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Understanding healthcare personnel’s (HCP) contact patterns are important to mitigate healthcare-associated infectious disease transmission. Little is known about how HCP contact patterns change over time or during outbreaks such as the COVID-19 pandemic.
Methods:
This study in a large United States healthcare system examined the social contact patterns of HCP via standardized social contact diaries. HCP were enrolled from October 2020 to June 2022. Participants completed monthly surveys of social contacts during a representative working day. In June 2022, participants completed a 2-day individual-level contact diary. Regression models estimated the association between contact rates and job type. We generated age-stratified contact matrices.
Results:
Three-hundred and sixty HCP enrolled, 157 completed one or more monthly contact diaries and 88 completed the intensive 2-day diary. In the monthly contact diaries, the median daily contacts were 15 (interquartile range (IQR) 8–20), this increased slightly during the study (slope-estimate 0.004, p-value 0.016). For individual-level contact diaries, 88 HCP reported 2,550 contacts over 2 days. HCP were 2.8 times more likely to contact other HCP (n = 1,592 contacts) than patients (n = 570 contacts). Rehabilitation/transport staff, diagnostic imaging technologists, doctors, nurses, mid-level, and laboratory personnel had higher contacts compared with the lowest contact group (Nursing aids). Contact matrices concentrated in working-age populations.
Conclusions:
HCP contacts concentrate in their work environment, primarily with other HCP. Their contacts remained stable over time even during large changes to societal contact patterns during the COVID-19 pandemic. This stability is critical for designing outbreak and pandemic responses.
A family of models for the representation and assessment of individual differences for multivariate data is embodied in a hierarchically organized and sequentially applied procedure called PINDIS. The two principal models used for directly fitting individual configurations to some common or hypothesized space are the dimensional salience and perspective models. By systematically increasing the complexity of transformations one can better determine the validities of the various models and assess the patterns and commonalities of individual differences. PINDIS sheds some new light on the interpretability and general applicability of the dimension weighting approach implemented by the commonly used INDSCAL procedure.
A method for externally constraining certain distances in multidimensional scaling configurations is introduced and illustrated. The approach defines an objective function which is a linear composite of the loss function of the point configuration X relative to the proximity data P and the loss of X relative to a pseudo-data matrix R. The matrix R is set up such that the side constraints to be imposed on X’s distances are expressed by the relations among R’s numerical elements. One then uses a double-phase procedure with relative penalties on the loss components to generate a constrained solution X. Various possibilities for constructing actual MDS algorithms are conceivable: the major classes are defined by the specification of metric or nonmetric loss for data and/or constraints, and by the various possibilities for partitioning the matrices P and R. Further generalizations are introduced by substituting R by a set of R matrices, Ri, i = 1, …r, which opens the way for formulating overlapping constraints as, e.g., in patterns that are both row- and column-conditional at the same time.
CHD predisposes children to neurodevelopmental delays. Frequent, prolonged hospitalisations during infancy prevent children with heart disease from participating in recommended language and cognitive development programmes, such as outpatient early childhood literacy programmes, and contribute to caregiver stress, a risk factor for adverse developmental outcomes. This study aims to describe the implementation of a single-centre inpatient early childhood literacy programme for hospitalised infants with heart disease and assess its impact on reading practices and patient–family hospital experience.
Methods:
Admitted infants ≤1 year old receive books, a calendar to track reading frequency, and reading guidance at regular intervals. Voluntary feedback is solicited from caregivers using an anonymous, QR-code survey on books. A prospective survey also assessed programme impact on hospital experience.
Results:
From February 2021 to November 2023, the Books@Heart programme provided 1,293 books to families of 840 infants, of whom 110 voluntarily submitted feedback. Caregivers reported a significant improvement in access to books (p < 0.001) and increased reading frequency after learning about Books@Heart (p = 0.003), with the proportion reading to their child daily increasing from 27% to 62%. Among 40 prospective survey responses, caregivers reported feeling a sense of personal fulfillment (60%), self-confidence (30%), connection (98%), and personal well-being (40%) while reading to their child.
