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Vaccines play a crucial role in improving human health by reducing the incidence and mortality of vaccine-preventable diseases, such as diphtheria, smallpox, polio, measles, mumps, and rubella. Vaccines confer protection against specific pathogens by triggering an immune response in the host and they can be produced on different platforms including inactivated or weakened pathogens or toxins, viral vectors (such as adenovirus or modified vaccinia virus Ankara), subunit vaccines, and genetic vaccines (e.g., mRNA vaccines). Adenovirus-based vaccines encode one or more disease-specific transgenes to induce immunity against the target disease. Adenoviral vectors present certain characteristics that make them excellent vaccine platforms, such as the induction of transgene-specific immunity, large packaging capacity (up to 35 kbp of transgenic sequence), and broad tropism. In the field of prophylactic vaccines, the use of adenoviral vectors is limited to non-replicating vectors. These vectors are engineered through genetic modifications of the virus to produce a non-replicating virion that can carry a transgene of interest. Adenovirus-based vaccines elicit strong immune responses against the transgene that they carry and these immune responses depend heavily on early events following vaccination. In this dissertation, we study early events after adenovirus-based vaccination to understand their role in shaping adaptive immune responses and the development of adverse effects.

Introducción: Sulfato de magnesio (MgSO4) y aminofilina son broncodilatadores intravenosos utilizados en el tratamiento de niños con broncoobstrucción (BO). La evidencia disponible para recomendar su uso es escasa. Objetivo: Caracterizar el perfil de uso y la respuesta terapéutica al MgSO4 y aminofilina en el tratamiento de la BO en niños hospitalizados en un centro de referencia de Uruguay. Materiales y métodos: Estudio descriptivo de corte transversal mediante revisión de historias y entrevistas. Se incluyeron a todos los menores de 15 años que utilizaron estos fármacos. Se evaluó la respuesta terapéutica a la administración de ambos fármacos en forma exclusiva y concomitante y la presencia de efectos adversos. Resultados: Se incluyeron 102 niños, mediana de edad 4 años, ≤5 años 62%. Los principales diagnósticos fueron: crisis asmática 56% y neumonía viral 31%. Recibieron ambos fármacos 48%, únicamente aminofilina 28% y exclusiva de MgSO4 24%. Se observó buena respuesta terapéutica a la administración: exclusiva de MgSO4 67%, consecutiva de MgSO4 y aminofilina 45% y exclusiva de aminofilina en 34%. En 38,2% se registró al menos un efecto adverso, 64% eran menores de 5 años, riesgo aumentado en 1,5 veces. Conclusiones: Se registraron variadas indicaciones, la mayoría en niños asmáticos y en un porcentaje menor indicaciones fuera de prospecto. Menos de la mitad presentaron buena respuesta luego de la administración de MgSO4 y/o aminofilina. En un porcentaje no despreciable se registraron efectos adversos, predominaron en menores de 5 años. Son necesarios nuevos estudios para continuar caracterizando el perfil de uso y seguridad de estos fármacos.

BackgroundClinical trials using psilocybin therapy to treat anorexia nervosa (AN) are currently underway. The safety and tolerability of psilocybin is of utmost importance in individuals with AN who may present unique medical vulnerabilities. The purpose of this review is to describe how the common physiologic adverse effects of psilocybin may impact medical complications experienced by individuals with AN in clinical trials of psilocybin therapy.Main bodyThe physiologic underpinnings of common adverse effects following psilocybin administration are described, including tachycardia, hypertension, electrocardiogram changes, nausea, headache, and lightheadedness. These anticipated physiologic changes are described in relation to the common medical correlates seen in individuals with AN. Risk mitigation strategies for each adverse effect are proposed.ConclusionEarly evidence suggests that psilocybin therapy is well-tolerated in individuals with AN. Understanding the unique medical complications of AN, and how they may be impacted by common physiologic adverse effects of psilocybin administration, leads to tailored risk mitigation strategies to enhance safety and tolerability of this novel intervention.

INTRODUCTION: Subjective improvement in gastrointestinal (GI) symptoms was assessed among patients using medical marijuana (MMJ). METHODS: Participants completed surveys at 0 days, 30 days, 6 months, and 12 months with questions about the severity of their GI symptoms on a scale from 1 (mild) to 3 (severe). RESULTS: In each survey, participants reported a significant decrease in GI symptom severity when using MMJ versus when not using MMJ (p < 0.05). The most common self-reported side effects from using MMJ were increased appetite (12-21.4%), fatigue (6-16.7%), anxiety (4-11.9%), cough (4-11.9%), headache (6-7.9%), and dry mouth (4-7.1%). CONCLUSION: In patients with chronic GI symptoms, MMJ may provide persistent symptom severity improvement. Limited product availability and mild to moderate side effects are factors to consider before trialing MMJ.

Bromide is the first effective antiseizure medication used in human medicine since the XIX century. Initially met with skepticism, bromide quickly gained enthusiasm within the medical field until being largely replaced by newer antiseizure medications with significantly fewer adverse effects in people. In veterinary medicine, bromide continues to be used in the management of epileptic patients for over 30 years, yet adverse effects can impact owners and patients alike. We sought to provide the general practitioner and veterinary neurologist with insightful information on both the positive and negative attributes of bromide, explore factors that may influence its desirability as an antiseizure medication in specific veterinary cases and elucidate its current role in modern epilepsy treatment for veterinary patients. It's also our endeavor to discuss the current use as an alternative or add-on with other known antiseizure medications and potential future studies that might enhance our understanding and use of this medication.

Background: Adherence to Helicobacter pylori (H. pylori) eradication treatment is a cornerstone for achieving adequate treatment efficacy. Objective: To determine which factors influence compliance with treatment. Methods: A systematic prospective non‐interventional registry (Hp‐EuReg) of the clinical practice of European gastroenterologists. Compliance was considered adequate if ≥90% drug intake. Data were collected until September 2021 using the AEG‐REDCap e‐CRF and were subjected to quality control. Modified intention‐to‐treat analyses were performed. Multivariate analysis carried out the factors associated with the effectiveness of treatment and compliance. Results: Compliance was inadequate in 646 (1.7%) of 38,698 patients. The non‐ compliance rate was higher in patients prescribed longer regimens (10‐, 14‐days) and rescue treatments, patients with uninvestigated dyspepsia/functional dyspepsia, and patients reporting adverse effects. Prevalence of non‐adherence was lower for first‐line treatment than for rescue treatment (1.5% vs. 2.2%; p < 0.001). Differences in non‐adherence in the three most frequent first‐line treatments were shown: 1.1% with proton pump inhibitor þ clarithromycin þ amoxicillin; 2.3% with proton pump inhibitor clarithromycin amoxicillin metronidazole; and 1.8% with bismuth quadruple therapy. These treatments were significantly more effective in compliant than in non‐compliant patients: 86% versus 44%, 90% versus 71%, and 93% versus 64%, respectively (p < 0.001). In the multivariate analysis, the variable most significantly associated with higher effectiveness was adequate compliance (odds ratio, 6.3 [95%CI, 5.2–7.7]; p < 0.001). Conclusions: Compliance with Helicobacter pylori eradication treatment is very good. Factors associated with poor compliance include uninvestigated/functional dyspepsia, rescue‐treatment, prolonged treatment regimens, the presence of adverse events, and the use of non‐bismuth sequential and concomitant treatment. Ad

Background The Outcome Measures in Rheumatology (OMERACT) Glucocorticoid (GC) Impact Working Group has been working to develop a core domain set to measure the impact of GCs on patients living with rheumatic and musculoskeletal diseases. The mandatory domains previously identified for inclusion in all clinical trials measuring the GC effects include infection, bone fragility, mood disturbance, hypertension, diabetes, weight, fatigue, and mortality. Before progressing to instrument selection, the Working Group sought to establish precise definitions of all mandatory domains within the core domain set. Methods OMERACT methodology was applied with the use of evidence and consensus-based decision making of all stakeholder groups (patient research partners, health care professionals, clinician researchers, industry members and methodologists) to develop detailed definitions for the broad domain, target domain and domain components, taking into consideration sources of variability that could affect measurement of the domain. The working group synthesized prior qualitative studies, quantitative work, and results from Delphi rounds, to develop a rich definition of ‘what’ is to be measured. Results Between 2021 and 2023, the OMERACT Working Group on GC Impact conducted virtual meetings to establish domain definitions. First, we mapped each domain onto an OMERACT Core Area. All domains were primarily represented within the Pathophysiological Manifestations Core Area, except from Fatigue which was primarily Life Impact and Weight which spanned both Core Areas. Sources of variability included cultural factors, age, gender, education level, socioeconomic status, personal experiences, emotional state, and language barriers. The domain definitions will form the foundation for instrument selection and the initial step of domain / concept match and content validity in the OMERACT pillar of ‘truth’ before moving on to feasibility and discrimination., Background: The Outcome Measures in Rheumatology (OMERACT) Glucocorticoid (GC) Impact Working Group has been working to develop a core domain set to measure the impact of GCs on patients living with rheumatic and musculoskeletal diseases. The mandatory domains previously identified for inclusion in all clinical trials measuring the GC effects include infection, bone fragility, mood disturbance, hypertension, diabetes, weight, fatigue, and mortality. Before progressing to instrument selection, the Working Group sought to establish precise definitions of all mandatory domains within the core domain set. Methods: OMERACT methodology was applied with the use of evidence and consensus-based decision making of all stakeholder groups (patient research partners, health care professionals, clinician researchers, industry members and methodologists) to develop detailed definitions for the broad domain, target domain and domain components, taking into consideration sources of variability that could affect measurement of the domain. The working group synthesized prior qualitative studies, quantitative work, and results from Delphi rounds, to develop a rich definition of ‘what’ is to be measured. Results: Between 2021 and 2023, the OMERACT Working Group on GC Impact conducted virtual meetings to establish domain definitions. First, we mapped each domain onto an OMERACT Core Area. All domains were primarily represented within the Pathophysiological Manifestations Core Area, except from Fatigue which was primarily Life Impact and Weight which spanned both Core Areas. Sources of variability included cultural factors, age, gender, education level, socioeconomic status, personal experiences, emotional state, and language barriers. The domain definitions will form the foundation for instrument selection and the initial step of domain / concept match and content validity in the OMERACT pillar of ‘truth’ before moving on to feasibility and discrimination. Conclusion: The OMERACT GC I

