[The evaluation of pharmacological drugs, medical devices, and non-pharmacological or public health interventions: Experimental design limitations. Moving towards new methods?] / Évaluer les effets d'un médicament, de dispositifs médicaux et d'interventions non médicamenteuses ou de santé publique : limites de l'essai expérimental. Vers de nouvelles méthodes ?

In the field of health, evidence-based medicine and associated methods like randomised controlled trials (RCTs) have become widely used. RCT has become the gold standard for evaluating causal links between interventions and health results. Originating in pharmacology, this method has been progressively expanded to medical devices, non-pharmacological individual interventions, as well as collective public health interventions. Its use in these domains has led to the formulation of several limits, and it has been called into question as an undisputed gold standard. Some of those limits (e.g. confounding biases and external validity) are common to these four different domains, while others are more specific. This paper describes the different limits, as well as several research avenues. Some are methodological reflections aiming at adapting RCT to the complexity of the tested interventions, and at overcoming some of its limits. Others are alternative methods. The objective is not to remove RCT from the range of evaluation methodologies, but to resituate it within this range. The aim is to encourage choosing between different methods according to the features and the level of the intervention to evaluate, thereby calling for methodological pluralism.

Psychological effect of exercise in women with breast cancer receiving adjuvant therapy: what is the optimal dose needed?

BACKGROUND: Several meta-analyses have examined the role of exercise interventions in improving psychological outcomes in cancer survivors but most did not focus on adjuvant therapy period and did not investigate the optimal dose of exercise needed. The present meta-analysis examines the impact of exercise interventions delivered at this particular period on fatigue, anxiety, depression, and quality of life (QoL) as well as dose-response relationships between volume of prescribed exercise and these psychological outcomes. MATERIALS AND METHODS: Randomized, controlled trials that proposed an exercise intervention to patients with breast cancer undergoing chemotherapy and/or radiotherapy were systematically identified and coded. Psychological outcomes effect sizes were calculated and analyzed for trends using linear and quadratic regressions. RESULTS: Pooled effects of the 17 included studies revealed improvement for all outcomes, significant for fatigue, depression, and QoL with pooled estimates ranging from 0.2 to 0.5 favoring intervention. Significant inverse associations of the volume of prescribed exercise with fatigue and QoL were observed. CONCLUSIONS: Exercise intervention improved fatigue, depression, and QoL in patients with breast cancer receiving adjuvant therapy. Prescription of relatively low doses of exercise (<12 MET h/week) consisting in ∼90-120 min of weekly moderate physical exercise seems more efficacious in improving fatigue and QoL than higher doses.

[Oxytocin administration during spontaneous labour: Guidelines for clinical practice. Guidelines short text]. / Recommandations pour l'administration d'oxytocine au cours du travail spontané. Texte court des recommandations.

OBJECTIVES: To define the different stages of spontaneous labour. To determine the indications, modalities of use and the effects of administering synthetic oxytocin. And to describe undesirable maternal and perinatal outcomes associated with the use of synthetic oxytocin. METHOD: A systematic review was carried out by searching Medline database and websites of obstetrics learned societies until March 2016. RESULTS: The 1st stage of labor is divided in a latence phase and an active phase, which switch at 5cm of cervical dilatation. Rate of cervical dilatation is considered as abnormal below 1cm per 4hour during the first part of the active phase, and below 1cm per 2hours above 7cm of dilatation. During the latent phase of the first stage of labor, i.e. before 5cm of cervical dilatation, it is recommended that an amniotomy not be performed routinely and not to use oxytocin systematically. It is not recommended to expect the active phase of labor to start the epidural analgesia if patient requires it. If early epidural analgesia was performed, the administration of oxytocin must not be systematic. If dystocia during the active phase, an amniotomy is recommended in first-line treatment. In the absence of an improvement within an hour, oxytocin should be administrated. However, in the case of an extension of the second stage beyond 2hours, it is recommended to administer oxytocin to correct a lack of progress of the presentation. If dynamic dystocia, it is recommended to start initial doses of oxytocin at 2mUI/min, to respect at least 30min intervals between increases in oxytocin doses delivered, and to increase oxytocin doses by 2mUI/min intervals without surpassing a maximum IV flow rate of 20mUI/min. The reported maternal adverse effects concern uterine hyperstimulation, uterine rupture and post-partum haemorrhage, and those of neonatal adverse effects concern foetal heart rate anomalies associated with uterine hyperstimulation, neonatal morbidity and mortality, neonatal jaundice, weak suck/poor breastfeeding latch and autism. CONCLUSION: The widespread use of oxytocin during spontaneous labour must not be considered as simply another inoffensive prescription without any possible deleterious consequences for mother or foetus. Conditions for administering the oxytocin must therefore respect medical protocols. Indications and patient consent have to be report in the medical file.

