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1.
Sci Rep ; 14(1): 11429, 2024 05 19.
Article de Anglais | MEDLINE | ID: mdl-38763960

RÉSUMÉ

This study aimed to explore the perception of an underutilised collaborative information system through qualitative research, utilizing semi-structured, in-depth interviews with independent midwives and physician. PROSPERO, is a collaborative information system designed to bridge the communication gap between community-based healthcare workers and hospital-based care teams for parturients in Lyon, France. Through 27 semi-structured in-depth interviews with midwives, obstetricians, and general practitioners, we identified key themes related to the system's adoption: implementation challenges, utilisation barriers, interprofessional dynamics, and hidden variables affecting system use. Participants recognised the potential of PROSPERO to improve information sharing and care coordination but expressed concerns about the system's integration into existing workflows, time constraints, and the need for adequate training and technical support. Interprofessional dynamics revealed differing perspectives between hospital and independent practitioners, emphasising the importance of trust-building and professional recognition. Hidden variables, such as hierarchical influences and confidentiality concerns, further complicated the system's adoption. Despite the consensus on the benefits of a collaborative information system, its implementation was hindered by mistrust between healthcare workers (i.e. between independent practitioners and hospital staff). Our findings suggest that fostering trust and addressing the identified barriers are crucial steps towards successful system implementation. The study contributes to understanding the complex interplay of factors influencing the adoption of collaborative healthcare technologies and highlights the need for strategies that support effective interprofessional collaboration and communication.ClinicalTrials ID NCT02593292.


Sujet(s)
Personnel de santé , Humains , France , Femelle , Personnel de santé/psychologie , Adulte , Comportement coopératif , Systèmes d'information , Grossesse , Recherche qualitative , Profession de sage-femme , Mâle , Relations interprofessionnelles
2.
Sci Rep ; 14(1): 11298, 2024 05 17.
Article de Anglais | MEDLINE | ID: mdl-38760478

RÉSUMÉ

Objective structured clinical examination (OSCE) is a valid method to evaluate medical students' competencies. The present cross-sectional study aimed at determining how students' coping and health-related behaviors are associated with their psychological well-being and performance on the day of the OSCE. Fourth-year medical students answered a set of standardized questionnaires assessing their coping (BCI) and health-related behaviors before the examination (sleep PSQI, physical activity GPAQ). Immediately before the OSCE, they reported their level of instant psychological well-being on multi-dimensional visual analogue scales. OSCE performance was assessed by examiners blinded to the study. Associations were explored using multivariable linear regression models. A total of 482 students were included. Instant psychological well-being was positively associated with the level of positive thinking and of physical activity. It was negatively associated with the level of avoidance and of sleep disturbance. Furthermore, performance was negatively associated with the level of avoidance. Positive thinking, good sleep quality, and higher level of physical activity were all associated with improved well-being before the OSCE. Conversely, avoidance coping behaviors seem to be detrimental to both well-being and OSCE performance. The recommendation is to pay special attention to students who engage in avoidance and to consider implementing stress management programs.Clinical trial: The study protocol was registered on clinicaltrial.gov NCT05393206, date of registration: 11 June 2022.


Sujet(s)
Adaptation psychologique , Étudiant médecine , Humains , Étudiant médecine/psychologie , Femelle , Mâle , Études transversales , Enquêtes et questionnaires , Adulte , Jeune adulte , Comportement en matière de santé , Compétence clinique , Exercice physique/psychologie , Évaluation des acquis scolaires/méthodes
3.
Acad Med ; 99(7): 784-793, 2024 Jul 01.
Article de Anglais | MEDLINE | ID: mdl-38534105

RÉSUMÉ

PURPOSE: Personality traits are associated with psychophysiological stress, but few studies focus on medical students. This study aimed to better understand the association of personality traits with the efficacy of stress management interventions for medical students. METHOD: A randomized controlled trial was conducted with fourth-year students who took the objective structured clinical examination at Bernard University Lyon 1 in December 2021. Students were randomized in cardiac biofeedback, mindfulness, and control groups. Each intervention was implemented for 6 minutes before the examination. Physiological stress levels were collected during the intervention. Psychological stress levels were rated by students at baseline and after the intervention. Personality traits were assessed via the Big-Five Inventory. Interactions between personality traits and the efficacy of the interventions were analyzed using multivariable linear regression models. RESULTS: Four hundred eighty-one students participated. Higher baseline psychological stress levels were associated with higher neuroticism and agreeableness ( ß = 10.27 [95% confidence interval {CI}, 7.40-13.13; P < .001] and ß = 3.42 [95% CI, 0.98-5.85; P = .006], respectively) and lower openness ( ß = -4.95; 95% CI, -7.40 to -2.49; P < .001). As compared with the control intervention, both stress management interventions led to lower levels of psychological ( P < .001 for both) and physiological stress levels (biofeedback: P < .001 and mindfulness: P = .009). Biofeedback efficacy varied by extraversion score for psychological ( ß = -5.66; 95% CI, -10.83 to -0.50; P = .03) and physiological stress reduction ( ß = -0.002; 95% CI, -0.003 to -0.00004; P = .045). Mindfulness efficacy varied by agreeableness score for psychological stress reduction ( ß = -7.87; 95% CI, -13.05 to -2.68; P = .003). CONCLUSIONS: Students with a high score in extraversion may benefit more from biofeedback interventions, while students with high scores in agreeableness may benefit more from mindfulness interventions.


