Adjunctive Brexpiprazole for Patient Life Engagement in Major Depressive Disorder: A Canadian, Phase 4, Open-Label, Interventional Study: Brexpiprazole d'appoint pour l'engagement dans la vie des patients souffrant de trouble dépressif majeur: une étude interventionnelle canadienne ouverte de phase 4.

OBJECTIVES: To characterize the effects of adjunctive brexpiprazole on patient life engagement and depressive symptoms in patients with major depressive disorder (MDD) using patient-reported outcomes. METHODS: An 8-week, Phase 4, open-label, interventional study was conducted at 15 Canadian trial sites between April 2021 and May 2022. Adult outpatients with MDD (at least moderately severe) and inadequate response to 1-2 antidepressants continued their current antidepressant and received oral adjunctive brexpiprazole 0.5-2 mg/day. Co-primary endpoints were change from baseline to Week 8 in Inventory of Depressive Symptomatology Self-Report (IDS-SR) 10-item Life Engagement subscale score, and IDS-SR 30-item total score. Safety was assessed by standard variables. RESULTS: Of 122 enrolled patients, 120 (98.4%) were treated (mean [SD] dose: 1.2 [0.4] mg/day) and analyzed, and 111 (91.0%) completed the study. Statistically significant least squares mean improvements to Week 8 were observed on IDS-SR10 Life Engagement subscale score (baseline mean [SD]: 16.1 [4.7]; change [95% confidence interval]: -8.11 [-9.34, -6.88]; p < 0.001) and IDS-SR total score (baseline mean [SD]: 41.3 [9.8]; change [95% confidence interval]: -17.38 [-20.08, -14.68]; p < 0.001). Improvements were observed from Week 2, onwards. Treatment-emergent adverse events with incidence ≥5% were fatigue (n = 13, 10.8%), headache (n = 13, 10.8%), insomnia (n = 12, 10.0%), nausea (n = 9, 7.5%), tremor (n = 8, 6.7%), and weight increase (n = 7, 5.8%). Six patients (5.0%) discontinued due to adverse events. Mean (SD) change in body weight from baseline to last visit was +1.9 (3.4) kg. CONCLUSIONS: Using an exploratory patient-reported outcome measure, patients with MDD and inadequate response to antidepressants who received open-label adjunctive brexpiprazole showed early and clinically meaningful improvement in patient life engagement, which should be further assessed in a prospective randomized controlled trial. Patient-rated depressive symptoms (on the validated 30-item IDS-SR) also improved. Adjunctive brexpiprazole was well tolerated, and no new safety signals were observed. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04830215.

Development and Evaluation of the Dietary Pattern Calculator (DiPaC) for Personalized Assessment and Feedback.

This study aimed to develop and validate a diet assessment screener - the Dietary Pattern Calculator (DiPaC). A scoping review identified currently available short diet quality assessment tools. Twenty-one articles covering 19 unique tools were included. The current tools mainly focused on individual nutrients or food groups or were developed for a specific population, and few ascertained overall dietary patterns. The 24-hour dietary recalls from the nationally representative Canadian Community Health Survey (CCHS)-Nutrition 2015 (n = 13,958) were used to derive and validate a personalized dietary pattern informed by the scoping review using weighted partial least squares. The dominant dietary pattern in CCHS-Nutrition 2015 was characterized by high consumption of fast foods, carbonated drinks, and salty snacks and low consumption of whole fruits, orange vegetables, other vegetables and juices, whole grains, dark green vegetables, legumes, and soy. The dietary pattern assessment was used to create and evaluate DiPaC following an agile and user-centred research and development approach. DiPaC, which demonstrated high validity and intermediate reliability (internal consistency = 0.47-0.51), is publicly available at https://www.projectbiglife.ca/. DiPaC can be used by the public, clinicians, and researchers for quick and robust assessment of diet quality, providing immediate feedback with the advantage of being easy to implement.

How do maternal and child health nurses incorporate infant mental health promotion into their clinical practice? Experiences of an Australian municipality.