Level of perinatal care of the maternity unit and rate of cesarean in low-risk nulliparas.

OBJECTIVE: To analyze the influence of level of perinatal care of the maternity unit on the rate of cesarean delivery during labor among women with low-risk pregnancies. METHODS: Using data from the PREMODA (PREsentation et MODe d'Accouchement: presentation and mode of delivery) study of 138 French maternity units, the delivery method in 3,654 low-risk nulliparas (live singleton fetus in cephalic presentation at term [37-41 weeks of gestation], born weighing 2,500-4,500 g, no uterine scar, no cesarean before labor, and no induction of labor for maternal or fetal disorders) was analyzed. Independent variables included maternal and fetal characteristics and the level of perinatal care of the maternity unit (level 1, 2a, 2b, and 3; where levels 2b and 3 routinely manage high-risk pregnancies). Univariable and multivariable analysis with a multilevel logistic model explored the factors associated with cesarean delivery during labor. RESULTS: Overall, the rate of cesarean during labor was 11.7%. The rate was significantly higher in level 2b (odds ratio 1.5, 95% confidence interval 1.1-2.1) and 3 (odds ratio 1.3, 95% confidence interval 1.0-1.9) maternity units than in level 1 facilities. The size and status of the facilities did not significantly affect these rates. Risk factors for cesarean were older maternal age, non-French origin, gestational age of 41 weeks, male sex, and high birth weight. CONCLUSION: Maternity units that frequently manage high-risk pregnancies (levels 2b and 3) have higher rates of cesareans during labor for their population of nulliparas at low risk than do facilities that deal mainly with low-risk pregnancies (level 1). LEVEL OF EVIDENCE: II-2.

Efficacy of theory-based interventions to promote physical activity. A meta-analysis of randomised controlled trials.

Implementing theory-based interventions is an effective way to influence physical activity (PA) behaviour in the population. This meta-analysis aimed to (1) determine the global effect of theory-based randomised controlled trials dedicated to the promotion of PA among adults, (2) measure the actual efficacy of interventions against their theoretical objectives and (3) compare the efficacy of single- versus combined-theory interventions. A systematic search through databases and review articles was carried out. Our results show that theory-based interventions (k = 82) significantly impact the PA behaviour of participants (d = 0.31, 95% CI [0.24, 0.37]). While moderation analyses revealed no efficacy difference between theories, interventions based on a single theory (d = 0.35; 95% CI [0.26, 0.43]) reported a higher impact on PA behaviour than those based on a combination of theories (d = 0.21; 95% CI [0.11, 0.32]). In spite of the global positive effect of theory-based interventions on PA behaviour, further research is required to better identify the specificities, overlaps or complementarities of the components of interventions based on relevant theories.

[Do women from Seine-Saint-Denis have different prenatal care compared to other women in the region?]. / Les femmes de Seine-Saint-Denis ont-elles un suivi prénatal différent de celui des autres femmes d'Île-de-France ?

OBJECTIVE: We compared the care of pregnant women residing in Seine-Saint-Denis (SSD) to those resident elsewhere in Île-de-France because of the high rate of perinatal and infant mortality in this district. MATERIALS AND METHODS: Data come from the French national perinatal surveys of 2003 and 2010 (n=969 in Seine-Saint-Denis, n=5636 other Île-de-France). We analyzed two indicators: inadequate prenatal care (late initiation, <3 ultrasounds, insufficient number of visits) and lack of knowledge of about screening and diagnostic tests for Down's Syndrome. Models were adjusted for sociodemographic characteristics. RESULTS: Nineteen percent of women in Seine-Saint-Denis and 12 % elsewhere in Île-de-France had inadequate care and 29 % and 16 % did not know if they had been screened for Down's Syndrome. These rates were higher among migrant women but did not differ by place of residence (25 and 40 % respectively). For French citizens, residence in Seine-Saint-Denis was a risk factor for both indicators. CONCLUSION: A reflection on how to improve care during pregnancy should be initiated in Seine-Saint-Denis.

[Mode of delivery and term breech presentation in the PREMODA cohort]. / Mode d'accouchement des femmes avec une présentation du siège à terme dans l'étude PREMODA (PREsentation et MODe d'Accouchement).

