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1.
Ann Plast Surg ; 92(5S Suppl 3): S355-S360, 2024 May 01.
Article in English | MEDLINE | ID: mdl-38689419

ABSTRACT

PURPOSE: The use of visuals to inquire about gender in the clinical setting has been rare. We developed a survey that included a visual spectrum to assess perceptions about the most and least inclusive ways of inquiring about gender in patients with gender dysphoria. METHODS: The survey included a multiple-choice question (MCQ), free-response question, and a visual spectrum on which respondents were asked to select one box that best depicts their gender. The survey was administered to all patients diagnosed with gender dysphoria at our institution between April and June 2022. RESULTS: A total of 223 of 856 patients responded. Those with more masculine gender identities selected boxes near the visual spectrum corner of "man," whereas responses were more variable for more feminine genders. The free-response question was identified by 59% of respondents as the most inclusive. The MCQ was identified as least inclusive by 70.4%. The visual spectrum was considered the most inclusive method by the majority of patients who self-identified as woman and demiwoman/demifemale. Being asked about pronouns was extremely or very important in the health care setting for 52% of respondents, but 68.6% indicated that they are rarely or sometimes asked about their pronouns in this setting. CONCLUSIONS: The traditional MCQ format for self-identifying gender may be lacking in inclusivity and fails to represent the nuances of gender identity. Free response was considered the most inclusive way to inquire about gender among our respondents. These findings highlight the importance of formatting gender identity questionnaires to foster inclusivity for transgender patients.


Subject(s)
Gender Dysphoria , Gender Identity , Humans , Male , Female , Gender Dysphoria/psychology , Surveys and Questionnaires , Adult , Middle Aged , Transgender Persons/psychology
2.
J Am Coll Cardiol ; 2024 May 14.
Article in English | MEDLINE | ID: mdl-38752899

ABSTRACT

AIM: The "2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease" provides recommendations to guide clinicians in the treatment of patients with lower extremity peripheral artery disease across its multiple clinical presentation subsets (ie, asymptomatic, chronic symptomatic, chronic limb-threatening ischemia, and acute limb ischemia). METHODS: A comprehensive literature search was conducted from October 2020 to June 2022, encompassing studies, reviews, and other evidence conducted on human subjects that was published in English from PubMed, EMBASE, the Cochrane Library, CINHL Complete, and other selected databases relevant to this guideline. Additional relevant studies, published through May 2023 during the peer review process, were also considered by the writing committee and added to the evidence tables where appropriate. STRUCTURE: Recommendations from the "2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease" have been updated with new evidence to guide clinicians. In addition, new recommendations addressing comprehensive care for patients with peripheral artery disease have been developed.

3.
J Neurol Surg B Skull Base ; 85(3): 241-246, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38721368

ABSTRACT

Objectives Iatrogenic injury to the internal carotid artery (ICA) is one of the most catastrophic complications of endoscopic sinus and skull base surgery. Previous research has shown that packing with a crushed muscle graft at the injury site can be an effective management technique to control bleeding and prevent the need for ICA sacrifice. Here, we describe a novel and readily available repair donor site-an autologous lateral tongue muscle patch. Design Three representative cases of a successful repair of ICA injuries using a lateral tongue muscle patch are included in this study. The graft measured approximately 2 × 3 cm and was taken from the lateral intrinsic tongue musculature. We describe the harvest of the graft, its advantages, and the details of operative repair. Results The lateral tongue provides a large and readily accessible source of muscle within the surgical field that can be quickly harvested during an endoscopic procedure. For the first case, an expanding parasellar ICA pseudoaneurysm was managed with a tongue muscle patch and nasal packing. In the second case, a cavernous ICA injury was sustained during craniopharyngioma resection. Case three involved an ICA injury during endonasal debridement of invasive fungal rhinosinusitis. None of the patients required embolization or neurovascular stenting. Postoperative angiograms and serial computed tomography angiograms showed complete resolution of the pseudoaneurysm, and the patients continued to do well at least 1 year after repair. Conclusion Lateral tongue muscle graft is an effective and efficient method to manage ICA injuries during endoscopic endonasal surgery. Advantages include the speed of harvest, donor site being readily accessible in the surgical field, and low donor site morbidity. It should be added to the repertoire of possible donor sites for addressing catastrophic sinonasal bleeding.