The field of infant mental health (IMH) has offered valuable insights into the critical importance of social-emotional development, including the enduring influence of early experiences throughout life. Maternal and Child Health (MCH) nurses are ideally placed to facilitate knowledge sharing with parents. This Australian-based qualitative exploratory descriptive study explored how MCH nurses incorporate IMH in their clinical practice, and how they share this information with caregivers. Ten community-based MCH nurses participated in voluntary, semi-structured interviews which were transcribed verbatim and analyzed thematically. Findings identified five themes that characterized how MCH nurses incorporated IMH concepts into their practice. These themes were: prioritizing physical health promotion activities, highlighting infant communications, variations in knowledge and application of IMH concepts, workplace time schedules, and the relational nature of the work. Recommendations include encouraging IMH as a health promotion activity, facilitating IMH assessment, further education, reflective supervision, and extension of predetermined appointment times to enable knowledge and skill sharing. Further research is also recommended to provide additional insights into how nurses with IMH training promote and share IMH concepts with caregivers. Adoption of these recommendations would further enhance the care given to families and the role of the MCH nurses.

El campo de la salud mental infantil (IMH) ha ofrecido perspectivas valiosas sobre la suma importancia del desarrollo socioemocional en los primeros años para el desarrollo social y emocional posterior. Las enfermeras de la salud materno-infantil (MCH) se encuentran en posición ideal para facilitar el proceso de compartir conocimiento con los progenitores. Este estudio cualitativo, exploratorio y descriptivo, llevado a cabo en Australia, exploró cómo las enfermeras MCH incorporan IMH en sus prácticas clínicas y cómo ellas comparten esta información con los cuidadores. Un grupo de enfermeras MCH de base comunitaria participó en entrevistas voluntarias semiestructuradas. Las entrevistas se transcribieron palabra por palabra y se analizaron temáticamente. Los resultados identificaron cinco temas que caracterizaban cómo incorporaron los conceptos de IMH en su práctica. Estos temas fueron: actividades para promover el darle prioridad a la salud física, enfatizar las comunicaciones del infante, variaciones en el conocimiento y la aplicación de conceptos de IMH, tablas de horarios del lugar de trabajo y la naturaleza relacional del trabajo. Entre las recomendaciones se incluyen el fomentar IMH como una actividad de promoción de la salud, facilitar la evaluación de IMH, más educación, supervisión con reflexión, así como extensión del horario de citas predeterminado para permitir el proceso de compartir conocimiento y habilidades. También se recomienda más investigación para ofrecer perspectivas adicionales de cómo las enfermeras con entrenamiento de IMH promueven y comparten los conceptos de IMH con los cuidadores. La adopción de estas recomendaciones mejoraría más el cuidado que se ofrece a familias y el papel de las enfermeras MCH.

Le domaine de la santé mentale du nourrisson (IMH en anglais) a permis de mieux comprendre l'importance critique du développement socio-émotionnel dans les premières années pour le développement social et émotionnel ultérieur. Les infirmiers et infirmières de la Santé Maternelle et de l'Enfant (MCH en anglais) sont idéalement situées pour faciliter le partage des connaissances avec les parents. Cette étude Qualitative Exploratoire Descriptive, en Australie, a exploré comment les infirmier/infirmières MCH incorporent l'IMH dans leur pratique clinique et comment ils/elles partagent cette information avec les personnes prenant soin des enfants. Une cohorte de 10 infirmiers/infirmières MCH basées dans leur communauté ont participé à des entretiens volontaires semi-structurés. Les entretiens ont été transcrits verbatim et analysé de manière thématique. Les résultats ont identifié cinq thèmes qui ont caractérisé les concepts IMH dans leur pratique. Ces thèmes étaient: donner la priorité à la promotion d'activités de santé physique, la mise en évidence des communications du nourrisson, les variations dans les connaissances et l'application des concepts IMH, les emplois du temps du lieu de travail et la nature relationnelle du travail. Les recommandations incluent la nécessité d'encourager l'IMH en tant qu'activité de promotion de la santé, la facilitation de l'évaluation IMH, une formation supplémentaire, une supervision de réflexion et l'extension de rendez-vous pour développer les connaissances et partager les compétences. De plus amples recherches sont recommandées afin d'éclairer la manière dont les infirmiers/infirmières formées en IMH promeuvent et partagent les concepts IMH avec les personnes prenant soin des enfants. L'adoption de ces recommandations pour améliorer davantage le soin offert aux familles et les rôles des infirmiers/infirmières MCH.