Background The Outcome Measures in Rheumatology (OMERACT) Glucocorticoid (GC) Impact Working Group has been working to develop a core domain set to measure the impact of GCs on patients living with rheumatic and musculoskeletal diseases. The mandatory domains previously identified for inclusion in all clinical trials measuring the GC effects include infection, bone fragility, mood disturbance, hypertension, diabetes, weight, fatigue, and mortality. Before progressing to instrument selection, the Working Group sought to establish precise definitions of all mandatory domains within the core domain set. Methods OMERACT methodology was applied with the use of evidence and consensus-based decision making of all stakeholder groups (patient research partners, health care professionals, clinician researchers, industry members and methodologists) to develop detailed definitions for the broad domain, target domain and domain components, taking into consideration sources of variability that could affect measurement of the domain. The working group synthesized prior qualitative studies, quantitative work, and results from Delphi rounds, to develop a rich definition of ‘what’ is to be measured. Results Between 2021 and 2023, the OMERACT Working Group on GC Impact conducted virtual meetings to establish domain definitions. First, we mapped each domain onto an OMERACT Core Area. All domains were primarily represented within the Pathophysiological Manifestations Core Area, except from Fatigue which was primarily Life Impact and Weight which spanned both Core Areas. Sources of variability included cultural factors, age, gender, education level, socioeconomic status, personal experiences, emotional state, and language barriers. The domain definitions will form the foundation for instrument selection and the initial step of domain / concept match and content validity in the OMERACT pillar of ‘truth’ before moving on to feasibility and discrimination., Background: The Outcome Measures in Rheumatology (OMERACT) Glucocorticoid (GC) Impact Working Group has been working to develop a core domain set to measure the impact of GCs on patients living with rheumatic and musculoskeletal diseases. The mandatory domains previously identified for inclusion in all clinical trials measuring the GC effects include infection, bone fragility, mood disturbance, hypertension, diabetes, weight, fatigue, and mortality. Before progressing to instrument selection, the Working Group sought to establish precise definitions of all mandatory domains within the core domain set. Methods: OMERACT methodology was applied with the use of evidence and consensus-based decision making of all stakeholder groups (patient research partners, health care professionals, clinician researchers, industry members and methodologists) to develop detailed definitions for the broad domain, target domain and domain components, taking into consideration sources of variability that could affect measurement of the domain. The working group synthesized prior qualitative studies, quantitative work, and results from Delphi rounds, to develop a rich definition of ‘what’ is to be measured. Results: Between 2021 and 2023, the OMERACT Working Group on GC Impact conducted virtual meetings to establish domain definitions. First, we mapped each domain onto an OMERACT Core Area. All domains were primarily represented within the Pathophysiological Manifestations Core Area, except from Fatigue which was primarily Life Impact and Weight which spanned both Core Areas. Sources of variability included cultural factors, age, gender, education level, socioeconomic status, personal experiences, emotional state, and language barriers. The domain definitions will form the foundation for instrument selection and the initial step of domain / concept match and content validity in the OMERACT pillar of ‘truth’ before moving on to feasibility and discrimination. Conclusion: The OMERACT GC I

Chronic obstructive pulmonary disease (COPD) is frequently associated with chronic heart failure (CHF) or coronary artery disease (CAD). In spite of the recommendation to use beta-blockers (BB) they are likely under-prescribed to patients with concurrent COPD and heart diseases. To find out the prevalence of use of BB, 256 COPD patients were consecutively recruited by pulmonary physicians from 14 hospitals in 7 regions of Spain in their outpatient offices if they had a diagnosis of COPD, were not on long-term oxygen therapy, had CHF or CAD, and met the criteria for BB treatment. In patients with indication 58% (95%CI, 52-64%) of the COPD patients and 97% of the non-COPD patients were on BB (p < 0.001). In patients with COPD, several factors were independently related to at least one visit to the emergency room in the previous year such as use of BB, adjusted OR = 0.27 (95% CI 0.15-0.50), GOLD stage D, OR = 2.52 (1.40-4.53), baseline heart rate >70, OR 2.19 (1.24-3.86) use of long-acting beta2-agonists OR = 2.18 (1.29-3.68), previous episodes of left ventricular failure OR 2.27 (1.19-4.33) and diabetes, OR = 1.82 (1.08-3.38). We conclude that, according to what is recommended by current guidelines, BB are still under-prescribed in COPD patients. COPD patients with CHF or CAD using BB suffer fewer exacerbations and visits to the ER. GOLD stage, use of long-acting beta2-agonists, baseline heart rate and comorbidities are also risk factors for exacerbations in this population., Depto. de Medicina, Fac. de Medicina, TRUE, pub

FI: 4,964 ; 55/172; Q2; Medicine, General & Internal, 2021; AP: SI, The clinical application of phentolamine mesylate (PM) as an anaesthetic reversal agent has been documented in the paediatric population and in conservative dentistry, but no studies have been conducted regarding dental implant surgery. A prospective randomised study was conducted on 60 patients eligible for mandibular implant treatment, randomly divided between a control group (CG) and an experimental group (EG), to whom PM was administered. Haemodynamic changes, adverse effects and patient satisfaction were assessed. No statistically significant differences in haemodynamic changes and postoperative pain were found between CG and EG (p < 0.05), except for systolic blood pressure (SBP), which increased slightly in EG, without posing a risk to patients. There were no differences in the occurrence of adverse effects between the two groups, except for greater difficulty in chewing and biting (p < 0.05) in CG and greater pain in the injection area (p = 0.043) in EG. Among EG patients, 83.3% reported that they would request PM again for future dental treatment. The use of PM offers an alternative to implant surgery, thereby increasing patients’ quality of life without increasing the risks., Depto. de Odontología Conservadora y Prótesis, Fac. de Odontología, TRUE, pub

The combination of negative mental and physical symptoms which can be experienced after a single episode of alcohol consumption, starting when blood alcohol concentration (BAC) approaches zero, are collectively referred to as the alcohol hangover. Previous research revealed that 10 to 20% of drinkers claim not to experience next-day hangovers. Past studies were usually limited to single timepoint assessments. The aim of the current semi-naturalistic study was to compare the next-day effects of an evening of alcohol consumption of self-reported hangover-resistant drinkers (n = 14) with those of a group of self-reported hangover-sensitive drinkers (n = 15) at hourly timepoint throughout the day (09:30 until 15:30). Assessments of 23 hangover symptoms, mood (Profiles of Mood States-Short Form), and daytime sleepiness (Karolinska Sleepiness Scale) were made hourly after both an alcohol day and an alcohol-free control day. Additional morning assessments were made for mood (State-Trait Anxiety Inventory-Y, Beck’s Depression Inventory-II), risk-taking behavior (RT-18), past night sleep (Groningen Sleep Quality Scale), alcohol consumption, and activities during the test days. No significant differences were found regarding the amount of alcohol consumed and the total sleep time of the two groups. The hangover-sensitive group reported having a hangover as well as the presence of a variety of hangover-related symptoms, which were most severe in the morning and then gradually decreased during the day. The most frequently reported and most severe symptoms were sleepiness and fatigue, concentration problems, and headache. In contrast, the hangover-resistant group reported the absence of a hangover and the presence and severity of next-day symptoms did not significantly differ from the control day, except for increased fatigue and reduced vigor. The next-day effects on sleepiness-related complaints and vigor were significantly more pronounced among hangover-sensitive drinkers com

Children and adolescents treated with antipsychotic drugs can experience severe and bothersome adverse drug reactions (ADRs), which can have a physical as well as an emotional impact on their lives. It is important to monitor these children and adolescents closely so that ADRs are identified early. The aim of this thesis was to assess the daily clinical practice of monitoring for ADRs of antipsychotic drugs in children and adolescents, including the facilitators for and barriers to monitoring. First, the need for monitoring was assessed. The frequencies of spontaneously reported ADRs in children and adolescents treated with antipsychotic drugs were determined using data from the worldwide database VigiBase. Many different ADRs were reported by young people and healthcare professionals, including weight gain, breast enlargement, and movement disorders. Second, monitoring in daily clinical practice was examined. How ADRs were monitored was studied in various ways: questionnaires were completed by Dutch child and adolescent psychiatrists, medical records of an organization for child and adolescent psychiatry were examined, and prescription data from British general practitioners were analyzed. In none of these studies monitoring was optimal. The monitoring frequencies as well as what was monitored varied between healthcare professionals. Healthcare professionals rarely reported the reason for not monitoring and guidelines were most often not completely followed. Third, the support provided during antipsychotic drug treatment was assessed. There are clinical guidelines available for healthcare professionals on how to monitor for ADRs. The clarity of presentation and the applicability of ADR-related monitoring instructions in six clinical practice guidelines for children and adolescents treated with antipsychotic drugs were assessed. These guidelines were clearly presented but differed in what and how often to monitor and were not always easily applicable in daily practi