Sujet(s)
Rétroaction biologique (psychologie) , Pleine conscience , Personnalité , Stress psychologique , Étudiant médecine , Humains , Étudiant médecine/psychologie , Étudiant médecine/statistiques et données numériques , Femelle , Mâle , Stress psychologique/thérapie , Stress psychologique/psychologie , Pleine conscience/méthodes , Rétroaction biologique (psychologie)/méthodes , Adulte , Jeune adulte
4.
Med Teach ; 46(2): 239-244, 2024 02.
Article de Anglais | MEDLINE | ID: mdl-37605843

RÉSUMÉ

PURPOSE: To assess interrater reliability and examiners' characteristics, especially specialty, associated with scoring of neurology objective structured clinical examination (OSCE). MATERIAL AND METHODS: During a neurology mock OSCE, five randomly chosen students volunteers were filmed while performing 1 of the 5 stations. Video recordings were scored by physicians from the Lyon and Clermont-Ferrand university teaching hospitals to assess students performance using both a checklist scoring and a global rating scale. Interrater reliability between examiners were assessed using intraclass coefficient correlation. Multivariable linear regression models including video recording as random effect dependent variable were performed to detect factors associated with scoring. RESULTS: Thirty examiners including 15 (50%) neurologists participated. The intraclass correlation coefficient of checklist scores and global ratings between examiners were 0.71 (CI95% [0.45-0.95]) and 0.54 (CI95% [0.28-0.91]), respectively. In multivariable analyses, no factor was associated with checklist scores, while male gender of examiner was associated with lower global rating (ß coefficient = -0.37; CI 95% [-0.62-0.11]). CONCLUSIONS: Our study demonstrated through a video-based scoring method that agreement among examiners was good using checklist scoring while moderate using global rating scale in neurology OSCE. Examiner's specialty did not affect scoring whereas gender was associated with global rating scale.


Sujet(s)
Médecine , Neurologie , Étudiant médecine , Humains , Mâle , Reproductibilité des résultats , Évaluation des acquis scolaires/méthodes , Compétence clinique
5.
J Gynecol Obstet Hum Reprod ; 53(1): 102695, 2024 Jan.
Article de Anglais | MEDLINE | ID: mdl-37995939

RÉSUMÉ

BACKGROUND: In breast cancer surgery, IBR (immediate breast reconstruction) is widely proposed to patients without indications of adjuvant treatments and without risk factors of surgical complications. New INCa's guidelines (2022) allow the expansion of IBR indications. OBJECTIVE: A retrospective, unicentric and safety study: post-operative complication rate after IBR in comparison with simple mastectomy (SM, reference treatment). MATERIEL AND METHOD: This retrospective study has included all major patients who have received mastectomy for breast cancer between 2016 and 2020 before application of new guidelines, in Hôpital de la Croix-Rousse, Lyon (France). They were distributed in two groups according to their surgery : IBR and SM. Usual risk factors of post-operative complications were collected (tabacco, obesity…). The primary endpoint was the occurrence of an early post-operative complication (within 3 months after surgery). Two secondary analysis focused on the impact of preoperative risk factors on complications, and the proportion of patients eligibled for an IBR among SM based on new INCA's guidelines. RESULTS: The study included 185 mastectomies: 153 SM, 32 mastectomies IBR.  IBR's patients presented less risk factors, and few indications of adjuvant treatments. The rate of major complications was identical in the two groups (14 % in SM group, 12 % in IBR group), and there were more minor complications in the SM group than in the IBR group (p 0,01). According to our study, the raw proportion of initially possible IBR was 68 % (36 % of breast reconstruction in this study). CONCLUSION: This analyse approve IBR in selected patients. In this context, INCa's guidelines (2022) can generalize IBR's proposal to patients. However, the analysis of pre-operative risk factors stay essential in medical care.


