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1.
J Infect Dis ; 2024 Sep 09.
Artículo en Inglés | MEDLINE | ID: mdl-39248523

RESUMEN

Evaluating the adaptive immune responses to natural infection with Crimean-Congo hemorrhagic fever (CCHF) virus (CCHFV) in human survivors is critical to the development of medical countermeasures. However, the correlates of protection are unknown. As the most prevalent tick-borne human hemorrhagic fever virus with case fatality rates of 5%-30% and worldwide distribution, there is an urgent need to fill these knowledge gaps. Here, we describe adaptive immune responses in a cohort of Ugandan CCHF survivors via serial sampling over 6 years. We demonstrate persistent antibodies after infection and cross-neutralization against various clades of authentic CCHFV, as well as potent effector function. Moreover, we show for the first time persistent, polyfunctional antigen-specific memory T-cell responses to multiple CCHFV proteins up to 9 years after infection. Together, this data provides immunological benchmarks for evaluating CCHFV medical countermeasures and information that can be leveraged toward vaccine immunogen design and viral target identification for monoclonal antibody therapies.

2.
Prog Rehabil Med ; 9: 20240029, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39280961

RESUMEN

Objectives: There is a lack of evidence regarding the association between whole-body exercise and independence in urination and defecation. This study aimed to evaluate the effect of chair-stand exercise on improving urination and defecation independence in post-stroke patients with sarcopenia. Methods: A retrospective study was conducted on stroke patients admitted to a community rehabilitation hospital between 2015 and 2021. Patients diagnosed with sarcopenia who required assistance with bladder and bowel management were included. The primary outcomes were the Functional Independence Measure (FIM) scores for urination (FIM-Bladder) and defecation (FIM-Bowel) at discharge. Multiple regression analysis was used to examine the association between chair-stand exercise and the outcomes, adjusting for potential confounders. Results: Of 586 patients, 187 patients (mean age 79.3 years, 44.9% male) were included in the urination analysis, and 180 patients (mean age 79.3 years, 44.4% male) were included in the defecation analysis. Multiple regression analysis showed that the number of chair-stand exercises was independently positively associated with FIM-Bladder at discharge (ß=0.147, P=0.038) and FIM-Bladder gain (ß=0.168, P=0.038). Similarly, the number of chair-stand exercises was independently positively associated with FIM-Bowel at discharge (ß=0.149, P=0.049) and FIM-Bowel gain (ß=0.166, P=0.049). Conclusions: Chair-stand exercise was positively associated with improved urination and defecation independence in post-stroke patients with sarcopenia. Incorporating whole-body exercises, such as chair-stand exercise, in addition to conventional rehabilitation programs may help improve voiding independence, reduce incontinence, and enhance quality of life in these patients.

3.
Artículo en Inglés | MEDLINE | ID: mdl-39117845

RESUMEN

Donor-recipient proximity emerged as an important factor influencing the efficacy of COVID-19 convalescent plasma (CCP) treatment during the early stages of the COVID-19 pandemic. This relationship was uncovered while analyzing data collected in the collaborative Expanded Access Program (EAP) for CCP at Mayo Clinic, a project aimed to establish protocols for CCP use amid the uncertainty of the novel disease. Analysis of data from nearly 28,000 patients revealed a significant reduction in risk of 30-day mortality for those receiving near-sourced plasma when compared to those receiving distantly sourced plasma [pooled relative risk, 0.73 (95% CI 0.67-0.80)], prompting adjustments in treatment protocols at selected institutions, and highlighting the importance of proximity in optimizing CCP outcomes. Despite its significance, subsequent studies of CCP effectiveness in COVID-19 have often overlooked donor-recipient proximity. Our findings emphasize the importance of donor-recipient proximity in CCP treatment in the current pandemic, and we discuss potential methods for improving CCP efficacy in future pandemics. Our recommendations include prioritizing virus genotyping for vulnerable patients, establishing a robust testing infrastructure, and collecting additional donor data to enhance plasma selection. This chapter underscores the importance of comprehensive data collection and sharing to navigate the evolving landscape of newly emerging infectious diseases.