Conclusion:
An inpatient early childhood literacy programme is a well-received intervention for infants with heart disease that promotes development, improves book access, increases reading exposure, and engages families. Further studies are needed to assess its impact on sustained reading practices and neurodevelopmental outcomes.
Around the world, people living in objectively difficult circumstances who experience symptoms of generalized anxiety disorder (GAD) do not qualify for a diagnosis because their worry is not ‘excessive’ relative to the context. We carried out the first large-scale, cross-national study to explore the implications of removing this excessiveness requirement.
Methods
Data come from the World Health Organization World Mental Health Survey Initiative. A total of 133 614 adults from 12 surveys in Low- or Middle-Income Countries (LMICs) and 16 surveys in High-Income Countries (HICs) were assessed with the Composite International Diagnostic Interview. Non-excessive worriers meeting all other DSM-5 criteria for GAD were compared to respondents meeting all criteria for GAD, and to respondents without GAD, on clinically-relevant correlates.
Results
Removing the excessiveness requirement increases the global lifetime prevalence of GAD from 2.6% to 4.0%, with larger increases in LMICs than HICs. Non-excessive and excessive GAD cases worry about many of the same things, although non-excessive cases worry more about health/welfare of loved ones, and less about personal or non-specific concerns, than excessive cases. Non-excessive cases closely resemble excessive cases in socio-demographic characteristics, family history of GAD, and risk of temporally secondary comorbidity and suicidality. Although non-excessive cases are less severe on average, they report impairment comparable to excessive cases and often seek treatment for GAD symptoms.
Conclusions
Individuals with non-excessive worry who meet all other DSM-5 criteria for GAD are clinically significant cases. Eliminating the excessiveness requirement would lead to a more defensible GAD diagnosis.
Maternal vitamin-D and omega-3 fatty acid (DHA) deficiencies during pregnancy have previously been associated with offspring neurodevelopmental traits. However, observational study designs cannot distinguish causal effects from confounding.
Methods
First, we conducted Mendelian randomisation (MR) using genetic instruments for vitamin-D and DHA identified in independent genome-wide association studies (GWAS). Outcomes were (1) GWAS for traits related to autism and ADHD, generated in the Norwegian mother, father, and child cohort study (MoBa) from 3 to 8 years, (2) autism and ADHD diagnoses. Second, we used mother–father–child trio-MR in MoBa (1) to test causal effects through maternal nutrient levels, (2) to test effects of child nutrient levels, and (3) as a paternal negative control.
Results
Associations between higher maternal vitamin-D levels on lower ADHD related traits at age 5 did not remain after controlling for familial genetic predisposition using trio-MR. Furthermore, we did not find evidence for causal maternal effects of vitamin-D/DHA levels on other offspring traits or diagnoses. In the reverse direction, there was evidence for a causal effect of autism genetic predisposition on lower vitamin-D levels and of ADHD genetic predisposition on lower DHA levels.
Conclusions
Triangulating across study designs, we did not find evidence for maternal effects. We add to a growing body of evidence that suggests that previous observational associations are likely biased by genetic confounding. Consequently, maternal supplementation is unlikely to influence these offspring neurodevelopmental traits. Notably, genetic predisposition to ADHD and autism was associated with lower DHA and vitamin-D levels respectively, suggesting previous associations might have been due to reverse causation.
Despite technological and medical advances, amputations continue to increase. Amputees face significant challenges when acquiring and using prosthetic devices, challenges which are made worse as their emotional needs, aspirations, mobility, prosthesis requirements and problems change over time. These challenges require custom solutions for each individual amputee, a fact that current amputee centered prosthesis services tend to ignore. The work reported in this paper contributes an AI based Prosthesis Development Service Framework to cater for the current and evolving needs of amputees.