There is an emerging current necessity of valid questionnaires, encompassing most of food, beverages, diseases, signs and symptoms currently related to the pathogenesis of adverse reactions to foodstuffs (ARFS) in the Spanish population. Objectives: this study aimed to design and validate two questionnaires to assess ARFS in the Spanish population, Food and Beverages Frequency Consumption Questionnaire to Identify Adverse Reactions to Foodstuffs (FBFC-ARFSQ-18); and Pathologies and Symptomatology Questionnaire associated with Adverse Reactions to Foodstuffs (PSIMP-ARFSQ-10). Methods: both questionnaires were designed adapting questionnaires from the literature; and validated, using the expert judgment method, in five phases: questionnaires development, pilot test and reliability, content validity, face validity, and ethical considerations. Questionnaires were developed using the REDCap™ tool hosted at the Universidad Politécnica de Madrid. A total of 20 Spanish experts evaluated the questionnaires. Cronbach’s alpha reliability coefficients were calculated using SPSS version 25.0 (IBM Corp., Armonk, NY-USA) and Aiken’s V coefficient values were calculated using ICaiken.exe (Visual Basic 6.0, Lima-Perú). Results: a final construct of questions was designed, ensuring no overlap, for FBFC-ARFSQ-18 and PSIMP-ARFSQ-10. Cronbach’s alpha reliability coefficients were 0.93 and 0.94; and Aiken’s V coefficient values were 0.90 (0.78-0.96 CI) and 0.93 (0.81-0.98 CI) for FBFC-ARFSQ-18 and PSIMP-ARFSQ-10, respectively. Conclusions: both validated questionnaires could be used to analyze the association between certain food and beverages consumption with ARFS, such as food allergies and food intolerances; also, to investigate the link between some specific diseases, signs and symptoms with ARFS., Unión Europea. Fondo Europeo de Desarrollo Regional (FEDER), Instituto de Salud Carlos III. CIBEROBN, Universidad Politécnica de Madrid, ImFINE Research Group, Depto. de Genética, Fisiología y Microbiología, Fac. de Ciencias Biológicas, Fac. de Medicina, TRUE, pub

Autism Spectrum Disorder (ASD), previously known as Pervasive Development Disorder (PDD) is a developmental disorder present from early childhood. Children diagnosed with ASD commonly exhibit symptoms of ADHD resulting in increased severity of symptoms and impairment of functioning. This group of children is frequently treated with methylphenidate which has been recommended by some but criticised by others. This systematic review aims to explore the effect of methylphenidate treatment on symptoms of ASD, functioning and adverse effects Six articles were extracted from five different databases (Medline, Psych INFO, PubMed, Scopus, and Web of Science) and chosen based on a pre-determined inclusion and exclusion criteria. The results show that MPH treatment may be successful as an intervention for some children with ASD showing ADHD symptoms while other children are very susceptible to adverse effects with some being unable to tolerate the treatment. The chosen studies provided limited acknowledgement of the effect on functioning making it an important focus for future research. It is important that professionals are aware of the negative effects MPH might cause to ensure a positive outcome and well-being for children with this disorder. There is a need for further understanding of the connection between ASD and ADHD with additional exploration of possible moderators such as IQ, dose size and level of functioning.

BACKGROUND: Adverse effects (AE) to TB treatment cause morbidity, mortality and treatment interruption. The aim of these clinical standards is to encourage best practise for the diagnosis and management of AE. METHODS: 65/81 invited experts participated in a Delphi process using a 5-point Likert scale to score draft standards. RESULTS: We identified eight clinical standards. Each person commencing treatment for TB should: Standard 1, be counselled regarding AE before and during treatment; Standard 2, be evaluated for factors that might increase AE risk with regular review to actively identify and manage these; Standard 3, when AE occur, carefully assessed and possible allergic or hypersensitiv-ity reactions considered; Standard 4, receive appropriate care to minimise morbidity and mortality associated with AE; Standard 5, be restarted on TB drugs after a serious AE according to a standardised protocol that includes active drug safety monitoring. In addition: Standard 6, healthcare workers should be trained on AE including how to counsel people undertaking TB treatment, as well as active AE monitoring and management; Standard 7, there should be active AE monitoring and reporting for all new TB drugs and regimens; and Standard 8, knowledge gaps identified from active AE monitoring should be systematically addressed through clinical research. CONCLUSION: These standards provide a person -centred, consensus-based approach to minimise the impact of AE TB treatment.

Clozapine has superior efficacy to other antipsychotics yet is underutilized due to its adverse effects, such as neutropenia, weight gain, and tachycardia. The current investigation aimed to introduce a pharmacometric approach to simultaneously model drug adverse effects, with examples from schizophrenia spectrum patients receiving clozapine. The adverse drug effects were represented as a function of time by incorporating a mixture model to describe individual susceptibility to the adverse effects. Applications of the proposed method were presented by analyzing retrospective data from patients’ medical records in Psychiatric Clinic, Penang General Hospital. Tachycardia, weight gain, and absolute neutrophils count (ANC) decrease were best described by an offset, a piecewise linear, and a transient surge function, respectively. 42.9% of the patients had all the adverse effects, including weight gain (0.01 kg/m2 increase every week over a baseline of 24.7 kg/m2 until stabilizing at 279 weeks), ANC decrease (20% decrease from 4540 cells/µL week 12-20.8), and tachycardia (14% constant increase over a baseline of 87.9 bpm for a clozapine maintenance dose of 450 mg daily). 32.5% of the patients had only tachycardia, while the remaining 24.6% had none of the adverse effects. A new pharmacometric approach was proposed to describe adverse drug effects with examples of clozapine-induced weight gain, ANC drop, and tachycardia. The current approach described the longitudinal time changes of continuous data while assessing patient susceptibility. Furthermore, the model revealed the possible co-existence of ANC drop and weight gain; thus, neutrophil monitoring might predict future changes in body weight.

BACKGROUND: Adverse effects (AE) to TB treatment cause morbidity, mortality and treatment interruption. The aim of these clinical standards is to encourage best practise for the diagnosis and management of AE. METHODS: 65/81 invited experts participated in a Delphi process using a 5-point Likert scale to score draft standards. RESULTS: We identified eight clinical standards. Each person commencing treatment for TB should: Standard 1, be counselled regarding AE before and during treatment; Standard 2, be evaluated for factors that might increase AE risk with regular review to actively identify and manage these; Standard 3, when AE occur, carefully assessed and possible allergic or hypersensitiv-ity reactions considered; Standard 4, receive appropriate care to minimise morbidity and mortality associated with AE; Standard 5, be restarted on TB drugs after a serious AE according to a standardised protocol that includes active drug safety monitoring. In addition: Standard 6, healthcare workers should be trained on AE including how to counsel people undertaking TB treatment, as well as active AE monitoring and management; Standard 7, there should be active AE monitoring and reporting for all new TB drugs and regimens; and Standard 8, knowledge gaps identified from active AE monitoring should be systematically addressed through clinical research. CONCLUSION: These standards provide a person -centred, consensus-based approach to minimise the impact of AE TB treatment.

Background: While complex public health challenges and the emergence of variants have impeded responses to the COVID pandemic, vaccines continue to represent a crucial tool in mitigating the risk of morbidity and mortality. Safety issues weigh heavily upon both the utility and acceptability of every vaccine. Reports of sight-threatening events are scarce.Case description: We report the case of a hypertensive 45-year-old Filipino who noted unilateral (right eye) blurring of vision within 48 hours of his first dose of CoronaVac (Sinovac, China), an inactivated SARS-CoV-2/COVID-19 vaccine, with macular retinal arterial occlusion noted on day 21 post-inoculation. Further work-up revealed abnormal glycemic, metabolic, inflammatory, and bleeding parameters. Vision improved from counting fingers to 20/100 at week 6 with no interventions.Conclusion: A potential association between retinal vasoocclusion and inoculation with CoronaVac in our patient is supported by the temporal sequence of events, multiple mechanisms put forward in other cases, and reports of vascular adverse reactions in large country-level trials. It is mitigated by the profound infrequency of such events and the potentially substantial risk for ocular ischemic events imparted by the patient's baseline clinical background. Continued understanding of vaccine adverse reactions, however rare, is important not only for individual patient safety. This is helpful in ensuring the utility of current vaccines and in preserving the acceptability of vaccines through and beyond the current pandemic.

BACKGROUND: Adverse effects (AE) to TB treatment cause morbidity, mortality and treatment interruption. The aim of these clinical standards is to encourage best practise for the diagnosis and management of AE. METHODS: 65/81 invited experts participated in a Delphi process using a 5-point Likert scale to score draft standards. RESULTS: We identified eight clinical standards. Each person commencing treatment for TB should: Standard 1, be counselled regarding AE before and during treatment; Standard 2, be evaluated for factors that might increase AE risk with regular review to actively identify and manage these; Standard 3, when AE occur, carefully assessed and possible allergic or hypersensitiv-ity reactions considered; Standard 4, receive appropriate care to minimise morbidity and mortality associated with AE; Standard 5, be restarted on TB drugs after a serious AE according to a standardised protocol that includes active drug safety monitoring. In addition: Standard 6, healthcare workers should be trained on AE including how to counsel people undertaking TB treatment, as well as active AE monitoring and management; Standard 7, there should be active AE monitoring and reporting for all new TB drugs and regimens; and Standard 8, knowledge gaps identified from active AE monitoring should be systematically addressed through clinical research. CONCLUSION: These standards provide a person -centred, consensus-based approach to minimise the impact of AE TB treatment.

Triazoles are a major group of azole fungicides commonly used in agriculture, and veterinary and human medicine. Maternal exposure to certain triazole antifungal medication causes congenital malformations, including skeletal malformations. We hypothesized that triazoles used as pesticides in agriculture also pose a risk of causing skeletal malformations in developing embryos. In this study, teratogenic effects of three commonly used triazoles, cyproconazole, paclobutrazol, and triadimenol, were investigated in zebrafish, Danio rerio. Exposure to the triazole fungicides caused bone and cartilage malformations in developing zebrafish larvae. Data from whole-embryo transcriptomics with cyproconazole suggested that exposure to this compound induces adipogenesis while repressing skeletal development. Confirming this finding, the expression of selected bone and cartilage marker genes were significantly downregulated with triazoles exposure as determined by quantitative PCR. The expression of selected adipogenic genes was upregulated by the triazoles. Furthermore, exposure to each of the three triazoles induced adipogenesis and lipid droplet formation in vitro in 3T3-L1 pre-adipocyte cells. In vivo in zebrafish larvae, cyproconazole exposure caused lipid accumulation. These results suggest that exposure to triazoles promotes adipogenesis at the expense of skeletal development, and thus they expand the chemical group of bona fide bone to fat switchers., QC 20230710

BACKGROUND: Adverse effects (AE) to TB treatment cause morbidity, mortality and treatment interruption. The aim of these clinical standards is to encourage best practise for the diagnosis and management of AE. METHODS: 65/81 invited experts participated in a Delphi process using a 5-point Likert scale to score draft standards. RESULTS: We identified eight clinical standards. Each person commencing treatment for TB should: Standard 1, be counselled regarding AE before and during treatment; Standard 2, be evaluated for factors that might increase AE risk with regular review to actively identify and manage these; Standard 3, when AE occur, carefully assessed and possible allergic or hypersensitiv-ity reactions considered; Standard 4, receive appropriate care to minimise morbidity and mortality associated with AE; Standard 5, be restarted on TB drugs after a serious AE according to a standardised protocol that includes active drug safety monitoring. In addition: Standard 6, healthcare workers should be trained on AE including how to counsel people undertaking TB treatment, as well as active AE monitoring and management; Standard 7, there should be active AE monitoring and reporting for all new TB drugs and regimens; and Standard 8, knowledge gaps identified from active AE monitoring should be systematically addressed through clinical research. CONCLUSION: These standards provide a person -centred, consensus-based approach to minimise the impact of AE TB treatment.