4.
Artículo en Inglés | MEDLINE | ID: mdl-39117847

RESUMEN

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) swept across the world in the waning months of 2019 and emerged as the cause of the coronavirus disease 19 (COVID-19) pandemic in early 2020. The use of convalescent plasma (CP) for prior respiratory pandemics provided a strong biological rationale for the rapid deployment of COVID-19 convalescent plasma (CCP) in early 2020 when no validated treatments or prior immunity existed. CCP is an antiviral agent, with its activity against SARS-CoV-2 stemming from specific antibodies elicited by the virus. Early efforts to investigate the efficacy of CCP in randomized clinical trials (RCTs) that targeted hospitalized patients with COVID-19 did not demonstrate the overall efficacy of CCP despite signals of benefit in certain subgroups, such as those treated earlier in disease. In contrast, studies adhering to the principles of antibody therapy in their study design, choice of patient population, and product qualification, i.e., those that administered high levels of specific antibody during the viral phase of disease in immunocompromised or very early in immunocompetent individuals, demonstrated benefits. In this chapter, we leverage the knowledge gained from clinical studies of CCP for COVID-19 to propose a framework for future studies of CP for a new infectious disease. This framework includes obtaining high-quality CP and designing clinical studies that adhere to the principles of antibody therapy to generate a robust evidence base for using CP.

5.
Artículo en Inglés | MEDLINE | ID: mdl-39117848

RESUMEN

COVID-19 convalescent plasma (CCP) is an important therapeutic option for immunocompromised patients with COVID-19. Such patients are at increased risk for serious complications of infection and may also develop a unique syndrome of persistent infection. This article reviews the rationale for CCP utilization in immunocompromised patients and the evidence for its value in immunosuppressed patients with both acute and persistent COVID-19. Both historical precedence and understanding of the mechanisms of action of antibody treatment support this use, as do several lines of evidence derived from case series, comparative studies, randomized trials, and systematic reviews of the literature. A summary of recommendations from multiple practice guidelines is also provided.

6.
Artículo en Inglés | MEDLINE | ID: mdl-39126485

RESUMEN

Convalescent plasma has increasingly been used to treat various viral infections and confer post-exposure prophylactic protection during the last decade and has demonstrated favorable clinical outcomes in patients infected with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) during the recent COVID-19 pandemic. The pandemic has highlighted the need for cost-effective, accessible, and easy-to-use alternatives to conventional blood plasmapheresis techniques, allowing hospitals to become more self-sufficient in harvesting and transfusing donor plasma into recipients in a single setting. To this end, the use of a membrane-based bedside plasmapheresis device (HemoClear) was evaluated in an open-label, non-randomized prospective trial in Suriname in 2021, demonstrating its practicality and efficacy in a low-to middle-income country. This paper will review the use of this method and its potential to expedite the process of obtaining convalescent plasma, especially during pandemics and in resource-constrained settings.