Aripiprazole is a third generation atypical antipsychotic and a dopamine serotonin system stabilizer, effective against positive and negative symptoms of schizophrenia. Within the group of atypical antipsychotics, aripiprazole shows a relatively benign safety profile (e.g. lower metabolic impact, mild effect on cardiovascular parameters), although the reported rate of extrapyramidal side effects is measurable.
Oculogyric crisis (OGC) is a rare movement disorder characterized by a prolongued involuntary upward deviation of the eyes, lasting minutes to hours. In most cases, OCG is a drug-induced adverse event with acute or tardive onset often attributable to a functional impairment of dopaminergic neurotransmission.
Objectives
OGC is seldom reported in children and young adults during treatment with aripiprazole, althouh it is commonly used in youths.
Methods
We report a case of an aripiprazole-induced oculogyric crisis in a 19 year old girl who diagnosed with schizophrenia (paranoid).
Results
There was a complete remission of the OGC’s following aripiprazole dose reduction, suggesting the clinical manifestation was a dose-dependent phenomenon.
Conclusions
The present report should raise awarness among clinicians for this relevant possible adverse event, that can happen also with the use of aripiprazol, not only with typical or more antidopaminergic antipsychotics. Future research in the field should emphasize neurobiological dysfunctions as the basis of EPS/OGC in patients.
Priapism is a painful and prolonged penile erection in the absence of sexual stimulation. It is a urology emergency that, if not treated, may cause erectile dysfunction. Pharmacologically induced priapism is the most common form of priapism and almost half of all cases are caused by antipsychotic (AP) drugs. Considering priapism is a rare but important side effect, it is of major importance that psychiatrists be aware of it. Thus, we herein report the case of a 46-year-old man that developed priapism upon receiving intramuscular APs in a psychiatric emergency setting.
Objectives
To alert for the importance of priapism as a potential side effect of AP drugs and to understand the physiological mechanisms involved in antipsychotic-induced priapism.
Methods
A non-systematic review of the literature was carried out on PubMed. We looked for reviews and case reports published in the last 10 years containing the terms “priapism”, “antipsychotics” and “psychopharmacology priapism”. We also present a clinical case of antipsychotics-induced priapism.
Results
We report the case of a 46-year-old man that was brought to the Psychiatric ER by police authorities due to disruptive and aggressive behaviour, a sense of increased energy and power and delusional speech of grandiose and persecutory content. No clinical records of psychosis or bipolar disorder were known, and the patient had never been medicated with AP drugs. The patient was involuntarily admitted to the psychiatric inward for treatment. Due to the aggravation of his aggressive behaviour, with potential danger for himself, other patients and the nursing staff, he was medicated with 5 mg of haloperidol and 25 mg of chlorpromazine. About an hour later the patient developed a painful erection that lasted at least for 4 hours. He was promptly sent to the Urology ER where an intracavernosal aspiration followed by injection of phenylephrine was needed to reverse priapism. APs are the most common cause of drug-induced priapism. Even though typical APs were pointed as more prone to cause this side effect, it is now known that atypical APs, including third-generation ones such as aripiprazole, may also cause priapism. It is thought that the α1- adrenergic antagonist action of most APs inhibits the contraction of smooth muscle in the corpus cavernosum of the penis, impeding venous outflow and thus causing ischemic priapism. To reduce the risk, the dosage of the AP may be reduced or changed to an AP with lower affinity for α1- adrenergic receptors.
Conclusions
Priapism is a rare but important side effect of APs. Being aware of it and of its physiological mechanism is of major importance when treating patients with APs.