Autism Spectrum Disorder (ASD), previously known as Pervasive Development Disorder (PDD) is a developmental disorder present from early childhood. Children diagnosed with ASD commonly exhibit symptoms of ADHD resulting in increased severity of symptoms and impairment of functioning. This group of children is frequently treated with methylphenidate which has been recommended by some but criticised by others. This systematic review aims to explore the effect of methylphenidate treatment on symptoms of ASD, functioning and adverse effects Six articles were extracted from five different databases (Medline, Psych INFO, PubMed, Scopus, and Web of Science) and chosen based on a pre-determined inclusion and exclusion criteria. The results show that MPH treatment may be successful as an intervention for some children with ASD showing ADHD symptoms while other children are very susceptible to adverse effects with some being unable to tolerate the treatment. The chosen studies provided limited acknowledgement of the effect on functioning making it an important focus for future research. It is important that professionals are aware of the negative effects MPH might cause to ensure a positive outcome and well-being for children with this disorder. There is a need for further understanding of the connection between ASD and ADHD with additional exploration of possible moderators such as IQ, dose size and level of functioning.

Arthrocentesis consists of puncturing a joint in order to extract intraarticular fluid, either for diagnostic or therapeutic purposes. Generally, not all patient who present to the emergency service with characteristic of swelling, pain and functional impotence of a joint require an arthrocentesis, so it has become essential to identify the cases in which it is warranted in the emergency service. It has been shown that with an adequate technique and under the correct aseptic measures it can be a safe practice, however, it is not considered an entirely harmless procedure. The most feared complication is bacterial inoculation, which can cause septic arthritis, as well as other non-infectious complications such as tendon rupture, nerve atrophy, skin changes, or even osteonecrosis. Currently, intraarticular infiltration of substances, such as glucocorticoids, has been implemented as a therapeutic measure due to the increase in degenerative diseases that compromise the joints, especially large joints such as the knee or hip. Since the indications for arthrocentesis are not entirely clear, this bibliographical review exposes some important aspects to consider when deciding whether to perform arthrocentesis in the emergency service., La artrocentesis consiste en puncionar una articulación con la finalidad de extraer líquido intraarticular, ya sea con fines diagnósticos o terapéuticos. Generalmente, no todas las personas que se presentan al servicio de emergencias con características de tumefacción, dolor e impotencia funcional de una articulación ameritan una artrocentesis, por lo que se ha vuelto imprescindible identificar los casos en que sí se amerita la realización en el servicio de emergencias. Se ha demostrado que con una técnica adecuada y bajo las correctas medidas asépticas puede ser una práctica segura, sin embargo, no se considera un procedimiento inofensivo del todo. La complicación más temida es la inoculación de bacterias, que puede generar una artritis séptica, así como otras complicaciones no infecciosas como ruptura de tendón, atrofia nerviosa, cambios cutáneos o hasta osteonecrosis. Actualmente, se ha implementado la infiltración intraarticular de sustancias, como glucocorticoides, como medida terapéutica por el aumento en enfermedades degenerativas que comprometen las articulaciones, especialmente articulaciones grandes, como es el caso de la rodilla o cadera. Ya que las indicaciones de artrocentesis no son del todo claras, se exponen en la presente revisión bibliográfica algunos aspectos importantes a considerar a la hora de decidir si es conveniente realizar o no una artrocentesis en el servicio de emergencias.

Introducción: La enfermedad de Parkinson es una enfermedad neurodegenerativa progresiva que se caracteriza por síntomas motores y no motores afectando a la calidad de vida. Su diagnóstico es fundamentalmente clínico, y su tratamiento es sintomático. Existen técnicas enfocadas a mejorar los síntomas como la estimulación cerebral profunda. - Objetivos: La finalidad de esta revisión es analizar la evidencia científica para determinar la diana óptima a la hora de realizar la estimulación cerebral profunda. Se comparará el núcleo subtalámico y el globo pálido interno con el fin de determinar si una diana es mejor que la otra, en cuanto a beneficios y efectos adversos. - Métodos: Se realizó una búsqueda sistemática usando las bases de datos: MEDLINE (vía PubMed), Cochrane y SciELO. Se incluyeron revisiones sistemáticas, metaanálisis, y ensayos clínicos aleatorizados que comparasen ambas dianas. Se utilizó la escala PEDro para valorar la calidad de los artículos y el riesgo de sesgos. - Resultados: Del total de 42 artículos obtenidos, se seleccionaron y se analizaron 9. Se recopilaron las características de muestra y los métodos de todos los estudios. se sometieron a análisis los datos de función motora y no motora comparando las dos dianas. - Conclusión: No existen diferencias significativas de una diana sobre otra en cuanto a función motora evaluada mediante la parte III de la escala UPDRS. De igual manera, no se evidenciaron diferencias significativas en lo relacionado a calidad de vida o efectos adversos. La estimulación cerebral profunda palidal parece ser superior en algunos aspectos neurocognitivos, en cambio, la estimulación subtalámica se asocia a una mayor reducción de la medicación dopaminérgica, Obxectivos: O obxectivo desta revisión é analizar a evidencia científica para determinar o obxectivo óptimo á hora de realizar a estimulación cerebral profunda. Compararase o núcleo subtalámico e o globo pálido interno co fin de determinar se unha diana é mellor ca outra en canto a beneficios e efectos adversos. - Métodos: Realizouse unha busca sistemática utilizando as bases de datos: MEDLINE (vía PubMed), Cochrane e SciELO. Incluíronse revisións sistemáticas, meta-análises e ensaios clínicos aleatorizados que comparasen ambos obxectivos. Utilizouse a escala PEDro para valorar a calidade dos artigos e o risco de sesgos. - Resultados: Do total de 42 artigos obtidos, seleccionáronse e analizáronse 9. Recompiláronseas características da mostra e os métodos de todos os estudos. Analizáronse os datos de función motora e non motora comparando ambos os obxectivos. - Conclusión: Non hai diferenzas significativas entre un obxectivo e outro en canto á función motora avaliada mediante a parte III da escala UPDRS. Da mesma maneira, non se evidenciaron diferenzas significativas en relación á calidade de vida ou aos efectos adversos. A estimulación cerebral profunda do globo pálido interno parece ser superior en algúns aspectos neurocognitivos, mentres que a estimulación subtalámica asóciase a unha maior redución da medicación dopaminérxica, Introduction: Parkinson's disease is a progressive neurodegenerative disorder characterized by motor and non-motor symptoms that affect quality of life. Its diagnosis is primarily clinical, and the treatment is symptomatic. There are techniques focused on improving symptoms, such as deep brain stimulation. - Objectives: The aim of this review is to analyze the scientific evidence to determine the optimal target for deep brain stimulation. The subthalamic nucleus and the internal globus pallidus will be compared to determine if one target is better than the other in terms of benefits and adverse effects. - Methods: A systematic search was conducted using the databases MEDLINE (via PubMed), Cochrane, and SciELO. Systematic reviews, meta-analyses, and randomized clinical trials comparing both targets were included. The PEDro scale was used to assess article quality and risk of bias. - Results: Out of a total of 42 articles obtained, 9 were selected and analyzed. Sample characteristics and methods from all studies were collected. Motor and non-motor function data comparing the two targets were subjected to analysis. - Conclusion: There are no significant differences between one target and the other in terms of motor function evaluated by Part III of the UPDRS scale. Similarly, no significant differences were found in quality of life or adverse effects. Pallidal deep brain stimulation appears to be superior in some neurocognitive aspects, while subthalamic stimulation is associated with a greater reduction in dopaminergic medication

Tryptase test can be used as a clinical marker of mast cell activation. The present study is was aimed to identify variations in serum tryptase levels and their possible relationships with allergic reactions to protamine in low-risk patients undergoing cardiac bypass surgery. Thirty patients according to American Society of Anesthesiologists physical status III who underwent cardiac bypass surgery were enrolled. This prospective, non-randomised, clinical study was conducted in an operating room. Venous blood samples for tryptase measurements were obtained from cardiac bypass surgery patients upon admission to the operating room and immediately before and 30 min after the initiation of protamine administration. Signs of allergic reactions were recorded and management steps based on rapid effect response-based clinical assessments for diagnosis and treatment decisions during protamine administrations were described. Serum tryptase levels and clinical signs of allergic reactions, primarily mean arterial pressure (MAP), were recorded. Serum tryptase levels increased significantly and progressively during the bypass procedure (study power, 80%; sample size, 28; power of analysis, 99.8% with alpha=0.05); however, tryptase levels did not reach a sufficiently high level to confirm an allergic reaction. The MAP and heart rate decreased in 50% of the patients. Although tryptase increased significantly when compared with baseline levels, protamine-associated increases were not significant and failed to provide an unequivocal indication of an allergic response to protamine., institutional fund of Hatay Mustafa Kemal University, Turkey [12200], The study (study code: 12200) was supported by the institutional fund of Hatay Mustafa Kemal University, Turkey.