4.
Am Surg ; : 31348241256087, 2024 May 23.
Article in English | MEDLINE | ID: mdl-38780449

ABSTRACT

BACKGROUND: Unlike large hemothoraces (HTX), small HTX after blunt trauma may be observed without drainage. We aimed to study if there were risk factors that would predict the need for intervention in initially observed small HTX. METHODS: A retrospective review of patients with blunt traumatic HTX from 2016 to 2022 was performed. Patients with small HTX (pleural fluid volume <400 mL on admission chest computerized tomography [CT]) were included. Patients were considered as being "initially observed" if there was no intervention for the HTX within 48 hours after admission. Primary outcome was any HTX-related intervention (open, thoracoscopic or percutaneous procedures) occurring after 48 hours and up to 6 months after injury. Univariable and multivariable statistical analyses were employed. A P-value of <.05 was considered significant. RESULTS: Of 335 patients with HTX, 188 (59.6%) met inclusion criteria. Median (interquartile range) HTX volume was 90 (36-134) ml. One hundred and twenty-seven (68%) were initially observed. Of these, 31 (24%) had the primary outcome. These patients had a larger HTX volume (median, 129 vs 68 mL, P = .0001), and number of rib fractures (median, 7 vs 4, P = .0002) compared to those without the primary outcome. Chest-related readmission occurred in 8 (6%) with a median of 20 days from injury. Of these, 7 required an HTX-related intervention. Logistic regression analysis found that both the number of rib fractures and HTX volume independently predicted the primary outcome. CONCLUSION: For small HTX initially observed, number of rib fractures and initial volume predicted delayed HTX-related intervention.

5.
Surgery ; 2024 May 19.
Article in English | MEDLINE | ID: mdl-38769036

ABSTRACT

BACKGROUND: In the United States, over 6 million people are affected by chronic wounds. Patients often rely on the Internet for treatment information; however, these educational materials typically exceed the average eighth-grade health literacy level. This study aimed to assess the readability and language accessibility of online patient education materials on wound care strategies. METHODS: A search was conducted on Google for articles related to wound care strategies. The first 12 unique websites from each search strategy were selected for further analysis. Readability was assessed using 11 tests, with the mean scores calculated for each. RESULTS: A total of 66 articles pertaining to wound care strategies were retrieved from 43 websites. All articles had an average reading grade level of 13.5 ± 2.5 and an average reading age of 18.7 ± 2.5 years. Websites were categorized by the following sources: academic (34.9%), reagent/biologic manufacturers (27.9%), wound care (18.6%), news media organizations (14%), and other (4.7%). Flesch Reading Ease Score, graded from 0 for most difficult to 100 for least difficult, was found to be highest for academic websites (44.2, P = .01) and lowest for news media websites (24.9, P = .01). Academic websites were available in the more languages compared to all other website categories (P < .01). CONCLUSION: Online materials related to wound care strategies often exceed the National Institute of Health recommended eighth-grade reading level. This study emphasizes the need for healthcare providers to create more accessible educational materials to address the gap in health literacy and optimize patient care.

6.
Circulation ; 2024 May 14.
Article in English | MEDLINE | ID: mdl-38743805

ABSTRACT

AIM: The "2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease" provides recommendations to guide clinicians in the treatment of patients with lower extremity peripheral artery disease across its multiple clinical presentation subsets (ie, asymptomatic, chronic symptomatic, chronic limb-threatening ischemia, and acute limb ischemia). METHODS: A comprehensive literature search was conducted from October 2020 to June 2022, encompassing studies, reviews, and other evidence conducted on human subjects that was published in English from PubMed, EMBASE, the Cochrane Library, CINHL Complete, and other selected databases relevant to this guideline. Additional relevant studies, published through May 2023 during the peer review process, were also considered by the writing committee and added to the evidence tables where appropriate. STRUCTURE: Recommendations from the "2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease" have been updated with new evidence to guide clinicians. In addition, new recommendations addressing comprehensive care for patients with peripheral artery disease have been developed.

