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Consensus on the Structure and Content of Birth Plans: A Modified Delphi Study
No full textInternational audienceBackground: Few pregnant women in France wrote birth plans as in many other countries. The literature stresses the heterogeneity of birth plan content, which limits the utility of assessing the effects of birth plans on women's experience of childbirth. This study aimed to obtain a French national consensus on the structure and content of birth plans. Methods: A multidisciplinary steering committee was established. An electronic modified Delphi study was conducted to develop a structure and content for birth plans between November 2022 and June 2023. During three Delphi consensus rounds, panellists, including perinatal health care professionals and user representatives, were asked to rate individually and independently each proposed section and subsection formulation of the birth plan for its appropriateness. An external board assessed the understandability of the final birth plan's preamble and content. Results: The steering committee proposed 103 formulations corresponding to items to be covered in a birth plan, categorized into 8 sections and 30 subsections, for evaluation in the Delphi rounds. The first round was completed by 42 panellists (mainly midwives), the second by 39, and the third by 36. Finally, the steering committee approved the final components of the structured birth plan in 8 sections and 19 subsections, after its reviewing by the 21 members of the external board. Conclusion: A French national Delphi process, after three rounds and validation by an external board, made it possible to reach a consensus on the structure and content of a birth plan in 8 sections and 19 subsections. Patient or Public Contribution: User representatives were included as experts in the Delphi rounds, and in the external board to approve the final version of the structured birth plan
Physical Activity and Sedentary Behavior During Pregnancy: Feasibility of videoconference-based programs - PregMouv faesability
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Tyrosine kinase inhibitors in cancers: Treatment optimization – Part I
No full textInternational audienceAimTo evaluate the effectiveness of a Bayesian adaptive dosing strategy in achieving target busulfan exposure in adult patients undergoing haematopoietic cell transplantation (HCT).MethodsThis study included 71 adult patients scheduled to receive high-dose busulfan. Busulfan was administered to achieve a cumulative area under the curve (AUC) of 66.0 mg/L/h (16 000 μM/min), 82.60 mg/L/h (20 000 μM/min) or 87.6 mg/L/h (21 200 μM/min) depending on the regimen. Individual pharmacokinetic (PK) parameters of busulfan were estimated from three blood samples using a one-compartment model and Bayesian estimation after the first standard dose. Individual PK parameters were used to adjust subsequent doses to achieve the target exposure.ResultsAll patients had their dose adjusted after the first dose administration. The final deviation from the target AUC was significantly improved compared to the initial deviation after standard mg/kg dosing (mean absolute deviation 19.5% vs 11.7%, P < .01). In addition, the proportion of patients with marked deviation from target exposure (ie, >25%) decreased significantly from 31% after standard dosing to 10% after PK-guided dosing (P < .01). Canonical busulfan-related toxicity, specifically veno-occlusive disease, was observed in 5% of patients who achieved successful PK-guided dosing. In contrast, one-third of patients with off-target exposure with poor dosing experienced toxicity.ConclusionThe Bayesian adaptive dosing strategy significantly improves the accuracy of achieving the target busulfan AUC in patients undergoing HCT. This approach not only reduces marked deviations from target exposure, but also reduces the incidence of busulfan-related toxicity, thereby maintaining a favourable toxicity/efficacy ratio
Ex Vivo Optimization of Donor Lungs with Inhaled Sevoflurane during Normothermic Ex Vivo Lung Perfusion (VITALISE): A Pilot and Feasibility Study in Sheep