Tryptase test can be used as a clinical marker of mast cell activation. The present study is was aimed to identify variations in serum tryptase levels and their possible relationships with allergic reactions to protamine in low-risk patients undergoing cardiac bypass surgery. Thirty patients according to American Society of Anesthesiologists physical status III who underwent cardiac bypass surgery were enrolled. This prospective, non-randomised, clinical study was conducted in an operating room. Venous blood samples for tryptase measurements were obtained from cardiac bypass surgery patients upon admission to the operating room and immediately before and 30 min after the initiation of protamine administration. Signs of allergic reactions were recorded and management steps based on rapid effect response-based clinical assessments for diagnosis and treatment decisions during protamine administrations were described. Serum tryptase levels and clinical signs of allergic reactions, primarily mean arterial pressure (MAP), were recorded. Serum tryptase levels increased significantly and progressively during the bypass procedure (study power, 80%; sample size, 28; power of analysis, 99.8% with alpha=0.05); however, tryptase levels did not reach a sufficiently high level to confirm an allergic reaction. The MAP and heart rate decreased in 50% of the patients. Although tryptase increased significantly when compared with baseline levels, protamine-associated increases were not significant and failed to provide an unequivocal indication of an allergic response to protamine., institutional fund of Hatay Mustafa Kemal University, Turkey [12200], The study (study code: 12200) was supported by the institutional fund of Hatay Mustafa Kemal University, Turkey.

Objective This meta-analysis assesses cognitive functioning in children with acute lymphoblastic leukemia post-treatment who were treated with either chemotherapy-only (CT-only) or in combination with radiation therapy (CTRT). Methods The databases Pubmed and PsychInfo were searched between 1-1-2000 and 31-12-2021. Data were analyzed using Comprehensive Meta-Analysis (version 2). Results Mean weighted intelligence after treatment was 100.2 (number of studies n = 51, 95% CI: 98.8-101.5). For CT-only, it was 100.8 (95% CI: 99.5-102.2) and for CTRT 97.8 (95% CI: 95.9-100.2). Compared to recruited healthy controls, treated children had on average lower IQ scores (n = 23, mean difference -7.8, 95% CI: -10.7 to -5.0, p < 0.001). When looking only at studies using controls recruited from the patient's family, results remained significant (n = 5, mean difference -6.0, 95% CI: -8.6 to -3.5, p = 0.001). Meta-regressions aimed at identifying predictors of IQ after treatment failed to find an effect for sex or age. We could demonstrate an effect of time between diagnosis and IQ measurement for the CTRT treated patient (B = -0.26, 95% CI: -0.40 to -0.1, p = 0.002). Conclusions IQ scores of patients treated with CT-only or CTRT treatment regimens did not differ from the normative population. However, compared to recruited control groups, patients showed lower mean IQ scores. The Flynn effect and/or selection effects may play a role in this discrepancy. Considering time since diagnosis may have a significant impact on IQ, at least in CTRT treated patients, long-term clinical follow-up of neurocognitive development may be prudent to detect possible (late) neurocognitive effects.

Introduction: Community-acquired pneumonia is a problem that affects the health systems of developed and underdeveloped countries, it represents the sixth cause of death in general and the first in infectious pathologies, with a mortality rate of 8 to 15% globally. The severity depends on criteria elaborated by scientific societies, which offer guidelines for management and adjuvant systemic corticosteroids. Objective: To describe the current evidence supporting the clinical benefit of the use of hydrocortisone in patients with severe community-acquired pneumonia. Development: Adjunctive therapy with hydrocortisone was shown to be beneficial for certain phenotypes with severe community-acquired pneumonia, it was shown to reduce mortality, hospital stay, risk of mechanical ventilation or its duration, it may be associated with hospital readmission and hyperglycemia, however, it was not associated with an increase in nosocomial infections or gastrointestinal bleeding. Conclusion: It is important as physicians caring for critically ill patients to find information from certified guidelines endorsed by competent local and international scientific bodies and institutions, in order to implement the best therapy for patients with severe community-acquired pneumonia., Introducción: La neumonía adquirida en la comunidad es un problema que afecta a los sistemas de salud de países desarrollados y subdesarrollados, representa la sexta causa de muerte de forma general y la primera en patologías infecciosas, ubicándose con una mortalidad del 8 al 15% globalmente. La gravedad depende de criterios elaborados por sociedades científicas, las cuales ofrecen los lineamientos para el manejo y la adyuvancia con corticoesteroides sistémicos. Objetivo: Describir la evidencia actual la cual sustente el beneficio clínico del uso de la hidrocortisona en pacientes con neumonía grave adquirida en la comunidad. Desarrollo: La terapia complementaria con hidrocortisona mostró ser beneficiosa para ciertos fenotipos con neumonía grave adquirida en la comunidad, se evidencio que reduce la mortalidad, estancia hospitalaria, riesgo de ventilación mecánica o su duración, puede estar asociada a reingreso hospitalario e hiperglucemia, sin embargo, no se vinculó con el aumento de infecciones nosocomiales o hemorragia gastrointestinal. Conclusión: Es importante como médicos que atendemos a pacientes en estado crítico, encontrar la información proveniente de guías certificadas y avaladas por organismos e instituciones científicas competentes locales e internacionales, para implementar la mejor terapia para pacientes con neumonía grave adquirida en la comunidad.

BACKGROUND: A small but significant group of patients with anorexia nervosa (AN) undergo multiple involuntary treatment (IT) events. To enhance our understanding of IT and potentially inform treatment, we explored experiences and perspectives on IT of these patients. METHODS: We designed a qualitative semi-structured interview study and used reflexive thematic analysis. Participants were at least 18 years of age, had multiple past IT events (≥ 5) related to AN over a period of at least one month of which the last IT event happened within the preceding five years. Participants had no current IT, intellectual disability, acute psychosis, or severe developmental disorder. We adopted an inductive approach and constructed meaning-based themes. RESULTS: We interviewed seven participants. The data portrayed a process of living and leaving a life of coercion with a timeline covering three broad themes: living with internal coercion, coercive treatment, and leaving coercion; and five subthemes: helping an internal battle, augmenting suffering, feeling trapped, a lasting imprint, and changing perspectives. We highlighted that patients with AN and multiple IT events usually experienced internal coercion from the AN prior to external coercion from the health care system. IT evoked significant negative affect when experienced, and often left an adverse imprint. Moreover, IT could help an internal battle against AN and perspectives on IT could change over time. CONCLUSIONS: Our study suggests that feeling internally coerced by AN itself sets the stage for IT. Clinicians should be conscious of the potential iatrogenic effects of IT, and reserve IT for potentially life-threatening situations.

Background Knowledge on adverse events in psychotherapy for youth with OCD is sparse. No official guidelines exist for defining or monitoring adverse events in psychotherapy. Recent recommendations call for more qualitative and quantitative assessment of adverse events in psychotherapy trials. This mixed methods study aims to expand knowledge on adverse events in psychotherapy for youth with OCD. Methods This is an analysis plan for a convergent mixed methods study within a randomized clinical trial (the TECTO trial). We include at least 128 youth aged 8–17 years with obsessive-compulsive disorder (OCD). Participants are randomized to either family-based cognitive behavioral therapy (FCBT) or family-based psychoeducation and relaxation training (FPRT). Adverse events are monitored quantitatively with the Negative Effects Questionnaire. Furthermore, we assess psychiatric symptoms, global functioning, quality of life, and family factors to investigate predictors for adverse events. We conduct semi-structured qualitative interviews with all youths and their parents on their experience of adverse events in FCBT or FPRT. For the mixed methods analysis, we will merge 1) a qualitative content analysis with descriptive statistics comparing the types, frequencies, and severity of adverse events; 2) a qualitative content analysis of the perceived causes for adverse events with prediction models for adverse events; and 3) a thematic analysis of the participants’ treatment evaluation with a correlational analysis of adverse events and OCD severity. Discussion The in-depth mixed methods analysis can inform 1) safer and more effective psychotherapy for OCD; 2) instruments and guidelines for monitoring adverse events; and 3) patient information on potential adverse events. The main limitation is risk of missing data., Background: Knowledge on adverse events in psychotherapy for youth with OCD is sparse. No official guidelines exist for defining or monitoring adverse events in psychotherapy. Recent recommendations call for more qualitative and quantitative assessment of adverse events in psychotherapy trials. This mixed methods study aims to expand knowledge on adverse events in psychotherapy for youth with OCD. Methods: This is an analysis plan for a convergent mixed methods study within a randomized clinical trial (the TECTO trial). We include at least 128 youth aged 8–17 years with obsessive-compulsive disorder (OCD). Participants are randomized to either family-based cognitive behavioral therapy (FCBT) or family-based psychoeducation and relaxation training (FPRT). Adverse events are monitored quantitatively with the Negative Effects Questionnaire. Furthermore, we assess psychiatric symptoms, global functioning, quality of life, and family factors to investigate predictors for adverse events. We conduct semi-structured qualitative interviews with all youths and their parents on their experience of adverse events in FCBT or FPRT. For the mixed methods analysis, we will merge 1) a qualitative content analysis with descriptive statistics comparing the types, frequencies, and severity of adverse events; 2) a qualitative content analysis of the perceived causes for adverse events with prediction models for adverse events; and 3) a thematic analysis of the participants’ treatment evaluation with a correlational analysis of adverse events and OCD severity. Discussion: The in-depth mixed methods analysis can inform 1) safer and more effective psychotherapy for OCD; 2) instruments and guidelines for monitoring adverse events; and 3) patient information on potential adverse events. The main limitation is risk of missing data. Trial registration: ClinicalTrials.gov identifier: NCT03595098. Registered on July 23, 2018.