7.
Ann Plast Surg ; 92(5): 564-568, 2024 May 01.
Article in English | MEDLINE | ID: mdl-38563574

ABSTRACT

PURPOSE: The benefits of paraspinous flaps in adult complex spine surgery patients are established in the literature; however, their use in pediatric patients has not been well described. This study compares clinical outcomes with and without paraspinous muscle flap closure in pediatric patients who have undergone spine surgery. METHODS: We conducted a retrospective review of all pediatric spine surgeries at the University of California, San Francisco from 2011 to 2022. Patients were divided into 2 cohorts based on whether the plastic surgery service closed or did not close the wound with paraspinous muscle flaps. We matched patients by age, American Society of Anesthesiology classification, prior spinal surgical history, and diagnosis. Surgical outcomes were compared between the 2 cohorts. RESULTS: We identified 226 pediatric patients who underwent at least one spinal surgery, 14 of whom received paraspinous flap closure by plastic surgery. They were matched in a 1:4 ratio with controls (n = 56) that did not have plastic surgery closure. The most common indication for plastic surgery involvement was perceived complexity of disease by the spine surgeon with concern for inadequate healthy tissue coverage (78.6%), followed by infection (21.4%). Postoperative complications were similar between the two groups. The plastic surgery cohort had a higher rate of patients who were underweight (57.1% vs 14.3%, P < 0.01) and had positive preoperative wound cultures (28.6% vs 8.9%, P = 0.05), as well as a higher rate of postoperative antibiotic usage (78.6 vs 17.9%, P < 0.01). There was no difference in recorded postoperative outcomes. CONCLUSIONS: Spine surgeons requested paraspinous flap closure for patients with more complex disease, preoperative infections, history of chemotherapy, or if they were underweight. Patients with paraspinous flap coverage did not have increased postoperative complications despite their elevated risk profile. Our findings suggest that paraspinous muscle flaps should be considered in high-risk pediatric patients who undergo spine surgery.


Subject(s)
Paraspinal Muscles , Plastic Surgery Procedures , Surgical Flaps , Humans , Retrospective Studies , Female , Male , Child , Adolescent , Plastic Surgery Procedures/methods , Surgical Flaps/transplantation , Child, Preschool , Postoperative Complications/epidemiology , Treatment Outcome , Spinal Diseases/surgery
8.
J Chem Neuroanat ; 138: 102422, 2024 Apr 23.
Article in English | MEDLINE | ID: mdl-38657828

ABSTRACT

L-3,4-dihydroxyphenylalanine (L-DOPA) is the treatment of choice for Parkinson's disease (PD) motor symptoms, but its chronic use is hindered by complications such as dyskinesia. Pre-clinical studies discovered that activation of metabotropic glutamate type 2 and 3 (mGlu2/3) receptors alleviates L-DOPA-induced dyskinesia. To gain mechanistic insight into the anti-dyskinetic activity of mGlu2/3 activation, we performed autoradiographic binding with [3H]-LY-341,495 in brain sections from L-DOPA-treated 6-hydroxydopamine (6-OHDA)-lesioned rats that developed mild or severe dyskinesia, as well as L-DOPA-untreated 6-OHDA-lesioned and sham-lesioned animals. In the ipsilateral hemisphere, mildly dyskinetic 6-OHDA-lesioned rats showed a decrease in [3H]-LY-341,495 binding in the entopeduncular nucleus (EPN, 30 % vs sham-lesioned rats, P<0.05), globus pallidus (GP, 28 % vs sham-lesioned rats, P<0.05; 23 % vs L-DOPA-untreated 6-OHDA-lesioned rats, P<0.001), and primary motor cortex (49 % vs sham-lesioned rats, P<0.05; 45 % vs L-DOPA-untreated 6-OHDA-lesioned rats, P<0.001). Severely dyskinetic 6-OHDA-lesioned rats exhibited an increase in binding in the primary motor cortex (43 % vs mildly dyskinetic 6-OHDA-lesioned rats, P<0.05). In the contralateral hemisphere, mildly dyskinetic 6-OHDA-lesioned rats harboured a decrease in binding in the EPN (30 % vs sham-lesioned rats; 24 % vs L-DOPA-untreated 6-OHDA-lesioned rats, both P<0.05), GP (34 % vs sham-lesioned rats, P<0.05; 23 % vs L-DOPA-untreated 6-OHDA-lesioned rats, P<0.001), and primary motor cortex (50 % vs sham-lesioned rats; 44 % vs L-DOPA-untreated 6-OHDA-lesioned rats, both P<0.05). Severely dyskinetic 6-OHDA-lesioned rats presented a decrease in binding in the GP (30 % vs sham-lesioned rats; 19 % vs L-DOPA-untreated 6-OHDA-lesioned rats, both P<0.05). Abnormal involuntary movements scores of 6-OHDA-lesioned animals were positively correlated with [3H]-LY-341,495 binding in the ipsilateral striatum, ipsilateral EPN, ipsilateral primary motor cortex and contralateral primary motor cortex (all P<0.05). These results suggest that alterations in mGlu2/3 receptor levels may be part of an endogenous compensatory mechanism to alleviate dyskinesia.