No full textInternational audienceVolatile anesthetics have been shown in different studies to reduce ischemia reperfusion injury (IRI). Ex vivo lung perfusion (EVLP) facilitates graft evaluation, extends preservation time and potentially enables injury repair and improvement of lung quality. We hypothesized that ventilating lungs with sevoflurane during EVLP would reduce lung injury and improve lung function. We performed a pilot study to test this hypothesis in a slaughterhouse sheep DCD model. Lungs were harvested, flushed and stored on ice for 3 h, after which EVLP was performed for 4 h. Lungs were ventilated with either an FiO 2 of 0.4 (EVLP, n = 5) or FiO 2 of 0.4 plus sevoflurane at a 2% end-tidal concentration (C et ) (S-EVLP, n = 5). Perfusate, tissue samples and functional measurements were collected and analyzed. A steady state of the target C et sevoflurane was reached with measurable concentrations in perfusate. Lungs in the S-EVLP group showed significantly better dynamic lung compliance than those in the EVLP group (p = 0.003). Oxygenation capacity was not different in treated lungs for delta partial oxygen pressure (PO 2 ; +3.8 (-4.9/11.1) vs. -11.7 (-12.0/-3.2) kPa, p = 0.151), but there was a trend of a better PO 2 /FiO 2 ratio (p = 0.054). Perfusate ASAT levels in S-EVLP were significantly reduced compared to the control group (198.1 ± 93.66 vs. 223.9 ± 105.7 IU/L, p = 0.02). We conclude that ventilating lungs with sevoflurane during EVLP is feasible and could be useful to improve graft function
Original salivary sex hormone data of naturally menstruating athletes and hormonal contraceptive users
No full textInternational audienceObjectives There is a lack of data on salivary sex hormones across the menstrual cycle (MC) or hormonal contraceptive (HC) cycle of elite athletes. We aimed to provide original data on salivary sex hormones (17β-estradiol, progesterone and free testosterone) in naturally menstruating female athletes with a regular cycle or irregular cycle and using combined HC. A secondary purpose was to compare these data with published data from the general population according to the menstrual status (MC or HC or irregularly menstruating). Methods 367 saliva tests were performed on 44 elite athletes during 6 months of follow-up to certify for cycle regularity. Athletes were grouped into regular MC, n=13; irregular MC, n=5; and HC, n=26. We compared salivary data of regular MC across six cycle phases (menses, mid-follicular, late follicular, early luteal, mid-luteal and late luteal phases) with published data from women with a similar MC or HC status from the general population. Results We provided salivary original data according to six sub-phases among elite athletes with regular MC. HC athletes showed lower salivary sex hormonal levels, markedly after the first week of active HC compared with regular MC. Athletes with irregular cycles do not show a progesterone rise from the first half to the second half of the cycle (Δirregular=0.38 (1.90), a rise detectable within regular MC group ΔregularMC=2.86 (2.88)). Conclusions We provided original data for salivary sex hormone levels in elite female athletes. These references may be valuable for research investigating MC or combined HC data, particularly in longitudinal follow-ups requiring repeated measurements
Right ventriculoarterial coupling surrogates and long-term survival in LVAD recipients: Results of the ASSIST-ICD multicentric registry
No full textInternational audienceBackground: Prediction of outcomes remains an unmet need in LVAD candidates. Development of right heart failure portends an excess in mortality but imaging parameters of right ventricular systolic function have failed to demonstrate a prognostic role. By integrating pulmonary pressure, right ventriculoarterial coupling could fill this gap.Methods: The ASSIST-ICD registry was used to test right ventriculoarterial coupling surrogate parameters at implantation for the prediction of all-cause mortality.Results: The ratio of the tricuspid annular plane systolic excursion over the estimated systolic pulmonary pressure (TAPSE/sPAP) was not associated with long-term survival in univariate analysis (p = 0.89), neither was the pulmonary artery pulsatility index (PAPi) (p = 0.13). Conversely, the ratio of the right atrial pressure over the pulmonary capillary wedge pressure (RAP/PCWP) was associated with all-cause mortality (p <0.01). After taking tricuspid regurgitation severity, LVAD indication, LVAD model, age, blood urea nitrogen, and pulmonary vascular resistance into account, RAP/PCWP remained associated with survival (HR 1.35 [1.10 - 1.65], p <0.01).Conclusion: Among pre-implant RVAC surrogates, only RAP/PCWP was associated with long-term all-cause mortality in LVAD recipients. This association was independent of established risk factors
Development and characterization of novel fast-dissolving pentobarbital suppositories for pediatric procedural sedation and comparison with lipophilic formulations