Sujet(s)
Tumeurs du sein , Mammoplastie , Humains , Femelle , Tumeurs du sein/chirurgie , Mastectomie/effets indésirables , Études rétrospectives , Mastectomie simple , Mammoplastie/effets indésirables , Complications postopératoires/étiologie
6.
BMC Pregnancy Childbirth ; 23(1): 241, 2023 Apr 12.
Article de Anglais | MEDLINE | ID: mdl-37046229

RÉSUMÉ

BACKGROUND: While the World Health Organisation (WHO) warned about mistreatment, disrespect and/or abuse during childbirth as early as 2014. This same year a social media movement with #payetonuterus brought to light the problematic of obstetrical violence in French speaking countries, and more specifically on issues of disrespect. The experience of care is an integral part of the quality of care, and perception on inadequate support during labour and loss of control in labour are some of the most frequently reported risk factors for childbirth-related post-traumatic stress disorder (CB-PTSD). Therefore, it seems crucial to study the associations between disrespect during childbirth and the mental well-being of mothers. METHODS: We performed a multicentered cohort study using auto-questionnaires within a French perinatal network. The main outcome was women's report of disrespect during childbirth measured by the Behavior of the Mother's Caregivers - Satisfaction Questionnaire (BMC-SQ) 3 days and 2 months after childbirth. CB-PTSD and Postpartum Depression (PPD) were assessed 2 months after childbirth using respectively the Post-Traumatic Checklist Scale (PCLS) and the Edinburgh Postnatal Depression Scale (EPDS). RESULTS: This study followed 123 mothers from childbirth to 2 months postpartum. Among them, 8.13% (n = 10/123) reported disrespect during childbirth at 3 days after childbirth. With retrospect, 10.56% (n = 13/123) reported disrespect during childbirth at 2 months postpartum, i.e. an increase of 31%. Some 10.56% (n = 13/123) of mothers suffered from postpartum depression, and 4.06% (n = 5/123) were considered to have CB-PTSD at 2 months after childbirth. Reported disrespect during childbirth 3 days after birth was significantly associated with higher CB-PTSD 2 months after birth (R2 = 0.11, F(1,117) = 15.14, p < 0.001 and ß = 9.11, p = 0.006), PPD at 2 months after childbirth was positively associated to reported disrespect in the birth room, 3 days after birth (R2 = 0.04, F(1, 117) = 6.28, p = 0.01 and ß = 3.36, p = 0.096). Meanwhile, PPD and CB-PTSD were significantly associated 2 months after childbirth (R2 = 0.41, F=(1,117) = 82.39, p < 0.01 and ß = 11.41, p < 0.001). CONCLUSIONS: Disrespect during childbirth was associated with poorer mental health during the postpartum period. Given the high prevalence of mental health problems and the increased susceptibility to depression during the postpartum period, these correlational results highlight the importance of gaining a deeper awareness of healthcare professionals about behaviours or attitudes which might be experienced as disrespectful during childbirth.


Sujet(s)
Dépression du postpartum , Troubles de stress post-traumatique , Grossesse , Femelle , Humains , Études de cohortes , Dépression du postpartum/épidémiologie , Dépression du postpartum/étiologie , Dépression du postpartum/psychologie , Santé mentale , Relations entre professionnels de santé et patients , Parturition/psychologie , Période du postpartum/psychologie , Enquêtes et questionnaires , Troubles de stress post-traumatique/épidémiologie , Troubles de stress post-traumatique/étiologie
7.
Int J Gynaecol Obstet ; 162(2): 676-683, 2023 Aug.
Article de Anglais | MEDLINE | ID: mdl-36762575

RÉSUMÉ

OBJECTIVE: The first trimester combined risk of trisomy 21 is obtained by multiplying the risk related to maternal age by the likelihood ratios of nuchal translucency, free beta-human chorionic gonadotrophin (ß-hCG) and placenta associated plasma protein-A. Beyond five multiples of the median (MoM) of ß-hCG, the risk of trisomy 21 is truncated. The objective of the present study was to evaluate the evolution of the first trimester combined risk of trisomy 21 in individuals with first-trimester free-ß-hCG levels between 5 and 10 MoM. METHODS: We conducted a non-interventional cohort study from a 6-year database of combined first-trimester trisomy 21 screening of all individuals who underwent the screening in a French specialized medical analysis center. We included all pregnant individuals who had a serum-free ß-hCG between 5 and 10 MoM. Patients for whom the status of the fetus, with or without trisomy 21, was not identified by the outcome of the pregnancy or by a karyotype result were excluded from the study. The discriminatory capacity of free-ß-hCG above 5 MoM was studied by a receiver operating characteristic curve. We used an orthogonal polynomial regression to represent the evolution of likelihood ratios according to free-ß-hCG in MoM. RESULTS: Among 413 216 combined first-trimester screens of trisomy 21, 2239 (0.5%) screens met the inclusion criteria. In the selected population, 801 (35.8%) were excluded from the study because of missing fetal or neonatal status, and 46 (3.2%) fetuses out of 1438 included were diagnosed with trisomy 21. For free ß-hCG values between 5 and 10 MoM, the area under the curve is 0.56 (0.46-0.65). The scatterplot of the likelihood ratio of ß-hCG showed an increasing parabolic pattern: the likelihood of trisomy 21 increases with the free-ß-hCG threshold. CONCLUSION: To override the truncated risk of trisomy 21 in case of free ß-hCG values between 5 and 10 MoM, the study has allowed us to estimate the adjusted risk of trisomy 21, enabling health professionals to offer appropriate prenatal counseling.