9.
Front Cardiovasc Med ; 11: 1352700, 2024.
Article in English | MEDLINE | ID: mdl-38572306

ABSTRACT

Spontaneous coronary artery dissection (SCAD) is an uncommon condition which is increasingly recognized as a cause of significant morbidity. SCAD can cause acute coronary syndrome and myocardial infarction (MI), as well as sudden cardiac death. It presents similarly to atherosclerotic MI although typically in patients with few or no atherosclerotic risk factors, and particularly in women. As more patients are recognized to have this condition, there is a great need for clinician familiarity with diagnostic criteria, as well as with contemporary treatment approaches, and with appropriate patient-centered counseling, including genetic testing, exercise recommendations, and psychological care. The standard of care for patients with SCAD is rapidly evolving. This review therefore summarizes the diagnosis of SCAD, epidemiology, modern treatment, cardiac rehabilitation and preconception counseling, and the current approach to genetic testing, exercise recommendations, and psychological care, all of which are crucial to the vascular medicine specialist.

10.
Exp Brain Res ; 242(5): 1203-1214, 2024 May.
Article in English | MEDLINE | ID: mdl-38526743

ABSTRACT

L-3,4-dihydroxyphenylalanine (L-DOPA) is the main treatment for Parkinson's disease (PD) but with long term administration, motor complications such as dyskinesia are induced. Glycine transporter 1 (GlyT1) inhibition was shown to produce an anti-dyskinetic effect in parkinsonian rats and primates, coupled with an improvement in the anti-parkinsonian action of L-DOPA. The expression of GlyT1 in the brain in the dyskinetic state remains to be investigated. Here, we quantified the levels of GlyT1 across different brain regions using [3H]-NFPS in the presence of Org-25,935. Brain sections were chosen from sham-lesioned rats, L-DOPA-naïve 6-hydroxydopamine (6-OHDA)-lesioned rats and 6-OHDA-lesioned rats exhibiting mild or severe abnormal involuntary movements (AIMs). [3H]-NFPS binding decreased in the ipsilateral and contralateral thalamus, by 28% and 41%, in 6-OHDA-lesioned rats with severe AIMs compared to sham-lesioned animals (P < 0.01 and 0.001). [3H]-NFPS binding increased by 21% in the ipsilateral substantia nigra of 6-OHDA-lesioned rats with severe AIMs compared to 6-OHDA-lesioned rats with mild AIMs (P < 0.05). [3H]-NFPS binding was lower by 19% in the contralateral primary motor cortex and by 20% in the contralateral subthalamic nucleus of 6-OHDA-lesioned rats with mild AIMs animals compared to rats with severe AIMs (both P < 0.05). The severity of AIMs scores positively correlated with [3H]-NFPS binding in the ipsilateral substantia nigra (P < 0.05), ipsilateral entopeduncular nucleus (P < 0.05) and contralateral primary motor cortex (P < 0.05). These data provide an anatomical basis to explain the efficacy of GlyT1 inhibitors in dyskinesia in PD.