7.
Front Pharmacol ; 15: 1421516, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39148549

RESUMEN

Objective: This study investigates the association between convalescent plasma therapy and the negative conversion rate in patients with persistent COVID-19 test positivity. Method: A retrospective analysis was conducted on patients with severe or mild to moderate COVID-19 whose viral nucleic acid tests remained positive for over 30 days. Patients were categorized into two groups: those who administered convalescent plasma therapy and those who were not. Data collected included information on therapy strategies used (convalescent plasma, corticosteroids, interferons, etc.), patients' demographic characteristics, comorbidities, therapeutic medications, and nucleic acid testing results. Patients in the convalescent plasma therapy group were matched 1:2 ratio with those in the non-convalescent plasma therapy group. Cumulative negative conversion rates on the fifth, tenth, and fifteenth days post-therapy initiation were analyzed as dependent variables. Independent variables included therapy strategies, demographic characteristics, comorbidities, and therapeutic medication usage. Univariate analysis was conducted, and factors with a p-value (P) less than 0.2 were included in a paired Cox proportional hazards model. Results: There was no statistically significant difference in the cumulative negative conversion rate between the convalescent plasma therapy group and the non-convalescent plasma therapy group on the fifth, tenth, and fifteenth days. Specifically, on day the fifth, the negative conversion rate was 41.46% in the convalescent plasma therapy group compared to 34.15% in the non-convalescent plasma therapy group (HR: 1.72, 95% CI: 0.82-3.61, P = 0.15). On the tenth day, it was 63.41% in the convalescent plasma therapy group and 63.41% in the non-convalescent plasma therapy group (HR: 1.25, 95% CI: 0.69∼2.26, P = 0.46). On the fifteenth day, the negative conversion rate was 85.37% in the convalescent plasma therapy group and 75.61% in the non-convalescent plasma therapy group (HR: 1.19, 95% CI: 0.71-1.97, P = 0.51). Conclusion: Our finding does not support the hypothesis that convalescent plasma therapy could accelerate the time to negative conversion in patients who consistently test positive for COVID-19.

8.
Nutrients ; 16(15)2024 Aug 02.
Artículo en Inglés | MEDLINE | ID: mdl-39125410

RESUMEN

We investigated the relationship between three nutritional indicators, the Mini Nutritional Assessment-Short Form (MNA-SF), Geriatric Nutritional Risk Index (GNRI), and Controlling Nutrition Status (CONUT), and physical activity at discharge in patients admitted to convalescent rehabilitation wards. The study included 1601 patients (77 ± 12 years, male 46.2%) discharged from convalescent rehabilitation wards between April 2018 and September 2023. MNA-SF, GNRI, and CONUT scores were obtained on admission. Patients were divided into two groups according to their level of Functional Independence Measure (FIM) walk score at discharge. The walking group (n = 1181, FIM walk score ≥ 5, 76 ± 13 years, male 47.2%) was significantly younger than the wheelchair group (n = 420, 79 ± 12 years, FIM walk score < 5, male 43.8%) and had significantly higher MNA-SF (6.5 ± 2.5 vs. 4.7 ± 2.4) and GNRI (93.1 ± 12.4 vs. 86.7 ± 10.9) scores and significantly lower CONUT (3.1 ± 2.3 vs. 3.9 ± 2.3) scores than the wheelchair group (all p < 0.01). Multivariate logistic regression analysis showed that age, handgrip strength, Functional Oral Intake Scale, and MNA-SF score were independently associated with walking ability at discharge (all p < 0.01). In addition, MNA-SF scores were independently associated with Rehabilitation Effectiveness. These results suggest that nutritional status, particularly MNA-SF scores on admission, is associated with improvement of physical activity at discharge.


Asunto(s)
Ejercicio Físico , Evaluación Geriátrica , Evaluación Nutricional , Estado Nutricional , Humanos , Masculino , Anciano , Femenino , Ejercicio Físico/fisiología , Anciano de 80 o más Años , Evaluación Geriátrica/métodos , Alta del Paciente , Centros de Rehabilitación , Caminata/fisiología , Persona de Mediana Edad
9.
Artículo en Inglés | MEDLINE | ID: mdl-39207508