Kratom (Mitragyna speciosa) is a psychoactive substance native to Thailand and Southeast Asia with stimulant-like effects at lower doses and opioid-like effects at higher doses. Kratom’s chemical composition, specifically mitragynine and 7-hydroxymitragynine, has partial agonist mu-opioid effect and antagonist effects at the kappa- and delta-opioid receptors. It is primarily sought out for stimulant and opioid-like properties and may be used either for its perceived therapeutic effects or as a recreational drug. It is used mainly for symptoms of pain, anxiety, depression, and opioid withdrawal. Regular use of kratom, especially at higher doses, is associated with dependence, tolerance, and withdrawal. Due to its addictive potential, accessibility, and legal status, there have been increasing cases of kratom use disorder. Concerns regarding its potential for abuse and severe adverse effects are rising. The perception that kratom is a milder and less dangerous opioid-like psychoactive substance is supported by the uptake of kratom use as an opiate substitute and is consistent with data on the unimpaired social functioning of regular kratom users.
Objectives
To alert for the importance of kratom consumption as a potential gateway to an opioid use disorder.
Methods
A non-systematic review of the literature was carried out on PubMed. We looked for reviews and case reports published in the last 10 years containing the terms “kratom”, “Mitragyna speciosa”, “drug abuse”, “drug addiction”, and “mitragynine”. We also present a clinical case of opioid use disorder.
Results
We report the case of a 38-year-old man that was observed as an outpatient with opioid abuse disorder treated with buprenorphine. He began consuming Kratom about 20 years ago. He learned about Kratom herbal preparations from the plant Mitragyna speciosa from internet forums and started to consume oral preparations. Noticing the low side-effects profile, he started to consume Kratom on a daily basis. The main effect of Kratom was to calm down hyperarousal, stop rumination, reduce anxiety, and enhance sociability. The patient did not report major side effects from the consumption but over time tolerance was reached. Knowing that this substance has opioid effects, the patient started to consume opioids like oxycodone in order to obtain Kraton-like effects. Kraton’s use was thus quickly replaced by oxycodone consumption and dependence.
Conclusions
The increasing popularity of kratom has been accompanied by dependence, adverse effects, and withdrawal symptoms following abstinence. Although it could be used for opioid withdrawal, Kraton consumption could be a gateway to opioid consumption and ultimately culminate in dependence.
Presenteeism is increasingly being seen as a threat to employee efficiency. Nursing professionals are exposed to occupational hazards that may compromise physical and mental health, interfere with the quality of life of the worker and the quality of care provided to the patient and cause illness and generate costs for the institutions.
Objectives
This study aimed to evaluate which are the personal (age, sex, educational qualifications), professional (organization, seniority in the organization, seniority in function, employment relationship, work regime and professional category) and health variables, that best relate to sickness presenteeism.
Methods
A quantitative cross-sectional study was conducted. The sample is probabilistic and the universe of this study included all nurses who work in Portuguese health institutions (whether they are of a public, private or public-private nature). Inclusion criteria were nurses with clinical activity and/or management in institutions in the aforementioned modalities, and nurses in teaching activity in higher education institutions were excluded from this study, on an exclusive basis. The final sample was composed of 424 nurses.
Results
Most of the nurses who answered the e-survey are female (86.8%), aged 40 years or over (59.9%), who live in the northern region of the country (31.4%), who work in public organizations (85.5%), in differentiated health care units (52.6%) and with an employment contract in public functions (63.7%). More than half (53.3%) of participants are specialist nurses and 72.4% of respondents did not have a previous disease condition. The variables that best correlated with presentism were the female gender, the organization where you work (public), and the presence of a previous disease condition.
Conclusions
The results presented may constitute a challenge for change for policymakers, managers and health professionals, in the sense of addressing presenteeism with the creation of occupational health programs directed to the needs of nurses. Other measures include flexible working hours, work policies that promote staff retention, and a strong commitment to the training and qualification of nurses capable of ensuring better performance and involvement in the organizational culture.