Subject(s)
Brain , Glycine Plasma Membrane Transport Proteins , Oxidopamine , Sarcosine/analogs & derivatives , Animals , Glycine Plasma Membrane Transport Proteins/metabolism , Glycine Plasma Membrane Transport Proteins/antagonists & inhibitors , Rats , Male , Oxidopamine/pharmacology , Brain/metabolism , Brain/drug effects , Parkinsonian Disorders/metabolism , Rats, Sprague-Dawley , Disease Models, Animal , Tritium , Functional Laterality/physiology
11.
J Am Heart Assoc ; 13(7): e032819, 2024 Apr 02.
Article in English | MEDLINE | ID: mdl-38533943

ABSTRACT

BACKGROUND: Myocardial infarction secondary to spontaneous coronary artery dissection (SCAD) can be traumatic and potentially trigger posttraumatic stress disorder (PTSD). In a large, multicenter, registry-based cohort, we documented prevalence of lifetime and past-month SCAD-induced PTSD, as well as related treatment seeking, and examined a range of health-relevant correlates of SCAD-induced PTSD. METHODS AND RESULTS: Patients with SCAD were enrolled in the iSCAD (International SCAD) Registry. At baseline, site investigators completed medical report forms, and patients reported demographics, medical/SCAD history, psychosocial factors (including SCAD-induced PTSD symptoms), health behaviors, and health status via online questionnaires. Of 1156 registry patients, 859 patients (93.9% women; mean age, 52.3 years) completed questionnaires querying SCAD-induced PTSD. Nearly 35% (n=298) of patients met diagnostic criteria for probable SCAD-induced PTSD in their lifetime, and 6.4% (n=55) met criteria for probable past-month PTSD. Of 811 patients ever reporting any SCAD-induced PTSD symptoms, 34.8% indicated seeking treatment for this distress. However, 46.0% of the 298 patients with lifetime probable SCAD-induced PTSD diagnoses reported never receiving trauma-related treatment. Younger age at first SCAD, fewer years since SCAD, being single, unemployed status, more lifetime trauma, and history of anxiety were associated with greater past-month PTSD symptom severity in multivariable regression models. Greater past-month SCAD-induced PTSD symptoms were associated with greater past-week sleep disturbance and worse past-month disease-specific health status when adjusting for various risk factors. CONCLUSIONS: Given the high prevalence of SCAD-induced PTSD symptoms, efforts to support screening for these symptoms and connecting patients experiencing distress with empirically supported treatments are critical next steps. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04496687.


Subject(s)
Coronary Vessel Anomalies , Stress Disorders, Post-Traumatic , Vascular Diseases , Female , Humans , Male , Middle Aged , Coronary Angiography , Coronary Vessels , Registries , Risk Factors , Stress Disorders, Post-Traumatic/diagnosis , Stress Disorders, Post-Traumatic/epidemiology , Stress Disorders, Post-Traumatic/psychology , Vascular Diseases/epidemiology , Vascular Diseases/congenital
12.
J Plast Reconstr Aesthet Surg ; 91: 284-292, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38432086

ABSTRACT

BACKGROUND: Acellular dermal matrix (ADM) is commonly used in plastic and reconstructive surgery. With the abundance of randomized controlled trials (RCTs) reporting P-values for ADM outcomes, this study used the fragility index (FI), reverse fragility index (rFI), and fragility quotient (FQ) to evaluate the statistical stability of the outcomes in ADM RCTs. METHODS: PubMed, Embase, SCOPUS, Medline, and Cochrane databases were reviewed for ADM RCTs (2003-present) reporting a dichotomous, categorical outcome. FI and rFI (event reversals influencing outcome significance) and FQ (standardized fragility) were calculated and reported as median. Subgroup analysis was performed based on intervention types. RESULTS: Among the 127 studies screened, 56 RCTs with 579 outcomes were included. The median FI stood at 4 (3-5) and FQ was 0.04 (0.03-0.07). Only 101 outcomes were statistically significant with a median FI of 3 (1-6) and FQ of 0.04 (0.02-0.08). The nonsignificant outcomes had a median FI of 4 (3-5) and FQ of 0.04 (0.03-0.07). Notably, 26% of the outcomes had several patients lost to follow up equal to or surpassing the FI. Based on the intervention type, the median FIs showed minor fluctuations but remained low. CONCLUSIONS: Outcomes from ADM-related RCTs were statistically fragile. Slight outcome reversals or maintenance of patient follow-up can alter the significance of results. Therefore, future researchers are recommended to jointly report FI, FQ, and P-values to offer a comprehensive view of the robustness in ADM literature.