Background: Knowledge on adverse events in psychotherapy for youth with OCD is sparse. No official guidelines exist for defining or monitoring adverse events in psychotherapy. Recent recommendations call for more qualitative and quantitative assessment of adverse events in psychotherapy trials. This mixed methods study aims to expand knowledge on adverse events in psychotherapy for youth with OCD. Methods: This is an analysis plan for a convergent mixed methods study within a randomized clinical trial (the TECTO trial). We include at least 128 youth aged 8–17 years with obsessive-compulsive disorder (OCD). Participants are randomized to either family-based cognitive behavioral therapy (FCBT) or family-based psychoeducation and relaxation training (FPRT). Adverse events are monitored quantitatively with the Negative Effects Questionnaire. Furthermore, we assess psychiatric symptoms, global functioning, quality of life, and family factors to investigate predictors for adverse events. We conduct semi-structured qualitative interviews with all youths and their parents on their experience of adverse events in FCBT or FPRT. For the mixed methods analysis, we will merge 1) a qualitative content analysis with descriptive statistics comparing the types, frequencies, and severity of adverse events; 2) a qualitative content analysis of the perceived causes for adverse events with prediction models for adverse events; and 3) a thematic analysis of the participants’ treatment evaluation with a correlational analysis of adverse events and OCD severity. Discussion: The in-depth mixed methods analysis can inform 1) safer and more effective psychotherapy for OCD; 2) instruments and guidelines for monitoring adverse events; and 3) patient information on potential adverse events. The main limitation is risk of missing data. Trial registration: ClinicalTrials.gov identifier: NCT03595098. Registered on July 23, 2018.

Inadequate recognition and treatment of extrapyramidal symptoms (EPS) pose as a major liability to providers, as EPS can be life-threatening to patients, as they develop into metabolic syndrome, tardive dyskinesia (TD), or even death. Thus, insufficient usage of AIMS testing can negatively impact providers’ ability to meet associated care practice standards, when treating psychotic patients with antipsychotic medications. As a result, an evidence-based practice, quasiexperimental project was completed, utilizing the Iowa Model Revised: Evidence-Based Practice to Promote Excellence in Healthcare. In alignment with this version of the revised Iowa Model, a pilot study was initiated to progress toward a formal practice change. This process was experimental in construct and execution. In this project, a group of novice Psychiatric-Mental Health Nurse Practitioners, who recently gained employment with iCare and Associates, LLC, were assessed on their baseline knowledge pertaining to Abnormal Involuntary Movement Scale (AIMS) testing, using a pretest examination. Each Nurse Practitioner was then provided formal AIMS testing-specific education, in the form of a lecture, handout materials, as well as a teach back-style question-and-answer period before a post-test examination was administered to test their knowledge retention. Upon competition of the education and post-test, a six-week study period was conducted to record and compare the number of AIMS testing documentation occurrences, per provider, as compared with the number of potential documentation occurrences. All documentation occurred within the Electronic Health Record (EHR) system of the organization. Based on statistical analyses, using paired t-testing, research findings indicated a match or increase in the number of AIMS testing and documentation occurrences of Nurse Practitioners post-educational intervention, as compared to the potential calculated number of occurrences possible. Thus, there exists statistic

BACKGROUND: Adverse effects (AE) to TB treatment cause morbidity, mortality and treatment interruption. The aim of these clinical standards is to encourage best practise for the diagnosis and management of AE. METHODS: 65/81 invited experts participated in a Delphi process using a 5-point Likert scale to score draft standards. RESULTS: We identified eight clinical standards. Each person commencing treatment for TB should: Standard 1, be counselled regarding AE before and during treatment; Standard 2, be evaluated for factors that might increase AE risk with regular review to actively identify and manage these; Standard 3, when AE occur, carefully assessed and possible allergic or hypersensitiv-ity reactions considered; Standard 4, receive appropriate care to minimise morbidity and mortality associated with AE; Standard 5, be restarted on TB drugs after a serious AE according to a standardised protocol that includes active drug safety monitoring. In addition: Standard 6, healthcare workers should be trained on AE including how to counsel people undertaking TB treatment, as well as active AE monitoring and management; Standard 7, there should be active AE monitoring and reporting for all new TB drugs and regimens; and Standard 8, knowledge gaps identified from active AE monitoring should be systematically addressed through clinical research. CONCLUSION: These standards provide a person -centred, consensus-based approach to minimise the impact of AE TB treatment.

Background and Objectives: The use of closed-circuit rebreathers (CCRs) in recreational diving is gaining interest. However, data regarding its physiological effects are still scarce. Immersion, cold water, hyperoxia, exercise or the equipment itself could challenge the cardiopulmonary system. The purpose of this study was to examine the impact of CCR diving on lung function and autonomous cardiac activity after a series of CCR dives in cold water. Materials and Methods: Eight CCR divers performed a diving trip (one week) in the Baltic Sea. Spirometry parameters, SpO2, and the lung ultrasonography score (LUS) associated with hydration monitoring by bioelectrical impedance were assessed at the end of the week. Heart rate variability (HRV) was recorded during the dives. Results: No diver declared pulmonary symptoms. The LUS increased after dives combined with a slight non-pathological decrease in SpO2. Spirometry was not altered, and all body water compartments were increased. Global HRV decreased during diving with a predominant increase in sympathetic tone while the parasympathetic tone decreased. All parameters returned to baseline 24 h after the last dive. Conclusions: The lung aeration disorders observed seem to be transient and not associated with functional spirometry alteration. The HRV dynamics highlighted physiological constraints during the dive as well as environmental-stress-related stimulation that may influence pulmonary changes. The impact of these impairments is unknown but should be taken into account, especially when considering long and repetitive CCR dives., SCOPUS: ar.j, info:eu-repo/semantics/published

Background: Comparative outcomes of minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) and traditional open TLIF (O-TLIF) for degenerative lumbar disc disease have been poorly studied. The purpose of this study was to prospectively compare the outcomes between MI-TLIF and O-TLIF for patients with a degenerative disc disease, focusing on the functional capacity of patients in daily life. Methods: A prospective cohort study was performed, comparing 54 patients who underwent O-TLIF and 55 patients who underwent MI-TLIF with a follow-up of 4 years. Clinical evaluation was performed using the Oswestry Disability Index (ODI), 36-item short form survey (SF-36), and a visual analog scale for pain (VAS pain). Radiological evaluation was also performed. Results: At the final follow-up, compared with O-TLIF, MI-TLIF was associated with significantly better intraoperative results, including similar operative time (p = 0.246), lower estimated blood loss (p = 0.001), and shorter hospital stay (p = 0.001). The final ODI score was significantly better in the MI-TLIF group (p = 0.031). The SF-36-physical (p = 0.023) and VAS pain (p = 0.024) scores were significantly better in the MI-TLIF group. There was no significant difference in the fusion rate (p = 0.747). Conclusions: The MI-TLIF technique is an effective and safe procedure for degenerative lumbar disc disease. Compared to traditional O-TLIF, MI-TLIF was associated with less disability and higher quality of life, with a low rate of intraoperative and postoperative complications.

OBJECTIVES: The COVID-19 vaccination in autoimmune diseases (COVAD) study aimed to assess short-term COVID-19 vaccination-related adverse events (AEs) in rheumatoid arthritis (RA) patients. METHODS: An online self-reported questionnaire (March-December 2021) was used to capture data related to COVID-19 vaccination-related AEs in RA, other autoimmune rheumatic diseases (AIRDs) (excluding RA and inflammatory myositis), non-rheumatic autoimmune diseases (nrAIDs), and healthy controls (HCs). Descriptive and multivariable regression analyses were performed. RESULTS: Of the 9462 complete respondents, 14.2% (n = 1347) had been diagnosed with RA who had a mean (standard deviation) age of 50.7 (13.7) years, and 74.2% were women, and 49.3% were Caucasian. In total, 76.9% and 4.2% of patients with RA reported minor and major AEs, respectively. Patients with active and inactive RA had similar AE and hospitalization frequencies. Overall, AEs were reported more frequently by BNT162b2 and mRNA-1273 recipients and less frequently by BBV152 recipients compared with the rest. Major AE and hospitalization frequencies were similar across recipients of different vaccines. Patients receiving methotrexate and hydroxychloroquine reported fewer minor AEs than those patients not on them. Compared with HCs and patients with other AIRDs, patients with RA reported similar total AEs, overall minor AEs, and hospitalizations. Compared with nrAIDs, patients with RA reported lower frequencies of overall AEs, minor AEs (both OR = 0.7; 95%CI = 0.5-0.9), and injection site pain (OR = 0.6; 95%CI = 0.5-0.8) with similar major AE and hospitalization frequencies. CONCLUSION: Despite the differences in AE frequency across different COVID-19 vaccines, all were well tolerated in patients with RA and were comparable to HCs providing reassurance to the safety of COVID-19 vaccination., Funding agency:National Institution for HealthResearch Manchester Biomedical Research Centre Funding Scheme

Huge technological and biomedical advances have improved the survival and quality of life of lung cancer patients treated with radiotherapy. However, during treatment planning, a probability that the patient will experience adverse effects is assumed. Radiotoxicity is a complex entity that is largely dose-dependent but also has important intrinsic factors. One of the most studied is the genetic variants that may be associated with susceptibility to the development of adverse effects of radiotherapy. This review aims to present the current status of radiogenomics in lung cancer, integrating results obtained in association studies of SNPs (single nucleotide polymorphisms) related to radiotherapy toxicities. We conclude that despite numerous publications in this field, methodologies and endpoints vary greatly, making comparisons between studies difficult. Analyzing SNPs from the candidate gene approach, together with the study in cohorts limited by the sample size, has complicated the possibility of having validated results. All this delays the incorporation of genetic biomarkers in predictive models for clinical application. Thus, from all analysed SNPs, only 12 have great potential as esophagitis genetic risk factors and deserve further exploration. This review highlights the efforts that have been made to date in the radiogenomic study of radiotoxicity in lung cancer.