OBJECTIVES: The purpose of this work was to report labor and birth management practices for term breech presentation in France and Belgium in 2001-2002 and to describe indications for cesarean sections (before labor, emergency situations) in breech presentations. MATERIAL AND METHODS: The PREMODA cohort is a survey population which included 19408 deliveries, 8108 of which were term breech presentations. RESULTS: Infants were delivered by cesarean section before labor (59.1%), emergency cesarean section during labor (18.4%) or vaginally (22.5%). The decision for cesarean section before labor was empirical (breech presentation) in 44.3% of the cases. Half of the cesarean sections performed during labor (n=704, 49.3%) were planned C-sections. Overall, 67.8% of the breech presentations were delivered during planned cesarean sections (before or during labor). When vaginal delivery was attempted, the rate of vaginal birth was 70%. CONCLUSION: These early results reveal a high rate of cesarean section as well as differences in inter-regional practices. Considering all cesarean sections performed before labor, the most frequent indication was an empirical decision because of the breech presentation. An increased rate of planned cesarean section does not reduce the rate of vaginal delivery when attempted.

[Neonatal mortality in Seine-Saint-Denis: analysis of neonatal death certificates]. / Mortalité néonatale en Seine-Saint-Denis : analyse des certificats de décès néonatals.

The neonatal mortality rate in Seine-Saint-Denis in 2008 was 3.7 per 1000 live births vs. 2.6 in Île de France and 2.4 in Metropolitan France. The analysis of neonatal death certificates between 2001 and 2008 did not find any specific difference in the causes or characteristics of these deaths when compared with Ile de France or Metropolitan France. It seems that excess mortality in SSD affects all deaths, regardless of their cause.

Physical activity targeted at maximal lipid oxidation: a meta-analysis.

Exercise is recognized as a part of the management of obesity and diabetes. Various protocols of exercise are proposed for the management of obesity, diabetes, and other metabolic diseases. One of the strategies proposed by several authors is low intensity endurance training targeted at the level of maximal oxidation. Large series using this technique are lacking. Addressing this issue, we performed a meta-analysis of the studies on anthropometric measurements. From a database of 433 articles, 15 were selected, including 279 subjects with 6 different populations. Studies duration ranged from 2 months to 12 months. Concerning weight loss, in the intervention versus control analysis, five studies with 185 participants were included with a significant effect size favors exercise (P = 0.02) without significant heterogeneity (I(2) = 0.0%, P = 0.83). Further randomized controlled trials for comparing it with other exercise protocols and defining its dose effectiveness on large samples are needed.

Elective induction of labor: failure to follow guidelines and risk of cesarean delivery.

BACKGROUND: Estimate the frequency of failure to follow the French consensus guidelines for elective induction, and assess how failure affects the rate of cesarean delivery. METHODS: We compared cesarean rates according to mode of onset of labor among 5,046 low-risk patients. Violation of the guidelines was defined as induction before 38 weeks or with a Bishop score <5 or with prostaglandins. The cesarean risk was analysed with a bivariable and then a multivariable analysis, which used a multilevel logistic model. RESULTS: Women with electively induced and spontaneous labor had identical cesarean rates (4.1%). The guidelines were not followed in 23.2% of elective inductions. The risk of cesarean was higher after induction with a Bishop score <5, than after spontaneous labor (adjusted OR=4.1, 95% CI [1.3-12.9]), while elective induction with a favourable cervix did not increase the cesarean risk. In nulliparas, failure to follow the guidelines tripled the risk of cesarean (adjusted OR=3.2 [1.0-10.2]). On the other hand, elective induction of labor for women with a favourable cervix did not increase the risk of cesarean over the risk with spontaneous labor. CONCLUSION: Elective induction does not appear to increase the cesarean rate when the guidelines are met. Electively inducing labor with a low Bishop score increased the risk of cesarean, especially in nulliparas.

Non-clinical determinants of planned cesarean delivery in cases of term breech presentation in France.

BACKGROUND: To explore non-clinical maternal and institutional factors associated with the decision for planned cesarean in cases of breech presentation at term in France, where planned vaginal delivery are recommended by the French College of Gynecologists and Obstetricians (CNGOF) when conditions are optimal. METHODS: The analysis included 6,080 women with a live fetus in breech presentation at term, from the PREMODA prospective survey, in 138 French maternity units between 1 June 2001 and 31 May 2002. Women with previous cesarean sections were excluded. The analysis to identify risk factors for planned cesarean used a multilevel logistic model. RESULTS: The planned cesarean rate was 63.5%. The maternal factors most strongly associated with a decision for planned cesarean were parity (adjusted OR: 2.56 (2.29-2.88)) and maternal age > or =35 years (ORa: 1.38 (1.18-1.61)). No association was found between institutional factors, such as maternity size and level of care, although a centre effect was documented (p<0.001). CONCLUSION: The variation in planned cesarean rates between maternity units was not associated with their structural characteristics, but was related to a characteristic specific to each centre, and, thus, suggests that despite the current guidelines in France, obstetricians have diverse opinions about the best mode of delivery for breech presentations.