Subject(s)
Acellular Dermis , Humans , Randomized Controlled Trials as Topic , Research Design , Databases, Factual
13.
Acad Radiol ; 31(2): 426-430, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38401988

ABSTRACT

RATIONALE AND OBJECTIVES: Digital flashcards are an increasingly popular study method for medical students today. The purpose of this study is to assess students' opinions on digital flashcards and to evaluate the need for radiology-focused digital flashcards. We created the first official Radiology-Pathology (Rad-Path) Correlation course digital flashcard deck sponsored by the Alliance of Medical Student Educators in Radiology (AMSER), and evaluated its effectiveness in increasing medical students' confidence levels of understanding Rad-Path concepts. MATERIALS AND METHODS: A 16-question survey was developed and publicly shared with medical students to assess the need for a high-quality radiology deck. In addition, students who trialed the AMSER Rad-Path Anki deck were assessed on their confidence of radiology pathology concepts prior to and after using these digital flashcards. RESULTS: 185 survey responses were received for the first survey about digital flashcard use. Overall, 87.6% of medical student respondents had used digital flashcards during medical school, and 33.5% had used digital flashcards to study radiology topics specifically. 67.6% of respondents stated they would use a digital flashcard deck if sponsored by an academic radiology society. Regarding the survey of the students who used the AMSER Rad-Path flashcards, 31 responses were received in the pre- and follow-up survey. Mean confidence in understanding the radiology pathology learning objectives increased when the Rad-Path Anki deck was utilized, and students rated the flashcards favorably. CONCLUSION: Students reported a high use of digital flashcards for studying topics in medical school. We identified a perceived need in students for a series of high-quality digital flashcards covering radiology topics. We created the first deck of AMSER Rad-Path flashcards which was well received by the medical students.


Subject(s)
Computer-Assisted Instruction , Education, Medical, Undergraduate , Students, Medical , Humans , Computer-Assisted Instruction/methods , Curriculum , Education, Medical, Undergraduate/methods , Educational Measurement/methods , Learning
14.
Ann Pharm Fr ; 2024 Feb 24.
Article in French | MEDLINE | ID: mdl-38408723

ABSTRACT

The reform of derogatory access authorisations (DAs) on 1st July 2021 has distorted the routine of the hospital pharmacists dealing with innovative medicines that are waiting for marketing authorization or approval. There are two distinct categories of DAs: Compassionate Access Authorisations (CAAs) are granted by the French National Agency for the Safety of Medicines (ANSM) while Early Access Authorisations (EAPs) are granted at the request of pharmaceutical companies by the French National Authority for Health (HAS). All AAPs and a majority of the AACs are supported by a Protocol for Therapeutic Use and Data Collection (PTU-DC). The aim of this study is to assess the impact of the reform on pharmacy process one year following its implementation, and to identify the risks related to the new circuits. The working group, composed of three pharmacists carried out an initial assessment of the effects first measured the impact of the reform on medicine processes in DAs. They performed a comparison of the changes in their management methods: 3 months prior to the reform (M0), and 3 (M3) and 12 months (M12) post-reform. Risks analysis was conducted using the Failure Modes, Effects and Criticality Analysis (FMEA) method. The analysis was limited to the process steps specific related to DAs drugs were analyzed. The critical severity of the risk situations identified was rated. A critical hierarchy matrix was used to establish priority actions. The priority actions to be taken were determined using the critical hierarchy matrix. Over the span of one year, the number of DAs in our establishment showed a 31.7% increase, from 41 at M0 to 54 at M12. At M0, the proportion of drugs needed inclusion via a drug-specific digital platform, specific to each drug, stood at 27% (11/41) of drugs at M0 while at M12, it rose to 52% (28/54). The percentage of PTU-DCs therefore increased by a factor of 1.7, rising from 29% (12/41) at M0 to 47% (21/45) at M3 and 60% (32/54) at M12. For orders, which are always nominative, approval depends on both the presence of the PTU-DC tracking sheet being present in 12% of PAAs, and the inclusion number in 26% of PAAs. The risk analysis shows 49 failure modes leading to risk situations. Among the failure modes, 36 have a consequence of acceptable or tolerable criticality under control, whilst 13 are deemed of unacceptable criticality. A suitable control method exists has been identifies for 5 of them. Finally, the ranking evaluation of criticalities has highlighted 4 situations which require immediate action as a priority: delivery times, obtaining completed tracking sheets and ordering procedures. The aim of the DAs reform is to simplify access to innovative medicines. However, the reform has significant and damaging repercussions on pharmaceutical activities. Corrective measures need to be taken in conjunction with all parties involved in the circuits including laboratories and service providers (CROs), authorities and healthcare professionals.