Sujet(s)
Syndrome de Down , Grossesse , Femelle , Nouveau-né , Humains , Premier trimestre de grossesse , Syndrome de Down/diagnostic , Études de cohortes , Diagnostic prénatal , Protéine A plasmatique associée à la grossesse/analyse , Sous-unité bêta de la gonadotrophine chorionique humaine , Gonadotrophine chorionique , Marqueurs biologiques , Trisomie , Mesure de la clarté nucale
8.
J Ultrasound Med ; 42(3): 559-573, 2023 Feb.
Article de Anglais | MEDLINE | ID: mdl-35869903

RÉSUMÉ

Focused ultrasound is a treatment modality increasingly used for diverse therapeutic applications, and currently approved for several indications, including prostate cancers and uterine fibroids. But what about breast cancer? Breast cancer is the most common and deadliest cancer in women worldwide. While there are different treatment strategies available, there is a need for development of more effective and personalized modalities, with fewer side effects. Therapeutic ultrasound is such an option, and this review summarizes the state of the art in their use for the treatment of breast cancer and evaluate potentials of novel treatment approaches combining therapeutic ultrasound, immuno- and chemo-therapies.


Sujet(s)
Tumeurs du sein , Ablation par ultrasons focalisés de haute intensité , Léiomyome , Tumeurs de la prostate , Ultrasonothérapie , Tumeurs de l'utérus , Mâle , Humains , Tumeurs du sein/imagerie diagnostique , Tumeurs du sein/traitement médicamenteux , Immunothérapie , Résultat thérapeutique
9.
Int J Gynaecol Obstet ; 160(3): 900-905, 2023 Mar.
Article de Anglais | MEDLINE | ID: mdl-35986606

RÉSUMÉ

OBJECTIVE: To assess the correlation between standard laboratory indicators at admission and severe maternal complications due to placental abruption (PA) with intrauterine fetal death (IUFD) after 24 weeks. METHODS: Retrospective study in three French tertiary referral hospitals. Correlation of laboratory indicators at admission (platelet count, prothrombin, activated partial thromboplastin time, fibrinogen) and severe maternal complications (massive transfusion, multiple organ failure, hysterectomy, or maternal deaths) in patients with PA and IUFD. RESULTS: Over 12 years, we identified 27/344 (7.8%) pregnant women presenting PA with IUFD. No patient had coagulopathy at admission. Fifteen individuals (55.5%) underwent delivery by cesarean section before or during labor. Fifteen individuals (55.5%) presented severe complications, and 17/27 (63%) lost more than 1 L of blood during delivery. Fibrinogen level was shown to be the laboratory indicator most correlated with severe complications (r = -0.52, P = 0.01). The receiver operating characteristic curve of fibrinogen less than 1.9 g/L in the prediction of severe complications (area under the curve = 0.80, 95% confidence interval [CI] 0.54-0.97) showed both a sensitivity and specificity of 83% (95% CI 54%-96%). CONCLUSIONS: In cases of IUFD with PA, fibrinogen levels at admission had a prognostic value for the prediction of severe maternal complications.


Sujet(s)
Hématome rétroplacentaire , Hémostatiques , Grossesse , Femelle , Humains , Fibrinogène , Études rétrospectives , Césarienne , Placenta , Mort foetale/étiologie , Mortinatalité
10.
Healthcare (Basel) ; 10(10)2022 Sep 23.
Article de Anglais | MEDLINE | ID: mdl-36292301

RÉSUMÉ

The objective of this study was to compare the mental well-being of French women who were and were not pregnant during the first COVID-19 pandemic lockdown. We performed a nationwide online quantitative survey including all women between 18 and 45 years of age during the second and third weeks of global lockdown (25 March-7 April 2020). The main outcome measure was mental well-being measured by the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). This study analysed 275 responses from pregnant women and compared them with those from a propensity score-matched sample of 825 non-pregnant women. In this French sample, the median WEMWBS score was 49.0 and did not differ by pregnancy status. Women living in urban areas reported better well-being, while those with sleep disorders or who spent more than an hour a day watching the news reported poorer well-being. During the first lockdown in France, women had relatively low mental well-being scores, with no significant difference between pregnant and non-pregnant women. More than ever, health-care workers need to find a way to maintain their support for women's well-being. Minor daily annoyances of pregnancy, such as insomnia, should not be trivialised because they are a potential sign of poor well-being.