Impact of pectus excavatum on pulmonary function and exercise capacity in patients treated with 3D custom-made silicone implants.

BACKGROUND: Pectus excavatum (PE) is the most common congenital chest wall deformity, whose cardiopulmonary consequences are controversial. PE surgery is in our experience usually performed for aesthetic reasons. OBJECTIVES: The aim of this study was to evaluate the impact of PE on respiratory function and exercise capacity in patients with PE before patient-specific silicone implant correction. METHODS: This monocentric prospective study conducted at Toulouse University Hospital included sixty patients scheduled for custom-made silicone implants correction. Respiratory function (pulmonary function tests (FPTs)) and exercise capacity (VO2 max) were measured before surgery. RESULTS: Before surgery, no (0/60) restrictive lung disease was detected, with a mean total lung capacity (TLC) of 98.5% of predicted value (IC 95%; 80.4-137). Median VO2 max (n=56) was normal (89% predicted), with no cardiac limitation. CONCLUSION: In this cohort, PE had no impact on respiratory function nor exercise capacity. In patients without cardiac or respiratory effects of PE, silicone implants should be considered the preferred approach as it adequately addressed patients' main complaint of low self-esteem.

[Inter-radiopharmacy audit, a tool for individual and collective progress]. / L'audit croisé inter-radiopharmacies, un outil de progrès individuel et collectif.

OBJECTIVE: Radiopharmacy is a high-risk hospital pharmacy carried out in a complex regulatory environment. Adopting an audit culture is a priority issue to secure the radiopharmaceutical drug circuit. The objective of the study is to demonstrate the value of cross auditing, a hybrid between internal and third party auditing. METHOD: A 125-item evaluation tool applying to the entire radiopharmacy activity was designed. Two radiopharmacies were audited internally and then a cross-audit was organized between the two units. RESULTS: For one of the units, 12 items were rated differently during the two audits. Four of the ten non-conformities that were not observed during the internal audit were rated as critical by the radiopharmacist auditor. For the second radiopharmacy, 15 items were rated differently, two of which were rated as critical. CONCLUSION: Personal opinion may unintentionally influence a reasoning, but the independence of the auditor during cross auditing is a guarantee of objectivity. It is an alternative to internal audits which have become routine and less efficient and unlike third party audits, the auditor is familiar with the constraints and concerns of the field. The interest of this approach goes beyond the simple evaluation of non-conformities. Cross auditing encourages the sharing of experience and know-how between professionals in the same field. It creates a dynamic collaboration between establishments and contributes to the individual and collective improvement of the safety of the radiopharmaceutical drug circuit.

[Comparative study of production and control processes of parenteral nutritional admixtures in neonatology]. / Étude comparative des processus de production et de contrôle analytique des préparations magistrales de mélanges nutritifs parentéraux en néonatalogie.

OBJECTIVES: To assess the impact of disparities in production and analytical control processes on the quality of parenteral nutrition (PN) preparations produced in the Auvergne-Rhône-Alpes region. METHODS: This study was carried out in four hospital pharmacies of the Auvergne-Rhône-Alpes region. To assess the impact of production processes, each centre produced ten PN preparations from the same prescription. Analytical controls (sodium, potassium and calcium dosage) were carried out on all the preparations. To assess the impact of the control processes, a batch of ten preparations was produced from the same prescription. Samples were sent to the four hospital pharmacies for analytical control (sodium, potassium and calcium dosage). RESULTS: Measurements of relative production bias show that there is a significant difference between the preparations from the four centres in terms of sodium and potassium content. Each centre had at least one production bias for one of the three electrolytes measured. Concerning analytical controls, there was a significant difference between the four centres in the sodium and potassium levels measured. With the exception of calcium, all the centres reported measurements within the usual specifications of±10% of the target value. The results obtained have no clinically significant impact. CONCLUSION: The diversity of NP practices has a real impact on the quality of the preparations made. A regional collaboration should be envisaged to standardise patient care.

[Securing the implantable medical device circuit]. / Arrêté du 8 septembre 2021 : sécurisation du circuit des dispositifs médicaux implantables.