RESUMEN

The use of the serum or plasma of patients or animals who have recovered from an infectious disease, or had been immunized with a relevant antigen, to treat or prevent the same infection in others began in the late 1880s when French and German scientists uncovered, one step at a time, several of the elements of the immune system's response to infection. A key finding was that the damage caused by some bacteria depends upon their secreted toxins which can be neutralized by biologic agents. Antitoxins to diphtheria and tetanus began to be manufactured in large animals in France, Germany, and the US in the 1890s and were soon being used worldwide. The impact of diphtheria antitoxin on childhood mortality was profound. Shortly after the development of antitoxins, convalescent serum began to be used for its anti-bactericidal properties thus addressing serious infections caused by non-toxin-producing organisms. The effectiveness of antitoxins and antisera was demonstrated by examining mortality rates in hospitals before and after the introduction of antitoxins, by comparisons of treated and untreated patients, by comparing early and late treatment and dosage, by examining vital data mortality trends, and by several randomized and alternate assignment trials. Antitoxins continue to have a role in the rare cases of diphtheria and other conditions largely eradicated by immunization, but serum therapy nearly disappeared from the medical armamentarium with the development of antibiotics in the 1940s. Inasmuch as new human pathogens are now emerging with unprecedented regularity as seen in the recent COVID-19 pandemic, and because specific therapies are unlikely to be available for them, plasma-based antibody therapies are likely to again carve out a niche in infectious disease control.

10.
Artículo en Inglés | MEDLINE | ID: mdl-39192049

RESUMEN

During the global health emergency caused by the coronavirus disease 2019 (COVID-19), evidence relating to the efficacy of convalescent plasma therapy-evidence critically needed for both public policy and clinical practice-came from multiple levels of the epistemic hierarchy. The challenges of conducting clinical research during a pandemic, combined with the biological complexities of convalescent plasma treatment, required the use of observational data to fully assess the impact of convalescent plasma therapy on COVID symptomatology, hospitalization rates, and mortality rates. Observational studies showing the mortality benefits of convalescent plasma emerged early during the COVID-19 pandemic from multiple continents and were substantiated by real-time pragmatic meta-analyses. Although many randomized clinical trials (RCTs) were initiated at the onset of the pandemic and were designed to provide high-quality evidence, the relative inflexibility in the design of clinical trials meant that findings generally lagged behind other forms of emerging information and ultimately provided inconsistent results on the efficacy of COVID-19 convalescent plasma. In the pandemic framework, it is necessary to emphasize more flexible analytic strategies in clinical trials, including secondary, subgroup, and exploratory analyses. We conclude that in totality, observational studies and clinical trials taken together provide strong evidence of a mortality benefit conferred by COVID-19 convalescent plasma, while acknowledging that some randomized clinical trials examined suboptimal uses of convalescent plasma.

11.
Clin Nutr ESPEN ; 63: 837-844, 2024 Aug 22.
Artículo en Inglés | MEDLINE | ID: mdl-39181533

RESUMEN

BACKGROUND AND AIMS: The triad approach combining rehabilitation, nutrition support, and oral management has garnered increasing interest for improving outcomes in older adults. However, evidence is limited regarding its effectiveness in post-stroke patients, who are at high risk for malnutrition, sarcopenia, oral problems, and dysphagia. This study aims to investigate the association between the triad approach and improvement in activities of daily living (ADL), muscle strength, and skeletal muscle mass in these patients. METHODS: A retrospective cohort study was conducted using post-stroke patients. Patients were divided into groups based on their exposure to the triad approach, defined as a combination of intensive chair-stand exercise (rehabilitation), personalized food prescriptions (nutrition support), and oral management by dental professionals. We investigated the association between the triad approach and outcomes using multiple linear regression analysis adjusted for covariates. Primary outcome was Functional Independence Measure motor score (FIM-motor) at discharge and its gain. Secondary outcomes were handgrip strength (HGS) and skeletal muscle mass index (SMI) at discharge. RESULTS: The study included 1012 post-stroke patients (median age 75.6 years; 54.1% men). Multiple linear regression analysis revealed that the triad approach had the strongest association with higher FIM-motor at discharge (ß = 0.262, p < 0.001) and FIM-motor gain (ß = 0.272, p < 0.001) compared to the individual or combined interventions. The triad also showed the strongest associations with higher HGS (ß = 0.090, p = 0.017) and SMI (ß = 0.041, p = 0.028) at discharge. CONCLUSIONS: The triad approach of intensive rehabilitation, personalized nutrition support, and oral management by dental professionals is strongly associated with improved ADL, muscle strength, and skeletal muscle mass in post-stroke rehabilitation patients. Implementing this multidisciplinary strategy may maximize functional and muscle health recovery.