11.
J Gynecol Obstet Hum Reprod ; 51(10): 102495, 2022 Dec.
Article de Anglais | MEDLINE | ID: mdl-36307022

RÉSUMÉ

OBJECTIVES: Evaluate the prevalence of uterine synechia after total uterine ligation (TUL) in comparison to TUL associated with compression-penetrating-sutures (CPS) in the conservative surgical management of severe postpartum hemorrhage (PPH). METHODS: Prospective observational study of pregnant women that underwent conservative surgical management for PPH in a single French tertiary referral center. We compared the risk of uterine synechia with TUL, in comparison to performing TUL in addition to CPS. The synechia rate was calculated after uterine cavity assessment by 3D hysterosonography. Hysterectomies, women with placenta accreta spectrum and patients that received additional embolization treatment were excluded. RESULTS: Over 6 years, 36 pregnant women underwent surgical treatment for PPH in 21,944 deliveries (1.64 per 1000). The median blood loss was 2700 [1570-3000] milliliters. Twenty-eight (77.7%) women underwent TUL, 8/36 (22.2%) underwent TUL in addition to CPS. Thirty-four (94,4%) cavity assessments were performed 2-to-6 months after delivery, since one woman of each group was lost to follow-up. When TUL was performed in addition to CPS, the prevalence of synechia was 42.9% (n = 3/7), versus 3.7% (n = 1/27) in TUL (p = 0.021; RR = 16.88, 95%CI [1.1-1051]). Synechia was absent in 30/34 (88.2%) women. CONCLUSION: The prevalence of synechia was very low after TUL unlike CPS. Further studies should evaluate TUL in the conservative surgical management of PPH, to confirm the lower prevalence of synechiae in TUL and evaluate its impact on fertility.


Sujet(s)
Placenta accreta , Hémorragie de la délivrance , Femelle , Humains , Grossesse , Mâle , Hémorragie de la délivrance/épidémiologie , Hémorragie de la délivrance/étiologie , Hémorragie de la délivrance/chirurgie , Techniques de suture , Matériaux de suture , Placenta accreta/chirurgie , Adhérences tissulaires/chirurgie , Période du postpartum
12.
Eur J Obstet Gynecol Reprod Biol ; 278: 45-50, 2022 Nov.
Article de Anglais | MEDLINE | ID: mdl-36115259

RÉSUMÉ

This study aimed to evaluate the value of an e-learning program for the diagnosis of rectosigmoid endometriosis lesions using rectal water contrast transvaginal ultrasonography (rectosonography/RSG). Theoretical RSG training using videos with a commentary was offered online to healthcare professionals involved in ultrasound screening for endometriosis. A test (without correction) with 24 RSG video loops was used to assess the participants' baseline level before the training and their improvement afterwards. If the success rate post-training was below 80 %, the participant could start over with another series of 24 videos. Between February and June 2020, thirty participants took the training course (of which 80 % were obstetrics-gynaecology residents). The e-learning program resulted in a significant performance increase in the diagnosis of rectosigmoid endometriosis lesions, with a higher test success rate after the training compared to before (74.4 % and 63.6 % respectively; +10.8 %; 95 % CI [6,6; 15]; p < 0.001). Significant improvement was also observed regarding the overall skills involved in the ultrasound diagnosis of deep infiltrating endometriosis (+9.2 %; p < 0.001), the accurate diagnosis of the height of bowel lesions (+14.7 %; p < 0.001) and uterosacral ligament lesions (+8%; p < 0.005). In conclusion, our e-learning program led to a significant improvement of the diagnostic performance of digestive endometriosis using transvaginal ultrasound with intrarectal water contrast (rectosonography). Adding feedback to the post-test video loops could further increase the efficacy of the e-learning training.


Sujet(s)
Enseignement assisté par ordinateur , Endométriose , Femelle , Humains , Endométriose/imagerie diagnostique , Endométriose/anatomopathologie , Eau , Sensibilité et spécificité , Échographie/méthodes
13.
Ultrasound Med Biol ; 48(7): 1328-1335, 2022 07.
Article de Anglais | MEDLINE | ID: mdl-35469632