OBJECTIVES: The decree concerning quality management of implantable medical device circuits came into force in healthcare establishments on 26 May 2022. The aim of this project is to assess the level of safety of this circuit within the pharmacy, in order to improve it and bring it into line with this future regulation. METHODS: A grid for compliance with the decree was drawn up, enabling compliance rates to be calculated. A second grid was drawn up in accordance with internal procedures. All these criteria were audited in pairs. Priority areas for improvement were identified and working groups were formed. The action plan was monitored by the Steering Committee. Control audits ensure the implementation and relevance of the action plan, as well as the effective securing of the circuit. RESULTS: The rate of circuit compliance with the decree rose from 58% (initial audits) to 72% (control audits). Over a period of 18 months, six workgroups were set to implement improvement measures allowing to ensure regulatory compliance and circuit security. Obstacles (equipment, IT) nevertheless hindered the presence of the unique identifier for medical devices at every stages of the circuit. CONCLUSIONS: This cross-functional project was carried out in "project mode", thanks to the involvement of field staff. It will be pursued at hospital level by the person in charge of the quality management system.

D-optimal mixture design inspired modified release tablet formulation of lamotrigine for the treatment of seizures: An in-depth characterization.

OBJECTIVE: Lamotrigine (LTG) an anticonvulsant drug with a dissociation constant (pKa: 5.7), suffers from enhanced blood plasma spike after each dose, when administered as fast release tablet. Being BCS class-II candidate and pH dependent solubility, development of release-controlled tablets of LTG is a major challenge. This investigation aims at designing the release-controlled tablet (RCT) formulation of LTG using a solid dispersion (SD) technique via addressing its solubility and release problems. MATERIAL AND METHODS: RCT of LTG was fabricated using SD blend of Eudragit RL and Eudragit RS and PVP K-30 with different polymer blend ratio (1:5 and 1:7). The optimization of RCT of LTG was performed using D-optimal mixture design with three independent variables, three response variables, and one constraint. The dissolution rate was determined and data were then fitted to different mathematical models. Scanning electron microscopy (SEM) and X-ray diffraction (XRD) studies and tableting parameters were analyzed. RESULT: In vitro studies of predicted optimized batches (POBs) have shown that drug release over a period of 12hours was 88.05±3.4% in media I, 86.10±3.7% in media II and 85.84±4.2% in media III. An in vitro kinetic model equating R2-value for all the tested models indicated that the first order and Higuchi release kinetics model were the most appropriate. CONCLUSION: Based on the optimized formulation consisting of SD of LTG with Eudragit RL, Eudragit RS and PVP K-30, the release rate was consistently similar throughout the GI tract, regardless of the pH of the environment.

A brief review on application of design of experiment for the analysis of pharmaceuticals using HPLC.

The quality pioneer Dr. Joseph M. Juran first proposed the idea of quality by design. According to him, pharmaceutical quality by design is an organised approach to product development that starts with predetermined goals and places an emphasis on product, process understanding, control based on reliable science and quality risk management. The quality of a product or process can typically be affected by a number of input elements. Design of experiments has been employed widely recently to understand the impacts of multidimensional and interactions of input parameters on the output responses of analytical procedures and pharmaceutical goods. Depending on the design of experiments objectives, screening, characterization, or optimization of the process and formulation, a variety of designs, such as factorial or mixture, can be used. The most popular designs used in the stage of screening or factor selection are the 2-Level Factorial and Plackett-Burman designs, both of which have two levels for each factor (k), both economical and effective, and in optimization widely used designs in this step are full factorial at three levels, central composite, Box-Behnken design. The analysis of variance, regression significance, and lack of fit of the regression model were some of the key topics covered in the discussion of the main components of multiple regression model adjustment. Design of experiments is thus the primary element of the formulation and analytical quality by design. The details about design of experiments used for the analysis of pharmaceutical formulation using HPLC.

Unlocking the secrets of doxepin hydrochloride's crystal structure: Insights from high-quality powder diffraction analysis.

