstetric hemorrhages are a frequent cause of maternal death all over the world, but are not routinely monitored. Health systems administrative databases could be used for this purpose, but data quality needs to be assessed. OBJECTIVES: Using blood transfusion data recorded in administrative databases to estimate the frequency of obstetric hemorrhages. Research design A population-based study. Subjects Validation sub-sample: all mothers who gave birth in a French region in 2006-07 (35 123 pregnancies). Main study: all mothers who gave birth in France in 2006-07 (1 629 537 pregnancies). METHOD: Linkage and comparison of administrative data on blood transfusions with data from the French blood agency ('gold standard'), and, based on this validation, the construction of a multivariable regression model to correct the number of pregnant women identified as having received a transfusion in the national administrative database. RESULTS: The blood transfusion rate observed in the gold standard was 7.12‰. The sensitivity of the administrative data was estimated at 66.3% and the positive predictive value at 91.3%. The estimated total number of pregnant women who received blood transfusions in France in 2006-07 was 10 941 (6.71‰). CONCLUSIONS: The administrative data, available in most countries, can be used to estimate the frequency of obstetric hemorrhages.

[Comparing results of methicillin-resistant Staphylococcus aureus (MRSA) surveillance using the French DRG-based information system (PMSI)]. / État des lieux et évaluation de la surveillance des Staphylococcus aureus résistants à la méticilline (SARM) : PMSI versus surveillance Raisin.

BACKGROUND: The surveillance of methicillin-resistant Staphylococcus aureus (MRSA) is a national priority. The rate of MRSA infections is one of six indicators tracked by the Department of Health. Since 2002, the French institute for public health surveillance (InVS) has monitored MRSA infections to estimate incidence density. Today, the use of the French administrative database (PMSI) could facilitate this surveillance. The aim of this study was to compare MRSA incidence density computed at a national level using PMSI databases with the results from the InVS taken as the reference. METHODS: PMSI databases for the years 2006 to 2009 were used. The reference results were those published by the InVS from 2006 to 2009. MRSA density defined as the number of MRSA infections recorded per year over 1000 hospital stays was computed. It was then compared with the MRSA incidence density measured by InVS. The time course of MRSA incidence in the PMSI records was modeled using a Poisson regression. RESULTS: The incidence density measured by the InVS was higher than the MRSA density computed using the PMSI, but this difference appeared to decrease over time. The PMSI density/InVS MRSA incidence density ratio was 0.8% in 2006 and about 9.2% in 2009. We observed inverted trends with a growing trend in MRSA density identified by the PMSI. Furthermore, the year of study was significantly associated with incidence density (P=0.01). CONCLUSION: Using PMSI data as an additional source of information in the hospital MRSA surveillance process makes it possible to detect and analyze patient repeats at the regional and national levels with linkage facilities. Estimation of incidence density for hospitals not participating to this surveillance system will be the next step.