RÉSUMÉ

Three-dimensional rectosonography (RSG) is a transvaginal sonography technique using rectal water contrast and 3-D acquisitions. The main points of interest of 3-D RSG could be its easy accessibility and its quick learning curve, especially with respect to rectosigmoid lesions. The objective of this prospective observational study was to assess the learning curve of 3-D RSG for the diagnosis of rectosigmoid lesions and for various other locations of deep endometriosis (DE), endometriomas and adenomyosis. From April 2017 to November 2017, 116 patients with suspected pelvic endometriosis were referred to the Croix-Rousse University Hospital, and those who underwent 3-D RSG were included in our study. After a short training period, four residents were asked to perform 3-D RSG by themselves. Each procedure was systematically controlled immediately afterward by a single expert sonographer. The success of the procedure involved the correct identification of various locations of endometriosis (rectosigmoid, uterosacral ligament, retrocervical space, vagina, bladder and ovaries) and adenomyosis, using the expert sonographer's examination as the reference technique. The learning curve was generated using these data and assessed using the Learning Curve Cumulative Summation Test (LC-CUSUM) method. The pooled LC-CUSUM revealed that the required level of achievement was reached after 24 3-D RSGs were performed for the diagnosis of rectosigmoid lesions. All four residents were significantly competent in diagnosing rectosigmoid lesions at the end of their training period, with an α risk <0.05 (T1, p = 0.03; T2, p = 0.0002; T3, p = 0.05; T4, p = 0.02). The LC-CUSUM analysis confirmed that competency was achieved for vaginal DE, torus uterinum DE, US DE, bladder DE, endometriomas and adenomyosis within 17, 27, 38, 19, 17 and 33 scans, respectively. This study provides evidence that the skills required to diagnose endometriosis lesions and adenomyosis with 3-D RSG can be acquired after a brief learning period in an expert center.


Sujet(s)
Endométriose intra-utérine , Endométriose , Endométriose intra-utérine/imagerie diagnostique , Endométriose/imagerie diagnostique , Femelle , Humains , Courbe d'apprentissage , Sensibilité et spécificité , Échographie/méthodes , Eau
15.
Cancers (Basel) ; 13(11)2021 Jun 02.
Article de Anglais | MEDLINE | ID: mdl-34199352

RÉSUMÉ

BACKGROUND: The benefit-risk assessments of new drugs for breast cancer (BC) face several challenges, as all stakeholders do not agree on the evidence bar required for market authorization, and by the fragmentation of breast cancer diagnosis. The aim of this study was to describe the changes in methods and designs of breast cancer confirmatory trials. METHODS: All phase III randomized trials published between 2001 and 2020 and assessing systemic BC therapies were included. Trials' main characteristics, endpoints, and statistical methods were collected using a standardized data extraction form. RESULTS: A total of 347 randomized controlled trials (RCTs) met the inclusion criteria. While most older trials (79%) included all subtypes of breast cancer, most recent trials populations were limited to one large intrinsic BC subgroup (69%). The use of gatekeeping testing strategies increased dramatically from 9% to 71%. The use of overall survival (OS) as an endpoint in the trials increased over time, but its use as a primary endpoint remained infrequent. The inclusion of OS testing in a hierarchical sequence in case of positive testing of a tumor-centered or composite endpoint appeared to have become the new standard. CONCLUSION: Our findings indicate some improvements in the quality of the evidence-base supporting new breast cancer drugs. The rigorous assessment of patient-relevant endpoints has increased over time, but this improvement is mainly related to the analysis of OS as a secondary endpoint analyzed in a hierarchical sequence.

16.
Birth ; 48(3): 328-337, 2021 09.
Article de Anglais | MEDLINE | ID: mdl-33686732

RÉSUMÉ

BACKGROUND: Quality care during childbirth requires that health care providers have not only excellent skills but also appropriate and considerate attitudes and behavior. Few studies have examined the proportion of women in Western countries expressing dissatisfaction with such inappropriate or inconsiderate behavior. This study evaluated this proportion in a sample presumably representative of French maternity units. METHODS: This prospective multicenter study, using data from a selfadministered questionnaire, took place in 25 French maternity units during one week in September 2018. The primary outcome measure was mothers' self-reported dissatisfaction with blatantly inappropriate behavior (ie, inappropriate attitude, inadequate respect for privacy, insufficient gentleness of care, and/or inappropriate language) by health care workers in the delivery room. The secondary outcome was their self-reported dissatisfaction with these workers' inconsiderate behavior (ie, unclear and inappropriate information, insufficient participation in decision-making, or deficient consideration of pain). RESULTS: Of 803 potentially eligible women, 627 completed the questionnaire after childbirth; 5.62% (35/623, 95% CI: 3.94-7.73) reported dissatisfaction with blatantly inappropriate behaviors and 9.79% (61/623, 95% CI: 7.57-12.40) with inconsiderate behaviors. The main causes of dissatisfaction reported by women in this survey were the inadequate consideration of their pain and the failure to share decision-making. CONCLUSIONS: Most of the women were satisfied with how health care workers behaved towards them in the delivery room. Nonetheless, health care staff must be aware of women's demands for greater consideration of their expressions of pain and of their voice in decisions.