Background To investigate if perioperative parenteral administration of fosfomycin given before or during gastrointestinal surgery could protect against postoperative infectious complications and characterise the administration of fosfomycin and its harms. Methods This systematic review included original studies on gastrointestinal surgery where parental administration of fosfomycin was given before or during surgery to≥5 patients. We searched three databases on March 24 2023 and registered the protocol before data extraction (CRD42020201268). Risk of bias was assessed with Cochrane Handbook risk of bias assessment tool or the Newcastle-Ottawa Scale. A narrative description was undertaken. For infectious complications, results from emergency and elective surgery were presented separately. Results We included 15 unique studies, reporting on 1,029 patients that received fosfomycin before or during gastrointestinal surgery. Almost half of the studies were conducted in the 1980s to early 1990s, and typically a dose of 4 g fosfomycin was given before surgery co-administered with metronidazole and often repeated postoperatively. The risk of bias across studies was moderate to high. The rates of infectious complications were low after fosfomycin; the surgical site infection rate was 0–1% in emergency surgery and 0–10% in elective surgery. If reported, harms were few and mild and typically related to the gastrointestinal system. Conclusion There were few postoperative infectious complications after perioperative parenteral administration of one or more doses of 4 g fosfomycin supplemented with metronidazole in various gastrointestinal procedures. Fosfomycin was associated with few and mild harms., Background To investigate if perioperative parenteral administration of fosfomycin given before or during gastrointestinal surgery could protect against postoperative infectious complications and characterise the administration of fosfomycin and its harms. Methods This systematic review included original studies on gastrointestinal surgery where parental administration of fosfomycin was given before or during surgery to≥5 patients. We searched three databases on March 24 2023 and registered the protocol before data extraction (CRD42020201268). Risk of bias was assessed with Cochrane Handbook risk of bias assessment tool or the Newcastle-Ottawa Scale. A narrative description was undertaken. For infectious complications, results from emergency and elective surgery were presented separately. Results We included 15 unique studies, reporting on 1,029 patients that received fosfomycin before or during gastrointestinal surgery. Almost half of the studies were conducted in the 1980s to early 1990s, and typically a dose of 4 g fosfomycin was given before surgery co-administered with metronidazole and often repeated postoperatively. The risk of bias across studies was moderate to high. The rates of infectious complications were low after fosfomycin; the surgical site infection rate was 0-1% in emergency surgery and 0-10% in elective surgery. If reported, harms were few and mild and typically related to the gastrointestinal system. Conclusion There were few postoperative infectious complications after perioperative parenteral administration of one or more doses of 4 g fosfomycin supplemented with metronidazole in various gastrointestinal procedures. Fosfomycin was associated with few and mild harms.

Background: Concern about disease exacerbations and fear of reactions after coronavirus disease 2019 (COVID-19) vaccinations are common in chronic urticaria (CU) patients and may lead to vaccine hesitancy. Objective: We assessed the frequency and risk factors of CU exacerbation and adverse reactions in CU patients after COVID-19 vaccination. Methods: COVAC-CU is an international multicenter study of Urticaria Centers of Reference and Excellence (UCAREs) that retrospectively evaluated the effects of COVID-19 vaccination in CU patients aged ≥18 years and vaccinated with ≥1 dose of any COVID-19 vaccine. We evaluated CU exacerbations and severe allergic reactions as well as other adverse events associated with COVID-19 vaccinations and their association with various CU parameters. Results: Across 2769 COVID-19–vaccinated CU patients, most (90%) received at least 2 COVID-19 vaccine doses, and most patients received CU treatment and had well-controlled disease. The rate of COVID-19 vaccination–induced CU exacerbation was 9%. Of 223 patients with CU exacerbation after the first dose, 53.4% experienced recurrence of CU exacerbation after the second dose. CU exacerbation most often started <48 hours after vaccination (59.2%), lasted for a few weeks or less (70%), and was treated mainly with antihistamines (70.3%). Factors that increased the risk for COVID-19 vaccination–induced CU exacerbation included female sex, disease duration shorter than 24 months, having chronic spontaneous versus inducible urticaria, receipt of adenovirus viral vector vaccine, having nonsteroidal anti-inflammatory drug/aspirin intolerance, and having concerns about getting vaccinated; receiving omalizumab treatment and Latino/Hispanic ethnicity lowered the risk. First-dose vaccine–related adverse effects, most commonly local reactions, fever, fatigue, and muscle pain, were reported by 43.5% of CU patients. Seven patients reported severe allergic reactions. Conclusions: COVID-19 vaccination lead

Background Knowledge on adverse events in psychotherapy for youth with OCD is sparse. No official guidelines exist for defining or monitoring adverse events in psychotherapy. Recent recommendations call for more qualitative and quantitative assessment of adverse events in psychotherapy trials. This mixed methods study aims to expand knowledge on adverse events in psychotherapy for youth with OCD. Methods This is an analysis plan for a convergent mixed methods study within a randomized clinical trial (the TECTO trial). We include at least 128 youth aged 8–17 years with obsessive-compulsive disorder (OCD). Participants are randomized to either family-based cognitive behavioral therapy (FCBT) or family-based psychoeducation and relaxation training (FPRT). Adverse events are monitored quantitatively with the Negative Effects Questionnaire. Furthermore, we assess psychiatric symptoms, global functioning, quality of life, and family factors to investigate predictors for adverse events. We conduct semi-structured qualitative interviews with all youths and their parents on their experience of adverse events in FCBT or FPRT. For the mixed methods analysis, we will merge 1) a qualitative content analysis with descriptive statistics comparing the types, frequencies, and severity of adverse events; 2) a qualitative content analysis of the perceived causes for adverse events with prediction models for adverse events; and 3) a thematic analysis of the participants’ treatment evaluation with a correlational analysis of adverse events and OCD severity. Discussion The in-depth mixed methods analysis can inform 1) safer and more effective psychotherapy for OCD; 2) instruments and guidelines for monitoring adverse events; and 3) patient information on potential adverse events. The main limitation is risk of missing data., Background: Knowledge on adverse events in psychotherapy for youth with OCD is sparse. No official guidelines exist for defining or monitoring adverse events in psychotherapy. Recent recommendations call for more qualitative and quantitative assessment of adverse events in psychotherapy trials. This mixed methods study aims to expand knowledge on adverse events in psychotherapy for youth with OCD. Methods: This is an analysis plan for a convergent mixed methods study within a randomized clinical trial (the TECTO trial). We include at least 128 youth aged 8–17 years with obsessive-compulsive disorder (OCD). Participants are randomized to either family-based cognitive behavioral therapy (FCBT) or family-based psychoeducation and relaxation training (FPRT). Adverse events are monitored quantitatively with the Negative Effects Questionnaire. Furthermore, we assess psychiatric symptoms, global functioning, quality of life, and family factors to investigate predictors for adverse events. We conduct semi-structured qualitative interviews with all youths and their parents on their experience of adverse events in FCBT or FPRT. For the mixed methods analysis, we will merge 1) a qualitative content analysis with descriptive statistics comparing the types, frequencies, and severity of adverse events; 2) a qualitative content analysis of the perceived causes for adverse events with prediction models for adverse events; and 3) a thematic analysis of the participants’ treatment evaluation with a correlational analysis of adverse events and OCD severity. Discussion: The in-depth mixed methods analysis can inform 1) safer and more effective psychotherapy for OCD; 2) instruments and guidelines for monitoring adverse events; and 3) patient information on potential adverse events. The main limitation is risk of missing data. Trial registration: ClinicalTrials.gov identifier: NCT03595098. Registered on July 23, 2018.

Falls are increasingly common among older people. One-third of people aged ≥ 65 years falls at least once annually. Among a diversity of risk factors for falls, medication use is considered as one of great importance. At least, community pharmacists’ role in fall prevention should include the identification and adaptation of use of fall risk-increasing drugs in patients at risk of falls. In this thesis, we aimed to answer the question how pharmacists can contribute to fall prevention and how fall prevention services can be implemented, including their barriers and facilitators. Also, this thesis aimed to assess the perspectives of patients, pharmacists, and other health care providers, for the provision of pharmacy-led fall prevention services. We found that community pharmacists are currently limited involved in fall prevention. Most patients are currently unaware of that their medications could have fall risk-increasing effects. Furthermore, other health care providers, including physiotherapist, practice nurses and home care nurses, experience suboptimal collaboration with community pharmacists in fall prevention. Fortunately, pharmacists indicated they wished to be more involved. Particularly, they believed they could contribute by advising on deprescribing of fall risk-increasing drugs. The following facilitators were identified for community pharmacists to provide fall prevention care, including deprescribing of fall risk-increasing drugs: patient engagement, good multidisciplinary collaboration, knowledge about fall risk-increasing drugs and deprescribing, and sufficient pharmacist communication skills. Lack of time and lack of reimbursement were often identified as barriers for implementation. To identify patients at medication-related fall risk more quickly, a contra-indication ‘fall risk’ could be added for saving in pharmacy information systems. This may support the screening of patients at risk, so targeted advice can be provided to them. Pharmacy techni

Objective: The aim of the study was to assess monitoring of adverse drug reaction (ADR)-related parameters in children, youth, and young adults treated with second-generation antipsychotic drugs (SGAs) prescribed by general practitioners (GPs). Methods: This retrospective follow-up study included children, youth, and young adults aged 0 - 24 years, who had an initial prescription of an SGA recorded in the Clinical Practice Research Datalink between 2000 and 2017, and who were prescribed an SGA more than once for a duration of at least 6 months. It included an assessment of which ADR-related physical parameters (weight, height, body-mass index, waist circumference, pulse, blood pressure, and heart examination) and laboratory parameters (glucose, HbA1c, lipids, and prolactin) were monitored in children, youth, and young adults at least once every 6-month period, stratified by sex, age categories, and calendar years. Results: In total, 7006 patients were included and the mean duration of follow-up was 1.6 years. Monitoring frequencies of all parameters were below 25%. Blood pressure and weight were monitored in 23.6% and 23.4%, respectively, of all children, youth, and young adults during the first half year; waist circumference was monitored in 0.2%. Females were monitored more often than males, some differences between age categories were observed, and monitoring frequencies increased after 2000, but did not exceed 35% in any year. Conclusion: Monitoring frequencies of ADR-related parameters in children, youth, and young adults treated with SGAs prescribed by a GP were low. Monitoring in primary care should be improved to enable a better evaluation of the benefit-risk balance during antipsychotic drug therapy.