Amputees face a number of challenges when acquiring and using a prosthesis, with major issues being the cost of the device, the time it takes for their custom prosthesis to be developed and delivered, as well as the challenges they face to get it regularly serviced and maintained. The other stakeholders involved, including the prosthetists and standard systems manufacturers, have a difficulty to collectively handle so many issues that occur to the different amputees. To address these challenges, our research reported in this paper contributes an approach to how these can be handled, through a Prescriptive approach entitled Adaptive Prosthetic Life-Cycle Service System (adProLiSS) Framework. Unlike other product service systems, adProLiSS is designed to explicitly involve and serve the amputee and their evolving needs during different phases throughout the amputee's life. This impacts how a prosthetic device needs to be designed to ensure a smoother interaction between the amputee and the device. The adProLiSS preliminary evaluation shows an improvement by which amputees can be efficiently provided with a prosthesis that evolves with their changing needs and aspirations, this fostering a longer term 'patient-centred care' service.
Mutism is the inability or unwillingness to speak, resulting in an absence or marked paucity of verbal output. Mutism is a common manifestation of psychiatric, neurological, and drug-related illnesses. Psychiatric disorders associated with mutism include schizophrenia, affective disorders, conversion reactions, dissociative states, and dementias. Neurological disorders causing mutism affect the basal ganglia, frontal lobes, or the limbic system.
Objectives
Outline the importance of setting a differential diagnosis of mutism in the Emergency Room.
Methods
Review of scientific literature based on a relevant clinical case.
Results
Male, 58 years old. He has lived in a residence for 3 months due to voluntary refusal to ingest. Diagnosed with paranoid personality disorder. He is refered to the Emergency Service due to sudden mutism. During this day, he has been stable and suitable with a good functionality. For 3 hours he is mutist, oppositional attitude and stiff limbs, refusing to obey simple orders. Hyperalert and hyperproxia. Not staring. After ruling out organic pathology: normal blood tests, negative urine toxins and cranial CT without alterations, he was admitted to Psychiatry for observation and, finally, he was diagnosed with Psychotic Disorder NOS.
Conclusions
Mutism most often occurs in association with other disturbances in behavior, thought processes, affect, or level of consciousness. The most common disorder of behavior occurring with mutism is catatonia. The differential diagnosis of mutism is complex. In some cases the diagnosis will be clarified only by careful observation and after a neurological evaluation. Published studies show neurological disorders presenting with mutism can be misdiagnosed as psychiatric.
There is a high comorbidity between psychiatric disorders and juvenile myoclonic epilepsy (JME), observed in up to 58% of these patients; specifically, mood disorders, anxiety and personality disorders (PD). In some patients with PD there are nonspecific alterations in the EEG, which nevertheless sometimes involve pathology. The presence of personality disorders along with JME has been repeatedly described. Previous studies have emphasized the difficulties in treating patients with JME, which have been attributed to some specific psychiatric, psychological and psychosocial characteristics.
Objectives
Describing distinctive personality traits in JME
Methods
Review of scientific literature based on a relevant clinical case.
Results
19-year-old woman, single. Psychiatric history since she was 12 due to anxiety-depressive symptoms, after being diagnosed with JME. 4 admissions in Psychiatry, with a variety of diagnoses: eating disorder, attention deficit hyperactivity disorder and borderline personality disorder. The evolution of both disorders has been parallel, presenting epileptic seizures due to irregular therapeutic adherence together with pseudo-seizures, which made difficult their differential diagnosis. In addition, he has had frequent visits to the emergency room for suicide attempts and impulsive behaviors.
Conclusions
In 1957, for the first time, distinctive personality traits were described in patients with JME: lack of control and perseverance, emotional instability, variable self-concept and reactive mood, which have been confirmed in subsequent studies. It is believed as epilepsy progresses, patients tend to develop symptoms of depression, anxiety, social problems, and attention deficit. Therefore, these patients have difficulty in following medical recommendations, especially precautions regarding precipitating factors for seizures.