Sujet(s)
Services de santé maternelle , Parturition , Enfant , Femelle , Personnel de santé , Humains , Nouveau-né , Satisfaction des patients , Soins périnatals , Grossesse , Études prospectives , Qualité des soins de santé , Enquêtes et questionnaires
17.
Midwifery ; 84: 102663, 2020 May.
Article de Anglais | MEDLINE | ID: mdl-32092607

RÉSUMÉ

OBJECTIVE: To determine the factors associated with dissatisfaction in women whose labour was induced, according to parity. DESIGN: Prospective population-based cohort study. SETTING: Seven French perinatal health networks including 94 maternity units PARTICIPANTS: Among 3042 consecutive women who underwent induction of labour (IoL) with a live foetus from November 17 to December 20, 2015, in participating maternity units, this study included the 1453 who answered the self-administered questionnaire about their experience of IoL at two months post-delivery. MEASUREMENTS: The associations between women's dissatisfaction at two months post-delivery and the characteristics of their pregnancy, labour, and delivery were assessed with multivariable logistic regression models. Analyses were stratified for nulliparous and parous women. Multivariable mixed models were used to take a random effect for the maternity unit into account. FINDINGS: The response rate was 47.8% (n = 1453/3042). Overall, 30% of the nulliparous women were dissatisfied (n = 231/770) and 19.7% (n = 130/659) of the parous women. The specific independent determinants of dissatisfaction for nulliparous women were antenatal birth classes that failed to include discussion of IoL (OR: 2.68, 95% CI [1.37; 5.23]) and lack of involvement in the decision-making process (OR: 1.92, 95% CI [1.23; 3.02]). For the parous women, a specific determinant was a delivery that lasted more than 24 h (OR: 4.04, 95% CI [1.78; 9.14]). Determinants of maternal dissatisfaction common to both groups were unbearable vaginal discomfort (respectively, OR: 1.98, 95% CI [1.16; 3.37] and OR: 4.23, 95% CI [2.04; 8.77]), inadequate pain relief (respectively, OR: 5.55, 95% CI [3.48; 8.86] and OR: 9.17, 95% CI [5.24; 16.02]), lack of attention to requests (respectively OR: 3.81, 95% CI [2.35; 6.19] and OR: 5.01, 95% CI [2.38; 10.52]), caesarean delivery (respectively, OR: 5.55, 95% CI [3.41; 9.03] and OR: 4.61, 95% CI [2.02; 10.53]) and severe maternal complications (respectively, OR: 2.45, 95% CI [1.02; 5.88] and OR: 5.29, 95% CI [1.32; 21.21]). KEY CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: To reduce dissatisfaction in nulliparous women, IoL should be discussed during antenatal birth classes and women should be made to feel that they shared in the medical decision to perform IoL. For parous women, care providers should inform them that the duration of delivery may exceed 24 h. Continuous support for all women during IoL should pay closer attention to vaginal discomfort, pain and women's requests. Postpartum discussions with mothers should be arranged to enable conversation about the experience of unexpected events.


Sujet(s)
Accouchement provoqué/psychologie , Parité/physiologie , Satisfaction des patients , Adulte , Loi du khi-deux , Études de cohortes , Femelle , Humains , Accouchement provoqué/normes , Accouchement provoqué/tendances , Grossesse , Études prospectives , Enquêtes et questionnaires
18.
Eur J Obstet Gynecol Reprod Biol ; 246: 29-34, 2020 Mar.
Article de Anglais | MEDLINE | ID: mdl-31927407

RÉSUMÉ

OBJECTIVE: Assess the impact of implementation by simple distribution of a "colour code" protocol for emergency caesareans on the course over time of the "decision-delivery interval" (DDI) and neonatal outcome. DESIGN: Observational study in 26 maternity units of the AURORE perinatal network, conducted between October 1, 2017, and April 30, 2018. Each maternity ward́ was supposed to prospectively include 20 consecutive cases of caesareans performed either as an emergency, that is, as a code orange, or an extreme emergency, that is, code red. We compared the DDIs observed in 2017 to those in 2007 according to the degree of emergency, the maternity unit level of care, and their adherence to the protocol. Neonatal outcome in 2007 and 2017, assessed from laboratory and clinical indicators, was also compared, overall and according to the degree of emergency. RESULTS: The DDI was significantly lower in 2017 (n = 478) than in 2007 (n = 447), regardless of the degree of emergency and the level of care (p < 0.0001). In 2017, all code red caesareans were performed in less than 15 min in level 3 maternity units compared with 73 % (p = 0.039) in 2007. Fewer than 20 % of the caesareans in the 2007 study period were performed in less than 15 min in level 1 and 2 maternity units. Today, this is the case for 83 % of these caesareans in level 2 units (p < 0.001) and 36 % in level 1 (p = 0.01). In 2017, code orange caesareans were performed in less than 30 min in 96 % of cases in level 3 units, 67 % in level 2, and 33 % in level 1, compared respectively with 67 % (p = 0.015), 25 % (p < 0.0001) and 16 % (p = 0.0003) in 2007. We did not observe any difference in the neonatal outcome between 2007 and 2017 or as a function of the DDI expected based on the caesarean colour code. CONCLUSION: The implementation of the colour code protocols was associated with an improved DDI and better adherence to the recommendations in all 26 maternity units in this perinatal network.