12.
Geriatr Gerontol Int ; 2024 Aug 27.
Artículo en Inglés | MEDLINE | ID: mdl-39188241

RESUMEN

AIM: Low body mass index (BMI) and poor oral health are prevalent among older stroke patients and associated with adverse outcomes. However, their combined impact on functional recovery after stroke remains unclear. This study investigated the synergistic effects of low BMI and poor oral health on activities of daily living (ADL) independence, swallowing function, and cognitive status in post-stroke older patients. METHODS: A retrospective cohort study was conducted on 708 hospitalized post-stroke patients aged ≥70 years. Low BMI was defined as <20 kg/m2, and poor oral health was assessed using the Revised Oral Assessment Guide (ROAG) with a score ≥13 indicating oral problems. The primary outcome was ADL independence (Functional Independence Measure-motor score >78) at discharge. Secondary outcomes included swallowing level (Food Intake Level Scale) and cognitive status (Functional Independence Measure-cognition score). Multiple regression analyses were performed to examine the associations of low BMI, poor oral health, and their combination with outcomes of interest. RESULTS: The coexistence of low BMI and poor oral health was independently associated with lower odds of achieving ADL independence (odds ratio 0.130, 95% confidence interval [CI] 0.023-0.718), worse swallowing level (B = -0.878, 95% CI -1.280 to -0.476), and poorer cognitive status (B = -1.872, 95% CI -2.960 to -0.784) at discharge, after adjusting for confounders. The combined impact was stronger than either condition alone. CONCLUSIONS: The coexistence of low BMI and poor oral health exerts a synergistic negative impact on functional recovery in older stroke inpatients. Comprehensive interventions integrating nutritional support, oral management, and rehabilitation are crucial to optimizing outcomes in this vulnerable population. Geriatr Gerontol Int 2024; 00: 000-000. Geriatr Gerontol Int 2024; ••: ••-••.

13.
Artículo en Inglés | MEDLINE | ID: mdl-39117846

RESUMEN

Antiviral passive antibody therapy includes convalescent plasma, hyperimmune globulin, and monoclonal antibodies. Passive antibodies have proven effective in reducing morbidity and mortality for SARS-CoV-2 and other infectious diseases when given early in the disease course with sufficiently high specific total and neutralizing antibody levels. Convalescent plasma can be delivered to patients before vaccination implementation or novel drug production. Carefully designed and executed randomized controlled trials near the pandemic outset are important for regulatory bodies, healthcare workers, guideline committees, the public, and the government. Unfortunately, many otherwise well-designed antibody-based clinical trials in COVID-19 were futile, either because they intervened too late in the disease or provided plasma with insufficient antibodies. The need for early treatment mandates outpatient clinical trials in parallel with inpatient trials. Early outpatient COVID-19 convalescent plasma transfusion with high antibody content within 9 days of symptom onset has proven effective in blunting disease progression and reducing hospitalization, thus reducing hospital overcrowding in a pandemic. Convalescent plasma offers the opportunity for hope by enabling community participation in outpatient curative therapy while monoclonal therapies, vaccines, and drugs are being developed. Maintaining the appropriate infrastructure for antibody infusion in both outpatient and inpatient facilities is critical for future pandemic readiness.