The Covid-19 pandemic brought enormous challenges for health professionals. As in past epidemics, the uncertainty, danger and fear of contamination and an excessive load of work under dramatic conditions may contribute to aggravate the mental health of health professionals.
Objectives
Explore how the Covid-19 crisis impacted the mental health of healthcare workers and how their mental status relates with perspectives on the recent past and near future.
Methods
A longitudinal study will be applied in two phases, Q1 and Q2, one year apart, to evaluate depression, anxiety and post-traumatic stress among health professionals from a healthcare center in Portugal. Phase Q1 is concluded and comprised the Depression, Anxiety and Stress Scale (DASS-21), the Impact of Event Scale – Revised (IES-R) and a questionnaire about the past and the future.
Results
The IES-R scale revealed that nurses are at a higher risk of developing post-traumatic stress disorder (PTSD) than other professionals. The levels of depression and anxiety in the DASS-21 show no significant differences. Interestingly, professionals who worked almost exclusively at inpatient wards show higher levels of depression, anxiety and stress than those who worked at several hospital units (emergency, inpatient and outpatient units). A positive correlation was found between depression and anxiety and negative perspectives about the past and the future.
Conclusions
Covid-19 posed a terrible challenge for health professionals. Its impact on the mental health of healthcare workers may be significant even after the pandemic is under control.
According to recent reports Covid-19 patients may exhibit psychiatric co-morbidities that cause dysfunction, loss of autonomy and emotional suffering even after the physical illness is treated. Considering the high impact Covid-19 may have on mental health, we have created a psychiatric consultation dedicated to the study, observation and support of patients that developed mental illness after being hospitalized due to Covid-19.
Objectives
We aim at 1) describe the profile of patients that developed psychiatric comorbidities following a hospitalization due to Covid-19 and 2) recognize and treat early psychiatric symptoms in Covid-19 patients.
Methods
Based on what was described in other epidemic crisis, we established a semi-structured interview to evaluate several dimensions of the patients’ life that may have been affected by Covid-19 and that may impact on mental health. The interview included the Depression, Anxiety and Stress Scale (DASS-21), the Impact of Event Scale – Revised (IES-R) and the Insomnia Severity Index (ISI). Each patient was observed multiple times over several months. Our evaluation was done in parallel with consultations in Internal Medicine.
Results
Most patients complained of symptoms directly related with the infection of SARS-CoV-2, namely fatigue, short breath and reduced tolerance to efforts. Importantly, many patients also reported de novo or aggravation of anxiety, stress, depression, sleep disturbances and grief often associated with feelings of existential emptiness and lack of purpose.
Conclusions
Hospitalization due to Covid-19 has a high impact on mental health, raising important questions on purpose and emptiness. An early psychiatric intervention is highly recommended.
Amputees face challenges with prosthesis such as cost, long delivery periods, as well as social discomfort. Simultaneously, the prosthetists and manufacturers have a difficulty to handle such diverse issues. We thus contribute a Prosthetic Life-Cycle Service System (ProLiSS) Framework, prescribed to involve amputees in different life phases. From an evaluation of ProLiSS, we conclude that it influences how prosthetics need to be designed and that it is beneficial to perform further research to provide manufacturers with a systematic, amputee-centered development and servicing framework.
The coronavirus disease 2019 (COVID-19) pandemic has caused a global health crisis and may have affected healthcare-associated infection (HAI) prevention strategies. We evaluated the impact of the COVID-19 pandemic on HAI incidence in Brazilian intensive care units (ICUs).
Methods:
In this ecological study, we compared adult patients admitted to the ICU from April through June 2020 (pandemic period) with the same period in 2019 (prepandemic period) in 21 Brazilian hospitals. We used the Wilcoxon signed rank-sum test in a pairwise analysis to compare the following differences between the pandemic and the prepandemic periods: microbiologically confirmed central-line–associated bloodstream infection (CLABSI) and ventilator-associated pneumonia (VAP) incidence density (cases per 1,000 central line and ventilator days, respectively), the proportion of organisms that caused HAI, and antibiotic consumption (DDD).