Sujet(s)
Césarienne/statistiques et données numériques , Prise de décision clinique , Urgences , Délai jusqu'au traitement/statistiques et données numériques , Hématome rétroplacentaire/chirurgie , Adulte , Attestation , Dystocie/chirurgie , Éclampsie/chirurgie , Extraction obstétricale , Femelle , Souffrance foetale/chirurgie , France , Rythme cardiaque foetal , Humains , Pré-éclampsie/chirurgie , Grossesse , Prolapsus , Cordon ombilical , Rupture utérine/chirurgie
19.
Ultrasound Med Biol ; 46(2): 225-232, 2020 02.
Article de Anglais | MEDLINE | ID: mdl-31708272

RÉSUMÉ

Tridimensional rectosonography (3-D RSG) is a transvaginal ultrasonography procedure combining intrarectal contrast with tridimensional technology. The objectives of this study were to assess the diagnostic performances of 3-D RSG in deep infiltrating rectosigmoid endometriosis using surgery and pathology as the gold standard, and to compare its results with those of magnetic resonance imaging (MRI). Patients referred for endometriosis with symptoms suggesting deep infiltrating intestinal endometriosis (DIE) were included if they agreed to undergo a 3-D RSG and MRI and if there was a surgical indication related to endometriosis. The study was a non-randomized monocentric prospective cohort study (Canadian task force classification Level II-2). From May 2012 to May 2017, 101 patients were included. Sixty patients (59.4%) had bowel involvement of the rectum (n = 21, 20.8%) or of the sigmoid (n = 39, 38.6%) confirmed in surgery and/or in pathologic testing. In the diagnosis of rectosigmoid DIE, 3-D RSG sensitivity, specificity, positive predictive value, negative predictive value, accuracy and κ index were 93%, 95%, 97%, 91%, 94% and 0.88, respectively. For MRI they were 87%, 90%, 93%, 82%, 88% and 0.76, respectively. The accuracy was not significantly different between 3-D RSG and MRI (p = 0.181). In conclusion, 3-D RSG is an effective technique to diagnose rectosigmoid endometriosis and seems to have similar diagnostic performances to MRI for this indication.


Sujet(s)
Endométriose/imagerie diagnostique , Imagerie tridimensionnelle , Imagerie par résonance magnétique , Maladies du rectum/imagerie diagnostique , Maladies du sigmoïde/imagerie diagnostique , Adulte , Études de cohortes , Femelle , Humains , Adulte d'âge moyen , Valeur prédictive des tests , Études prospectives , Échographie/méthodes , Jeune adulte
20.
Eur J Obstet Gynecol Reprod Biol ; 240: 288-292, 2019 Sep.
Article de Anglais | MEDLINE | ID: mdl-31357094

RÉSUMÉ

STUDY OBJECTIVE: Comparison of 3D-rectosonography (3D-RSG), rectal endoscopic sonography (RES), and MRI performances in the diagnosis of rectosigmoid endometriosis using surgery as the Gold Standard. DESIGN: Monocentric retrospective longitudinal study on diagnostic procedures. DESIGN CLASIFICATION: Canadian Task Force II-2. SETTING: University Hospital of Lyon Croix-Rousse. PATIENTS: A total of 37 patients treated surgically for pelvic endometriosis. INTERVENTIONS: Expert 3D-RSG (3D Transvaginal sonography with water contrast in the rectum), MRI and RES performed by expert examiners. Sensitivity, specificity, accuracy, positive and negative predictive value, positive and negative likelihood ratios were calculated. Depth, size, and volume of intestinal lesions were also compared to the type of surgery performed (shaving versus segmental resection). MEASUREMENTS AND MAIN RESULTS: Rectosigmoid endometriosis lesion was confirmed by surgery in 31 patients on 37 (84%). Sensitivity, specificity, accuracy, positive and negative predictive value, positive and negative likelihood ratios for 3D-RSG were 94%, 100%, 95%, 100%, 75%, +∞ and 0.06 respectively; for RES 81%, 100%, 84%, 100%, 50%, +∞ and 0.19 respectively; while for MRI 90%, 100%, 92%, 100%, 67%, +∞ and 010 respectively. There was no significant difference between the 3 procedures (p > 0.05). CONCLUSION: 3D-RSG, RES and MRI seem to be 3 effective procedures in the diagnosis of rectosigmoid endometriosis. Their performances seem equivalent.


Sujet(s)
Maladies du côlon/imagerie diagnostique , Endométriose/imagerie diagnostique , Imagerie par résonance magnétique/méthodes , Maladies du rectum/imagerie diagnostique , Échographie/méthodes , Adulte , Endosonographie/méthodes , Femelle , Humains , Études longitudinales , Adulte d'âge moyen , Études rétrospectives , Sensibilité et spécificité , Jeune adulte
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