Introduction: After the diagnosis of acute ST elevation myocardial infarction, the preferred reperfusion strategy is primary angioplasty. Even with the success of the procedure, these patients are not exempt from complications during follow-up. Objective: To identify the prognostic factors of major adverse cardiac events in the medium-term follow-up of patients diagnosed with acute myocardial infarction, treated by primary percutaneous coronary intervention. Methods: An analytical, observational, prospective and cohort study was carried out to identify prognostic factors of major adverse cardiovascular events in patients diagnosed with acute ST elevation myocardial infarction, who underwent primary percutaneous coronary intervention. Results: Male sex (72.7 %), arterial hypertension (93.5 %), smoking (55.8 %) and dyslipidemia (46.6 %) were the predominant risk factors. Acute unstable angina (18.1 %), stent thrombosis (10.3 %), and cardiac death (10.3 %) were the most common adverse events during follow-up. Diabetes mellitus (p = 0.04), balloon door time greater than 120 minutes (p = 0.01), creatinine (p = 0.01) and left ventricular dysfunction (p = 0.00) established predictors of major adverse cardiovascular events. Conclusions: Male sex, hypertension, smoking and dyslipidemia were the predominant risk factors. Diabetes mellitus, balloon door time greater than 120 minutes, increased creatinine, and left ventricular dysfunction were the predictors of major adverse cardiovascular events in the follow-up of these patients., Introducción: Tras el diagnóstico del infarto agudo de miocardio con elevación del ST, la estrategia de reperfusión preferida es la angioplastia primaria. Aún con el éxito del proceder, estos pacientes no están exentos de complicaciones durante su seguimiento. Objetivo: Identificar los factores pronósticos de eventos cardíacos adversos mayores en el seguimiento a mediano plazo de pacientes con diagnóstico de infarto agudo de miocardio, tratados mediante el intervencionismo coronario percutáneo primario. Métodos: Se realizó un estudio analítico, observacional, prospectivo y de cohorte para la identificación de factores pronósticos de eventos cardiovasculares adversos mayores en pacientes con diagnóstico de infarto agudo de miocardio con elevación del ST, que fueron llevados a intervencionismo coronario percutáneo primario. Resultados: El sexo masculino (72,7 %), la hipertensión arterial (93,5 %), el tabaquismo (55,8 %) y la dislipidemia (46,6 %) fueron los factores de riesgo que predominaron. La angina inestable aguda (18,1 %), la trombosis del stent (10,3 %) y la muerte cardíaca (10,3 %) fueron los eventos adversos más frecuentes durante el seguimiento. La diabetes mellitus (p = 0,04), el tiempo puerta balón mayor de 120 minutos (p = 0,01), la creatinina (p = 0,01) y la disfunción del ventrículo izquierdo (p = 0,00) constituyeron factores predictores de eventos cardiovasculares adversos mayores. Conclusiones: El sexo masculino, la hipertensión arterial, el hábito de fumar y la dislipidemia constituyeron los factores de riesgo predominantes. La diabetes mellitus, el tiempo puerta balón mayor de 120 minutos, la creatinina aumentada y la disfunción del ventrículo izquierdo constituyeron los factores predictores de eventos cardiovasculares adversos mayores en el seguimiento de estos pacientes.

Producción Científica, The literature suggests that real-world data on the effectiveness and safety of the BNT162b2 vaccine depend on the characteristics of the vaccinated volunteers. The purpose of this study was to evaluate antibody responses and kinetics, established association with sociodemographic and clinical characteristics, and adverse reactions after complete vaccination with the BNT162b2 vaccine. A single-center prospective case series study was conducted with 112 eligible volunteers who were institutionalized elderly and health care workers with had a negative anti-SARS-CoV-2 IgG test prior to receiving the first dose of vaccine. At least one serological antibody test after each dose of vaccine was performed. Volunteers with a positive SARS-CoV-2 PCR test before vaccination were excluded. A chemiluminescent immunoassay anti-S1 antibody assay performed a serological evaluation. Both vaccine doses elicited positive IgG antibodies 3799.0 ± 2503.0 AU/mL and 8212.0 ± 4731.0 AU/mL after 20 days of the first and second doses of BNT162b2, respectively. Comirnaty® vaccine induced an immune response with antibody production against SARS-CoV-2 in 100% of participants, regardless of age (Spearman rho = −0.10, p-value = 0.312), body mass index (Spearman rho = 0.05, p-value = 0.640), blood group first dose (p-value for Kruskal–Wallis test = 0.093) and second dose (p-value for Kruskal–Wallis test = 0. 268), number of drugs (Spearman rho = −0.07, p-value = 0.490), and number of chronic diseases first dose (p-value for Kruskal–Wallis test = 0.632) and second dose (p-value for Kruskal–Wallis test = 0.510). IgG antibodies to SARS-CoV-2 were intensely elevated after the second administration of the BNT162b2 vaccine. The higher the titer of anti-peptide IgG antibodies generated after the first dose of vaccine, the higher the titer generated by the second dose of vaccine (Spearman rho = 0.86, p-value < 0.001) and the total antibody titer (Spearman rho = 0.93, p-value < 0.001). Furthermore, no serio, Universidad de Valladolid, Cátedra de Conocimiento e Innovación “Caja Rural de Soria” - (project SO-2-2020), Junta de Castilla y León y Fondo Europeo de Desarrollo Regional (FEDER) - (projects on SARSCoV- 2 and COVID-19 disease by the FONDO-COVID-19 n 07.04.467804.74011.0))

OBJECTIVE: The aim of the study was to determine the incidence and associated risk factors for falls in older adults in the 12 mos after elective, primary total knee replacement surgery. DESIGN: A prospective observational cohort of older adults undergoing total knee replacement were followed. Baseline measurements included risk factors of history of falls, using a gait aid and number of medications. Falls data were recorded after discharge for 12 mos alongside patient reported outcomes (Oxford Knee Score). Analyses used logistic and negative binomial regression modeling. RESULTS: There were 267 participants (mean age = 70 [6.7] yrs) enrolled. Participants who fell (n = 102 [40.6%]) reported 200 falls in the 12 mos after surgery. The incidence of falls was 2.4 falls per 1000 patient days in the 12 mos after surgery, with the highest incidence (2.6 falls per 1000 patient days) in month 1. Risk factors for falling were a history of falls (adjusted odds ratio = 2.41, 95% confidence interval = 1.35-4.31) and number of central nervous system acting medications taken before surgery (adjusted odds ratio = 1.66, 95% confidence interval = 1.25-2.21). Using a walking aid at baseline was associated with falls after discharge (adjusted incident rate ratio = 2.38, 95% confidence interval = 1.57-3.60). CONCLUSIONS: Older adults experience a high incidence of falls after elective total knee replacement. Further research that investigates falls prevention after total knee replacement is required.

The spectrum of diseases associated with vitamin B12 deficiency is broad, ranging from no symptoms to malabsorption syndrome, spinal cord injury, neurological symptoms accompanied by paresthesia, myelopathy, or neuropathy. There is suggestive evidence that long-term use of proton pump inhibitors (PPIs) can lower serum levels of vitamin B12. Additionally, previous studies have associated vitamin B12 deficiency with high doses consumption of metformin; however, the mechanism in which this occurs is not clear. An additive association between the administration of proton pump inhibitors / Histamine H2 receptor antagonists, and metformin has been described, which suggest that these promote vitamin B12 malabsorption. Both categories of drugs are widely used, in many cases without a prescription, and its use should not be overlooked. When clinically indicated, their use should be monitored in view of the possibility of vitamin B12 malabsorption and its consequences. This article aims to review general aspects of vitamin B12 and delve into the state of the art regarding vitamin B12 deficiency in patients with metformin and / or proton pump inhibitor consumption., El espectro de enfermedades  asociadas con la deficiencia de la vitamina B 12 es amplio y abarca desde la ausencia de síntomas hasta el síndrome de malabsorción, insuficiencia medular, o síntomas neurológicos acompañados de parestesias, mielopatía o neuropatía. Existe evidencia sugestiva que indica que el empleo de inhibidores de bomba de protones (IBP) a largo plazo puede disminuir los niveles séricos de vitamina B12.  Igualmente, estudios previos han asociado el déficit de vitamina B 12 a consumo en dosis altas de metformina, sin embargo, el mecanismo por el cual  se genera la descompensación no está claro. Se ha llegado a describir una asociación aditiva de la administración de inhibidores bomba de protones/ Antagonistas receptor Histamina - 2 y metformina, sugiriendo que promueven la malabsorción de Vitamina B 12. Ambas categorías de medicamentos son ampliamente utilizadas, y en muchos casos sin prescripción médica, y su uso no debería ser pasado por alto. Cuando están clínicamente indicados, su uso debería ser monitorizado debido a la posibilidad de malabsorción de vitamina B 12 y sus consecuencias. Por tanto, en este artículo se revisan  aspectos generales sobre la vitamina B12 y el estado del arte sobre la deficiencia de vitamina B12 en pacientes con consumo  de metformina  o  uso de inhibidor de bomba de protones.

Vaccines are the solution to overcome SARS-CoV-2. This study aimed to determine the post-Sinopharm vaccine safety-profile and immunity through antibody titers. Data were collected using a structured questionnaire from Egyptian participants who received two doses of Sinopharm vaccine. Data were divided into three parts, the first and second parts were to detect participants' post-first and second dose symptoms and practices, and the third for the results of IgG anti spike protein antibodies test and laboratory tests. Pain, redness, swelling at the injection site, headache, fatigue, and lethargy were the most common post-vaccine symptoms for both first and second doses. Most of the participants felt mild or no symptoms after vaccination. The symptoms started mostly during the first day post-vaccination and lasted for no more than two days. Forty-nine percent of the participants resulted in positive antibodies tests on day 18 post-vaccination. The average antibody level for vaccinated participants with past SARS-CoV-2 infection was much higher than that for non-past infected participants. These vaccines' administration methods need to be reevaluated by changing the dose, dose interval, adding a third dose, or mixing it with other vaccines with different techniques to improve their protection rates. Further studies are required to validate this finding.