14.
J Oral Rehabil ; 2024 Aug 29.
Artículo en Inglés | MEDLINE | ID: mdl-39210682

RESUMEN

BACKGROUND: Treating oral problems with dentist intervention during hospitalisation may improve patients' food intake status. OBJECTIVES: This study aimed to clarify whether convalescent rehabilitation ward inpatients in a hospital with hospital dentistry (HHD) had a better diet at discharge than those in a hospital without hospital dentistry (HNHD). METHODS: Retrospective observational study including inpatients with dental involvement in a HHD with dentists and dental hygienists and HNHD with dental hygienist and visiting dental service between 1 March and 31 August 2022. Data included age, sex, body mass index (BMI), Functional Independent Measure (FIM) motor and cognitive, Oral Health Assessment Tool (OHAT) score, Food Intake LEVEL Scale (FILS), whether the FILS ≥8 (indicating that patient eats also a non-texture-modified diet), remained and functional tooth numbers and speech language hearing therapist (SLHT) and dentist interventions. Comparisons between the two hospitals and factors that affected the FILS ≥8 were examined. RESULTS: A total of 333 and 89 inpatients were included in the HHD and HNHD groups, respectively. After propensity score matching, the HHD group had a significantly higher rate of FILS ≥8, functional tooth numbers at discharge, and SLHT and dentist intervention rates. The multivariable logistic regression analysis for propensity score matching participants showed that the significant independent variables for FILS ≥8 were age, BMI, FILS, FIM motor (all at admission) and SLHT and dentist interventions. Odds ratio for dentist intervention was 14.46 (95% CI: 4.36-48.01). CONCLUSIONS: Dentists are necessary to improve patients' food intake status in convalescent rehabilitation wards.

15.
Microorganisms ; 12(8)2024 Jul 23.
Artículo en Inglés | MEDLINE | ID: mdl-39203346

RESUMEN

Convalescent sera, rich in pathogen-specific antibodies, offers passive immunity to patients with infectious diseases. Screening assays using convalescent sera are crucial for evaluating therapeutic efficacy, selecting suitable serum donors, and standardizing assays. They measure antibody levels, neutralizing potential, and specificity against viruses like SARS-CoV-2, ensuring therapeutic serum contains potent antibodies. Standardized procedures enable reliable results and wider adoption of serum therapy for COVID-19. We have developed a high-content image-based assay for screening convalescent sera against SARS-CoV-2 variants. Using various cell lines, we identified optimal candidates, employed immunofluorescence to visualize infected cells, and assessed neutralizing antibody efficacy. Screening convalescent sera for therapeutic potential identified neutralizing activity against SARS-CoV-2 variants. Dose-response analysis showed variable neutralizing activity, with some sera exhibiting broad neutralization. Additionally, we explored the synergy between neutralizing sera and ß-d-N4-hydroxycytidine (NHC), an initial metabolite of molnupiravir. These assays enhance serum therapy's benefits for COVID-19 treatment and aid in understanding neutralizing activity against SARS-CoV-2 variants, addressing viral challenges.

16.
J Stroke Cerebrovasc Dis ; 33(11): 107966, 2024 Aug 24.
Artículo en Inglés | MEDLINE | ID: mdl-39187215

RESUMEN

PURPOSE: Evidence is scarce on the associations between impaired oral health and cognitive level related to independence in activities of daily living (ADLs) among hospitalized older patients. We aimed to evaluate the associations between baseline oral problems and changes in cognitive level in post-stroke patients. METHODS: A retrospective cohort study was conducted, encompassing consecutively hospitalized post-stroke patients. Revised Oral Assessment Guide (ROAG) as a measure of oral health and function was assessed at admission. Primary outcomes included discharge scores for cognitive function assessed by the cognitive domain of the Functional Independence Measure (FIM-cognition) and the corresponding change in FIM-cognition during hospitalization. Another outcome measure was the motor domain of FIM (FIM-motor). Multivariate linear regression analyses were employed to assess the association between baseline ROAG and the designated outcomes, adjusting for potential confounding factors. RESULTS: Data from 955 patients (mean age 73.2 years; 53.6% men) were included in the analysis. The median ROAG was 10 [9, 12], with 811 patients (84.9%) presenting oral problems. After fully adjusting for confounding factors, the ROAG was significantly and negatively associated with FIM-cognition at discharge (ß = -0.107, p = 0.031) and FIM-cognition gain (ß = -0.093, p = 0.018). Further, the ROAG was independently and negatively associated with FIM-motor at discharge (ß = -0.043, p = 0.013) and FIM-motor gain (ß = -0.065, p = 0.013). CONCLUSION: Oral problems were associated with compromised cognitive levels and a decline in physical function during the hospitalization in post-stroke patients. These results underscore the critical importance of addressing oral health in this patient population.