Doxepin hydrochloride, a versatile pharmaceutical compound, has been the subject of extensive research aimed at elucidating its crystal structure and solid-state characteristics. In this manuscript, we explore the significance of high-quality powder diffraction data in unveiling the intricate details of doxepin hydrochloride's crystal lattice. By examining the refined atom coordinates, density functional theory (DFT) optimization, and intermolecular interactions, we gain valuable insights into its structural conformation. This knowledge highlights the importance of precise crystallographic data in advancing our understanding of complex compounds and their pharmaceutical applications.

[IMPLEMENTING AN OPERATING ROOM PHARMACY SATELLITE IN AN UNIVERSITY HOSPITAL]. / MISE EN PLACE D'UNE ANTENNE PHARMACEUTIQUE DE BLOCS OPÉRATOIRES DANS UN CENTRE HOSPITALIER UNIVERSITAIRE.

OBJECTIVES: An operating room pharmaceutical unit centralizes medical devices and drugs for various surgical specialities. The aim of this work is to present the methodology used in our establishment to set up the operating room pharmaceutical unit. METHODS: This approach involved the formation of multi-professional working groups. The needs of operating theatres were defined based on an analysis of healthcare product consumption and stock inventories. Material sheets were defined for each procedure. On the basis of simulations, material supply arrangements were selected, specifying material flows, equipment, workstations and information systems. RESULTS: Over 3,200 healthcare product references were identified and 862 equipment files were created. Local stocks have been limited to medical trolleys for nursing staff. Emergency operating packs have been deployed for unforeseen operations. Cabinets have been dedicated to transporting re-sterilizable medical devices, and carts have been purchased for Programmed Operating Packs. The equipment is made available by logistics agents and pharmacy assistants under pharmaceutical responsibility. CONCLUSIONS: This innovative approach is a model for facilities desiring to centralize and secure the logistics of healthcare products in the operating room. Ongoing adjustments will be required to meet new operating rooms needs.

[Setting up a training program in a geriatric short-stay department]. / Mise en place d'un programme de formations au sein d'un service de court séjour gériatrique.

As the department's team had been renewed in less than two years, it was necessary to invent a method to improve cohesion and communication, and to enhance the skills of professionals. This led to the creation of a training program using a variety of methods (theoretical training, care approaches and quality coffees).

[Staff hebdomadaire qualité et gestion des risques en gériatrie: un outil d'appropriation de la démarche qualité pour le management des unités]. / Staff hebdomadaire qualité et gestion des risques en gériatrie : un outil d'appropriation de la démarche qualité pour le management des unités.

The quality approach has become essential in geriatric hospital services, but also in the medico-social sector. This process is continuous and shared by all those in charge of the care units, to facilitate unit management and support caregivers in this approach. The weekly structured quality staff meeting is a relevant tool to facilitate the understanding and appropriation of this approach by the medical and nursing managers of the care units.

[Improving the experience of racialized immigrant seniors in Quebec]. / Améliorer l'expérience des personnes âgées immigrantes racialisées au Québec.

In Quebec, racialized immigrant seniors (AIRs) are a significant presence in long-term care facilities (CHSLDs) in the Greater Montreal area. To identify interventions that best meet their needs, this study interviewed 12 RIAs, including their families, about their experience in CHSLDs. The results show that RIAs face three challenges: food, clothing and play. Addressing these issues could improve their LTRCC experience.

[Cooperation protocols in emergency departments]. / Les protocoles de coopération au sein des services d'urgences.

Cooperation protocols enable healthcare professionals to work together to meet patients' needs. One of the challenges of these protocols is to offer a wider range of care by reducing the time taken to access care, while also optimising the patient's pathway. Four cooperation protocols have been validated for emergency services.

[The benefits of physical activity in the workplace for maintaining employee health]. / Intérêts de l'activité physique au travail pour le maintien de la santé des salariés.

Some jobs, particularly in the service sector, involve little physical activity on the part of employees. To improve their health, several areas or periods could be used to increase the amount of daily physical activity. Active transport to and from work is one such initiative, but physical activity can also be envisaged outside and during working hours. The aim of this article is to provide insights and research perspectives to better measure the importance of physical activity in the workplace.

[The transition of adolescents with sickle cell disease: an interdisciplinary exchange]. / La transition des adolescents drépanocytaires, un échange interdisciplinaire.