No full textInternational audienceFor pediatric radiological procedures (RP), pentobarbital sodium (PNa) can be used orally or rectally to replace intravenous anesthesia. Since no commercial PNa suppositories exist, they must be prepared by compounding pharmacies. This study aims to develop fast-dissolving PNa suppositories for fast pharmacological activity during RP. We prepared gelatin (G), gelatin/polyethylene glycol 4000 (GP), and polyethylene glycol 4000 (P) suppositories, with and without pH adjustment, and assessed their dosage uniformity (DU), softening time, rupture resistance, and in-vitro dissolution. An optimal formulation was selected, and PNa release was compared to that of fat-based suppositories using dissolution tests. Additionally, the quality control process (analytical performance, safety/eco-friendliness and productivity/practical effectiveness) of these formulas were compared using a RGB method. All hydrophilic formulas (HF) met the DU requirement (AV < 8 %) except for P (AV 15.62 ± 4 %). pH adjustment enhanced G and GP suppositories resistance to 2.2 ± 0.2 kg and 2.0 ± 0.3 kg, respectively, and allowed 100 % release of PNa in under 10 min. In contrast, lipophilic formulas released less than 80 % of PNa at best after 120 min. These results show the biopharmaceutical suitability of HF for RP compared to lipophilic ones, but a pharmacokinetic study is needed to confirm data
Organization for Caries Research-European Federation of Conservative Dentistry Consensus Report on Clinical Recommendations for Caries Diagnosis Paper II: Caries Lesion Activity and Progression Assessment
No full textInternational audienceIntroduction: This consensus paper provides recommendations for oral health professionals on why and how to assess caries activity and progression with special respect to the site of a lesion. Methods: An expert panel was nominated by the executive councils of the European Organization for Caries Research (ORCA) and the European Federation of Conservative Dentistry (EFCD). The steering committee built three working groups that were asked to provide recommendations on (1) caries detection and diagnostic methods, (2) caries activity and progression assessment, and (3) obtain individualized caries diagnoses. The experts of work group 2 phrased and agreed on provisional general and specific recommendations on caries lesion activity and progression, based on a review of the current literature. These recommendations were then discussed and refined in a consensus workshop followed by an anonymous Delphi survey to determine the agreement on each recommendation. Results: The expert panel agreed on general (n = 7) and specific recommendations (n = 6). The specific recommendations cover coronal caries on pits and fissures, smooth surfaces, proximal surfaces, as well as root caries and secondary caries/caries adjacent to restorations and sealants. 3/13 recommendations yielded perfect agreement. Conclusion: The most suitable method for lesion activity assessment is the visual-tactile method. No single clinical characteristic is indicative of lesion activity; instead, lesion activity assessment is based on assessing and weighing several clinical signs. The recall intervals for visual and radiographic examination need to be adjusted to the presence of active caries lesions and recent caries progression rates. Modifications should be based on individual patient characteristics
Radiochirurgie des névralgies trigéminales avec accélérateur linéaire dédié sans cadre invasif : de la mise en service de l’appareil aux premiers résultats cliniques
No full textInternational audienceLa radiochirurgie pour le traitement de la névralgie du trijumeau délivre une très forte dose en une seule séance, sur quelques millimètres, au niveau d’un isocentre unique placé le long du nerf. Nous présentons ici les différentes étapes qui ont été réalisées pour valider des petits faisceaux par collimateurs coniques, et rapportons les résultats cliniques des premiers patients pris en charge sur Novalis Tx® sans cadre invasif.Nous avons d’abord été évalué l’exactitude géométrique des collimateurs coniques de 4 et 6 mm à l’aide de tests de Winston-Lutz ; puis l’acquisition des données dosimétriques a été réalisée grâce à des détecteurs de haute résolution spatiale (microdiamant PTW 60019 et une diode E PTW 60017). Les facteurs correctifs du rapport TRS no 483 ont été appliqués pour le calcul des facteurs d’ouverture du collimateur. Ces données dosimétriques ont ensuite été comparées avec les données implémentées dans le système de planification de traitement iPlan®. Puis des tests end-to-end ont permis de contrôler l’ensemble du processus de traitement à l’aide d’un fantôme anthropomorphique stereotactic end-to-end verification. Entre 2020 et 2022, 18 patients ont été traités pour névralgie trigéminale réfractaire sur Novalis Tx® sans cadre invasif avec repositionnement par Exactrac®. Dix-sept patients ont été évalués (un a été perdu de vue) à l’aide du score du Barrow Neurological Institute pour l’évaluation de la douleur, et par IRM avec un suivi médian de 12 mois