15.
J Pediatr Gastroenterol Nutr ; 78(2): 360-368, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38374568

ABSTRACT

OBJECTIVES: Data driven strategies for acute pancreatitis (AP) in pediatrics are limited; adult data suggests lactated ringers (LR) compared to normal saline (NS) resulted in favorable outcomes, but has not been studied in pediatrics. Our objective was to evaluate the efficacy of LR during the first 48 h of an AP episode compared with NS. STUDY DESIGN: A multisite randomized controlled clinical trial, from 2015 to 2020 (Clinical Trials.gov NCT03242473). Patients were randomized to exclusively LR or NS for the first 48 h. Primary outcomes were serial C-reactive protein (CRP) values. Secondary outcomes included other lab values, time to feeds, length of stay (LOS), systemic inflammatory response syndrome (SIRS) development, and progression to severe AP (SAP). RESULTS: We studied 76 patients (38 LR, 38 NS). CRP at 24 and 48 h were not significantly different between LR or NS group. Additionally, there were no differences in trends of BUN, amylase, lipase, SIRS status, or SAP development between the LR and NS group at 24 and 48 h. A higher proportion of LR patients (32%, 12/38) were discharged before 48 h compared to NS (13%, 5/38). The LR group had a significantly higher rate of discharge within the first 72 h compared to the NS group (p = 0.02). CONCLUSION: The use of LR was associated with a faster rate of discharge during the intervention period and in the first 72 h, but no other differences compared to NS. This reduction in length of hospitalization has significant implications for patients and healthcare costs.


Subject(s)
Fluid Therapy , Pancreatitis , Patient Discharge , Child , Humans , Acute Disease , Fluid Therapy/methods , Pancreatitis/therapy , Ringer's Lactate/therapeutic use , Saline Solution/therapeutic use , Systemic Inflammatory Response Syndrome/therapy
16.
Annu Rev Immunol ; 2024 Jan 25.
Article in English | MEDLINE | ID: mdl-38271641

ABSTRACT

The choice of developing thymocytes to become CD8+ cytotoxic or CD4+ helper T cells has been intensely studied, but many of the underlying mechanisms remain to be elucidated. Recent multiomics approaches have provided much higher resolution analysis of gene expression in developing thymocytes than was previously achievable, thereby offering a fresh perspective on this question. Focusing on our recent studies using CITE-seq (cellular indexing of transcriptomes and epitopes) analyses of mouse thymocytes, we present a detailed timeline of RNA and protein expression changes during CD8 versus CD4 T cell differentiation. We also revisit our current understanding of the links between T cell receptor signaling and expression of the lineage-defining transcription factors ThPOK and RUNX3. Finally, we propose a sequential selection model to explain the tight linkage between MHC-I versus MHC-II recognition and T cell lineage choice. This model incorporates key aspects of previously proposed kinetic signaling, instructive, and stochastic/selection models. Expected final online publication date for the Annual Review of Immunology, Volume 42 is April 2024. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.

17.
Sci Immunol ; 9(91): eadi2848, 2024 Jan 26.
Article in English | MEDLINE | ID: mdl-38277466

ABSTRACT

Psoriasis vulgaris and other chronic inflammatory diseases improve markedly with therapeutic blockade of interleukin-23 (IL-23) signaling, but the genetic mechanisms underlying clinical responses remain poorly understood. Using single-cell transcriptomics, we profiled immune cells isolated from lesional psoriatic skin before and during IL-23 blockade. In clinically responsive patients, a psoriatic transcriptional signature in skin-resident memory T cells was strongly attenuated. In contrast, poorly responsive patients were distinguished by persistent activation of IL-17-producing T (T17) cells, a mechanism distinct from alternative cytokine signaling or resistance isolated to epidermal keratinocytes. Even in IL-23 blockade-responsive patients, we detected a recurring set of recalcitrant, disease-specific transcriptional abnormalities. This irreversible immunological state may necessitate ongoing IL-23 inhibition. Spatial transcriptomic analyses also suggested that successful IL-23 blockade requires dampening of >90% of IL-17-induced response in lymphocyte-adjacent keratinocytes, an unexpectedly high threshold. Collectively, our data establish a patient-level paradigm for dissecting responses to immunomodulatory treatments.