17.
Acta Med Philipp ; 58(2): 5-15, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38966161

RESUMEN

Background and Objective: Convalescent plasma therapy (CPT) may reduce the risk of disease progression among patients with COVID-19. This study was undertaken to evaluate the efficacy and safety of CPT in preventing ICU admission among hospitalized COVID-19 patients. Methods: In this open-label randomized controlled trial, we randomly assigned hospitalized adult patients with COVID-19 in a 1:1 ratio to receive convalescent plasma as an adjunct to standard of care or standard of care alone. The primary endpoint was ICU admission within first 28 days of enrolment. Primary safety endpoints include rapid deterioration of respiratory or clinical status within four hours of convalescent plasma transfusion and cumulative incidence of serious adverse events during the study period including transfusion-related acute lung injury (TRALI), transfusion-associated circulatory overload (TACO), severe allergic reactions, and transfusion-related infections. Results: A total of 22 patients were assigned to receive convalescent plasma as an adjunct to standard of care and 22 to receive standard of care alone. The median time from onset of COVID-19 symptoms to study enrolment was eight days (IQR, 4 to 10). Two patients (9.1%) in the CPT group and one patient (4.5%) in the control group were admitted to the ICU. The primary outcome measure, ICU admission, was not different between the two groups (q-value >0.9). No patient who received convalescent plasma had rapid deterioration of respiratory/clinical status within four hours of transfusion and none developed TRALI, TACO, anaphylaxis, severe allergic reactions, or transfusion-related infections. There was also no significant difference in the secondary outcomes of 28-day mortality (two patients in the CPT group and none in the control group, q-value >0.90), dialysis-free days, vasopressor-free days, and ICU-free days. Conclusions: Among hospitalized COVID-19 patients, no significant differences were observed in the need for ICU admission between patients given CPT as adjunct to standard of care and those who received standard of care alone. Interpretation is limited by early termination of the trial which may have been underpowered to detect a clinically important difference.

18.
Life (Basel) ; 14(7)2024 Jun 22.
Artículo en Inglés | MEDLINE | ID: mdl-39063547

RESUMEN

Background: Sample size estimation is an essential step in the design of randomized controlled trials (RCTs) evaluating a treatment effect. Sample size is a critical variable in determining statistical significance and, thus, it significantly influences RCTs' success or failure. During the COVID-19 pandemic, many RCTs tested the efficacy of COVID-19 convalescent plasma (CCP) in hospitalized patients but reported different efficacies, which could be attributed to, in addition to timing and dose, inadequate sample size estimates. Methods: To assess the sample size estimation in RCTs evaluating the effect of treatment with CCP in hospitalized COVID-19 patients, we searched the medical literature between January 2020 and March 2024 through PubMed and other electronic databases, extracting information on expected size effect, statistical power, significance level, and measured efficacy. Results: A total of 32 RCTs were identified. While power and significance level were highly consistent, heterogeneity in the expected size effect was relevant. Approximately one third of the RCTs did not reach the planned sample size for various reasons, with the most important one being slow patient recruitment during the pandemic's peaks. RCTs with a primary outcome in favor of CCP treatment had a significant lower median absolute difference in the expected size effect than unfavorable RCTs (20.0% versus 33.9%, P = 0.04). Conclusions: The analyses of sample sizes in RCTs of CCP treatment in hospitalized COVID-19 patients reveal that many underestimated the number of participants needed because of excessively high expectations on efficacy, and thus, these studies had low statistical power. This, in combination with a lower-than-planned recruitment of cases and controls, could have further negatively influenced the primary outcomes of the RCTs.