With the rising incidence of sickle cell disease, this chronic pathology is becoming the most common genetic disease in France. Advances in care have led to a marked improvement in life expectancy. Caregivers in pediatric facilities are therefore increasingly confronted with the question of the transition to adulthood of the adolescents they have been following since birth. As nurses working in Robert-Debré's transfusion and curative medicine unit, in 2022, adolescents accounted for 57 % of sickle cell patients enrolled in our transfusion exchange program. Adolescence is a period of major change, and the repercussions of the disease are all the more pronounced. This raises the issue of transferring them to the adult sector.

[Reconciling pregnancy and business continuity at the Roubaix hospital center]. / Concilier la grossesse et le maintien de l'activité au sein du centre hospitalier de Roubaix.

This project is a way of improving the quality of working life for female professionals during their pregnancy, with shared benefits for the agent and the team. But it's also a lever of attractiveness for caregivers and a guarantee of quality for users.

[E-Satis : A new method for analysis of Patient-Reported Outcome Measures (PROMs)]. / Valoriser e-Satis : nouvelle méthode d'analyse de l'Expérience Patient.

OBJECTIVE: Almost 80% of the patients responding to the nationwide French patient experience and satisfaction survey (e-Satis) provided free text comments. The objective of this article is to describe an innovative methodology for analysis of this qualitative data. METHODOLOGY: This methodological approach is based on analysis of qualitative data from the comments (verbatims) of respondents to the e-Satis survey. Analysis of the verbatims consists in three main steps: (i) analysis of the meaning of the words, with constitution of a thematic dictionary through exploratory research without preconceived notions; (ii) analysis of the syntax, i.e., the way in which the ideas are articulated, which will enable calculation of a linguistic indicator of speakers' involvement in their speech; (iii) production of statistics and characterisation of the themes, which will include three indicators: occurrence of the themes, the average satisfaction shown in the respondents' discourse, and the positive and negative involvement with which they express themselves. Given these results, a priority matrix of four categories of action is established: strong points, priority areas, good practices, and weak signals. RESULTS: This methodological approach was applied to 5868 e-Satis questionnaires out of a total of 10,061 verbatims by respondents hospitalised at the Hospices Civils de Lyon between 2018 and 2019. The analysis identified 28 major themes with 184 sub-themes. An extract is presented in this article for illustration purposes. DISCUSSION: A methodological approach based on analysis of qualitative data will enable transformation of unstructured data (verbatims) into measurable and comparable data. This methodology is structured to overcome the limitations of closed questions; open questions allow respondents to describe their experiences and perceptions in their own words. Moreover, it is a first step toward comparability of results over time with those of other establishments. This approach is unique in France on account of (a) its exploratory thematic research without preconceived notions and (b) its syntactic analysis of verbatims. CONCLUSIONS: This verbatim analysis methodology should enable precise and operational characterization of Patient Experience and induce prioritized improvement actions in healthcare institutions.

Association of health literacy with physical and mental health in people with chronic diseases.

OBJECTIVE: to explore the association of health literacy domains with physical and mental quality of life in people with selected chronic diseases. METHODS: Community-dwelling people with selected chronic diseases planned for immunization against influenza in 2017/2018 were included in the study. All non-vaccinated people and the corresponding number of randomly selected vaccinated people matched on town of residence were included. Data were collected by means of socio-demographic questionnaire, Health Literacy Questionnaire (HLQ) and Short Form-36 (SF-36). The Physical and Mental Composite Scores as well as their domains were observed as the study outcomes. RESULTS: A total of 295 people were studied. The adjusted logistic regression showed that Physical and Mental composite scores were associated with all HLQ domains except 5) Appraisal of health information. Better Physical Functioning was associated with higher scores on 1) Feeling understood and supported by healthcare providers, 6) Ability to actively engage with healthcare providers, 7) Navigating the healthcare system and 8) Ability to find good health information. Better scores on Vitality, Social Functioning, Role Emotional and Mental Health were associated with higher scores on all HLQ domains except 5) Appraisal of health information. CONCLUSION: Health literacy is important for physical and mental quality of life among people with chronic diseases. Health care providers and other stakeholders should continuously work to improve health literacy of their patients.