Results:
We detected a significant increase in median CLABSI incidence during the pandemic: 1.60 (IQR, 0.44–4.20) vs 2.81 (IQR, 1.35–6.89) (P = .002). We did not detect a significant difference in VAP incidence between the 2 periods. In addition, we detected a significant increase in the proportion of CLABSI caused by Enterococcus faecalis and Candida spp during the pandemic, although only the latter retained statistical significance after correction for multiple comparisons. We did not detect a significant change in ceftriaxone, piperacillin–tazobactam, meropenem, or vancomycin consumption between the studied periods.
Conclusions:
There was an increase in CLABSI incidence in Brazilian ICUs during the first months of COVID-19 pandemic. Additionally, we detected an increase in the proportion of CLABSI caused by E. faecalis and Candida spp during this period. CLABSI prevention strategies must be reinforced in ICUs during the COVID-19 pandemic.
This work aimed to investigate the effects of early progeny exposure to methylglyoxal (MG), programming for metabolic dysfunction and diabetes-like complications later in life. At delivery (PN1), the animals were separated into two groups: control group (CO), treated with saline, and MG group, treated with MG (20 mg/kg of BW; i.p.) during the first 2 weeks of the lactation period. In vivo experiments and tissue collection were done at PN90. Early MG exposure decreased body weight, adipose tissue, liver and kidney weight at adulthood. On the other hand, MG group showed increased relative food intake, blood fructosamine, blood insulin and HOMA-IR, which is correlated with insulin resistance. Besides, MG-treated animals presented dyslipidaemia, increased oxidative stress and inflammation. Likewise, MG group showed steatosis and perivascular fibrosis in the liver, pancreatic islet hypertrophy, increased glomerular area and pericapsular fibrosis, but reduced capsular space. This study shows that early postnatal exposure to MG induces oxidative stress, inflammation and fibrosis markers in pancreas, liver and kidney, which are related to metabolic dysfunction features. Thus, nutritional disruptors during lactation period may be an important risk factor for metabolic alterations at adulthood.
Background: Phase 3 COMET trial (NCT02782741) compares avalglucosidase alfa (n=51) with alglucosidase alfa (n=49) in treatment-naïve LOPD. Methods: Primary objective: determine avalglucosidase alfa effect on respiratory muscle function. Secondary/other objectives include: avalglucosidase alfa effect on functional endurance, inspiratory/expiratory muscle strength, lower/upper extremity muscle strength, motor function, health-related quality of life, safety. Results: At Week 49, change (LSmean±SE) from baseline in upright forced vital capacity %predicted was greater with avalglucosidase alfa (2.89%±0.88%) versus alglucosidase alfa (0.46%±0.93%)(absolute difference+2.43%). The primary objective, achieving statistical non-inferiority (p=0.0074), was met. Superiority testing was borderline significant (p=0.0626). Week 49 change from baseline in 6-minute walk test was 30.01-meters greater for avalglucosidase alfa (32.21±9.93m) versus alglucosidase alfa (2.19±10.40m). Positive results for avalglucosidase alfa were seen for all secondary/other efficacy endpoints. Treatment-emergent adverse events (AEs) occurred in 86.3% of avalglucosidase alfa-treated and 91.8% of alglucosidase alfa-treated participants. Five participants withdrew, 4 for AEs, all on alglucosidase alfa. Serious AEs occurred in 8 avalglucosidase alfa-treated and 12 alglucosidase alfa-treated participants. IgG antidrug antibody responses were similar in both. High titers and neutralizing antibodies were more common for alglucosidase alfa. Conclusions: Results demonstrate improvements in clinically meaningful outcome measures and a more favorable safety profile with avalglucosidase alfa versus alglucosidase alfa. Funding: Sanofi Genzyme