19.
Clin Nutr ESPEN ; 63: 508-514, 2024 Jul 23.
Artículo en Inglés | MEDLINE | ID: mdl-39053700

RESUMEN

BACKGROUND & AIMS: Depression symptoms are both prevalent and associated with poor prognosis in patients with convalescent stroke. Therefore, the improvement of depression symptoms is important for patients with convalescent stroke. This study aimed to examine whether malnutrition diagnosed using the Global Leadership Initiative on Malnutrition (GLIM) criteria and its components are associated with improvements in depression symptoms in patients with stroke undergoing rehabilitation. METHODS: This was a retrospective cohort study of older adult patients with convalescent stroke. Inclusion criteria comprised patients aged ≥65 years experiencing their first occurrence of stroke and admitted for rehabilitation therapy. Patients were classified into either the malnutrition or normal nutrition groups based on the diagnosis of malnutrition using the GLIM criteria. The Geriatric Depression Screening Scale (GDS)-15 was used to evaluate depression symptoms. The primary outcome of the study was the change in depression symptoms, indicating a change in GDS score from admission to discharge. The association between malnutrition diagnosed using the GLIM criteria and change in depression symptoms was assessed using multiple regression analysis. Additionally, associations with the constructs of the GLIM criteria were investigated. RESULTS: The malnutrition group comprised 64 (45%) patients, with a mean age of 78.2 years; 77 (54%) and 66 (46%) were males and females, respectively. Multiple regression analysis showed that malnutrition, diagnosed using the GLIM criteria (ß: -0.306, p < 0.001), was independently associated with changes in depression symptoms. Moreover, the GLIM criterion component of reduced muscle mass (ß: -0.235, p < 0.001) demonstrated a negative association with a change in depression symptoms. CONCLUSION: Malnutrition and reduced muscle mass, diagnosed using the GLIM criteria in patients with stroke undergoing convalescent rehabilitation, were found to suppress the improvement of depression symptoms.

20.
Health Sci Rep ; 7(7): e2171, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-39011149

RESUMEN

Background and Aims: The COVID-19 pandemic has revealed the importance of organizational resilience, the ability to effectively respond to a disruptive event before, during, and after it occurs. Team improvisation is an important component of organizational resilience as it describes characteristics of team skills and contextual qualities to create order from chaos. In Spring 2020, the Dutch national blood bank, began the convalescent plasma project (CCP). We aimed to study which elements of team improvisation in the CCP group were found and how lessons learned can contribute towards a non-crisis situation for blood establishments. Methods: Using Vera and Crossan's framework of improvisation, semi-structured interviews with eight members of the CCP group were conducted. This was simultaneous to performing a document analysis of 21 Intranet posts and seven internal reports. MAXDA 2020 was used to conduct deductive and inductive thematic analyses. Results: The CCP group showed strong characteristics of expertise and memory, teamwork quality, experimental culture, and real-time information and communication that enabled them to improvise in all aspects of the donation process. Improvisation examples included comprehensive communication methods to identify and obtain new donors, asking additional intake questions and collecting additional aliquots to store while waiting for an internal antibody test to be developed, and regulatory respondents allowing a flexible change control procedure to meet the pace of the crisis. Training was evident to a lesser degree. Conclusion: While improvisation impacted set routines and procedures, the safety and quality of the product were not affected. Regarding organizational resilience, our results showed that the CCP group "coped" well using elements of team improvisation. Blood establishments may consider introducing improvisational training and innovation teams throughout the organization for future preparedness and improving organizational resilience.

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