Subject(s)
Interleukin-17 , Psoriasis , Humans , Interleukin-23 , Skin , Psoriasis/drug therapy , Keratinocytes
18.
J Am Heart Assoc ; 13(2): e031778, 2024 Jan 16.
Article in English | MEDLINE | ID: mdl-38214278

ABSTRACT

BACKGROUND: Pulse wave velocity (PWV) is a noninvasive measure of arterial stiffness and predictor of cardiovascular disease. However, the association between PWV and vascular calcification across different vascular beds has not been fully investigated. This study aimed to quantify the association between PWV and multiterritory calcification and to explore whether PWV can identify individuals with vascular calcification beyond traditional risk factors. METHODS AND RESULTS: Among 1351 older adults (mean age, 79.2 years [SD, 4.1]) from the ARIC (Atherosclerosis Risk in Communities) study, we measured segment-specific PWVs: heart-carotid, heart-femoral, carotid-femoral, heart-ankle, brachial-ankle, and femoral-ankle. Dependent variables were high calcium score (≥75th percentile of Agatston score) across different vascular beds: coronary arteries, aortic valve ring, aortic valve, mitral valve, ascending aorta, and descending aorta. Quartiles of carotid-femoral, heart-femoral, heart-ankle, and brachial-ankle PWV were significantly associated with coronary artery calcium (eg, adjusted odds ratio [OR] for the highest versus lowest quartile of carotid-femoral PWV, 1.84 [95% CI, 1.24-2.74]). Overall, PWVs were most strongly associated with descending aorta calcification, with significant results for carotid-femoral, heart-femoral, heart-ankle, and brachial-ankle PWV (eg, adjusted OR for the highest versus lowest quartile of carotid-femoral PWV, 3.99 [95% CI, 2.61-6.17]). In contrast, femoral-ankle PWV was inversely associated with descending aorta calcification. Some PWVs improved the discrimination of coronary artery calcium and descending aorta calcification beyond traditional risk factors. CONCLUSIONS: The associations of PWV with vascular calcification varied substantially across segments, with descending aorta calcification most closely linked to PWVs. Our study suggests that some PWVs, especially carotid-femoral PWV, are helpful to identify individuals with coronary artery calcium and descending aorta calcification.


Subject(s)
Atherosclerosis , Cardiovascular Diseases , Vascular Calcification , Vascular Stiffness , Humans , Aged , Pulse Wave Analysis/methods , Calcium , Vascular Calcification/epidemiology , Atherosclerosis/diagnosis , Atherosclerosis/epidemiology
20.
Int J Speech Lang Pathol ; 26(1): 118-130, 2024 Feb.
Article in English | MEDLINE | ID: mdl-37272330

ABSTRACT

PURPOSE: This study aims to describe the experiences and needs of Canadian speech-language pathologists (SLPs) who conducted communication assessments via telepractice across the lifespan during the first year (2020) of the COVID-19 pandemic. METHOD: The present study consisted of an online survey that aimed to capture both quantitative aspects of telepractice-based communication assessment and the qualitative experience of shifting to telepractice. One hundred sixty-eight practicing SLPs across Canada participated in the survey, between September 2020 and January 2021. Quantitative results were analysed using descriptive statistics while open-ended responses were analysed using thematic analysis. RESULT: SLPs identified challenges and opportunities relating to client and family engagement, access to and knowledge of technology, and the reliability of assessment tools. SLPs also identified a future need for online assessment materials and training, such as materials adapted for different communication needs (e.g. augmentative and alternative communication). CONCLUSION: The present study contributes to a growing understanding worldwide of potential benefits and challenges related to telepractice, fuelled by the necessary shift in practices in our field during the COVID-19 pandemic. The results provide direction for continuing to build a valid and inclusive approach to telepractice in the future.


Subject(s)
COVID-19 , Communication Disorders , Speech-Language Pathology , Humans , Speech , Longevity , Pandemics , Reproducibility of Results , Canada , Speech-Language Pathology/methods
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